BURLINGTON, Mass., July 17, 2013 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that surveyed pulmonologists in the United States consider a drug's effect on reducing morbidity/mortality to be the attribute that most influences their prescribing for pulmonary hypertension (PH). This provides a strong opportunity for Actelion's Opsumit, the first oral pulmonary arterial hypertension (PAH) therapy to be investigated in a large-scale placebo-controlled outcomes study. Opsumit met its primary end point in the Phase III SERAPHIN study, demonstrating a significant (45 percent) risk reduction in mortality/morbidity events compared with placebo and is currently under review by the U.S. Food and Drug Administration (FDA).
The U.S. Physician & Payer Forum report entitled How Will Payers and Physicians Respond to Novel Agents in Late-Stage Clinical Development for Pulmonary Hypertension? also finds that surveyed U.S. managed care organization (MCO) pharmacy directors consider therapies promising significant improvements in mean pulmonary arterial pressure and with evidence of benefit in multiple PAH etiologies to be among the most important features driving tier placement. Therapies that offer an improvement on these end points are most likely to benefit from favorable tier status.
Current PH treatment is dominated by the use of three drug classes and, while a total of nine therapies are approved for the treatment of Group 1 PH (PAH), no agents are currently licensed by the FDA for the treatment of Groups 2-5 PH. Bayer's riociguat is likely to become the first as it is currently under FDA review for inoperable chronic thromboembolic pulmonary hypertension (chronic thromboembolic pulmonary hypertension; PH Group 4).
Due to the absence of approved therapies, surveyed clinicians report off-label prescribing of drugs approved for PAH in all these populations. And while a majority of surveyed MCO pharmacy directors indicate an awareness of this off-label prescribing, less than a third actually approve reimbursement for it, irrespective of the severity of the circumstances.
"Payers are loath to support the off-label prescribing of drugs in patient populations for which they have no license," said Decision Resources Principal Analyst Matthew Scutcher, Ph.D. "Payers and physicians will be looking for novel therapies with proven efficacy in PH groups other than PAH, and any agent gaining a license in these populations is likely to quickly dominate."
Members of the media are welcome to attend our upcoming webinar entitled U.S. Physician and Payer Perspectives on Novel Emerging Agents for Pulmonary Hypertension. This webinar will be held on August 7 at 10 a.m. U.S. Eastern Time. For more information, please contact Christopher Comfort at firstname.lastname@example.org.
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SOURCE Decision Resources