Cladribine (Mavenclad)

Coverage Summary

Coverage stance: covered_with_criteria for cladribine (Mavenclad) in adults with relapsing forms of multiple sclerosis. Scope: defines medical necessity criteria, prior authorization requirements, dosing limits, contraindications, and coverage exclusions across Commercial, HIM/ICHRA, and Medicaid lines of business. Subject/status: Cladribine (Mavenclad) for relapsing forms of multiple sclerosis — CURRENT policy.

Covered indications: Relapsing-remitting MS and active secondary progressive MS (relapsing forms of MS). Excluded indications: Clinically isolated syndrome (CIS) and Primary progressive MS are not authorized for coverage.

Key thresholds/requirements: Age ≥ 18 years; member must not have received Mavenclad in the last 12 months and must have received <= 2 courses lifetime (policy enforces a 2 courses lifetime limit). Dose/course limits: ≤ 2 tablets/day; ≤ 10 tablets/cycle; ≤ 2 cycles/course; 1 course/year (approval duration: 12 months — up to 1 course).

I. Initial Approval Criteria — Multiple Sclerosis

I. Initial Approval Criteria - Multiple Sclerosis

Must meet ALL of the following:

ALL of the following

Diagnosis (one of)
- Relapsing-remitting MS
- Secondary progressive MS
For relapsing-remitting MS - prior therapy requirement
- For Illinois HIM requests only: Failure of one drug indicated for the treatment of MS (see Appendix B and D), unless clinically significant adverse effects are experienced or all are contraindicated
- For all other requests: Failure of all of the following at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated: Dimethyl fumarate (generic Tecfidera®); Teriflunomide (generic Aubagio®); Fingolimod (Gilenya®); An interferon-beta agent (Avonex®, Betaseron®/Extavia®, Rebif®, or Plegridy®) or glatiramer (Copaxone®, Glatopa®)
Prescribed by or in consultation with a neurologist
Age ≥ 18 years
If request is for Mavenclad (brand), member must use generic cladribine, unless contraindicated or clinically significant adverse effects are experienced
Mavenclad is not prescribed concurrently with other disease modifying therapies for MS (see Appendix D)
Member has not previously received treatment with Mavenclad in the last 12 months
Member has not previously received ≥ 2 Mavenclad treatment courses total per lifetime
Request is for 1 treatment course
Dose limits (all must be met)
- 2 tablets per day
- 10 tablets per cycle
- 2 cycles per course
- 1 course per year

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II. Continued Therapy / Renewal Criteria — Multiple Sclerosis

II. Continued Therapy / Renewal Criteria - Multiple Sclerosis

Must meet ALL of the following:

ALL of the following

Eligibility for continued therapy
- Member currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations
Member is responding positively to therapy
If request is for Mavenclad (brand), member must use generic cladribine, unless contraindicated or clinically significant adverse effects are experienced

II. Initial/Continued Approval — Other Diagnoses / Indications

II. Initial/Continued Approval - Other Diagnoses/Indications

If not listed in approved indications

ANY of the following

If drug label recently changed within last 6 months and policy not updated, follow formulary/no coverage or non-formulary policy as applicable (references: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16)
If requested use is not listed under section III and above does not apply, refer to off-label use policy (CP.CPA.09, HIM.PA.154, CP.PMN.53)

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III. Diagnoses / Indications Not Authorized

III. Diagnoses/Indications Not Authorized

Coverage is NOT authorized for the following:

ANY of the following

Non-FDA approved indications not addressed in this policy unless sufficient documentation exists per off-label use policies
Clinically isolated syndrome (CIS)
Primary progressive MS

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Provider Actions & Prior Authorization Requirements

Documentation Required

Documentation required for PA

Provider must submit supporting documentation demonstrating the member meets all approval criteria. Examples include office chart notes, laboratory results, and other relevant clinical information.

Office notes
Laboratory results
Other clinical information

Step Therapy

Prior therapy requirements

Prior therapy requirements vary by line of business. For Illinois HIM requests: failure of one drug indicated for the treatment of MS (see Appendix B and D), unless clinically significant adverse effects or contraindications. 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, teriflunomide, fingolimod, and an interferon‑beta agent or glatiramer.

Applicable Codes & Therapeutic Alternatives

Relevant drug references and therapeutic alternatives (informational)mixed

No codes listed

Dimethyl fumarate (Tecfidera) — informationalmixed

No codes listed

Teriflunomide (Aubagio) — informationalmixed

No codes listed

Fingolimod (Gilenya) — informationalmixed

No codes listed

Interferon-beta agents (Avonex, Betaseron/Extavia, Rebif, Plegridy) — informationalmixed

No codes listed

Glatiramer (Copaxone, Glatopa) — informationalmixed

No codes listed

Clinical Evidence & Guidance

Primary evidence references include the Mavenclad Prescribing Information, May 2024 (manufacturer PI) and the American Academy of Neurology guideline: AAN disease-modifying therapies guideline (2018; reaffirmed 2024).

Safety profile/context: the PI and policy note Mavenclad is generally recommended only for patients with an inadequate response to or intolerance of an alternate MS drug due to safety concerns; this safety-based positioning informs prior therapy/step therapy expectations in the policy (use after failure or intolerance of other MS DMTs).

Definitions

Definitions provided in the policy: Clinically isolated syndrome (CIS) — term defined as CIS in the abbreviation key and listed among diagnoses/indications not authorized for coverage.

Course definition: A treatment course consists of up to 2 cycles delivered in one year; cumulative dosing guidance per label is 3.5 mg/kg over 2 courses (each course divided into 2 cycles; dosing schedules and tablet counts vary by weight; do not administer more than 2 tablets daily).

Revision History

02.12.25 / 2Q 2025 annual reviewrevised

Administrative/criteria simplification: removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response.

06.25.25revisedLatest

State-specific step therapy change for Illinois HIM: revised step therapy to require any one MS drug for IL HIM per IL HB 5395. (material)

01.13.26revised

Added generic-first redirection for brand requests: for brand Mavenclad requests, added redirection to generic cladribine. (material)