Industry Reacts to CMS Medicare Coverage Determination Proposal

Payers are reacting to the CMS proposed Medicare coverage determination for Alzheimer’s treatments that use monoclonal antibodies directed at amyloid, such as Biogen’s Aduhelm.

“Americans deserve access to prescription drugs that are safe and effective, and we applaud CMS for putting patients first in their proposed coverage policy for monoclonal antibodies for treating patients with Alzheimer’s,” Matt Eyles, president and chief executive officer of AHIP, said in a publicly available statement.

Along with this affirmation, however, Eyles recognized that more work was necessary.

“We agree with CMS that there is a need to obtain more clinical data on efficacy, which will be essential to ensuring these new medications deliver real value to patients before broadening access,” Eyles added. “We look forward to commenting in greater detail during the comment period.”

AHIP also pointed to its earlier letter to CMS about the Medicare coverage determination process for Alzheimer’s treatments that use monoclonal antibodies directed at amyloid. That process began in the summer of 2021.

At the time, the payer organization noted that “substantial concerns have been raised about the safety and effectiveness of aducanumab,” a controversial drug that uses the same method of treatment. In light of the lack of data, the letter recommended approving coverage of the drug through a coverage with evidence development process. 

This process was the approach that CMS suggested employing in its proposal.

The organization also provided feedback on what metrics CMS should use to assess the drug’s efficacy and what would be considered a meaningful improvement for patients. For AHIP, these included few adverse events, improving or sustaining a patient’s ability fo function, and evidence that the drug slows or stops the progress of Alzheimer’s.

Ceci Connolly, president and chief executive officer of Alliance of Community Health Plans (ACHP), shared a response that was similar to AHIP’s in an emailed statement. She applauded the agency’s decision to evaluate this treatment option more closely and emphasized the uncertainties around this drug.

However, Connolly also touched on another set of concerns apart from efficacy.

“Given the limited scope of the drug's coverage within clinical trials, we hope this decision will factor into CMS' reevaluation of Part B premium increases,” Connolly stressed. 

Connolly referenced the agency’s announcement that 2022 premiums would rise in part to provide contingency reserves during the national coverage determination for Aduhelm. This increase boosted premiums from $148.50 per month in 2021 to $170.10 per month in 2022.

The contingency reserves would be necessary because Aduhelm’s original price tag was $56,000. Since CMS the Part B premiums for 2022, Biogen, the pharmaceutical manufacturer behind Aduhelm, halved the drug’s price to $28,000. 

Biogen pushed back on the agency’s proposal of a national coverage determination for treatments that use monoclonal antibodies directed at amyloid to treat Alzheimer’s.

Primarily, the pharmaceutical company cited the impact of delaying treatment for patients and called the national coverage determination repetitive, considering that the FDA had already approved Aduhelm, which uses this approach.

“If a final NCD, expected to be issued in April, continues to require a randomized controlled trial as outlined in this draft, it would likely take in excess of a year to begin enrolling patients, further delaying reimbursement for Medicare beneficiaries,” Biogen’s press release stated.

“It is imperative to change this draft decision to be aligned with reimbursement for other therapies for progressive diseases, where patients have immediate and equal access to medicines approved by the FDA.”

But the stakeholder with the highest stakes in this debate is, as always, the member and patient. In March 2020, a Blue Cross Blue Shield Association claims data analysis found that the prevalence of early-onset dementia and Alzheimer’s disease had increased 200 percent in just four years, from 2013 to 2017.

However, patient advocacy organizations and provider organizations are not all in agreement on whether to support or decry the CMS proposal.

Right Care Alliance, a grassroots organization of providers and patients, agreed with the proposal and called for CMS to reimburse seniors who had to pay higher premiums due to the contingency reserve.

“We also maintain our call on the FDA to withdraw this drug from the market immediately and thoroughly re-examine their processes for granting Accelerated Approvals so that such ill-considered decisions can be avoided in the future,” Vikas Saini, MD, chair of the Right Care Alliance, said in a statement.

Meanwhile, the Alzheimer’s Association took the opposite position, calling the proposal discriminatory against patients who have Alzheimer’s.

“Critically, this draft decision is not about one treatment but about this class of potential future treatments targeting amyloid for the treatment of Alzheimer’s disease. This draft decision appears focused on an individual treatment rather than a class, which is not what CMS set out to do,” Harry Johns, chief executive officer of the Alzheimer’s Association, argued in his statement against the proposal.

The industry will have 30 days to submit comments to the agency before CMS makes its final decision on the proposal by April 11, 2022.