Medicare to decide when new Alzheimer’s drug is covered

As a rule, Medicare covers all federally approved treatments and medicines. But, there are always exceptions. Rachel Cohrs and Ed Silverman report for Stat that coverage for Aduhelm, the ridiculously expensive new Alzheimer’s drug, which is not at all guaranteed to be effective, will be one of them. In this case, Medicare is doing the right thing.

The Food and Drug Administration (FDA) should never have approved Aduhelm as broadly as it did, if at all. In fact, it approved the drug against the advice of its advisors. After a large outcry, it narrowed its approval to people with mild cognitive impairments, the condition studied in the clinical trial.

Whether the drug is clinically effective is still questionable, and it appears it can cause serious side effects, such as brain swelling and bleeding. Interestingly, two large hospital systems have just announced that they will not administer Aduhelm, Mount Sinai Health System in New York and the Cleveland Clinic in Ohio.

The FDA does not approve drugs based on their cost. But, in this case, approving Aduhelm, which costs $56,000 a year, opens the door to driving up Medicare, spending and depleting the Medicare Trust Fund, at a rapid rate, as well as increasing the cost of Medicare supplemental coverage.

It’s therefore good news that Medicare is making a national coverage determination with regard to Aduhelm. Medicare will determine who qualifies for Medicare coverage of Aduhelm and when.

There’s some evidence that people with mild Alzheimer’s symptoms could benefit from the drug. If Medicare approved the drug for this cohort, it could cover as many as 1-2 million people. But, should it? To understand how this would impact Medicare spending, it would cost $29 billion to pay for the drug for 500,000 people.

Since Medicare does not provide full drug coverage for any drug and copays can be significant, it’s not clear how many people with Medicare could even afford the drug.

Stakeholders will be able to weigh in on Medicare’s decision. So, it will likely take nine months.

Here’s more from Just Care:

• New Alzheimer’s drug has questionable benefits and costs a small fortune
• FDA hides data on medical device malfunctions and injuries
• One in three FDA-approved drugs have safety risks
• Avoid supplements with these 15 ingredients
• The deadly consequences of out-of-pocket drug costs