Understanding medicine access strategies for innovative medicines registered in South Africa

Understanding medicine access strategies for innovative medicines registered in South Africa | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Understanding medicine access strategies for innovative medicines registered in South Africa Thulasizwe Njabulo Qiniso Jama, Fatima Suleman This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4502549/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 11 Oct, 2024 Read the published version in BMC Health Services Research → Version 1 posted 4 You are reading this latest preprint version Abstract Background South Africa is composed of two tiers, viz. A private healthcare system that is funded through medical insurance, comprised of people who can afford to make monthly payments towards their medical insurance, and a government-funded public healthcare system, which covers the majority of the population. This study explored the barriers that exist in South Africa that hinder access to innovative medicines, along with the current strategies being utilised by the pharmaceutical industry to increase access to medicines. Objectives The objectives of the study were to (1) quantify and classify innovative medicines registered between 2010 and 2020 by the South African Health Products Regulatory Authority (SAHPRA), (2) identify barriers to accessing innovative medicines in South Africa through interviews with market access managers from innovator companies, and (3) explore the current market access strategies used by the pharmaceutical industry. Design This study employed a quantitative and qualitative methodology, whereby the former involved the extraction of a list of innovator medicines from the regulator database, and the latter involved 9 semi structured interviews. Purposive sampling was conducted through pharmaceutical association member companies. The interviews included seven market access managers and two medicine managers from one of the payers in South Africa. Thematic analysis was used to interpret the data collected from the study. Results According to the regulator database, during the review period, 238 innovative medicines were registered. Only 14.77 % were available in the public sector in the form of tenders, whereas in the private sector (based on the products having a SEP), 76.92 % were available. From the interviews, six themes emerged: reimbursement of medicines, types of reimbursement, partnerships, technology, legislative challenges, and other factors (e.g., real-world evidence). Conclusion Access to innovative medicines in South Africa is a challenge, as the price of these therapies is high. Therefore, various stakeholders in the health sector must collaborate to identify and implement solutions that are locally relevant. The government needs to proactively update policies that would allow for alternative reimbursement methods to be explored. Alternative reimbursement models Private sector healthcare Public sector healthcare Cost of innovative medicines Policies South Africa Introduction It is imperative that people are not denied life-saving medicines for economic and/or social reasons, as the need for safe and effective medicines is also recognised as a basic human right by the World Health Organisation (WHO) [ 1 ]. Health care is fundamentally important because it affects our ability to pursue life goals, reduce pain and suffering, and prevent premature loss of life [ 2 ]. Having good health is important, as it also contributes to other goals, such as education, freedom from poverty and overall improvement in quality of life [ 3 ]. Access to pharmaceuticals is an important aspect of health care [ 4 ]. Access to innovative medicines primarily includes an availability component and an affordability component, with availability being constrained by patent protection, which could result in high prices for the patented medicine [ 5 ], which in turn impacts decisions as to whether to include innovative therapies in formularies for reimbursement [ 6 ]. Section 27 (1)(a) of the South African Constitution states that everyone has the right to have access to healthcare services, including reproductive health care [ 7 ]. The South African healthcare system is two-tiered, composed of privately funded healthcare paid for by individuals and a public healthcare system funded by the government. The majority of the population relies on the government to provide healthcare; therefore, the government holds the key to the pharmaceutical market [ 8 ]. Because the majority of the public relies on the government to provide healthcare, the affordability of innovative medicines is a challenge, as budgetary constraints exist. Therefore, understanding the barriers to improving access to innovative medicines may result in workable solutions being sought, thus allowing patients access to these therapies. Methodology Study settings The study was conducted in South Africa, with members of a pharmaceutical association. This association comprises member companies that are research-based pharmaceutical companies. This makes up 43% of the pharmaceutical private sector in South Africa [ 9 ]. Study design The study employed a quantitative and a qualitative design. The quantitative design involved extracting the number of innovative medicines that were registered between 2010 and 2020 from the SAHPRA database. A qualitative study design was employed, with interviews being conducted as the primary means of collecting data. Study population and sampling strategy The data for this study concerning medicines registered by innovator pharmaceutical companies in South Africa between 2010 and 2020 were retrieved from the SAHPRA registered health products database. Innovator medicines registered within the study period were identified and extracted from the South African National Department of Health Tenders repository. For the private sector, innovator medicines that had a registered single-exit price as indicated on the Medicines Price Registry between 16th and 26th March 2023 were extracted. Interviews were conducted to obtain information on the market access strategies that were employed and to identify barriers to accessing innovative medicines in South Africa. Market access managers who were from companies that were members of the pharmaceutical association were requested to be part of the study. Interviews were also conducted with representatives of private payers. Data collection The quantitative data were collected between 01 March 2023 and 14 June 2023. The qualitative data collection (interviews) took place between 13th April 2023 and 05 February 2024. A total of 23 participants were invited to participate in the research via email. A total of 9 participants agreed to participate in the research. The study was carried out in Gauteng, where the majority of the participants are based, as this is the location of the innovative pharmaceutical companies in South Africa. Participants were chosen based on their role in market access and reimbursement for medicines in South Africa. The data were collected through online one-on-one semi structured interviews, as semi structured interviews are most frequently used in qualitative research and in the healthcare context (Kallio, et al., 2016). The semi structured interview method of data collection was employed due to its versatility and flexibility, whereby the interviewer can add follow-up questions based on the participant’s responses while allowing the participants to express themselves verbally (Kallio, et al., 2016). The interview questions included open-ended questions that explored market access strategies, barriers to such strategies, and opinions on what needs to change in South Africa to enable access to innovative medicines. The interview guide also explored policies employed by the government and their role in either increasing or impeding access, along with the role that industry is playing in shaping polices. The interviews were conducted virtually using Microsoft Teams, with each interview lasting approximately 1 hour, and only one interview was held face-to-face (although it was still recorded through Microsoft Teams). However, the confidentiality of the participants was maintained. Participants were sent a consent form to sign along with the interview questions in advance. Data analysis Microsoft Excel was used to list products that were registered by innovator pharmaceutical companies between 2010 and 2020. The list was then used to extract information from pharmaceutical tenders that have been awarded by the South African National Department of Health. For the qualitative portion of the study, inductive analysis was adopted to analyse the data. Each recording was coded separately, which then resulted in themes emerging from the data collected. Ethical consideration The study and questionnaire were reviewed and approved by the Biomedical Research Ethics Committee, University of KwaZulu-Natal (BREC/00005116/2022). To conduct the interviews and collect patient data at the healthcare facilities, permission was sought and granted by the research participants at their individual capacity. Written informed consent was obtained separately for each interview from each participant, and the anonymity of the participants was maintained during the data collection, analysis and reporting of the results. Participants were offered the opportunity to review their transcripts, but all declined. Results Quantitative Study There were 233 innovator medicines registered in South Africa between 2010 and 2020, according to SAHPRA (medapps.sahpra.org.za:6006), of which 166 were new chemical entities, 44 were clones and 15 were line extensions of the new chemical entities. The National Department of Health, pharmaceutical tenders database was used to look at tenders that had been awarded during the study period. Pharmaceutical tenders are awarded through competitive bids submitted by the respective pharmaceutical companies. Therefore, according to the database, since 2019, only 33 (14.16%) innovative medicines have been awarded tenders and are thus available in the public sector. There were also 3 that had alternatives in the public sector, as they were clones of innovator medicines. The availability of innovative medicines in the private sector was defined by having an SEP, of which 178 of the 233 had SEP, representing 76%. The availability of these innovative medicines was divided into classes and their availability in both the public sector and private sector. The percentage availability was based on the total number of innovative medicines that were available in that sector at the time of data collection, these results are presented in Table 1 below. Table 1 Class availability in the public sector and private sector Medicine Class Percentage (%) available in the public sector (n = 33) Percentage (%) available in the private sector (n = 178) Antibacterial agents - 3.4% Anticoagulation agents 9.1% 5.1% Antidepressants - 1.1% Antidiabetic agents 3.0% 11.2% Antiemetics - 0.6% Antifibrotic agents - 1.1% Antifungal - 1.7% Antihistamine - 1.1% Antihypertensive - 9.0% Antiretroviral agents 18.2% 3.4% Antitubercular agents 3.0% 0.6% Antiviral 3.0% 1.1% Asthma and pulmonary agents 3.0% 2.8% Biological 3.0% 10.7% CNS agents - 1.7% Contraceptive 3.0% 3.9% Contrast media - 0.6% Enzymatic agents 3.0% 1.7% Hormone replacement therapy - 0.6% Hypercholesterolemia - 0.6% Immunological agents - 2.2% Influenza agents - 1.1% Insulin - 1.7% Non-steroidal anti-inflammatory drugs (NSAIDs) - 0.6% Oncology 18.2% 18.0% Ophthalmology agents - 1.7% Prostate agents - 0.6% Rheumatic agents - 0.6% Thrombopoietin - 0.6% Thyroid agents 3.0% 1.1% Vaccines 30.3% 9.6% Vasodilator - 0.6% Qualitative Study A total of 9 interviews were conducted. Seven of the interviews involved professionals who are market access managers, and two involved private funders. The themes that emerged were reimbursement of medicines, types of reimbursement, partnerships, technology, and legislative challenges, as well as themes that were added to the overarching themes of other issues. These themes not only addressed challenges but also included suggestions for improving access to innovative medicines. The identified themes are presented in Table 2 and expanded further below. Table 2 Themes identified in access to innovative medicines in South Africa Themes Sub-themes Reimbursement of medicines Cost of medicines Pricing transparency Copayments Type of reimbursement Alternative reimbursement models Risk sharing Value based contracting Single Exit Price (SEP) Partnerships Relationships/Partnerships/Stakeholders Technology Use of technology Data integration Legislative challenges Lack of regulations and legislation NHI Lack of Pharmacoeconomics in government/HTA presence and usage Other themes EML Listing Fragmented insurer space Pharmaceutical industry Real world evidence Formulary listing and prescribed minimum benefits Theme 1: Reimbursement of medicines Cost of medicines The participants in general felt that innovative medicines are expensive. They add tremendous clinical value to patients, but the price of these treatments impedes access. There was a feeling that “me-too” medicines should not have a premium price, as doing so does not benefit South Africans. For medicine to be considered innovative and reimbursed as such, it needs to be valuable to patients. The majority of the participants believed that the cost of innovative medicines needs to be based on value and innovation, which is priced based on the research and development that has gone into bringing the medicine into the market. Private funders need to see the value of the medicine, and then discussions on the price of the medicine need to take place. Prescribers and patients should also see value in that medicine. From the funder perspective, there was a feeling that the government failed to hold the pharmaceutical industry accountable for the pricing, which limits access to innovative medicines. “Often you find that our innovative treatments have tremendous clinical value that they bring to patients. But with that comes a price tag” – Interview 3 “It's not about the patient, it’s about Pharma profit margins, and they not held accountable. Government does not cross question pharma on their pricing. They don't adjudicate anything, and they get blanket increases, even though they've got exploitative pricing here. The entire system is bent towards appreciating the profit margins of pharma and not taking care of patients.” – Interview 6 Pricing transparency Participants expressed the feeling that transparent pricing regulation in South Africa is counterproductive in that it is meant to increase competition among pharmaceutical companies, thus resulting in a reduction in medicine prices and consequently an increase in access. However, this has proven to not work for innovative medicines, as pricing is visible globally. “…for innovative medicines, we have the worst system in the world because we transparently disclose all our prices, which everybody else sees and benchmarks.” – Interview 6 As a result, innovative medicines are being launched at a premium price. Participants felt that pricing should be confidential between innovative pharmaceutical companies and funders, including the government, as this would allow patients to benefit by having increased access to innovative medicines through models such as discounting, bonusing and rebates. To increase competition, there was also a suggestion that transparent pricing should be kept within the borders of South Africa only, with controlled access that is available only to stakeholders within South Africa. “I think it is probably one of the big things we need that and removing the visibility of single exit prices.” – Interview 9 “So the barrier is