CurrentMass General Brigham Health PlanPolicy N/A

Mavenclad (cladribine) coverage and prior authorization

Defines prior authorization, specialty pharmacy routing, and medical necessity criteria for Mavenclad (oral cladribine) for adult members with relapsing-remitting MS or active secondary progressive MS under Mass General Brigham Health Plan.

Policy Summary

PayerMass General Brigham Health Plan

PolicyMavenclad (cladribine) coverage and prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 1, 2019

Next Review DateN/A

Key ActionObtain prior authorization and ensure specialty pharmacy dispensing; approve for one 12-month cycle with one allowable refill for the second-year cycle.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+min age

3prior therapies failed

12 moinitial approval

1second-year refill

Mavenclad (cladribine) Coverage Criteria

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Initial Authorization

Age: Member is at least 18 years of age>= 18
Diagnosis of relapsing-remitting MS (RRMS) or active secondary progressive MS (SPMS)
Active SPMS defined as >= 1 relapse in the past 2 years
Prescriber is a neurologist or neurology consult notes are provided
Prior therapies: Member has had an inadequate response or adverse reaction to THREE of the listed disease-modifying MS agents OR has a contraindication to all disease-modifying agents3 of list
Listed agents include teriflunomide (Aubagio), fingolimod (Gilenya), siponimod (Mayzent), interferon therapies, glatiramer acetate, ocrelizumab (Ocrevus), dimethyl fumarate (Tecfidera), natalizumab (Tysabri)

Care Continuation Exception: Authorization may be granted for members currently receiving treatment with Mavenclad (excludes product obtained as samples or via manufacturer's patient assistance program)

Authorization may be granted for members who are currently receiving treatment with Mavenclad. Requests for continuation should exclude products obtained as samples or provided through a manufacturer's patient assistance program; authorizations will not be issued for doses supplied via those means. Providers should submit documentation showing the member is actively on Mavenclad and that the medication was obtained through regular channels.

Provider Requirements, Prior Authorization, and Fill Routing

Prior Authorization

Prior Authorization and Specialty Fill

Prior authorization is required. Mavenclad is designated specialty and must be filled at a contracted specialty pharmacy. Phone and fax contact for specialty medications: Phone: 877-519-1908; Fax: 855-540-3693. Non-specialty medication contact: Phone: 800-711-4555; Fax: 844-403-1029.

Specialty fill required — contracted specialty pharmacy
Prior authorization required

Step Therapy

Step Therapy Requirement

Member must have an inadequate response or documented adverse reaction to THREE of the listed disease-modifying MS agents prior to approval, unless there is a contraindication to all agents.

Step therapy: failure/intolerance to 3 agents required
Alternately, documented contraindication to all disease-modifying MS agents satisfies this requirement

Documentation Required

Required Documentation

Documentation must be submitted showing: diagnosis, member age (≥ 18 years), prescriber specialty or neurology consult notes, and prior treatment history supporting step therapy or contraindications.

Diagnosis: relapsing-remitting MS (RRMS) or active secondary progressive MS (SPMS)
Age: member is at least 18 years
Prescriber: neurologist or neurology consult notes required
Treatment history: documentation of inadequate response or adverse reaction to three listed agents or contraindication to all agents

Denial Risk

Denial Triggers and Limitations

Authorization may be granted only for members currently receiving Mavenclad (excludes product obtained as samples or via manufacturer's patient assistance program). Requests for new starts that do not meet the criteria may be denied. Approvals are limited to one 12‑month cycle with one allowable refill for the second‑year cycle.

Denial trigger: product obtained as samples or via manufacturer's patient assistance program are excluded from continuation consideration
Approval length: one 12-month cycle with one allowable refill for the second-year cycle

Clinical Background

Cladribine (Mavenclad) is an oral nucleoside inhibitor used in multiple sclerosis. Its therapeutic effect is achieved through cytotoxic action on B and T lymphocytes, producing lymphocyte depletion that modulates disease activity. Mavenclad is FDA-approved for adults with relapsing‑remitting multiple sclerosis (RRMS) and for active secondary progressive MS (active SPMS).

The policy applies to adult members only; under the coverage criteria approval is contingent on meeting the specified clinical requirements (see criteria), including documentation of diagnosis and prescriber specialty. Prior authorization is required and approvals are issued per the limits described in the coverage section.

Key Definitions

Relapsing-remitting MS (RRMS)

DefinitionRelapsing-remitting MS (RRMS) is characterized by clearly defined attacks (relapses or exacerbations) with full or incomplete recovery and minimal disease progression between relapses.

Clinical courseMarked by discrete relapses followed by periods of remission with little or no progression between attacks.

Indication in policyRRMS is an approved diagnosis for Mavenclad coverage when documented by prescriber/neurology notes.

Active secondary progressive MS (Active SPMS)

DefinitionActive secondary progressive MS (active SPMS) is SPMS with at least one relapse in the past two years; SPMS follows an initial relapsing-remitting course with gradual worsening.

Clinical featuresSPMS may include occasional or minor relapses and periods of plateau but shows gradual neurologic worsening over time.

Policy implicationActive SPMS is an approved diagnosis for Mavenclad coverage when documented and meeting the relapse criterion (>=1 relapse in past 2 years).