BURLINGTON, Mass., Sept. 17, 2014 /PRNewswire/ -- Decision Resources Group finds that among Crohn's disease/ulcerative colitis (CD/UC) patients eligible for biologic therapy, only a proportion of patients currently receive a biologic. Surveyed gastroenterologists cite patients' discomfort with biological therapy as the main reason for low penetration rates, followed by cost-related issues and payer restrictions. Among CD and UC patients receiving biologics, Janssen Biotech's Remicade and AbbVie's Humira are the preferred first- and second-line agents by gastroenterologists. In addition, Remicade and Humira are covered by most plans on a preferred tier, a significant hurdle for other branded and emerging therapies.
Other key findings from the U.S. Physician and Payer Forum report entitled Crohn's Disease and Ulcerative Colitis: U.S. Physician and Payer Perspectives on Established and Recently Launched Biologics, Emerging Novel Agents and Biosimilars:
- Opportunity for emerging agents: Gastroenterologists estimate that approximately 20 percent of patients on Remicade or Humira ultimately discontinue treatment, primarily because of treatment failure. In addition, approximately 20 percent of the patients are dissatisfied with these agents and are eager to switch to another therapy with a novel mechanism of action. High opportunity exists for emerging therapies with a different mechanism of action. Takeda's Entyvio, Janssen Biotech's Stelara, and Pfizer's Xeljanz are likely to challenge the currently available anti-TNFs, if they demonstrate improved safety and efficacy compared to Remicade and Humira.
- Challenges for emerging agents: Emerging therapies are likely to face many challenges in obtaining favorable coverage. To place emerging agents on the same tier as anti-TNFs, managed care organizations (MCOs) seek cost incentives, such as lower list price and the potential for discounts that result in a net price similar to that of anti-TNFs. To win placement on a lower tier, advantages such as improved safety compared with the anti-TNFs and comparative data with anti-TNFs are also required.
- Impact of biosimilar anti-TNFs: The launch of biosimilar versions of anti-TNFs represents a notable threat to the respective brands, as well as other branded biologics. A mix of clinical factors and payer decisions will likely influence biosimilars' roles in CD and UC treatment, with a large proportion of gastroenterologists citing lower out-of-pocket costs and payer request as the main reason.
Comments from Decision Resources Group Analyst Adi Reske, Ph.D.:
- "No cases of progressive multifocal leukoencephalopathy (PML) have been reported with Entyvio to date, yet the risk of PML is the greatest concern in prescribing the agent. Among surveyed gastroenterologists who expect to use Entyvio for CD and UC, the majority will prescribe the agent following failure with at least one TNF-alpha inhibitor."
- "By the end of 2017, biosimilars will account for at least one-quarter of the patient share currently captured by Remicade and Humira. The availability of biosimilars on formularies will depend on their price discount to the brand with savings of at least 20 percent likely needed to merit widespread formulary inclusion. At these discounts, MCOs will encourage use of the biosimilar before the brand through lower copays."
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