FDA’s new drug approval means little if CMS won’t update amyloid PET policy, imaging advocate says

A leading imaging trade group says federal health administrators need to update PET scanning reimbursement policies to ensure patients can access a newly approved treatment for Alzheimer’s disease.

Just yesterday, the Food & Drug Administration announced its controversial decision to greenlight Biogen’s Aduhelm (aducanumab) drug. Patients with any stage of Alzheimer’s will have to undergo a brain PET scan to show the presence of beta-amyloid in order to receive treatment.

While the FDA approved amyloid PET scans in 2012, Medicare doesn’t currently cover such imaging, which is the most accurate and least invasive method for detecting amyloid, the Medical Imaging & Technology Alliance said June 8. It’s calling on the U.S. Centers for Medicare & Medicaid Services to change that.

“CMS should revise the legacy coverage and payment policies that will hinder access to this life-changing treatment,” Executive Director Patrick Hope said in a statement on Tuesday. “Specifically, MITA calls on CMS to expeditiously open the amyloid PET reconsideration request that has been pending before the agency since September 2020 to ensure appropriate Medicare access.”

A massive project launched in 2016, known as the IDEAS study, found adding amyloid PET imaging altered management in 60% of patients with mild cognitive impairment and dementia. In 36% of cases, there was a change in diagnosis. But amyloid imaging agents are still not covered unless approved under a Coverage with Evidence study, MITA noted.

In its June 8 request, the imaging advocate said it’s time to expand access and also update Medicare’s packaged payment policy for radiopharmaceuticals in order to ensure patients have access to amyloid diagnostic tests.

“The action taken … by the FDA will give patients and caregivers access to the first-ever Alzheimer’s disease-modifying treatment,” Hope explained. “Now, CMS needs to act to update its outdated coverage and payment policies and provide patients with access to amyloid PET diagnostic drugs.”

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