Will PET imaging be covered alongside new Alzheimer's drugs? CMS dodges topic in new coverage decision
Although many stakeholders have applauded the Centers for Medicare and Medicaid Services coverage determination regarding a new class of highly anticipated drugs that treat Alzheimer’s, some are concerned that the decision stopped short of addressing imaging related to the drugs’ use.
In a June 1 announcement, CMS indicated that the new class of drugs will be covered once they are granted the FDA's traditional approval, with a stipulation attached that requires patients with Medicare Part B to be enrolled in registries that collect real-world data on the treatments' effectiveness. What the announcement did not include was any mention of coverage for beta-amyloid PET imaging that is necessary for both diagnosing Alzheimer’s and monitoring the effectiveness of related treatments.
On June 5, the Medical Imaging and Technology Alliance (MITA) expressed concern over the decision to exclude guidance related to beta-amyloid PET imaging.
“Beta-amyloid PET has become a key tool in the diagnostic workup of dementia patients,” the statement reads. ”There is a considerable amount of published evidence that the use of beta-amyloid imaging positively impacts patient management and leads to changes in diagnosis, even in the absence of a disease-modifying therapy.”
Eisai’s Leqembi (also known as lecanemab) is slated to be the first drug in line to receive coverage, as the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee is scheduled to discuss trial results on June 9, with a possible approval to follow soon after. Lecanemab is an intravenous drug that targets amyloid—a naturally occurring protein known to disrupt cell function that has played a starring role in Alzheimer’s research for some time.
In clinical trials, Alzheimer’s patients being treated with lecanemab showed a 27% reduction in clinical decline. However, the effectiveness of such therapeutics (and any adverse effects) must be monitored via imaging.
Currently, CMS limits coverage of these vital scans to patients enrolled in a CMS-approved clinical trial under coverage with evidence development (CED). After being subjected to much criticism from experts in the imaging community, CMS announced that it would reconsider its previous coverage determination, specifically as it pertains to scan limits.
However, that determination was delayed when CMS was presented with additional clinical evidence and the timeline on when an updated decision will be made remains unclear.
In a May 30 letter to CMS, MITA requested that they “expeditiously finalize” their coverage determination pertaining to beta-amyloid PET imaging. Failure to do so prior to the FDA’s traditional approval of new therapies, MITA stated, will inhibit beneficiaries’ access to the appropriate imaging needed to qualify them for such treatments.
View MITA's full letter here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She joined Innovate Healthcare in 2021 and has since put her unique expertise to use in her editorial role with Health Imaging.