Insurers Weigh Costly Manmade Spine Discs

Johnson & Johnson and other makers of new artificial spine discs face an uphill battle as they spar with health insurers unsure of the devices’ benefits, company officials said.

The artificial spine disc, first introduced by J&J and designed to replace damaged natural discs that absorb shocks to the vertebrae, aims to provide better range of motion compared to standard bone fusion surgery. But evidence comparing it against the surgery is scant as it only recently won clearance in the United States. And the $2,400 price tag is raising eyebrows among health plans and employers battling double-digit health inflation. “I would suspect that many (health plans) are not paying for it,” said Robert Haralson, executive director for medical affairs for the American Academy of Orthopaedic Surgeons. “We need to generate some data, which will take a number of years.” That is, a number of years to get data to show how patients fare with the new procedure versus standard bone fusion surgery. The U.S. Food and Drug Administration in October cleared J&J’s disc, called Charite, for patients with degenerative disc disease in the lower spine with no pain relief despite at least six months of non-surgical treatment. The conventional surgery is only partially successful, restricts range of motion, and often leads to pressure on surrounding discs, requiring further surgery. Johnson & Johnson officials told investors on a conference call on Tuesday that it is disappointed with the reimbursement the Medicare federal health insurance program for the elderly is offering, and that it is not getting the prices it would like from private insurers, either. In addition to Johnson & Johnson, Swiss medical implant maker Synthes also markets a disc, and Medtronic Inc. is working on its own version. Blue Cross of California, a big unit of the No. 1 health plan WellPoint Inc., and No. 3 health insurer Aetna Inc. both label the technology “investigational.” Expert panels at the health plans will be meeting in February to debate the discs and whether to cover them. But the high-profile recall of Merck & Co.’s painkiller Vioxx may raise the bar for evidence, as payers give more scrutiny to side effects that may seem insignificant in clinical trials. “Especially given recent events, our members are more careful today to be vigilant for any possibilities for adverse reactions that may occur down the road,” said Mohit Ghose, a spokesman for America’s Health Insurance Plans, representing most health insurers. (Source: Reuters Health, January 2005)