Cambridge-based Biogen said in a statement, as it did after several subsidiaries of Blue Cross and Blue Shield in other states decided not to cover the drug, that “Aduhelm is FDA approved and is neither experimental nor experimental ”.
“We are disappointed that this inaccurate characterization has led some commercial plans to temporarily deny patients access to Aduhelm, but these plans represent a very small portion of the potential patient population,” said Biogen.
James Chambers, associate professor of medicine at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, has followed how private insurers run Aduhelm in the United States. On Friday, he identified at least nine other insurers who called the drug experimental or investigative and refused to cover it.
The move by Point32Health and other private insurers is a black eye on Aduhelm, but will hardly have the impact of what would happen if the federal government imposed restrictions on Medicare patients. The Centers for Medicare & Medicaid Services, or CMS, recently began a review of Aduhelm’s Medicare coverage, a process expected to take about nine months.
Sherman said two Point32Health committees, one made up of outside medical experts and the other made up of employees who have consulted with experts, recently voted unanimously that the insurer should not cover Aduhelm.
The votes were driven by several factors, he said, including conflicting results in two late-stage clinical trials and the fact that up to 40% of people treated in the studies had side effects such as dizziness. and small bleeding in the brain.
The insurer has also taken into account recent developments, he said. He noted that an independent expert advisory panel to the FDA voted overwhelmingly in November that there was not enough evidence to recommend Aduhelm’s approval. After the FDA ignored the panel’s recommendation last month, three members resigned in protest, including Harvard Medical School professor Dr. Aaron Kesselheim.
In addition, the executive committee of the American Neurological Association recently concluded that “based on clinical evidence, Aduhelm should not have been approved at this time.”
Sherman also noted that the Acting Commissioner of the FDA, Dr Janet Woodcock, on July 9 asked the Independent Office of the Inspector General of the Department of Health and Human Services to investigate the process that led to approval. She cited interactions between Biogen employees and drug regulators, first reported by STAT, which “may have taken place outside of the formal correspondence process.”
Michel Vounatsos, CEO of Biogen, said Thursday in a presentation of quarterly results that Biogen supports data from the clinical trials that led to the drug’s approval and that there was nothing unusual about the interactions between company employees and federal regulators. He said the negative media coverage was misleading patients who could benefit from the drug.
Point32Health’s decision regarding Aduhelm came as no surprise. A month ago, Sherman said the insurer may not cover the drug at the current price, accusing Biogen of putting “excessive corporate profits” before patients. But he said on Friday that the price was not factored into the committee’s reviews.
He noted that several leading health systems, the Cleveland Clinic, the New York-based Mount Sinai Health System and Providence of Renton, Wash., Have said they will not administer Aduhelm, citing the federal investigation, the potential side effects and the lack of convincing clinical evidence that the drug works.
Ultimately, Sherman said, the insurer based its decision on the results of two large clinical trials, which gave conflicting results. In one study, a high dose of Aduhelm delayed cognitive decline by 22%, an encouraging result. The other trial failed to prove the drug was effective.
“If the efficacy data were positive, then these [other] items would have been less relevant, but they provide an even greater affirmation that our decision is the right one for those we serve, ”Sherman said.
Point32Health has approximately 2.2 million members in Connecticut, Maine, Massachusetts, New Hampshire, and Rhode Island. About half of them receive their insurance through government-sponsored programs, such as Medicare Advantage, which Point32Health helps administer.
Aduhelm’s CMS review is expected to have a much larger effect on whether patients in the United States are eligible for insurance coverage than the decisions of private insurers. The vast majority of the roughly 6 million Americans with Alzheimer’s disease – 96% by one estimate – are over 65 and would rely on Medicare as their primary insurer for coverage. Biogen estimates that there are 1 million to 2 million people who show early symptoms and could benefit from the drug, which the FDA recently recommended that doctors start patients only if they have mild cognitive impairment.
Sherman said if CMS determines Medicare or Medicaid will cover Aduhelm, Point32 will need to change its policy to allow members of those programs to submit claims.
Jonathan Saltzman can be reached at [email protected]