Introduction:
On What Attributes Will Neurologists and Payers Differentiate Novel Therapies for Secondary-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)