Which Efficacy and Safety Achievements Will Differentiate Emerging Therapies in a Crowded Market Filled with Efficacious Drugs?
Nine biologics are approved to treat rheumatoid arthritis (RA), along with an oral kinase inhibitor (tofacitinib [Pfizer/Takeda Pharmaceutical’s Xeljanz]). Given rheumatologists’ long-standing familiarity with the safety and efficacy profiles of the tumor necrosis factor-alpha (TNF-α) inhibitors and, increasingly, of non-TNF-α agents abatacept (Bristol-Myers Squibb/Ono Pharmaceutical’s Orencia), rituximab (Biogen Idec/Roche/Chugai/Zenyaku Kogyo’s Rituxan, Roche’s MabThera), and tocilizumab (Roche/Chugai’s RoActemra/Actemra), new agents face challenges in gaining uptake. To help drug developers negotiate the formidable barriers to uptake in this market, this report identifies attributes with the greatest power to influence rheumatologists’ prescribing decisions and the gaps in efficacy and safety of select current and emerging therapies.
Questions Answered in This Report:
- Induction of clinical remission and reduction of signs and symptoms of RA are key goals in the treatment of RA. 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 RA?
- Improvements in the ability to induce clinical remission and halt structural damage progression are key areas of unmet need for RA according to the insights of surveyed U.S. and European rheumatologists. Which therapies in development for RA 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 drug’s effect on the signs and symptoms of RA and risk of serious infections are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new RA 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 RA? 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 RA?
- Based on its clinical profile, tocilizumab 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 tocilizumab as the future gold standard in 2018 or 2023?
Attributes included in conjoint analysis-based assessment of target product profiles for RA:
- American College of Rheumatology (ACR) 20 response rate in methotrexate (MTX)-refractory patients at six months (placebo-adjusted)
- Mean decrease in HAQ-DI score in MTX-refractory patients at six months (placebo-adjusted)
- Mean change (from baseline) in modified total Sharp score (mTSS) in MTX-refractory patients at one year
- Remission (DAS28 < 2.6)="" in="" mtx-refractory="" patients="" at="" six="" months="" (placebo-adjusted)="">
- Rate of serious infections per 100 patient-years (placebo-adjusted)
- Delivery burden (dosing formulation and frequency)
- Price per day
Attributes included in assessment of U.S. payers’ receptivity to new therapies for RA:
- Effect on signs and symptoms of RA (ACR 20 response rate) in MTX-refractory patients at six months
- Effect on progression of structural damage (mTSS) in MTX-refractory patients at one year
- Effect on remission (DAS28 < 2.6)="" in="" mtx-refractory="" patients="" at="" six="">
- Associated risk of serious infections (per 100 patient-years)
Physicians surveyed: 60 U.S. and 31 European rheumatologists.
Payers surveyed: 21 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and Modeling:
- Adalimumab (AbbVie/Eisai’s Humira)
- Tofacitinib (Pfizer/Takeda’s Xeljanz)
- Tocilizumab (Roche/Chugai’s Actemra/RoActemra)
- Abatacept (Bristol-Myers Squibb/Ono Pharmaceutical’s Orencia)
- Rituximab (Biogen Idec/Roche/Chugai/Zenyaku Kogyo’s Rituxan, Roche’s MabThera)
- Baricitinib (Eli Lilly/Incyte)
- Sirukumab (Janssen/GlaxoSmithKline)
- Sarilumab (Sanofi/Regeneron)
- Secukinumab (Novartis’s Cosentyx)
- Mavrilimumab (AstraZeneca)