Risk-sharing agreements, present and future

Abstract

Risk-sharing agreements between pharmaceutical companies and payers stand out as a recent practice, the use of which has been increasing in the case of innovative medicines, particularly in the field of oncology, which aims to ensure better budgetary control and a lower risk of spending on medicinal products without full evidence of clinical benefit.In this article, the authors discuss the types of existing agreements, as well as those used in Portugal, their advantages, disadvantages and future challenges of implementation, as well as their potential role in access to therapeutic innovation, namely medicines for cancer treatment. For this purpose, a nonsystematic review of indexed and nonconventional literature was carried out.There is a tendency for the risk-sharing agreements established between payers and pharmaceutical companies to include a component of monitoring the use of medicines and outcomes measurement, involving real life data collection. Portugal is no exception and, although most agreements are still financial in nature, there is already a strong desire for other agreements, in particular clinical outcomes based.It is concluded that there is not yet a gold standard methodology in relation to the type of agreements to be practiced. Moreover, its opportunity cost, including the cost of implementation, remains to be scrutinised. However, regardless of the type of agreement, the advantages of adopting these agreements are well known, inevitably related with challenges of implementation. The need for an infrastructure to support information sharing is undisputed and urgent.The future of therapeutic innovation and increased pressure on health budgets will require alternative, more flexible models, personalized reimbursement models that allow alignment of medicines prices with the value they deliver in treating the several diseases.

International experience with performance-based risk-sharing arrangements: implications for the Chinese innovative pharmaceutical market

“…How to strictly restrict the use of patient data for justified purposes? Answers to all of these need clear and well-defined legal terms and administrative infrastructure of data processing (17).…”

How can we improve patients’ access to new drugs under uncertainties?: South Korea’s experience with risk sharing arrangements

“…A lack of transparency also serves as another issue [2,5,37,42]. In most cases, the detailed condition of agreements and the results from evaluating patients' health outcome remain con dential.…”

Health technology assessment in Japan: a work in progress

“…Similar to the previous pricing system in Japan, there is limited opportunity under the new system for industry to negotiate once prices are set, which may exclude benefits that can arise from tendering, risk-sharing agreements, and price-volume agreements, particularly for innovative drugs for which the clinical benefit in practice has not been well established 11,20,21 . Differential pricing for indications is an alternate solution for the methodological problems encountered with weighted ICERs.…”