The Centers for Medicare and Medicaid Services announced that it would only cover the expensive new Alzheimer’s treatment from Biogen for patients enrolled in clinical trials, significantly limiting the patient population that could benefit from it.
“CMS has proposed an evidence-based coverage policy after experts reviewed all relevant publicly available evidence and feedback received from stakeholders,” said CMS Administrator Chiquita Brooks-LaSure.
The treatment, marketed by Biogen under the name Aduhelm, will be covered for seniors in the early stages of the disease who are enrolled in CMS-approved clinical trials as well as clinical trials funded by the National Institutes of Health. CMS will hold a 30-day public comment period for the proposed policy and expects to issue a final coverage decision April 11.
IN COST-SAVING MOVE, MEDICARE COULD LIMIT PATIENT ACCESS TO ALZHEIMER’S TREATMENT
Aduhelm was approved by the Food and Drug Administration last June against the counsel of 10 out of 11 of the agency’s panel of experts, who argued that scant evidence that the treatment works to slow cognitive decline did not outweigh the health risks. Some of the risks involved in receiving the treatment, which is given as a monthly intravenous medication, are headaches and brain bleeds.
“This proposed National Coverage Determination is the result of robust evidence analysis conducted through a thorough review process that found while there may be the potential for promise with this treatment, there is also the potential for harm to patients,” said CMS Chief Medical Officer Dr. Lee Fleisher.
The infusion’s high cost is also a sticking point for Medicare beneficiaries. Biogen initially priced the drug at $56,000 for a year’s supply but halved that price amid outrage over the cost and its implications for Medicare premiums overall. In November, before a coverage decision was made, CMS imposed a 15% increase for premiums in Medicare Part B, which covers physician and outpatient hospital services, bringing monthly costs to $170.10 for 2022. Patient advocates have mounted pressure on Secretary of Health and Human Services Xavier Becerra to reassess the premium hikes given the price cut.
It is unusual for Medicare to deliberate on whether to cover an FDA-approved drug, but the potential financial harm to the government healthcare program of paying for it could be significant.
“With the 50% price drop of Aduhelm on January 1, there is a compelling basis for CMS to reexamine the previous recommendation,” Becerra said Monday.
CLICK HERE TO READ MORE FROM THE WASHINGTON EXAMINER
The treatment has gotten relatively little traction since its approval, with many major health systems declining to offer it while evidence of its effectiveness, as well as the agency’s standards for approval, are evaluated. For instance, the Cleveland Clinic and Mount Sinai Health System in New York announced last summer that it would not administer Aduhelm over scarce evidence that it works.
The Alzheimer’s Association praised the FDA’s decision last summer, which marked the first approval of a treatment for the disease in nearly two decades. However, the organization slammed Tuesday’s policy proposal, calling the restricted coverage “shocking discrimination against everyone with Alzheimer’s disease.”
“With this approach, access to treatment would now only be available to a privileged few, those with access to research institutions, exacerbating and creating further health inequities,” said Harry Johns, the group’s CEO. “For those in the administration to treat those with Alzheimer’s disease differently than those with other diseases is simply unacceptable.”
