IBX Excludes Coverage of Drugs with Accelerated Approvals for 18 Months

Independence Blue Cross (IBX), a Philadelphia-based Blue Cross Blue Shield Plan, has issued a new policy for 2025 that excludes for 18 months drugs, biologics, or gene therapies that have received an accelerated approval. The exclusion applies to therapies that have accelerated approval based on a surrogate endpoint and the FDA has indicated that a confirmatory trial is needed to demonstrate clinical benefit. These exclusions became effective Jan. 1, 2025.

The exclusion, however, does not apply to drugs with accelerated approval that are used to treat patients with cancer or where coverage is required by federal or state regulations.

New-to-market blocks on coverage for new drugs are common and have traditionally been for six months after a drug approval. About 90% of payers surveyed recently by MMIT report that clinical trial data on safety and efficacy is important for their review process. MMIT found that 70% of payers are concerned about expedited approvals.

A spokesperson with Independence Blue Cross told Formulary Watch that the exclusion applies to a small number of drugs and therapies where there is “a lack of acknowledged clinical benefit that the FDA has nonetheless granted accelerated approval for. To ensure that our members receive treatments that are truly safe and effective in treating their diagnosis or condition, IBX 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 18-month exclusion, the spokesperson said provides time to review emerging studies and data and any additional clinical evidence supporting the drug’s safety and efficacy. “If new information becomes available that demonstrates that the treatment is effective, we will update the benefits to include coverage,” she said.

Independence Blue Cross has said that it supports the accelerated approval pathway, but the program doesn’t guarantee that drugs are safe or effective. The spokesperson points to the example of consider Aduhelm (aducanumab-avwa), a biologic that previously received accelerated approval from the FDA to treat patients with Alzheimer’s disease.

Related: Biogen Stops Selling Alzheimer’s Drug Aduhelm

Aduhelm had received accelerated approval in June 2021, but its approval was controversial from the start. Initial data had suggested it worked by reducing beta amyloid plaques in the brain, which many experts believe causes the disease. The late-stage development program for the drug consisted of two phase 3 clinical trials: one met the primary end point, showing a reduction in clinical measures of the effects of Alzheimer’s disease on cognition, but the other did not. The FDA approved the therapy even after an advisory committee voted against it, saying the data created uncertainties about the drug’s clinical benefit.

But its high price and lack of coverage from payers, that considered the drug experimental, including a final coverage decision by the Centers for Medicare and Medicaid Services that Medicare coverage would be provided for Aduhelm those who are enrolled in clinical trials, Biogen stopped selling the product in January 2024.

Peter Rubin

Peter Rubin, executive director of No Patient Left Behind, a nonprofit founded by patient advocates, policy leaders and pharmaceutical leaders and investors, said the policy restricts access to potentially life-saving treatments for people facing terminal or severe conditions.

“A policy that says we're not going to cover an FDA approved product that’s recommended by a physician arbitrarily for 18 months no matter what evidence you present in that individual case, is a horrible policy and should be revoked,” he said in an interview.

The Independence Blue Cross policy, Rubin said, creates a dangerous precedent. Health plans, he said, have the potential to manage people’s care in the most efficient way and maximize care outcomes.

Rubin said a policy that limits coverage for drugs with accelerated approval hurts the sickest patients. “Patients who at that stage where they are relying on accelerated approval treatments, they’ve exhausted every other option,” he said. “This isn’t about first-line coverage. They have prohibited them from being used as last-line therapies.”

The FDA approves therapies under the accelerated approval pathway because there are no other options for patients. “This is a something that can make a big difference to individual patients in these extreme cases. This is something that is bigger than just simply an FDA the approval process. It’s more nuanced.”

Rubin also expressed concerns about a lack of transparency about a new policy this is announced after contracting timelines. “To have this policy creep in after many people have made their decision about choosing a plan is also quite insidious. It’s not just the policy itself; it's also how the plan went about it.”