Biotechnology Healthcare - July/August 2008 - (Page 31)

ing paragraph articulates the industry’s big worry: “BIO is concerned that comparative effectiveness information may be used strictly as a means to contain costs, rather than deliver healthcare value by improving patient health outcomes.” Payers and purchasers say they agree, although CER should lead to reduced costs as a happy byproduct of encouraging the right clinical decisions. They also say they concur on how CER evidence should be used, as articulated in BIO’s issues paper: “Payers should not use comparative effectiveness information to establish ‘one-size-fits-all’ coverage and payment policies that ignore the variability among individual patients in treatment, efficacy, safety, and tolerability of treatment interventions.” No word yet on how payers will react to BIO’s recommendation that the scope of CER include their own policies and practices. John Siracusa, no longer with BIO but who was, at the time this article was researched, manager of Medicare reimbursement and economic policy at BIO, says CER should extend beyond therapeutic options to look at systemic issues that affect a patient’s care. “Let’s also look at payers’ utilization management techniques and how those affect patient outcomes,” he says. “That has a real impact on whether patients’ medication usage is carried out [as recommended], and whether patients seek care and those types of consideration.” THE REALITY CHECK Dan Mendelson, president of Avalere Health, a healthcare analysis company, does not believe the development of new evidence will translate into changes in clinical practice, the key to reducing health- care spending. The sticking point, he noted during the previously mentioned audioconference, is getting clinicians to use the evidence. “There is a lot that we know about clinical medicine [already] that is simply not being adopted,” said Mendelson, a former associate director for health at the Office of Management and Budget. “I have a strong degree of skepticism that CER in and of itself without any cost-control mechanisms will reduce costs.” Changes in the payment system can force adoption, but that sort of change comes slowly. “It will sometimes take 5 to 10 years to obtain the proper coding and make clinicians aware,” he said. “And the converse is true, as well. Once the medical profession has adopted a particular procedure or technology, it takes a very long time to drop it — even [in the case of] care that may injure patients.” Both CBO and Commonwealth agree that providing new evidence alone is unlikely to generate significant cost savings in the short term. However, Philip Ellis, a senior analyst at CBO, has said CER is a first step toward developing financial incentives that could drive major savings in the long run. Mendelson has no confidence in the long run. During the audioconference, he raised his suspicions that a weak-willed Congress will nix any CER entity before any substantial savings are generated. He recalled the death of the shortlived federal Office of Technology Assessment after some influential corporations protested its conclusions. “We have to question from the outset whether there is going to be sustainability of such an agency, and whether we will have the stom- ach politically to embrace the concept of a relatively independent agency that is looking into these issues,” he said. THE INTERIM Mendelson expected that the debate over whether and how to pursue CER through a federal initiative will go on for a long time. So, how should an ophthalmologist decide about ranibizumab versus bevacizumab in the meantime? A clinical trial, funded by the National Eye Institute, started enrolling participants on Jan. 1, 2008, in a head-to-head comparison of the effectiveness of the two treatments. The primary outcome measure will be change in visual acuity after one year of treatment. Among the secondary measures to be reviewed is the price differential. The University of Pennsylvania, which is overseeing the multisite trial, has reported that if bevacizumab is shown to be safe and effective in the treatment of wet macular degeneration, Medicare could save up to $3 billion a year. And that’s a finding that may very well define many courses of action. REFERENCES Biotechnology Industry Organization. Issues surrounding comparative effectiveness research: supporting patientcentered care to improve health outcomes. «http://bio.org/healthcare/ compeffective/20071001BIO_comp_ effect.pdf». Accessed July 24, 2008. Congressional Budget Office. Research on the comparative effectiveness of medical treatments: issues and options for an expanded federal role. December 2007. «http://www.cbo. gov/ftpdocs/88xx/doc8891/12-18ComparativeEffectiveness.pdf». Accessed July 24, 2008. Lola Butcher, who writes about health policy and the business of healthcare, lives in Springfield, Mo. JULY/AUGUST 2008 · BIOTECHNOLOGY HEALTHCARE 31 http://bio.org/healthcare/compeffective/20071001BIO_comp_effect.pdf http://bio.org/healthcare/compeffective/20071001BIO_comp_effect.pdf http://bio.org/healthcare/compeffective/20071001BIO_comp_effect.pdf http://www.cbo.gov/ftpdocs/88xx/doc8891/12-18-ComparativeEffectiveness.pdf http://www.cbo.gov/ftpdocs/88xx/doc8891/12-18-ComparativeEffectiveness.pdf http://www.cbo.gov/ftpdocs/88xx/doc8891/12-18-ComparativeEffectiveness.pdf

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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