the visible price in South Africa. It's actually the biggest barrier currently that we have. It serves a purpose to ensure that prices are standardized and there isn't perverse incentives. However, the visibility of that price globally is impacting what we can give to South Africans.” - Interview 9. Copayments Some participants felt that the private payer benefit packages are designed such that for better benefits as a patient, you will have to go on a higher plan, which includes reimbursement for innovative medicine. The higher plans subsidise the patients on lower plans if an innovative medicine is a prescribed minimum benefit (PMB). Each plan has a limit or a cap to which a funder will pay for a medicine, and then copayments will apply. Patient support programmes assist patients with copayments when an innovative medicine is not fully reimbursed to ensure access to innovative medicines. “…an access barrier where the patient might have a copayment etcetera. There are also some programmes there that will support patients in terms of helping with a copayment.” – Interview 4 This is seen by funders as the admission of guilt by the pharmaceutical industry with respect to highly priced innovative medicines. “…the fact that you have patient support programs is your admission of guilt, that your price is that your product is priced excessively in SA…” – Interview 6. Participants felt that the basket of medicines for a disease area should be increased for lower plan patients, and they should be given the option to have copayments provided it is the most clinically appropriate medicine for that medical condition. The participants expressed that this would result in funders losing people on the higher plans, as it would be pointless to remain on the higher plan. “…forcing the members to buy up to be able to get the innovator products, because otherwise there'd be no reason to buy the bells and whistles everyone would be on the bottom plan and have access…” – Interview 1 Theme 2: Type of reimbursement Alternative reimbursement models Overall, the participants expressed frustration because there was a lack of alternative reimbursement models (ARMs) in South Africa, which was attributed mostly to the SEP. "… you know with South Africa we have this SEP limitation legislation which actually literally limits us to do any alternative models…” – Interview 5. Participants felt that alternative reimbursement models would allow for varying methods to be introduced to fund innovative medicines and thus increase access to these innovative therapies. “It's a great consideration where you've got inherent risk, so if you launching an innovative product and your funder is not sure…” - Interview 4 The participants strongly felt that ARMs would allow risk sharing between the funders and the innovator pharmaceutical company. They would also allow funders to reimburse innovative medicines based on the value of the medicine. “managed entry agreements are absolutely what we need.” – Interview 9 “. There's actually even like a group that has come together that comprises of the innovative pharma industry, patient advocacy groups of funders as the key stakeholders that are putting forward a proposal to Department of Health, to allow alternative reimbursement models to be included in the law in the regulations…” – Interview 3 Risk sharing To increase access to innovative medicines in the public sector, there could be some form of risk sharing whereby the government commits to numbers as well as a budget to treat those numbers, and when those funds are exhausted for the year, then the pharmaceutical industry can take over to assist for the remainder of the year. “I would even go to an extent of saying why don't you also prove that your product is actually innovative by entering into those agreement where you will pay for performance.” – Interview 2 “I think in managed entry agreement then allows this particular type of risk sharing between the company and the and the payer and I think it is a good tool to consider to allow access to innovation in my knowledge at this point in time” – Interview 4 Value-based contracting Participants believed that there should be a mindset shift, whereby the value of the medicine should be considered before the pricing negotiations, as this would result in an outcome-based focus. However, the difficulty would be in proving the actual outcomes and agreeing with the funder on what the outcomes should be, as the value of a medicine should not result in that medicine being made unaffordable. "if we can start having the mindset change? From just looking at a price of the product but looking at the value that the product is providing to a specific patient.” – interview 1 “Then you've got to both parties have got to agree that the outcomes that have been measured are accurate.” – Interview 3 Single Exit Price The greatest hurdle to ARMs is the Single Exit Price (SEP), as stated by participants; the SEP has negatively impacted access to innovative medicines. Participants believed that scrapping the SEP policy would increase access. “…why not just take away the Single Exit Price and because we're the only ones in the world with the SEP..” – Interview 7 The argument raised is that the SEP is the ex-manufacturer price, the logistic fee and the value added tax. However, the manufacturer price and logistic fee are determined by the manufacturer, so there is no real transparency. “Because SEP in as much as it's supposed to be bringing in transparency, there's no transparency in SEP.” – Interview 7 Some participants believed that the SEP has done well and therefore should not be completely scrapped; however, it should have flexibility that allows for alternative reimbursement models. “We don't want SEP to be scrapped because we understand the fundamental role of SEP” – Interview 5 SEP allows for annual increases in which funders feel that the pharmaceutical industry accepts, at times even when it is unwarranted, which further increases lack of access, as innovative medicines are already highly priced. “…they get blanket SEP increases, and they take these increases…” – Interview 6 Due to pricing transparency as a result of SEP, medicines are launched at premium prices, as the South African price could then be used for reference pricing by other countries, as the SEP is visible globally. “So as global companies that visibility hinders our ability to give the best value of price for the market because there's something called international reference pricing where they reference prices” – Interview 9 The pharmaceutical industry does, in certain instances, offer temporary price reductions, which assist with affordability. However, since they are temporary, when the price increases, affordability decreases. To try and increase access to the public sector, differential pricing is used, which normally offers innovative medicine to the public sector at a reduced cost. “. So another thing that's done is temporary price reduction. So TPR's. So now and again, companies will, you'll notice will do a TPR, which is basically reducing their price by a certain amount or percentage for a given time.” – interview 8 Theme 3: Partnerships The participants expressed the importance of having relationships with various stakeholders, such as those between the pharmaceutical industry, private funders, patient advocacy groups, healthcare providers, patients and the government. Participants within the private sector believe that there was a lack of willingness from public sector stakeholders to partner, as the government views the pharmaceutical industry as a profit-driven industry and not as a partner to improve the lives of patients. There needs to be more private‒public partnerships in healthcare to be able to address the accessibility of innovative medicines to everyone irrespective of the payment plan. “…the biggest thing is partnerships.” – Interview 7 “it’s really about partnering with somebody to actually support the patient.” – Interview 4 The participants felt that the government needed to update its policies. “I think we are still lagging from government side to actually have a clear policy on alternative reimbursement models” – Interview 5 Theme 4: Technology Use of technology Participants stated that South Africa could use technology to strengthen healthcare. The use of technology was not harnessed because it could assist in improving healthcare and allowing access to medicines. Data integration Participants mentioned that technology can be used to harness real-world evidence. This would assist in determining the value of innovative medicines. “I don't think that the technology isn't there. The technology is there. It's about now getting it implemented and maintaining it after that.” – Interview 3 “It’s really about again, the data opening up a registry so that we actually have the data collection, real-world evidence that we're able to collect that real world evidence and demonstrate impacted people” – Interview 4 Theme 5: Legislative challenges Lack of regulations and legislation As previously mentioned above, one of the greatest hurdles to accessing innovative medicines according to most of the participants was the SEP, which is unique to South Africa and does not allow for alternative reimbursement models. Although the SEP has benefits, as the only pricing mechanism in South Africa, it has become regressive rather than progressive. “…why not just take away the Single Exit Price and because we're the only ones in the world with the SEP.” – Interview 7 When participants were asked about policies and what could be done from a policy perspective to increase access to innovative medicines, they all pointed to the government’s inability to implement such policies. Participants also pointed out that there is no legislation that governs risk-sharing agreements or outcome-based contracts in South Africa. There is also no implementation of current legislation. “There is guidelines on pharmacoeconomics and all this stuff, but this is it. They haven't applied it.” – Interview 2 “the government does nothing to increase access to innovative medicines” – Interview 6 Participants felt that the government needs to look at policies that govern alternate reimbursement models, which will allow for risk-sharing agreements between the industry and payers. New legislation needs to be introduced that will support alternative reimbursement models, as well as legislation to fight corruption. “I would definitely look at these type of value-based contracting agreements and being more flexible in terms of within governance obviously, I'm not saying move outside of governance and transparency, but I think that we need to be a lot more flexible in terms of putting forward, reviewing and approving value-based type of pricing and contracting so that we can actually start implementing it” – Interview 4 “I think we are still lagging from government side to actually have a clear policy on alternative reimbursement models. And like I said, it's been a topic for over 10 years now, but nothing is happening” – Interview 5 National Health Insurance (NHI) Participants agreed that the NHI is important and should be implemented. However, in its current format, it cannot be implemented. Rather, the government should look at public-private partnerships. To make the NHI a success, participants believe that it is not a one-size-fits-all project; rather, South Africa should learn from other countries where it has worked and where it has not worked and then tailor it to meet the needs and challenges of South Africa. For the NHI to succeed, it has to make use of alternative reimbursement models to be able to access innovative medicines. “We can leverage of global experiences. We can see what not to do. That didn't work in their countries, and we can tailor South African rules for South African people. I guess it's not a one size fits all. It's never going to be we have challenges that other people don't have.” – Interview 6 The government has to leverage private funders’ experience and skills with operational matters, such as using technology to ensure that patients are not lost in the system, being able to track claims, process payments, and negotiating with service providers. “So there's a lot that government can learn. We can learn a lot from government in terms of how they establish their standard treatment guidelines and because it's very robust, so that joint learning is what's needed.” -interview 9 Lack of health technology assessment capacity Another issue raised regarding the success of the NHI is that there is no HTA to speak off from the Department of Health, and it would benefit the country if South Africa had one independent HTA body. “There's so much that needs to be done in creating an independent HTA body.” – Interview 7 Knowledge sharing also needs to occur, whereby the pharmaceutical industry learns from the government on how to create robust standard treatment guidelines. The pharmaceutical industry was looking at ways to support the government with the strengthening of pharmacoeconomics, such that there is a fully functional independent HTA body to guide policy on alternative reimbursement models for medicines in South Africa. “So, pharmacoeconomics is not there in the government. It’s only there as a word, but not being used to manage the cost.” – Interview 2 “But right now, there is no HTA process in place, nothing.” – Interview 5 South Africa’s HTA body needs to function independently of the government to make pharmacoeconomic recommendations that are based on the evidence presented, as well as global best practices. There also needs to be HTA in both the public and private sectors. The HTA needs to clearly communicate what affordability is like for South Africa for both the state and private sectors. “, if you have one national HTA body that basically has got people who are not biased and that can basically look at the different models for the different therapeutic areas.” – Interview 7 “I would still say the government should have a proper HTA process across 2 sectors… Even if we have one private HTA process and then the government HTA process but then the government should take ownership in terms of owning the policies.” – Interview 5 Therefore, industry could design alternative reimbursement models that cater to the findings of HTA. Due to the limited financial resources available to the government, there is an opportunity for alternative reimbursement models, whereby the industry can introduce various models that cater to the limited resources available to the government to increase access to innovative medicines. Theme 6: Other themes Some participants also mentioned that SAHPRA needs to reduce its registration timelines to ensure timely access to medicines. The government could perhaps look at tax exemptions for innovative medicines to decrease the price of medicines and provide rebates to support distribution. These savings could then be passed on to the patient. “So why are we being taxed for accessing meds?” – Interview 3 Funders promote the enforcement of generic substitution, as it encourages innovator pharmaceutical companies to rethink their pricing strategy, as some generics may form a therapeutic alternative to an innovator medicine. Thus, innovative medicines have to demonstrate value over other therapies irrespective of whether they are first-line or third-line treatments. The introduction of a medicine to funders is supported by cost-effectiveness data as well as positioning the product in a niche, whereby it targets patients who have failed in currently available treatments. “The biggest thing that the government did actually was just enforcing the use of generics, because then that forced the companies to price differently.” – Interview 1 EML Listing The pharmaceutical industry also looks at