CurrentColorado Rocky Mountain Health PlansPolicy N/A

Prior Authorization/Medical Necessity — Bonjesta (doxylamine/pyridoxine) and Diclegis (doxylamine/pyridoxine)

Defines prior authorization and medical necessity criteria for Bonjesta and Diclegis for treatment of nausea and vomiting of pregnancy, including required trials of lifestyle modification and a five-day OTC doxylamine plus pyridoxine regimen before approval.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyPrior Authorization/Medical Necessity — Bonjesta and Diclegis

Policy CodePolicy N/A

Change TypeAdministrative review — no material changes

Effective DateJun 1, 2026

Next Review DateMar 1, 2026

Key ActionObtain prior authorization after documenting diagnosis, failure/contraindication to lifestyle measures, and trial/failure or contraindication to a five-day OTC doxylamine plus pyridoxine regimen.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

9 monthsauthorization duration

5 daysrequired OTC trial

typically excludedplan exclusion status

FDA-approvedindication

Coverage Criteria for Bonjesta and Diclegis

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Initial Authorization

Covered when ALL of the following are met

Initial authorization criteria: 1) Diagnosis of nausea and vomiting associated with pregnancy; 2) Documented failure or contraindication to lifestyle modifications (e.g., diet, avoidance of triggers); 3) Documented trial and failure or contraindication to a five-day trial of over-the-counter doxylamine taken together with pyridoxine as separate formulations (not a combined dosage form).Authorization will be issued for 9 months

Bonjesta and Diclegis are typically excluded at the plan level; state mandates and member-specific benefit plans may affect coverage.

The policy notes that Bonjesta and Diclegis are typically excluded from coverage. Coverage may vary by plan; verify the member’s specific benefit plan and any applicable state or federal mandates to determine whether these products are excluded for the patient.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approval is granted when all specified clinical criteria are met, including diagnosis and required trials of lifestyle and OTC measures. Authorization duration: 9 months. State mandates, federal requirements, and member-specific benefits may affect coverage; Bonjesta and Diclegis may be excluded under some plans.

Authorization length: 9 months
Bonjesta and Diclegis may be plan-excluded; verify member benefits

Step Therapy

OTC Step Therapy Requirement

A documented trial and failure or documented contraindication to a five-day over-the-counter regimen of separate doxylamine plus pyridoxine (taken concomitantly) is required prior to approval.

OTC regimen must be doxylamine and pyridoxine in separate formulations taken together for five days
Failure or contraindication to the OTC regimen must be documented

Documentation Required

Required Documentation

Providers must document the diagnosis of nausea and vomiting associated with pregnancy and that lifestyle measures were tried and failed or are contraindicated. Include medication trial dates, dosages, and reason for failure or contraindication.

Diagnosis: pregnancy-associated nausea and vomiting
Documentation of trial and failure or contraindication to lifestyle modifications (e.g., diet, avoidance of triggers)
Documentation of five-day OTC doxylamine + pyridoxine trial (dates, dose, response) or contraindication

Denial Risk

Triggers for Denial

Denial will be issued if required documentation or trials are missing or inadequate. Common triggers for denial include absence of a pregnancy-associated nausea/vomiting diagnosis, no documentation of lifestyle modification trial/failure or contraindication, and no documented five-day trial (or documented contraindication) of separate doxylamine plus pyridoxine.

No documentation of pregnancy-associated nausea and vomiting
No documented trial and failure or contraindication to lifestyle modifications
No documented five-day trial of separate doxylamine + pyridoxine (or lack of documented contraindication)

Key Definitions

inv-08: Indication — Nausea and vomiting associated with pregnancy.

IndicationNausea and vomiting associated with pregnancy

FDA statusBonjesta and Diclegis are FDA‑approved fixed‑dose combinations of doxylamine and pyridoxine for treatment of nausea and vomiting of pregnancy

Place in therapyFor women who have not responded to conservative management (e.g., lifestyle and dietary measures)

Authorization durationAuthorization will be issued for 9 months

inv-09: Required OTC trial — Five-day trial of OTC doxylamine taken together with pyridoxine as separate formulations (not combined).

Required OTC trialFive‑day trial of over‑the‑counter doxylamine taken together with pyridoxine as separate formulations (not a combined dosage form)

Order of trialMust be documented that trial and either failure or contraindication occurred before approval of Bonjesta or Diclegis

Formulation requirementSeparate OTC doxylamine and pyridoxine products taken concomitantly — combined prescription products do not satisfy the OTC trial requirement

Documentation neededProvider must document the five‑day OTC trial and outcomes in the medical record