A study published this week by ITG's Majestic Market Research revealed that Novartis' recently approved drug, Gilenya, continues to steal share from market leaders in the multiple sclerosis (MS) market, and uptake is expected to increase significantly over the next year. Gilenya came onto the market in late September 2010 as the first FDA-approved oral disease-modifying MS drug. Despite negative sentiment around Gilenya's lengthy initiation process, neurologists are embracing the new drug at an impressive rate. Real time data from ITG's proprietary physician panel indicate that Gilenya was the disease-modifying treatment of choice for 20% of new written MS prescriptions in April. Furthermore, surveyed neurologists indicated that their prescribing of Gilenya will increase significantly over the course of 2011 as they continue to shift inadequate responders from other MS therapies to the new drug (see also Multiple Sclerosis).
The study takes an in-depth look at how Gilenya's multi-step initiation process is impacting neurologists' use of the drug. According to neurologists, new treatment starts for Gilenya typically take between three to six weeks and involve the scheduling and organization of prescreening tests and ongoing monitoring for adverse events.
Physicians reported that Novartisplays an important role in facilitating these steps. In fact, 63% of Gilenya prescribers indicated that they receive support from Novartis during this process, and 25% of them classified this assistance as superior to what competing companies offer for their products.
By comparison, neurologists appear unable to get over similar concerns about Acorda Therapeutics' Ampyra, which was launched in March 2010 as the first FDA approved drug to improve walking in MS patients. Like Gilenya, Ampyra is associated with an onerous initiation process. Neurologists described an overwhelming degree of red tape affiliated with the reimbursement of Ampyra. Of surveyed Ampyra prescribers, 40% reported reimbursement issues with the drug. Unlike Gilenya, Ampyra's launch appears to be greatly hindered by these issues. Since neurologists view Ampyra's efficacy as questionable and limited to a niche subset of the MS population, they seem less willing to jump through hoops to get patients on it. The difference in how neurologists are handling Gilenya versus Ampyra is indicative of the cost-benefit analysis that is inherent in every treatment decision. Neurologists have made more of a commitment to Gilenya because they believe it can deliver meaningful benefits to their patients and Novartis is facilitating the delivery of those benefits. This hasn't been the case with Ampyra. Data from ITG's proprietary physician panel have pointed to waning demand for Ampyra, which the study concludes is unlikely to improve without material changes to the drug's reimbursement situation.
Conducted in April - May 2011, the study includes analysis of a targeted Internet survey of 100 neurologists and proprietary longitudinal treatment data from a panel of 225 neurologists spanning 2005-2011. Through triangulation of quantitative and qualitative findings from these two data sources, the report provides an in-depth look at the launch of Gilenya and the potential for future oral disease-modifying drugs in the multiple sclerosis market. In addition, the report evaluates uptake and use of Acorda Therapeutics' Ampyra as a supportive agent in the MS space.
Keywords: Autoimmune Diseases of the Nervous System, Biotechnology, CNS Demyelinating Autoimmune Diseases, Drug Development, FDA, ITG, Immune System Diseases, Multiple Sclerosis, Neuroimmunology, Neurology, Novartis AG, Pharmaceutical Business, Pharmaceutical Company, Regulatory Actions, Therapy, Treatment, U.S. Food and Drug Administration.
This article was prepared by Medical Letter on the CDC & FDA editors from staff and other reports. Copyright 2011, Medical Letter on the CDC & FDA via NewsRx.com.
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