Expedited FDA Review Does Not Necessarily Lead to Better Health Plan Access

Health plans do not appear to issue coverage policies faster or offer fewer restrictions for many drugs approved through US Food and Drug Administration (FDA) expedited review, according to study results published in the Journal of Managed Care & Specialty Pharmacy.

“Our findings suggest that factors such as a drug’s annual cost and whether a drug is indicated for cancer are more influential in health plan coverage policy than a drug’s inclusion in an FDA-expedited review program,” wrote researchers from the Tufts Medical Center, Boston, Massachusetts, and Janssen Scientific Affairs, Titusville, New Jersey.

The study investigated how quickly 17 commercial health plans issued coverage policies for drugs included approved through FDA Priority Review, Accelerated Approval, Fast Track, and/or Breakthrough Therapy programs compared with other drugs approved in 2018.

Overall, plans issued 62% of policies within a year of a drug’s FDA approval, according to the study. Although the speed with which policies were issued at first seemed to increase with each additional expedited review program the drug was in, the effect diminished when researchers controlled for cancer and orphan conditions. In other words, cancer and orphan drugs aside, plans did not issue policies any faster for drugs approved through multiple expedited review programs.

The study also examined the association between FDA-expedited review and coverage restrictiveness. Plans imposed coverage restrictions in 33% of policies for drugs the FDA included in at least one expedited review program compared with 51% of policies for drugs the FDA excluded from expedited programs, the study found. Multivariable regression, however, showed no links between FDA expedited review and fewer coverage restrictions after controlling for other decision-making factors.

“In particular,” researchers wrote, “multivariable regressions suggest coverage restrictions were most strongly associated with a drug being indicated for a disease other than a cancer and the availability of alternatives, along with financial factors, such as a drug’s annual cost, the prevalence of the indicated disease, and that the drug is not a biosimilar.”

Reference:
Panzer AD, Ingham M, Martin S, Chambers JD. The association between US Food and Drug Administration-expedited review designations and health plan specialty drug coverage. J Manag Care Spec Pharm. Published online March 29, 2023. doi:10.18553/jmcp.2023.22415