Innovative Pricing Models Potentially Drive Payer Coverage: A Market Access Case Study for RNAi Therapeutics
CitationMayo, Tara C. 2017. Innovative Pricing Models Potentially Drive Payer Coverage: A Market Access Case Study for RNAi Therapeutics. Master's thesis, Harvard Extension School.
AbstractThe objective of this thesis is to establish a strong understanding of the US payer landscape and key influencers in the orphan disease space. This investigation will also provide a foundational understanding of the payer perspective on novel RNAi therapeutics and how innovative, value-based pricing structures can potentially drive payer coverage for such products. Through primary research with payers and experts in the field, as well as a literature review, we aim to answer the following key questions:
1. What is the current payer environment for orphan drugs launched in the US?
2. What drives willingness to pay for orphan products today and in the future?
3. What potential innovative structures (such as Performance-Based Risk Sharing Agreements, PBRSAs) could exist for RNAi therapeutics?
The key findings suggest that establishing novel reimbursement arrangements may be challenging, however there does exist potential for such arrangements to be implemented under the right set of circumstances. The structure of such arrangements will need to be straightforward and easily administered. Early discussions and continued proactive interactions, including targeted payer engagement from Phase II clinical development through post-approval, should be leveraged in order to best understand payer needs and develop robust evidence packages. Finally, expanded market access and medical affairs teams will be essential to educate the intricate network of influencers and payers, develop value propositions that resonate with key stakeholders, and ensure the novel RNAi mechanism is reasonably well understood.
Recommended actions to bolster the likelihood of success with innovative, performance-based agreements may include the following:
(a) Conduct studies to tie target knockdown to clinically meaningful outcomes and to understand potential inter-patient response variability;
(b) Draft potential contracting schemes considering areas of greatest uncertainty;
(c) Develop outreach plans prioritize education of the payers most willing to be innovative and leaders in the industry.
Citable link to this pagehttp://nrs.harvard.edu/urn-3:HUL.InstRepos:33813400