Crohn’s disease (CD) and ulcerative colitis (UC) are the two gastrointestinal inflammatory disorders that constitute inflammatory bowel disease (IBD), affecting approximately million people in the United States. Use of biologics is becoming more commonplace in these disorders, with five approved in the CD market and four in the UC market. Janssen’s Remicade (infliximab) and AbbVie’s Humira (adalimumab) are the contenders to beat for emerging agents vying for share in patients who are refractory to less expensive, conventional agents. gastroenterologists indicate a strong preference for novel agents with alternative mechanisms of action that can offer improvements on the key goals of CD/UC pharmacotherapy: induction and maintenance of remission. In this report, we present key insights from physicians’ and payers’ opinions on current biologics and emerging therapies in order to address the potential actions necessary to keep pace with the evolving prescribing and reimbursement landscape for CD and UC. We focus on the available TNF-? inhibitors Remicade, Humira, Janssen’s Simponi (golimumab), and UCB’s Cimzia (certolizumab pegol); the cell adhesion molecule inhibitors Biogen’s Tysabri (natalizumab) and Takeda’s Entyvio (vedolizumab); and the emerging therapies Janssen’s Stelara (ustekinumab) and Pfizer’s Xeljanz (tofacitinib), as well as biosimilars infliximab and adalimumab.

Questions Answered in This Report:

  • In an expanding CD and UC market, physician interests and payer policies have important impact on the treatment landscape for CD and UC. What biologics do gastroenterologists most frequently prescribe compared with what they would prefer to prescribe? What impact do payer policies have on these therapies, and what cost-containment strategies present the greatest challenge to gastroenterologists’ prescribing habits?

  • In the face of healthcare reform and an ongoing shift to a pay-for-value model, emerging therapies face significant challenges to secure favorable placement on formularies for CD and UC as well as to persuade gastroenterologists to use them ahead of the more established TNF-alpha inhibitors. What factors do physicians consider most persuasive in their decision to prescribe a new therapy? What is the anticipated impact and expected line of use for late-stage emerging therapies Stelara and Xeljanz in CD and UC, and how well do physicians’ and payers’ opinions align? What factors are most important to payers when deciding where a novel therapy should be included on their formulary?

  • The arrival of biosimilars in the U.S. market for CD and UC is expected to substantially impact how current and emerging therapies are used and covered by MCOs. What is physicians’ anticipated uptake and line of use of biosimilars for CD and UC? What size price discount relative to branded TNF-alpha inhibitors do payers expect, and what impact will it have on the CD and UC reimbursement landscape? What are physicians’ opinions on how they anticipate their prescription habits for biosimilars to be impacted by payer decisions?


Markets covered: United States.

Primary research: Online survey of 101 gastroenterologists and 32 PDs/MDs.

Epidemiology: 2014-2024 diagnosed prevalent cases of CD and UC in the United States.

Market analysis: 2014 total U.S. sales of biologics for CD and UC.

Author(s): Michael Darcy, Ph.D.

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