Physicians Would Welcome Therapies Causing Lower Rate of Serious Infections than Remicade, but Will Payers View Such Agents Favorably?

Treatment for Crohn’s disease (CD)—a relapsing/remitting inflammatory bowel disease marked by abdominal pain, diarrhea, and complications including gastrointestinal fistulas—requires acute management of disease flares and chronic, long-term maintenance therapy. 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. Emerging therapies with different mechanisms of action and/or less-burdensome delivery are in clinical development for moderate to severe CD. However, interviewed thought leaders do not expect these drugs to displace the TNF-α inhibitors as the dominant drug class for moderate to severe CD, and substantial opportunity exists for additional therapies that can improve on the efficacy and safety of marketed agents.

Questions Answered in This Report:

  • A drug’s performance on at least eight efficacy end points, including the percentage of patients who maintain clinical remission at 54 weeks, 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 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 the treatment of 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?

  • Infliximab is the 2012 major-market sales leader for moderate to severe CD. What weaknesses exist in its profile that would allow emerging therapies to gain a foothold in the market? Have emerging therapies demonstrated strengths 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?

  • Despite the potential launch of several emerging therapies in the moderate to severe CD market over the next ten years, TNF-α inhibitor adalimumab will remain the gold-standard therapy in our Drug Comparator Model. On what clinical attributes is adalimumab most differentiated from its competitors? What are the weaknesses of this therapy on which emerging therapies can capitalize? Which emerging therapies, if any, pose the greatest threat to adalimumab as well as the other key current therapies?

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 (dosage formulation and dosing 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: 61 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)

- 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)

- Tofacitinib (Pfizer’s Xeljanz)


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