Evaluating reduction of opioid and barbiturate use following rimegepant initiation in the United States

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Nurtec
• Study drug International non-proprietary name (INN) or common name:
  RIMEGEPANT
• Anatomical Therapeutic Chemical (ATC) code:
  (N02CD06) rimegepant

  rimegepant
• Medical condition to be studied:
  Migraine

Population studied

• Short description of the study population:
  The study includes adult patients who had their first prescription for rimegepant between March 1, 2020, and October 1, 2022, with an initial fill of 8 tablets intended for acute migraine treatment. Eligible participants must have used rimegepant for at least 180 days, be 18 years or older on the index date, and maintain continuous commercial health plan enrollment with both medical and pharmacy benefits before and after the index date. Additionally, patients must have a recorded diagnosis of migraine and at least one prior prescription for certain drugs, including opioids, barbiturates, alprazolam, rescue inhalers, or statins. Individuals are excluded if they previously used other novel acute migraine treatments, such as ubrogepant or lasmiditan, or have a diagnosis of malignant neoplasm (cancer) during the designated periods.
• Estimated number of subjects:
  4000

Study design details

• Study design:
  This is a non-interventional, retrospective, observational, cohort study that will assess changes in opioid and barbiturate utilization after initiation of rimegepant among adults in the US.
• Main study objective:
  The study aims to assess changes in opioid and barbiturate utilization patterns after the initiation of rimegepant among US adults with migraine.
• Setting:
  This study will analyze an administrative claims database (IQVIA PharMetrics Plus) with information on individuals in the US with commercial, managed Medicare, or managed Medicaid health plans. The study will examine data from September 1, 2019, to March 31, 2023. The first date of rimegepant initiation during this period will be defined as the index date.
• Outcomes:
  Outcomes include changes in opioid and barbiturate utilization patterns before and after rimegepant initiation, measured by prescription fills, quantity dispensed, average dose, duration of use, and discontinuation. Key covariates are demographic and clinical characteristics (age, sex, region, comorbidities, chronic pain, prior preventive treatments) assessed during the baseline period.
• Data analysis plan:
  Among each medication use group, a report with descriptive statistics of the demographic and clinical baseline characteristics as well as medication use prior to rimegepant will be created.