GE Healthcare (GEHC) was poised to gain significant business after Medicare agreed to pay for Eisai and Biogen's (BIIB) Alzheimer's drug Leqembi after the FDA fully approved it earlier this year.
But there is still one barrier hampering a potential revenue boost: The federal Centers for Medicare & Medicaid Services (CMS) only covers one positron emission tomography, or PET brain scan, per patient in their lifetime, for a clinical study.
That won't be enough to monitor patients who get on Leqembi, which reduces cognitive decline in mild to moderate Alzheimer's patients to avoid severe side effects, according to the company.
It's a policy that dates back to 2013 — around the same time GE and Eisai formed a partnership for the latter's Alzheimer's drug clinical trials — in which CMS said it would only cover one scan for those clinical trials to help identify beta-amyloid plaques, the controversial indicator of Alzheimer's disease.
GE Healthcare fits into the picture because it is the only company with both the equipment in hospitals, known as PET scans, as well as one of three companies with the necessary imaging agent to help identify the plaques — and help doctors select patients who could benefit from the drug, according to the company's US and Canada CEO Catherine Estrampes.
In addition, follow-up scans are needed to help doctors determine who is benefitting, and who may be at risk for serious side effects — an important part of the drug's post-approval data collection required by the FDA.
But those required follow-up scans are only MRIs. GE sees an opportunity for PET scans here, as it could help identify the effect of the treatment
Limitations on coverage from CMS means patients may not get access to Leqembi, according to Estrampes. The matter is personal for her as she lost her mother, who developed Alzheimer's, roughly five years ago, and said she understands the toll it takes on families.
It's why, she said, the company has been advocating in D.C. for CMS to remove the one-scan limit. The company wants to leave it up to doctors to determine how many scans a patient might need.
"What we are doing right now is being advocates for the fact that once in a lifetime amyloid PET scan is going to be the barrier to entry for patients and for access to those therapies," Estrampes told Yahoo Finance.
And it's the first time the company gets to play a lead role in Alzheimer’s treatment. In some ways it is a key part of what could be a $12.8 billion drug for Eisai and Biogen by 2028.
And while the company doesn't have a target number of scans it think CMS should allow, it is clear that multiple will be needed.
The follow-up for the treatment requires four MRI scans. But MRIs won't capture the plaque, which needs to be measured, Estrempes said, which is why the company has been strongly advocating for the use of its machines.
Soon after Leqembi's approval in July, CMS proposed removing that limitation on PET scans. The public comment period is over and a decision is due by October 17.
Follow Anjalee on Twitter @AnjKhem.
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