CurrentUnitedHealthcarePolicy 2025 P 3013-17

Step therapy for Extavia (interferon β-1b)

This document governs UnitedHealthcare's step therapy requirement that members try Betaseron before Extavia for treatment of relapsing forms of multiple sclerosis; it affects prescribers and members seeking coverage for Extavia.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy for Extavia (interferon β-1b)

Policy CodePolicy 2025 P 3013-17

Change TypeNo material change

Effective DateDec 1, 2025

Next Review DateOct 1, 2025

Key ActionObtain prior authorization and document a ≥4-week Betaseron trial with dates and duration or documented intolerance/failure before Extavia will be approved.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moauthorization duration

>=4 wkadequate trial

Stepprogram type

Typically excludedcoverage stance

NCapplicable state

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Initial/Continuation Approval Criteria

Extavia will be approved when at least one of the following criteria is met:

Extavia approval pathways

Continuation of therapy pathway: (1) As continuation of therapy AND (2) Patient has not received a manufacturer supplied sample or other Novartis Extavia Go Program assistance to establish current Extavia use.
Members with current Extavia use documented in claims history are allowed to continue; document dates and duration of prior therapy as applicable.
Sample-established current user with prior failure/intolerance: (i) Patient has received a manufacturer supplied sample or other Novartis Extavia Go Program assistance to establish current Extavia use AND (ii) history of failure following a trial of Betaseron for at least 4 weeks or history of intolerance to Betaseron (document date and duration of trial).>= 4 weeks
Document date and duration of Betaseron trial.
Direct failure/intolerance pathway: History of failure following a trial of Betaseron for at least 4 weeks or history of intolerance to Betaseron (document date and duration of trial).>= 4 weeks
Document date and duration of Betaseron trial.

Policy note: Authorization will be issued for 12 months; state mandates, federal requirements, and member benefit plans may affect coverage. Extavia is typically excluded from coverage; coverage reviews may be required by law or the benefit plan.

This policy notes that Extavia is typically excluded from coverage. Coverage reviews may still occur when required by applicable law or the member's benefit plan, and any state mandates, federal requirements, or specific plan terms may affect whether a coverage review is performed.

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Extavia. Approval is granted when continuation criteria are met, or when there is documented failure of or intolerance to Betaseron (interferon β-1b). Members currently on Extavia as shown in claims history may continue therapy; members new to therapy must meet initial authorization criteria.

Extavia requires prior authorization
Approval when continuation criteria met OR documented Betaseron failure/intolerance

Step Therapy

Betaseron Required Prior to Extavia

Members must try Betaseron (interferon β-1b) for a minimum trial period of at least 4 weeks prior to approval of Extavia, unless there is documented intolerance. Treatment failure is defined as increased relapse frequency/severity, increased disability progression (sustained EDSS worsening or neurologic observation), or MRI evidence of increased lesion activity.

Adequate Betaseron trial = minimum 4 weeks
Treatment failure = clinical relapse increase OR disability progression OR MRI changes

Documentation Required

Provider Documentation Specifics

Document the dates and duration of the Betaseron trial and/or documentation of intolerance. If the member was established on Extavia via manufacturer-provided samples or assistance programs, document that history; such members seeking initial authorization must still meet initial criteria if established only by samples or program assistance.

Record trial start and end dates and total duration of Betaseron therapy
If sample or program-used to establish Extavia use, note that and provide supporting documentation

Denial Risk

Denial Risk for Insufficient Documentation

Failure to document a Betaseron trial of at least 4 weeks, or failure to document intolerance to Betaseron, may result in denial of authorization for Extavia.

Insufficient documentation of ≥ 4-week Betaseron trial = denial risk
Lack of documented intolerance = denial risk

Definitions

inv-10: Adequate trial — a medication trial lasting a minimum of four weeks.

Adequate trial (definition)A medication trial lasting a minimum of four weeks.

Treatment failure — relapsesIncrease in frequency, severity and/or sequelae of relapses.

Treatment failure — disability progressionSustained worsening of Expanded Disability Status Scale (EDSS) score or routine neurological observation indicating increased disability.

Treatment failure — MRI changesMRI evidence such as increased number or volume of gadolinium-enhancing lesions, T2 hyperintense lesions, and/or T1 hypointense lesions.

inv-11: Treatment failure — increase in relapses, sustained worsening of EDSS or routine neurological observation, or MRI changes.

Treatment failure (summary)Increase in relapses, sustained worsening of EDSS or routine neurological observation, or MRI changes (gadolinium-enhancing, T2 hyperintense, or T1 hypointense lesions).

Relapse criteriaIncrease in frequency, severity and/or sequelae of relapses.

Disability progression criteriaSustained worsening of EDSS score or routine neurological observation documenting progression.

Imaging criteriaMRI changes such as increased number or volume of gadolinium-enhancing lesions, T2 hyperintense lesions, and/or T1 hypointense lesions.

Initial Therapy Requirements

Initial therapy requirements

Initial authorization for Extavia for members new to therapy requires meeting step criteria.

Step requirement: Member must have trialed Betaseron (interferon β-1b) for at least 4 weeks unless there is documented intolerance or another approved exception.>= 4 weeks

Document dates and duration of the Betaseron trial; treatment failure is defined as increased relapse frequency/severity, sustained EDSS worsening, or MRI evidence of increased lesions.

Continuation of Extavia

Continuation allowed for members currently on Extavia as documented in claims history; authorization issued for 12 months.

Continuation documented: Member has current Extavia use documented in claims history.

Authorization duration: 12 months. State mandates and member-specific benefit plans may affect coverage.

Step Therapy Requirements

Step	Requirement	Exceptions/Notes
{"text":"1","status":""}\|{"text":"Member must trial Betaseron (interferon β-1b) for at least 4 weeks (adequate trial) with documented failure (increase in relapses, sustained EDSS worsening, or MRI evidence) or documented intolerance before Extavia will be approved.","status":""}\|{"text":"Documentation must include dates and duration of the Betaseron trial; adequate trial defined as ≥ 4 weeks.","status":""}
{"text":"2","status":""}\|{"text":"Continuation pathway: Members currently on Extavia as documented in claims history are allowed to continue without meeting the Betaseron trial requirement.","status":""}\|{"text":"Authorization for continuation is issued for 12 months; document claims history showing current Extavia use.","status":""}
{"text":"3","status":""}\|{"text":"Sample-established user exception: If patient received manufacturer‑supplied samples or assistance that established current Extavia use, initial authorization will be evaluated as if new to therapy and requires documented failure/intolerance to Betaseron after ≥4 weeks.","status":""}\|{"text":"Patients established via manufacturer samples must provide documentation of sample receipt and history of failure/intolerance to Betaseron (dates and duration).","status":""}