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Treatment Algorithms in Multiple Sclerosis

Authors
Madhuri Borde, Ph.D.
Michael J. Malecki, Ph.D.
Jason LaBonte, Ph.D.
Treatment Algorithms -- March 2008

  In This Issue...

Introduction:

Although multiple sclerosis (MS) afflicts a small percentage of the population, the MS market in the United States swelled to $3 billion in 2006. Expensive, biological therapies are often prescribed first line because they are the only drugs that provide disease-modifying treatment. The interferon-beta (IFN-beta) therapies make up the lion’s share of the MS market, but Teva Pharmaceutical’s Copaxone (glatiramer acetate) has been gaining significant market share because of its benign side-effect/safety profile and adequate efficacy in mild disease. Within the IFN-beta drug class, Biogen Idec’s Avonex (IFN-beta-1a [intramuscular (IM)]) amasses the highest patient and market share. However, physicians increasingly favor Merck Serono/Pfizer’s Rebif (IFN-beta-1a [subcutaneous (SC)]) for its greater efficacy. The introduction of a newly reformulated version of Rebif, Rebif New Formulation (RNF), has the potential to draw more patients to the Rebif franchise because of its more tolerable side-effect/safety profile compared with the current formulation of the drug.

Questions Answered in This Report:

- Lines of therapy: While MS treatment guidelines recommend that physicians initiate disease-modifying treatment soon after a definite diagnosis of MS, they also allow for individual patient and physician choice and, therefore, variability in treatment. What percentage of MS patients begin treatment after receiving their first diagnosis for the disease? What percentages of relapsing-remitting MS (RR-MS) patients receive Avonex, Rebif, Betaseron, or Copaxone as first-line treatment? Which disease-modifying therapies have the greatest retention rates in the first year after diagnosis? 

- Pathways to key therapies: Tysabri relaunched in July 2006 under a limited prescribing program owing to its rare but fatal side effects. What drugs are used directly before Tysabri? How do the pathways to each of the MS drugs differ? What do the drugs used prior to each disease-modifying therapy tell us about why patients move to a new line of therapy in MS?

- Physician behavior: Although many interviewed thought leaders consider Avonex’s efficacy profile superior to that of Copaxone, the two drugs aggressively compete for patient share among patients with early-stage or mild disease. What attributes of Copaxone and Avonex drive neurologists and PCPs to choose one over the other?  What are the main triggers for practicing physicians to move a patient to Rebif or Betaseron? What factors influence each physician type when making drug choices?

- Forecast: Although Avonex’s superior side-effect/safety profile is a key factor in its rise to sales leader in the IFN-beta drug class, RNF (launching in 2008) offers Rebif’s superior efficacy coupled with greater tolerability compared with the current formulation of the drug. How will neurologists and PCPs shift their prescribing of Avonex, Rebif, and RNF over the next two years? To what extent will physicians embrace Tysabri? How will they integrate the newly emerging therapies oral cladribine (from Merck Serono), FTY-720 (from Novartis and Mitsubishi Tanabe), and daclizumab (from PDL BioPharma and Biogen Idec)?

Includes:

Primary research: Quantitative results from our survey of 150 physicians (75 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 55 million lives from more than 80 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, CellCept, azathioprine, methotrexate, cyclophosphamide, mitoxantrone, prednisone, other oral corticosteroids, injectable methylprednisolone, and other injectable corticosteroids.

- Flowcharts tracking the preceding therapy patterns for patients taking each of the following key therapies: Avonex, Rebif, Betaseron, Copaxone, Tysabri, CellCept, azathioprine, mitoxantrone, prednisone, and injectable methylprednisolone.

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