Biotechnology Healthcare - September/October 2008 - (Page 40)

“The reality is that we do ration healthcare,” says senior analyst Murray Aiken, of IMS Health. “We just don’t do it in a very transparent way.” ment agencies, providing more of a complete package of cost/benefit analyses,” he says. A WARNING SHOT There are plenty of signs that payers are increasingly determined to find out more about the costs and comparative effectiveness of therapies — with or without manufacturers’ active cooperation. In the United States, lawmakers are gearing up for a war of words over new legislation that could provide billions of dollars for a new institute devoted to comparative effectiveness studies. And even without such an institute, Medicare has signaled that it wants more data that will help it make value-based reimbursement decisions. When Norwalk, Conn.-based IMS Health toted up its “Harbingers of Change” report this year, senior analyst Murray Aitken focused on the explosive potential effects of a $16 million National Eye Institute head-to-head study comparing the efficacy of bevacizumab (Avastin) and ranibizumab (Lucentis) in treating wet age-related macular degeneration (AMD). Genentech developed both drugs, establishing bevacizumab as one of the most effective new cancer therapies to hit the market in years, and then took ranibizumab — a derivative of the drug — through some expensive clinical trials for treating the eye disease. But bevacizumab is still used off-label for wet AMD at a fraction of the cost of ranibizumab. If the new clinical trial — which wraps up in 2010 — proves that bevacizumab is just as effective as ranibizumab, IMS says Genentech can expect changed sales for ranibizumab. The impact of that would show up swiftly, right on the company’s bottom line. Ranibizumab is pricey — up to $2,000 per injection, compared with a paltry $45 to $70 per treatment with bevacizumab. “For developers of technologically advanced but expensive new biotech therapies, this should be seen as a warning shot,” Aitken wrote. “The United States will no longer categorically accept the pricing of these therapies. Given that the United States is disproportionately important for the sales of these specialist therapies, and that the payer environment in all other markets is distinctly tougher, this is not good news for pharmaceutical companies developing such products — especially if less expensive products on the market offer treatment alternatives.” The U.S. Agency for Healthcare Research and Quality (AHRQ) set out five years ago to start mounting comparative effectiveness studies, acting on a section of the Medicare Modernization Act. The agency also has been studying the metrics used in cost-effectiveness analyses. “If you look at the literature, there’s a lot of investigator choice,” says AHRQ researcher Bill Lawrence, MD. “Do you use quality adjusted life years [QALYs], and how do you do it? How do you get the costs? We’ve been working on the methods, working to standardize how these things are done, so when you look at analyses in the literature, it’s comparable.” As a government agency, AHRQ is careful to steer clear of policy disputes, like the one brewing over a national institute for comparative effectiveness studies. But you don’t have to go far to find critics of any proposal that includes making decisions on cost-effectiveness as part of its mandate. “A national institute ought to be focused on clinical effectiveness,” says Gail Wilensky, PhD, the onetime chief of Medicare and Medicaid, now a senior fellow at Project Hope. CMS, she says, “should do cost-effectiveness analysis along with insurers who can band together, such as Blue Cross and Blue Shield.” But cost-effectiveness, she adds, is too controversial for a new institute to take on. “I feel that cost-effectiveness information should be used but primarily for reimbursement rather than coverage decisions. I don’t assume that it will be a unitary decision. While private payers may follow the lead of Medicare, they should be able to do otherwise, as they also sometimes do.” By all means, let a new institute gather data that payers can use for cost-effectiveness analysis, she adds. But let the payers reach their own individual conclusions. And don’t expect uniformity in a field where no one marches in lock-step formation. Says Wilensky: “Some of the decisions that need to be made are not decisions for which there is a single right answer.” MOVING FORWARD Peter Neumann, ScD, has heard these debates before. “You tend not to see cost-effec- 40 BIOTECHNOLOGY HEALTHCARE · SEPTEMBER/OCTOBER 2008

Table of Contents Feed for the Digital Edition of Biotechnology Healthcare - September/October 2008

Biotechnology Healthcare - September/October 2008 Openers Editorial/David B. Nash, MD, MBA Contents At a Glance: Multiple Sclerosis Drug Track Personalized Medicine Healthcare Reform’s Effects on Biologic Access Breast Cancer Status Testing: A Crapshoot With Deadly Odds Trends, Issues, and Perspectives In the Management of MS So High-Tech, Yet So Simple The Evolution of Ascertaining the Value Proposition Specialty Pharmacy Employer to Employer Health Plan Confidential Trends

Biotechnology Healthcare - September/October 2008

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