State’s second-largest health insurer says it won’t cover new Alzheimer’s drug

The state’s second-biggest private health insurer said Friday it will not cover Biogen’s controversial new Alzheimer’s drug because of fundamental concerns about the effectiveness and safety of the $56,000-a-year medicine.

Point32Health, the company formed by the recent merger of Tufts Health Plan and Harvard Pilgrim Health Care, is the first insurer in Massachusetts to balk at covering Aduhelm, which was approved by the US Food and Drug Administration on June 7. Several affiliates of Blue Cross and Blue Shield in other states have declined to cover it.

“We have concluded it’s experimental and investigational and therefore not a covered benefit,” said Michael Sherman, chief medical officer for the insurer, who couldn’t recall a similar decision in his 10 years at Harvard Pilgrim and Point32Health. “We all want to see a cure [for Alzheimer’s], but most of the experts believe that approval was premature.”

The decision was not entirely unexpected. A month ago, Sherman expressed deep reservations about coverage for Aduhelm, the first new Alzheimer’s treatment since 2003, citing the conflicting results of Biogen’s two late-stage clinical trials and the drug’s steep list price. Still, it is another black eye for the Cambridge drug firm that one of its hometown insurers is rejecting its signature medicine.

Point32Health has about 2.2 million members in Connecticut, Maine, Massachusetts, New Hampshire, and Rhode Island.

Biogen said in a statement, as it did after several Blue Cross and Blue Shield affiliates in other states decided not to cover the drug, that “Aduhelm is approved by the FDA and is neither experimental nor investigational.”

“We are disappointed that this inaccurate characterization is leading some commercial plans to temporarily deny patients access to Aduhelm, however these plans represent a very small portion of the potential patient population,” Biogen said.

James Chambers, an associate professor of medicine at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, has been tracking how private insurers handle Aduhelm. As of Friday, he had identified at least nine other insurers — all affiliates of Blue Cross and Blue Shield — that have characterized the drug as experimental or investigational and declined to cover it.

Blue Cross Blue Shield of Massachusetts, the state’s largest private health insurer, with 2.8 million members, has said it is reviewing trial data and conferring with doctors and expects to make a coverage decision by the end of the month.

The resistance of private insurers may not amount to a material blow to Biogen, as the big insurer for Alzheimer’s treatments remains the federal Medicare program. The vast majority of the roughly 6 million Americans with the disease — 96 percent by one estimate — are over age 65 and would rely on Medicare as their primary insurer. The Centers for Medicare & Medicaid Services, or CMS, recently began a review of Medicare coverage of Aduhelm, a process expected to take about nine months.

At Point32Health, Sherman said two committees, one made up of outside medical experts and another made up of employees who consulted experts, recently voted unanimously that the insurer should not cover Aduhelm.

The votes were driven by several factors, he said, chiefly the conflicting trial results and the fact that up to 40 percent of those treated in the studies had side effects such as dizziness and small brain bleeds.

The insurer also considered recent developments, he said. He noted that an independent advisory panel of experts to the FDA voted overwhelmingly in November that there was insufficient evidence to recommend Aduhelm’s approval. After the FDA disregarded the panel’s recommendation last month, three members resigned in protest, including Dr. Aaron Kesselheim, a Harvard Medical School professor.

In addition, the executive committee of the American Neurological Association recently concluded that “based on the clinical evidence, Aduhelm should not have been approved at this time.”

Sherman also noted that the FDA’s acting commissioner, Dr. Janet Woodcock, on July 9 asked the Department of Health and Human Services’ independent Office of the Inspector General to investigate the process that led to the approval. She cited interactions between Biogen employees and drug regulators, first reported by the news site STAT, that “may have occurred outside of the formal correspondence process.”

Michel Vounatsos, Biogen’s chief executive, said in a quarterly earnings presentation Thursday that Biogen stands behind the clinical trial data that led to the drug approval and that there was nothing unusual about interactions between company employees and federal regulators. He said negative media coverage was misleading patients who might benefit from the medicine.

In late June, Sherman issued an unusually pointed criticism of Aduhelm, warning that the insurer might not cover the drug at the current price. At the time, he accused Biogen of putting “excessive corporate profits” ahead of patients, but on Friday he said that price didn’t come into play in the committee reviews.

He noted that several prominent health systems, Cleveland Clinic, New York City-based Mount Sinai Health System, and Providence of Renton, Wash., have said they will not administer Aduhelm, citing the federal investigation, potential side effects, and a lack of compelling clinical evidence that the drug works.

Ultimately, Sherman said, the insurer largely based its decision on the outcomes of two large clinical trials, which yielded contradictory results. In one study, a high dose of Aduhelm delayed cognitive decline by 22 percent, an encouraging result. The other trial failed to prove the drug was effective.

“If the efficacy data were positive, then those [other] elements would have been less relevant but they do provide even greater affirmation that our decision is the correct one for those that we serve,” Sherman said.

Roughly half of Point32Health’s members receive their insurance through government-sponsored programs, such as Medicare Advantage, which private insurers help administer.

The CMS review of Aduhelm is expected to have a much greater effect on whether patients in the US can receive insurance coverage than the decisions of private insurers. Biogen estimates there are 1 million to 2 million people who have early symptoms and might benefit from Aduhelm, which the FDA recently recommended that doctors start patients on only if they have mild cognitive impairment.

Sherman said that if CMS determines that Medicare or Medicaid will cover Aduhelm, Point32Health would have to change its policy to let members in those programs submit claims for reimbursement.

Jonathan Saltzman can be reached at jonathan.saltzman@globe.com.