A Combination Product of Sumatriptan and Naproxen Sodium Versus Single-entity Oral Triptans: An Analysis of Real World Data

Study Overview
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Brief Summary
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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.

Official Title
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A Combination Product of Sumatriptan and Naproxen Sodium Versus Single-entity Oral Triptans: An Analysis of Real World Data

Conditions
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Migraine Disorders

Intervention / Treatment
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* Drug: Combination therapy with sumatriptan and naproxen sodium (SumaRT/Nap)
* Drug: Single-entity oral triptans


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 to 64 years Patients with continuous health plan eligibility during the 6-month pre-index period and follow-up period Patients in the triptan switch analysis must have at least one pharmacy claim for an oral triptan in the 6 month, pre-index period Exclusion Criteria: Patients with a pharmacy claim for a nasal triptan at any time during the study period Patients with pharmacy claims for more than one type of oral triptan on the index date Patients in the single-entity oral triptan study groups who have a pharmacy claim for SumaRT/Nap during the 6-month follow-up period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study-treatment naive insured adults with migraine<br>Adult health care plan members with a pharmacy claim for a combination product of sumatriptan and naproxen sodium (SumaRT/Nap) and propensity score matched controls with a pharmacy claim for a single-entity triptan | Drug: Combination therapy with sumatriptan and naproxen sodium (SumaRT/Nap)<br>* 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<br>* Other names: Treximet® is a registered trademark of GlaxoSmithKline;Drug: Single-entity oral triptans<br>* 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.<br>* Other names: Imitrex® is a registered trademark of GlaxoSmithKline;|
| Insured adults with migraine who switch study treatment<br>Adult health plan members with a pharmacy claim for SumaRT/Nap following at least one single-entity triptan pharmacy claim in the previous 6 months and propensity-score matched controls who switched from one single-entity triptan to another | Drug: Combination therapy with sumatriptan and naproxen sodium (SumaRT/Nap)<br>* 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<br>* Other names: Treximet® is a registered trademark of GlaxoSmithKline;Drug: Single-entity oral triptans<br>* 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.<br>* Other names: Imitrex® is a registered trademark of GlaxoSmithKline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean number of tablets dispensed | The mean number of tables dispensed as measured by pharmacy claims for prescription medications including triptans, NSAIDs, and opioids | In the 6 months immediately preceding the index date and during the 6-month follow-up period that begins at the index date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean and total migraine-related pharmacy costs | All costs will be adjusted to 2009 US dollars. Results will include costs to the health plan and costs to the patients. Costs will be reported for triptans, migraine prophylaxis, NSAIDs, opioids, and antiemetics | During the 6-month follow-up period that begins at the index date | 
| Mean and total migraine-related medical costs | All costs will be adjusted to 2009 US dollars. Costs will include those for hospitizations, emergency department visits, physician visits, other outpatient visits, and other medical costs | During the 6-month follow-up period that begins at the index date | 
| Mean numbers of migraine-related medical visits | Results will include hospitalizations, visits to the emergency department, physician visits, and other outpatient visits | During the 6-month follow-up period that begins at the index date | 
| Mean numbers and costs (adjusted to 2009 US dollars) of all-cause resource use measures | Results will include all-cause hospitalizations, emergency department visits, physician visits, and outpatient visits. Costs reported by total, pharmacy and medical | During the 6-month follow-up period that begins at the index date | 
| Presence of preventive medications | Pharmacy claims for migraine prophylactic medications including tricyclic antidepressants, calcium channel blockers, beta blockers, mirtazapine, venlafaxine, valproic acid, gabapentin, tiagabine, topiramate, carbamazapine, and botulinium toxin | During the 6-month follow-up period that begins at the index date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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resource utilization, naproxen sodium, cost and cost analysis, triptan, migraine