The Food and Drug Administration’s June 13 guidance on communications between drug and medical device companies and payers could be seen as part of a more broad effort to boost flexibility for company-payer communications, according to a Health Affairs blog post.
Drug companies, according to the report, have made clear their concerns about the lack of guidance impeding a streamlined real-world data sharing process and clear economic models about the value of a product.
“For example, in the payer communications guidance, the FDA takes an expansive view of what it means to ‘relate’ to an approved indication, expressing the idea that in their economic analyses drug companies can extrapolate long-term endpoints based on validated surrogate markers and use quality-adjusted life years,” the report states.
The agency’s guidance regarding information labeling could also help facilitate value-based contracts as it would give companies the opportunity to promote post-marketing studies based on RWD.
To read the full blog post on Health Affairs, click here.