PharmaVOICE Blog Post

Early Access – Where do Payers Stand?

Posted By: Dan Limbach
September 12, 2017

This article covers 5 key issues related to payers’ treatment of pricing and reimbursement.

Issue 1:
It is not rocket science: Less substantiated value propositions for molecules that launch with Phase II data translate into less positive benefit assessments by national agencies.

Issue 2:
In 2017, payers across the EU and US have shown significant concern when molecules are submitted for pricing and reimbursement with a value proposition supported only by Phase II data, specifically in the areas of oncology and CNS.

Issue 3:
Trial challenges meet payer and HTA requirements: Launching with Phase II data is like walking into an anticipated battle.

Issue 4:
According to payers, data uncertainties of single-arm trials and surrogate endpoints present the biggest blockage to value determination of molecules seeking price and reimbursement based on Phase II data.

Issue 5:
Early strategizing and planning for market access at regional and local levels is even more imperative for molecules that launch with Phase II data than for regular launches.

Read the full article

About the Blog Poster: Dan Limbach

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