New Alzheimer’s Drug Struggles To Get Insurance Coverage

Some private insurers say they will not cover Leqembi, a newly approved Alzheimer’s drug that made waves after its Food and Drug Administration (FDA) approval last month.

Insurers told the Associated Press they will not cover the drug over doubts about the drug’s effectiveness. These include Highmark, a Blue Cross Blue Shield (BCBS) affiliate in Delaware, New York, Pennsylvania and West Virginia; BCBS North Carolina and a Philadelphia-based BCBS affiliate Independence.

“Existing evidence does not allow for conclusions to be drawn about the safety and effectiveness of Leqembi,” Heidi Syropoulos, M.D., medical director of Independence, told the Associated Press about the decision.

The FDA granted approval to the drug in January under its Accelerated Approval pathway, which required further trials to be completed after the approval in order to remain on the market. 

It received full approval in July, a signal to insurers and patients alike that the drug is safe, effective and ready to be used. However, there are still some doubts surrounding it.

The drug, developed jointly by Biogen and Eisai, works by reducing amyloid beta proteins on the brain. When these proteins accumulate they cause plaque on the brain that some scientists have linked to cognitive decline.

Clinical trials showed that the drug could slow the progression of Alzheimer’s for some participants by around 27% over 18 months. This would make it the most effective drug against the disease on the market. However, some have cast doubts on the findings. The deaths of three patients in clinical trials have also raised alarm over the medications safety profile.

The drug will cost $26,000 per year. A majority of costs will be covered by tax payer-funded Medicare for users over the age of 65. This accounts for a vast majority of Alzheimer’s patients. However, some advocacy groups warn that patients may have to jump through hoops before coverage first.

Some people below the Medicare-eligible age may also struggle to find coverage. 

Leqembi is most effective in the disease’s earliest stages, and younger patients who start to show early signs of the disease are the ideal candidate to receive it. If insurers balk on coverage then access could be limited, though.

More than 6 million Americans over the age of 65 have been diagnosed with Alzheimer’s, two-thirds of them women. The chronic, progressive disease destroys memory and can impact other important mental functions, including the ability to perform basic tasks like cooking a meal or getting dressed. Options to treat the disease are relatively limited. There is currently no cure for Alzheimer’s disease.