ModifiedUnitedHealthcarePolicy 2025 P 3123-7

Mavenclad® (cladribine) - Step Therapy - UnitedHealthcare Commercial Plansopen_in_new

UnitedHealthcare commercial plan step therapy program requiring trial and failure (or contraindication/intolerance) of at least one listed disease-modifying therapy (DMT) prior to coverage of Mavenclad for relapsing forms of multiple sclerosis; includes exceptions for current users and lifetime treatment limits. Applies to new and continuing members per claims history and plan rules.

Policy Summary

PayerUnitedHealthcare

PolicyMavenclad® (cladribine) - Step Therapy - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 3123-7

Change TypeRevised: lifetime limit clarified; drug list updated; authorization duration set

Effective DateJul 1, 2025

Next Review Date

Key ActionNew-to-therapy members must have trial and failure (>=4 weeks), contraindication, or intolerance to at least one listed DMT documented (medication, dose, duration) prior to approval; authorization issued for 2 months and limited to two authorizations to cover two cumulative treatment courses (4 cycles).

SourceLink

POLICY UPDATE CHANGES

Program effective date set to 7/1/2025 and P&T approvals listed through 4/2025.

Revised criteria to clarify maximum recommended lifetime treatment (2 courses / 4 cycles).

Updated drug list to add Briumvi as an acceptable prior DMT option.

Clarified current user exception excludes those established via manufacturer samples or EMD Serono assistance.

Authorization duration updated to 2 months and limited to two authorizations to cover two cumulative treatment courses (4 cycles).

1Required prior DMT trials

Maximum lifetime treatment courses

4Maximum treatment cycles (lifetime)

2 monthsAuthorization duration (per approval)

Summary of Key Changes

Material changes effective 2025-07-01: added Briumvi (ublituximab) to the list of acceptable prior DMTs; explicitly enforce the FDA-recommended lifetime limit of 2 treatment courses (4 cycles); clarify that patients established via manufacturer samples or EMD Serono assistance do NOT qualify as current users and must meet new-to-therapy criteria; and update authorization duration/limits to 2 months per authorization with a maximum of 2 authorizations to cover the two cumulative courses.

Stats at a glance — required prior DMT trials: 1; maximum lifetime courses: 2; maximum cycles (lifetime): 4; authorization duration (per approval): 2 months.

2025-07-01Program number and effective date included in header.Latest

Program effective date set to 7/1/2025 and P&T approvals listed through 4/2025.

2025-04Revised criteria to clarify maximum recommended lifetime treatment.

Revised criteria to clarify maximum recommended lifetime treatment (2 courses / 4 cycles).

2025-04Added Briumvi (ublituximab) to list of therapies satisfying step requirement.

Updated drug list to add Briumvi as an acceptable prior DMT option.

2025-04Clarified current user exception excludes those established via manufacturer samples or EMD Serono assistance.

Clarified current user exception excludes those established via manufacturer samples or EMD Serono assistance; such patients must meet initial authorization criteria as if new to therapy.

2025-04Authorization duration updated to 2 months and limited to two authorizations to cover two cumulative treatment courses.

Authorization duration updated to 2 months and limited to two authorizations to allow two cumulative treatment courses (4 cycles).

Coverage Criteria for Mavenclad

A. Relapsing Forms of Multiple Sclerosis (MS) - Initial Authorization

Mavenclad will be approved based on both of the following criteria:

ALL of the following

ONE of the following
- Trial and failure (after trial of at least 4 weeks), contraindication, or intolerance to one of the following disease-modifying therapies for MS [document medication used, dose, and duration]: Interferon β-1a (e.g., Avonex, Rebif, Plegridy); Interferon β-1b (e.g., Betaseron); Glatiramer acetate (e.g., Copaxone); Dimethyl fumarate (e.g., Tecfidera); Teriflunomide (e.g., Aubagio); Fingolimod (e.g., Gilenya); Mayzent (siponimod); Tysabri (natalizumab); Ocrevus (ocrelizumab); Lemtrada (alemtuzumab); Zeposia (ozanimod); Kesimpta (ofatumumab); Bafiertam (monomethyl fumarate); Briumvi (ublituximab)>= 4 weeks
  Document medication used, dose, and duration
- OR

Codes Referenced

ICD-10 (diagnosis codes referenced for automated approvals)ICD-10

No codes listed

What Providers Must Do

Prior Authorization

Step therapy prior authorization required

New-to-therapy members must have trial and failure (>=4 weeks), contraindication, or intolerance to at least one listed disease-modifying therapy (DMT) documented prior to approval. Authorization will be issued for 2 months and duration is limited to two authorizations to cover two cumulative treatment courses (4 treatment cycles).

