CurrentMass General Brigham Health PlanPolicy N/A

Doxylamine with pyridoxine

Pharmacy benefit prior-authorization policy for doxylamine succinate with pyridoxine delayed-release tablets (generic Diclegis) for treatment of nausea and vomiting of pregnancy; excludes Bonjesta (nonformulary). Governs authorization criteria, limits, and quantity limits effective 01/01/2026.

Policy Summary

PayerMass General Brigham Health Plan

PolicyDoxylamine with pyridoxine

Policy CodePolicy N/A

Change TypeFormulary change; authorization language clarified

Effective DateJan 1, 2026

Next Review Date

Key ActionPrior authorization is required for doxylamine with pyridoxine (generic Diclegis) under the pharmacy benefit; authorization may be granted per the policy criteria including for members new to plan within 90 days who are currently receiving therapy (excluding samples or patient assistance).

SourceLink

POLICY UPDATE CHANGES

Bonjesta removed from the policy as the agent moved to nonformulary status.

Updated language clarifying authorization may be granted for members new to the plan within the past 90 days who are currently receiving treatment (excluding samples or manufacturer's patient assistance programs).

4Initial approval months

6Max reauthorization months

4Tablets per day limit

Nonformulary agent (Bonjesta)

Coverage Summary

Pharmacy benefit prior-authorization policy for doxylamine succinate with pyridoxine delayed-release tablets (generic Diclegis); Bonjesta is nonformulary. Governs authorization criteria, limits, and quantity limits effective 01/01/2026. Last review date: 10/08/2025.

Authorization thresholds and policy status

Initial approval duration4 months

Reauthorization durationUp to an additional 6 months

Quantity limit4 tablets per day

Policy subjectDoxylamine with pyridoxine (generic Diclegis)

Coverage stanceCovered with criteria (prior authorization required); Bonjesta is nonformulary

Authorization Criteria (Initial Therapy)

Authorization Criteria

Authorization may be granted when the following conditions are met:

ANY of the following

ALL of the following
- Member is new to the plan within the past 90 days AND is currently receiving treatment with the requested medication (excluding when the product is obtained as samples or via manufacturer's patient assistance programs).
ALL of the following
- Member has a diagnosis of nausea and vomiting associated with an active pregnancy.
- ONE of the following
  - Member has had an inadequate response to combination therapy with pyridoxine and doxylamine taken concurrently.

Continuation / Reauthorization

Initial approval duration is 4 months. Reauthorizations may be granted for up to an additional 6 months. Members new to the plan within the past 90 days who are currently receiving treatment with the requested medication (excluding products obtained as samples or via manufacturer's patient assistance programs) are eligible for authorization per the policy. No separate continuation criteria tree is provided; continuation follows these reauthorization limits and the coverage guidelines.

Nonformulary / Exclusions

Bonjesta is designated as nonformulary under this policy and is therefore not covered. See code group note 'Formulary status / product notes' and policy update removing Bonjesta effective 01/01/2026.

Applicable Codes

Formulary status / product notesmixed

generic Diclegis	Doxylamine succinate and pyridoxine delayed-release tablet (generic Diclegis) - covered with prior authorization per criteria
Bonjesta	Bonjesta (doxylamine and pyridoxine delayed-release) tablets - nonformulary

Provider Actions & Billing Rules

Prior Authorization

Prior authorization required

Prior authorization is required for doxylamine with pyridoxine (generic Diclegis) under the pharmacy benefit. Authorization may be granted per the policy criteria, including for members new to the plan within the past 90 days who are currently receiving treatment with the requested medication (excluding when the product is obtained as samples or via manufacturer's patient assistance programs).

Documentation Required

Clinical rationale for alternatives

If the member has not tried concurrent pyridoxine and doxylamine, the provider must document an inadequate response to that combination or submit clinical rationale why concurrent use of pyridoxine and doxylamine is not appropriate.

Clinical Evidence

Prescribing information: Doxylamine/pyridoxine prescribing information, Endo USA, April 2019.

Clinical studies referenced: BJOG 2019;126:1201 and Am J Obstet Gynecol 2016;214:664.

4Initial approval months

6Maximum reauthorization months

4Tablets per day limit

Background

Doxylamine with pyridoxine delayed-release tablets are indicated for treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Bonjesta is nonformulary per this policy.

Revision History

01/01/2026material_changeLatest

Policy language updated for members new to the Plan; effective 01/01/2026. Bonjesta removed from the policy as the agent moved to nonformulary status.

10/08/2025review_update

Reviewed and updated for September P&T; removed Bonjesta from the policy as agent is moving to nonformulary status and updated language for members who are new to the Plan.

clarification

Authorization may be granted for members new to the plan within the past 90 days who are currently receiving treatment with the requested medication, excluding when the product is obtained as samples or via manufacturer's patient assistance programs.

Policy Summary

PayerMass General Brigham Health Plan

PolicyDoxylamine with pyridoxine

Policy CodePolicy N/A

Change TypeFormulary change; authorization language clarified

Effective DateJan 1, 2026

Next Review Date

SourceLink

On This Page

Provider submits clinical rationale why treatment with the concurrent use of pyridoxine and doxylamine is not appropriate.

New to the plan: Member enrolled within the past 90 days.

Billing Rule

Quantity limit enforcement

Quantity limit for doxylamine with pyridoxine 10 mg/10 mg is enforced at 4 tablets per day.

Tablets per day limit: 4 tablets per day
Enforcement: Quantity limits applied per drug name and dosage form as specified in policy

authorization_criteria

Authorization may be granted when member has a diagnosis of nausea and vomiting associated with an active pregnancy AND either has had an inadequate response to concurrent pyridoxine and doxylamine or provider submits clinical rationale why concurrent use is not appropriate.

limits

Initial approvals for generic Diclegis are for 4 months; reauthorizations may be granted for up to an additional 6 months; quantity limit is 4 tablets per day for doxylamine with pyridoxine 10mg/10mg.

02/20/2014 - 11/16/2022review_history_summary

Policy review history includes implementation 02/20/19 and multiple reviews (2014–2022); Bonjesta was added 03/22/18 and later removed per 10/08/2025 review.