The FDA may have approved both Edwards Lifesciences’ (NYSE:EW) Sapien and Medtronic‘s (NYSE:MDT) CoreValve replacement heart valves, but Anthem Blue Cross & Blue Shield will reportedly only cover the Sapien transcatheter aortic valve implant – and only for patients who are too sick to undergo open heart surgery.
The insurer’s decision leaves 2 cohorts of patients without reimbursement for the TAVI devices: The extreme-risk group and high-risk patients whose aortic valves are too large for the Sapien device, according to heartwire.
"Blue Cross has decided that if the patient is inoperable, they will pay for it, but they won’t pay for Medtronic’s device. If you’re an [inoperable] patient, you can only get the Edwards device. That’s pretty limiting," an interventional cardiologist Dr. Paul Teirstein of California’s Scripps Clinic told the website. "I have a lot of patients, if they have a big aorta, we had to wait for the Medtronic approval before treating them, but if they carry Blue Cross we still can’t treat them.
"If you’re a Blue Cross patient, they have their own approval process," Teirstein said. "To me, it’s incredible. They’ve made their own decisions about what they’ll pay for and what they won’t, and the public has no clue about it."
The FDA 1st approved the Sapien valve for extreme-risk patients in late 2011, adding the high-risk indication in October 2012. The watchdog agency granted the CoreValve PMA for extreme-risk patients in January after foregoing an advisory panel meeting for the device.
But the Anthem Blue Cross & Blue Shield policy, citing the CoreValve pivotal trial, maintains that "there is a lack of published data showing that the CoreValve system has demonstrated a net health benefit or that the device is at least as effective as available alternatives," according to heartwire.
Medtronic said it doesn’t comment on specific payer-coverage policies, the website reported. An Edwards representative said the company continues "to work with private insurers to provide the most up-to-date information for their reference as they engage in policy reviews," according to the report. Anthem Blue Cross answered repeated requests for an interview with an emailed copy of its TAVI policy, heartwire said.