- HHS Secretary Xavier Becerra has instructed CMS to reassess its recommendation for Medicare premiums this year after Biogen cut the price for its controversial Alzheimer's drug Aduhelm in half.
- CMS in November published a historic 14.5% hike in monthly premiums for outpatient care in 2022 — the program's largest premium increase ever. One of the factors regulators cited for the increase was uncertainty over the cost of Aduhelm, a new and pricey drug that has raised eyebrows for unclear effectiveness.
- It's an unusual step for HHS, given the plan year has already begun, and comes just days before a CMS deadline to issue a draft decision that will shape Aduhelm coverage nationwide.
Biogen cut the price of Aduhelm nearly in half from $56,000 a year to $28,200 in December following disappointing sales, a price some still maintain is higher than necessary. Despite the pharma giant's high hopes for the drug, other healthcare operators have proved less certain of its efficacy.
A number of health systems have said they wouldn't prescribe the drug to patients. Meanwhile, most major payers are waiting on CMS to issue a national coverage determination before deciding whether to cover the expensive drug.
CMS is currently hammering out a single, nationwide policy for all amyloid-targeting treatments for Alzheimer's, which purport to slow dementia by reducing clumps of plaque in the brain.
Aduhelm is currently the only greenlit drug of that type, after being approved by the Food and Drug Administration in June. That approval resulted in fierce backlash, with many experts arguing Biogen had not clearly demonstrated Aduhelm was effective. Three of the agency's advisors quit over the decision, which also sparked a government watchdog investigation.
Regulators are bumping up against a Wednesday deadline to issue a draft of their national coverage determination. The decision could create clinical guidelines around who can receive the drug and other future therapies that function similarly to Aduhelm, and relies on whether such drugs are determined "reasonable and necessary" for treating Alzheimer's, a disease that affects more than 6 million people in the U.S. Regulators traditionally aren't supposed to take cost into account when making their determination.
After issuing the draft, the agency has another three months to finalize it. A final coverage decision scheduled to be released by April 12.
With the new order, Becerra is bowing to pressure from some Democratic lawmakers over concerns Medicare premiums for 2022 were too high for U.S. seniors. In November, CMS said standard monthly Medicare Part B premiums would be $170.10 for this year, compared to $148.50 in 2021.
Regulators chalked about half of that increase up to contingency planning if Medicare decides to cover Aduhelm, which would add to the cost of outpatient coverage because it's administered intravenously in a doctor's office and paid for under Part B.
But "given the dramatic price change" of the drug, Becerra has instructed CMS to reassess its Medicare Part B premiums for 2022, the HHS secretary said in a Monday statement, noting the 50% price drop is a "compelling basis" for reexamining the recommendation.