What Are the Key Areas of Opportunity for Differentiation According to Dermatologists and Payers?
Affecting more than 3 million people in the major pharmaceutical markets, moderate to severe psoriasis represents a large market with substantial commercial opportunity. The increasing use of biologics, including the 2012 sales leader, adalimumab (AbbVie/Eisai’s Humira), is driving the growth of the market, but a significant opportunity remains for additional therapies that can offer higher short-term and long-term efficacy as well as lower risk of malignancies and serious infections. The market will become increasingly competitive following the anticipated approval of as many as six therapies (from at least four drug classes). These efficacious agents will significantly raise the bar for psoriasis treatments.
Questions Answered in This Report:
- A drug’s performance on at least seven 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?
- Higher sustained long-term response with continuous therapy, greater effect on quality of life, and greater effect on psoriatic plaques at 52-60 weeks are key areas of unmet need for moderate to severe psoriasis therapies, according to the insights of surveyed U.S. and European dermatologists. Which therapies in development for moderate to severe psoriasis 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?
- PASI 75 and PASI 90 responses at 12 and 60 weeks are key drivers of physicians’ prescribing decisions and are 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?
- Despite the potential launch of several emerging therapies in the moderate to severe psoriasis market over the next ten years, adalimumab (AbbVie/Eisai’s Humira) 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?
Attributes included in conjoint analysis-based assessment of target product profiles for moderate to severe psoriasis:
- PASI 75 response at 12 weeks
- PASI 90 response at 12 weeks
- PASI 75 response at 60 weeks
- Risk of serious infections
- Monitoring burden
- Delivery burden
Attributes included in assessment of U.S. payers’ receptivity to new therapies for moderate to severe psoriasis:
- Improved PASI 75 response at 12 weeks
- Improved PASI 75 response at 52-60 weeks
- Lower rate of serious infections (per 100 patient-years, placebo-adjusted)
- Lesser burden of delivery (formulation and dosing frequency)
Physicians surveyed: 61 U.S. and 30 European dermatologists.
Payers surveyed: 20 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and Modeling:
- Adalimumab (AbbVie/Eisai’s Humira)
- Etanercept (Amgen/Stiefel/Pfizer/Takeda’s Enbrel)
- Infliximab (Janssen/Merck/Mitsubishi Tanabe’s Remicade)
- Ustekinumab (Janssen’s Stelara)
- Apremilast (Celgene’s Otezla)
- Tofacitinib (Pfizer’s Xeljanz)
- Secukinumab (Novartis)
- Brodalumab (Amgen/AstraZeneca/Kyowa Hakko Kirin)
- Tildrakizumab (Merck)
- Ixekizumab (Eli Lilly