Introduction:Amid Unmet Need for Improved Induction and Maintenance
Therapies, What Magnitude of Improvement Do Surveyed Gastroenterologists and
Payers Expect of a Novel Therapy?
Crohn’s disease (CD) is an inflammatory bowel disease that
requires chronic therapy (sometimes with expensive biological agents) to treat
symptoms of diarrhea and abdominal pain. 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. Although current therapies used to treat moderate to
severe disease will see increased competition from novel biologics and oral
small-molecule drugs expected to launch in the near term, substantial
opportunity will remain for additional therapies that can improve upon the
efficacy and safety of marketed agents.
Questions Answered in This Report:
A drug’s performance on at least eight efficacy end points,
including maintenance of clinical remission, 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 greater percentage of
patients maintaining remission and a greater percentage of patients achieving
induction of remission are key areas of unmet need in moderate to severe CD,
according to the insights of surveyed U.S. and European gastroenterologists.
Which therapies in development for moderate to severe CD 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?
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 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?
Based on its clinical profile, adalimumab (AbbVie/Eisai’s
Humira) is the current clinical gold standard in our Drug Comparator Model. What
attributes do thought leaders believe differentiate this therapy from competing
current and emerging therapies? Will any therapies in development challenge
adalimumab as the future gold standard in 2016 or 2021?
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 (dosing formulation and frequency).
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: 60 U.S.
and 31 European gastroenterologists.
Payers surveyed: 20 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and
- 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)
- Ustekinumab (Janssen’s Stelara)
- Vedolizumab (Takeda)
- Vercirnon (GlaxoSmithKline/ChemoCentryx’s Traficet-EN)
- Tofacitinib (Pfizer’s Xeljanz)