ways to obtain a formulary listing based on the proven clinical benefit that the medicine can provide. The Essential Medicines List (EML) and Standard Treatment Guidelines (STG) were used to determine which medicines were the standard of care. "So I think being included on a formulary will facilitate and enable access. If a product is not on the formulary, it’s not a complete barrier to access, and I think also the converse there is that even if a product is on the formulary, it does not guarantee access.” – Interview 4 Pharmaceutical Industry In an attempt to increase access, participants stated that innovator pharmaceutical companies, as another initiative, are working together to partner with the government as well as private funders to put through a proposal to the National Department of Health to gazette into law alternative reimbursement models. Participants also provided solutions based on current global trends to address barriers to accessing innovative medicines in South Africa. The proposed solutions are provided below, as they have been identified as initiatives that could aid in increasing access to innovative medicines in South Africa. CMS needs to update treatment algorithms proactively to make it simpler for payers to fund innovative medicines, as they will be on the treatment. There also needs to be an increase in clinical trials conducted in South Africa, as this would provide data that are relevant and specific to South Africa. Payers suggested that innovator pharmaceutical companies need to be more flexible in pricing for innovative medicines. Within the public sector, there needs to be strict implementation of the Public Finance Management Act. (PFMA), to increase funds in the public sector. The South African treatment guidelines need to be updated proactively to be in line with international standards of care to ensure that patients receive a clinically appropriate product in line with international standards. “so ideally someone actually needs to actively update the algorithms because that actually makes funding decisions easier.” – Interview 1 "…many clinical trials globally are focused on European and U.S. markets. So many of our clinical trials, I mean, most of them actually are done in those markets.” One participant suggested that there needs to be decentralisation of funds in public hospitals and to allow them to function as a business. Hospitals should use the funds that are paid by patients who can, however, be small to improve the functioning of the hospital, which could aid in increasing access to medicines. Consideration should be given to reducing hospitalisation due to innovative medicine, reducing polypharmacy, and improving the overall quality of life of patients. “…let the hospitals also run as a business.” – Interview 2 Fragmented insurer space The private insurance sector needs to have one program that is not as fragmented as it is currently and to make uniform decisions. Currently, different payers offer different copayment percentages. Within the private insurance space, there needs to be uniformity within the specific disease areas. This approach would aid in providing the same level of assistance for all impacted patients. In addition, within the private insurance space, the gap between the different plan types is too wide, which disadvantages certain patients who cannot afford the higher plan. The benefits for a disease area should be driven by treatment protocols, irrespective of the plan. Private payers should try to find common ground for various treatment baskets for the benefit of the patient. “Another barrier would be within the private sector because you know that we have a very fragmented insurer space. So you do find different levels of reimbursement.” – Interview 5 Real-world evidence In the public sector, there needs to be an increase in the use of technology to better monitor patients, as well as to have a central patient database. Within the usage of technology, there needs to be a single point where there is central data that is available to the payers as well as industry, whereby each stakeholder can access the outcome data of a medicine. This would then facilitate the reimbursement models, as the database would have been following a treatment over a certain period of time and linked to outcomes, thus showing the impact of the innovative medicine. This would have to be done within the confines to the current legal framework protecting personal information, as the purpose of the database would be to show the value of the innovative medicine in the patient journey. “And then you imagine the amount of value you can get out of an electronic health system. The records you can get out of there, the real-world evidence generation, You could do such amazing data mining with that.” – Interview 3 Discussion The quantitative results indicate that a limited number of innovative medicines were available during the time period studied. Between 2010 and 2020, the SAHPRA faced challenges inherited from the Medicines Control Council (MCC), the chief of which was the revision and implementation of new regulatory pathways [ 10 ]. By 2018, SAHPRA had up to 8220 applications, with a median approval time of approximately 5 years [ 10 ]. This could be attributed to the low number of new chemical entities registered by the SAHPRA (formerly MCC). SAHPRA also faces the challenge of a lack of resources and therefore does not have sufficient capacity to evaluate a dossier [ 10 ]. This also results in delays in evaluating submissions, which then has a domino effect on the registration timelines [ 10 ] and availability of generic medicines. One of the challenges mentioned by the participants was that innovative medicines were costly. The pharmaceutical industry’s justification for high-priced medicines is that they add value and thus should be reimbursed for research and development [ 11 ]. The high cost of innovative medicines in South Africa was attributed to pricing transparency, which is visible globally. Price transparency has been implemented by some countries; however, there is no conclusive evidence of price control and/or a reduction in medicine expenditure [ 12 ]. To reduce the price of innovative medicines, pricing transparency should be used with other alternative reimbursement models, such as volume-based contracting [ 12 ]. Participants agreed that there is a need for alternative reimbursement models (ARMs) to be able to reimburse innovative medicines. ARMs involve value-based contracting, whereby the price of the medicine is linked to the perceived value, and this strategy is increasingly being utilised to try and increase access to innovative medicines [ 13 ]. Value-based reimbursement is considered a method of choice for new technologies due to advantages such as price negotiations or internal or external referencing; aligning the patient, the payer and the provider; and offering incentives to providers who can deliver better outcomes for the patient without necessarily increasing costs [ 14 ] [ 15 ]. However, there is no clear way to measure the value of an innovation and/or the value of a medicine; therefore, there should be clear policies that define value along with the factors to be measured [ 16 ]. There is also the reality that because value-based pricing looks at the value of the innovation, that value could be both unaffordable and unacceptable at a societal level [ 17 ]. Even though South Africa has SEP policies aimed at reducing the price of medicines, participants alluded to the fact that innovative medicines are still unaffordable in South Africa. The South African reimbursement model is based on the SEP, which provides transparency. The overall aim is to improve access to medicines by reducing the price of innovative and generic medicines and controlling the price of medicines [ 18 ]. As a single intervention, the SEP cannot provide affordable, innovative medicines to patients [ 19 ]. The cost of innovative medicines is driven primarily by factors such as patent protection, monopolistic markets for new entities, regulatory issues, taxes and tariffs, geographic location, income status and lack of internal price regulation [ 20 ]. South Africa, as an LMIC, will generally have limited negotiating power for medicine pricing [ 21 ]. The industry needs to evaluate ways in which the prices of these medicines could be reduced. Payers indicated that the pharmaceutical industry needs to show flexibility in the pricing of innovative medicines. This means that there must be a balance between maintaining innovation and increasing access, which could be achieved by considering models such as tax benefits, differential pricing, patent changes, medicine discounts, and national health insurance, as innovation must be rewarded and sustained [ 21 ]. Some participants mentioned that tax exemptions for innovator medicines can be applied to reward innovation and reduce the price of medicines. Globally, the value-added tax on medicines can reach 20 %; hen this tax is added to other taxes that are imposed during the supply value chain, the end price of a medicine increases [ 22 ]. Tax incentives are crucial to the investment choices of pharmaceutical companies, as seen in a study in Uganda; this was also evident in India, where a tax credit system supporting the private sector led to an increase in research and development investment within the pharmaceutical industry [ 23 ]. Participants felt that partnerships between stakeholders are critical to ensuring increased access to innovative medicines. However, currently, the participants believe that the relationships between various healthcare stakeholders are fractured, primarily due to a lack of trust between the government and industry. Thus, there is fragmentation between national departments, between private and public funders, between national departments of health and provincial health departments, and within provinces and districts [ 24 ]. Partnerships can leverage the strengths of each sector based on experience, resources and expertise [ 25 ]. South Africa has no formal HTA structure, even though it is reminiscent of other healthcare decision-making bodies, such as private insurance companies, on the National Essential Medicines List Committee [ 26 ]. The participants expressed the willingness of the industry to partner with the government to assist in the development of policies that will aid in strengthening health technology assessment (HTA). The government would need to find a way to address the three-tier system of governance (national, provincial and local), each with executive and legislative authority, as healthcare falls under national and provincial legislatures [ 26 ]. South Africa could emulate the National Institute for Health and Care Excellence (NICE), whereby various stakeholders (such as the National Health Service, clinical experts, external assessment groups, patient and carer organisations, companies, healthcare professionals, etc.) work collaboratively in a robust manner towards one goal, with a single vision of determining whether there is clinical efficacy as well as value for money into using a technology [ 27 ]. Consistent with the results of this study, [ 28 ] found that to be able to develop an HTA that is open, trustworthy and acceptable to all healthcare stakeholders, the government needs to collaborate with the pharmaceutical industry as well as private funders to improve the South African Guidelines for Pharmacoeconomic Submissions (SAGPS), such that it covers medical, legal, social and ethical considerations [ 28 ]. The emphasis of the SAGPS is currently more on the economic aspect than on the medical aspect when it concerns new medicines [ 28 ]. Private insurers need to re-evaluate the basket of medicines for different conditions. A rich basket of medicines should be limited not only to those that contribute the most but also to other plans that are available. According to [ 29 ], if members do not see the value of paying monthly contributions and then have to pay copayments because a medicine is not fully reimbursed by the insurance, they will end up terminating their cover. As a formulary is used as a guide for reimbursement, to increase access to innovative medicines, private insurers should base their formulary of global standards of care for a condition to ensure the best clinical outcome for their members. There is little competition between funders who can benefit patients in terms of improved affordability and value-for-money coverage [ 30 ]. The pharmaceutical industry is an important player in the health sector, as governments around the world need to decide which new medicines will be included as part of their respective country health services [ 31 ]. As an important stakeholder in the health sector, there is a perception that the pharmaceutical industry’s only focus is on the development of expensive novel molecules and/or technologies and losing interest in the production of cheaper medicines that are equally effective and affordable due to their pricing policies and aggressive patent policy issues [ 31 ]. The costs of medicines and healthcare in general are increasing, but there is a disparity between the amount of money spent and patient outcomes [ 32 ]. Conclusion Finding solutions to access barriers, including the prices of these barriers, requires various stakeholders in the health sector to collaborate to ensure that patients have access to the latest innovative medicines. Finally, the government needs to proactively update policies that would allow for alternative reimbursement methods or other access strategies to be explored. Abbreviations Abbreviation Meaning ARM Alternative Reimbursement Model BREC Biomedical Research Ethics Committee CNS Central Nervous System EML Essential Medicines List HTA Health Technology Assessment IPASA The Innovative Pharmaceutical Association South Africa LMIC Low- or Middle-Income Country MCC Medicines Control Council NHI National Health Insurance NICE National Institute for Health and Care Excellence NSAIDs Non-steroidal anti-inflammatory drugs PFMA Public Finance Management Act PMB Prescribed Minimum Benefit SA South Africa SAGPS South African Guidelines for Pharmacoeconomic Submissions SAHPRA South African Health Products Regulatory Authority SEP Single Exit Price STG Standard Treatment Guidelines WHO World Health Organization Declarations Ethics approval and consent to participate The study was granted ethical approval by the University of KwaZulu Natal subcommittee of the Biomedical Research Ethics Committee (ethics number: BREC/00005116/2022). All participants provided consent to participate and signed informed consent forms. Consent for publication Consent from participants to publish the data were obtained in the informed consent form, which explained that the data would be aggregated and coded and that no identifying information from the participants would be used. Availability of data and materials The datasets generated and/or analysed during the current study are not publicly available, as the results are generated from a master’s degree who is still under examination but are available from the corresponding author upon reasonable request. The datasets generated and/or analysed during the current study for quantitative results are available in the SAHPRA Registered Health Products Database repository, https://medapps.sahpra.org.za:6006/ Competing interests The authors declare that they have no competing interests. Funding No funding was received for this study. Acknowledgements Not applicable. Authors’ contributions FS and TJ designed the study. TJ undertook the data collection and data analysis. FS performed the data validation and reviewed the paper. Both authors read and approved the final manuscript. Author information Not applicable. References Adebisi YA, Nwongu IB, Alaran AJ, Badmos AO, Bamgboye AO, Rufai BO, Okonji OC, Malik MO, Teibo JO, Abdalla SF, Lucero-Prinso DE III, Samai M. and W. Akande-Sholabi, Revisiting the issue of access to medicines in Africa: Challenges and recommendations, Publi Health Challenges , vol. 1, no. 2, 15 June 2022. American Medical Association. 