The costs and benefits of an early access scheme for oncology medicines in Ireland

Background Access to new oncology medicines is subject to delays in many countries due to lengthy appraisal processes. This study examines the cost to the Irish healthcare system of implementing a cost- sharing agreement to expedite access to oncology medicines.

The hypothetical cost of implementing an early access scheme in Ireland was estimated for oncology medicines commencing appraisal in 2022. The scheme would have required the manufacturer to cover the cost for the first 180-day period and provide a further rebate if costs per patient over the whole duration of access exceeded those that would have arisen from the finally agreed price. Costs of the new medicine and savings arising from any therapies displaced were estimated on a daily basis using data published in the technical summaries of the National Centre for Pharmacoeconomics, Ireland (NCPE) assessment for each medicine.

The scheme would have reduced the time patients waited to access oncology medicines by more than two years on average. Assuming new medicines attract a discount of 30% at reimbursement and that medicines with an existing agreement are subject to a 30% discount, and that a further discount of 10% would be negotiated at reimbursement for the new indication, the costs to the government over the duration of the scheme would have been €61.9m. Earlier access would have generated an additional 1,621 quality-adjusted life years (QALY) over the lifetime of patients accessing the scheme, after discounting. Costs were sensitive to assumptions on discounts negotiated at reimbursement. Costs fell substantially if patients with private insurance were assumed to access care through that insurance.

Protracted assessment times lead to substantial health losses to patients with cancer in Ireland. A cost-sharing scheme would accelerate access to new treatments by more than two years and at costs which are unlikely to exceed €62m. Competing Interest Statement KM is an employee and shareholder of AstraZeneca. RM owns shares in Novartis AG. Funding Statement The study was funded by AstraZeneca Ireland. One of the co-authors, KM, who is responsible for the conceptualisation and design of the study, along with preparation of the manuscript is employed by AstraZeneca Ireland. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Secondary data analysis of data in the public domain. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data Availability The data analysed in this publication are taken from published sources.