Senator Collins Questions FDA Official on Whether Medicare Overstepped in Restricting Alzheimer's Treatments

Press Release

At a hearing focused on the Food and Drug Administration (FDA), U.S. Senator Susan Collins (R-ME), a member of the Senate Health Committee and a founder and co-chair of the Congressional Task Force on Alzheimer's Disease, questioned Dr. Patrizia Cavazzoni, the Director of the Center for Drug Evaluation and Research at FDA, about the Centers for Medicare and Medicaid Services' (CMS) decision to significantly curtail coverage of a new class of Alzheimer's treatments.

Senator Collins: "[CMS] recently finalized the national coverage determination for monoclonal antibodies directed at the amyloid plaque for the treatment of Alzheimer's disease. Under the NCD, if these monoclonal antibodies received accelerated approval, Medicare will cover them only in FDA or NIH approved trials. Now, Congress charged the FDA, not CMS, to be the agency responsible for evaluating the safety and efficacy of biomedical products, but CMS often makes coverage decisions on the basis of cost, an area where Congress has not empowered the FDA to weigh in. In this case, however, CMS routinely cites concerns about patient safety to justify their coverage determination, calling into question FDA's ability to evaluate this product class, so CMS is saying that in order to cover a drug that FDA has determined is safe for marketing, more safety data need to be generated. In light of the decision by CMS, do you question the FDA's decision making regarding Aduhelm's accelerated approval?"

Dr. Cavazzoni: "First, I would like to emphasize how committed we are to continue to utilize expedited pathways, including accelerated approval, to bring medicines to underserved populations, such as people suffering from Alzheimer's, and our decision on Aducanumab exemplifies our commitment. And we stand by that decision. We believe that the data are solid, and that the drug is appropriately made available to patients based on FDA's decision. It is important to distinguish FDA's role and CMS' role. FDA is squarely and solely responsible for determining whether a drug is safe and effective. And we made that determination when we approved Aducanumab. And that determination entailed our belief, that represented our belief, that the drug can be made available to patients. Now FDA does not have a role in making decisions about coverage. CMS works in tandem with FDA and have a different standard than the safe and effective standard, which is reasonable and necessary. And based on that standard, CMS have made decisions about coverage and reimbursement, which are translated into the setting in which they will be covering the drug for their beneficiaries."

Senator Collins followed up to caution that CMS' decision to go beyond its role of making coverage decisions threatens advances in research and development of Alzheimer's disease treatments.

Senator Collins said: "What concerns me in this case is not FDA's approach. I think you stayed within your lane, whether one agrees with the decision or not, you clearly stayed within your lane. But CMS did not because CMS commented not just on the reasonableness and the cost, but on the safety. And my next question for you is do you think that CMS getting outside of its lane and imposing additional restrictions will affect the number of pipeline products that may be reviewed through this pathway and may be of benefit to those suffering from Alzheimer's?"

Dr. Cavazzoni responded: "I cannot, I mean I'm not in a position to explain CMS' thinking, having said so, when it comes to the pipeline, it is actually very robust. We have a lot of drugs in the pipeline for Alzheimer's disease, including drugs in the same class as Aducanumab. It would be speculation to try to guess whether the decision might or might not impact future development, having said so, what I can tell you is that the pipeline is very healthy and we're very encouraged by the advances that are taking place in the fields of our time and science in general."

Senator Collins concluded: "And I guess what I would respond to that is CMS is so broad in its coverage decision on this that I fear it will discourage research and have an impact on the pipeline of drugs. I hope I'm wrong about that."

Last month, Senators Collins and Shelley Moore Capito (R-WV) wrote to CMS Administrator Chiquita Brooks-LaSure, urging her to carefully consider stakeholder feedback as her agency worked to finalize coverage for this product class. They emphasized the importance of ensuring that CMS' action did not inappropriately threaten patient access to treatment, including for those living in rural areas, or thwart advances in research and development in Alzheimer's disease treatments.

Source