CurrentmhnPolicy CP.PMN.197

Clomipramine (Anafranil)

Defines medical necessity criteria, limits, and prior authorization requirements for clomipramine (Anafranil) for Medicaid line of business, including initial and continuation criteria for OCD, autistic disorder (off-label), and handling of other indications.

Policy Summary

Payermhn

PolicyClomipramine (Anafranil)

Policy CodePolicy CP.PMN.197

Change TypeTemplate and continued therapy clarifications; periodic reference updates

Effective Date06.01.19

Next Review Date

Key ActionProvider must submit documentation supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added requirement to use generic clomipramine unless contraindicated or intolerant (template change noted 2Q2023).

Revised continued therapy criteria to allow continuity of care for all indications (noted 06.05.24).

Periodic reference updates and annual reviews with no significant changes (2022-2026).

2Covered Indications (listed)

1Off-label Indication explicitly addressed

250 mg/dayMaximum adult daily dose

30 daysMinimum prior therapy duration for continuity of care

Coverage Summary

Coverage stance: covered_with_criteria. Scope summary: Defines medical necessity criteria, limits, and prior authorization requirements for clomipramine (Anafranil) for the Medicaid line of business, including initial and continuation criteria for obsessive-compulsive disorder (OCD) and autistic disorder (off-label), requirements to document prior medication trials and current therapy, a generic clomipramine requirement for Anafranil requests (unless contraindicated or intolerant), a maximum adult dose limit of 250 mg/day, and approval durations of 12 months for approved indications. Initial OCD criteria require diagnosis of OCD and documented failure of 2 SSRIs each used ≥ 4 weeks at up to maximally indicated doses unless contraindicated or intolerant. Initial autistic disorder (off-label) criteria require diagnosis of autistic disorder and documented failure of a 4-week trial of fluoxetine at up to maximally indicated doses unless contraindicated or intolerant. Continued-therapy criteria require current use via the Centene benefit or ≥ 30 days prior therapy and evidence of positive response; dose increases must not exceed 250 mg/day.

Key thresholds and stats

SSRI trial duration (OCD)Each SSRI used ≥ 4 weeks at up to maximally indicated doses

Fluoxetine trial duration (Autistic disorder)4 weeks at up to maximally indicated doses

Maximum adult daily dose≤ 250 mg/day

Minimum prior therapy duration for continuity of careAt least 30 days of prior therapy (currently receiving via benefit or documentation of ≥30 days)

Initial Therapy Criteria

I. Initial Approval Criteria

Provider must submit documentation supporting that member has met all approval criteria. Anafranil is medically necessary when the following criteria are met:

A. Obsessive-Compulsive Disorder (must meet all)

Diagnosis of OCD
Failure of 2 selective serotonin reuptake inhibitors (SSRIs), each used for at least 4 weeks at up to maximally indicated doses unless clinically significant adverse effects are experienced or all are contraindicatedEach SSRI ≥ 4 weeks
For Anafranil requests, member must use generic clomipramine, unless contraindicated or clinically significant adverse effects are experienced

Continuation Therapy Criteria

II. Continued Therapy (All Indications in Section I)

All Indications in Section I (must meet all):

ALL of the following

Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Anafranil for a covered indication and has received this medication for at least 30 days≥ 30 days or Centene benefit
Member is responding positively to therapy
For Anafranil requests, member must use generic clomipramine, unless contraindicated or clinically significant adverse effects are experienced
If request is for a dose increase, new dose does not exceed 250 mg per day

Unapproved / Not Authorized Indications

III. Diagnoses/Indications Not Authorized

Non-FDA approved indications which are not addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety according to the off-label use policy CP.PMN.53 for Medicaid or evidence of coverage documents

Provider Actions & Authorization Requirements

Documentation Required

Support for approval criteria

Provider must submit office chart notes, laboratory results, or other clinical information that documents the member meets the approval criteria for clomipramine (Anafranil).

Prior Authorization

Generic product requirement

Requests for Anafranil must use generic clomipramine unless the member has a contraindication or clinically significant adverse effects to the generic product.

Applicable Codes & Cross-References

Policy References / Cross-referenced policiesmixed

CP.PMN.255	No coverage criteria policy (Medicaid) - referenced for recent label changes
CP.PMN.16	Non-formulary policy (Medicaid) - referenced for recent label changes
CP.PMN.53	Off-label use policy (Medicaid) - referenced for uses not listed

Clinical Evidence & Guideline References

Evidence summary: Clomipramine (Anafranil) is a tricyclic antidepressant with an FDA-approved indication for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD). Clinical guidance (American Psychiatric Association OCD guideline) identifies serotonin reuptake inhibitors as first-line therapies for OCD and notes SSRIs are generally preferred prior to clomipramine due to a better safety profile; clomipramine may be used when SSRIs fail. For autism spectrum disorder, the American Academy of Child and Adolescent Psychiatry practice parameter indicates pharmacotherapy may be used for specific target symptoms; randomized controlled trials have shown that clomipramine and fluoxetine can decrease repetitive behaviors in autistic disorder (use is off-label).

Background & Definitions

Background: Clomipramine is a tricyclic antidepressant and is FDA-approved for treating obsessions and compulsions in OCD. Per guideline guidance, SSRIs are considered first-line for OCD and are generally preferred before clomipramine because of their safety profile; clomipramine may be used when SSRIs have failed. There is some evidence supporting clomipramine’s off-label use to reduce repetitive behaviors in autistic disorder. This policy and its criteria apply to the Medicaid line of business; when state Medicaid coverage provisions conflict with this clinical policy, state Medicaid provisions take precedence.

Definitions

MAOImonoamine oxidase inhibitor

FDAFood and Drug Administration

OCDobsessive-compulsive disorder

SSRIselective serotonin reuptake inhibitor

Revision History

2023-02-06clarified

Template requirement added to use generic clomipramine unless contraindicated or intolerant (added requirement noted in 2Q2023 revision log).

2024-06-05revised

Continued therapy criteria revised to allow continuity of care for all indications (revision noted 06.05.24).

2022-2026updatedLatest

Periodic reference updates and annual reviews with no significant clinical policy statement changes (annual reviews and reference updates documented 2022–2026; last review 05.26.26 marked as most recent).