CurrentmhnPolicy CP.PMN.137

Carbamazepine ER (Equetro)

Defines medical necessity and prior authorization criteria for Equetro (carbamazepine ER) for bipolar I disorder, trigeminal neuralgia, and epilepsy for members covered by Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyCarbamazepine ER (Equetro) - Clinical Policy

Policy CodePolicy CP.PMN.137

Change TypeNo material clinical or coverage changes in this revision.

Effective Date06.01.18

Next Review Date

Key ActionSubmit prior authorization with supporting documentation showing diagnosis, age criteria, step-therapy status and that dose limits are not exceeded.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsInitial approval duration

1,600 mg/dayMax dose (bipolar/epilepsy)

1,200 mg/dayMax dose (trigeminal neuralgia)

Adults ≥18Age requirement

ER 100/200/300 mgProduct availability

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Initial Approval – Bipolar Disorder, Trigeminal Neuralgia, or Epilepsy

Covered when ALL of the following are met:

Initial criteria group: 1) Diagnosis of bipolar disorder OR trigeminal neuralgia OR epilepsy (partial seizures, generalized tonic-clonic [grand mal], or mixed types).

Age requirement (when applicable): 2) If diagnosis is bipolar disorder OR trigeminal neuralgia, member is ≥ 18 years of age.

Step therapy / immediate‑release requirement: 3) Member meets one of the following: a) Request is for a member in a State with limitations on step therapy in certain mental health settings (see Appendix D); OR b) Member has used immediate‑release carbamazepine unless it is contraindicated or clinically significant adverse effects occurred.

Extended‑release trial or state exception: 4) Member meets one of the following: a) Request is for a member in a State with limitations on step therapy in certain mental health settings (see Appendix D); OR b) Member has used extended‑release carbamazepine (e.g., Tegretol XR) unless it is contraindicated or clinically significant adverse effects occurred.

Dose limits: 5) Dose does not exceed: a) Bipolar disorder or epilepsy: 1,600 mg per day; b) Trigeminal neuralgia: 1,200 mg per day.see text

Approval duration: 12 months

Continuation/Renewal – Bipolar Disorder, Trigeminal Neuralgia, or Epilepsy

Covered when ALL of the following are met:

Current therapy or prior approval: 1) Member meets one of the following: a) Currently receiving medication via Centene benefit or previously met initial approval; OR b) Documentation shows current Equetro use for bipolar disorder or epilepsy for at least 30 days.

Clinical response: 2) Member is responding positively to therapy.

Dose increase limitation: 3) If request is for a dose increase, the new dose does not exceed: a) Bipolar disorder or epilepsy: 1,600 mg per day; b) Trigeminal neuralgia: 1,200 mg per day.see text

Other Diagnoses/Indications

Requests not covered in initial sections must meet one of the following:

Other uses: 1) If the drug labeling changed within the last 6 months and the policy is not yet updated, follow the applicable formulary/no‑coverage or non‑formulary policy for the line of business (see CP.CPA.190, CP.PMN.255, CP.PMN.16).

Off‑label referral: 2) If the requested use is not specifically listed under the policy's disallowed indications and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (CP.CPA.09 for commercial; CP.PMN.53 for Medicaid).

References to CP.CPA.190, CP.PMN.255, CP.PMN.16, CP.CPA.09, CP.PMN.53

Requests for uses that are not FDA‑approved and are not specifically addressed in this policy will not be authorized unless the provider supplies sufficient documentation of efficacy and safety consistent with the plan’s off‑label use policies (see CP.CPA.09 for commercial lines of business and CP.PMN.53 for Medicaid) or other evidence of coverage supporting the indication. Such non‑FDA approved indications are outside the routine scope of this policy.

Use of carbamazepine extended‑release for absence seizures (petit mal) is not medically necessary and is not authorized under this policy.

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must meet all applicable initial or continuation criteria including diagnosis, age limits, step therapy/redirection requirements, and dosing limits. Approval durations and dose maximums follow the policy criteria.

Approval duration: 12 months
Dose limits: Bipolar disorder/epilepsy — 1,600 mg/day; Trigeminal neuralgia — 1,200 mg/day

Step Therapy

Step Therapy / Redirection

Step therapy/redirection applies: members must use immediate‑release carbamazepine first (and extended‑release when specified) unless contraindicated or clinically inappropriate. Exceptions apply for members in states with limits on redirection/step therapy (see Appendix D).

Member must use immediate‑release carbamazepine unless contraindicated or clinically significant adverse effects are experienced
Member must use extended‑release carbamazepine (e.g., Tegretol XR) when required unless contraindicated
See Appendix D for state-specific restrictions on redirection/step therapy

Documentation Required

Required Documentation

Provider must submit documentation (e.g., office chart notes, lab results, medication history) supporting that the member meets all approval criteria. Documentation should demonstrate diagnosis, prior therapies or contraindications to step therapy, duration of current therapy (if continuation), and clinical response.

Examples: office notes, lab results, medication administration records, prior authorization history, documentation of contraindications or adverse reactions to carbamazepine formulations
For continuations: documentation that member has received Equetro for ≥30 days and is responding positively

Denial Risk

Provider Actions for Non‑FDA Indications and Absence Seizures

Requests for non‑FDA approved (off‑label) indications or for absence seizures may be denied if there is insufficient supporting evidence. For off‑label uses, submit supporting literature or evidence of efficacy and safety per off‑label use policies CP.CPA.09 (commercial) or CP.PMN.53 (Medicaid), or applicable evidence of coverage documents.

Non‑FDA indications require sufficient documentation of efficacy/safety per CP.CPA.09 or CP.PMN.53, or evidence of coverage documents
Absence seizures (petit mal) are not authorized by this policy and requests may be denied

Product Definitions and State Limitations

Equetro (carbamazepine ER)

Product descriptionEquetro (carbamazepine ER) is an extended‑release formulation of carbamazepine — an antiepileptic drug and mood stabilizer.

FDA‑approved bipolar indicationTreatment of acute manic or mixed episodes associated with bipolar I disorder.

Other FDA‑approved indicationsPain associated with trigeminal neuralgia; partial seizures with complex symptomatology, generalized tonic‑clonic seizures, and mixed seizure patterns.

Limitations of useNot indicated for absence seizures (petit mal); carbamazepine may increase frequency of generalized convulsions in these patients.

Redirection / step therapy limitation

State limitation notedNevada is listed in Appendix D as a state with limitations against redirections in certain mental health settings.

Effect on step therapyMembers in states with these limitations may not be required to complete trials of alternative formulations or formulary products prior to coverage.

ScopeAppendix D notes the limitation applies to Medicaid requests and specifies use of immediate‑release or extended‑release carbamazepine unless contraindicated or adverse effects occur.

OpenPayer

Carbamazepine ER (Equetro)

Coverage / Medical Necessity Criteria

Dose Limits and Coding Information

Prior Authorization, Step Therapy, and Documentation Requirements

Product Definitions and State Limitations

Background