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Research & Reports

Searching in Biopharma (1575)

Chronic-Progressive Multiple Sclerosis

The chronic-progressive multiple sclerosis (CP-MS)
population, which encompasses secondary-progressive MS (SP-MS) and
primary-progressive MS (PP-MS), accounts for approximately one-third of the
total diagnosed prevalent MS population. However, the progressive MS population
is considerably underserved by current disease-modifying MS therapies; indeed,
few such therapies are approved to treat SP-MS and no therapies are approved
for PP-MS owing to mixed or negative therapeutic benefits demonstrated in the
handful of clinical trials conducted in these patient subtypes. Nevertheless,
despite these earlier setbacks, a small but growing number of current and
emerging therapies are being assessed in these progressive subpopulations. With
a larger population and, in many cases, active inflammatory pathology, SP-MS
arguably represents a more commercially viable opportunity than PP-MS; thus, we
focus much of our analysis on the SP-MS subpopulation. Both neurologists and
managed care organization pharmacy directors (MCO PDs) surveyed by Decision
Resources identify a greater effect on disability progression as an area of
considerable unmet need in SP-MS, although therapies offering improvements in
other areas, including safety and delivery, will be welcomed as well.

Questions Answered in This Report:

  • Delaying the accumulation of disability progression is a key goal in the treatment of SP-MS. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European neurologists weight specific efficacy end points and other drug attributes in their prescribing decisions for SP-MS?

  • Therapies that offer a greater effect on physical disability or are associated with a low risk of serious or life-threatening side effects are key areas of unmet need for SP-MS, according to surveyed U.S. and European neurologists. Which therapies in development for SP-MS 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 effect on disability progression (as measured by the Kurtzke Expanded Disability Status Scale [EDSS]) and its rate of serious or life-threatening side effects (including infections) are key drivers of physicians’ prescribing decisions and/or the focus of drug development for new therapies for SP-MS. What trade-offs across these and other clinical attributes are U.S. neurologists willing to make when considering the use of emerging therapies for SP-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 SP-MS?

  • Based on its clinical profile, glatiramer acetate (Teva’s Copaxone) 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 glatiramer acetate as the future gold standard for SP-MS in 2016 or 2021?

Scope:

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

- Effect on Expanded Disability Status Scale (EDSS) progression

- Effect on brain atrophy

- Rate of serious or life-threatening infections (e.g., progressive multifocal leukoencephalopathy [PML], other opportunistic infections)

- Rate of other serious or life-threatening adverse events (e.g., autoimmune adverse events, malignancy, cardiac risk)

- Monitoring burden: frequency (e.g., first-dose only, monthly) and complexity (e.g., number/difficulty of unique tests, need for referral)

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

- Price

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

- Effect on EDSS progression

- Rate of serious adverse events (e.g., serious infections, including opportunistic infections such as PML, malignancy, cardiac risk)

- Monitoring burden, taking into account both the frequency and complexity of monitoring required

- Burden of delivery, comprising both dosing frequency and dosage formulation of a drug

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-β-1b (Bayer HealthCare’s Betaseron/Betaferon; Novartis’s Extavia)

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

- Natalizumab (Biogen Idec/Elan’s Tysabri)

- Mitoxantrone (Merck Serono/EMD Serono/Amgen/Pfizer/Meda’s Novantrone, other brands, generics)

Emerging Therapies

- Siponimod (Novartis)

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

- Daclizumab (AbbVie [formerly Abbott]/Biogen Idec)

- Ocrelizumab (Roche/Genentech)

- Masitinib (AB Science)