27 10 2021. [Online]. Available: https://www.ama-assn.org/delivering-care/ethics/defining-basic-health-care . Hashemi G, Wickenden M, Bright T, Kuper H. Barriers to accessing primary healthcare services for people with disabilities in low and middle-income countries, a Meta-synthesis of qualitative studies. Taylor Francis Online, pp. 1–15, 2020. Zaric GS, Critchley GJ. The impact of pharmaceutical marketing on market access, treatment coverage, pricing, and social welfare. Health Econ. 2019;28(8):1035–51. Dai R, Watal J. Product patents and access to innovative medicines. Social Science Medicine, 291, 2021. Moye-Holz D, Saucedo RS, van Dijk JP, Reijneveld SA, Hogerzeil HV. Access to innovative cancer medicines in a middle-income country - the case of Mexico, Journal of Pharmaceutical Policy and Practice , vol. 11, no. 25, 24 October 2018. Government of South Africa. Constitution of the Republic of South Africa, 1996 - Chap. Volume 2. Pretoria: Bill of Rights, Government of South Africa; 1996. Kumar A, Juluru K, Thimmaraju P, Reddy J. Pharmaceutical market access in emerging markets: concepts, components, and future. Journal Market Access Health Policy. 2014;2:1–5. IPASA, IPASA., 2023. [Online]. Available: https://ipasa.co.za/members/ . [Accessed 19 05 2023]. Moeti L, Litedu M, Joubert J. 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Barriers for Access to New Medicines: Searching for the Balance Between Rising Costs and Limited Budgets, Frontiers in Public Health , vol. 6, 05 December 2018. Gonçalves E. Value-based pricing for advanced therapy medicinal products: emerging affordability solutions, The European Journal of Health Economics , vol. 23, pp. 155–163, March 2022. de Silva Etges APB, Liu HH, Jones P, Polanczyk CA. Value-based Reimbursement as a Mechanism to Achieve Social and Financial Impact in the Healthcare System. J Health Econ Outcomes Res, pp. 100–3, 31 October 2023. Antoñanzas F, Terkola R, Postma M. The Value of Medicines: A Crucial but Vague Concept. PharmacoEconomics, 34, pp. 1227–39, 21 July 2016. Koleva-Kolarova R, Buchanan J, Vellekoop H, Huygens S, Versteegh M, Rutten-van Mölken M, Szilberhorn L, Zelei T, Nagy B, Tsiachristas A. Financing and Reimbursement Models for Personalised Medicine: A Systematic Review to Identify Current Models and Future Options. Appl Health Econ Health Policy, 20, pp. 501–24, 04 April 2022. Naidoo K, Suleman F. Evaluating the impact of single exit pricing (SEP) on medicine product withdrawal from the private healthcare market in South Africa. South Afr Med J. 2021;111(5):444–7. Moodley R, Suleman F. Evaluating the impact of the single exit price policy on a basket of originator medicines in South Africa from 1999 to 2014 using a time series analysis. BMC Health Serv Res, 19, 576, 2019. Mattila P, Babar Z, Suleman F. Assessing the prices and affordability of oncology medicines for three common cancers within the private sector of South Africa. BMC Health Serv Res, pp. 1–10, 2021. Mattila PO, Ahmad R, Hasan SS, Babar Z-U-D. Availability, Affordability, Access, and Pricing of Anti-cancer Medicines in Low- and Middle-Income Countries: A Systematic Review of Literature. Front Public Health, 9, 2021. Network G. Accelerating access to medicines: Policy recommendations for achieving the health-related Sustainable Development Goals, 2019. Onyinyi B, Asiimwe N. Key drivers of investment initiatives in Uganda's pharmaceutical industry, Social Science & Medicines , vol. 344, March 2024. Kredo T, Abrams A, Young T, Louw Q, Volmink J, Daniels K. Primary care clinical practice guidelines in South Africa: qualitative study exploring perspectives of national stakeholders. BMC Health Serv Res. 2017;17(608):1–12. Ebulue CC, Ebulue OR, Ekesiobi CS, PUBLIC-PRIVATE PARTNERSHIPS, IN HEALTH SECTOR INNOVATION: LESSONS FROM AROUND THE WORLD., nternational Med Sci Res J, 4, 4, pp. 484–99, 18 April 2024. Mueller D. Addressing the challenges of implementing a Health Technology Assessment Policy Framework in South Africa. Int J Technol Assess Health Care, 36, 4, pp. 453–8, 13 August 2020. NICE. National Institute for Health and Care Excellence, 31 October 2023. [Online]. Available: https://www.nice.org.uk/process/pmg36/chapter/introduction-to-health-technology-evaluation . Marsh SE, Truter I. The South African Guidelines for Pharmacoeconomic Submissions’ Evidence Requirements Compared with Other African Countries and The National Institute for Health and Care Excellence in England. Expert Rev Pharmacoeconomics Outcomes Research, 20, 2, pp. 155–68, 22 May 2019. Mpanza N. Factors that influence medical scheme insured consumers to co-pay for prescription medicines at private community pharmacies in Pretoria, Gauteng Province, South Africa. University of Western Cape; 2016. pp. 1–98. Solanki G, Cornell J, Besada D, Morar R, Wilkinson T. The Competition Commission Health Market Inquiry Report: An overview and key imperatives. South Afr Med J. 2020;110(2):88–91. Rocha MdM, de Andrade EP, Alves ER, Cândido JC, Borio MdM. Access to innovative medicines by pharma companies: Sustainable initiatives for global health or useful advertisement? Glob Public Health. 2020;15(6):777–89. Larsson S, Clawson J, Howard R. Value-Based Health Care at an Inflection Point: A Global Agenda for the Next Decade. NEJM Catalyst, 2023. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Published Journal Publication published 11 Oct, 2024 Read the published version in BMC Health Services Research → Version 1 posted Editorial decision: Revision requested 06 Jun, 2024 Editor assigned by journal 05 Jun, 2024 Submission checks completed at journal 05 Jun, 2024 First submitted to journal 30 May, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4502549","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":311195064,"identity":"e33bfb6f-0d33-4d42-8289-00670e154eee","order_by":0,"name":"Thulasizwe Njabulo Qiniso Jama","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAyUlEQVRIiWNgGAWjYBACxgYILQciDjwgWssBBgZjsJYEoq0CakkE20aUFub204mfP+6wTp8fdvgh0BY7Od0GQg7ryd0scfBMeu7G22kGQC3JxmYHCGlpyN0gcbDtcO7G2QkgLQcStxHU0v928w+glnTD2ekfiNQyI3cbyJYEeekcYm2Z8Xabxdm2dMMN0jkFBxIMiPCLYX/u5huVbdby8rPTN3/4UGEnR1hLA5hiZjAAqzQgoBwE5BmgWuQbiFA9CkbBKBgFIxMAADjfTIOVrpFoAAAAAElFTkSuQmCC","orcid":"","institution":"University of KwaZulu-Natal (Westville Campus), KwaZulu-Natal","correspondingAuthor":true,"prefix":"","firstName":"Thulasizwe","middleName":"Njabulo Qiniso","lastName":"Jama","suffix":""},{"id":311195065,"identity":"0d8b66cc-fc94-47ef-b529-23d13e85db52","order_by":1,"name":"Fatima Suleman","email":"","orcid":"","institution":"University of KwaZulu-Natal (Westville Campus), KwaZulu-Natal","correspondingAuthor":false,"prefix":"","firstName":"Fatima","middleName":"","lastName":"Suleman","suffix":""}],"badges":[],"createdAt":"2024-05-30 11:07:27","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4502549/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4502549/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12913-024-11696-4","type":"published","date":"2024-10-11T15:58:04+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":66597304,"identity":"133dc91c-07ff-4bb5-b196-4a893d22e4a1","added_by":"auto","created_at":"2024-10-14 16:09:22","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":767362,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4502549/v1/33b5330d-10cf-48c9-b3d4-ba6d99548a24.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Understanding medicine access strategies for innovative medicines registered in South Africa","fulltext":[{"header":"Introduction","content":"\u003cp\u003eIt is imperative that people are not denied life-saving medicines for economic and/or social reasons, as the need for safe and effective medicines is also recognised as a basic human right by the World Health Organisation (WHO) [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Health care is fundamentally important because it affects our ability to pursue life goals, reduce pain and suffering, and prevent premature loss of life [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Having good health is important, as it also contributes to other goals, such as education, freedom from poverty and overall improvement in quality of life [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Access to pharmaceuticals is an important aspect of health care [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Access to innovative medicines primarily includes an availability component and an affordability component, with availability being constrained by patent protection, which could result in high prices for the patented medicine [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e], which in turn impacts decisions as to whether to include innovative therapies in formularies for reimbursement [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eSection 27 (1)(a) of the South African Constitution states that everyone has the right to have access to healthcare services, including reproductive health care [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. The South African healthcare system is two-tiered, composed of privately funded healthcare paid for by individuals and a public healthcare system funded by the government. The majority of the population relies on the government to provide healthcare; therefore, the government holds the key to the pharmaceutical market [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Because the majority of the public relies on the government to provide healthcare, the affordability of innovative medicines is a challenge, as budgetary constraints exist. Therefore, understanding the barriers to improving access to innovative medicines may result in workable solutions being sought, thus allowing patients access to these therapies.\u003c/p\u003e"},{"header":"Methodology","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy settings\u003c/h2\u003e \u003cp\u003eThe study was conducted in South Africa, with members of a pharmaceutical association. This association comprises member companies that are research-based pharmaceutical companies. This makes up 43% of the pharmaceutical private sector in South Africa [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eStudy design\u003c/h2\u003e \u003cp\u003eThe study employed a quantitative and a qualitative design. The quantitative design involved extracting the number of innovative medicines that were registered between 2010 and 2020 from the SAHPRA database. A qualitative study design was employed, with interviews being conducted as the primary means of collecting data.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eStudy population and sampling strategy\u003c/h2\u003e \u003cp\u003eThe data for this study concerning medicines registered by innovator pharmaceutical companies in South Africa between 2010 and 2020 were retrieved from the SAHPRA registered health products database. Innovator medicines registered within the study period were identified and extracted from the South African National Department of Health Tenders repository.\u003c/p\u003e \u003cp\u003eFor the private sector, innovator medicines that had a registered single-exit price as indicated on the Medicines Price Registry between 16th and 26th March 2023 were extracted. Interviews were conducted to obtain information on the market access strategies that were employed and to identify barriers to accessing innovative medicines in South Africa. Market access managers who were from companies that were members of the pharmaceutical association were requested to be part of the study. Interviews were also conducted with representatives of private payers.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eData collection\u003c/h2\u003e \u003cp\u003eThe quantitative data were collected between 01 March 2023 and 14 June 2023. The qualitative data collection (interviews) took place between 13th April 2023 and 05 February 2024. A total of 23 participants were invited to participate in the research via email. A total of 9 participants agreed to participate in the research. The study was carried out in Gauteng, where the majority of the participants are based, as this is the location of the innovative pharmaceutical companies in South Africa. Participants were chosen based on their role in market access and reimbursement for medicines in South Africa.\u003c/p\u003e \u003cp\u003eThe data were collected through online one-on-one semi structured interviews, as semi structured interviews are most frequently used in qualitative research and in the healthcare context (Kallio, et al., 2016). The semi structured interview method of data collection was employed due to its versatility and flexibility, whereby the interviewer can add follow-up questions based on the participant\u0026rsquo;s responses while allowing the participants to express themselves verbally (Kallio, et al., 2016). The interview questions included open-ended questions that explored market access strategies, barriers to such strategies, and opinions on what needs to change in South Africa to enable access to innovative medicines. The interview guide also explored policies employed by the government and their role in either increasing or impeding access, along with the role that industry is playing in shaping polices. The interviews were conducted virtually using Microsoft Teams, with each interview lasting approximately 1 hour, and only one interview was held face-to-face (although it was still recorded through Microsoft Teams). However, the confidentiality of the participants was maintained. Participants were sent a consent form to sign along with the interview questions in advance.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eData analysis\u003c/h2\u003e \u003cp\u003eMicrosoft Excel was used to list products that were registered by innovator pharmaceutical companies between 2010 and 2020. The list was then used to extract information from pharmaceutical tenders that have been awarded by the South African National Department of Health. For the qualitative portion of the study, inductive analysis was adopted to analyse the data. Each recording was coded separately, which then resulted in themes emerging from the data collected.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eEthical consideration\u003c/h2\u003e \u003cp\u003e The study and questionnaire were reviewed and approved by the Biomedical Research Ethics Committee, University of KwaZulu-Natal (BREC/00005116/2022). To conduct the interviews and collect patient data at the healthcare facilities, permission was sought and granted by the research participants at their individual capacity. Written informed consent was obtained separately for each interview from each participant, and the anonymity of the participants was maintained during the data collection, analysis and reporting of the results. Participants were offered the opportunity to review their transcripts, but all declined.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eQuantitative Study\u003c/h2\u003e \u003cp\u003eThere were 233 innovator medicines registered in South Africa between 2010 and 2020, according to SAHPRA (medapps.sahpra.org.za:6006), of which 166 were new chemical entities, 44 were clones and 15 were line extensions of the new chemical entities. The National Department of Health, pharmaceutical tenders database was used to look at tenders that had been awarded during the study period. Pharmaceutical tenders are awarded through competitive bids submitted by the respective pharmaceutical companies. Therefore, according to the database, since 2019, only 33 (14.16%) innovative medicines have been awarded tenders and are thus available in the public sector. There were also 3 that had alternatives in the public sector, as they were clones of innovator medicines. The availability of innovative medicines in the private sector was defined by having an SEP, of which 178 of the 233 had SEP, representing 76%.