PET may also get a boost from FDA certification of FDGThe soundyou hear may be gridlock breaking. Positron emission tomographypassed two regulatory milestones last month that could help breathelife into moribund sales of this high-end nuclear
The soundyou hear may be gridlock breaking. Positron emission tomographypassed two regulatory milestones last month that could help breathelife into moribund sales of this high-end nuclear imaging technique.A long-awaited evaluation of rubidium-82 PET imaging was passedto the Health Care Financing Administration (HCFA) early in Augustfor Medicare reimbursement review of this procedure.
Shortly thereafter, the Food and Drug Administration certifiedDownstate Clinical PET Center's new drug application for the marketingof 18-fluorodeoxyglucose (FDG-18) for use with PET in locatingepileptic seizure foci in the brain. The FDA's go-ahead for thisagent could also lead to Medicare reimbursement. Ultimately, however,PET's market prospects hinge on convincing both private and publicinsurance payors that the modality offers both positive clinicaloutcomes and relative cost-effectiveness.
"This is a step forward," said Benjamin F. Armbruster,manager of marketing services for Siemens' nuclear medicine divisionin Hoffman Estates, IL. "It signifies at long last a recognitionon the part of the federal government that at least PET shouldbe made available to a large portion of the population that heretoforewas unable to receive it because of the Medicare reimbursementquestion."
HCFA is evaluating a report on the use of rubidium in cardiacPET imaging that was prepared by the Office of Health TechnologyAssessment (OHTA), according to Janice M. Flaherty, director ofthe division of medical services coverage policy in HCFA's bureauof policy development.
"They (OHTA) found PET could be used to evaluate myocardialperfusion in most patients referred to cardiac centers. Previously,we had considered it experimental and investigational. This givesus the opportunity to look at it for coverage purposes, whichwe are doing," Flaherty told SCAN. "We plan on providingcoverage, but first we have to look at different related issues,such as patient and facility selection criteria. We are lookingat this as quickly as we possibly can."
Industry and government sources agree that Medicare reimbursementfor PET could arrive by this month or next -- in time for thefive-year anniversary of rubidium's market certification by theFDA. Squibb's CardioGen-82, a generator-based PET agent, was giventhe FDA go-ahead in January 1990 (SCAN 1/31/90).
Rubidium had been the only FDA-approved PET agent until theFDG decision last month. That statement is somewhat misleading,however. FDG has been widely used in clinical PET imaging foryears. Until the FDA showed a desire to review FDG in 1989, certificationof the agent was not required. FDG, as a cyclotron-based radiopharmaceutical,was classified under the practice of pharmacy rather than as adrug.
This regulatory authority issue is still under debate in theclinical community. Although the FDA has approved FDG for theepilepsy indication, there is no formal policy on whether institutionswith cyclotrons are required to receive FDA certification forthe agents they produce, said Michael McGehee, president of theInstitute for Clinical PET in Washington, DC. Most PET centers,in fact, continue to operate under the jurisdiction of state boardsof pharmacy.
Ironically, it was bureaucratic wheel-spinning over FDG thatcaused the holdup on rubidium and Medicare reimbursement.
"The FDA indicated that it wanted to regulate cyclotron-basedtracers," McGehee told SCAN. "HCFA's initial requestto OHTA for (PET) assessment did not make a distinction betweenrubidium and cyclotron-based tracers. So the people at OHTA refusedto make that distinction and separate out those two types of PETtracers. As a result, rubidium has been hampered by this anchorof FDA approval of a cyclotron-based tracer for five years."
Helped by members of Congress with PET centers in their districts,pressure was put on the regulatory apparatus to break the PETtracer logjam. In March, HCFA requested that OHTA separate rubidiumfrom FDG in its study. This resulted in the August report.
Private insurance carriers and even the U.S. military insurancesystem have not waited for Medicare reimbursement. Payments arebeing made for PET exams, although positive statements by boththe FDA and Medicare could help speed private payments for PET,McGehee said.
"This (FDA certification of FDG safety and efficacy) willmake it easier for third-party payors that have in past wantedto pay for PET scans but said they had to wait for FDA approvalbecause of legal concerns," he said.
PET camera sales have stagnated over the past two years. Thereare 73 PET facilities and 82 cameras installed in the U.S., McGeheesaid. The number of facilities was around 60 two years ago (SCAN11/18/92).
Both wider reimbursement and the introduction of less expensivecameras, such as Siemens' ECAT ART selling for under $1 million(SCAN 6/15/94), should help stimulate PET sales, he said.