Research highlights a disconnect between regulatory signals and health plan decision-making.
The U.S. Food and Drug Administration (FDA) speeds approval of important clinical advancements through four programs: Priority Review, Accelerated Approval, Fast Track and Breakthrough Therapy, which are designed to accelerate approval for drugs that address serious conditions or unmet needs.
But are health plans keeping pace when it comes to coverage?
This study reviewed commercial health plan policies for over 160 specialty drugs approved from 2013 onward to assess whether inclusion in these FDA-expedited review programs led to faster or less restrictive coverage.
The research found that health plans were not more likely to issue faster coverage policies for drugs included in multiple expedited programs after adjusting for cancer and orphan disease indications. Similarly, plans were more generous in coverage. Plans imposed restrictions less frequently on drugs in at least 1 expedited program, compared to those that were not in any program, 33% versus 51% respectively. Once other factors like cost, disease prevalence and alternatives were considered, the association was not found.
While the FDA’s expedited review programs are meant to signal clinical advancement, many insurers appear to base coverage decisions on other factors, such as disease type (e.g., oncology), cost and availability of alternatives.
After controlling for other decision-making factors, we did not find that FDA-expedited approval was associated with faster coverage policy issuance, nor did we find that plans covered drugs the FDA included in expedited review programs less restrictively than drugs excluded from these programs. The findings raise questions about why plans do not also accelerate access for these clinical advancements.
This research was funded by Johnson & Johnson and conducted in collaboration with researchers at the Center for the Evaluation of Value and Risk in Health Institute for Clinical Research and Health Policy Studies, Tufts Medical Center. For full details on the study design, methods and limitations, see: Panzer AD, et. al. The association between US Food and Drug Administration-expedited review designations and health plan specialty drug coverage. Published online May 2023. J Manag Care Spec Pharm. 2023;29(5):464-471 doi.org/10.18553/jmcp.2023.22415.
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