Medical Device Daily Washington Editor

The Centers for Medicare & Medicaid Services has issued a decision regarding reimbursement for pharmacogenomic testing for warfarin sensitivity, opting to provide coverage with evidence development (CED) rather than rendering an outright yes-or-no decision.

The decision for provisional coverage – which may seen odd given that some Medicare carriers have been paying for the test for some time – has been in the works for close to a year, with the initial comment period opening up last August. CMS detailed much of the information backing the agency's thinking in its May 4 notice, but the underlying message is, "the current data are sparse on health outcomes." The announcement also noted that current care guidelines do not require that doctors take test results into account when deciding whether or how much warfarin to prescribe.

Members of the American Association for Clinical Chemistry (AACC; Washington) seemed divided last summer over the validity of the test if the results of an informal poll at the association's annual meeting were reliable (Medical Device Daily, July 30, 2008). At the beginning of a debate over pharmacogenomic testing for sensitivity to the blood thinner, the audience was roughly split over whether the test is reliable enough to guide medical decision making. By the end of the debate, however, a substantial number of the several hundred attendees seemed to have migrated toward the view that the idea lacks sufficient scientific support.

One of those who entered a comment to CMS is Carmella Bocchino, VP for clinical affairs and strategic planning for America's Health Insurance Plans (AHIP; Washington), who said in a Sept. 2, 2008, letter that "some of our member plans have decided to cover" the test while others have not due to "questions about the effectiveness of improving patient outcomes." However, Bocchino comes up short of an explicit recommendation other than to urge CMS to take into account "upcoming results from several clinical trials currently underway."

Ironically, Larry Broussard, AACC's president, told CMS in an Aug. 28 letter that the association "recommends that CMS provide coverage." However, he seemed to evince a distaste for the CED route, suggesting that any decision other than full coverage ought to be "a 'no national coverage' decision so as not to stifle this promising and rapidly expanding field."

At least one company that makes such assays is not taking the news too hard. Mike McGarrity, chief marketing officer for Nanosphere (Northbrook, Illinois) told Medical Device Daily that a decision was not unexpected. "We knew they were debating it. I don't know that we were surprised" at the decision to go with CED, he said. "I think they came down somewhere in the middle, which supports long-term data collection."

McGarrity said that the reimbursement landscape is not utterly desolate, but acknowledged "we have a number of customers who have struggled with reimbursement," which he said "varies from carrier to carrier."

FDA gives nod to vaccine plant in U.S.

FDA has announced that it has given the green light to a new vaccine manufacturing plant built by Sanofi Pasteur (Lyon, France), a move that the agency's May 6 statement says is just in time to meet demand for vaccines for the current strain of swine flu, H1N1.

Jesse Goodman, MD, the agency's deputy commissioner for scientific and medical programs, said in the statement that the opening of the plant in Swiftwater, Pennsylvania, "enhances the ability to produce and provide vaccines to protect the public from seasonal influenza, still estimated to cause more than 30,000 deaths per year." He attributed the opening to "strategic investments by the federal government and proactive efforts and engagement by the FDA and the vaccine industry."

According to both the FDA statement and a May 6 statement by the company, the bulk of the plant's work will go toward producing the Fluzone vaccine. Neither the company nor FDA directly address whether Fluzone will inoculate against H1N1, but the firm's statement suggests the product will not.

Wayne Pisano, president/CEO of Sanofi Pasteur, said in the company's statement that the firm "is assessing its capabilities to support public health efforts should the WHO [World Health Organization] and national health authorities request that influenza vaccine manufacturers start supplying vaccine to protect against the new influenza A (H1N1) virus."

UCB seeks patent extension for NeuPro

FDA announced in Friday's edition of the Federal Register that it and the U.S. Patent and Trademark Office may grant UCB (Brussels, Belgium) an extension of 744 days for the Neupro transdermal drug delivery system. The news comes on the heels of a nationwide recall of the combination product announced in March, which was triggered by the potential for under-delivery of the drug ingredient, rotigotine, formulated to treat Parkinson's disease.

According to the May 8 edition of Federal Register, "the applicable regulatory review period" for the device "is 4,367 days," almost 3,600 of which were taken up with product testing and trials. Despite the 10-plus years that have passed during that stretch, the FR states that the appropriate calculation for extending the patent would employ a start date of Jan. 28, 2005, the date on which UCB filed its final PMA paperwork, and an end date of May 9, 2007, when FDA approved the application.