DecisionBase

March 2013

Relapsing-Remitting Multiple Sclerosis

Introduction:

Where Do Physicians and Payers Signal the Greatest Need—and Greatest Opportunity—for New Therapeutic Advances?

The market for disease-modifying therapies for the treatment of relapsing-remitting multiple sclerosis (RR-MS) is active and commercially compelling. Despite a small diagnosed prevalent population relative to many other neurological indications, drug-treatment rates for RR-MS are high, and neurologists emphasize early treatment intervention 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 launches of the first oral disease-modifying drugs in this historically injectable market—but marketed agents have drawbacks that leave ample opportunity for new therapies offering clinical improvements in efficacy, safety and tolerability, and delivery.

Questions Answered in This Report:

  *   A drug’s performance on at least eight efficacy end points, including a reduction in the annualized relapse rate (ARR) over two years, is important for drug approval and physician use. What are the key primary and secondary clinical trial end points on which new therapies are evaluated? How do U.S. and European neurologists weight efficacy measures and other drug attributes in their prescribing decisions for RR-MS?

  *   A greater effect on sustained disability progression and fewer/less burdensome monitoring requirements are key areas of unmet need in RR-MS, according to the insights of surveyed U.S. and European neurologists. Which emerging therapies, 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 disease-modifying MS therapies on key clinical attributes for which surveyed physicians indicate there is high unmet need?

  *   The incidence of serious or life-threatening side effects and a reduction in the ARR relative to placebo are key drivers of physicians’ prescribing decisions and/or are the focus of drug development of new RR-MS therapies. What trade-offs across these and other clinical attributes are U.S. neurologists willing to make when considering the use of emerging disease-modifying therapies for RR-MS? Based on the trade-offs in price and performance across key drug attributes that U.S. neurologists are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for RR-MS?

  *   By 2016, Genzyme/Sanofi/Bayer HealthCare’s alemtuzumab (Lemtrada) 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 alemtuzumab most differentiated from its competitors? Which current therapies are at greatest risk of being replaced by alemtuzumab?

Scope:

Attributes included in conjoint-analysis-based assessment of target product profiles for RR-MS:

- Reduction in ARR relative to placebo.

- Reduction in risk of six-month sustained disability progression (i.e., Kurtzke Expanded Disability Status Scale [EDSS] progression) relative to placebo.

- Incidence of serious or life-threatening side effects (e.g., opportunistic infections, bradycardia, autoimmune adverse events).

- 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).

- Delivery burden (i.e., dosing frequency and formulation).

- Price/day

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

- Effect on ARR.

- Effect on risk of six-month sustained disability progression.

- Monitoring burden.

- Burden of delivery (dosing frequency and formulation).

Physicians surveyed: 61 U.S. and 30 European neurologists.

Payers surveyed: 20 U.S. MCO PDs.

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Glatiramer acetate (Teva’s Copaxone)

- Interferon-beta-1a intramuscular (Biogen Idec’s Avonex)

- Natalizumab (Biogen Idec/Elan’s Tysabri)

- Fingolimod (Novartis/Mitsubishi Tanabe Pharma’s Gilenya/Imusera)

- Teriflunomide (Sanofi/Genzyme’s Aubagio)

Emerging Therapies

- BG-12 (Biogen Idec’s Tecfidera)

- Alemtuzumab (Genzyme/Sanofi/Bayer HealthCare’s Lemtrada)

- Daclizumab (AbbVie/Biogen Idec)

- Ocrelizumab (Roche/Genentech)

- Laquinimod (Teva/Active Biotech)


Search Reports

Mentioned in this report:

  • - AbbVie
  • - Active Biotech
  • - Barr Pharmaceuticals
  • - Baxter
  • - Bayer HealthCare
  • - Biogen Idec
  • - Chugai
  • - Dava Pharmaceuticals
  • - EMD Serono
  • - Genentech
  • - Genzyme
  • - Merck Serono
  • - Mitsubishi Tanabe Pharma
  • - Nuron Biotech
  • - Onko
  • - Pfizer
  • - Prometheus
  • - Roche
  • - Sanofi
  • - Teva
  • - Vifor Pharma
  • - Xenoport
  • - Zenyaku Kogyo
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