CurrentUnitedHealthcarePolicy N/A

Multiple Sclerosis agents — prior authorization/notification program

Defines UnitedHealthcare's prior authorization/notification requirements and coverage stance for multiple sclerosis (MS) disease-modifying therapies for affected members and providers.

Policy Summary

PayerUnitedHealthcare

PolicyMultiple Sclerosis agents — prior authorization/notification program

Policy CodePolicy N/A

Change TypeNo material change

Effective Date8/1/2025

Next Review DateN/A

Key ActionSubmit prior authorization/notification with an MS diagnosis to request approval (approved for 12 months).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~20MS drugs listed

12 moAuthorization duration

2025-08-01Effective

2016-2025P&T approval range

Coverage Criteria

Initial Authorization

Policy Summary

PayerUnitedHealthcare

PolicyMultiple Sclerosis agents — prior authorization/notification program

Policy CodePolicy N/A

Change TypeNo material change

Effective Date8/1/2025

Next Review DateN/A

Key ActionSubmit prior authorization/notification with an MS diagnosis to request approval (approved for 12 months).

SourceLink

On This Page

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This policy applies to disease‑modifying therapies for relapsing forms of multiple sclerosis and defines UnitedHealthcare’s coverage stance for products included in the program. Prior authorization/notification is required for the agents listed in the program, and approval is contingent on a documented diagnosis of multiple sclerosis (MS). Authorizations are issued for 12 months, and state mandates, federal requirements, or the member’s benefit plan may affect coverage decisions.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Requests for the listed disease‑modifying therapies will require prior authorization. Approval is contingent on documentation that the member has a diagnosis of multiple sclerosis (MS). Authorization is typically issued for 12 months. State mandates, federal requirements, and the member's specific benefit plan may affect requirements and coverage.

Affected products include: Aubagio, Avonex, Bafiertam, Betaseron, Copaxone, dimethyl fumarate (Tecfidera), Extavia, fingolimod (Gilenya), Glatopa, glatiramer acetate, Kesimpta, Mayzent, Plegridy, Ponvory, Rebif, Tascenso ODT, teriflunomide, Vumerity.

Step Therapy

Step Therapy and Supply Limits

Supply limits and/or step therapy requirements may apply depending on the member's benefit plan. Prior authorization determinations may incorporate these utilization management rules; confirm plan‑specific constraints when submitting requests.

Supply limits and/or step therapy may be enforced per benefit plan.
Check member benefit details for any plan‑specific quantity limits or required prior therapies.

Documentation Required

Supporting Documentation and Automated Review

Supporting documentation may be requested and UnitedHealthcare may use automated review based on prior claims, medication history, and diagnosis codes (ICD‑10). Provide relevant clinical records, prior treatment history, and ICD‑10 diagnosis codes to facilitate timely review.

Submit documentation of MS diagnosis (see Diagnosis Requirement).
Include prior medication/claim history when available to support initial or reauthorization requests.

Denial Risk

Diagnosis Requirement

Diagnosis Requirement — Requests that do not document a diagnosis of multiple sclerosis (MS) may not meet authorization criteria and can be denied. Ensure the submitted clinical information clearly states the MS diagnosis and relevant diagnostic evidence.

A clear MS diagnosis (ICD‑10 code) must be included with the authorization request.
If available, include supporting clinical evidence (neurology notes, MRI reports, EMG/evoked potentials) to corroborate the diagnosis.

Initial Therapy Criteria

Initial Therapy

Initial coverage criteria

Initial therapy: Prescribed drug is included in the program list AND the patient has a diagnosis of relapsing forms of MS as described in product labeling (including clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease).

Follow product labeling for age-specific indications (e.g., fingolimod/Gilenya and Tascenso ODT indications for patients 10 years and older) and any required first-dose monitoring per labeling.

Step Therapy & Quantity Limits

Program rule	Details
Step therapy may be applied	Supply limits and/or step therapy may be in place; exact step details depend on the member's benefit plan and program rules.
Authorization based on prior history	UnitedHealthcare may approve initial and reauthorization requests based solely on previous claim/medication history, diagnosis codes (ICD‑10), and/or claim logic (automated approval processes vary by program).
Plan-dependent limits	Supply limits and specific step requirements are determined by the member's benefit plan and are not specified in this document.

Site of Care & Monitoring

Note

First‑dose observation for fingolimod (Gilenya/Tascenso ODT)

Per product labeling, first‑dose observation is required for fingolimod (Gilenya/Tascenso ODT): monitor for bradycardia/AV conduction for at least 6 hours after the first dose and when restarting after >14 days or with dose increases.

Observation applies in office or infusion center settings per labeling.
Manufacturer program (GILENYA First‑Dose Observation) is available to support monitoring.

Definitions

Relapsing forms of MS — definition list

DefinitionRelapsing forms of multiple sclerosis: includes clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease as used in product indications.

Included agents' indication noteSeveral Disease‑modifying therapies listed in this policy (e.g., Avonex, Rebif, Betaseron/Extavia, Plegridy, Copaxone/Glatopa, Aubagio, Mayzent, Tecfidera, Bafiertam, Kesimpta, Ponvory, Vumerity, Gilenya/Tascenso ODT) are indicated for treatment of relapsing forms of MS.

Pediatric indication (fingolimod)Gilenya (fingolimod) and Tascenso ODT (fingolimod) are indicated for treatment of relapsing forms of MS in patients 10 years of age and older.

Scope for coverage decisionsPolicy coverage and authorization for listed agents apply when the diagnosis is relapsing forms of MS per product labeling.

Source contextWording derived from product indications summarized in the policy background stating inclusion of clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease.

First‑dose observation (fingolimod/Gilenya)

DefinitionFirst‑dose observation: monitoring for bradycardia and atrioventricular (AV) conduction for at least 6 hours after the first dose of fingolimod (Gilenya) or when restarting after >14 days or with dose increases.

RationaleGilenya can cause a decrease in heart rate and/or AV conduction after the first dose; monitoring is required per product labeling.

Manufacturer programNovartis provides a First‑Dose Observation program for GILENYA at no cost to the patient through the GILENYA Go Program, per the labeling note.

Site of care implicationFirst‑dose observation may be performed in an appropriate monitored setting (e.g., office or infusion center) consistent with product labeling and program resources.

Background

Numerous disease‑modifying therapies are indicated for relapsing forms of multiple sclerosis, including injectable interferons and glatiramer acetate products, oral agents (e.g., fingolimod, teriflunomide, dimethyl/diroximel fumarate, siponimod, ponesimod), and monoclonal antibodies (e.g., ofatumumab/Kesimpta). Some products have pediatric indications and product‑specific safety requirements; for example, fingolimod (Gilenya/Tascenso ODT) labeling requires first‑dose observation for monitoring of bradycardia/AV conduction. Certain agents (e.g., Mavenclad, Zeposia) may be managed under separate product‑specific programs.

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