\u003c/p\u003e \u003cp\u003eThe availability of these innovative medicines was divided into classes and their availability in both the public sector and private sector. The percentage availability was based on the total number of innovative medicines that were available in that sector at the time of data collection, these results are presented in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e below.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eClass availability in the public sector and private sector\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMedicine Class\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePercentage (%) available in the public sector (n\u0026thinsp;=\u0026thinsp;33)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePercentage (%) available in the private sector (n\u0026thinsp;=\u0026thinsp;178)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAntibacterial agents\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3.4%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAnticoagulation agents\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9.1%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e5.1%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAntidepressants\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1.1%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAntidiabetic agents\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e11.2%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAntiemetics\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.6%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAntifibrotic agents\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1.1%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAntifungal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1.7%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAntihistamine\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1.1%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAntihypertensive\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e9.0%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAntiretroviral agents\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e18.2%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3.4%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAntitubercular agents\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.6%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAntiviral\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1.1%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAsthma and pulmonary agents\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2.8%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBiological\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e10.7%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCNS agents\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1.7%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eContraceptive\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e3.9%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eContrast media\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.6%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEnzymatic agents\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1.7%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHormone replacement therapy\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.6%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHypercholesterolemia\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.6%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eImmunological agents\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e2.2%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInfluenza agents\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1.1%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eInsulin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1.7%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNon-steroidal anti-inflammatory drugs (NSAIDs)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.6%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOncology\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e18.2%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e18.0%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOphthalmology agents\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1.7%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eProstate agents\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.6%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRheumatic agents\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.6%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eThrombopoietin\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.6%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eThyroid agents\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.0%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e1.1%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVaccines\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e30.3%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e9.6%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVasodilator\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e-\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e0.6%\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eQualitative Study\u003c/h2\u003e \u003cp\u003eA total of 9 interviews were conducted. Seven of the interviews involved professionals who are market access managers, and two involved private funders. The themes that emerged were reimbursement of medicines, types of reimbursement, partnerships, technology, and legislative challenges, as well as themes that were added to the overarching themes of other issues. These themes not only addressed challenges but also included suggestions for improving access to innovative medicines. The identified themes are presented in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e and expanded further below.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eThemes identified in access to innovative medicines in South Africa\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eThemes\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSub-themes\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eReimbursement of medicines\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eCost of medicines\u003c/p\u003e \u003cp\u003ePricing transparency\u003c/p\u003e \u003cp\u003eCopayments\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eType of reimbursement\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAlternative reimbursement models\u003c/p\u003e \u003cp\u003eRisk sharing\u003c/p\u003e \u003cp\u003eValue based contracting\u003c/p\u003e \u003cp\u003eSingle Exit Price (SEP)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePartnerships\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRelationships/Partnerships/Stakeholders\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTechnology\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eUse of technology\u003c/p\u003e \u003cp\u003eData integration\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLegislative challenges\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eLack of regulations and legislation\u003c/p\u003e \u003cp\u003eNHI\u003c/p\u003e \u003cp\u003eLack of Pharmacoeconomics in government/HTA presence and usage\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOther themes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eEML Listing\u003c/p\u003e \u003cp\u003eFragmented insurer space\u003c/p\u003e \u003cp\u003ePharmaceutical industry\u003c/p\u003e \u003cp\u003eReal world evidence\u003c/p\u003e \u003cp\u003eFormulary listing and prescribed minimum benefits\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eTheme 1: Reimbursement of medicines\u003c/h2\u003e \u003cdiv id=\"Sec13\" class=\"Section3\"\u003e \u003ch2\u003eCost of medicines\u003c/h2\u003e \u003cp\u003eThe participants in general felt that innovative medicines are expensive. They add tremendous clinical value to patients, but the price of these treatments impedes access. There was a feeling that \u0026ldquo;me-too\u0026rdquo; medicines should not have a premium price, as doing so does not benefit South Africans. For medicine to be considered innovative and reimbursed as such, it needs to be valuable to patients. The majority of the participants believed that the cost of innovative medicines needs to be based on value and innovation, which is priced based on the research and development that has gone into bringing the medicine into the market. Private funders need to see the value of the medicine, and then discussions on the price of the medicine need to take place. Prescribers and patients should also see value in that medicine. From the funder perspective, there was a feeling that the government failed to hold the pharmaceutical industry accountable for the pricing, which limits access to innovative medicines.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;Often you find that our innovative treatments have tremendous clinical value that they bring to patients. But with that comes a price tag\u0026rdquo; \u0026ndash; Interview 3\u003c/em\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;It's not about the patient, it\u0026rsquo;s about Pharma profit margins, and they not held accountable. Government does not cross question pharma on their pricing. They don't adjudicate anything, and they get blanket increases, even though they've got exploitative pricing here. The entire system is bent towards appreciating the profit margins of pharma and not taking care of patients.\u0026rdquo; \u0026ndash; Interview 6\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003ePricing transparency\u003c/h2\u003e \u003cp\u003eParticipants expressed the feeling that transparent pricing regulation in South Africa is counterproductive in that it is meant to increase competition among pharmaceutical companies, thus resulting in a reduction in medicine prices and consequently an increase in access. However, this has proven to not work for innovative medicines, as pricing is visible globally.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;\u0026hellip;for innovative medicines, we have the worst system in the world because we transparently disclose all our prices, which everybody else sees and benchmarks.\u0026rdquo; \u0026ndash; Interview 6\u003c/em\u003e \u003c/p\u003e \u003cp\u003eAs a result, innovative medicines are being launched at a premium price. Participants felt that pricing should be confidential between innovative pharmaceutical companies and funders, including the government, as this would allow patients to benefit by having increased access to innovative medicines through models such as discounting, bonusing and rebates. To increase competition, there was also a suggestion that transparent pricing should be kept within the borders of South Africa only, with controlled access that is available only to stakeholders within South Africa.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;I think it is probably one of the big things we need that and removing the visibility of single exit prices.\u0026rdquo; \u0026ndash; Interview 9\u003c/em\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;So the barrier is the visible price in South Africa. It's actually the biggest barrier currently that we have. It serves a purpose to ensure that prices are standardized and there isn't perverse incentives. However, the visibility of that price globally is impacting what we can give to South Africans.\u0026rdquo; - Interview 9.\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eCopayments\u003c/h2\u003e \u003cp\u003eSome participants felt that the private payer benefit packages are designed such that for better benefits as a patient, you will have to go on a higher plan, which includes reimbursement for innovative medicine. The higher plans subsidise the patients on lower plans if an innovative medicine is a prescribed minimum benefit (PMB). Each plan has a limit or a cap to which a funder will pay for a medicine, and then copayments will apply. Patient support programmes assist patients with copayments when an innovative medicine is not fully reimbursed to ensure access to innovative medicines.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;\u0026hellip;an access barrier where the patient might have a copayment etcetera. There are also some programmes there that will support patients in terms of helping with a copayment.\u0026rdquo; \u0026ndash; Interview 4\u003c/em\u003e \u003c/p\u003e \u003cp\u003eThis is seen by funders as the admission of guilt by the pharmaceutical industry with respect to highly priced innovative medicines.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;\u0026hellip;the fact that you have patient support programs is your admission of guilt, that your price is that your product is priced excessively in SA\u0026hellip;\u0026rdquo; \u0026ndash; Interview 6.\u003c/em\u003e \u003c/p\u003e \u003cp\u003eParticipants felt that the basket of medicines for a disease area should be increased for lower plan patients, and they should be given the option to have copayments provided it is the most clinically appropriate medicine for that medical condition. The participants expressed that this would result in funders losing people on the higher plans, as it would be pointless to remain on the higher plan.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;\u0026hellip;forcing the members to buy up to be able to get the innovator products, because otherwise there'd be no reason to buy the bells and whistles everyone would be on the bottom plan and have access\u0026hellip;\u0026rdquo; \u0026ndash; Interview 1\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eTheme 2: Type of reimbursement\u003c/h2\u003e \u003cdiv id=\"Sec17\" class=\"Section3\"\u003e \u003ch2\u003eAlternative reimbursement models\u003c/h2\u003e \u003cp\u003eOverall, the participants expressed frustration because there was a lack of alternative reimbursement models (ARMs) in South Africa, which was attributed mostly to the SEP.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\"\u0026hellip; you know with South Africa we have this SEP limitation legislation which actually literally limits us to do any alternative models\u0026hellip;\u0026rdquo; \u0026ndash; Interview 5.\u003c/em\u003e \u003c/p\u003e \u003cp\u003eParticipants felt that alternative reimbursement models would allow for varying methods to be introduced to fund innovative medicines and thus increase access to these innovative therapies.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;It's a great consideration where you've got inherent risk, so if you launching an innovative product and your funder is not sure\u0026hellip;\u0026rdquo; - Interview 4\u003c/em\u003e \u003c/p\u003e \u003cp\u003eThe participants strongly felt that ARMs would allow risk sharing between the funders and the innovator pharmaceutical company. They would also allow funders to reimburse innovative medicines based on the value of the medicine.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;managed entry agreements are absolutely what we need.