DecisionBase

April 2013

Ulcerative Colitis

Introduction:

Which Clinical Attributes Will Most Effectively Position Emerging Agents Against Infliximab in the Moderate to Severe Patient Segment?

Significant opportunity remains for therapies that target the moderate to severe UC population, particularly for emerging drugs with novel mechanisms of action that can maintain long-term disease remission more effectively than the TNF-α inhibitor infliximab (Janssen/Merck/Mitsubishi Tanabe’s Remicade). Current therapies for moderate to severe UC are associated with either insufficient efficacy or serious safety concerns, and there is great need for additional pharmacological agents outside the TNF-α inhibitor class that can serve as alternatives to life-altering colectomy. With a cell adhesion molecule (CAM) inhibitor and an oral Janus-activated kinase (Jak) inhibitor in late-stage development for UC, the competition in the TNF-refractory space is intensifying as novel therapies battle to differentiate themselves and capture market share.

Questions Answered in This Report:

  *   A drug’s performance on at least eight efficacy end points, including sustained remission, maintenance of remission, and mucosal healing, is important for drug approval and physician use. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European gastroenterologists weight the importance of efficacy measures and other drug attributes in their prescribing decisions for moderate to severe UC?

  *   Infliximab is the 2011 major-market sales leader for UC. What weaknesses exist in its profile that would allow emerging therapies to gain a foothold in the market? Have emerging therapies demonstrated potential improvements on the attributes that surveyed gastroenterologists indicate are the most important in their prescribing decisions? Which emerging therapies will offer the clinical improvements over currently available therapies that surveyed MCO PDs seek from new therapies?

  *   A therapy’s effect on induction and maintenance of remission and 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 2016, vedolizumab (from Takeda) will emerge as the gold-standard therapy in our Drug Comparator Model owing to 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

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

- Monitoring burden (e.g. hematologic events, liver enzymes): frequency (e.g., first-dose only, monthly) and complexity (e.g., number/difficulty of unique tests)

- Dosage formulation

- Dosing frequency

- Price/day

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, taking into account both the frequency and complexity of monitoring required

- Burden of delivery, comprising both dosing frequency and dosage formulation

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)

- Adalimumab (AbbVie/Eisai’s Humira)

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

Emerging Therapies

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

- Vedolizumab (Takeda)

- Tofacitinib (Pfizer’s Xeljanz)

- Eldelumab (Bristol-Myers Squibb)


Search Reports

Mentioned in this report:

  • - AbbVie
  • - Bristol-Myers Squibb
  • - Eisai
  • - GlaxoSmithKline
  • - Janssen
  • - Merck
  • - Mitsubishi Tanabe
  • - Novartis
  • - Pfizer
  • - Prometheus Laboratories
  • - Takeda
  • - UCB
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