CurrentmhnPolicy CP.PHAR.422

Cladribine (Mavenclad) for relapsing multiple sclerosis

Defines medical necessity, prior authorization, dosing limits, and coverage criteria for Mavenclad (cladribine) in adults with relapsing forms of multiple sclerosis for Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyCladribine (Mavenclad) for relapsing multiple sclerosis

Policy CodePolicy CP.PHAR.422

Change TypeNo material change

Effective DateSep 1, 2019

Next Review Date

Key ActionProvider must submit documentation (office notes, labs) demonstrating the member meets all approval criteria and prior authorization requirements.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2lifetime treatment courses allowed

12approval duration (months)

≥18minimum age

3.5 mg/kgtotal cumulative dosing

10 mgproduct availability

Coverage Criteria for Cladribine (Mavenclad)

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Initial Approval — Multiple Sclerosis

Covered when ALL of the following are met:

Initial MS criteria: 1. Diagnosis of one of the following: a. Relapsing-remitting multiple sclerosis, and either: i. For Illinois HIM requests only: failure of one drug indicated for the treatment of MS (see Appendices B and D) unless clinically significant adverse effects or contraindications; OR ii. For all other requests: failure of all of the following at up to maximally indicated doses unless clinically significant adverse effects or contraindications: dimethyl fumarate (Tecfidera), teriflunomide (Aubagio), fingolimod (Gilenya), and an interferon-beta agent (Avonex, Betaseron/Extavia, Rebif, or Plegridy) or glatiramer (Copaxone, Glatopa). b. Secondary progressive MS. 2. Prescribed by or in consultation with a neurologist. 3. Age ≥ 18 years. 4. Mavenclad (cladribine) is not prescribed concurrently with other disease-modifying therapies for MS (see Appendix D). 5. Dose limits (must not exceed): a. 2 tablets per day; b. 10 tablets per cycle; c. 2 cycles per course; d. 1 course per year. Approval duration: 12 months — up to 1 course (2 courses lifetime total).

Cumulative dosing: total cumulative dose over 2 courses = 3.5 mg/kg (see Dosage and Administration).

Continuation Therapy

Covered for continuation when ALL of the following are met:

Continued therapy: 1. Member meets one of the following: a. Currently receiving medication via the Centene benefit or previously met initial approval criteria; OR b. Currently receiving medication and enrolled in a state/product with continuity-of-care regulations. 2. Member is responding positively to therapy. 3. Mavenclad is not prescribed concurrently with other disease-modifying therapies for MS (see Appendix D). 4. Dose limits (must not exceed): a. 2 tablets per day; b. 10 tablets per cycle; c. 2 cycles per course; d. 1 course per year. Approval duration: 12 months — up to 1 course (2 courses lifetime total).

Cumulative dosing: total cumulative dose over 2 courses = 3.5 mg/kg (see Dosage and Administration).

Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless there is sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents. CIS (clinically isolated syndrome) is explicitly listed among diagnoses for which coverage is not authorized.

When there is a conflict between the coverage provisions in this clinical policy and state Medicaid coverage provisions for a Medicaid member, the state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for any state‑specific coverage guidance.

Use of this medication for clinically isolated syndrome (CIS) is explicitly not authorized by this policy and is considered not medically necessary. Requests for CIS should be denied unless alternative coverage pathways apply per the off‑label or other evidence of coverage policies referenced in this document.

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization may be required for disease modifying therapies for multiple sclerosis. Provider must document prior trials and failures of required agents when applicable and follow any applicable state-specific step therapy requirements (for example, Illinois HIM requests require failure of any one MS drug per IL HB 5395 unless contraindicated or clinically significant adverse effects occur).

Prior authorization may be required for all disease modifying therapies for MS
Illinois HIM: failure of any one MS drug (see Appendix B and D) required per IL HB 5395, unless contraindicated or clinically significant adverse effects
All other requests: failure of all listed first-line agents (dimethyl fumarate, teriflunomide, fingolimod, and an interferon-beta agent or glatiramer) at up to maximally indicated doses unless contraindicated or intolerable

Documentation Required

Documentation and Provider Responsibilities

Providers must submit documentation supporting that the member has met all approval criteria. Acceptable documentation includes office chart notes, diagnostic and laboratory results, and other clinical information that justify the requested therapy and demonstrate prior use and failure of required agents when applicable.

Submit office notes and lab results showing diagnosis and prior therapies
Document clinical rationale when prescribing contrary to step therapy (e.g., contraindication, intolerance, or clinically significant adverse effects)
Maintain documentation consistent with professional standards and plan administrative policies

Step Therapy

Step Therapy Requirements

Step therapy requirements apply as specified in the approval criteria. For initial approval of Mavenclad for relapsing‑remitting MS, failure of required first-line disease‑modifying therapies must be documented unless there is a documented contraindication or intolerable adverse effects. Providers should follow state- and plan-specific step therapy rules and note that revisions (e.g., IL HB 5395) may alter step requirements for certain lines of business.

Initial approval generally requires failure of: dimethyl fumarate; teriflunomide; fingolimod; and an interferon‑beta agent or glatiramer, unless contraindicated or intolerant
Illinois HIM requests: revised step therapy to require failure of any one MS drug per IL HB 5395
Document reasons for exceptions (contraindication, intolerance, or clinically significant adverse effects)

Definitions and Key References

CIS — definition

DefinitionClinically isolated syndrome (CIS): a first clinical episode suggestive of demyelination that may represent the first manifestation of multiple sclerosis (abbreviation: CIS).

ContextListed in Appendix A: Abbreviation/Acronym Key as 'CIS: clinically isolated syndrome'.

Policy implicationUse for CIS is explicitly not authorized under this policy (CIS is excluded).

Mavenclad Prescribing Information (EMD Serono, May 2024)

Reference (prescribing information)Mavenclad Prescribing Information. Rockland, MD: EMD Serono, Inc.; May 2024. Available at: https://www.mavenclad.com. Accessed January 24, 2025.

Document typeManufacturer prescribing information (package insert).

Use in policySource for dosing, administration, and product availability details cited in this clinical policy.

AAN guideline (2018, reaffirmed 2024)

Guideline citationRae-Grant A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis. Neurology. 2018;90:777-788. Reaffirmed Oct 19, 2024.

ScopePractice guideline recommendations summary for disease-modifying therapies in MS (AAN guidance).

ReaffirmationGuideline originally published 2018 and reaffirmed on October 19, 2024.

OpenPayer

Cladribine (Mavenclad) for relapsing multiple sclerosis

Coverage Criteria for Cladribine (Mavenclad)

Product Coding and Dosing Details

Prior Authorization, Step Therapy, and Documentation Requirements

Background and Drug Information

Definitions and Key References