DecisionBase

April 2014

Ulcerative Colitis (Moderate to Severe)

Introduction:

Amid significant unmet need, what attributes do gastroenterologists and payers expect of a therapy with a mechanism of action different from that of the currently available TNF-alpha inhibitors?

Significant opportunity remains for therapies that target the moderate to severe UC population, particularly for emerging drugs with novel mechanisms of action that can more effectively achieve mucosal healing and maintain long-term disease remission relative to the leading TNF-α inhibitor, infliximab. Current therapies for moderate to severe UC are associated with insufficient efficacy, sometimes serious safety concerns, and a high burden of delivery. With the cell adhesion molecule (CAM) inhibitor vedolizumab (Takeda’s Entyvio) and the oral Janus-activated kinase (Jak) inhibitor tofacitinib (Pfizer’s Xeljanz) in late-stage development for UC, the competition in the TNF-refractory space is intensifying as companies battle to differentiate their novel therapies and capture market share.

Questions Answered in This Report:

  *   Induction of remission, maintenance of remission, and mucosal healing are key goals in the treatment of UC. What are the key primary and secondary clinical trial end points on which new therapies are evaluated? How do U.S. and European gastroenterologists weigh specific efficacy end points and other drug attributes in their prescribing decisions for moderate to severe UC?

  *   Improved effect on mucosal healing and improved effect on the maintenance of remission are key areas of unmet need for moderate to severe UC, according to the insights of surveyed U.S. and European gastroenterologists. Which therapies in development for moderate to severe UC are poised to fulfill these needs? What clinical and/or regulatory challenges must drug developers overcome to capitalize on these areas of unmet need? What degree of improvement over currently available therapies do surveyed U.S. MCO PDs seek from new therapies on key clinical attributes for which surveyed physicians indicate there is high unmet need?

  *   Effect on induction of clinical remission and a therapy’s incidence of serious, life-threatening effects (e.g., serious/opportunistic infections, malignancy) are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new moderate to severe UC therapies. What trade-offs across these and other clinical attributes are U.S. gastroenterologists willing to make when considering the use of emerging therapies for the treatment of moderate to severe UC? Based on the trade-offs in price and performance across key drug attributes that U.S. gastroenterologists are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for moderate to severe UC?

  *   By 2017, vedolizumab (Takeda’s Entyvio) will replace infliximab (Janssen/Merck/Mitsubishi Tanabe’s Remicade) as the gold-standard therapy in our Drug Comparator Model because of its superior clinical profile over the key current therapies we evaluated. On what clinical attributes is vedolizumab most differentiated from its competitors? Which current therapies are at greatest risk of being replaced by vedolizumab?

Scope:

Attributes included in conjoint analysis-based assessment of target product profiles for moderate to severe UC:

- Effect on induction of clinical remission at 8 weeks.

- Effect on maintenance of clinical remission at 54 weeks.

- Effect on mucosal healing at 54 weeks.

- Incidence of serious, life-threatening effects (e.g., serious/opportunistic infections, malignancy).

- Monitoring burden (frequency and complexity).

- Delivery burden (dosing formulation and frequency).

- Price/day (UC maintenance setting).

Attributes included in assessment of U.S. payers’ receptivity to new therapies for moderate to severe UC:

- Effect on induction of remission.

- Effect on maintenance of remission.

- Monitoring burden (frequency and complexity).

- Burden of delivery (dosage formulation and dosing frequency).

Physicians surveyed: 60 U.S. and 30 European gastroenterologists.

Payers surveyed: 20 U.S. MCO PDs.

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Infliximab (Janssen/Merck/Mitsubishi Tanabe’s Remicade)

- Azathioprine (GlaxoSmithKline/Prometheus Laboratories/UCB’s Imuran, Eisai’s Imurek, generics)

- Adalimumab (AbbVie/Eisai’s Humira)

- Golimumab (Janssen/Merck/Mitsubishi Tanabe’s Simponi)

Emerging Therapies

- Vedolizumab (Takeda’s Entyvio)

- Tofacitinib (Pfizer’s Xeljanz)

- Etrolizumab (Genentech)

- Eldelumab (Bristol-Myers Squibb)


Search Reports

Mentioned in this report:

  • - AbbVie
  • - Bristol-Myers Squibb
  • - Eisai
  • - Genentech
  • - GlaxoSmithKline
  • - Janssen
  • - Merck
  • - Mitsubishi Tanabe
  • - Novartis
  • - Pfizer
  • - Prometheus Laboratories
  • - Takeda
  • - UCB
Decision Resources Group brands include: