With the Entry of New Oral and Biological Agents, Where Are the Remaining Areas of Opportunity in an Increasingly Crowded Market?

Affecting more than three million people in the major pharmaceutical markets, moderate to severe psoriasis represents a large market with substantial commercial opportunity. However, competition is set to intensify with the recent launch of the first approved IL-17 inhibitor, secukinumab (Novartis’s Cosentyx), and other highly efficacious biologics in the late-stage pipeline. These agents’ efficacy on more-stringent measures of response (i.e., PASI 90 and PASI 100 response rates) and superior efficacy to current agents in head-to-head studies will significantly raise the bar for psoriasis therapies.

Questions Answered in This Report:

  • A drug’s performance on at least six efficacy end points, including PASI 75 response 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 and greater effect on quality of life are key areas of unmet need for moderate to severe psoriasis 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 12-16 weeks and Physician’s Global Assessment (PGA) at 12-16 weeks are primary short-term measures of efficacy in clinical trials and key drivers of physicians’ prescribing decisions. 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 clinical data and the opinions of interviewed thought leaders, ustekinumab (Janssen’s Stelara) is the gold-standard therapy in our Drug Comparator Model, but, based on its outstanding efficacy in Phase III trials and favorable safety profile, the IL-17 inhibitor secukinumab (Novartis’s Cosentyx) will displace ustekinumab as the gold-standard therapy in moderate to severe psoriasis. On what clinical attributes is secukinumab most differentiated from its competitors? Which emerging therapies, if any, pose the greatest threat to secukinumab and other key current therapies?

Scope:

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

- PASI 75 response at 12-16 weeks.

- PASI 75 response at 60 weeks.

- PGA at 12-16 weeks.

- Rate of serious infections per 100 patient-years.

- Rate of malignancies per 100 patient-years (excluding non-melanoma skin cancer).

- Dosing frequency (maintenance regimen).

- Price/day.

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

- Improved PASI 75 response rate at 12-16 weeks.

- Improved PASI 90 response rate at 12-16 weeks.

- Improved PASI 100 response rate at 12-16 weeks.

- Lower rate of injection-site or infusion reactions.

Physicians surveyed: 61 U.S. and 30 European dermatologists.

Payers surveyed: 22 U.S. MCO PDs.

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Adalimumab (AbbVie/Eisai’s Humira)

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

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

- Ustekinumab (Janssen’s Stelara)

- Apremilast (Celgene’s Otezla)

Emerging Therapies

- Secukinumab (Novartis’s Cosentyx)

- Ixekizumab (Eli Lilly)

- Brodalumab (AstraZeneca/Kyowa Hakko Kirin)

- Tofacitinib (Pfizer’s Xeljanz)

- Tildrakizumab (Sun Pharma/Merck)


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