The Majority of Surveyed Neurologists in the EU5 Expect Both Gilenya and Oral Cladribine to Secure Initial European Approval for Relapsing Forms of Multiple Sclerosis
BURLINGTON, Mass., Dec. 15, 2010 /PRNewswire/ — Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that the majority of surveyed neurologists in the EU5–France, Germany, Italy, Spain and the United Kingdom–expect that both Novartis/Mitsubishi Tanabe’s oral agent Gilenya (FTY-720/fingolimod) and Merck Serono’s oral cladribine will most likely secure initial European approval for use in relapsing forms of multiple sclerosis (MS), which includes relapsing-remitting MS (RR-MS) and relapsing forms of secondary progressive MS (SP-MS).
The new European Physician & Payer Forum report entitled Multiple Sclerosis in Europe: How Will Clinician Attitudes and Payer Hurdles Determine How Late-Stage Oral Therapies Will Compete with Current Disease-Modifying Drugs? finds that the greatest proportion of surveyed neurologists expect that the first approved use of either disease-modifying drug will be for the treatment of patients with relapsing forms of MS who have failed first line therapy. However, very few neurologists in any market under study anticipate that either agent will not attain European regulatory approval–an important finding given the previous rejection of oral cladribine by European regulators in September 2010.
“Despite the convenient oral formulations and robust efficacy offered by Gilenya and oral cladribine, surveyed neurologists anticipate that regulatory authorities will stipulate that both drugs be used in the later line, a restriction that currently only applies to Biogen Idec/Elan’s Tysabri,” said Decision Resources Director Bethany Kiernan, Ph.D. “This finding likely reflects neurologists’ conservative attitude towards these drugs, owing to safety concerns.”
Surveyed neurologists expect that, one year after its launch, a greater percentage of RR-MS patients will receive Gilenya than any other subtype of the disease. When asked to assign a patient share for oral cladribine one year after its launch, surveyed neurologists in the EU5 anticipate that they will likewise prescribe the drug to more RR-MS patients than patients within other disease subtypes.
The report also finds that the anticipated high cost of Gilenya and oral cladribine will not be a significant hurdle to their reimbursement.
“Even as most European markets are instituting more stringent cost-containment measures to reign in overall healthcare costs, interviewed reimbursement experts in each of the EU5 countries expect that–assuming each agent attains approval–Gilenya and oral cladribine will be fully reimbursed according to their labeled indications,” Dr. Kiernan said. “These experts likewise anticipate that emerging disease-modifying therapies will not have a sizeable impact on the reimbursement status of currently available therapies, reinforcing the perception of new agents as an addition to–not as a replacement for–the current MS armamentarium.”
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