Deena Bearsley

(Reuters] – Aduhelm, Biogen Inc’s expensive and controversial Alzheimer’s drug is in danger of being canceled by the U.S. Medicare Program. It will decide this week whether the Medicare program will cover the cost.

Centers for Medicare and Medicaid Services worked since July to develop a nationwide coverage policy for Aduhelm. It was approved last June by the U.S. Food and Drug Administration despite being questionable in its effectiveness against this brain-wasting condition. Aduhelm was only shown to slow Alzheimer’s patient’s cognitive decline in one of Biogen’s pivotal trials.

Many experts questioned the FDA’s rationale for Aduhelm’s approval without more definitive proof of benefit and doctors have held back on prescribing it.

A number of key healthcare providers such as the U.S. Veterans Health Administration and Mount Sinai Health System have indicated that Aduhelm would not be prescribed for their patients.

So far, sales have not been strong and Biogen cut last month the list price of the medication by half to $28,200 annually.

Aduhelm’s price is high and has caused concern about how it will affect Medicare, America’s government healthcare plan for seniors 65+. Around 85% of those who could use Aduhelm are covered by the government health plan as Alzheimer’s disease is an age-related condition.

Aduhelm, a monoclonal anti-inflammatory antibody, is administered as a monthly injection. This treatment removes a form of plaque in the brain that can lead to Alzheimer’s Disease. Potential side effects such as brain swelling should be closely monitored by patients.

The agency’s final coverage terms, due by April 12, are expected to apply to all drugs in the class, including experimental medications in development by Eli Lilly & Co (NYSE:), Roche Holding AG (OTC:) and Biogen partner Eisai Co (OTC:) Ltd.

FOUR OPTIONS

According to James Chambers (researcher at the Center for the Evaluation of Value and Risk in Health, Tufts Medical Center), Medicare offers four options.

Aduhelm could be covered by the agency for patients that meet FDA criteria. Chambers stated that it was unlikely after all the opposition from the medical profession.

He said that it would be politically difficult for Medicare to refuse coverage. This makes the possible option of “something in between”.

Medicare could limit Aduhelm use to a specific population. But, these limits wouldn’t reflect the wide range of Medicare patients.

Chambers indicated that Medicare would be most likely to cover a program that collects evidence on Aduhelm’s effects on patient outcomes like a patient registry.

BMO Capital Markets estimates that Biogen could be supported by full Medicare coverage at $468. A decision to deny access would see Biogen rise to $190.

Biogen shares, which rose to $400 after Aduhelm was approved by the FDA in June, are down 13% since then, closing Monday at $235.31.

Patient advocacy group UsAgainstAlzheimer’s on Monday urged a coverage decision “that is free of restrictions which would limit access for appropriate patients.”

Biogen thinks Medicare should provide Aduhelm coverage for patients that took part in clinical trials. This includes those with Alzheimer’s early stage who show evidence of amyloid brain spots.

Initial approval by the FDA for this medication was given to all Alzheimer’s patients. Despite criticisms from its advisers and others, FDA narrowed down the population that would be eligible for the medication a few weeks later.

“We believe that the patients who are consistent with those that we studied in our clinical trials is the right population,” Chris Leibman, Biogen’s head of value & access, told Reuters.

He stated that any requirement for monitoring patient outcomes would not be a duplicate of the efforts Biogen has made.