Surveyed Gastroenterologists Say That an All-Oral, Interferon-Free Regimen Priced the Same as peg-IFN-alpha-2a/ribavirin Would Have to Provide Considerably Improved Efficacy for Treatment-Naive Patients, According to Findings from Decision Resources
BURLINGTON, Mass.--(BUSINESS WIRE)-- Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that the majority of surveyed U.S. gastroenterologists (68 percent) and surveyed managed care organizations’ (MCOs) pharmacy directors (60 percent) identified the market and patient share leading regimen, peg-IFN-alpha-2a (Roche’s Pegasys)/ribavirin (Roche’s Copegus, Merck & Co.’s Rebetol, generics), as the most efficacious therapy for hepatitis C virus (HCV), when compared to other available therapies.
The findings from Decision Resources’ analysis of the HCV drug market reveal that interviewed thought leaders and data from several large clinical trials do not support the perception that peg-IFN-alpha-2a/ribavirin is more efficacious than the other marketed therapy, peg-IFN-alpha-2b/ribavirin (Merck’s PegIntron), but instead demonstrate that there is no significant difference between the two regimens. However, practical experience and greater familiarity with peg-IFN-alpha-2a/ribavirin may drive surveyed gastroenterologists’ perception of its superiority over peg-IFN-alpha-2b/ribavirin. For both peg-IFN-alpha-2a/ribavirin and peg-IFN-alpha-2b/ribavirin, surveyed gastroenterologists were most satisfied with sustained virological response rates of treatment-naive genotype 2- or 3-infected patients. Data from clinical trials in this population demonstrate much higher efficacy for both regimens compared with efficacy in genotype 1 patients. Also, specialists were least satisfied with sustained virological response rates in treatment-nonresponder genotype 1-infected patients, for both interferon-based therapies.
The findings also reveal that the cost of an all-oral, interferon-free regimen consisting of two HCV-specific antivirals in combination with ribavirin generally plays an important role in the efficacy, safety and tolerability, and delivery expectations of surveyed gastroenterologists.
“However, regardless of cost, gastroenterologists are not willing to compromise on efficacy in certain subpopulations,” said Decision Resources Analyst Courtney Stanton, Ph.D. “If an all-oral, interferon-free regimen priced the same as the current gold standard—peg-IFN-alpha-2a/ribavirin—were available, surveyed gastroenterologists indicate that such a regimen would have to provide considerable improvement in efficacy for treatment-naive HCV genotype 1-infected patients.”
The findings also reveal that surveyed gastroenterologists and MCO pharmacy directors agree that the ability to achieve sustained virological response in treatment-naive HCV genotype 1-infected patients is one of the attributes that most influences their decisions regarding prescribing and tier placement decisions, respectively, in HCV. Clinical data and the opinions of interviewed thought leaders indicate that regimens combining a pegylated interferon and ribavirin plus Vertex/Johnson & Johnson/Mitsubishi Tanabe’s telaprevir, Merck’s boceprevir, Roche/Pharmasset’s RG-7128, Johnson & Johnson/Medivir’s TMC-435 or Bristol-Myers Squibb’s BMS-650032 and BMS-790052 in a quadruple regimen have advantages over sales-leading peg-IFN-alpha-2a on this attribute.
Through 2019, the launch of novel HCV-specific agents will increase the size of the drug-treated population due mainly to re-treatment of prior nonresponders as well as increased referral and drug-treatment rates. As a result, Decision Resources forecasts that the HCV drug market will more than triple from approximately $2 billion in 2009 to nearly $6.4 billion in 2014 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. Thereafter, the market will decrease to $4.6 billion in 2019 due to a decline in the size of the treatment-eligible population, decreasing disease prevalence and the high efficacy of new treatment regimens.
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