Trial/failure (>=4 weeks) of ≥1 listed DMT required
Authorization issued for 2 months
Limit of two authorizations to cover two cumulative treatment courses (4 cycles)

Documentation Required

Documentation of prior DMT use

Document the medication used, dose, and duration for the required trial/failure of an alternative DMT. Patients claiming current use based solely on manufacturer samples or assistance from an EMD Serono sponsored program must meet initial authorization criteria as if new to therapy.

Clinical Background & Definitions

Background: This step therapy program encourages use of lower-cost, preferred DMT alternatives before covering Mavenclad for relapsing forms of MS in adults. Because of Mavenclad’s safety profile, it is generally reserved for patients with inadequate response to or intolerance of an alternate MS DMT.

Clinical dosing context: the recommended cumulative dosing is two yearly treatment courses, each course consisting of two treatment cycles (second cycle given 23–27 days after the first); additional cycles beyond the two courses are not to be administered and the safety of reinitiating Mavenclad more than 2 years after completing two courses has not been studied.

term	definition
Treatment course
One yearly course of Mavenclad consisting of 2 treatment cycles; two courses equal the FDA-recommended lifetime limit.
Treatment cycle
A treatment cycle within a course; the 2nd cycle is administered 23-27 days after the last dose of the 1st cycle.

Source	Citation
Mavenclad prescribing information
EMD Serono, May 2024
AAN guideline
Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis. Neurology. 2019;92(2):112-112.

Policy Update Details

2025-07-01Program number and effective date included in header.Latest

Program effective date set to 7/1/2025 and P&T approvals listed through 4/2025.

2025-04Revised criteria to clarify maximum recommended lifetime treatment.

Revised criteria to clarify maximum recommended lifetime treatment (2 courses / 4 cycles).

2025-04Added Briumvi (ublituximab) to list of therapies satisfying step requirement.

Quick Reference / Key Action

Actionable items

Effective date2025-07-01

Authorization duration2 months per approval

Required prior DMT trials1 (>=4 weeks)

Lifetime course limit2 courses (4 cycles)

Policy number2025 P 3123-7

Scope summaryUnitedHealthcare commercial plan step therapy program requiring trial and failure (or contraindication/intolerance) of at least one listed DMT prior to coverage of Mavenclad for relapsing forms of multiple sclerosis; includes exceptions for current users and lifetime treatment limits.

Policy Summary

PayerUnitedHealthcare

PolicyMavenclad® (cladribine) - Step Therapy - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 3123-7

Change TypeRevised: lifetime limit clarified; drug list updated; authorization duration set

Effective DateJul 1, 2025

Next Review Date

SourceLink

On This Page

Patient has not received a manufacturer supplied sample at no cost in the prescriber's office, or any form of assistance from an EMD Serono sponsored program (e.g., sample card which can be redeemed at a pharmacy for a free supply of medication) as a means to establish as a current user of Mavenclad

Patients requesting initial authorization who were established on therapy via the receipt of a manufacturer supplied sample at no cost in the prescriber's office or any form of assistance from an EMD Serono sponsored program shall be required to meet initial authorization criteria as if patient were new to therapy.

Patient has not already received the FDA-recommended limit of 2 lifetime treatment courses (4 treatment cycles) of MavencladMaximum lifetime: 2 treatment courses (4 treatment cycles)

Authorization will be issued for 2 months; duration limited to 2 authorizations to allow 2 cumulative treatment courses (4 cycles)

title": "A. Relapsing Forms of Multiple Sclerosis (MS) - Initial Authorization

Allowed Use for Other Diagnoses

B. Other Diagnoses

Mavenclad will be approved for other diagnoses per plan rules

Authorization will be issued for 2 months; duration limited to 2 authorizations to allow 2 cumulative treatment courses (4 cycles). State mandates, federal requirements, and member-specific benefit plan coverage may impact criteria

Surface thresholds

Required trial duration for alternative DMT>= 4 weeks

Maximum lifetime treatment courses2 treatment courses (4 treatment cycles)

Authorization duration (per approval)2 months

Required prior DMT trials1

Document medication, dose, and duration
Manufacturer samples or EMD Serono assistance do not establish current user status; such patients must meet new-to-therapy criteria

Denial Risk

Lifetime treatment limit enforcement

Claims will be denied or not approved if the patient has already received the FDA-recommended limit of 2 lifetime treatment courses (4 treatment cycles) of Mavenclad.

Billing Rule

Automated approval possibility

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic; use of automated approval and re-approval processes varies by program.

Automated approvals may use previous claims/medication history and ICD-10 diagnosis codes

Updated drug list to add Briumvi as an acceptable prior DMT option.

2025-04Clarified current user exception excludes those established via manufacturer samples or EMD Serono assistance.

Clarified that patients established via manufacturer samples or EMD Serono assistance must meet initial authorization criteria as if new to therapy.

2025-04Authorization duration updated to 2 months and limited to two authorizations to cover two cumulative treatment courses.

Authorization will be issued for 2 months and limited to 2 authorizations to allow 2 cumulative treatment courses (4 treatment cycles) of Mavenclad therapy.