\u0026rdquo; \u0026ndash; Interview 9\u003c/em\u003e \u003c/p\u003e \u003cp\u003e\u003cem\u003e\u0026ldquo;. There's actually even like a group that has come together that comprises of the innovative pharma industry, patient advocacy groups of funders as the key stakeholders that are putting forward a proposal to Department of Health, to allow alternative reimbursement models to be included in the law in the regulations\u0026hellip;\u0026rdquo; \u0026ndash; Interview 3\u003c/em\u003e\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eRisk sharing\u003c/h2\u003e \u003cp\u003eTo increase access to innovative medicines in the public sector, there could be some form of risk sharing whereby the government commits to numbers as well as a budget to treat those numbers, and when those funds are exhausted for the year, then the pharmaceutical industry can take over to assist for the remainder of the year.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;I would even go to an extent of saying why don't you also prove that your product is actually innovative by entering into those agreement where you will pay for performance.\u0026rdquo; \u0026ndash; Interview 2\u003c/em\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;I think in managed entry agreement then allows this particular type of risk sharing between the company and the and the payer and I think it is a good tool to consider to allow access to innovation in my knowledge at this point in time\u0026rdquo; \u0026ndash; Interview 4\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eValue-based contracting\u003c/h2\u003e \u003cp\u003eParticipants believed that there should be a mindset shift, whereby the value of the medicine should be considered before the pricing negotiations, as this would result in an outcome-based focus. However, the difficulty would be in proving the actual outcomes and agreeing with the funder on what the outcomes should be, as the value of a medicine should not result in that medicine being made unaffordable.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\"if we can start having the mindset change? From just looking at a price of the product but looking at the value that the product is providing to a specific patient.\u0026rdquo; \u0026ndash; interview 1\u003c/em\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;Then you've got to both parties have got to agree that the outcomes that have been measured are accurate.\u0026rdquo; \u0026ndash; Interview 3\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eSingle Exit Price\u003c/h2\u003e \u003cp\u003eThe greatest hurdle to ARMs is the Single Exit Price (SEP), as stated by participants; the SEP has negatively impacted access to innovative medicines. Participants believed that scrapping the SEP policy would increase access.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;\u0026hellip;why not just take away the Single Exit Price and because we're the only ones in the world with the SEP..\u0026rdquo; \u0026ndash; Interview 7\u003c/em\u003e \u003c/p\u003e \u003cp\u003eThe argument raised is that the SEP is the ex-manufacturer price, the logistic fee and the value added tax. However, the manufacturer price and logistic fee are determined by the manufacturer, so there is no real transparency.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;Because SEP in as much as it's supposed to be bringing in transparency, there's no transparency in SEP.\u0026rdquo; \u0026ndash; Interview 7\u003c/em\u003e \u003c/p\u003e \u003cp\u003e Some participants believed that the SEP has done well and therefore should not be completely scrapped; however, it should have flexibility that allows for alternative reimbursement models.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;We don't want SEP to be scrapped because we understand the fundamental role of SEP\u0026rdquo; \u0026ndash; Interview 5\u003c/em\u003e \u003c/p\u003e \u003cp\u003eSEP allows for annual increases in which funders feel that the pharmaceutical industry accepts, at times even when it is unwarranted, which further increases lack of access, as innovative medicines are already highly priced.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;\u0026hellip;they get blanket SEP increases, and they take these increases\u0026hellip;\u0026rdquo; \u0026ndash; Interview 6\u003c/em\u003e \u003c/p\u003e \u003cp\u003eDue to pricing transparency as a result of SEP, medicines are launched at premium prices, as the South African price could then be used for reference pricing by other countries, as the SEP is visible globally.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;So as global companies that visibility hinders our ability to give the best value of price for the market because there's something called international reference pricing where they reference prices\u0026rdquo; \u0026ndash; Interview 9\u003c/em\u003e \u003c/p\u003e \u003cp\u003eThe pharmaceutical industry does, in certain instances, offer temporary price reductions, which assist with affordability. However, since they are temporary, when the price increases, affordability decreases. To try and increase access to the public sector, differential pricing is used, which normally offers innovative medicine to the public sector at a reduced cost.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;. So another thing that's done is temporary price reduction. So TPR's. So now and again, companies will, you'll notice will do a TPR, which is basically reducing their price by a certain amount or percentage for a given time.\u0026rdquo; \u0026ndash; interview 8\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section2\"\u003e \u003ch2\u003eTheme 3: Partnerships\u003c/h2\u003e \u003cp\u003eThe participants expressed the importance of having relationships with various stakeholders, such as those between the pharmaceutical industry, private funders, patient advocacy groups, healthcare providers, patients and the government. Participants within the private sector believe that there was a lack of willingness from public sector stakeholders to partner, as the government views the pharmaceutical industry as a profit-driven industry and not as a partner to improve the lives of patients. There needs to be more private‒public partnerships in healthcare to be able to address the accessibility of innovative medicines to everyone irrespective of the payment plan.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;\u0026hellip;the biggest thing is partnerships.\u0026rdquo; \u0026ndash; Interview 7\u003c/em\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;it\u0026rsquo;s really about partnering with somebody to actually support the patient.\u0026rdquo; \u0026ndash; Interview 4\u003c/em\u003e \u003c/p\u003e \u003cp\u003eThe participants felt that the government needed to update its policies.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;I think we are still lagging from government side to actually have a clear policy on alternative reimbursement models\u0026rdquo; \u0026ndash; Interview 5\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section2\"\u003e \u003ch2\u003eTheme 4: Technology\u003c/h2\u003e \u003cdiv id=\"Sec23\" class=\"Section3\"\u003e \u003ch2\u003eUse of technology\u003c/h2\u003e \u003cp\u003eParticipants stated that South Africa could use technology to strengthen healthcare. The use of technology was not harnessed because it could assist in improving healthcare and allowing access to medicines.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec24\" class=\"Section2\"\u003e \u003ch2\u003eData integration\u003c/h2\u003e \u003cp\u003eParticipants mentioned that technology can be used to harness real-world evidence. This would assist in determining the value of innovative medicines.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;I don't think that the technology isn't there. The technology is there. It's about now getting it implemented and maintaining it after that.\u0026rdquo; \u0026ndash; Interview 3\u003c/em\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;It\u0026rsquo;s really about again, the data opening up a registry so that we actually have the data collection, real-world evidence that we're able to collect that real world evidence and demonstrate impacted people\u0026rdquo; \u0026ndash; Interview 4\u003c/em\u003e \u003c/p\u003e \u003cdiv id=\"Sec25\" class=\"Section3\"\u003e \u003ch2\u003eTheme 5: Legislative challenges\u003c/h2\u003e \u003cdiv id=\"Sec26\" class=\"Section4\"\u003e \u003ch2\u003eLack of regulations and legislation\u003c/h2\u003e \u003cp\u003eAs previously mentioned above, one of the greatest hurdles to accessing innovative medicines according to most of the participants was the SEP, which is unique to South Africa and does not allow for alternative reimbursement models. Although the SEP has benefits, as the only pricing mechanism in South Africa, it has become regressive rather than progressive.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;\u0026hellip;why not just take away the Single Exit Price and because we're the only ones in the world with the SEP.\u0026rdquo; \u0026ndash; Interview 7\u003c/em\u003e \u003c/p\u003e \u003cp\u003eWhen participants were asked about policies and what could be done from a policy perspective to increase access to innovative medicines, they all pointed to the government\u0026rsquo;s inability to implement such policies. Participants also pointed out that there is no legislation that governs risk-sharing agreements or outcome-based contracts in South Africa. There is also no implementation of current legislation.\u003c/p\u003e \u003cp\u003e\u003cem\u003e \u0026ldquo;There is guidelines on pharmacoeconomics and all this stuff, but this is it. They haven't applied it.\u0026rdquo; \u0026ndash; Interview 2\u003c/em\u003e\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;the government does nothing to increase access to innovative medicines\u0026rdquo; \u0026ndash; Interview 6\u003c/em\u003e \u003c/p\u003e \u003cp\u003eParticipants felt that the government needs to look at policies that govern alternate reimbursement models, which will allow for risk-sharing agreements between the industry and payers. New legislation needs to be introduced that will support alternative reimbursement models, as well as legislation to fight corruption.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;I would definitely look at these type of value-based contracting agreements and being more flexible in terms of within governance obviously, I'm not saying move outside of governance and transparency, but I think that we need to be a lot more flexible in terms of putting forward, reviewing and approving value-based type of pricing and contracting so that we can actually start implementing it\u0026rdquo; \u0026ndash; Interview 4\u003c/em\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;I think we are still lagging from government side to actually have a clear policy on alternative reimbursement models. And like I said, it's been a topic for over 10 years now, but nothing is happening\u0026rdquo; \u0026ndash; Interview 5\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec27\" class=\"Section3\"\u003e \u003ch2\u003eNational Health Insurance (NHI)\u003c/h2\u003e \u003cp\u003eParticipants agreed that the NHI is important and should be implemented. However, in its current format, it cannot be implemented. Rather, the government should look at public-private partnerships. To make the NHI a success, participants believe that it is not a one-size-fits-all project; rather, South Africa should learn from other countries where it has worked and where it has not worked and then tailor it to meet the needs and challenges of South Africa. For the NHI to succeed, it has to make use of alternative reimbursement models to be able to access innovative medicines.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;We can leverage of global experiences. We can see what not to do. That didn't work in their countries, and we can tailor South African rules for South African people. I guess it's not a one size fits all. It's never going to be we have challenges that other people don't have.\u0026rdquo; \u0026ndash; Interview 6\u003c/em\u003e \u003c/p\u003e \u003cp\u003eThe government has to leverage private funders\u0026rsquo; experience and skills with operational matters, such as using technology to ensure that patients are not lost in the system, being able to track claims, process payments, and negotiating with service providers.\u003c/p\u003e \u003cp\u003e\u003cem\u003e\u0026ldquo;So there's a lot that government can learn. We can learn a lot from government in terms of how they establish their standard treatment guidelines and because it's very robust, so that joint learning is what's needed.\u0026rdquo; -interview 9\u003c/em\u003e\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec28\" class=\"Section2\"\u003e \u003ch2\u003eLack of health technology assessment capacity\u003c/h2\u003e \u003cp\u003eAnother issue raised regarding the success of the NHI is that there is no HTA to speak off from the Department of Health, and it would benefit the country if South Africa had one independent HTA body.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;There's so much that needs to be done in creating an independent HTA body.\u0026rdquo; \u0026ndash; Interview 7\u003c/em\u003e \u003c/p\u003e \u003cp\u003e Knowledge sharing also needs to occur, whereby the pharmaceutical industry learns from the government on how to create robust standard treatment guidelines. The pharmaceutical industry was looking at ways to support the government with the strengthening of pharmacoeconomics, such that there is a fully functional independent HTA body to guide policy on alternative reimbursement models for medicines in South Africa.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;So, pharmacoeconomics is not there in the government. It\u0026rsquo;s only there as a word, but not being used to manage the cost.\u0026rdquo; \u0026ndash; Interview 2\u003c/em\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;But right now, there is no HTA process in place, nothing.\u0026rdquo; \u0026ndash; Interview 5\u003c/em\u003e \u003c/p\u003e \u003cp\u003eSouth Africa\u0026rsquo;s HTA body needs to function independently of the government to make pharmacoeconomic recommendations that are based on the evidence presented, as well as global best practices. There also needs to be HTA in both the public and private sectors. The HTA needs to clearly communicate what affordability is like for South Africa for both the state and private sectors.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;, if you have one national HTA body that basically has got people who are not biased and that can basically look at the different models for the different therapeutic areas.\u0026rdquo; \u0026ndash; Interview 7\u003c/em\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;I would still say the government should have a proper HTA process across 2 sectors\u0026hellip; Even if we have one private HTA process and then the government HTA process but then the government should take ownership in terms of owning the policies.\u0026rdquo; \u0026ndash; Interview 5\u003c/em\u003e \u003c/p\u003e \u003cp\u003eTherefore, industry could design alternative reimbursement models that cater to the findings of HTA. Due to the limited financial resources available to the government, there is an opportunity for alternative reimbursement models, whereby the industry can introduce various models that cater to the limited resources available to the government to increase access to innovative medicines.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec29\" class=\"Section2\"\u003e \u003ch2\u003eTheme 6: Other themes\u003c/h2\u003e \u003cp\u003eSome participants also mentioned that SAHPRA needs to reduce its registration timelines to ensure timely access to medicines. The government could perhaps look at tax exemptions for innovative medicines to decrease the price of medicines and provide rebates to support distribution. These savings could then be passed on to the patient.