State’s second-largest health insurer condemns Biogen over costly Alzheimer’s drug

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“If Biogen came to us with a fair price, we would strongly consider covering it for people who might need it,” said Sherman, who was Harvard Pilgrim’s chief medical officer for 10 years, in an interview.

If Biogen doesn’t lower the price, he said in an email, Cambridge-based biotechnology “demonstrates its willingness to put excessive corporate profits ahead of the well-being of the patients we all serve.”

Point32Health is the first Massachusetts health insurer to publicly oppose Aduhelm’s price and could be an indicator for the industry.

Biogen spokeswoman Allison Parks said the drug company declined to comment.

Biogen faces a backlash against Aduhelm, which the US Food and Drug Administration approved on June 7 over objections from the agency’s science advisory board, including three members who resigned in protest, claiming Biogen did not had failed to prove its effectiveness. It is the first new drug for Alzheimer’s disease to be cleared by the FDA since 2003 and is expected to be a multi-billion dollar blockbuster, despite the doubts of many experts as to its effectiveness. .

The nonprofit Alzheimer’s Association lobbied for approval of the drug despite conflicting results from two late-stage clinical trials. But the advocacy group called the price “just plain unacceptable” and urged Biogen to lower it.

So are lawmakers on Capitol Hill, some of whom also skewered the FDA for approving the drug. Rep. Jim Cooper, a Democrat from Tennessee, said his wife recently died of Alzheimer’s disease and effective therapies are needed for the devastating form of dementia.

“But this drug doesn’t seem to be working,” he said in a statement, according to a Bloomberg article on Tuesday. “Charging $ 56,000 for a drug that doesn’t work is a scam.”

One of the biggest concerns is the cost of Aduhelm for Medicare. Analysts have predicted that Medicare and its registrants, who pay a share of their prescription drug costs, will spend between $ 5.8 billion and $ 29 billion a year on the drug, which could be more than the U.S. government spends. for some entire agencies, such as Nasa.

The vast majority of people with Alzheimer’s disease are 65 years of age and over and are therefore covered by the federal medicare program. With FDA approval, the drug is automatically covered under Part B.

But it is possible that some restrictions will be put in place that will slow access to Medicare beneficiaries, industry experts have said. Regional contractors who process health insurance claims may decide to limit coverage. And the Centers for Medicare and Medicaid Services, or CMS, may be asked to conduct a study to establish national standards for Aduhelm, a process called National Coverage Determination, which could take months or even a year.

Sherman said Point32Health must follow federal government guidelines on how the insurance company covers Aduhelm for people on Medicare Advantage, the government-funded program provided by private insurers.

But Point32Health, which has around 1.1 million clients with government-funded insurance, will have the ability to cover Aduhelm for its other business clients, Sherman said.

“We are not rushing to create a positive hedging policy,” he said. “We do not say no, but we hope that [Biogen] rethink their price expectations and come up with something that will promote market access. “

“If Biogen chooses to maintain its prices, our policies will likely be restrictive,” he added.

In recent years, pharmaceutical companies have gained approval for drugs that are much more expensive than Aduhelm, but these drugs were typically intended for rare diseases that affect thousands of people, not millions.

In 2019, for example, AveXis, a subsidiary of Swiss pharmaceutical giant Novartis, fixed the price of Zolgensma, a breakthrough gene therapy, at $ 2.1 million to treat children under 2 years of age with spinal muscular atrophy, a rare disease that kills more infants than any other. other inherited disorder. Zolgensma is a one-time treatment.

Aduhelm is much cheaper, but it requires monthly intravenous infusions and will have a much greater impact on the healthcare system. Alzheimer’s disease affects approximately 5.8 million Americans and is the sixth leading cause of death in the United States. Biogen said the drug is designed to slow cognitive decline in people with early symptoms of the disease, around 1 million to 2 million in the United States, but the FDA label does not limit it only to patients with the disease. early-onset Alzheimer’s disease.

In recommending that Biogen only charge $ 5,400, Sherman was using the midpoint of what Boston’s drug price watchdog, the Institute for Clinical and Economic Review, or ICER, suggested in an early draft report. May, before the drug gets FDA approval.

This group said Biogen generated “insufficient” evidence to conclude that the drug would help patients. Citing worrying potential side effects, including swelling of the brain that usually does not cause severe symptoms, the ICER said the drug justifies an annual price of $ 2,500 to $ 8,300, if approved.

Amy McHugh, spokesperson for Blue Cross Blue Shield of Massachusetts, said the state’s largest insurer is still considering the benefits of the new drug and how to cover it. The review process, she said, typically takes one to four months.

Lora Pellegrini, president of the Massachusetts Association of Health Plans, a trade group that represents Point32Health and more than a dozen small insurers, said its members consult experts and review research before deciding how to cover the drug. They will also see how Medicare manages Aduhelm’s coverage.

“In the end, will it be effective? It all has to be weighed, ”Pellegrini said. “There is a lot of debate about its effectiveness at this point. “

Priyanka Dayal McCluskey and Felice Freyer of Globe staff contributed to this report.


Jonathan Saltzman can be reached at [email protected]

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