CMS reached its final judgment on coverage for FDA-approved monoclonal antibodies. These antibodies are used against amyloid for the purposes of Alzheimer’s disease treatment. The service occurs under Coverage with Evidence Development (CED) in FDA-approved, CMS-approved, or NIH-sponsored controlled trials with the national coverage determination (NCD) originally proposed in January. To the great disappointment of advocates, CMS finalized the decision to include no additional coverage for beta-amyloid PET scans. Even more, the PET scans will remain under the present policy, which contains massive restrictions including providing coverage only when meeting requirements for clinical trial protocol. Another striking aspect is the reality that the restriction imposed is limited to only one per patient per lifetime. The decision by CMS is a blow to the many groups including radiology stakeholders like the Society of Nuclear Medicine and Molecular Imaging (SNMMI) who have put forth effort into Alzheimer’s disease advocacy, promoting sharp comments in rebuke.
Comments and Consequences
Alzheimer’s remains a massive threat to healthcare and public health. According to the Alzheimer’s Association, one in three seniors dies of this disease or a related dementia, with over 6 million Americans living with the disease presently. This number is projected to skyrocket to 13 million by 2050. Even more, the COVID-19 pandemic has given fuel to the fire, with the association stating, “In 2020, COVID-19 contributed to a 17% increase in Alzheimer’s and dementia deaths.” The staggering cost in 2022 is expected to reach $321 billion nationwide for healthcare related to this disease and other dementias. This unfortunately is only one slope of the economic avalanche, with an estimated 11 million Americans providing unpaid care, and “In 2021, these caregivers provided more than 16 billion hours of care valued at nearly $272 billion.”
Comments and Consequences
The implications of Alzheimer’s and related dementias to healthcare are alarming, creating an imperative for advocacy related to the disease such as the future of amyloid PET. Understandably, any decision made by CMS related to this topic will be met with backlash and controversy.
SNMMI made several points in an online statement last month in regard to the decision. One of the surprises that SNMMI notes about the decision is that “In stark contrast, the decision explicitly covers other tests for detection of beta amyloid (e.g., cerebral spinal fluid) without limitation, despite the fact that beta-amyloid PET is the standard of care—and, in fact, the only test approved by the FDA—for detecting beta amyloid.”
SNMMI had rallied for the coverage of beta-amyloid PET scans, previously sending detailed arguments in multiple letters to CMS, expressing the advantages, especially in contrast against the use of cerebrospinal fluid and blood biomarkers, to guarantee correct and timely Alzheimer’s disease diagnosis.
The society notes that at present beta-amyloid PET is the only biomarker with FDA approval with the objective of detecting beta-amyloid plaque, and the only one available for detection of beta-amyloid plaque in the brain. As SNMMI explained at length in their previous letters, “There is no evidence to suggest that a single amyloid PET scan per patient is appropriate or that a scan performed years ago can provide the diagnostic information needed to determine whether a patient is currently a candidate for therapy. CMS should allow as many PET scans as are needed to ensure that any trial design is optimal and reliable and provides physicians with the information they need to make informed decisions about initiating and continuing therapy.”
Stakeholders also took note of the silence surrounding the removal or retirement of the beta-amyloid PET NCD. Pre-trial beta-amyloid PET scans are the hallmark for the identification of amyloid plague in the brain. Pre-trial beta-amyloid scans are a tool for weeding out any patients who may not obtain benefit from monoclonal antibody treatment, “sparing them the stress and anxiety of participating in a clinical trial for a product that will not be beneficial as well as the potential negative effects of drug-related toxicities.”
Another point of contention surrounds the failure to remove the CED requirement since it would have been timed with the approval of both aducanumab and the coverage of tau PET diagnostics which were approved on January 1. Acting on this recommendation would have aided in keeping fair access to the new therapy. Furthermore, SNMMI points out that “It is ironic that patients now have access to a potentially unlimited number of tau PET scans but are limited to only one amyloid PET scan, and, even then, only as part of a clinical trial. Further, access will be limited by current CMS rules that systematically under-reimburse for amyloid PET scans due to bundling in the outpatient hospital setting.”
One point that was welcome by the society and other stakeholders was the fact that CMS took time to clarify requirements associated with a qualifying randomized controlled trial and the understanding that CMS has decided not to put limits or restrictions regarding the location of service in the final NCD.
Fighting for the Future
The society stresses that it will continue to scrutinize the final NCD and keep members in the loop in regard to any continued conversations with CMS. Although SNMMI was disappointed in the lack of further coverage inclusion for amyloid PET scans, the society did acknowledge the reality that in terms of monoclonal antibodies, “CMS’s final decision to cover monoclonal antibodies that have been FDA approved based on clinical efficacy rather than surrogate biomarkers—and as part of a registry rather than a prospective randomized controlled clinical trial—is a step forward.” For amyloid PET, the fight is not over. SNMMI reassured its members that it will advocate, striving to obtain “broad national coverage of amyloid PET scans by either a positive NCD or through Medicare Administrative Contractor discretion.”