Placeholder Banner

BIO Comments on ICER’s Value Assessment Framework for Transformative Therapies

September 6, 2019

We are writing on behalf of the Biotechnology Innovation Organization (BIO) to provide comments on the Institute for Clinical and Economic Review’s (ICER’s) solicitation for input on draft revisions to its Value Assessment Framework for the assessment of “single or short-term transformative therapies” (SSTs).

...

We appreciate ICER’s recognition that the burgeoning field of transformative and curative therapies requires serious discussion around how these treatments are valued by not just payors, but society at large. These therapies have the potential to fundamentally change how we view the treatment of disease. Yet as we strive to shift our health care system to one that rewards valuable care, BIO is concerned that the science of value assessment for all therapies – not just those that are curative or transformational – is woefully behind where it should be for these tools to be used in a substantive way.

Download Full Comments Below
BIO Comments on SST Updates
Discover More
July 31, 2020 Re: Docket No. FDA–2020-N-0837: Raare Disease Clinical Trial Network; Request for Information. Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the…
July 30, 2020 Re: Docket No. FDA–2019-D-5799: FDA’s Public Meeting, Modernizing the Food and Drug Administration’s Data Strategy. Dear Sir/Madam: The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or…
The following letter provides BIO’s feedback on a number of regulatory proposals by the Centers for Medicare & Medicaid Services that would ease barriers to use of value-based purchasing arrangements within Medicaid and commercial plans, broaden…