A Combination Product of Sumatriptan and Naproxen Sodium Versus Single-entity Oral Triptans: An Analysis of Real World Data
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Observational

Summary: 
      The goal of this study is to measure medical resource utilization, treatment patterns, and
      costs for 1.) triptan-naïve patients with new pharmacy claims for a combination treatment of
      sumatriptan and naproxen sodium (SumaRT/Nap) or single-entity triptan and 2.) patients who
      are switched from one triptan to either SumaRT/Nap or a different single-entity triptan. The
      analysis will compare the mean number of prescription tablets used (including triptans,
      NSAIDs, opioids, and ergots) and migraine-specific medical resource utilization/costs and
      pharmacy costs incurred by health plan members who switched to SumaRT/Nap from a
      single-entity triptan. The null hypothesis for the triptan-naïve analysis is that no
      difference will be observed between resource utilization and costs incurred by patients
      treated with SumaRT/Nap and those treated with a single-entity triptan. The test hypothesis
      is that one group will incur significantly fewer costs and/or significantly lower health care
      utilization. For the triptan switch analysis, the null hypothesis is that no difference will
      be observed in the costs or health care utilization between triptan patients who are switched
      to SumaRT/Nap compared with those switched to a new triptan. The test hypothesis is that one
      treatment group will experience significantly lower costs and/or lower health care
      utilization.

      The source of data for this analysis is the Lifelink Health Plan Claims Database (owned by
      IMS Health, Inc). This claims database includes more than 60 million covered lives. In
      addition to inpatient and outpatient records, this database includes standard and mail-order
      pharmacy claims with paid and charged amounts and dates of service.

      Data from July 1, 2008 to December 31, 2009 (study period) will be used to conduct these
      retrospective analyses. Patients with at least one pharmacy claim for SumaRT/Nap between
      January 1, 2009 and June 30, 2009 (enrollment period) will be identified. The date of the
      first SumaRT/Nap pharmacy claim will be the index date for those patients. Each patient will
      be propensity score matched with an oral triptan patient based on the following pre-index
      covariates: age; gender; payer; geographic region; average monthly number of tablets of
      triptans, NSAIDs, and opioids; and average number of hospitalizations, emergency department
      visits, and physician visits in the month immediately preceding the index date as well as the
      mean number of hospitalizations, emergency department visits, and physician visits in the
      5-month pre-index period. SumaRT/Nap patients and their single-entity matched controls who
      had no pharmacy claims for triptans prior to the index date will be analyzed in the triptan
      naïve group, and the SumaRT/Nap patients and their single-entity matched controls who
      switched to a new triptan will be analyzed in the switch analysis.
    


Intervention name(s): Combination therapy with sumatriptan and naproxen sodium (SumaRT/Nap); Single-entity oral triptans
Intervention type(s): Drug; Drug
Intervention description(s): Patients with new pharmacy claims for SumaRT/Nap with separate analyses for patients with at least one triptan pharmacy claim in the 6-month, pre-index period and those who are triptan-naive based on 6 months of data; Patients are propensity score matched to patients in the SumaRT/Nap groups and analyzed separately if patient has a pharmacy claim for a different type of triptan in the previous 6 months or is triptan treatment naive. Triptans included almotriptan, naratriptan, rizatriptan, eletriptan, zolmitriptan, frovatriptan, sumatriptan.
Other intervention name(s): Treximet® is a registered trademark of GlaxoSmithKline; Zomig® is a registered trademark of AstraZeneca; Maxalt® is a registered trademark of Merck & Co; Inc; Relpax® is a registered trademark of Pfizer; Frova® is a registered trademark of Elan Pharmaceuticals/UCB Pharma; Amerge® is a registered trademark of GlaxoSmithKline; Axert® is a registered trademark of Pharmacia; Imitrex® is a registered trademark of GlaxoSmithKline
Intervention MeSH terms: Naproxen; Sumatriptan
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study will be conducted using retrospective health care claims data from insured
        migraine patients aged 18 to 64. Patients with a pharmacy claim for a combination treatment
        of sumatriptan and naproxen sodium (SumaRT/Nap) during the index period will be identified.
        If the SumaRT/Nap prescription is not preceeded by a single-entity triptan pharmacy claim
        in the 6-month, pre-index period, that patient will be included in the triptan-naive
        cohort. Propensity score matching will be used to identify migraine patients with new
        single-entity triptan claims as a comparator group. Patients with a pharmacy claim for a
        single-entity triptan in the 6-month, pre-index period and a pharmacy claim for SumaRT/Nap
        will be included in the triptan switch cohort. Propensity score matching will be used to
        identify patients with similar characteristics who switch to a new triptan as a comparator
        group.
      
Keywords: resource utilization; naproxen sodium; cost and cost analysis; triptan; migraine