CurrentUnitedHealthcarePolicy 2024 P 2024-12

Diclegis® (doxylamine/pyridoxine delayed-release) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

UnitedHealthcare prior authorization/medical necessity policy for Bonjesta (extended-release) and Diclegis (delayed-release) for treatment of nausea and vomiting of pregnancy, specifying initial authorization criteria, trial requirements, authorization duration, and program notes.

Policy Summary

PayerUnitedHealthcare

PolicyDiclegis® (doxylamine/pyridoxine delayed-release) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plans

Policy CodePolicy 2024 P 2024-12

Change TypeAnnual review; clarifications and prior updates

Effective DateApr 1, 2024

Next Review Date

Key ActionPrior authorization is required; document diagnosis, failure/contraindication to lifestyle modifications, and a 5-day trial/failure or contraindication to separate over-the-counter doxylamine plus pyridoxine for approval.

SourceLink

POLICY UPDATE CHANGES

Annual review with no changes noted (1/2024).

Increased initial authorization from 3 to 9 months (7/2016).

Clarified trial/failure requirement to specify separate dosage forms for doxylamine and pyridoxine (10/2020 and 9/2019 updates).

Added Bonjesta to criteria and noted Bonjesta and Diclegis are typically excluded from coverage (7/2018, 9/2019).

9Initial authorization duration

5Required OTC trial (days)

Coverage Summary

UnitedHealthcare covers Bonjesta and Diclegis under a prior authorization/medical necessity policy when all criteria are met. Coverage is governed by the plan’s prior authorization requirements and medical necessity criteria for these doxylamine/pyridoxine products. Note that coverage may vary by benefit plan and these products are typically excluded from coverage for some plans — check plan-specific details and state mandates.

Policy quick facts

Initial authorization duration9 months

Required OTC trial duration5 days (separate doxylamine plus pyridoxine taken concomitantly)

Coverage variability across plansBonjesta and Diclegis are typically excluded from coverage; plan-specific exclusions may apply

Policy effective date2024-04-01

Policy number2024 P 2024-12

StatusCURRENT

Initial Therapy Criteria

Initial Authorization

Bonjesta or Diclegis will be approved based on all of the following criteria:

Diagnosis of nausea and vomiting associated with pregnancy
Lifestyle modifications: Documented failure or contraindication to lifestyle modifications (e.g., diet, avoidance of triggers)
OTC separate formulations trial: 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 days
Definition: Separate formulations trial = a five-day trial using over-the-counter doxylamine and pyridoxine as separate products taken concomitantly (not a combined dosage form).

Continuation / Reauthorization Criteria

Initial authorizations are issued for 9 months. Policy history notes that the initial authorization duration was increased from 3 to 9 months and reauthorization criteria were removed during prior updates. In programs using automation, UnitedHealthcare may approve initial and reauthorization requests based on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic where program automation is in use.

Unproven / Plan Exclusions

Bonjesta and Diclegis are typically excluded from coverage for some plans. Authorizations may be denied based on member-specific benefit plan exclusions, state mandates, or other plan-specific coverage rules; providers should verify exclusion status for the member’s plan.

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required; approval is granted only when all initial authorization criteria are documented (diagnosis of nausea and vomiting of pregnancy; documented failure/contraindication to lifestyle modifications; documented trial and failure or contraindication to a five-day trial of separate over‑the‑counter doxylamine taken together with pyridoxine).

Documentation Required

Document trials and contraindications

Document and submit evidence of failure or contraindication to lifestyle interventions (e.g., diet, avoidance of triggers) and a five-day trial of over‑the‑counter doxylamine taken together with pyridoxine as separate formulations (not a combined product).

Applicable Codes

Relevant diagnosis codes (ICD-10) referenced for automated approval or claim logicICD-10

No codes listed

Clinical Evidence & Definitions

Primary evidence sources referenced in the policy include the Diclegis and Bonjesta package inserts (2022–2023) and the ACOG Practice Bulletin on nausea and vomiting of pregnancy (2018).

Separate formulations trial: a five-day trial using over-the-counter doxylamine and pyridoxine as separate products taken concomitantly (not a combined dosage form).

Background

Background: Bonjesta and Diclegis are FDA-approved fixed-dose combinations of doxylamine and pyridoxine for the treatment of nausea and vomiting of pregnancy in women who have not responded to conservative management. This policy defines prior authorization and medical necessity requirements for these medications within UnitedHealthcare commercial plans, including required trials and authorization duration.

Revision History

7/2016material

Increased initial authorization from 3 months to 9 months and removed reauthorization criteria.

7/2018material

Added Bonjesta to the criteria and updated note that Bonjesta and Diclegis are typically excluded from coverage.

9/2019material

Clarified trial/failure requirement to specify trial of separate dosage forms (separate doxylamine and pyridoxine taken concomitantly rather than a combined product).