How Will the Complex Interplay Between Benefit, Risk, and Cost Impact Prescriber Preferences, and Payer Acceptance of, Future Disease-Modifying Therapies?
The market for disease-modifying therapies for the treatment of relapsing-remitting multiple sclerosis (RR-MS) is highly active and commercially compelling. In spite of a small diagnosed prevalent population relative to many other neurological indications, drug-treatment rates for RR-MS are high, and neurologists emphasize early intervention and long-term treatment to improve long-term outcomes in this chronic disease. The number of disease-modifying therapies approved to treat RR-MS is expanding steadily, including the availability of multiple oral disease-modifying drugs in this historically injectable market. However, because the MS disease course is heterogeneous and therapeutic response is unpredictable, a continued need exists for more-effective, more-tolerable, and less-burdensome treatment alternatives.
Attributes included in conjoint analysis based assessment of target product profiles for RR-MS:
- Reduction in annualized relapse rate (ARR) relative to placebo.
- Reduction in risk of three-month sustained disability progression (i.e., Kurtzke Expanded Disability Status Scale [EDSS] progression) relative to placebo.
- Reduction in brain atrophy relative to placebo.
- Incidence of serious or life-threatening side effects (e.g., opportunistic infections, bradycardia, autoimmune adverse events, malignancy, cardiac risk).
- Incidence of less-serious side effects (e.g., injection-site reactions, flu-like symptoms, flushing).
- Monitoring burden: frequency (e.g., first-dose only, monthly) and complexity (e.g., number/difficulty of unique tests, need for referrals).
Attributes included in assessment of U.S. payers’ receptivity to new therapies for RR-MS:
- Effect on ARR.
- Effect on risk of three-month sustained disability progression.
- Monitoring burden: the combined frequency and complexity (e.g., number of unique tests [laboratory/blood, urinalysis, MRI, cardiac], need for physician referrals) of monitoring required.
- Burden of delivery: dosing frequency and formulation.
Physicians surveyed: 60 U.S. and 31 European neurologists.
Payers surveyed: 30 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and Modeling:
- Glatiramer acetate (Teva’s Copaxone)
- IFN-β-1a (IM) (Biogen Idec’s Avonex)
- Natalizumab (Biogen Idec’s Tysabri)
- Fingolimod (Novartis/Mitsubishi Tanabe Pharma’s Gilenya/Imusera)
- Dimethyl fumarate (Biogen Idec’s Tecfidera)
- Pegylated IFN-β-1a (SC; Biogen Idec’s Plegridy)
- Alemtuzumab (Genzyme/Sanofi/Bayer HealthCare’s Lemtrada; approved in Europe in 2013)
- Daclizumab (AbbVie/Biogen Idec)
- Orelizumab (Roche/Genentech)
- Laquinimod (Teva/Active Biotech’s Nerventra)