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?
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
- PASI 90 response at 12 weeks (% of patients achieving a PASI 90
- 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,
- LDL cholesterol level (% increase in mean levels relative to
- Delivery burden (drug formulation and dosing).
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
- 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)
- Tofacitinib (Pfizer’s Xeljanz)
- Secukinumab (Novartis)
- Brodalumab (Amgen/AstraZeneca/Kyowa Hakko Kirin)
- MK-3222 (Merck)
- Ixekizumab (Eli Lilly)