DecisionBase

June 2013

Psoriasis (Moderate to Severe)

Introduction:

Which Clinical Attributes Will Most Effectively Position Emerging Agents Against the Market Leader, Adalimumab?

2.7 million people in the major pharmaceutical markets are diagnosed with moderate to severe psoriasis. This relatively large population and the increasing use of biologics to treat the disease have made the therapy market one of substantial commercial opportunity. In 2011, driven by its better efficacy and dosing schedule and dermatologists’ positive perception of its safety profile, adalimumab (AbbVie/Eisai’s Humira) displaced etanercept (Amgen/Stiefel/Pfizer/Takeda’s Enbrel) as the G7 sales leader. Although the current moderate to severe psoriasis market is crowded with efficacious biologics, opportunity still exists for new agents that offer improvements in short- and long-term efficacy and in safety, particularly a lower risk of malignancy and serious infections. The moderate to severe psoriasis pipeline contains several agents with novel mechanisms of action that have the potential to fulfill these unmet needs.

Questions Answered in This Report:

  *   A drug’s performance on at least six efficacy end points, including PASI 75 response rate at 12-16 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 dermatologists weight efficacy measures and other drug attributes in their prescribing decisions for moderate to severe psoriasis?

  *   Adalimumab (AbbVie/Eisai’s Humira) is the 2011 major-market sales leader for moderate to severe psoriasis. What weaknesses exist in its profile that would allow emerging therapies to gain a foothold in the market? Have emerging therapies demonstrated potential on the attributes that surveyed dermatologists 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?

  *   PASI 75 response rates at 12-16 weeks and at 60 weeks are key drivers of physicians’ prescribing decisions and/or the focus of drug development for new moderate to severe psoriasis therapies. What trade-offs across these and other clinical attributes are U.S. dermatologists willing to make when considering the use of emerging therapies for the treatment of moderate to severe psoriasis? Based on the trade-offs in price and performance across key drug attributes that U.S. dermatologists are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for moderate to severe psoriasis?

  *   Based on its clinical profile, ustekinumab (Janssen’s Stelara) is the current clinical gold standard in our Drug Comparator Model. What attributes do thought leaders believe differentiate this therapy from competing current therapies and emerging therapies? Will any therapies in development challenge ustekinumab 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 psoriasis:

- PASI 75 response at 12 weeks (% of patients achieving a PASI 75 response, placebo-adjusted).

- PASI 90 response at 12 weeks (% of patients achieving a PASI 90 response, placebo-adjusted).

- PASI 75 response at 60 weeks (% of patients achieving a PASI 75 response, NOT placebo-adjusted).

- Risk of serious infections (rate per 100 patient-years, placebo-adjusted).

- LDL cholesterol level (% increase in mean levels relative to baseline).

- Delivery burden (drug formulation and dosing).

- Price/day.

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

- Improved effect on PASI 75 response at 12 weeks.

- Improved effect on PASI 75 response at 52-60 weeks.

- Lower rate of serious infections.

- Improved formulation and dosing frequency.

Physicians surveyed: 60 U.S. and 31 European dermatologists.

Payers surveyed: 20 U.S. MCO PDs.

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Adalimumab (AbbVie/Eisai’s Humira)

- Etanercept (Amgen/Stiefel/Pfizer/Takeda’s Enbrel)

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

- Ustekinumab (Janssen’s Stelara)

Emerging Therapies

- Apremilast (Celgene)

- Tofacitinib (Pfizer’s Xeljanz)

- Secukinumab (Novartis)

- Brodalumab (Amgen/AstraZeneca/Kyowa Hakko Kirin)

- MK-3222 (Merck)

- Ixekizumab (Eli Lilly)


Search Reports

Mentioned in this report:

  • - AbbVie
  • - Amgen
  • - Astellas
  • - AstraZeneca
  • - Biogen Idec
  • - Celgene
  • - Dava
  • - Eisai
  • - Eli Lilly
  • - Genentech
  • - Janssen
  • - Kyowa Hakko Kirin
  • - Merck
  • - Merck Serono
  • - Mitsubishi Tanabe
  • - Novartis
  • - Pfizer
  • - Stiefel
  • - Takeda
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