Compromising Patient Access Is Not a Path Forward for Alzheimer’s Disease

We have serious concerns about how the NCD severely limits access to an entire category of new treatments for Alzheimers disease and will exacerbate health disparities.

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Retrieved on: 
Friday, April 8, 2022
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FDA, Public Policy, Government, Clinical Trials, Healthcare Reform, Biotechnology, Managed Care, Health, Pharmaceutical, General Health, Risk, Cancer, Partnership, Neutralizing antibody, Conditional sentence, Therapy, Degenerative disease, Caregiver, Color, CMS, Centers for Medicare & Medicaid Services, National coverage determination, Amyloid, Chronic condition, Safety, NCD, Hope, Physician, Center, Medicare, FDA, Patient, Health insurance, Pharmaceutical industry
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DISTRICT OF COLUMBIA, UNITED STATES, NORTH AMERICA
Summary
Key Points: 
  • We have serious concerns about how the NCD severely limits access to an entire category of new treatments for Alzheimers disease and will exacerbate health disparities.
  • The unparalleled precedent this weeks decision makes has compounded those concerns across the chronic disease community.
  • We have waited decades for disease-modifying treatments for Alzheimers disease.
  • A thousand people a day progress from mild Alzheimers disease to moderate disease and, accordingly, become ineligible for these treatments.


The Partnership to Fight Chronic Disease (PFCD) released the following statement from Chair Ken Thorpe regarding the Centers for Medicare and Medicaid Services (CMS) National Coverage Determination requiring Coverage with Evidence Development (NCD) for monoclonal antibodies (mABs) targeting amyloid for the treatment of Alzheimer’s disease.

“We have serious concerns about how the NCD severely limits access to an entire category of new treatments for Alzheimer’s disease and will exacerbate health disparities. The unparalleled precedent this week’s decision makes has compounded those concerns across the chronic disease community. CMS’s decision not only sets back access and hope for the well more than six million Americans living with Alzheimer’s disease, their families, and caregivers, it sets a dangerous precedent for others living with serious or life-threatening illnesses with limited to no treatment options. By singling out drugs approved through the FDA’s accelerated approval pathway, the decision sends shockwaves far beyond the Alzheimer’s community, impacting millions more living with serious chronic conditions including cancers and rare diseases.

“This decision threatens access for all Alzheimer’s treatments within the class identified as well as any new therapies for which Medicare deems FDA approval and associated clinical data provide insufficient evidence of clinical benefit to Medicare beneficiaries. The clinical trial criteria outlined will exacerbate known health disparities by raising barriers to access. These barriers disproportionately affect people living in rural areas and people of color already underrepresented in clinical research.

“Further, it puts at risk future innovations seeking the FDA’s accelerated approval pathway which has been delivering breakthrough treatments for three decades now and transforming the lives of some of our nation’s most vulnerable patients.

“People living with chronic diseases, in consultation with their care partners and treating physicians, should have the option to use FDA-approved therapies and CMS should not undercut those treatment options by compromising access and coverage. By setting an unprecedented new standard for coverage of FDA-approved therapies and significantly undermining FDA’s authority on the safety and effectiveness of therapeutics, this decision will have a devastating effect.

“We have waited decades for disease-modifying treatments for Alzheimer’s disease. A thousand people a day progress from mild Alzheimer’s disease to moderate disease and, accordingly, become ineligible for these treatments. CMS’s decision affects an entire promising class of new, disease-modifying treatments by making what is in essence a non-coverage decision with limited exceptions. This decision will set back innovation for Alzheimer’s disease significantly.”

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