Introduction:
Although multiple sclerosis (MS) afflicts only a small
percentage of the U.S. population, the MS market is substantial and growing,
owing to the expensive biological therapies that provide a disease-modifying
effect and can delay progression of disability and to the anticipated launch of
oral disease-modifying drugs within the next two years—a transformative market
event. Shifts in medical practice as more primary care physicians (PCPs) become
involved with the diagnosis and treatment of MS and increases in the diagnosis
of early-stage disease (i.e., clinically isolated syndrome [CIS]) are also
contributing to the growth of the U.S. MS market. Interferon-beta (IFN-beta)
therapies and the sole agent of the peptide and polypeptide class, Teva Pharmaceutical’s
Copaxone (glatiramer acetate), are the mainstays of disease-modifying treatment
for MS. While interviewed experts state that Copaxone and Biogen Idec’s Avonex
(IFN-beta-1a) are favored in early-line treatment, our 2009 analysis of patient-level
claims data reveals that Merck Serono/Pfizer’s Rebif (IFN-beta-1a) also plays
a critical role in the treatment of newly diagnosed patients, as physicians are
becoming more aggressive about turning to high-dose, high-frequency IFN-beta
therapies in earlier lines of treatment. Using patient-level claims data, as
well as insight from 151 surveyed U.S. neurologists and PCPs, this report
determines the share of each currently marketed drug by line of therapy,
analyzes the factors driving physicians to choose key disease modifiers over
others, and details how physicians predict that this dynamic will change over
the next two years with the expected approval of the first oral
disease-modifying agents, starting with Merck Serono’s oral cladribine and
Novartis/Mitsubishi Tanabe’s fingolimod (FTY-720) in 2010 and 2011,
respectively.
Questions Answered in This Report:
*
Lines of therapy: Data contained in this report show that as
patients are increasingly diagnosed earlier in the progression of their
disease, those therapies with moderate efficacy and less frequent dosing and/or
benign side effect/safety profiles continue to receive greater use in earlier
lines of treatment.
What is the treatment initiation rate for newly
diagnosed MS patients? How do the early-line patient shares for Copaxone,
Avonex, Rebif, and Betaseron compare? What are the retention rates of each of
the IFN-betas and Copaxone in the first year after diagnosis?
*
Pathways to key therapies: Physicians (and patients)
consider agents’ side effects, efficacy, and ease of use when deciding among
the disease-modifying therapies and, along with an individual’s response to a
given therapy, these factors drive differences in switching rates among key
therapies.
What percentage of the total use of each IFN-beta and
Copaxone is attributed to each line of therapy? What percentages of the
patients who start Copaxone versus Avonex, Rebif, or Betaseron do so after
another disease-modifying drug? What do these patterns suggest about each
agent’s positioning relative to other disease modifying drugs? Which agents
most frequently precede the use of Biogen Idec/Elan’s Tysabri (natalizumab)? How
has Tysabri’s use in the MS treatment paradigm evolved since last year’s
report?
*
Physician behavior: Physicians surveyed for this
report indicate that neurologists make the primary treatment decisions for the
majority of MS patients, most often initiating treatment with tolerable
therapies of moderate efficacy (i.e., Avonex or Copaxone) in patients with
moderate disease.
What differences underlie PCPs’ and neurologists’
diagnosis and treatment of newly-diagnosed patients? How does treatment
initiation differ for patients of different MS subtypes (e.g., relapsing-remitting
MS [RR-MS] and CIS)? Which factors are the most critical differentiators when
physicians are deciding between Avonex and Copaxone, Rebif and Betaseron, and
Rebif and Avonex? What do physicians cite as the most common reasons to switch
patients to a new disease modifier after Avonex versus Copaxone, and
which disease-modifier is most frequently selected? How do these reasons
compare with the factors most likely to cause a switch among patients treated
with Rebif or Betaseron?
*
Forecast: Increasing comfort among physicians with high-dose
IFN-beta therapy and two emerging therapies—both offering an advantage in
delivery and one in efficacy—are expected to steal patient share of currently
available disease-modifying therapies.
How will neurologists and PCPs shift their
prescribing of current disease-modifying therapies over the next two
years? How will the emerging therapies Merck Serono’s oral cladribine, Novartis/Mitsubishi
Tanabe’s fingolimod (FTY-720), and BioMS Medical/Eli Lilly’s dirucotide
(MBP-8298) be integrated into the MS treatment paradigm? Which current drugs
are most likely to be replaced by each of these emerging drugs? Scope:
Primary research: Quantitative results from our
survey of 151 physicians (76 neurologists and 75 PCPs):
- Physician opinion on how drug use differs by patient severity.
- Most influential drug attributes when physicians choose between
agents.
- Anticipated changes in the line of therapy in which physicians
use key agents.
Primary patient-level data: Quantitative findings
from our analysis of data covering 61 million lives from 98 geographically
diverse U.S. health plans:
- Quantified lines of therapy analysis showing exact share of each
agent in each line of therapy, including rate of progression between lines and
length of time patients are on each line.
- Progression flowcharts through one year of treatment for newly
diagnosed patients receiving each of the following first-line agents: Avonex,
Rebif, Betaseron, Copaxone, Tysabri, Rituxan, corticosteroids, CellCept,
azathioprine, mitoxantrone, methotrexate, and cyclophosphamide.
- Flowcharts tracking the preceding therapy patterns for patients
taking each of the following key therapies: Avonex, Rebif, Betaseron,
Copaxone, Tysabri, Rituxan, corticosteroids, Cellcept, azathioprine, and
mitoxantrone.