CurrentColorado Rocky Mountain Health PlansPolicy N/A

Mavenclad (cladribine) step therapy

Step therapy program governing prior authorization for Mavenclad (cladribine) for adults with relapsing forms of multiple sclerosis, requiring trial of an alternate disease-modifying therapy prior to coverage; applies to Colorado Rocky Mountain Health Plans members.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyMavenclad (cladribine) step therapy

Policy CodePolicy N/A

Change TypeAdded drug to step listclarified lifetime treatment limit

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain and document trial, dose, and duration of at least one alternative DMT (≥4 weeks) or document contraindication/intolerance before requesting authorization for Mavenclad.

SourceLink

POLICY UPDATE CHANGES

Added Briumvi (ublituximab) as an acceptable prior therapy option.

Clarified the maximum recommended lifetime treatment is two lifetime treatment courses (four treatment cycles).

2 monthsinitial authorization duration per approval

2 coursesmaximum FDA-recommended Mavenclad exposure

1step therapy: prior DMT required

7/1/2025policy effective date

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage criteria for Mavenclad (cladribine)

Initial authorization criteria

Covered when ALL of the following are met:

Relapsing forms of MS authorization: 1) Patient has a diagnosis of a relapsing form of multiple sclerosis (including relapsing-remitting and active secondary progressive disease).

Prior therapy or current Mavenclad use

A: Prior DMT trial: a) Trial and failure (after trial of at least 4 weeks), documented contraindication to, or intolerance of one of the listed disease-modifying therapies for MS with medication, dose, and duration recorded. Listed therapies: Interferon beta-1a; Interferon beta-1b; Glatiramer acetate; Dimethyl fumarate; Teriflunomide; Fingolimod; Siponimod (Mayzent); Natalizumab (Tysabri); Ocrelizumab (Ocrevus); Alemtuzumab (Lemtrada); Ozanimod (Zeposia); Ofatumumab (Kesimpta); Monomethyl fumarate (Bafiertam); Ublituximab (Briumvi).
B: Currently on Mavenclad: b) Patient is currently on Mavenclad AND the patient has not been established solely via receipt of a manufacturer-supplied sample or any EMD Serono–sponsored assistance program; AND the patient has not already received more than the FDA-recommended limit of 2 lifetime treatment courses (4 treatment cycles) of Mavenclad.

Authorization limits: Authorization will be issued for 2 months. Duration of coverage is limited to two authorizations to allow two cumulative treatment courses (4 treatment cycles) of Mavenclad.

Other diagnoses

Other diagnoses: Mavenclad will be approved for other diagnoses as specified by applicable state mandates, federal regulatory requirements, and the member-specific benefit plan; other policies and utilization management programs may apply.

Authorization limits for other diagnoses: Authorization will be issued for 2 months and is limited to two authorizations to allow two cumulative treatment courses (4 treatment cycles) of Mavenclad therapy.

Automated approval exception: Notwithstanding the above, initial or reauthorization may be approved based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic where program rules permit.

Mavenclad is not recommended for use in patients with clinically isolated syndrome (CIS) due to its safety profile and uncertain benefit in this population.

Patients who were "established" on Mavenclad solely through receipt of manufacturer‑supplied free samples or any EMD Serono sponsored assistance program must meet initial authorization criteria as if they were new to therapy; members currently on Mavenclad documented in claims may continue without meeting the new step requirement.

Claims and coding information

Claims/diagnosis codingICD-10

ICD-10

Diagnosis codes used in claims logic may be used for automated approval; specific ICD-10 codes not enumerated in document

Prior DMT trial duration

Required prior DMT trial duration>= 4 weeks

Documentation required for prior DMTMedication name, dose, and duration must be documented

Acceptable alternatives includeInterferon beta-1a, Interferon beta-1b, Glatiramer acetate, Dimethyl fumarate, Teriflunomide, Fingolimod, Siponimod (Mayzent), Natalizumab (Tysabri), Ocrelizumab (Ocrevus), Alemtuzumab (Lemtrada), Ozanimod (Zeposia), Ofatumumab (Kesimpta), Monomethyl fumarate (Bafiertam), Ublituximab (Briumvi)

Prior authorization, step therapy and provider requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for Mavenclad (cladribine). Initial approvals are issued for 2 months. Approvals may be issued up to two times to allow the FDA‑recommended maximum of 2 lifetime treatment courses (4 treatment cycles).

Authorization duration: 2 months per approval
Maximum approvals: Up to 2 authorizations to cover 2 cumulative treatment courses (4 treatment cycles)

Step Therapy

Step therapy requirement

Step therapy applies: Member must have trialed and failed after at least 4 weeks, be intolerant of, or have a contraindication to one listed disease‑modifying therapy (DMT) for MS prior to coverage of Mavenclad.

Required prior DMT trial: one of the following — Interferon β‑1a (Avonex, Rebif, Plegridy), Interferon β‑1b (Betaseron), Glatiramer acetate (Copaxone), Dimethyl fumarate (Tecfidera), Teriflunomide (Aubagio), Fingolimod (Gilenya), Siponimod (Mayzent), Natalizumab (Tysabri), Ocrelizumab (Ocrevus), Alemtuzumab (Lemtrada), Ozanimod (Zeposia), Ofatumumab (Kesimpta), Monomethyl fumarate (Bafiertam), Ublituximab (Briumvi)

Definitions

Relapsing forms of multiple sclerosis

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

Indication for MavencladMavenclad is indicated for treatment of relapsing forms of MS in adults; use generally reserved for patients with inadequate response or intolerance to alternate DMTs due to safety profile.

Treatment course limitsRecommended cumulative dosing is two yearly treatment courses, each divided into two cycles; additional cycles beyond two courses are not to be administered.

Background and indications

Mavenclad (cladribine) is indicated for the treatment of relapsing forms of multiple sclerosis in adults, including relapsing‑remitting and active secondary progressive disease. Because of its safety profile, Mavenclad is generally reserved for patients with inadequate response to or intolerance of alternate disease‑modifying therapies. The recommended cumulative dosing is given as two yearly treatment courses, each split into two treatment cycles, and additional cycles beyond the two courses are not recommended.

Policy revision history

2025-07-01effective_dateLatest

Policy effective date established.

2025-04material_change_added

Added Briumvi (ublituximab) to the enumerated list of disease-modifying therapies that satisfy the prior therapy (step) requirement.

2025-04clarification