CurrentCignaPolicy N/A

Doxylamine and Pyridoxine Combination Products — Drug Quantity Management

Defines per-prescription and per-days quantity limits and override criteria for Bonjesta and Diclegis (doxylamine/pyridoxine) for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyDoxylamine and Pyridoxine Combination Products — Drug Quantity Management

Policy CodePolicy N/A

Change TypeRevised quantity limits / override criteria

Effective DateN/A

Next Review DateN/A

Key ActionApprove extended quantities up to annual totals (Bonjesta 540 tablets/365 days; Diclegis 1,080 tablets/365 days) when nausea/vomiting of pregnancy persists beyond 6 months; approvals are valid for 1 year.

SourceLink

POLICY UPDATE CHANGES

Policy updated to reflect existing quantity limits when product is obtained via home delivery and clarified per Rx limits and per Days override criteria for Bonjesta and Diclegis.

Per Days override criteria revised to approve 540 tablets/365 days for Bonjesta and 1,080 tablets/365 days for Diclegis when nausea/vomiting of pregnancy continues beyond 6 months.

540Bonjesta max (>6 mo)

1,080Diclegis max (>6 mo)

60Bonjesta bottle size

100Diclegis bottle size

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Coverage Criteria

Quantity limits and override criteria

Covered when ALL of the following are met:

Bonjesta per-rx and per-days limits: Per Rx: no overrides recommended. Per Days: If the patient has continued nausea and vomiting of pregnancy beyond 6 months, approve a total of 540 tablets per 365 days at retail or home delivery.540 tablets/365 days

Approvals provided for 1 year

Diclegis (generic) per-rx and per-days limits: Per Rx: no overrides recommended. Per Days: If the patient has continued nausea and vomiting of pregnancy beyond 6 months, approve a total of 1,080 tablets per 365 days at retail or home delivery.1,080 tablets/365 days

Approvals provided for 1 year

Any quantities or uses outside the stated criteria are considered not medically necessary. The policy’s Drug Quantity Limits specify that product amounts provided per prescription are intended to supply up to 6 months of therapy; coverage for additional quantities beyond that requires a coverage review.

Any other exception beyond the specified quantity management criteria is considered not medically necessary. Per the Drug Quantity Management policy, requests for quantities that exceed the per‑Rx/per‑Days criteria must undergo the required coverage review and will not be approved by exception outside that process.

Coding and Dose Limits

Maximum recommended daily dose

Bonjesta maximum daily dose2 tablets per day

Diclegis maximum daily dose4 tablets per day

Tablet administrationTablets must be swallowed whole; do not crush, chew, or split

Provider Actions and Requirements

Documentation Required

Coding and Documentation Requirements

When submitting claims or prior authorization requests, providers must use the most appropriate diagnosis and procedure codes effective on the date of submission. Claims or requests not accompanied by covered diagnosis/procedure codes referenced in the applicable coverage policy may be denied as not covered. Medical directors may exercise clinical judgment; coverage determinations depend on the terms of the member's benefit plan, applicable laws/regulations, and the specific facts of each case.

Providers must submit services with the most appropriate codes as of the submission date.
Claims submitted without a covered diagnosis and/or procedure code under the applicable coverage policy will be denied as not covered.
Medical directors retain discretion and must consider applicable benefit plan terms, laws/regulations, and case-specific facts when making coverage determinations.
All approvals under this Drug Quantity Management program are provided for 1 year unless noted otherwise.

Prior Authorization

Background

Bonjesta and Diclegis are single‑class products of doxylamine and pyridoxine managed under the plan’s Drug Quantity Limits. The policy states that standard dispensing provides enough medication for up to 6 months of therapy. If additional quantities are needed (for example, to extend therapy beyond 6 months), a coverage review is required to determine medical necessity; any use or quantity outside the stated criteria without such review is considered not medically necessary.

Definitions

Conservative management

DefinitionNonpharmacologic and first-line measures for nausea and vomiting of pregnancy that are attempted prior to using Diclegis or Bonjesta (conservative management).

Indication prerequisiteDiclegis and Bonjesta are indicated for nausea and vomiting of pregnancy in women who do not respond to conservative management.

Examples (context)Conservative measures are implied as initial therapy before medication; see product overview for indication context.

Initial Therapy Criteria

Initial dosing

Dosing initiation per labeling

Bonjesta initial dosing: Day 1: one tablet at bedtime. If symptoms persist on Day 2, increase to two tablets daily (one in the morning and one at bedtime). Maximum recommended dose: 2 tablets per day.max 2 tablets/day

Tablets must be swallowed whole

Diclegis initial dosing: Day 1: two tablets at bedtime. If symptoms persist into the afternoon of Day 2, increase to three tablets daily on Day 3 (one in the morning and two at bedtime); if needed, may increase to four tablets daily. Maximum recommended dose: 4 tablets per day.max 4 tablets/day

Delayed-release tablets; swallow whole; do not crush, chew, or split

Continuation Therapy

Continuation therapy

Continuation beyond initial supply

Continuation when pregnancy-related symptoms persist beyond 6 months: Approve extended quantities up to the per-product annual totals: Bonjesta 540 tablets per 365 days; Diclegis (generic) 1,080 tablets per 365 days.See per-product annual totals

Approvals valid for 1 year; approvals may be provided at retail or home delivery

Step Therapy

Step	Requirement	Coverage
1	Use of Diclegis or Bonjesta is indicated only after failure of conservative management for nausea and vomiting of pregnancy	Use indicated only after conservative measures fail

Quantity Limits

Bonjesta 20 mg/20 mg — Quantity limits

Per Rx policyPer Rx limits: no overrides recommended (see history for retail vs home delivery specifics).

Per Days override (annual)When nausea/vomiting persists beyond 6 months, approve up to 540 tablets per 365 days at retail or home delivery.

Bottle sizeBonjesta supplied as 60-tablet bottles (20 mg/20 mg).

Diclegis (generic) 10 mg/10 mg — Quantity limits

Per Rx policyPer Rx limits: no overrides recommended (see history for retail vs home delivery specifics).

Per Days override (annual)When nausea/vomiting persists beyond 6 months, approve up to 1,080 tablets per 365 days at retail or home delivery.