CMS Reverses Non-Coverage of Oncology PET Tracers

In a victory for new oncology PET tracer producers and users, CMS reversed the previous blanket non-coverage of PET tracers, allowing local contractors to determine coverage.

This decision allows a subset of new oncologic radiopharmaceuticals approved by the FDA to be covered by individual Medicare Administrative Contractors (MACs) for their approved labeled indications.

“If there are new oncologic tracers coming out, this puts them on equal footing with other drugs and diagnostics,” if local carriers deem it appropriate, said Gail Rodriguez, Medical Imaging Technology Alliance (MITA) executive director. The approval is less comprehensive than MITA’s request. “We got part of what we asked for but not all of it,” she said. CMS did not include tracers for neurological or cardiac uses.

The decision doesn’t change coverage for PET use of FDG (2-deoxy-2-[F-18] fluoro-D-Glucose (fluorodeoxyglucose)), NaF-18 (fluorine-18 labeled sodium fluoride), ammonia N-13, or rubidium-82 (Rb-82). Rodriguez said that MITA’s request did not include these tracers which are already workhorses approved for most or many applications in their field. She said that FDG is already approved for most cancer applications, rubidium-82 for cardiac tests and NaF-18 for bone imaging, so these being excluded from the MITA request is a nonissue.

This process was two years in the making. Traditionally, CMS excludes coverage for a PET tracer unless the manufacturer seeks and gains approval for specific use. MITA formally requested reconsideration of this policy two years ago, asking that CMS allow local MACs to determine coverage for any new radiopharmaceuticals approved by the FDA. Last July, CMS formally began considering the request.

As for how it will affect the oncology landscape, Rodriguez said the short term impact will be minimal. “There’s not a great number in the pipeline right now, so I don’t think you’ll see a slew of things happening, because most oncology is done with FDG,” she said.

While the impact on oncology tracers isn’t dramatic, Rodriguez said that the new cardiology and Alzheimer’s disease tracers are “ground breaking and earth changing.” She said the beauty of PET tracers is that they’re sensitive, with quantifiable results. “These agents will be very useful for research efforts.”

Eli Lilly and Co.’s Alzheimer’s agent Amyvid (Florbetapir F 18 Injection) was approved by the FDA last summer and is under separate consideration by CMS for approval.  Lilly is seeking approval to cover Amyvid for beta amyloid plaque detection.

“We’re not quite sure what this new decision means for [Lilly],” Rodriguez said. “We’re hopeful that agent will receive coverage. It opens up a new field for research purposes and patients at risk. This is a kind of development that opens up a whole new world.”

In terms of excluding non-oncology tracers, CMS said in its statement, “we considered whether the current imaging environment was sufficiently mature in various clinical areas that we could confidently permit our local contractors to exercise coverage discretion. We searched for evidence that established the strength or weakness of the infrastructure of evidence-based clinical guidelines for general clinical areas, e.g., oncologic imaging, cardiac imaging, etc. We believe that a robust and organized infrastructure of evidence-based clinical guidelines will facilitate our contractors’ ability to efficiently develop consistent local coverage policies. ”

CMS also said that they use the number and breadth of available guidelines to determine specialty coverage, and support an evidence-based infrastructure to measure new technologies against. Guidelines for cardiology and neurology were much smaller than oncology, and CMS said they were insufficient to grant the same local MAC determination.

Rodriguez disagreed that there isn’t enough information about appropriate use. “The Society of Nuclear Medicine and the Alzheimer’s Association did develop a set of appropriateness criteria,” she said, adding that CMS didn’t pay attention to that.

In terms of cardiac use, Rodriguez said that there are longstanding imaging guidelines and appropriateness criteria, adding, “There’s very good data on the appropriate use of cardiac PET.” She said the clinicians and others in the field have gone to great lengths to make sure CMS understood that they don’t want to screen everyone who wants to undergo a cardiac PET scan.

While MITA was seeking CMS coverage for tracers approved by the FDA for specific uses, CMS makes it clear they operate under different statutory regulations than the FDA, and that they don’t “automatically default our ‘reasonable and necessary’ standard to FDA’s ‘reasonable assurance of safety and effectiveness’ standard.”

Rodriguez acknowledged that there are reasons why CMS is conservative in their decision making. She applauded them for being “very open to meeting with all the stakeholders,” noting that they participate in various joint workshops. “We’ll continue to meet with them to make these tracers available to Medicare patients,” she said. And the decision doesn’t stop drug sponsors from soliciting CMS approval for specific use by individual tracers.

AT A GLANCE

What’s covered: Oncology tracers gaining FDA approval after September 1, 2012

Indications: FDA approved labeled indications for oncology diagnostics (not screening)

Excluded: Neurological and cardiology tracers, new oncology indications for FDG. CMS reserves the right to determine national coverage for any future radiopharmaceutical use.

What’s next: Nothing dramatic is in the pipeline for PET oncology tracers; not much will change currently. Lilly awaits CMS determination on Alzheimer’s agent Amyvid.