In a Market Dominated by Effective TNF-Alpha Inhibitors for Moderate to Severe Disease, Where Do Physicians and Payers See Viable Areas for Differentiation?

Ankylosing spondylitis (AS) is a chronic inflammatory disease that belongs to the group of spondyloarthritides (SpA) and primarily affects the sacroiliac (SI) joints and the axial skeleton, causing chronic back pain and stiffness. The key treatment goals for AS include improving the signs and symptoms of the disease, improving physical function, preventing disability, and slowing or preventing structural damage. Treatment of moderate to severe disease is dominated by tumor necrosis factor-alpha (TNF-? inhibitors); however, the market is poised to expand with the anticipated approval of novel biologic and oral therapies that will attempt to compete with the established therapies on the basis of novel mechanisms of action, efficacy, and/or differences in formulation and dosing frequency.

Questions Answered in This Report:

  • Improvement in the signs and symptoms of the disease/physical function (e.g., Assessment in Ankylosing Spondylitis [ASAS] 20 response, Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] 50) are key goals in the treatment of AS. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European rheumatologists weight specific efficacy end points and other drug attributes in their prescribing decisions for AS?

  • Greater ability to inhibit the progression of structural damage and lower risk of serious infections (e.g., tuberculosis, sepsis) are key areas of unmet need for AS according to the insights of surveyed U.S. and European rheumatologists. Which therapies in development for AS, if any, 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?

  • The percentage of patients achieving an ASAS 20 response at three to six months and the percentage of patients achieving a BASDAI 50 response at three to six months are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new AS therapies. What trade-offs across these and other clinical attributes are U.S. rheumatologists willing to make when considering the use of emerging therapies for the treatment of AS? Based on the trade-offs in price and performance across key drug attributes that U.S. rheumatologists are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for AS?

  • By 2022 (or earlier), ustekinumab (Janssen Biotech’s Stelara) will emerge as the gold-standard therapy in our Drug Comparator Model because of its superior clinical profile over the key current therapies we evaluated. On what clinical attributes is ustekinumab most differentiated from its competitors? Which current therapies are at greatest risk of being replaced by ustekinumab?

Scope:

Attributes included in conjoint analysis based assessment of target product profiles for AS:

- Percentage of patients achieving an ASAS 20 response at three to six months.

- Percentage of patients achieving an ASAS 40 response at three to six months.

- Percentage of patients achieving a BASDAI 50 response at three to six months.

- Mean change from baseline in modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) at two years.

- Incidence of serious infections per 100 patient-years.

- Delivery burden (drug formulation and dosing).

- Price/day.

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

- Improved ASAS 20 response at three to six months (placebo-adjusted).

- Improved ASAS 40 response at three to six months (placebo-adjusted).

- Major improvement in Ankylosing Spondylitis Disease Activity Score (ASDAS) at three to six months (placebo-adjusted).

- Improved formulation and dosing frequency.

Physicians surveyed: 60 U.S. and 30 European rheumatologists.

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/Pfizer/Takeda Pharmaceutical’s Enbrel)

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

- Golimumab (Janssen Biotech/Merck/Mitsubishi Tanabe Pharma’s Simponi)

- Certolizumab pegol (UCB/Astellas Pharma’s Cimzia)

Emerging Therapies

- Secukinumab (Novartis)

- Apremilast (Celgene’s Otezla)

- Ustekinumab (Janssen Biotech’s Stelara)

- Tofacitinib (Pfizer/Takeda Pharmaceutical’s Xeljanz)


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