Opportunity Exists in the U.S. for Novel Agents in Crohn's Disease and Ulcerative Colitis, Owing to Discontinued Use of Leading Anti-TNF Agents Driven by Efficacy Failures

BURLINGTON, Mass., Dec. 10, 2013 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that lack of initial response or waning efficacy over time are the main reasons that patients discontinue treatment with leading anti-TNFs, Janssen's Remicade and AbbVie's Humira in Crohn's disease (CD) and ulcerative colitis (UC), according to surveyed gastroenterologists. Furthermore, gastroenterologists estimate that one-fifth of their patients taking these agents express dissatisfaction and are eager to switch to an alternative therapy that can achieve higher rates of clinical remission and maintain clinical remission. If the following emerging therapies with novel mechanisms of action—Takeda's CAM inhibitor vedolizumab for CD and UC, Janssen's IL-12/IL-23 inhibitor Stelara for CD and Pfizer's oral Jak inhibitor Xeljanz for UC—can meet physicians' expectations about efficacy, such agents should be well positioned. However, because cost-related issues such as a lower list price than anti-TNFs are cited by managed care organizations (MCOs) as key drivers for favorable formulary inclusion, such therapies will likely face challenges obtaining preferential coverage since many plans already cover Remicade and Humira on tier 2.

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The U.S. Physician & Payer Forum report entitled Promising Pipelines for Crohn's Disease and Ulcerative Colitis: Payer and Prescriber Receptivity as the Market for Premium-Priced Therapies Expands Beyond the TNF-alpha Inhibitors finds that, among all emerging therapies, the greatest opportunity exists for vedolizumab's use in CD, with over two-thirds of gastroenterologists expecting to prescribe this agent within a year of its launch. Fewer expect to prescribe vedolizumab for UC; the approval of Janssen's Simponi for UC in 2013 may have lessened the urgency for movement out of the anti-TNF drug class. While surveyed gastroenterologists cite preference for a different mechanism of action and potential for improved long-term remission over Remicade as the main factors for prescribing vedolizumab (at the same copay) before prescribing anti-TNFs, MCO data suggest the likelihood that the novel agent will have same copay as Remicade is low.   

"While 93 percent of surveyed payers indicate that their plan would reimburse vedolizumab if priced the same as Remicade, patients are unlikely to encounter the same copay with the highest percentage of payers anticipating its placement on specialty tier, thus likely delaying use to after failure with at least one anti-TNF," said Decision Resources Analyst Kathrina Quinn, Ph.D.

The novel agent Xeljanz will also face difficulty in achieving favorable formulary inclusion for UC. According to most surveyed payers, the oral agent is currently covered as a non-preferred brand for rheumatoid arthritis, with over half of these plans not expecting its tiering to change within its first year of availability for UC.

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SOURCE Decision Resources