UPDATE: July 12, 2021: The Centers for Medicare and Medicaid Services announced it would initiate a National Coverage Determination process for “monoclonal antibodies targeting amyloid for the treatment of Alzheimer’s disease,” a class of drugs that includes Aduhelm and other experimental drugs in development. The agency began a 30-day comment period Monday and will hold two listening sessions in July to hear public input, after which it will decide whether a national coverage policy is necessary.
- The Alzheimer's Association, an influential patient advocacy group, is urging the Centers for Medicare and Medicaid Services to issue a nationwide coverage policy for Biogen's new drug Aduhelm to prevent "barriers to appropriate and equitable access." The request came days after the Food and Drug Administration reversed course and narrowed its guidance for who should receive treatment.
- Insurers are also seeking a single Medicare coverage policy, called a National Coverage Determination, to set guidelines on reimbursement. Biogen set Aduhelm's average price at $56,000 a year, concerning experts who argue the drug could inflate Medicare drug spending by tens of billions of dollars annually.
- Biogen has been under pressure over Aduhelm's price, given the the controversial and contradictory data supporting the drug's approval. The FDA, meanwhile, has also faced heavy criticism, and recently sought a federal investigation of its review process to address concerns that contacts with Biogen swayed its decisionmaking.
The conflicting clinical trial evidence backing Aduhelm, as well as the FDA's initial decision to approve the drug's use in all Alzheimer's patients, have spurred calls for CMS to set national coverage policies for how treatment through Medicare would be reimbursed.
As Alzheimer's primarily affects older adults, Medicare will likely cover the vast majority of patients who will receive Aduhelm.
The Alzheimer's Association, which argued in favor of Aduhelm's approval and has appeared an ally of Biogen throughout the FDA's review, called for a National Coverage Determination to "prevent regional and community level disparities due to barriers that would be difficult to overcome, particularly by those who have greater challenges accessing healthcare services."
Without an NCD, coverage policies could be set by private insurers and regional contractors who process Medicare claims, which could lead to differing criteria for authorizing reimbursement depending on what kind of plan a patient has or what part of the country they live.
The group also wants the NCD to be accompanied by a so-called rapid evidence development process that can provide clues on which patients benefit most while Biogen continues to research Aduhelm. The FDA granted Aduhelm an accelerated approval, which requires Biogen to conduct a confirmatory trial. But the drugmaker has many years to do so after the FDA set a 2030 deadline for submitting final data to the agency.
Uproar over the timeline led to a June 14 meeting between FDA officials and Biogen executives, and the agency has since said it expects Biogen to complete the trial "as soon as is feasible."
"We remain concerned that the subsequently announced confirmatory trial will not be conducted in a timeframe and manner that meaningfully informs important near term decision making by policymakers, payers, healthcare providers, and patients and their families," the association said in a statement. A CMS evidence development study "would create rapid, open access to crucial information" regarding the drug's safety and efficacy, the association said.
Meanwhile, America's Health Insurance Plans, a trade group representing insurers, has also sought an NCD. In a letter sent June 30, before the FDA narrowed the eligible patient population, AHIP also asked for a rapid evidence development plan, as well as clear guidance on when Aduhelm will be determined to be medically necessary.
AHIP also asked for clear guidance on coverage of the pricey brain imaging that's necessary to determine whether a patient has the characteristic brain plaques which Aduhelm is designed to clear.