December 9, 2013

Developers of New Agents Must Show Superiority Over Marketed Therapies and Expect Tough Pricing and Reimbursement Negotiations, According to a New Report from Decision Resources

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BURLINGTON, Mass., Dec. 9, 2013 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that surveyed gastroenterologists across the EU5 (France, Germany,Italy, Spain and the United Kingdom) anticipate prescribing Gilead's sofosbuvir to approximately 20 percent of their hepatitis C virus genotype 1 (HCV-1) patients and Janssen/Medivir's simeprevir to approximately 7 percent of these patients by the end of 2015. Surveyed specialists also indicated that they expect to prescribe sofosbuvir-based regimens to more than one-third of their HCV-2 and HCV-3 patients in this timeframe. Additionally, with sofosbuvir anticipated to be the first approved drug not requiring combination usage with interferon (IFN) in HCV-2 and/or HCV-3 patients, surveyed physicians expect that close to two-thirds of sofosbuvir-treated patients will receive it as part of IFN-free regimens by the end of 2015.

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Currently available first-generation protease inhibitors (Janssen's Incivo and Merck/Roche's Victrelis) and pegylated IFNs (Roche's Pegasys and Merck's PegIntron) receive government reimbursement and coverage in the EU5 markets. However, country-specific cost-effectiveness analyses and prescribing parameters that tie guideline adherence to reimbursement are increasingly being implemented and inform physician prescribing practices. These mechanisms demonstrate the growing importance of health technology assessment, value-based pricing and patient access programs and will continue to be key market access hurdles in the evaluation, reimbursement and uptake of all future HCV therapies.

The new European Physician and Payer Forum report entitled The Impending Inteferon-Free Era of Hepatitis C Virus Treatment: How Will All-Oral Regimens Shape EU5 Prescribing, and What Market Access Challenges Will They Face? also finds that individual European markets have implemented varying mechanisms for aggressively promoting the rational use of HCV medicines, including hospital-based prescribing (France), national online registers to track the use of costly therapies (Italy) and reimbursement oversight boards (United Kingdom).

"The revolutionary developments in the treatment of HCV in the coming years will bring to the market tremendous improvements in efficacy, tolerability and convenience of HCV regimens. However, in the cost-constrained EU5 markets, drug developers will need to balance payer authorities' price expectations with uptake potential for maximum return on investment," said Decision Resources Analyst David Holman, Ph.D. "As competition escalates in the HCV market, budget constraints at regional, local and institutional levels must all be carefully considered."

Manufacturers seeking to penetrate the EU5 HCV market must also optimize pivotal trial design, preferably offering head-to-head comparison against currently marketed protease inhibitors, and should provide thorough cost-effectiveness analyses on their products. Such data is increasingly vital in all EU5 countries as cost-constrained healthcare authorities strive to draw out value for money.

About Decision Resources
Decision Resources (www.decisionresources.com) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources Group company.

About Decision Resources Group
Decision Resources Group is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources Group at www.DecisionResourcesGroup.com.

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