ModifiedHealth NetPolicy CP.PCH.46

Interferon Beta-1b (Betaseron, Extavia)

Medical necessity and coverage criteria for interferon beta-1b (Betaseron, Extavia) for treatment of relapsing forms of multiple sclerosis and related indications for Health Net lines of business identified in the document.

Policy Summary

PayerHealth Net

PolicyInterferon Beta-1b (Betaseron, Extavia)

Policy CodePolicy CP.PCH.46

Change TypeCriteria revisions and approval-duration wording changes (2Q 2025)

Effective Date03.01.22

Next Review Date

Key ActionSubmit prior authorization with supporting clinical documentation showing member meets approval criteria; note that documentation of baseline relapses/EDSS is no longer required for continued approval.

SourceLink

POLICY UPDATE CHANGES

Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response for continued approval.

Modified HIM continued approval duration language to reference total duration of treatment (changed phrasing to 12 months).

Removed specialist prescribing requirement.

0.25 mg QODmaximum dose per policy

>= 12minimum covered age

6 motypical approval duration

J1830

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billing code referenced

2Q 2025most recent review

Coverage Criteria

Initial Therapy (Multiple Sclerosis)

Covered when ALL of the following are met for Multiple Sclerosis initial therapy

Initial MS criteria: 1) Diagnosis of one of: clinically isolated syndrome OR relapsing-remitting MS OR secondary progressive MS (active).

For Extavia requests, step therapy or documented contraindication/adverse effect to listed agents applies; Illinois HIM requests exempt from step therapy per IL HB 5395 effective 1/1/2026.

Age requirement: 2) Age >= 12 years.

Dose limit: 3) Requested dose does not exceed 0.25 mg (1 vial) every other day.<= 0.25 mg QOD

Concomitant therapy: 4) Interferon beta-1b is not prescribed concurrently with other disease-modifying therapies for MS.

See Appendix D for DMT listing.

Extavia step therapy: 5) If request is for Extavia, prior failure of specified alternative disease-modifying therapies at maximally indicated doses, or documented contraindication/clinically significant adverse effects to those agents, unless exempt per state-specific rules.

Step therapy exceptions for Illinois HIM per IL HB 5395 effective 1/1/2026.

Continuation Therapy

Continued therapy is covered when ALL of the following are met

Continuation eligibility: 1) Member is currently receiving the medication via the Centene benefit OR member previously met initial approval criteria.

Continuity of care considerations apply per state-specific addendums.

Clinical response: 2) Member is responding positively to therapy.

As of 2Q 2025, documentation of baseline relapses/EDSS and specific measures of positive response are no longer required for continued approval.

Concomitant therapy: 3) Interferon beta-1b is not prescribed concurrently with other disease-modifying therapies for MS.

See Appendix D.

Dose change: 4) If request is for a dose increase, the new dose does not exceed 0.25 mg (1 vial) every other day.

Coverage criteria (summary of changes)

Policy coverage criteria were updated in 2Q 2025 and earlier revisions; specific required clinical measures for continued approval were removed and approval duration language modified.

Revised continued approval: Documentation of baseline relapses and expanded disability status score (EDSS) and specific measures of positive response is no longer required for continued approval as of the 2Q 2025 annual review.

Change made per competitor analysis during 2Q 2025 review.

HIM approval duration revision: HIM continued approval duration language was revised to reference total duration of treatment and is represented as 12 months in the current policy.12 months

Revision noted in 2Q 2023 and reaffirmed in 2Q 2025 review.

Removed requirements: Specialist-prescribing requirement was removed (policy separation from prior consolidated policy and November SDC updates).

Refer to policy history for prior policies (CP PHAR.256) and SDC notes.

Primary progressive multiple sclerosis (PPMS) is specifically excluded from coverage under this policy.

Non–FDA approved indications that are not addressed in this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy (see CP.CPA.09 for Commercial and HIM.PA.154 for Health Insurance Marketplace) or other applicable evidence of coverage documents.

Use of interferon beta‑1b for primary progressive MS or for unspecified non‑FDA indications when the provider has not supplied sufficient supporting documentation per the off‑label use policy is considered not authorized.

The HCPCS code J1830 describes Injection interferon beta‑1b, 0.25 mg. This code may be used for Medicare when the drug is administered under the direct supervision of a physician and is not appropriate for situations where the drug is self‑administered.

Inclusion or exclusion of a HCPCS or other code in this policy does not by itself guarantee payment. Providers should be aware that coding guidance may change and that coverage determination can be affected by how a service or drug is coded; follow the most current professional coding guidance when submitting claims.

Coding and Billing

Covered HCPCS/Codes referencedHCPCS

J1830

Injection interferon beta-1b, 0.25 mg

Covered/Referenced HCPCS CodesHCPCS

J1830

Injection interferon beta-1b, 0.25 mg (note: may be used for Medicare when drug administered under direct physician supervision; not for self-administered use)

inv-11: Maximum dose — 0.25 mg every other day

Maximum dose0.25 mg every other day (0.25 mg QOD).

Starting titrationTypically initiated at 0.0625 mg SC every other day and increased over ~6 weeks to 0.25 mg QOD.

Dose unitSubcutaneous (SC) injection; 1 vial = 0.25 mg as referenced in policy.

inv-12: HIM continued approval duration — 12 months

HIM continued approval duration12 months total treatment (HIM continued approval referenced as 12 months).

