Health Net Mavenclad (cladribine) Coverage Update

Coverage Criteria

Initial Therapy

Initial approval — Covered when ALL of the following are met

Initial Therapy Criteria

Prescriber and age: 2) Medication is prescribed by or in consultation with a neurologist; 3) Patient age is >= 18 years.
Prior therapy and step: 4) For some requests (including Illinois HIM requests), failure of or intolerance to other disease‑modifying therapies may be required per Appendices B and D; for Illinois HIM requests failure of one MS‑indicated drug is acceptable unless contraindicated or intolerable (examples: dimethyl fumarate, teriflunomide, fingolimod, interferon‑beta agents, glatiramer acetate).
Concurrent therapy: 5) Mavenclad (cladribine) is not prescribed concurrently with other disease‑modifying therapies for MS (see Appendix D).
Dosing and course limits: 6) Dosing and course limits observed: do not exceed 2 tablets per day; do not exceed 10 tablets per cycle; 2 cycles per course; maximum 1 course per year; approval granted for up to 1 course (2 courses lifetime total).
Dose and course limits per dosing/administration section; cumulative dose over 2 courses = 3.5 mg/kg per prescribing information.

Continuation Therapy

Continuation therapy — Covered when ALL of the following are met

Continuation Therapy Criteria

Concurrent therapy and limits: 3) Mavenclad is not prescribed concurrently with other disease‑modifying therapies for MS; 4) Dosing and course limits continue to be observed: do not exceed 2 tablets per day; do not exceed 10 tablets per cycle; 2 cycles per course; maximum 1 course per year; up to 2 courses lifetime total.
Approval duration: 5) Approval duration for continuation is 12 months.

Use of Mavenclad (cladribine) is not authorized for clinically isolated syndrome (CIS). The medication is contraindicated in patients with a current malignancy, in individuals with HIV infection, and in those with a history of hypersensitivity to cladribine. Mavenclad should not be used in patients with active chronic infections such as hepatitis or tuberculosis, and it is contraindicated for women who are pregnant.

Because of teratogenic risk and other safety concerns, Mavenclad must not be used by women or men of reproductive potential who do not plan to use effective contraception during dosing and for 6 months after the last dose in each treatment course. Women intending to breastfeed should not receive Mavenclad during treatment and for 10 days after the last dose.

Non–FDA‑approved indications and treatments for CIS are not authorized under this policy unless there is sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies (see related off‑label policies). Requests that lack required supporting documentation for an authorized indication or that seek coverage for diagnoses explicitly listed as not authorized (for example, CIS) may be denied.

For Medicaid members, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, the state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for any state‑specific coverage requirements that supersede this policy.

Treatment of clinically isolated syndrome (CIS) and other non‑FDA‑approved indications not addressed in this policy are not authorized unless the request is supported by sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09, HIM.PA.154, CP PMN.53) or other evidence of coverage documents.

Initial Therapy

Initial approval — Covered when ALL of the following are met

Initial Therapy Criteria and Dosing Limits: 1) Diagnosis: relapsing forms of multiple sclerosis (relapsing‑remitting MS or active/relapsing secondary progressive MS). 2) Prescribed by or in consultation with a neurologist. 3) Age >= 18 years. 4) Mavenclad must not be used concurrently with other disease‑modifying therapies for MS. 5) Dosing limits: do not exceed 2 tablets per day; 10 tablets per cycle; 2 cycles per course; 1 course per year; up to 2 courses lifetime (initial approval typically for 1 course). 6) For some requests, documentation of failure or intolerance to other MS disease‑modifying therapies per Appendices B and D may be required (examples include dimethyl fumarate, teriflunomide, fingolimod, interferon‑beta agents, and glatiramer acetate).

Refer to dosing chart for weight‑based tablets per cycle and to prescribing information for cumulative dosing (3.5 mg/kg over 2 courses).

Continuation Therapy

Continuation therapy — Covered when ALL of the following are met

Continuation Therapy Criteria

Concurrent therapy and dosing: 3) Mavenclad is not prescribed concurrently with other disease‑modifying therapies for MS; 4) Ongoing dosing and course limitations apply: do not exceed 2 tablets per day; 10 tablets per cycle; 2 cycles per course; 1 course per year; up to 2 courses lifetime total.
Approval duration: 5) Approval duration for continuation is 12 months.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for Mavenclad (cladribine) and may be required for other disease‑modifying therapies for multiple sclerosis. Providers must request prior authorization and supply the diagnosis and clinical information necessary to determine medical necessity.

Prior authorization may be required for all disease modifying therapies for MS.
Requests for Mavenclad are reviewed under this policy to determine coverage.

