Crohn’s disease (CD) and ulcerative colitis (UC) are two gastrointestinal autoimmune/inflammatory indications that commonly feature treatment with biological therapies. The U.S. CD market consists of five approved biologics, and the UC market consists of four; the most recent agent—Takeda’s Entyvio (vedolizumab; CD and UC)—received FDA approval in May 2014. In both CD and UC, Janssen’s Remicade (infliximab) continues to lead the U.S. market in sales and patient share as the therapy to beat for agents targeting patients refractory to conventional, less-costly agents, followed by AbbVie’s Humira (adalimumab). Despite the positive impact of these TNF-α inhibitors on CD and UC treatment, U.S. gastroenterologists indicate that novel agents are still needed that offer the basic clinical attributes of inducing and maintaining clinical remission at higher rates. With the recent launch of Entyvio and the anticipated launches of Janssen’s Stelara (ustekinumab) for CD and Pfizer’s Xeljanz (tofacitinib) for UC in the near future, the competitive environment will intensify, presenting physicians with additional therapy options for moderate-to-severe disease.

In this report, we gauge physicians’ and payers’ opinions of current biologics and emerging therapies for CD and UC to anticipate potential changes in the prescribing patterns and reimbursement climate. We focus on the available TNF-α inhibitors Remicade, Humira, Janssen’s Simponi (golimumab), and UCB’s Cimzia (certolizumab pegol); the cell adhesion molecule inhibitors Biogen Idec’s Tysabri (natalizumab) and Entyvio; and the emerging therapies Stelara and Xeljanz. In addition, we discuss physicians’ and payers’ opinions of biosimilars for infliximab and adalimumab, which we anticipate will launch during the same time frame as the branded agents, and how they will affect 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 gastroenterologists treating CD and UC? What has been the impact of payer policies on these drugs in the treatment 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 Humira’s and Simponi’s ability to fulfill the unmet need for additional therapies for UC? What biologics do gastroenterologists currently prescribe the most for CD and UC and for each line of therapy?

  • Emerging therapies in CD and UC: Do the emerging profiles of late-stage agents suggest any key advantages that would weaken the standing of the TNF-α inhibitors? Which emerging therapies appear to be gaining favor among gastroenterologists and payers for potential use within the CD/UC TNF-refractory subpopulation? How do gastroenterologists and MCO PDs/MDs prioritize clinical outcomes when asked what features emerging therapies must demonstrate to challenge the positioning of the TNF-α inhibitors? What formulary decisions will MCOs make based on price for emerging therapies? What will be the impact of MCO tiering decisions on physician prescribing?

  • Biosimilars in CD and UC: What will be the impact of biosimilar versions of infliximab and adalimumab on prescribing of current and emerging agents? How do gastroenterologists and MCO PDs/MDs differ in their willingness to prioritize biosimilar TNF-α inhibitors owing to these agents’ potential for cost savings despite the clinical uncertainties?

Scope:

Decision Resources Group’s Physician & Payer Forum report “Crohn’s Disease and Ulcerative Colitis: U.S. Physician and Payer Perspectives on Established and Recently Launched Biologics, Emerging Novel Agents and Biosimilars” 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 biologics that are currently available or will launch over the next few years, as well as their perceptions of biosimilar versions of infliximab and adalimumab and their impact on current therapy use. This report is based on a survey of 103 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 103 gastroenterologists and 30 PDs/MDs.

Epidemiology: 2013-2023 diagnosed prevalent cases of CD and UC in the United States.

Market analysis: 2013 total U.S. sales of biologics for CD and UC.

Author(s): Adi Reske, Ph.D.

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