Gaurav Gupta Comment on the Proposed Decision for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease
Incubate Advisory Council member Gaurav Gupta's comment on CMS's Proposed Decision for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease
02.10.2022
February 10, 2022
Tamara Syrek Jensen, JD
Director, Coverage and Analysis Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
Electronically Submitted
RE: Proposed Decision Memo for Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer’s Disease
Director Jensen:
In my training as a neurosurgeon, I have seen the devastation neurological conditions bring to patients and their families. I have also seen how lives can be changed through new treatment breakthroughs. I am a venture capital investor in early stage biotechnology companies, making investments to ensure these breakthroughs can continue. The proposed National Coverage Determination to only cover anti-amyloid monoclonal antibody treatments (mAbs) for Medicare patients enrolled in clinical trials is incredibly concerning, and will have disastrous effects on future medical innovation and investment into new Alzheimer’s treatments. Therefore, I believe this decision must be withdrawn.
Historically, venture capitalists incur losses on investments into Alzheimer’s treatments because these drugs have a less than 1% chance of making it through clinical trials. However, we continue to invest because we know new treatments do not start from square one – we can learn from and build on those initial failures and inject capital into therapeutic area research and development to spur future successes. Research into a certain area of drug development can mean approval and coverage for more– one Alzheimer’s drug could open the door to many others down the line.
From an investor’s perspective, the decision to apply this proposal to the entire class of mAbs will have a chilling effect on innovation in this area of drug development. Investors will struggle to justify risking capital in Alzheimer’s research if there is uncertainty around whether CMS will cover FDA approved drugs. In turn, biotech companies in this space will be unable to raise funding, and will move into other areas of research, leaving Alzheimer’s patients with no options.
This decision also undermines the FDA’s gold-standard system by restricting access to drugs that have already undergone the Agency’s review and approval process. By law, Medicare Part B must cover medicines that are “reasonable and necessary” for treatment. Covering mAbs only for patients who are enrolled in clinical trials goes against CMS’s commitment to covering medicines that all patients need to access.
Pharmaceutical investment comes with a great deal of risk, yet the benefit to patients nationwide is unmatched when the system works properly. On behalf of my colleagues in the venture capital community, and on behalf of the patients we aim to help, we ask that this decision be changed. Thank you for the opportunity to comment on this matter.
Sincerely,
Gaurav Gupta, MD, MS
Founder and Managing Partner of Ascendant BioCapital