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;So why are we being taxed for accessing meds?\u0026rdquo; \u0026ndash; Interview 3\u003c/em\u003e \u003c/p\u003e \u003cp\u003eFunders promote the enforcement of generic substitution, as it encourages innovator pharmaceutical companies to rethink their pricing strategy, as some generics may form a therapeutic alternative to an innovator medicine. Thus, innovative medicines have to demonstrate value over other therapies irrespective of whether they are first-line or third-line treatments. The introduction of a medicine to funders is supported by cost-effectiveness data as well as positioning the product in a niche, whereby it targets patients who have failed in currently available treatments.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;The biggest thing that the government did actually was just enforcing the use of generics, because then that forced the companies to price differently.\u0026rdquo; \u0026ndash; Interview 1\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eEML Listing\u003c/h3\u003e\n\u003cp\u003eThe pharmaceutical industry also looks at ways to obtain a formulary listing based on the proven clinical benefit that the medicine can provide. The Essential Medicines List (EML) and Standard Treatment Guidelines (STG) were used to determine which medicines were the standard of care.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\"So I think being included on a formulary will facilitate and enable access. If a product is not on the formulary, it\u0026rsquo;s not a complete barrier to access, and I think also the converse there is that even if a product is on the formulary, it does not guarantee access.\u0026rdquo; \u0026ndash; Interview 4\u003c/em\u003e \u003c/p\u003e \u003cdiv id=\"Sec31\" class=\"Section2\"\u003e \u003ch2\u003ePharmaceutical Industry\u003c/h2\u003e \u003cp\u003eIn an attempt to increase access, participants stated that innovator pharmaceutical companies, as another initiative, are working together to partner with the government as well as private funders to put through a proposal to the National Department of Health to gazette into law alternative reimbursement models. Participants also provided solutions based on current global trends to address barriers to accessing innovative medicines in South Africa. The proposed solutions are provided below, as they have been identified as initiatives that could aid in increasing access to innovative medicines in South Africa.\u003c/p\u003e \u003cp\u003e\u003cul\u003e\u003cli\u003e\u003cp\u003eCMS needs to update treatment algorithms proactively to make it simpler for payers to fund innovative medicines, as they will be on the treatment.\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eThere also needs to be an increase in clinical trials conducted in South Africa, as this would provide data that are relevant and specific to South Africa.\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003ePayers suggested that innovator pharmaceutical companies need to be more flexible in pricing for innovative medicines.\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eWithin the public sector, there needs to be strict implementation of the Public Finance Management Act. (PFMA), to increase funds in the public sector.\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003e The South African treatment guidelines need to be updated proactively to be in line with international standards of care to ensure that patients receive a clinically appropriate product in line with international standards.\u003c/p\u003e\u003c/li\u003e\u003c/ul\u003e\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;so ideally someone actually needs to actively update the algorithms because that actually makes funding decisions easier.\u0026rdquo; \u0026ndash; Interview 1\u003c/em\u003e \u003c/p\u003e \u003cp\u003e \u003cem\u003e\"\u0026hellip;many clinical trials globally are focused on European and U.S. markets. So many of our clinical trials, I mean, most of them actually are done in those markets.\u0026rdquo;\u003c/em\u003e \u003c/p\u003e \u003cp\u003eOne participant suggested that there needs to be decentralisation of funds in public hospitals and to allow them to function as a business. Hospitals should use the funds that are paid by patients who can, however, be small to improve the functioning of the hospital, which could aid in increasing access to medicines. Consideration should be given to reducing hospitalisation due to innovative medicine, reducing polypharmacy, and improving the overall quality of life of patients.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;\u0026hellip;let the hospitals also run as a business.\u0026rdquo; \u0026ndash; Interview 2\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec32\" class=\"Section2\"\u003e \u003ch2\u003eFragmented insurer space\u003c/h2\u003e \u003cp\u003eThe private insurance sector needs to have one program that is not as fragmented as it is currently and to make uniform decisions. Currently, different payers offer different copayment percentages. Within the private insurance space, there needs to be uniformity within the specific disease areas. This approach would aid in providing the same level of assistance for all impacted patients. In addition, within the private insurance space, the gap between the different plan types is too wide, which disadvantages certain patients who cannot afford the higher plan. The benefits for a disease area should be driven by treatment protocols, irrespective of the plan. Private payers should try to find common ground for various treatment baskets for the benefit of the patient.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;Another barrier would be within the private sector because you know that we have a very fragmented insurer space. So you do find different levels of reimbursement.\u0026rdquo; \u0026ndash; Interview 5\u003c/em\u003e \u003c/p\u003e \u003cdiv id=\"Sec33\" class=\"Section3\"\u003e \u003ch2\u003eReal-world evidence\u003c/h2\u003e \u003cp\u003eIn the public sector, there needs to be an increase in the use of technology to better monitor patients, as well as to have a central patient database. Within the usage of technology, there needs to be a single point where there is central data that is available to the payers as well as industry, whereby each stakeholder can access the outcome data of a medicine. This would then facilitate the reimbursement models, as the database would have been following a treatment over a certain period of time and linked to outcomes, thus showing the impact of the innovative medicine. This would have to be done within the confines to the current legal framework protecting personal information, as the purpose of the database would be to show the value of the innovative medicine in the patient journey.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;And then you imagine the amount of value you can get out of an electronic health system. The records you can get out of there, the real-world evidence generation, You could do such amazing data mining with that.\u0026rdquo; \u0026ndash; Interview 3\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe quantitative results indicate that a limited number of innovative medicines were available during the time period studied. Between 2010 and 2020, the SAHPRA faced challenges inherited from the Medicines Control Council (MCC), the chief of which was the revision and implementation of new regulatory pathways [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. By 2018, SAHPRA had up to 8220 applications, with a median approval time of approximately 5 years [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. This could be attributed to the low number of new chemical entities registered by the SAHPRA (formerly MCC). SAHPRA also faces the challenge of a lack of resources and therefore does not have sufficient capacity to evaluate a dossier [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. This also results in delays in evaluating submissions, which then has a domino effect on the registration timelines [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e] and availability of generic medicines.\u003c/p\u003e \u003cp\u003eOne of the challenges mentioned by the participants was that innovative medicines were costly. The pharmaceutical industry\u0026rsquo;s justification for high-priced medicines is that they add value and thus should be reimbursed for research and development [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. The high cost of innovative medicines in South Africa was attributed to pricing transparency, which is visible globally. Price transparency has been implemented by some countries; however, there is no conclusive evidence of price control and/or a reduction in medicine expenditure [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. To reduce the price of innovative medicines, pricing transparency should be used with other alternative reimbursement models, such as volume-based contracting [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eParticipants agreed that there is a need for alternative reimbursement models (ARMs) to be able to reimburse innovative medicines. ARMs involve value-based contracting, whereby the price of the medicine is linked to the perceived value, and this strategy is increasingly being utilised to try and increase access to innovative medicines [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. Value-based reimbursement is considered a method of choice for new technologies due to advantages such as price negotiations or internal or external referencing; aligning the patient, the payer and the provider; and offering incentives to providers who can deliver better outcomes for the patient without necessarily increasing costs [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e] [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. However, there is no clear way to measure the value of an innovation and/or the value of a medicine; therefore, there should be clear policies that define value along with the factors to be measured [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. There is also the reality that because value-based pricing looks at the value of the innovation, that value could be both unaffordable and unacceptable at a societal level [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eEven though South Africa has SEP policies aimed at reducing the price of medicines, participants alluded to the fact that innovative medicines are still unaffordable in South Africa. The South African reimbursement model is based on the SEP, which provides transparency. The overall aim is to improve access to medicines by reducing the price of innovative and generic medicines and controlling the price of medicines [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. As a single intervention, the SEP cannot provide affordable, innovative medicines to patients [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. The cost of innovative medicines is driven primarily by factors such as patent protection, monopolistic markets for new entities, regulatory issues, taxes and tariffs, geographic location, income status and lack of internal price regulation [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. South Africa, as an LMIC, will generally have limited negotiating power for medicine pricing [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. The industry needs to evaluate ways in which the prices of these medicines could be reduced.\u003c/p\u003e \u003cp\u003ePayers indicated that the pharmaceutical industry needs to show flexibility in the pricing of innovative medicines. This means that there must be a balance between maintaining innovation and increasing access, which could be achieved by considering models such as tax benefits, differential pricing, patent changes, medicine discounts, and national health insurance, as innovation must be rewarded and sustained [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Some participants mentioned that tax exemptions for innovator medicines can be applied to reward innovation and reduce the price of medicines. Globally, the value-added tax on medicines can reach 20 %; hen this tax is added to other taxes that are imposed during the supply value chain, the end price of a medicine increases [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. Tax incentives are crucial to the investment choices of pharmaceutical companies, as seen in a study in Uganda; this was also evident in India, where a tax credit system supporting the private sector led to an increase in research and development investment within the pharmaceutical industry [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eParticipants felt that partnerships between stakeholders are critical to ensuring increased access to innovative medicines. However, currently, the participants believe that the relationships between various healthcare stakeholders are fractured, primarily due to a lack of trust between the government and industry. Thus, there is fragmentation between national departments, between private and public funders, between national departments of health and provincial health departments, and within provinces and districts [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. Partnerships can leverage the strengths of each sector based on experience, resources and expertise [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eSouth Africa has no formal HTA structure, even though it is reminiscent of other healthcare decision-making bodies, such as private insurance companies, on the National Essential Medicines List Committee [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. The participants expressed the willingness of the industry to partner with the government to assist in the development of policies that will aid in strengthening health technology assessment (HTA). The government would need to find a way to address the three-tier system of governance (national, provincial and local), each with executive and legislative authority, as healthcare falls under national and provincial legislatures [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. South Africa could emulate the National Institute for Health and Care Excellence (NICE), whereby various stakeholders (such as the National Health Service, clinical experts, external assessment groups, patient and carer organisations, companies, healthcare professionals, etc.) work collaboratively in a robust manner towards one goal, with a single vision of determining whether there is clinical efficacy as well as value for money into using a technology [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eConsistent with the results of this study, [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e] found that to be able to develop an HTA that is open, trustworthy and acceptable to all healthcare stakeholders, the government needs to collaborate with the pharmaceutical industry as well as private funders to improve the South African Guidelines for Pharmacoeconomic Submissions (SAGPS), such that it covers medical, legal, social and ethical considerations [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. The emphasis of the SAGPS is currently more on the economic aspect than on the medical aspect when it concerns new medicines [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e].