A study published this week by ITG (NYSE: ITG) revealed that Novartis recently approved drug, Gilenya, has already taken 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 as the first FDA-approved oral disease-modifying MS drug, and Novartis initially faced safety concerns and monitoring requirements that deterred some physicians from adopting the new drug. Over 60% of neurologists in ITG's study cited safety concerns and monitoring as limiting their use of the drug, but most 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. Early switching data from ITG's proprietary panel of neurologists indicates that BIIB's Avonex may be the biggest loser of all, as nearly one-third of switches to Gilenya thus far have been from Avonex.
The study titled Event Pulse: Launch of Gilenya shows that Gilenya has been detailed heavily to neurologists since its launch. Neurologists in the study reported more frequent details on Gilenya in November than any of the other MS therapies. Study findings reveal that Novartis reps seem to be promoting the drug's unique oral formulation and its efficacy compared to market leaders, especially Biogen Idec's Avonex. Still, results from the study show that Novartis has not been able to completely allay neurologists' concerns about Gilenya's safety. Until resolved, Gilenya will likely be prescribed primarily for patients who have discontinued or have had an inadequate response to other MS therapies.
On the plus side, future prospects for Gilenya look positive, as 90% of neurologists in the study reported they plan to prescribe Gilenya in the future. "We view Gilenya's launch and future outlook in the multiple sclerosis space as very promising," said Jemma Lampkin, lead researcher on the study. "Gilenya's launch trajectory and penetration into our physician panel is encouraging. In addition, payors have been very receptive to Gilenya thus far, which bodes well for the drug from a reimbursement standpoint." According to ITG's interviews with pharmacy benefit managers at 10 managed care organizations, planned reimbursement restrictions for Gilenya will be similar to those required for other disease-modifying MS agents. Furthermore, the majority of interviewed managed care organizations already reimburse the drug.
Event Pulse: Launch of Gilenya includes analysis of a targeted Internet survey of 75 neurologists, 10 in-depth telephone interviews with pharmacy directors at major managed care organizations, and proprietary longitudinal treatment data from a panel of 200 neurologists spanning 2005-2010. Conducted in November 2010, the report takes an in-depth look at how the launch of Gilenya will affect the multiple sclerosis market. In addition, Event Pulse: Launch of Gilenya evaluates uptake and use of recently launched Ampyra, the first drug approved by the FDA to improve walking in MS patients. The qualitative portion also examines the current reimbursement climate for multiple sclerosis drugs as well as the response from managed care organizations to Gilenya and other new MS drugs in development.