Editor's note: This story has been updated to include a statement from Independence Blue Cross.
Philadelphia-based Independence Blue Cross has set a benefit exclusion for products that receive accelerated approval from the FDA in most plans.
The health insurer said in a notice that drugs, biologics or gene therapies that earn an accelerated approval "are considered a benefit contract exclusion for most plans" and as such are not eligible for reimbursement for 18 months after the approval is made.
Independence said in the notice that these therapies will be covered after the 18-month mark based on certain criteria, including that they do not have a traditional FDA approval in place and that the accelerated approval was based on a surrogate endpoint.
The third element is ensuring the FDA has indicated a confirmatory trial is required to prove the drug's clinical benefits, according to the notice. The policy is in effect as of Jan. 1.
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Through the 18-month period, the insurer will review available data and at the end of that window will evaluate its coverage position based on that information.
Independence outlined some exemptions, too, as it will not apply the exclusion to cancer therapies that secure accelerated approval. It will also cover drugs that are approved under the accelerated path if required under state or federal statute.
This is true in Medicaid, for example, which is required to cover all drugs that are approved by the FDA, barring a few rare exemptions.
In a statement, IBX said that it has "always had a non-coverage position for these few drugs based on the fact there is no research proving they are clinically effective." The notice seeks to clarify its stance.
"Clinical effectiveness is one of the most important factors to consider when making coverage decisions," Independence Blue Cross said. "We support the FDA's accelerated approval pathway, as it helps to expedite patient access to promising new treatments. However, it does not guarantee that drugs are safe or effective."
Limiting coverage for drugs that are fast-tracked through the approval process is common, as health plans generally lean on clinical trial data and other evidence to make determinations, and that's often more limited for accelerated approvals.
Analysts at MMIT surveyed health plans on the topic late last year, and the results, which were released in November, showed that 90% find clinical trial data on safety and efficacy of drug products key to their coverage decisions. Most (70%) said they were concerned about the reduction in data required for drugs that are fast-tracked.
In addition, 80% said they are more likely to cover a drug that has more robust clinical trial data behind it.
A prime example of a drug that would fall into the benefit exclusion criteria is Aduhelm, or aducanumab, Independence Blue Cross said. That therapy received accelerated approval from the FDA to treat Alzheimer's disease, despite significant concern from the medical community about its effectiveness paired with a high price tag.
"The drug ultimately failed to show that it safely and effectively treated Alzheimer’s disease and was subsequently removed from the market," IBX said. "Beyond Aduhelm, there are other examples of drugs failing to show clinical benefit after their initial accelerated approval from the FDA."