ModifiedCentenePolicy CP.PHAR.422

Cladribine (Mavenclad) clinical policy — coverage criteria and prior authorization

Defines Centene's coverage criteria, prior authorization requirements, dosing limits, and exclusions for cladribine (Mavenclad) for treatment of relapsing forms of multiple sclerosis in adults; applies to Commercial, HIM/ICHRA, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyCladribine (Mavenclad) clinical policy

Policy CodePolicy CP.PHAR.422

Change TypeDocumentation removalstep therapy revisionadded indication

Effective Date09.01.19

Next Review Date

Key ActionPrior authorization is required and provider must document prior failures on specified disease-modifying therapies (or per Illinois HIM, failure of one MS drug) and submit supporting clinical documentation.

SourceLink

POLICY UPDATE CHANGES

Requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response were removed.

Revised step therapy to require any one MS drug for IL HIM per IL HB 5395.

Added primary progressive MS to section III to align with other MS agents.

Adults ≥18age requirement for therapy

2 coursesmaximum lifetime treatment courses

12 monthsapproval duration

10 mg

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial Approval - MS: 1) Diagnosis of relapsing-remitting multiple sclerosis or secondary progressive multiple sclerosis; 2) For relapsing-remitting MS: (Illinois HIM requests only: failure of one drug indicated for MS unless contraindicated or intolerant) OR (all other requests: failure of all of the following at up to maximally indicated doses unless contraindicated or intolerant: dimethyl fumarate, teriflunomide, fingolimod, and an interferon-beta agent or glatiramer); 3) Prescribed by or in consultation with a neurologist; 4) Age ≥ 18 years; 5) If request is for Mavenclad, member must use generic cladribine unless contraindicated or clinically significant adverse effects are experienced; 6) Mavenclad is not prescribed concurrently with other disease-modifying therapies for MS; 7) Member has not received Mavenclad in the last 12 months; 8) Member has not previously received ≥ 2 Mavenclad treatment courses total per lifetime; 9) Request is for 1 treatment course; 10) Dose limits: ≤2 tablets/day, ≤10 tablets/cycle, ≤2 cycles/course, ≤1 course/year.

Approval duration: 12 months - up to 1 course (2 courses lifetime total)

Continuation Therapy

Covered when ALL of the following are met:

Continuation Therapy - MS: 1) Member is currently receiving medication via the Centene benefit or previously met initial approval criteria (or has continuity of care per state regulations); 2) Member is responding positively to therapy; 3) If request is for Mavenclad, member must use generic cladribine unless contraindicated or clinically significant adverse effects are experienced; 4) Mavenclad is not prescribed concurrently with other disease-modifying therapies for MS; 5) Member has not received Mavenclad in the last 12 months; 6) Member has not previously received ≥ 2 Mavenclad treatment courses total per lifetime; 7) Request is for 1 treatment course; 8) Dose limits: ≤2 tablets/day, ≤10 tablets/cycle, ≤2 cycles/course, ≤1 course/year.

Approval duration: 12 months - up to 1 course (2 courses lifetime total)

Contraindications and boxed warnings for Mavenclad (cladribine) include current malignancy; pregnancy and failure to use effective contraception during dosing and for 6 months after the last dose in each treatment course; HIV infection; active chronic infections (for example, hepatitis or tuberculosis); history of hypersensitivity to cladribine; and breastfeeding on a Mavenclad treatment day and for 10 days after the last dose. The product carries boxed warnings for malignancies and risk of teratogenicity.

When state Medicaid coverage provisions conflict with this clinical policy, state Medicaid coverage provisions take precedence. Providers and reviewers should consult the applicable state Medicaid manual for any state-specific coverage requirements or differences.

Use of Mavenclad for clinically isolated syndrome (CIS) or primary progressive multiple sclerosis is not authorized under this policy and may be denied; non‑FDA approved indications are also not authorized unless addressed by the applicable off‑label use policies or evidence of coverage documentation.

Product & Coding Information

Product availability / Tablet strengthNDC

10 mg

Tablet strength available (product availability)

Dosing and lifetime limits — Mavenclad (cladribine) — key limits

Maximum tablets per dayDo not administer more than 2 tablets daily.

Maximum tablets per cycleMaximum 10 tablets per cycle (administered as 1–2 tablets once daily over 4–5 consecutive days).

Cycles per courseEach treatment course is divided into 2 treatment cycles (≤2 cycles per course).

Courses per lifetimeMaximum of 2 treatment courses total (do not administer additional Mavenclad during the next 2 years after 2 courses).

Administration spacingSeparate administration from any other oral drug by at least 3 hours; follow cycle scheduling in dosing regimen (see package insert).

Provider Actions & Requirements

Prior Authorization

Prior Authorization and Step Therapy Requirements

Prior authorization is required. For non-Illinois requests, members must have documented failure of all listed disease-modifying therapies (dimethyl fumarate, teriflunomide, fingolimod, and an interferon-beta agent or glatiramer) at up to maximally indicated doses unless clinically significant adverse effects or contraindications exist. For Illinois HIM requests per IL HB 5395, step therapy is revised to require failure of any one MS drug (see Appendix B and D). For brand Mavenclad requests, redirection to the generic product may be applied.

Affected drugs: dimethyl fumarate, teriflunomide, fingolimod, interferon-beta agents (Avonex, Betaseron/Extavia, Rebif, Plegridy) or glatiramer (Copaxone, Glatopa).
Illinois HIM: any one MS drug required per IL HB 5395 (see Appendix B and D).
Brand redirection: brand Mavenclad may be redirected to generic per SDC request.

Documentation Required

Supporting Documentation Required

Providers must submit supporting clinical documentation such as office chart notes, laboratory results, and other relevant clinical information demonstrating the member meets all approval criteria. Note that requirements for baseline relapses/Expanded Disability Status Scale (EDSS) and specific measures of positive response were removed in 2Q 2025.

Background

Cladribine (Mavenclad) is an oral cytotoxic purine antimetabolite indicated for treatment of relapsing forms of multiple sclerosis in adults. The policy targets use in relapsing‑remitting MS and secondary progressive MS under defined criteria, and includes safety precautions and boxed warnings related to malignancy risk and teratogenicity. Because of these risks, the policy specifies contraindications (see boxed warnings and Appendix C) and excludes use for CIS and primary progressive MS unless otherwise supported by off‑label policy provisions.

Definitions

CIS (Clinically Isolated Syndrome) — definition and policy note

DefinitionCIS: clinically isolated syndrome (per Appendix A abbreviation key).

ContextCIS is listed in the policy appendix as the abbreviation for clinically isolated syndrome and is an unauthorized diagnosis for coverage under this policy.

Coverage stanceUse of Mavenclad for clinically isolated syndrome (CIS) is not authorized (not medically necessary) under this policy.

Mavenclad — Prescribing Information (reference)

Prescribing information citationMavenclad Prescribing Information. Rockland, MD: EMD Serono, Inc.; May 2024. Available at: https://www.mavenclad.com. Accessed February 3, 2026.

Use in policy