Currentmedical mutual - ohioPolicy N/A

Betaine anhydrous powder (Cystadane) — Coverage Criteria for Homocystinuria

Covers prior-authorization criteria and coverage guidance for betaine anhydrous powder used to treat homocystinuria for Medical Mutual - Ohio members; applies to prescribers and pharmacy benefit reviewers.

Policy Summary

Payermedical mutual - ohio

PolicyBetaine anhydrous powder (Cystadane) — Coverage Criteria for Homocystinuria

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateN/A

Next Review DateSep 18, 2025

Key ActionObtain prior authorization and document genetic testing confirming homocystinuria plus evidence of vitamin B6/B12/folate trial or concurrent supplementation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yrInitial approval duration

1 yrExtended approval duration

Prior authAuthorization requirement

HomocystinuriaPrimary approved indication

Coverage Criteria

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Initial Approval Criteria

Initial Approval — Initial approval duration and criteria

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

Homocystinuria authorization

Confirmed diagnosis (A): Patient has a confirmed diagnosis based on genetic testing demonstrating one of: i) Cystathionine beta-synthase deficiency; OR ii) 5,10-methylenetetrahydrofolate reductase deficiency; OR iii) Cobalamin cofactor metabolism defect
genetic testing confirmation required
Supplementation (B): Patient has tried or is concurrently receiving vitamin B6 (pyridoxine), vitamin B12 (cobalamin), or folate supplementation
trial or concurrent use required
Prescriber specialty (C): Medication is prescribed by or in consultation with a geneticist, metabolic disease specialist, or physician who specializes in the management of homocystinuria
specialist involvement required

ref): "b0_0"

title": "COVERAGE CRITERIA

ref": "b0_0"

Requirement	Details
Supplementation requirement	Trial or concurrent use of vitamin B6 (pyridoxine), vitamin B12 (cobalamin), or folate is required prior to or during therapy as part of authorization criteria.

Provider Actions and Documentation

Prior Authorization

Prior Authorization Recommended

Prior authorization recommended — Prior authorization is recommended for pharmacy benefit coverage of betaine anhydrous powder; approval follows the recommended authorization criteria in the policy statement and Recommended Authorization Criteria sections.

Prior Authorization

Supplementation Requirement

Supplementation requirement — Patients must have tried or be concurrently receiving vitamin B6 (pyridoxine), vitamin B12 (cobalamin), or folate supplementation as part of the management of homocystinuria when requesting betaine anhydrous powder.

Documentation Required

Documentation May Be Requested

Documentation request — The Company may request patient records, test results, and/or provider credentials to support medical necessity; additional documentation supporting medical necessity must be made available upon request.

Denial Risk

Denial Conditions

Denial conditions — The Company may deny reimbursement when it determines the drug provided was not medically necessary, investigational/experimental, not within the scope of benefits, or when a pattern of inappropriate or excessive billing or practice is identified.

Background

Betaine anhydrous is a methylating agent indicated to decrease elevated homocysteine concentrations in pediatric and adult patients with homocystinuria. Use for this condition should follow the policy’s authorization criteria, including genetic confirmation of the diagnosis and specialist involvement when appropriate.

Definitions

Homocystinuria — definition and relevant details

DefinitionAn inherited metabolic disorder characterized by elevated homocysteine levels treatable with betaine in specific genetic subtypes (e.g., cystathionine beta-synthase deficiency).

Typical presentationElevated homocysteine concentrations in pediatric and adult patients requiring therapy to reduce levels.

Genetic subtypes qualifying for therapyCystathionine beta-synthase deficiency; 5,10-methylenetetrahydrofolate reductase deficiency; cobalamin cofactor metabolism defect.

Recommended therapy agentBetaine anhydrous powder (methylating agent) to decrease elevated homocysteine levels.

Prescriber guidanceMedication should be prescribed by or in consultation with a geneticist, metabolic disease specialist, or physician who specializes in management of homocystinuria.