CED Will Limit and Delay Patient Access
This CED will make a bad situation worse by severely restricting access to medications for people living with AD while their disease progresses every day. It will limit, delay and deny people living with AD-especially those in our most vulnerable and underserved communities-access to FDA-approved medications now and in the future.
Coverage would be available only through CMS-approved randomized controlled clinical trials (RCTs) and trials supported by the
Furthermore, only half of the patients in the trial would receive the FDA-approved medication. The other half could receive placebo or the current standard of care, which is treatment for symptoms or prevention efforts via lifestyle modifications and exercise.
Use of CED Duplicates FDA Processes and Sets Precedents with Unintended Consequences
We have grave concerns about the potential use of CED in a way that undermines the scientifically rigorous accelerated approval pathway-which has operated for the benefit of patients for decades-and attempts to duplicate the role of the FDA in assessing innovation without the necessary statutory authority nor the scientific expertise to do so.
The NCD draft restricts coverage for the drug approved under accelerated approval pathway with this devastating disease and discriminates against people living with AD as compared to other diseases, such as cancer and HIV/AIDS.
CED Proposal Contains Scientific and Analytic Limitations Regarding the Clinical Evidence
In our opinion, CMS' approach is not based in science. The agency is assuming that all drugs in the class are identical, which is incorrect. Essentially, the agency is extrapolating from its assessment of failed clinical trial results from the first generation of these medications (e.g., bapineuzumab and solanezumab) to restrict patients' access to not only an FDA-approved medication but all future drugs that operate by the same mechanism, without regard to FDA decisions on such products and the availability of much more relevant and growing evidence.
There are significant scientific and analytic limitations to the clinical evidence CMS considered, as well as the systematic review and meta-analysis conducted by scientists at the
In particular, the evidence review does not acknowledge recent Phase 2 clinical trial data from monoclonal antibodies with robust amyloid clearance, which support amyloid as a surrogate reasonably likely to predict clinical benefit.
CED Should Not Apply to Investigational Therapies
The overly restrictive CED means normal access to all drugs in this class would be delayed years; even for new drugs still being tested in clinical trials or not yet invented. Deciding before FDA approval to severely limit patients access to these potential medicines in development is wrong and contrary to applicable law.
There is no scientific reason for a CED to apply to lecanemab. Clarity AD will serve as the confirmatory Phase 3 study needed to verify clinical efficacy and safety of lecanemab in early AD patients and will report out only months after conclusion of the NCD.
Furthermore, approximately 25% of the total
The FDA granted lecanemab Breakthrough Therapy designation in June of 2021, based on the findings from the phase 2b clinical trial and its long-term extension exploring the impacts of lecanemab on reducing brain amyloid-beta and clinical decline. In
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