Anthem Blue Cross/Blue Shield Restricts TAVR Coverage

April 29, 2014—Medscape’s Heartwire reported that Anthem Blue Cross and Blue Shield, which provides medical insurance to patients in California and 12 other states, is restricting coverage of transcatheter aortic valve replacement (TAVR) to patients who are not candidates for surgery. Anthem will not cover TAVR to high-risk but surgically eligible patients, despite US Food and Drug Administration (FDA) approval of this indication. Anthem’s revised TAVR policy SURG.00121, became effective on February 17, 2014.

Additionally, among the inoperable and extreme-risk patients that it will cover, the Anthem Blue Cross and Blue Shield policy restricts the choice of device to the Edwards Lifesciences Sapien transfemoral system, although Medtronic, Inc.’s CoreValve system was approved for this indication in January.

In October 2012, the FDA expanded the Sapien label to include high-risk yet operable patients. The CoreValve device, at present, is approved only for inoperable/extreme-risk patients, but positive results from the CoreValve High-Risk Study were presented in March at the American College of Cardiology 2014 Scientific Sessions.

Anthem is the trade name of multiple Blue Cross and Blue Shield health insurance plans throughout the United States, including plans in California, Colorado, Connecticut, Georgia, Indiana, Kentucky, Maine, Missouri, Nevada, New Hampshire, Ohio, Virginia, and Wisconsin.

As noted in the Heartwire article by Michael O'Riordan, the Anthem policy states that the CoreValve device was approved in inoperable patients on the basis of the CoreValve Extreme Risk study, which did not have a medical-therapy randomization. The randomization was dropped after the positive mortality benefit with TAVR in PARTNER B—testing patients ineligible for surgery—and the approval occurred without an independent advisory committee hearing.

The Anthem policy states, “Currently, 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.”

The Heartwire article added that one of the biggest discrepancies between the FDA indications for TAVR and Anthem Blue Cross reimbursement is in the high-risk yet operable patients with severe aortic stenosis, the PARTNER cohort A patients treated with the Sapien valve.

As reported by Heartwire, the PARTNER A study showed that TAVR was noninferior to surgery at 30 days and at 1 year in this patient population. Overall, the rate of stroke was numerically higher with TAVR, and the combined endpoint of stroke or transient ischemic attack was significantly higher among the TAVR-treated patients.

Heartwire reported that the Anthem Blue Cross/Blue Shield policy advises that PARTNER A failed to demonstrate a mortality benefit, unlike what was observed in the PARTNER B trial of inoperable patients undergoing TAVR. In addition, Anthem takes issue with the stroke risk and complication rate.

The Anthem policy states, “Thus, while there are efficacy data regarding the use of TAVR in the high-risk group, the increased stroke and vascular complication rates are a significant negative health outcome, which means that TAVR in the high-risk group is not as beneficial as the established alternative of surgical AVR.”

The Heartwire report by Michael O'Riordan includes an interview with Paul Teirstein, MD, who is an interventional cardiologist at the Scripps Clinic in La Jolla, California. 

Dr. Teirstein stated in the Heartwire article that the Anthem policy means that no high-risk yet operable patients end up undergoing TAVR at his hospital. He dismissed the argument about the increased risk of stroke and vascular complications because 3-year data from PARTNER A suggests there is less stroke among those treated with Sapien compared with those treated with surgery. And while there are more vascular complications, Dr. Teirstein said this makes sense, given that the devices go through the vasculature. “And every surgical patient has a big hole in their chest,” he said. “If we were measuring sternal wounds, it would be 100% in the surgery arm.”

A spokesperson for Edwards Lifesciences told Heartwire that it is not uncommon for private payers to update coverage policies and that the company will continue “to work with private insurers to provide the most up-to-date information for their reference as they engage in policy reviews.” Edwards Lifesciences further advised that it shares the frustration that a patient in need is being denied what their physician believes to be best care as supported by the large body of TAVR evidence, because they are not in a position to pay out of pocket. Medtronic said it does not comment on specific payer-coverage policies, reported Michael O'Riordan in Heartwire.