CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Doxylamine-pyridoxine for nausea and vomiting of pregnancy — Coverage Criteria

Policy governs authorization, quantity, and duration of doxylamine succinate with pyridoxine hydrochloride for pregnant Medicaid members treated for nausea and vomiting, with exclusions for hyperemesis gravidarum.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDoxylamine-pyridoxine for nausea and vomiting of pregnancy — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateSep 1, 2017

Next Review DateMar 1, 2025

Key ActionObtain prior authorization and document gestational age, diagnosis of nausea/vomiting of pregnancy, and prior failure or intolerance to pyridoxine plus doxylamine.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

7–14 wksAuthorized treatment window

4/dayQuantity limit

HyperemesisExclusion

Prior intoleranceRequirement

MedicaidPopulation

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Coverage Criteria for Doxylamine-Pyridoxine

Approval criteria

Covered when ALL of the following are met:

Main approval criteria

A: Patient is pregnant and currently in gestational weeks 7 to 14
B: Patient is being treated for nausea and vomiting in pregnancy
C: Patient has failed or has a documented intolerance to pyridoxine (vitamin B6) in combination with doxylamine
D: Patient is not diagnosed with hyperemesis gravidarum

Patients diagnosed with hyperemesis gravidarum are excluded from authorization under this policy.

Use outside of gestational weeks 7–14, use for patients diagnosed with hyperemesis gravidarum, or use without documented failure or intolerance to pyridoxine (vitamin B6) in combination with doxylamine is not covered under this policy.

Medication, Limits, and Duration

Covered medication (by product/strength)mixedCovered

Doxylamine Succinate and Pyridoxine Hydrochloride 10mg/10mg

Medication and strength as listed in quantity limit

Daily tablet limit — 4 tablets per day

Daily tablet limitDoxylamine Succinate and Pyridoxine Hydrochloride 10mg/10mg — 4 tablets per day

RationaleQuantity limit specifies maximum tablets per day for covered product as listed in the policy's quantity limit section.

ApplicabilityApplies during the authorized treatment window when all approval criteria are met (pregnancy weeks 7–14).

Coverage duration — up to and including gestational week 14

Coverage durationUp to and including gestational week 14

Treatment window contextAuthorization is limited to patients who are pregnant and currently in gestational weeks 7 to 14; coverage ends at week 14.

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required and will be approved only when ALL approval criteria are met: patient is pregnant (gestational weeks 7–14), being treated for nausea and vomiting of pregnancy, has failed or is intolerant to pyridoxine (vitamin B6) combined with doxylamine, and is not diagnosed with hyperemesis gravidarum.

Approval requires documented gestational age (weeks 7–14).
Approval requires documentation of diagnosis: nausea and vomiting of pregnancy.
Approval requires documentation of prior trial and failure or intolerance to pyridoxine + doxylamine.
Exclude patients diagnosed with hyperemesis gravidarum.

Step Therapy

Step Therapy Requirement

A documented trial of pyridoxine (vitamin B6) in combination with doxylamine with evidence of treatment failure or intolerance is required before authorization will be granted.

Document medication name(s), dose, duration of trial, and reason for failure or intolerance (e.g., lack of response, adverse effects).

Background

Nausea and vomiting of pregnancy is common in early pregnancy. The combination of doxylamine and pyridoxine is an established treatment for nausea and vomiting in pregnancy and is intended for short-term use during the first trimester; authorization is limited to members meeting the policy criteria during gestational weeks 7–14.

Definitions

Hyperemesis gravidarum — definition and distinction

DefinitionHyperemesis gravidarum is a severe form of pregnancy-related vomiting distinguished from typical nausea and vomiting of pregnancy.

Policy distinctionPatients diagnosed with hyperemesis gravidarum are excluded from authorization under this policy (approval criterion D).

Clinical implicationUse of doxylamine/pyridoxine per this policy is intended for nausea and vomiting of pregnancy, not for hyperemesis gravidarum cases which require alternative management.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDoxylamine-pyridoxine for nausea and vomiting of pregnancy — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateSep 1, 2017

Next Review DateMar 1, 2025

Key ActionObtain prior authorization and document gestational age, diagnosis of nausea/vomiting of pregnancy, and prior failure or intolerance to pyridoxine plus doxylamine.

SourceLink

On This Page

Prior auth requirementPrior authorization required and valid only when duration criterion and other approval criteria are met.

Step therapy applies to initial authorization requests for treatment of nausea and vomiting of pregnancy.

If pyridoxine + doxylamine cannot be used due to intolerance or contraindication, provide supporting clinical rationale.

Failure due to non-adherence should include attempts to address adherence before considering step therapy exception.

Documentation Required

Required Documentation

Submit documentation that confirms pregnancy status with gestational age (in weeks), the clinical diagnosis of nausea and vomiting of pregnancy, and details of prior therapy trial and outcome.

Gestational age (weeks) documented in the medical record.
Diagnosis documentation (clinical notes) stating nausea and vomiting of pregnancy.
Details of prior pyridoxine + doxylamine trial: dates, dosing, duration, and reason for discontinuation or documented intolerance.
Supporting lab or clinical notes if intolerance or contraindication to pyridoxine + doxylamine is cited.

Denial Risk

Denial Triggers

Authorization may be denied if approval criteria are not met or required documentation is incomplete.

Patient is not pregnant or gestational age outside 7–14 weeks.
Diagnosis of hyperemesis gravidarum is documented.
No documented trial or intolerance to pyridoxine + doxylamine.
Incomplete documentation of pregnancy status, gestational age, diagnosis, or prior therapy details.