Pharmacy Prior Authorization Criteria

Bonjesta, Diclegis (doxylamine/pyridoxine)

For diagnosis of Nausea and vomiting of pregnancy
Indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.
Limitations of Use: Bonjesta and Diclegis have not been studied in women with hyperemesis gravidarum.

Prior Authorization

Length of Approval: 9 Months

AND

Trial and failure or intolerance to generic doxylamine and generic pyridoxine (Vitamin B6) taken together [5, 7]

2024-07-10, 2023-07-31, 2022-08-02, 2021-09-10, 2021-05-20, 2021-02-12, 2020-04-20, 2020-03-16, 2019-12-02, 2019-07-03, 2019-07-19

Diclegis prescribing information. Duchesnay USA, Inc. Bryn Mawr, PA. June 2023.
ACOG Practice Bulletin. Nausea and vomiting of pregnancy. American College of Obstetricians and Gynecologists. Obstet Gynecol. 2018; 131(1): 190-193. (Practice Bulletin No. 189)
Arsenault MY, Lane CA. The Management of Nausea and Vomiting in Pregnancy. J Obstet Gynaecol Can 2002; 24(10):817-23.
Ebrahimi N, Maltepe C, Einarson A. Optimal management of nausea and vomiting of pregnancy. Int J Womens Health. 2010; 2: 241–248.
Matthews A, Haas DM, O'Mathúna DP, et al. Interventions for nausea and vomiting in early pregnancy. Cochrane Database Syst Rev. 2015 Sep 8; 9:CD007575.
Bonjesta prescribing information. Duchesnay USA, Inc. Bryn Mawr, PA. October 2022.
Campbell K, Rowe H, Azzam H, Lane C. The Management of Nausea and Vomiting of Pregnancy. Journal of Obstetrics and Gynaecology Canada. 2016;38(12):1127-1137. doi:10.1016/j.jogc.2016.08.009

2024-07-10: 2024 UM Annual Review. No criteria changes
2023-07-31: 2023 UM Annual Review. No criteria changes. Updated references
2022-08-02: 2022 Annual Review, no criteria changes.
2021-09-10: Updated references section.
2021-05-20: Addition of EHB formulary to guideline, no changes to criteria
2021-02-12: Under Product Name section, updated listed product from "generic doxylamine/pyridoxine extended-release" to "Generic doxylamine/pyridoxine delayed-release"; No other changes to guideline made.
2020-04-20: Updated for June annual reviews- no changes
2020-03-16: Revised criteria to require a trial of combination doxylamine and pyridoxine.
2019-12-02: Fixed UMCS search function, no changes to guideline.
2019-07-03: Verified generic populates in product field
2019-07-19: July P&T: add generic Diclegis to the program, for 9/1/19 effective date. Removal of criteria due to PA team feedback (use with MAOI and T/F conservative management).