DecisionBase

June 2013

Crohn’s Disease (Moderate to Severe)

Introduction:

Amid Unmet Need for Improved Induction and Maintenance Therapies, What Magnitude of Improvement Do Surveyed Gastroenterologists and Payers Expect of a Novel Therapy?

Crohn’s disease (CD) is an inflammatory bowel disease that requires chronic therapy (sometimes with expensive biological agents) to treat symptoms of diarrhea and abdominal pain. Moderate to severe CD is typically treated with oral corticosteroids and/or immunosuppressants to induce and maintain remission, respectively, after which patients graduate to treatment with tumor necrosis factor-alpha (TNF-α) inhibitors. The first approved TNF-α inhibitor for CD, infliximab (Janssen/Merck/Mitsubishi Tanabe’s Remicade), remains the market leader for this indication, but the second approved agent in this class, adalimumab (AbbVie/Eisai’s Humira), is experiencing increasing uptake as a first-line biologic. Although current therapies used to treat moderate to severe disease will see increased competition from novel biologics and oral small-molecule drugs expected to launch in the near term, substantial opportunity will remain for additional therapies that can improve upon the efficacy and safety of marketed agents.

Questions Answered in This Report:

  *   A drug’s performance on at least eight efficacy end points, including maintenance of clinical remission, 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 efficacy measures and other drug attributes in their prescribing decisions for moderate to severe CD?

  *   A greater percentage of patients maintaining remission and a greater percentage of patients achieving induction of remission are key areas of unmet need in moderate to severe CD, according to the insights of surveyed U.S. and European gastroenterologists. Which therapies in development for moderate to severe CD are poised to fulfill these needs? What clinical and/or regulatory challenges must drug developers overcome in order 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?

  *   A therapy’s effects on maintenance of clinical remission and mucosal healing are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new moderate to severe CD 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 moderate to severe CD? 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 CD?

  *   Based on its clinical profile, adalimumab (AbbVie/Eisai’s Humira) is the current clinical gold standard in our Drug Comparator Model. What attributes do thought leaders believe differentiate this therapy from competing current and emerging therapies? Will any therapies in development challenge adalimumab as the future gold standard in 2016 or 2021?

Scope:

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

- Effect on induction of clinical remission at four weeks.

- Effect on maintenance of clinical remission at 54 weeks.

- Effect on closure of all draining fistulas at 54 weeks.

- Effect on mucosal healing at 54 weeks.

- Rate of serious infections (e.g., tuberculosis, sepsis, pneumonia, abscess) at one year.

- Delivery burden (dosing formulation and frequency).

- Price/day.

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

- Effect on induction of remission.

- Effect on maintenance of remission.

- Effect on maintenance of response.

- Rate of serious infections.

Physicians surveyed: 60 U.S. and 31 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)

- Certolizumab pegol (UCB’s Cimzia)

- Natalizumab (Biogen Idec’s Tysabri)

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

Emerging Therapies

- Ustekinumab (Janssen’s Stelara)

- Vedolizumab (Takeda)

- Vercirnon (GlaxoSmithKline/ChemoCentryx’s Traficet-EN)

- Tofacitinib (Pfizer’s Xeljanz)


Search Reports

Mentioned in this report:

  • - AbbVie
  • - Biogen Idec
  • - ChemoCentryx
  • - Eisai
  • - Genentech
  • - GlaxoSmithKline
  • - Janssen
  • - Johnson & Johnson
  • - Merck
  • - Mitsubishi Tanabe
  • - Pfizer
  • - Prometheus Laboratories
  • - Takeda
  • - UCB
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