Insurers are reluctant to pay biogen’s $ 56,000 per year for Alzheimer’s treatment


U.S. health insurers say they want more evidence before paying for Biogen Inc.’s Aduhelm, blocking sales of expensive new Alzheimer’s therapy that the company has hailed as a breakthrough for patients .

None of the 25 major insurers that responded to a Bloomberg News survey deemed the $ 56,000 a year drug “medically necessary,” a term used to describe treatments needed for specific illnesses and meeting medical standards. Most have deemed Aduhelm experimental, while some say they are still evaluating it.

Insurers cited uncertainty about the benefits and side effects of their denials. Still, Humana Inc., the nation’s second-largest Medicare insurer, covers the drug for members who look like those it helped in clinical trials.

Health insurers and government programs will play an outsized role as custodians of Aduhelm, which the Food and Drug Administration has approved despite objections from its scientific advisers and conflicting clinical trial results. Some patients are paying for treatment out of pocket or looking for free supplies, while doctors who want to prescribe the drug have to work hard to justify it.

For each person deemed eligible for Aduhelm, staff members can spend five hours trying to get approval from insurers, said Paul Schulz, a physician at McGovern Medical School at UTHealth Houston and Memorial Hermann-Texas Medical. Center. It is rarely granted.

“It’s very difficult to spend so much time getting something approved on a case-by-case basis,” said Schulz, who deals with about half a dozen people with Aduhelm. He received honoraria from Biogen for giving speeches.

Medicare, which covers 63 million elderly and disabled Americans, will not set its final policy for Aduhelm until April, although the program is already increasing premiums in anticipation of demand. Private insurers say they need more evidence that treatment actually slows the rate at which Alzheimer’s patients deteriorate.

Aduhelm is not medically necessary for the treatment of Alzheimer’s disease “because a clinical benefit has not been established,” said a representative from Health Care Service Corp. in an email. The company has nearly 17 million members in Blue Cross Blue Shield plans in five states, including Texas.

Biogen did not respond to requests for comment for this story.

Doctors, patients and families desperately need relief from the memory-stealing Alzheimer’s disease that affects some 6 million Americans, mostly seniors. Aduhelm eliminates amyloid plaques, protein deposits that are believed to play a role in attacking the disease on the brain.

Questions about the drug’s effectiveness have persisted since it faltered in the U.S. market, with evidence so controversial that three FDA advisers resigned after its approval in June. The European regulator has indicated that it will not recommend the authorization.

As critics have warned the expensive therapy threatens to overwhelm government health programs, sales have been a trickle, disappointing investors in Biogen and its partner Eisai Co. Biogen shares have been riding high. drug fortune. Stocks touched close to $ 415 in June as the outlook for use still looked promising; since then they have fallen by more than a third.

Certain patient prescriptions are covered. Kaiser Permanente, the giant California-based health maintenance organization, said it pays for the drug when a member’s doctor determines it is medically necessary.

Humana’s decision to cover patients who meet the criteria for the trial is not final, a spokesperson said. The medicare-focused insurer remains concerned about conflicting data on the drug and said the health program’s decision will influence its final policy. Neither company reported how many members received the drug.

Other insurers are more restrictive. In Biogen’s June press release announcing the drug’s launch, an executive at Cigna Corp. said the company “is working to ensure that patients who will benefit the most from this new treatment have a clear path to access it.”

Since then, however, Cigna has called the drug “unproven” and will not cover it, according to its policy. In an emailed statement, the company cited “emerging concerns about its safety and effectiveness.”

At First Choice Neurology, a large chain of clinics in South Florida, about 80 patients receive Aduhelm, according to Jeffrey Gelblum, an office physician. Some commercial insurers approve claims for the drug, he said, without providing names.

Many patients who haven’t gotten the go-ahead get the drug for free from Biogen at least temporarily while the practice calls on their insurers, he said, which can take months. Gelblum said it was problematic for a drug most likely to work early in the disease.

“I don’t want to waste time,” he said in an interview. “You have a two-year window of intervention here, and if a patient comes in and says, ‘Look, I’ve had this problem for a year,’ well, now I know I already have a year of trouble. “

Determining whether patients are eligible for treatment can also be a barrier. One way to look for telltale amyloid plaques is a brain scan. The procedure costs around $ 5,000 and insurers will not pay.

Some of Marwan Sabbagh’s patients at the Barrow Neurological Institute in Phoenix paid for the exam themselves. Another option is a lumbar puncture. Biogen can even cover the cost of the test analysis. Still, many people fear the procedure. The neurologist offered entry to a clinical trial where analysis and treatment are paid for.

“There are a lot of bottlenecks,” said Sabbagh, who has been paid to advise Biogen. “It’s not exclusive to our health care system.

Major insurers who have not publicly disclosed their positions on Aduhelm and have not responded to questions from Bloomberg include Anthem Inc., CVS Health Corp. and Centene Corp. UnitedHealth Group Inc. referred to comments from July, when the company said it was still evaluating the drug and awaiting advice from Medicare.

While the government’s health program still decides to cover Aduhelm, millions of patients will soon be paying both ways: Medicare premiums will rise by around $ 11 per person per month in 2022 to prepare for the costs. potentials of the drug and similar therapies that may follow. .

Other insurers have said they will cover Aduhelm in their plans that administer Medicaid, the state’s federal health program for low-income people, if necessary. Molina Healthcare Inc., which has 4.8 million members primarily in Medicaid plans, said Aduhelm would only be covered as requested by states.

The drug is not covered by the company’s Affordable Care Act market offerings, where individuals and families can purchase government-subsidized health plans. Molina has yet to receive any requests for coverage, a spokeswoman said.

State Medicaid programs are required to cover the drug because Biogen participates in the Medicaid drug reimbursement program, a spokesperson for the U.S. agency said in an email.

Most of the insurers who answered Bloomberg’s questions said they would continue to assess new evidence and consider Medicare’s decision when it arises. As a condition of drug approval, Biogen is to do another study to confirm the benefits of Aduhelm. Adding to the turmoil, Biogen said this month that head of research Alfred Sandrock, 64, a key figure behind Aduhelm, will retire at the end of the year.

Meanwhile, doctors and patients who want the drug are looking for it through clinical trials or Biogen’s access program. Jonathan Liss, founder of Columbus Memory Center in Georgia, said two of his patients obtained the drug through the company’s program and that he personally covered the costs of a third.

Liss, who received money from Biogen to serve on advisory boards, said he was wary of starting patients on the drug who might have to quit if Medicare decides not to cover it.

“What I’ve said to a number of patients is ‘Look, I can get you the medicine,'” he said, “but I don’t know if it’s going to be paid for.”

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