Novel Disease-Modifying Therapies and Reformulations Will Experience Distinct Positioning and Market Access Challenges, According to a New Report from Decision Resources
September 3, 2013—Burlington, Mass. —Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that more than half of surveyed neurologists consider Biogen Idec’s Tecfidera to be a breakthrough in the treatment of multiple sclerosis (MS), slightly greater than those who feel the same about Novartis’s Gilenya and nearly twice as many as for Genzyme’s Aubagio. Conversely, less than one-third of surveyed managed care organization (MCO) pharmacy directors/medical directors (PDs/MDs) identify Gilenya, Aubagio or Tecfidera as breakthrough treatments, perhaps underscoring their decision to most commonly cover all three oral agents on nonpreferred tiers in their largest commercial plans. Notably, approximately one-quarter of surveyed MCO PDs/MDs did not cover Aubagio or Tecfidera at the time the survey was fielded, which is likely due to the recent launches of these agents.
The U.S. Physician and Payer Forum report entitled The Rapidly Evolving Multiple Sclerosis Treatment Landscape: How Are U.S. Physicians and Payers Responding to the Influx of New Disease-Modifying Therapies? also finds that two emerging products, Biogen Idec’s Plegridy (a pegylated version of Biogen Idec’s Avonex) and Teva’s Copaxone 40 mg/ml, dosed three-times weekly (a reformulation of Teva’s once-daily 20mg/ml Copaxone), will experience usage patterns and market access positioning similar to those of their respective predecessor compounds. This finding suggests that physicians and payers consider the clinical value of these new products to be sufficient to drive use and coverage, but that they lack strong differentiation from their respective predecessor compounds.
The report also finds that novel late-stage emerging disease-modifying therapies (DMTs) for the treatment of MS—Genzyme/Bayer HealthCare’s Lemtrada, Biogen Idec/AbbVie’s daclizumab and Roche/Genentech’s ocrelizumab—will generally be reserved for treatment-refractory patients, likely reflecting safety concerns about each. Furthermore, while surveyed MCO PDs/MDs anticipate formulary coverage of these DMTs on their commercial plans broadly similar to their coverage of existing DMTs, the new entrants are more likely to be subject to indications restrictions than current DMTs and emerging reformulations.
“As more DMTs enter the MS market in the U.S., uptake and coverage of each agent will depend on clear demonstration of its value to stakeholders, driven in particular by the balance of cost, advancements in efficacy and acceptable safety,” said Decision Resources Senior Director Jonathan Searles. “Moreover, MCO PDs/MDs indicate that post-marketing studies supporting the health economic benefits of a DMT will be an influential factor in determining future formulary coverage—as a result, generating compelling evidence of pharmacoeconomic benefit represents an important potential opportunity for nonclinical differentiation.”
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