BURLINGTON, Mass., June 20, 2013 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that surveyed U.S. and European neurologists identify efficacy improvements in the percentage of seizure-free patients as one of the greatest unmet needs in controlling partial-onset seizures in treatment-refractory epilepsy patients. However, clinical data and the opinions of interviewed thought leaders indicate that none of the five novel agents assessed in the report has clearly demonstrated the potential to fulfill this unmet need, thus leaving considerable opportunity for future therapeutics to bring about meaningful advancements in this arena.
The DecisionBase report entitled Epilepsy: What Type and Magnitude of Clinical Improvements Over Current Mainstays of Treatment Would Make Neurologists and Payers Receptive To a New Therapy? finds that surveyed U.S. neurologists would prescribe the emerging agents profiled—Eisai's Fycompa, UCB's Rikelta and three reformulations of currently available products—to no more than 10 percent of their drug-treated epilepsy patients. Compared with the market-leading, second-generation antiepileptic drug (AED) levetiracetam immediate release (UCB/Otsuka Pharmaceutical's Keppra/E Keppra/Keppra XR, generics), investigational products appear to lack differentiation in efficacy, safety and tolerability, and/or delivery that would be necessary for them to assume a more dominant role in clinical care.
The findings also reveal that 95 percent of surveyed U.S. managed care organization (MCO) pharmacy directors report a willingness to grant preferred formulary status to a drug delivering improvements in seizure-free efficacy, with 45 percent indicating a high willingness. Payers also indicate receptivity to new products that increase the percentage of adult treatment-refractory patients successfully completing a conversion to monotherapy trial and/or more-effectively reduce partial-onset seizure frequency as an adjunctive therapy in pediatric treatment-refractory patients. However, 30-40 percent of surveyed MCO pharmacy directors would require a 75 percent improvement over lamotrigine immediate release (GlaxoSmithKline/Juste's Lamictal, other brands, generics) on these metrics to consider reimbursement, the highest level of improvement assessed in the report.
"While our findings suggest that most payers will require that a drug deliver a strong clinical performance in these arenas to inspire coverage, they indicate they will accept price premiums under either scenario, although tier-dependent cost controls are likely," said Decision Resources Business Insights Analyst John Crowley, Ph.D. "Moreover, conjoint analysis signals neurologists' own price sensitivity for products that cost considerably more than current second- and third- generation AED brands, which generally fall within a range of $10-15/day in the United States."
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SOURCE Decision Resources