CurrentColorado Rocky Mountain Health PlansPolicy N/A

Bonjesta® and Diclegis® (doxylamine/pyridoxine) prior authorization and medical necessity

Prior authorization and medical necessity criteria for coverage of Bonjesta and Diclegis (doxylamine/pyridoxine formulations) for treatment of nausea and vomiting of pregnancy, including required trials, documentation, and authorization duration; notes on automation, plan exclusions, and supply limits.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyBonjesta® and Diclegis® (doxylamine/pyridoxine) prior authorization and medical necessity

Policy CodePolicy N/A

Change TypeAnnual review (references updated)

Effective DateJun 1, 2026

Next Review Date

Key ActionSubmit evidence of pregnancy-related nausea and vomiting plus documentation of failure/contraindication to lifestyle modifications and a 5-day trial/failure (or contraindication) of separately administered doxylamine and pyridoxine; authorization will be issued for 9 months.

POLICY UPDATE CHANGES

Annual review dated 3/2026 with updated references.

Initial authorization duration increased historically to 9 months (change noted in 7/2016 history).

3Required Criteria (AND conditions)

9Authorization Duration (months)

1Five-day OTC trial required

Coverage Summary

Coverage: Bonjesta® and Diclegis® (doxylamine/pyridoxine) are covered_with_criteria when prior authorization and the medical necessity criteria are met. Scope: prior authorization and medical necessity requirements include documented diagnosis of pregnancy-related nausea and vomiting, documented failure or contraindication to conservative management, and documented trial and failure (or contraindication) to a 5-day trial of separately administered over-the-counter doxylamine together with pyridoxine. Authorization duration: 9 months. Effective date: 2026-06-01; Last review: 2026-03-01. Plan/state exclusions: Bonjesta and Diclegis are typically excluded from coverage in many plans; state mandates and member-specific benefit plan exclusions may affect coverage and should be checked for each member.

Quick facts / thresholds

Authorization duration9 months

OTC doxylamine + pyridoxine trial5-day trial (separate formulations taken concomitantly)

Required criteria (AND conditions)3

Initial Therapy Criteria

Initial Authorization

Bonjesta or Diclegis will be approved when ALL of the following are met:

Diagnosis of nausea and vomiting associated with pregnancy
Documented failure or contraindication to lifestyle modifications (e.g., diet, avoidance of triggers)
Conservative management defined as non-pharmacologic measures such as dietary adjustments and avoidance of triggers.
Documented trial and failure or contraindication to a five-day trial of over-the-counter doxylamine taken together with pyridoxine (separate formulations taken concomitantly; not a combined dosage form)5-day trial

Authorization will be issued for 9 months.

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required per criteria

Submit evidence of pregnancy-related nausea and vomiting plus documentation of failure or contraindication to conservative management (e.g., diet, avoidance of triggers) and a five-day trial/failure (or documented contraindication) of separately administered over-the-counter doxylamine taken together with pyridoxine (not a combined dosage form). Authorization will be issued for 9 months.

Documentation Required

Document conservative management and OTC trial

Retain records demonstrating trials of lifestyle modifications and a five-day trial of separately administered doxylamine and pyridoxine (or documented contraindications to these interventions) for prior authorization review.

Billing Rule

Supply limitations and plan exclusions

Supply limitations may be in place and Bonjesta and Diclegis are typically excluded from coverage under many plan benefits. Check member-specific plan coverage and applicable state mandates to determine whether coverage or exclusions apply.

Documentation Required

Automated approval possibility

UnitedHealthcare may approve initial and reauthorization requests based solely on prior claim/medication history, diagnosis codes, and/or claim logic using automated approval processes where applicable.

Clinical Evidence & References

Evidence and references: Package inserts for Diclegis (June 2023) and Bonjesta (October 2022) are cited as primary sources. Clinical guidance includes ACOG Practice Bulletin No. 189: Nausea and vomiting of pregnancy (2018, reaffirmed 2024). Additional literature cited includes clinical reviews such as Herrell HE (Am Fam Physician 2014). Further detail and expansion of the evidence will be provided by the content agent.

Background & Definitions

Background: Bonjesta and Diclegis are FDA-approved fixed-dose combinations of doxylamine and pyridoxine for treatment of nausea and vomiting of pregnancy in women who have not responded to conservative management. These agents are typically excluded from coverage in many plans; coverage may be impacted by state mandates and member-specific benefit plan exclusions. Supply limitations may apply, and UnitedHealthcare may use automated approval processes based on prior claims, diagnosis codes, or medication history.

Definitions

Conservative management / lifestyle modificationsNon-pharmacologic measures such as dietary adjustments and avoidance of triggers.