April 5th, 2020

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Latency of 17-Hydroxyprogesterone Caproate Initiation in Patients Receiving Compounded Versus Commercial Product
Authors:  Rebecca H. Stone, Pharm.D., Rebekah Anguiano, Pharm.D., Christina Bobowski, Pharm.D., Kristina Falk, Pharm.D., Pedro Alvarez, M.D., and Dimitrios Mastrogiannis, M.D.
  OBJECTIVE: 17-hydroxyprogesterone caproate (17-OHP) is used for prevention of preterm birth. In 2011 commercial 17-OHP became available as an expensive specialty medication; previously it was only compounded 17-OHP. This study compares latency to first dose of compounded 17-OHP versus commercial 17-OHP, and related obstetric outcomes.

STUDY DESIGN: Retrospective cohort study of women who received 17-OHP injections at an obstetrics clinic between 2010–2015. Women were included if they received at least 1 dose of 17-OHP and obstetric care at this site until delivery.

RESULTS: Of 193 women prescribed 17-OHP, 163 received a dose: 69 received compounded 17-OHP and 94 received commercial 17-OHP. Compounded 17-OHP less frequently required insurance prior authorization (1% vs. 92%, p<0.001), required fewer days from prescribing to initiation (median 6 [range 0–62] vs. 12 [0–66], p<0.001), was less likely initiated after 17 0/7 weeks’ gestational age (45% vs. 86%, p<0.001), and required less administrative encounter(s) to procure (median 1 [range 0–5] vs. 4 [0–11], p<0.001).

CONCLUSION: There is significant latency from prescription to initiation of this time-sensitive medication, particularly commercial 17-OHP formulation. Commercial 17-OHP formulation procurement required more administrative encounters, which may create barriers to patient access. We recommend expedited insurance approval and decreased procurement barriers for eligible women requiring commercial 17-OHP to prevent therapy delay.
Keywords:  17-hydroxyprogesterone, 17OHP, assisted reproductive technologies, compounding, hydroxyprogesterones, Makena, preterm birth, preterm labor
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