\u003c/p\u003e \u003cp\u003ePrivate insurers need to re-evaluate the basket of medicines for different conditions. A rich basket of medicines should be limited not only to those that contribute the most but also to other plans that are available. According to [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e], if members do not see the value of paying monthly contributions and then have to pay copayments because a medicine is not fully reimbursed by the insurance, they will end up terminating their cover. As a formulary is used as a guide for reimbursement, to increase access to innovative medicines, private insurers should base their formulary of global standards of care for a condition to ensure the best clinical outcome for their members. There is little competition between funders who can benefit patients in terms of improved affordability and value-for-money coverage [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe pharmaceutical industry is an important player in the health sector, as governments around the world need to decide which new medicines will be included as part of their respective country health services [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. As an important stakeholder in the health sector, there is a perception that the pharmaceutical industry\u0026rsquo;s only focus is on the development of expensive novel molecules and/or technologies and losing interest in the production of cheaper medicines that are equally effective and affordable due to their pricing policies and aggressive patent policy issues [\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. The costs of medicines and healthcare in general are increasing, but there is a disparity between the amount of money spent and patient outcomes [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e].\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eFinding solutions to access barriers, including the prices of these barriers, requires various stakeholders in the health sector to collaborate to ensure that patients have access to the latest innovative medicines. Finally, the government needs to proactively update policies that would allow for alternative reimbursement methods or other access strategies to be explored.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eAbbreviation\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eMeaning\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eARM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eAlternative Reimbursement Model\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eBREC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eBiomedical Research Ethics Committee\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eCNS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eCentral Nervous System\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eEML\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eEssential Medicines List\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eHTA\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eHealth Technology Assessment\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eIPASA\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eThe Innovative Pharmaceutical Association South Africa\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eLMIC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eLow- or Middle-Income Country\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eMCC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eMedicines Control Council\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eNHI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eNational Health Insurance\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eNICE\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eNational Institute for Health and Care Excellence\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eNSAIDs\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eNon-steroidal anti-inflammatory drugs\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003ePFMA\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003ePublic Finance Management Act\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003ePMB\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003ePrescribed Minimum Benefit\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eSA\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eSouth Africa\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eSAGPS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eSouth African Guidelines for Pharmacoeconomic Submissions\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eSAHPRA\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eSouth African Health Products Regulatory Authority\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eSEP\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eSingle Exit Price\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eSTG\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eStandard Treatment Guidelines\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eWHO\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"50%\" valign=\"top\"\u003e\n \u003cp\u003eWorld Health Organization\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study\u0026nbsp;was\u0026nbsp;granted ethical approval by the University of KwaZulu Natal\u0026nbsp;subcommittee\u0026nbsp;of the Biomedical Research Ethics Committee\u0026nbsp;(ethics\u0026nbsp;number: BREC/00005116/2022). All participants\u0026nbsp;provided\u0026nbsp;consent to participate and signed informed consent forms.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConsent from participants to publish the data were obtained in the informed consent form,\u0026nbsp;which explained that\u0026nbsp;the\u0026nbsp;data\u0026nbsp;would\u0026nbsp;be aggregated and coded and\u0026nbsp;that\u0026nbsp;no identifying information\u0026nbsp;from the\u0026nbsp;participants\u0026nbsp;would\u0026nbsp;be used.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eThe datasets generated and/or analysed during the current study are not publicly available,\u0026nbsp;as the results are generated from a master\u0026rsquo;s degree\u0026nbsp;who\u0026nbsp;is still under examination but are available from the corresponding author\u0026nbsp;upon\u0026nbsp;reasonable request.\u003c/li\u003e\n \u003cli\u003eThe datasets generated and/or analysed during the current study for quantitative results are available in the\u0026nbsp;SAHPRA\u0026nbsp;Registered Health Products Database repository,\u0026nbsp;\u003ca href=\"https://medapps.sahpra.org.za:6006/\"\u003ehttps://medapps.sahpra.org.za:6006/\u003c/a\u003e\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo funding was received for this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFS and TJ designed the study. TJ undertook\u0026nbsp;the\u0026nbsp;data collection and data analysis. FS performed\u0026nbsp;the\u0026nbsp;data validation and\u0026nbsp;reviewed\u0026nbsp;the paper. Both authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;information\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eAdebisi YA, Nwongu IB, Alaran AJ, Badmos AO, Bamgboye AO, Rufai BO, Okonji OC, Malik MO, Teibo JO, Abdalla SF, Lucero-Prinso DE III, Samai M. and W. Akande-Sholabi, Revisiting the issue of access to medicines in Africa: Challenges and recommendations, \u003cem\u003ePubli Health Challenges\u003c/em\u003e, vol. 1, no. 2, 15 June 2022.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAmerican Medical Association. 27 10 2021. [Online]. 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October 2020;16(10):1359\u0026ndash;69.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGodman B, Bucsics A, Bonanno PV, Oortwijn W, Rothe CC, Ferrario A, Bosselli S, Hill A, Martin AP, Simoens S, Kurdi A, Gad M, Gulbinovic J, Timoney A, Bochenek T, Salem A, Hoxha I, Sauermann R, Massele A, Guerra AA Jr., Petrova G, Mitkova Z, Achniotou G, Laius O, Sermet C, Selke G, Kourafalos V, Yfantopoulos J, Magnusson E, Joppi R, Oluka M, Kwon H-Y, Jakupi A, Kalemeera F, Fadare JO, Melien O, Pomorski M, Wladysiuk M, Morkovic-Pekovic V, Mardare I, Meshkov D, Navakovic T, Furst J, Tomek D, Zara C, Diogene E, Meyer JC, Malmstrom R, Wettermark B, Matsebula Z, Campbell S, Haycox A. Barriers for Access to New Medicines: Searching for the Balance Between Rising Costs and Limited Budgets, \u003cem\u003eFrontiers in Public Health\u003c/em\u003e, vol. 6, 05 December 2018.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGon\u0026ccedil;alves E. 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Financing and Reimbursement Models for Personalised Medicine: A Systematic Review to Identify Current Models and Future Options. Appl Health Econ Health Policy, 20, pp. 501\u0026ndash;24, 04 April 2022.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNaidoo K, Suleman F. Evaluating the impact of single exit pricing (SEP) on medicine product withdrawal from the private healthcare market in South Africa. South Afr Med J. 2021;111(5):444\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMoodley R, Suleman F. Evaluating the impact of the single exit price policy on a basket of originator medicines in South Africa from 1999 to 2014 using a time series analysis. BMC Health Serv Res, 19, 576, 2019.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMattila P, Babar Z, Suleman F. Assessing the prices and affordability of oncology medicines for three common cancers within the private sector of South Africa. 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Primary care clinical practice guidelines in South Africa: qualitative study exploring perspectives of national stakeholders. BMC Health Serv Res. 2017;17(608):1\u0026ndash;12.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEbulue CC, Ebulue OR, Ekesiobi CS, PUBLIC-PRIVATE PARTNERSHIPS, IN HEALTH SECTOR INNOVATION: LESSONS FROM AROUND THE WORLD., nternational Med Sci Res J, 4, 4, pp. 484\u0026ndash;99, 18 April 2024.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMueller D. Addressing the challenges of implementing a Health Technology Assessment Policy Framework in South Africa. Int J Technol Assess Health Care, 36, 4, pp. 453\u0026ndash;8, 13 August 2020.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNICE. National Institute for Health and Care Excellence, 31 October 2023. [Online]. 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Factors that influence medical scheme insured consumers to co-pay for prescription medicines at private community pharmacies in Pretoria, Gauteng Province, South Africa. University of Western Cape; 2016. pp. 1\u0026ndash;98.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSolanki G, Cornell J, Besada D, Morar R, Wilkinson T. The Competition Commission Health Market Inquiry Report: An overview and key imperatives. South Afr Med J. 2020;110(2):88\u0026ndash;91.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRocha MdM, de Andrade EP, Alves ER, C\u0026acirc;ndido JC, Borio MdM. Access to innovative medicines by pharma companies: Sustainable initiatives for global health or useful advertisement? Glob Public Health. 2020;15(6):777\u0026ndash;89.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLarsson S, Clawson J, Howard R. Value-Based Health Care at an Inflection Point: A Global Agenda for the Next Decade. NEJM Catalyst, 2023.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-health-services-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bhsr","sideBox":"Learn more about [BMC Health Services Research](http://bmchealthservres.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/BHSR/default.aspx","title":"BMC Health Services Research","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Alternative reimbursement models, Private sector healthcare, Public sector healthcare, Cost of innovative medicines, Policies South Africa","lastPublishedDoi":"10.21203/rs.3.rs-4502549/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4502549/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSouth Africa is composed of two tiers, viz. A private healthcare system that is funded through medical insurance, comprised of people who can afford to make monthly payments towards their medical insurance, and a government-funded public healthcare system, which covers the majority of the population. This study explored the barriers that exist in South Africa that hinder access to innovative medicines, along with the current strategies being utilised by the pharmaceutical industry to increase access to medicines.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjectives\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe objectives of the study were to (1) quantify and classify innovative medicines registered between 2010 and 2020 by the South African Health Products Regulatory Authority (SAHPRA), (2) identify barriers to accessing innovative medicines in South Africa through interviews with market access managers from innovator companies, and (3) explore the current market access strategies used by the pharmaceutical industry.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDesign\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study employed a quantitative and qualitative methodology, whereby the former involved the extraction of a list of innovator medicines from the regulator database, and the latter involved 9 semi structured interviews. Purposive sampling was conducted through pharmaceutical association member companies. The interviews included seven market access managers and two medicine managers from one of the payers in South Africa. Thematic analysis was used to interpret the data collected from the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAccording to the regulator database, during the review period, 238 innovative medicines were registered. Only 14.77 % were available in the public sector in the form of tenders, whereas in the private sector (based on the products having a SEP), 76.92 % were available. From the interviews, six themes emerged: reimbursement of medicines, types of reimbursement, partnerships, technology, legislative challenges, and other factors (e.g., real-world evidence).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAccess to innovative medicines in South Africa is a challenge, as the price of these therapies is high. Therefore, various stakeholders in the health sector must collaborate to identify and implement solutions that are locally relevant. The government needs to proactively update policies that would allow for alternative reimbursement methods to be explored.\u003c/p\u003e","manuscriptTitle":"Understanding medicine access strategies for innovative medicines registered in South Africa","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-06-19 10:02:40","doi":"10.21203/rs.3.rs-4502549/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-06-06T06:49:55+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-06-06T03:52:35+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-06-06T03:51:57+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Health Services Research","date":"2024-05-30T11:06:01+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-health-services-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bhsr","sideBox":"Learn more about [BMC Health Services Research](http://bmchealthservres.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/BHSR/default.aspx","title":"BMC Health Services Research","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"2218855a-c905-4be2-9c9a-fbee14a5e929","owner":[],"postedDate":"June 19th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-10-14T16:03:53+00:00","versionOfRecord":{"articleIdentity":"rs-4502549","link":"https://doi.org/10.1186/s12913-024-11696-4","journal":{"identity":"bmc-health-services-research","isVorOnly":false,"title":"BMC Health Services Research"},"publishedOn":"2024-10-11 15:58:04","publishedOnDateReadable":"October 11th, 2024"},"versionCreatedAt":"2024-06-19 10:02:40","video":"","vorDoi":"10.1186/s12913-024-11696-4","vorDoiUrl":"https://doi.org/10.1186/s12913-024-11696-4","workflowStages":[]},"version":"v1","identity":"rs-4502549","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4502549","identity":"rs-4502549","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}