Effective revisionModified wording made in 2Q 2025 annual review to reference a 12-month HIM continued approval duration.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for interferon beta-1b (Betaseron, Extavia) per payer rules. Requests without required prior authorization may be denied or delayed. Approval durations: Commercial — 6 months or to the member's renewal date, whichever is longer; HIM — typically 6 months (see policy for HIM continuation/total treatment duration rules).

Commercial approval duration: 6 months or to member renewal date, whichever is longer
HIM approval duration: 6 months (refer to continued-therapy language for HIM total treatment duration)

Note

Follow Updated Prior Authorization Rules

Providers must follow current prior authorization rules and any policy updates (for example, specialist-prescribing requirement was removed in a prior revision). When submitting requests, follow the most recent policy criteria and state-specific exceptions (e.g., Illinois HB 5395 changes to step therapy applicability).

Policy revision: specialist-prescribing requirement removed (see policy history)

Background

Interferon beta‑1b (Betaseron, Extavia) is indicated for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing‑remitting MS, and active secondary progressive MS in adults. Interferon products have demonstrated efficacy in decreasing risk of conversion to MS for clinically isolated syndrome; see policy criteria for covered indications and required documentation.

Definitions

inv-22: Relapsing forms of MS — Relapsing forms include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease

DefinitionRelapsing forms of MS include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

ScopeApplies to adult patients for whom interferon beta-1b (Betaseron, Extavia) is indicated per FDA labeling.

Exclusion notePrimary progressive MS is excluded from coverage under this policy (see exclusions).

inv-23: Interferon Beta-1b — Definition/identification of the agent

Agent identificationInterferon beta-1b (Betaseron, Extavia).

Indications (per FDA/labeling)Indicated for treatment of patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Revision History

2025-02-11annual_reviewLatest

2Q 2025 annual review: removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response for continued approval; modified HIM continued approval duration language to reference 12 months total treatment; references reviewed and updated.

2023-01-30annual_review

2Q 2023 annual review: revised HIM continued approval duration wording to reference duration of total treatment received rather than number of re-authorizations; references reviewed and updated.

2022-09-29template_update

Policy Summary

PayerHealth Net

PolicyInterferon Beta-1b (Betaseron, Extavia)

Policy CodePolicy CP.PCH.46

Change TypeCriteria revisions and approval-duration wording changes (2Q 2025)

Effective Date03.01.22

Next Review Date

SourceLink

On This Page

Approval duration: 5) Approval duration varies by line of business (Commercial: typically 6 months or to member renewal date, whichever is longer; HIM: 12 months).HIM 12 months; Commercial 6 months

HIM continued approval references total duration of treatment as specified in policy updates.

Review dateChange documented in policy 2Q 2025 (references reviewed 02.11.25; P&T Approval Date 05.25).

State-specific note: Illinois step therapy exceptions effective per IL HB 5395

Documentation Required

Submit clinical documentation to support that the member meets all approval criteria. Acceptable documentation includes office chart notes, laboratory results, and other clinical information. Failure to provide supporting documentation may result in denial of the request.

Examples: office chart notes, lab results, relevant clinical test results
Note: Recent revisions removed requirements for baseline relapse counts and expanded disability status score documentation for continued therapy

Billing Rule

Coding and Billing Guidance

Coding guidance: J1830 may be used to report interferon beta-1b 0.25 mg when the drug is administered under direct physician supervision (not for self-administered drugs). Inclusion or exclusion of codes in this policy does not guarantee coverage — providers should reference up-to-date professional coding guidance when submitting claims.

Example code: J1830 — Injection, interferon beta-1b, 0.25 mg (note limitations for self-administration)
Inclusion/exclusion of codes here is informational only; verify current coding rules prior to claim submission

Denial Risk

Coding-related Denial Risk

Claims may be subject to denial or payment issues if incorrect coding is used. Inclusion of codes in this policy is informational and does not guarantee coverage or correct reimbursement. Always verify coding with current payer and professional coding resources before claim submission.

Incorrect coding can affect claim processing and payment
Refer to most up-to-date coding guidance and payer-specific billing rules

Step Therapy

Step Therapy for Extavia (when applicable)

Step therapy: For Extavia requests, step therapy requirements may apply — generally requiring failure, intolerance, or contraindication to specified alternative disease-modifying therapies at maximally tolerated doses. State-specific exceptions (e.g., Illinois HIM) may remove step therapy requirements per statute.

Extavia step therapy: failure of listed alternatives (e.g., dimethyl fumarate, fingolimod, teriflunomide, interferon-beta/glatiramer as specified) at maximally indicated doses unless contraindicated or not tolerated
Illinois HIM: step therapy requirements do not apply as of effective date per IL HB 5395

Denial Risk

Failure to Provide Required Documentation May Result in Denial

Providers should ensure documentation supports prior authorization criteria and coding submitted. Failure to submit required clinical documentation (office notes, labs, other clinical information) may result in denial. Stay current with policy changes that affect required documentation and approval durations.

Required documentation supports member meets approval criteria and helps avoid denials
Recent policy changes removed some specific documentation requirements for continued therapy; check effective dates and revision history

Dosage examplesTypical maintenance dose: 0.25 mg SC every other day; titration from 0.0625 mg SC QOD over ~6 weeks noted in dosing guidance.

Template changes applied to other diagnoses/indications and continued therapy section.

2021-11-30administrative_change_removed

Per November SDC, specialist-prescribing requirement was removed when policy was separated from CP PHAR.256 (policy creation/separation activity noted in late 2021).