Study of Pregnancy Outcomes in Women Exposed to Rimegepant During Pregnancy

Inclusion criteria

(All Pregnancies):

All pregnant women aged 16 to 49 years, inclusive, at the estimated LMP within the study observation period are eligible to enter in the study.

Exclusion criteria

(All Pregnancies):

• Has insufficient information to estimate LMP
• Has at least 1 pharmacy dispensing for ditans (i.e., lasmiditan) within a 5-half-life time window before the estimated LMP through whichever is first: end of pregnancy or end of the study period
• Has at least 1 pharmacy dispensing for a CGRP receptor antagonist other than rimegepant (i.e., ubrogepant, atogepant, and zavegepant) within a 5-half-life time window before the estimated LMP through whichever is first: end of pregnancy or end of the study period
• Has at least 1 pharmacy dispensing for CGRP monoclonal antibodies (i.e., erenumab, fremanezumab, eptinezumab, and galcanezumab) within a 5-half-life time window before the estimated LMP through whichever is first: end of pregnancy or end of the study period

Additional Eligibility Criteria (Rimegepant-Exposed Group):

• Have a migraine diagnosis any time before the estimated LMP and through whichever is first: end of pregnancy or end of the study period
• Have at least 1 pharmacy dispensing for rimegepant within the 30-day time window before the estimated LMP and through whichever is first: end of pregnancy or end of the study period
• Have a recorded outcome of pregnancy within the study period
• Had continuous enrollment in a health care plan with medical and pharmacy benefits during the 6-month period before the estimated LMP through a postpartum period of 42 days

Additional Inclusion Criteria (Primary Comparator Group):

• Have a migraine diagnosis any time before the estimated LMP and through whichever is first: end of pregnancy or end of the study period
• Have at least 1 pharmacy dispensing for a medication indicated for the treatment of migraine within the 30-day time window before the estimated LMP and ending with whichever is first: end of pregnancy or end of the study period.
• Have a recorded outcome of pregnancy within the study period
• Had continuous enrollment in a health care plan with medical and pharmacy benefits during the 6-month period before the estimated LMP through a postpartum period of 42 days

Additional Exclusion Criteria (Primary Comparator Group):

• Have at least 1 pharmacy dispensing for rimegepant within the 30-day time window before the estimated LMP and through whichever is first: end of pregnancy or end of the study period

Additional Inclusion Criteria (Secondary Comparator Group):

• Have no migraine diagnosis any time before the estimated LMP through whichever is first: end of pregnancy or end of the study period
• Have a recorded outcome of pregnancy within the study period
• Had continuous enrollment in a health care plan with medical and pharmacy benefits during the 6-month period before the estimated LMP through a postpartum period of 42 days

Additional Exclusion Criteria (Secondary Comparator Group):

• Have at least 1 pharmacy dispensing for rimegepant within the 30-day time window before the estimated LMP through whichever is first: end of pregnancy or end of the study period