"We need new tracers, for example in oncology, that are more specific and show higher sensitivity," says Dr. Masanori Ichise, professor of clinical oncology at Columbia University, New York. "FDG goes to many tumors, but it goes to infections and inflammations as well. We need some tumor-specific tracers."

Securing approval for new agents is not an easy process. Any proposed tracer must go through rigorous clinical trials that are both time-consuming and expensive.


"The problem is showing efficacy and cost effectiveness at the start, so that CMS will reimburse and if CMS doesn't reimburse, then it's hard to do the studies to show efficacy," says Dr. Graham. "We're in an area of a terrible catch-22 here: you can't show that it works and you can't get paid for it to show that it works because you can't show that it works," he says.

The lack of new agents may hamper the awareness and adoption of PET/CT technology. Manufacturers reiterate the difficulty of approving new tracers.

"Our medical diagnostics business is very much a part of the molecular imaging business and we are always looking at ways to improve our communication with the government regarding diagnostic tracers," says Lynn Bender, global marketing manager of PET/CT for GE Healthcare. The company works "to explain that these are diagnostic tools and not therapeutic and that there's really a difference and probably should be treated differently," says Bender.

Dr. Graham acknowledges that there is no simple solution to the hurdles of approving new agents and that SNM is working on it.

"A lot of it is economics. Somehow we have to pay for the clinical trials to show efficacy to get reimbursement, but the companies don't have infinite amounts of money, nor does NIH," he says.

Reimbursement for bone scans is still in the works. In February, CMS announced that the NaF-18 PET agent used to identify bone metastasis would only be reimbursed through coverage with evidence development (CED).

"That means clinical trials have to be done and they will reimburse for the patients in the clinical trials. They have to be in a well-designed clinical trial," says Dr. Graham. "And thus far, I'm not aware [if] there is a CMS approved clinical trial that's underway, so we're trying to get that organized," he says.

Despite the challenges, some new agents are on the horizon. There is a new type of myocardial perfusion tracer for PET close to approval from Lantheus Medical Imaging, a Massachusetts-based company. Amyloid imaging agents for Alzheimer's disease are also in the development stages.

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