DecisionBase

March 2013

Migraine (Acute Treatment)

Introduction:

Opportunity Remains for Novel Therapies That Address Neurologists’ and Payers’ Shared Views on Unmet Need

Migraine is among the most prevalent neurological disorders worldwide, affecting more than 75 million people across the major markets alone. A broad array of analgesics are prescribed for acute treatment of migraine attacks, but only one class of migraine-specific drugs, the triptans, is commonly prescribed. Opportunity exists for new mechanisms of action to treat patients who do not respond to the triptans or in whom they are contraindicated, but many drug developers are reformulating current therapies to offer greater efficacy or tolerability through improved bioavailability and to offer administration options for patients with migraine-associated nausea and vomiting. As the acute treatment market becomes increasingly populated with generic triptan options, payers and physicians become increasingly price-sensitive, and emerging therapies must offer substantial improvement over current therapies to gain widespread reimbursement and prescribing. However, our data indicate that physicians and payers value similar efficacy and safety attributes, which will make it easier for emerging therapies to capitalize on these opportunities.

Questions Answered in This Report:

  *   A drug’s performance on at least eight efficacy end points, including the percentage of patients who experience sustained pain freedom from 2-24 hours postdose, is important for drug approval and physician use. 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 efficacy measures and other drug attributes in their prescribing decisions for the acute treatment of migraine?

  *   Increased rates of pain freedom at ≤ 30 minutes and increased rates of sustained pain freedom are key areas of unmet need in the acute treatment of migraine, according to the insights of surveyed U.S. and European neurologists. Which therapies in development for the acute treatment of migraine are poised to fulfill these needs? What clinical and/or regulatory challenges must drug developers overcome to capitalize on these areas of unmet need? What degree of improvement over currently available therapies do surveyed U.S. managed care organization pharmacy directors (MCO PDs) seek from new therapies on key clinical attributes for which surveyed physicians indicate there is high unmet need?

  *   Pain relief rate at two hours and price/dose are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new acute migraine therapies. What trade-offs in these and other clinical attributes are U.S. neurologists willing to make when considering the use of emerging therapies for the acute treatment of migraine? 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 the acute treatment of migraine?

  *   Based on its clinical profile, the sumatriptan/naproxen fixed-dose combination (GlaxoSmithKline/Pozen’s Treximet) 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 the sumatriptan/naproxen fixed-dose combination as the future gold standard in 2016 or 2021?

Scope:

Attributes included in conjoint analysis-based assessment of target product profiles for acute treatments for migraine:

- Pain relief rate at 2 hours

- Pain freedom rate at 2 hours

- Pain relief rate at 30 minutes

- Sustained pain freedom rate beyond 2 hours

- Freedom from nausea rate

- Drug formulation

- Price/dose

Attributes included in assessment of U.S. payers’ receptivity to new therapies for acute treatments for migraine:

- Pain relief at two hours

- Sustained pain freedom from 2-24 hours

- Pain relief at 30 minutes

- Nausea freedom at two hours

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

- Sumatriptan oral (GlaxoSmithKline’s Imitrex, Imigran, generics)

- Rizatriptan oral (Merck’s Maxalt, Maxalt MLT, generics)

- Eletriptan oral (Pfizer’s Relpax, Relert)

- Sumatriptan/naproxen fixed-dose combination (GlaxoSmithKline/Pozen’s Treximet)

- Sumatriptan subcutaneous injectable (GlaxoSmithKline’s Imitrex STATdose, generics)

Emerging Therapies

- Orally inhaled dihydroergotamine (MAP Pharmaceuticals/Allergan’s Levadex)

- Sumatriptan transdermal patch (NuPathe’s Zecuity)

- Lasmiditan (CoLucid)

- Sumatriptan intranasal powder (OptiNose)

- NXN-188 (NeurAxon)


Search Reports

Mentioned in this report:

  • - Allergan
  • - Astellas Pharma
  • - AstraZeneca
  • - Bristol-Myers Squibb
  • - CoLucid
  • - Desitin Pharmaceuticals
  • - GlaxoSmithKline
  • - IntelGenx
  • - MAP Pharmaceuticals
  • - Merck & Co.
  • - NeurAxon
  • - NuPathe
  • - OptiNose
  • - Pfizer
  • - Pozen
  • - RedHill Biopharma
  • - Valeant Pharmaceuticals International
  • - Zogenix
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