CurrentUnitedHealthcarePolicy 2025 P 3013-17

Clinical Pharmacy Programs

Defines UnitedHealthcare's step therapy program requiring trial of Betaseron (interferon β-1b) prior to coverage of Extavia (interferon β-1b) for relapsing forms of multiple sclerosis; includes definitions of adequate trial, treatment failure, continuation allowances, sample/assistance program handling, authorization duration, and administrative notes.

Policy Summary

PayerUnitedHealthcare

PolicyClinical Pharmacy Programs

Policy CodePolicy 2025 P 3013-17

Change TypeAnnual review (no coverage change) / Clarification

Effective DateDec 1, 2025

Next Review Date

Key ActionProviders must submit documentation of prior Betaseron trial (date and duration) or documentation of intolerance/failure to Betaseron for new-to-therapy members; members currently on Extavia per claims history may continue without meeting initial criteria.

SourceLink

POLICY UPDATE CHANGES

Annual review with no changes to coverage criteria noted for 10/2025.

Sample pack and manufacturer assistance language clarified across prior updates.

1Step therapy required (Betaseron prior to Extavia)

12Authorization duration

4Minimum trial duration (weeks)

This step therapy program requires a trial of Betaseron (interferon β-1b) before Extavia (interferon β-1b) will be approved for relapsing forms of multiple sclerosis. For members new to therapy, documentation of the Betaseron trial (date and duration) or documentation of intolerance/failure to Betaseron is required.

An adequate trial is defined as a medication trial lasting a minimum of four weeks. Treatment failure is defined as increase in relapse frequency/severity/sequelae, increase in disability progression (sustained EDSS worsening or routine neurological observation), or MRI evidence of disease activity (new/increased gadolinium-enhancing, T2 hyperintense, or T1 hypointense lesions).

Members currently on Extavia as documented in claims history may continue on their current therapy without meeting the initial step requirement. Authorizations will be issued for 12 months. Extavia is typically excluded from coverage and state mandates, federal requirements, or member benefit plans may affect coverage.

Minimum trial durationminimum of 4 weeks

Authorization duration12 months

What providers must do

Prior Authorization

Prior authorization required per step therapy

Providers must submit documentation of a prior Betaseron (interferon β-1b) trial including the date and duration, or documentation of intolerance or failure to Betaseron for members new to therapy. Members already on Extavia as shown in claims history may continue without meeting initial criteria.

Documentation Required

Sample/assistance program documentation

Document whether the patient received a manufacturer-supplied sample or any assistance from the Novartis Extavia Go Program. Patients established via a manufacturer sample or program assistance are treated as new-to-therapy and must meet initial authorization criteria.

Billing Rule

Authorization duration

Authorizations will be issued for 12 months.

Denial Risk

Default exclusion and state/benefit constraints

Extavia is typically excluded from coverage. Coverage is provided only when step-therapy criteria are met or as required by state mandates, federal regulatory requirements, or the member's benefit plan.

Documentation Required

Clinical failure/ progression evidence

Acceptable evidence of treatment failure includes: increase in relapse frequency, severity, and/or sequelae; sustained disability progression (worsening EDSS score or routine neurological observation); or MRI changes such as increased number or volume of gadolinium-enhancing, T2 hyperintense, or T1 hypointense lesions.

Definitions and references

Adequate trial: A medication trial lasting a minimum of four weeks.

Treatment failure: Increase in relapse frequency, severity and/or sequelae OR increase in disability progression (sustained EDSS worsening or routine neurological observation) OR MRI changes such as increased number or volume of gadolinium-enhancing, T2 hyperintense, and/or T1 hypointense lesions.

Reference	Details
{"text":"Package inserts referenced","status":""},{"text":"Betaseron (July 2023); Extavia (July 2023)","status":""}
{"text":"Clinical reference","status":""},{"text":"Coyle PK. Switching algorithms: from one immunomodulatory agent to another. J Neurol. 2008 Mar;255 Suppl 1:44-50.","status":""}
{"text":"Program and approval dates","status":""},{"text":"Program Number 2025 P 3013-17; P&T approval dates include annual reviews through 10/2025; Effective Date 12/1/2025.","status":""}
{"text":"Step therapy requirement","status":""},{"text":"Requires trial of Betaseron (interferon β-1b) prior to coverage of Extavia (interferon β-1b); adequate trial defined as minimum 4 weeks.","status":""}
{"text":"Treatment failure definition","status":""},{"text":"Increase in relapse frequency/severity/sequelae, or increased disability progression (sustained EDSS worsening or routine neurological observation), or MRI changes (increased gadolinium-enhancing, T2 hyperintense, or T1 hypointense lesions).","status":""}
{"text":"Continuation allowance","status":""},{"text":"Members currently on Extavia as documented in claims history will be allowed to continue their current therapy.","status":""}
{"text":"Sample/assistance program handling","status":""},{"text":"Patients established via manufacturer supplied sample or Extavia Go Program assistance must meet initial authorization criteria as if new to therapy unless claims document ongoing use.","status":""}
{"text":"Authorization duration","status":""},{"text":"Authorizations will be issued for 12 months.","status":""}

Policy update log

2025-12-01revisedLatest

Effective date set to 12/1/2025; policy shows annual reviews with no changes to coverage criteria noted for 10/2025.

10/2025revised

Annual review with no changes to coverage criteria.

10/2024revised

Annual review with no changes to coverage criteria.

10/2023revised

Annual review with no changes to coverage criteria.

10/2022revised

Annual review. Minor updates to exclusion verbiage but no change to clinical intent.

10/2021revised

Annual review. Minor updates to background and criteria but no change to clinical intent.

10/2020revised

Annual review. Minor updates to background and criteria but no change to clinical intent.

clarified

Sample pack and manufacturer assistance language clarified; patients established via manufacturer samples or assistance must meet initial authorization criteria as if new to therapy unless claims document ongoing use.

revised

Program requires trial of Betaseron (minimum 4 weeks) prior to coverage of Extavia; defines treatment failure criteria (relapse increase, disability progression including sustained EDSS worsening, or MRI changes) and allows members currently on Extavia per claims to continue therapy.

6/9/2009 - 10/2025revised

P&T approval history includes multiple approval dates from 6/9/09 through annual reviews up to 10/2025; program number 2025 P 3013-17.

Policy Summary

PayerUnitedHealthcare

PolicyClinical Pharmacy Programs

Policy CodePolicy 2025 P 3013-17

Change TypeAnnual review (no coverage change) / Clarification

Effective DateDec 1, 2025

Next Review Date

SourceLink

On This Page

OpenPayer

Clinical Pharmacy Programs

Summary of changes and headline stats

Extavia coverage criteria

Referenced diagnosis codes

What providers must do

Definitions and references

Policy update log