Crohn’s disease (CD) and ulcerative colitis (UC) are two autoimmune/inflammatory indications that commonly feature treatment with biologic therapies. While the former market consists of four approved biologics, the latter consists of three, with the most recent agent receiving approval in May 2013. The approved biologics are Janssen’s Remicade (infliximab; CD and UC), AbbVie’s Humira (adalimumab; CD and UC), UCB’s Cimzia (certolizumab pegol; CD), Janssen’s Simponi (golimumab; UC), and Biogen Idec’s Tysabri (natalizumab; CD). In both CD and UC, Remicade continues to lead the U.S. market in sales. The drug stands as the therapy to beat for agents targeting patients refractory to conventional, and less-costly agents, is followed by its competitor, Humira. Despite the impact these current TNF-α inhibitors have on the CD and UC markets, gastroenterologists indicate that there is still unmet need for novel agents that offer the basic clinical attributes of inducing and maintaining clinical remission at higher rates. Two emerging therapies are each expected to launch for CD and UC in the near future, presenting physicians with additional therapy options for moderate-to-severe patients, while payers modulate demand for these costly therapies in order to balance their own mission of managing costs while still permitting access.
In this report, we focus on Takeda’s vedolizumab, which has been preregistered for CD and UC since June 2013; Janssen’s Stelara (ustekinumab), in Phase III development for CD; GlaxoSmithKline/ChemoCentryx’s Traficet-EN (vercirnon), which was in Phase III development for CD; and Pfizer’s Xeljanz (tofacitinib) in Phase III development for UC. After Traficet-EN’s failure to reach the primary end point of clinical response in an induction trial, its Phase III program was terminated while physician and payer surveys were in the field; in this report, Traficet-EN is discussed in terms of the impact a novel oral therapy for moderate to severe CD would have on TNF-α inhibitor use and its potential pricing and reimbursement. In addition, we probe on biosimilars for infliximab and adalimumab, which we anticipate will launch during the same time frame as these branded agents, and how they will impact potential patient share of currently available and emerging therapies.
Questions Answered in This Report:
Current treatment for CD and UC:
What are the prescribing patterns for biologics by physicians treating CD and UC? What has been the impact of payer policies on these drugs for the treatments of CD and UC? Are payers more open in their attitudes and permissive in their policies toward CD versus UC? What are physician and payer perceptions of whether Humira and Simponi have fulfilled the unmet need for additional therapies for UC patients? What biologics do gastroenterologists currently prescribe the most for CD and UC, and for each line of therapy?
Emerging therapies in CD and UC:
What formulary decisions will MCOs make based on price for emerging therapies? What will be the impact of MCO tiering decisions on physician prescribing? How will payers respond if emerging therapies launch at higher doses, and thus potentially higher costs, for CD and UC than the doses for indications that these agents are already marketed for (e.g., RA and psoriasis)? How do gastroenterologist and MCO PD/MDs prioritize clinical outcomes when asked what features emerging therapies must demonstrate to challenge the positioning of the TNF-α inhibitors? Will the emerging profiles of late-stage agents suggest any key advantages that would weaken the standing of the TNF-α inhibitors? What is payer pricing tolerance for a novel oral agent matching Traficet -EN’s profile for which CD will be its first indication?
Biosimilars in CD and UC:
What will be the impact of biosimilars for infliximab and adalimumab on prescribing of current and emerging agents? How do gastroenterologists and MCO PD/MDs differ in their willingness to prioritize biosimilar TNF-α inhibitors owing to these agents’ potential for cost savings despite the clinical uncertainties?
Decision Resources’ Physician & Payer Forum report “Promising Pipelines for Crohn’s Disease and Ulcerative Colitis: Payer and Prescriber Receptivity as the Market for Premium-Priced Therapies Expands Beyond the TNF-α Inhibitors” explores the factors that shape current and future treatment patterns as well as reimbursement trends in CD and UC. Additionally, this report reveals gastroenterologists’ and payers’ perceptions of biologic therapies that are currently available or will launch over the next few years as well as biosimilar versions of infliximab and adalimumab and their impact on current therapy use. This report is based on a survey with 100 gastroenterologists and 30 pharmacy and medical directors (PDs and MDs) of managed care organizations (MCOs) that offer commercial health insurance.
Markets covered: United States.
Primary research: Online survey of 100 gastroenterologists and 30 pharmacy and medical directors.
Epidemiology: 2012-2022 diagnosed prevalent cases of CD and UC in the United States.
Market analysis: 2012 total U.S. sales of biologics for CD and UC.