CurrentCignaPolicy N/A

Mavenclad (cladribine) — Coverage with Criteria for Relapsing Forms of Multiple Sclerosis

Coverage policy for Mavenclad (cladribine tablets) for treatment of relapsing forms of multiple sclerosis for members of Cigna-administered health benefit plans; establishes prior authorization, prescriber requirements, approved indications, and exclusions.

Policy Summary

PayerCigna

PolicyMavenclad (cladribine) — Coverage with Criteria for Relapsing Forms of Multiple Sclerosis

Policy CodePolicy N/A

Change TypeMaterial coverage and criteria updates (added therapy to Appendixadded exception for highly-active MS)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document relapsing MS diagnosis, prior therapy history or exception criteria, and neurologist/MS specialist involvement.

SourceLink

POLICY UPDATE CHANGES

Ocrevus Zunovo was added to the Appendix of disease-modifying therapies that count toward prior-therapy requirements.

For Initial Therapy, an exception was added allowing approval if the patient has highly-active or aggressive MS meeting one of four specified conditions.

Requirement that patients prescribed Mavenclad be evaluated/prescribed by or in consultation with a neurologist or MS specialist is restated.

1 yearinitial approval duration

≥1 yearrenewal interval

Malignancy/Teratogenicityboxed warnings

Policy Summary

PayerCigna

PolicyMavenclad (cladribine) — Coverage with Criteria for Relapsing Forms of Multiple Sclerosis

Policy CodePolicy N/A

Change TypeMaterial coverage and criteria updates (added therapy to Appendixadded exception for highly-active MS)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document relapsing MS diagnosis, prior therapy history or exception criteria, and neurologist/MS specialist involvement.

SourceLink

On This Page

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Coverage Criteria for Mavenclad (cladribine)

Conditions Not Covered

Not Medically Necessary Uses: Mavenclad is considered not medically necessary for: (1) Clinically Isolated Syndrome; (2) concurrent use with other disease-modifying agents used for multiple sclerosis; (3) non-relapsing forms of multiple sclerosis (e.g., primary progressive MS)

List may not be exhaustive

The policy excludes use of Mavenclad in specific clinical situations where safety or lack of evidence precludes coverage. Clinically isolated syndrome is explicitly excluded because Mavenclad is not recommended for patients with this presentation due to its safety profile. The policy also excludes concurrent use with other disease‑modifying agents for multiple sclerosis; these agents are generally not indicated in combination and additional data are needed to establish safety and added efficacy. Finally, Mavenclad is not covered for non‑relapsing forms of MS (for example, primary progressive multiple sclerosis) because efficacy in non‑relapsing disease has not been established.

Mavenclad is considered not medically necessary for the following: Clinically Isolated Syndrome; concurrent use with other disease‑modifying agents used for multiple sclerosis; and non‑relapsing forms of multiple sclerosis (for example, primary progressive MS).

What Providers Must Do / Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required; approvals are provided for the duration cited in the policy (typically 1 year). Approval requires the medication be prescribed by, or in consultation with, a physician who specializes in the condition being treated (e.g., neurologist).

Prior authorization required for Mavenclad® (cladribine tablets).
Approvals typically for 1 year.
Prescriber requirement: prescribed by or in consultation with a neurologist or physician who specializes in multiple sclerosis.

Step Therapy

Prior Therapy Requirements (Initial Therapy)

For initial therapy, patient must have a relapsing form of multiple sclerosis and meet prior therapy or disease activity criteria. Specifically, approval for initial therapy requires documentation that the patient meets ALL of the following: relapsing MS; meets ONE of the prior-therapy/highly-active disease criteria; and the medication is prescribed by or in consultation with a neurologist or MS specialist.

Initial therapy prior therapy requirements: inadequate efficacy or significant intolerance to two disease-modifying agents used for MS; OR inadequate efficacy or significant intolerance to one of the listed higher-efficacy alternatives (Kesimpta, a natalizumab IV product, Briumvi, Lemtrada, Ocrevus, or Ocrevus Zunovo); OR prior receipt of Mavenclad; OR documented highly-active/aggressive MS (see criteria).

Background on Multiple Sclerosis and Mavenclad

Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central nervous system that most commonly presents in adults as relapsing forms such as relapsing‑remitting MS and active secondary progressive MS. Mavenclad (cladribine) is an oral purine antimetabolite indicated for relapsing forms of MS but is reserved for patients who meet the policy’s prior‑therapy and specialist prescriber requirements because of safety considerations, including a Boxed Warning for increased malignancy risk and teratogenicity. The policy therefore defines covered indications, required documentation, and explicit exclusions to align use with available evidence and safety concerns.

Definitions and Safety Warnings

Relapsing forms of multiple sclerosis — Includes relapsing remitting disease and active secondary progressive disease.

DefinitionRelapsing forms of multiple sclerosis include relapsing‑remitting disease and active secondary progressive disease.

ExamplesRelapsing‑remitting MS; active secondary progressive MS.

Clinical noteMavenclad is indicated for these relapsing forms in adults; it is not recommended for clinically isolated syndrome due to safety concerns.

Boxed Warning

Boxed warningsIncreased risk of malignancy and teratogenicity.

Contraception requirementWomen and men of reproductive potential must use effective contraception during Mavenclad dosing and for 6 months after the last dose in each treatment course.

Documentation Required

Required Clinical Documentation

Required clinical documentation must be submitted with the prior authorization request to support the FDA-approved indication or continuation criteria.

Documentation of diagnosis: evidence patient has a relapsing form of multiple sclerosis (e.g., relapsing remitting or active secondary progressive disease).
Prior therapy history or intolerance: documentation supporting inadequate efficacy or significant intolerance to prior disease-modifying agents, or prior receipt of Mavenclad, or documentation meeting highly-active/aggressive MS criteria.
Objective measures for continuation: if currently receiving Mavenclad ≥1 year, documentation of beneficial clinical response by at least one objective measure (examples include MRI findings, EDSS stabilization, NEDA-3/NEDA-4 criteria, FSIQ-RMS, relapse reduction, walking tests, MSFC).
Specialist involvement: documentation that medication is prescribed by or in consultation with a neurologist or MS specialist.