A Systematic Approach for Introduction of Novel Treatments to a Chronic Patient Group: sacubitril-valsartan as a case study

Abstract Background When novel treatments prove to be better than conventional therapy there is a need for effective introduction, both for cost-effectiveness and to minimize patient suffering. Effective implementation is a challenge in patients with chronic diseases who may be treated both in primary care and/or specialist clinics. Studies have shown that introduction is often unnecessary delayed. Our aims were to develop a model for systematic introduction and to test the feasibility of this model on a new treatment of a chronic disease. We also investigated how such an approach would be received by the patients. Methods The systematic introduction approach is a seven step procedure; Step 1 - define a few main criteria for the specific therapy, Step 2 – primary scan patients with the one or two main criteria using computerised medical records, databases or clinical registries, Step 3 – identify patients applying the other predefined criteria, Step 4 - evaluate if any examinations or laboratory test updates are required, Step 5 - summon identified patients to the clinic with an information letter, Step 6 – discuss treatment with the patient and prescribe to appropriate patients, Step 7 – follow-up on initiated therapy and evaluate the applied process. The model was tested in a case study during introduction of the new drug sacubitril-valsartan in a heart failure population. Patient experiences with the approach were investigated in an interview study with general inductive approach using qualitative content analysis. Results By applying the systematic introduction approach in the case study, 76 out of 1924 patients were identified to be eligible for sacubitril-valsartan and summoned to the clinic to discuss treatment. The content analysis resulted in three final categories of how the model was received by the patients; A good approach , Role of the information letter , and Trust in care . Conclusions The systematic introduction approach ensures that strict criteria are used in the selection process and that a treatment can be implemented in eligible patients within a specified population with limited resources and time. The model was effective in our case study and maintained the patient’s confidence in health care.