Migraine, estimated to affect 36 million people in the United States, is a disabling disease characterized by unilateral or bilateral headache pain that may be accompanied by aura and the associated symptoms of nausea and/or vomiting, photophobia, and phonophobia. Treatment of the disease is divided into two strategies: acute and prophylactic therapy. The primary goal of acute treatment is to provide both immediate and sustained relief of migraine-associated pain; patients who experience more frequent attacks or who do not respond to acute treatment are candidates for migraine prophylaxis, entailing daily therapy of some duration to reduce migraine frequency and severity. The goal of prophylactic treatment is to pre-emptively decrease the frequency, severity, and duration of future migraine attacks, reducing disability and potentially increasing the responsiveness of migraine attacks to acute treatment. The prophylactic migraine market is largely comprised of generic options, including antiepileptic drugs, antidepressants, and beta blockers; these three classes of agents form the cornerstone of current prophylactic treatment. The prophylactic use of neuromuscular blocking agents has increased following the 2010 FDA approval of Allergan’s Botox (onabotulinumtoxinA) for chronic migraine prevention—the only therapy approved for this population of migraine patients, and among the few branded therapies used to treat the disease. In general, available prophylactic treatments offer suboptimal efficacy and many prophylactic drugs are associated with side effects that reduce compliance with long-term use and result in discontinuation; thus, unmet need in the migraine prophylaxis market is high.

Using national patient-level claims data, the Treatment Algorithms in Migraine Prophylaxis report explores the use of key therapies and drug classes among prophylactically naive and recently treated migraine prophylaxis patient populations. Among prophylactically naive patients, the report provides a quantitative analysis of treatment patterns and share by line of therapy, as well as progression between lines, duration of treatment on each line, and use of concomitant prophylactic treatment. Among recently treated patients, the report quantifies a drug’s overall drug share, use in combination with other prophylactic therapies, and source of business compared with its competitors, detailing which prophylactic drugs precede others through an analysis of add-versus-switch patterns. Two additional claims database queries explore persistency and compliance by therapy.

Questions Answered in This Report:

  • Prophylactically naive patients: More than half the prophylactically naive migraine patients initiate treatment with a prophylactic therapy within the one-year tracking period. What percentage of these patients progress to a second- or third-line prophylactic drug within the first year, and how quickly do patients progress? Which products capture the most patient share in the first, second, and third lines of treatment? How often is combination prophylactic therapy used in each line of therapy?

  • Recently treated patients: In Q3 2014, agents from the antiepileptic, antidepressant, and beta blocker classes of agents led prophylactic treatment. Which specific drugs garner the most patient share for recently treated migraine prophylaxis patients? How has Allergan’s Botox (onabotulinumtoxinA) been incorporated into prophylactic treatment? Which therapies have experienced market growth or decline over the key therapy periods studied?

  • Pathways to key therapies: Among patient-share leaders for migraine prophylaxis, topiramate is the treatment likely to precede most agents, consistent with this drug’s leading position in early lines of therapy. How long does it take a migraine patient to progress to each key prophylactic therapy? What are the various sources of business for each agent (i.e., new, add/switches, or continuing business)?

Scope:

Primary patient-level data: This report provides quantitative findings from our analysis of data covering approximately 40 million lives and provides the most representative sample of U.S. treatment practice for Medicare and commercially insured patients. This report is delivered as a key findings slide deck and a dashboard that can be accessed using the Internet, and presents claims that are between 6-12 months’ old at time of publication.

Patient Sample: Patients who are continuously enrolled for the complete two-year study period must meet the following conditions: at least three claims with a diagnosis code for migraine (International Classification of Diseases, Ninth Revision [ICD-9] diagnostic codes 346.00 to 346.93) during the study period. All patients must be age 15 or older to qualify.

Prophylactically naive patients:

- Patient share by prophylactic drug class and key products across three lines of therapy, tracked for one year.

- Patient flowcharts through one year of treatment for all first-line prophylactic products, including progression rates and add/switch behavior.

- Polypharmacy and key concomitant prophylactic therapies by line of therapy.

- Quarterly trending of patient share by line of therapy.

Recently treated patients:

- Quarterly snapshot of patient share by drug class and key products.

- Pathway to key prophylactic therapy flowcharts tracking the preceding therapy patterns for all key therapies including add/switch behavior.

- Brand source of business including share for continuing, new (switches/adds), and new (initial therapy) business.

- Polypharmacy and key concomitant prophylactic therapies.

- Drug persistence and compliance.

- Quarterly trends in patient share for all key therapies.

Drug persistence (One year, all-brand).

Drug compliance (6-month, Medication Possession Ratio [MPR]).

Author(s): Angela Sparrow

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