Prior Authorization

Prior Authorization for Cladribine (Mavenclad)

Prior authorization specifically governs coverage determinations for cladribine (Mavenclad). Coverage is subject to the policy’s approval criteria (including diagnosis, prior treatment/step requirements, prescriber specialty, age, dosing limits, and limits on concurrent DMT use). Approval duration and lifetime course limits specified in the policy apply.

Mavenclad is not to be prescribed concurrently with other disease‑modifying therapies for MS (see Appendix D).

Step Therapy / Therapeutic Trial Requirements

Step	Required prior therapy	Notes
1	Failure of or intolerance to other disease-modifying therapies for multiple sclerosis as listed in Appendices B and D (examples include dimethyl fumarate [Tecfidera], fingolimod [Gilenya], teriflunomide [Aubagio], interferon‑beta agents, glatiramer acetate).	Some requests require documentation of trial and failure or intolerance to these alternatives prior to approval of cladribine (see Appendices B and D for the full list). Prior authorization may be required for DMTs.

Revision period	Change	Scope / applicability
2Q 2025	Revised step therapy to require documentation of failure of any one MS drug for Illinois HIM in compliance with Illinois HB 5395; removed certain baseline documentation requirements per 2Q 2025 annual review.	Applies to Illinois HIM line of business; reflects statewide legislative requirement (IL HB 5395) and policy-level step therapy revision. See policy Appendices for the list of MS drugs referenced.

Dosing, Codes and Formulation

Body weight-based cycle dosing — tablets per cycle

40 to <50 kg40 mg per cycle — 4 tablets per cycle

50 to <60 kg50 mg per cycle — 5 tablets per cycle

60 to <70 kg60 mg per cycle — 6 tablets per cycle

70 to <80 kg70 mg per cycle — 7 tablets per cycle

80 to <90 kgCycle 1: 80 mg (8 tablets); Cycle 2: 70 mg (7 tablets)

90 to <100 kgCycle 1: 90 mg (9 tablets); Cycle 2: 80 mg (8 tablets)

100 to <110 kg(per dosing chart) — cycle dosing escalates up to 100 mg (10 tablets) for higher weight bands

Quantity Limits and Dosage Constraints

cladribine (Mavenclad) — formulation and dosing summary

FormulationTablet: 10 mg

Per-tablet strength10 mg cladribine per tablet (Mavenclad)

Dosing summaryAdminister cycle dosage as 1 or 2 tablets once daily over 4–5 consecutive days; do not exceed 2 tablets/day or 10 tablets/cycle

Maximum total treatment courses allowed

Maximum total courses2 courses lifetime

Course frequency limitNo more than 1 course per year

Cumulative dose over 2 courses

Site of Care

Note

Site of care — oral administration; home allowed

Mavenclad is an oral medication and may be administered at home; the policy does not specify a site-of-care restriction.

Site of care is listed as 'home' with no additional restrictions in the site-of-care section.

Definitions and Reference Sources

clinically isolated syndrome — definition and coverage note

TermClinically Isolated Syndrome (CIS)

Definition (brief)CIS: a single clinical demyelinating event — listed in appendices as 'CIS: clinically isolated syndrome'

Coverage stanceUse for CIS is not authorized under this policy

Mavenclad Prescribing Information — reference

Manufacturer PI (citation)Mavenclad Prescribing Information. EMD Serono, Inc.; 2024.

UseReferenced as primary source for dosing and safety information for cladribine

Location

Background

Cladribine (Mavenclad) is a purine antimetabolite indicated as a disease‑modifying therapy for relapsing forms of multiple sclerosis in adults. Because of safety concerns (including risks of malignancy and teratogenicity noted in the prescribing information), Mavenclad is generally reserved for patients who meet the policy’s entry criteria and for whom alternative disease‑modifying therapies have been considered or trialed where specified.

Revision History

2025-06policy_revisionLatest

2Q 2025 annual review: removed documentation requirements for baseline relapses/EDSS and specific measures of positive response; removed notation that Extavia is the preferred interferon beta-1b for Medicaid (Extavia no longer available).

2025-02-12references_update

References reviewed and updated; noted beta-1b product for Medicaid no longer available on market (references updated).

2021-02-08

OpenPayer

Cladribine (Mavenclad) coverage

Coverage Criteria

Initial Therapy

Continuation Therapy

Provider Actions and Requirements

Step Therapy / Therapeutic Trial Requirements

Dosing, Codes and Formulation

Quantity Limits and Dosage Constraints

Site of Care

Definitions and Reference Sources

Background

Revision History