CurrentUnitedHealthcarePolicy 2025 P 3013-17

Step therapy for Extavia (interferon β-1b)

Defines UnitedHealthcare's step therapy requirement that members must try Betaseron (interferon β-1b) before coverage of Extavia (interferon β-1b), and documents continuation and authorization rules for members and providers.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy for Extavia (interferon β-1b)

Policy CodePolicy 2025 P 3013-17

Change TypeNo material changes

Effective Date12/1/2025

Next Review Date

Key ActionObtain prior authorization and document a ≥4‑week trial of Betaseron (or evidence of current Extavia use) to support approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

4 weeksadequate trial

1step required

typically excludedcoverage note

Coverage Criteria for Extavia (interferon β-1b)

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Approval pathways: Approval granted if ANY of the following pathways are met:

Continuation of therapy as a current user of Extavia as documented in claims history.

See manufacturer sample/assistance rules to establish current user status (chunks 2-3).

Sample-established current user with documented Betaseron failure/intolerance: Patient received a manufacturer-supplied sample or assistance from the Novartis Extavia Go Program to establish current Extavia use AND has history of failure or intolerance to Betaseron after a trial of at least 4 weeks (document dates and duration).>= 4 weeks

Patients started via manufacturer sample must still have documented failure/intolerance to Betaseron to qualify (chunks 3-4).

Documented Betaseron failure/intolerance: History of failure following a trial of Betaseron for at least 4 weeks or history of intolerance to Betaseron (interferon beta-1b); document date and duration of trial.>= 4 weeks

Applicable for members new to therapy (chunk 5).

Provider Actions — Prior Auth, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for Extavia; approvals are issued for 12 months. Authorization is granted for continuation of therapy or when step-therapy and documentation requirements are met.

Approval duration: 12 months
Prior authorization required

Step Therapy

Step Therapy Requirement

Members new to therapy must try Betaseron (interferon beta-1b) before Extavia. An adequate trial is defined as a minimum of 4 weeks. Exceptions include members documented as current Extavia users in claims history or those meeting continuation criteria.

Adequate trial = minimum 4 weeks
Preferred first-step: Betaseron
Current Extavia users in claims history may continue without step

Documentation Required

Required Documentation

Document the date and duration of the Betaseron trial when requesting authorization for Extavia. If the patient was established on Extavia by receipt of manufacturer samples or assistance programs, they are treated as new to therapy unless continuation criteria are met.

Document: date and duration of Betaseron trial
Sample-established users are considered new unless continuation criteria met

Denial Risk

Denial Risk for Missing Step or Documentation

Failure to document a Betaseron trial of at least 4 weeks, or lack of documentation of intolerance or treatment failure to Betaseron, may result in denial of the request. Also, patients established on Extavia via free samples who do not meet continuation criteria are subject to initial authorization requirements and potential denial if step therapy/documentation is missing.

Denial risk if Betaseron trial < 4 weeks or undocumented
Denial risk if no history of intolerance or treatment failure documented
Sample-established Extavia users treated as new — missing documentation may lead to denial

Background

Betaseron and Extavia (both interferon β-1b) are indicated for relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease. Step therapy using Betaseron as the preferred initial option is intended to encourage use of a lower‑cost alternative; an adequate trial is defined as a minimum of 4 weeks, and treatment failure may be demonstrated by increased relapse frequency or severity, sustained worsening of disability (EDSS or neurological exam), or new/enlarging MRI lesions.

Definitions

inv-09: Adequate trial definition — minimum of four weeks

DefinitionAdequate trial: a medication trial lasting a minimum of four weeks.

Policy applicationApplies to members new to therapy who must trial Betaseron before Extavia

Continuation exceptionMembers currently on Extavia per claims may continue without meeting new-to-therapy trial requirement

inv-10: Treatment failure — increase in relapse frequency/severity or sustained EDSS worsening / other criteria

Primary clinical indicators of treatment failureIncrease in relapse frequency, severity and/or sequelae

Disability progressionSustained worsening of EDSS score or routine neurological observation indicating increased disability

MRI evidenceNew or increased gadolinium-enhancing lesions, increased T2 hyperintense lesions, or T1 hypointense lesions

Most actionable failure definitionTreatment failure is met by any of: increased relapse frequency/severity, sustained EDSS worsening, or MRI evidence of disease activity (use to document failure after >=4-week Betaseron trial)

Initial Therapy Criteria

Initial therapy — authorization requirements for members new to therapy

Initial authorization requirements for members new to therapy

New to therapy requirement: Members new to therapy must trial Betaseron (interferon β-1b) for a minimum of 4 weeks and have documented failure or intolerance to Betaseron to qualify for Extavia; document dates and duration of the trial.>= 4 weeks

Adequate trial defined as minimum 4 weeks (chunk 1).

Documentation pathways: Provide either: (a) documentation of failure/intolerance to Betaseron after >=4 weeks, OR (b) documentation that patient received manufacturer sample/assistance AND documentation of failure/intolerance to Betaseron after >=4 weeks.>= 4 weeks

Patients who were established on therapy only by receipt of manufacturer samples are treated as new to therapy unless documentation establishes current use (chunks 2-4).

Continuation of Therapy Criteria

Continuation of therapy — rules for members currently on Extavia

Continuation of therapy rules for members currently on Extavia

Continuation: Approval when used as continuation of therapy for members documented in claims history as current Extavia users.

Members currently on Extavia as documented in claims history will be allowed to continue (chunk 1).

Establishing current user status: Current user status may be established by claims history OR receipt of manufacturer-supplied sample/assistance from the Novartis Extavia Go Program; however, patients initially started solely via manufacturer sample must meet initial authorization criteria unless documentation establishes ongoing use.

See sample/assistance program details (chunks 2-3).

Step Therapy Requirement

Step	Requirement	Adequate trial	Continuation for current users
1
Members new to therapy must trial Betaseron (interferon β-1b) prior to coverage of Extavia (interferon β-1b). Approval of Extavia requires documentation of failure or intolerance to Betaseron after the trial.
>= 4 weeks (minimum trial)
Members currently on Extavia as documented in claims history will be allowed to continue on their current therapy (continuation authorized).

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy for Extavia (interferon β-1b)

Policy CodePolicy 2025 P 3013-17

Change TypeNo material changes

Effective Date12/1/2025

Next Review Date

Key ActionObtain prior authorization and document a ≥4‑week trial of Betaseron (or evidence of current Extavia use) to support approval.

SourceLink

On This Page

OpenPayer

Step therapy for Extavia (interferon β-1b)

Coverage Criteria for Extavia (interferon β-1b)

Coding and Trial Duration Definitions

Provider Actions — Prior Auth, Documentation, and Step Therapy

Background

Definitions

Initial Therapy Criteria

Continuation of Therapy Criteria

Step Therapy Requirement