Kerry Dooley Young, Medscape Medical News: February 16, 2022
Medicare has received a key endorsement of its plan to restrict payment for the controversial Alzheimer’s disease (AD) drug aducanumab (Aduhelm) — but also drew pleas from other groups for more generous reimbursement of the drug, as well as expected similar medications currently in development.
The Centers for Medicare & Medicaid Services (CMS) received more than 9900 comments on its plan, according to the current tally posted on its website. However, it is unclear when the final count will be available.
CMS intends to limit federal payment for monoclonal antibodies that target amyloid to clinical trials. Among supporters of this approach is the influential Medicare Payment Advisory Commission (MedPAC), an expert panel that helps Congress and CMS manage the federal health program.
Opponents of the CMS plan include several pharmaceutical companies. Patient and consumer groups, individuals, and lawmakers had mixed views.
CMS officials will weigh the feedback provided in the comments when setting a final coverage policy for aducanumab. It is expected the agency’s final decision will be announced on April 11.
In his comment to CMS, MedPAC chairman Michael E. Chernew, PhD, noted the change in CDR-SB score of 0.39 in EMERGE’s high-dose aducanumab group. CMS has described this as being “less than the 1 to 2 point change that has been suggested as a minimal clinically important difference,” Chernew wrote.
MedPAC does not normally comment on Medicare coverage decisions, but did so in this case because of its significance and because of the potential fiscal implications, he noted.
In its comment to CMS, Biogen questioned the agency’s legal grounds for limiting coverage of aducanumab. A mandate on clinical trials as part of the CED proposal “runs afoul of the Administrative Procedure Act’s prohibition against arbitrary and capricious agency action,” Biogen said.
Patient groups such as UsAgainstAlzheimer’s told CMS the CED approach would worsen disparities, despite the aim of Medicare officials to increase participation of Black and Latinx patients in future testing.
“CMS will be hard-pressed to achieve diversity if such hospitals are the only locations where Medicare beneficiaries are able to access mAbs,” USAgainstAlzheimer’s wrote in a February 10 comment.
In contrast, the nonprofit National Center for Health Research (NCHR) praised CMS for what it described as an effort to address a lack of representation of Black and Latinx patients in earlier aducanumab research.
However, the NCHR also suggested CMS revise its plan to mandate that clinical trials include patients who are representative of the national population diagnosed with AD.
“Rather than being concerned about the percentage of patients in specific racial and ethnic groups, we propose that CMS include sufficient numbers of patients in different racial, ethnic, and age groups to ensure that there is enough statistical power for subgroup analyses to determine safety and efficacy for each of the major demographic groups,” the NCHR wrote.
Patient Health, Medicare at Risk
On February 8, a group of House Republican lawmakers asked CMS to reverse its stance. In a publicly released letter , Rep. Cathy McMorris Rodgers of Washington state, the ranking Republican on the House Energy and Commerce Committee, and colleagues urged broader coverage of aducanumab.
In the letter, the group emphasized the idea of aducanumab as a potential treatment for patients with Down syndrome who are at-risk for AD.
On the other hand, CMS garnered earlier support from influential Democrats. On January 13, House Energy and Commerce Chairman Frank Pallone Jr (D-NJ) and House Oversight and Reform Chairwoman Carolyn B. Maloney (D-NY) released a letter praising CMS for its plan for covering aducanumab.
In addition to the HHS-OIG review of the FDA’s approval of the drug, the two House committees are in the midst of their own investigation of the agency’s decision to clear the drug.
“Any broader coverage determination before there is clarity on Aduhelm’s approval process and findings from the myriad ongoing investigations may put the health of millions of Alzheimer’s patients on the line and the financial stability of the nation’s health insurance program for American seniors at risk,” Pallone and Maloney wrote.
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