Bonjesta & Diclegis – NC Standard

Restriction applies to brand and generic products

• Bonjesta (doxylamine/pyridoxine ER)
• Diclegis (doxylamine/pyridoxine DR) 

• For the treatment of pregnancy-associated nausea and vomiting (not responsive to conservative management).

1. The patient has a diagnosis of pregnancy-associated nausea and vomiting (not including hyperemesis gravidarum); AND
2. The patient has failed or has a contraindication to lifestyle modifications (e.g., diet, avoidance of triggers); AND
3. The patient has tried and failed or has a clinical contraindication/intolerance to over-the-counter doxylamine taken together with pyridoxine (separate formulations taken concomitantly); AND
4. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 270 days (9 months)

Quantity limitations apply to brand and associated generic products.

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed). 

All information referenced is from FDA package insert unless otherwise noted below.

January 2021: Original utilization management criteria issued.