Biotechnology Healthcare - July/August 2008 - (Page 30)

one is that cost-effectiveness and clinical effectiveness should be addressed simultaneously in CER; the other is that issues of cost should be addressed after clinical effectiveness has been ascertained. AHIP is the leading advocate for the simultaneous perspective. Steven Pearson, MD, a Harvard professor and senior fellow at the association, says rigorous and transparent research on cost and costeffectiveness is required for two reasons: to allow the use of modeling THE CAMPS that captures the full That level of detail spectrum of benefits was not included within and problems, along a bipartisan CER prowith the impact of techposal that would have nology on the system as provided $3 billion in a whole; and to provide federal and private information that allows funds over 5 years. The patients, physicians, proposal died in gridand others to underlock in Congress last year. But most ob- “The easiest political stand issues of value in servers think another pathway toward com- healthcare. That view got an improposal will emerge parative effectiveness would be to leave portant endorsement this year or the next. when the CBO issued “This is still an area cost-effectiveness its analysis of CER. in which there is broad out, but the easy pathway is often not “The Congressional agreement that it repre- the best,” says Steven sents one of the tools Pearson, MD, of AHIP. Budget Office has certainly suggested that that can help us moderwithout looking at cost, much of the ate spending,” Wilensky says. As with most things in health- impact of comparative effectiveness care, CER is an easy-to-embrace may come to naught,” Pearson says. concept until dollars are attached to He also noted that the American it. Indeed, CER is so attractive at the College of Physicians recently entheoretical level that the cost of con- dorsed cost-effectiveness as a part ducting the research — estimates of comparative effectiveness. The second camp is more fostart at $500 million a year and rise from there — is not even mentioned cused on steps. “Is a particular treatment, technology, or drug effecas a deterrent to the movement. But whether CER should include tive?” asks Helen Darling, president issues of costs — that is, whether of the Business Group on Health. one treatment option is more cost- “Is it at all effective in terms of the effective than another — is a dif- alternatives, including doing nothferent matter entirely. That’s where ing? That’s step one.” After clinical parameters, inall those CER proponents start glarcluding benefits and risks, are deing at one another across the table. There are two camps of thinking: termined, costs can be reviewed. Guterman, senior program director at Commonwealth, said those savings would come not directly from the new evidence generated by CER, but by a corresponding policy that would require increased copayments for medical treatments inconsistent with CER findings. “That’s where we put the teeth in this [theoretical] policy and that’s where we would get the savings,” he noted. 30 BIOTECHNOLOGY HEALTHCARE · JULY/AUGUST 2008 Rob Crandall Supporters of this viewpoint feel that looking at clinical- and costeffectiveness simultaneously invites distrust of payers’ and purchasers’ motivations. “The process has to be one that ensures, for example, that when someone says a new drug or a new technology — which may be very expensive — is not needed for a patient for a particular condition, we don’t want that patient to say, ‘You are saying that because all you care about is the cost,’” says Darling. In some cases, the two-step approach will avoid the waste of costeffectiveness research on a therapy that does not prove its clinical worth. “On the other hand,” she continues, “if a treatment is found to be 10 percent better, or 50 percent better, and especially if the rate varies by individual — which it often does — then we might want to say, ‘OK, what does it cost?’” Wilensky sides with the view that issues of cost and cost-effectiveness need to be off the table until clinical effectiveness is determined. One key reason: Politically, it will be impossible to get CER off the ground if cost is mandated in the evaluation, and that payers will regret pushing for it. “It is political death to put it in,” she says. “Would you rather not have this concept at all? The payers are the first and foremost gainers of comparative clinical effectiveness.” If the cost-effectiveness divide can be breached, CER supporters appear to have consensus that payers should use the information for decision making, not specifically for eliminating treatment options. BIO issued a paper stating its support of CER and listing many issues to consider when developing CER policy (BIO 2008). The open-

Table of Contents Feed for the Digital Edition of Biotechnology Healthcare - July/August 2008

Biotechnology Healthcare - July/August 2008 Openers Contents Editorial/David B. Nash, MD, MBA Drug Track Health Plan Confidential Rheumatoid Arthritis A Decade of Trial, Error, False Starts, and Hope What Path Will Comparative Effectiveness Research Take? RA Therapies in Development: A New Generation of Relief Assessing the Full Impact of RA on Employers and Payers Stem Cells: Health Insurance You Can Bank On Specialty Pharmacy Employer to Employer Personalized Medicine Trends Clinical Briefs

Biotechnology Healthcare - July/August 2008

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