Leading Economists call for a new Approach to Facilitating Effective Negotiations and Broader Access to Innovative Medicines in New Peer-review Research, proposing a “Value-Based Negotiation Framework”
A “Value-Based Negotiation Framework” (VBNF) designed to accelerate and improve pricing and reimbursement negotiations has been published in the International Journal of Technology Assessment in Health Care. The framework is the result of a collaborative effort between Dolon, Hict; an international team of economic experts; and Alnylam, a leading RNAi therapeutics company.
Innovative therapeutic solutions have a high potential value but are often characterized by high cost and clinical and/or financial uncertainties. This situation is not new, however the introduction of cell, gene, immune and RNA-based therapies in recent years has vastly improved the potential outlook for patients in high need and reinforced the necessity for a new approach to effectively manage disagreements or uncertainties on the value of these new medicines. The lack of alignment between industry and health authorities on uncertainties, their impact, and the best way to manage them can lead to fraught and lengthy negotiations and, in some cases, to negative outcomes, depriving patients of access to innovative drugs altogether. The use of innovative agreements or managed entry-agreements (MEA) has often been suggested as a solution to this problem, yet their use remains limited in Europe. As Gérard de Pouvourville, Professor Emeritus at ESSEC Business School, explains: "Managed Entry Agreements (MEAs) have been suggested on several occasions to improve market access for innovative medicines, but they cover a wide variety of solutions, and their full implementation is sub-optimal. Instead of listing existing models or inventing a new one, we decided to develop a simple, yet more powerful tool, for improving reimbursement negotiations”.
The VBNF aims to address this issue by providing a systematic, transparent and structured approach for company-health authority dialogue, constructively identifying key sources of uncertainty, and coming to a reasoned agreement between companies and health authorities. The proposed negotiation framework is comprised of four steps (assess, prioritize, identify, decide) to address uncertainties and thus empower stakeholders to better resolve unmet patient needs.
A value-based negotiation framework supports the identification of medicines with a more uncertain outcome and financial impact. It helps in designing an optimal and feasible combination of managed entry agreements. It can expedite the pricing and reimbursement negotiation process, making it more structured and predictable.
In addition to the publication, pilot negotiation exercises based on the VBNF have been conducted with health authorities, biotech companies, patient representatives, health economists and public policy experts in Belgium, the Netherlands, France, and at the EU level. The framework has been presented at several conferences, including ISPOR (The Professional Society for Health Economics and Outcomes Research). On February 7th, Alnylam announced a research partnership with ESSEC Business School, with the goal to test the framework using an experimental approach based on Game Theory.
Julien Patris, Head of Policy for Europe at Alnylam, who initiated the project, emphasizes that the approach "is part of a permanent search for new models and approaches that allow faster access to innovation for patients, on terms that allow public authorities and manufacturers to truly share the risks, but above all the benefits of innovation. Pioneering novel approaches to health authority dialogue and negotiations with the VBNF is in line with Alnylam’s Patient Access Philosophy that serves as a guide to reach its commitments to ensuring broad access to RNAi therapeutics. The VBNF has high potential value for patients, healthcare systems and society.”
Dolon is a strategic pricing and market access consultancy specialising in rare diseases. With headquarters in London and staff located across Europe, we’re dedicated to accelerating access to life-saving treatments for patients all over the world.
Hict is a Belgian Healthcare consultancy, we provide result-driven expertise for healthcare Providers (hospitals, care centres, home care), suppliers (pharma, biotech, medical devices, technology) and public Services on Strategy, Process, Value, Health-economics, market access and reimbursement, and policy. Our goal is simple: optimising healthcare.
About Alnylam Pharmaceuticals
Alnylam (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and prevalent diseases with unmet need. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach yielding transformative medicines. Since its founding 20 years ago, Alnylam has led the RNAi Revolution and continues to deliver on a bold vision to turn scientific possibility into reality.
Patrick Birken | Portland Communications
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