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Special report: Are radiopharmaceuticals in their element?

by Nancy Ryerson, Staff Writer | June 17, 2013
From the June 2013 issue of HealthCare Business News magazine


In January, the Society of Nuclear Medicine and Molecular Imaging (SNMMI) joined with the Alzheimer’s Association to publish appropriate use criteria for amyloid imaging. The groups met with CMS in April to continue making a case for the radioisotopes.

The criteria said it would not be appropriate to scan based solely on family history, for example, but would be appropriate for patients whose clinical tests indicated progressive or persistent cognitive impairment, or whose tests showed the chance of Alzheimer’s but were inconclusive.

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“There’s a subsection of the population where this would be useful, and then over time we’ll have to build up evidence on how to really use these tools. Hopefully, we will do that and then have a clear idea of which populations will make the most sense,” says Jonathan Allis, general manager of PET Medical Diagnostics at GE.

PET is a relatively new imaging method, another possible reason CMS has been slow to accept amyloid imaging, and up until now, most PET scans used FDG, which remains the “workhorse” of the industry. When CMS first began reimbursing PET scans around 10 years ago, it explicitly stated non-coverage for future applications of PET. That rule has recently been loosened for new oncology tracers, but not for cardiology and neurology tracers.

“We’re starting with an exclusionary policy, and that makes it an uphill climb,” says Dr. Daniel Skovronsky, CEO of Avid Radiopharmaceuticals and VP of Tailored Therapeutics for Eli Lilly, which manufactures Amyvid.

A new draft decision from CMS is slated to come out in July, followed by a period for public comment.

The Lantheus nuclear
medicine product portfolio

Beyond the brain
Skovronsky says he’s concerned that a decision not to reimburse Amyvid would discourage innovation in the rest of the radiopharmaceutical industry.

“It takes a long time and a lot of money and perseverance to bring a novel molecular imaging agent to market as we did,” says Skovronsky. “If it’s not covered, I think that could have a very chilling effect on the industry because people will say if even an Alzheimer’s diagnosis is not valued by our society, why should we work on diagnosing any other diseases?”

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