ModifiedmhnPolicy CP.PHAR.255

Clinical Policy: Interferon Beta-1a (Avonex, Rebif)

Medical necessity and coverage criteria for interferon beta-1a (Avonex, Rebif) for treatment of relapsing forms of multiple sclerosis across specified Centene-affiliated lines of business.

Policy Summary

Payermhn

PolicyInterferon Beta-1a (Avonex, Rebif)

Policy CodePolicy CP.PHAR.255

Change TypeDocumentation relaxation and approval-duration updates

Effective Date09.01.16

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis, neurologist involvement, age criteria, no concurrent DMTs, and dosing within specified limits.

SourceLink

POLICY UPDATE CHANGES

Removed requirements for documentation of baseline relapses/EDSS and specific measures of positive response; modified HIM and Medicaid continued approval duration to 12 months.

For Medicaid and HIM, extended initial approval duration from 6 to 12 months for this maintenance medication for a chronic condition.

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

Made continued therapy more inclusive for members continuing therapy from a different benefit by revising Medicaid/HIM continued approval duration language.

Revised Medicaid/HIM continued approval duration to reference duration of total treatment received rather than number of re-authorizations (historical change noted).

2brands covered (Avonex, Rebif)

12mMedicaid/HIM/ICHRA approval duration

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Commercial approval duration

J1826,Q3027,Q3028HCPCS codes referenced

2Q2026Most recent annual review

Coverage Criteria for Interferon Beta-1a (Avonex, Rebif)

Initial Approval - Multiple Sclerosis

Covered when ALL of the following are met:

Initial Approval - MS: 1) Diagnosis of one of the following: a) Clinically isolated syndrome; b) Relapsing‑remitting MS; c) Secondary progressive MS; 2) Prescribed by or in consultation with a neurologist; 3) Age: a) Rebif: ≥ 2 years; b) Avonex: ≥ 18 years; 4) Interferon beta‑1a is not prescribed concurrently with other disease‑modifying therapies for MS (see Appendix D); 5) Dose does not exceed one of the following: a) Avonex: 30 mcg per week (1 syringe/autoinjector per week); b) Rebif: i) 44 mcg three times per week; ii) 1 syringe/autoinjector three times per week.

See Appendix D for list of other DMTs

Continued Therapy - Multiple Sclerosis

Covered when ALL of the following are met:

Continued Therapy - MS: 1) Member meets one of the following: a) Currently receiving medication via Centene benefit or previously met initial approval criteria; b) Member is currently receiving medication and is enrolled in a state/product with applicable continuity of care regulations; 2) Member is responding positively to therapy; 3) Interferon beta‑1a is not prescribed concurrently with other disease‑modifying therapies for MS (see Appendix D); 4) If request is for a dose increase, new dose does not exceed: a) Avonex: 30 mcg per week (1 syringe/autoinjector per week); b) Rebif: i) 44 mcg three times per week; ii) 1 syringe/autoinjector three times per week.

Approval duration: Medicaid/HIM/ICHRA 12 months; Commercial 6 months or to member renewal date, whichever is longer.

Other Diagnoses/Indications

For uses not covered in Section I/III:

Other Indications: 1) If the drug has had a label change within the last 6 months not yet reflected in this policy, refer to: a) for drugs on formulary/PDL, the no coverage criteria policy for the relevant line of business (CP.CPA.190 commercial; HIM.PA.33 ICHRA; CP.PMN.255 Medicaid) OR b) for drugs NOT on formulary/PDL, the non‑formulary policy for the relevant line of business (CP.CPA.190 commercial; HIM.PA.103 ICHRA; CP.PMN.16 Medicaid); OR 2) If the requested use (diagnosis, age, dosing) is NOT listed under section III and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (CP.CPA.09 commercial; HIM.PA.154 ICHRA; CP.PMN.53 Medicaid).

See policy cross‑references in document.

Coverage is NOT authorized for primary progressive multiple sclerosis under this policy.

When state Medicaid coverage provisions conflict with this clinical policy, state Medicaid provisions take precedence; refer to the applicable state Medicaid manual for specific coverage rules.

Non–FDA approved indications that are not specifically addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety according to the applicable off-label use policy (CP.CPA.09 for commercial, HIM.PA.154 for HIM/ICHRA, CP.PMN.53 for Medicaid) or supporting evidence of coverage.

Coding and Billing Codes

HCPCS Codes (informational)HCPCS

J1826	Injection, interferon beta-1a, 30 mcg.
Q3027	Injection, interferon beta-1a, 1 mcg for intramuscular use.

HCPCS Codes (informational)HCPCS

Q3028

Injection, interferon beta-1a, 1 mcg for subcutaneous use.

HCPCS CodesHCPCSCovered

Q3028

Injection, interferon beta-1a, 1 mcg for subcutaneous use

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for interferon beta-1a (Avonex, Rebif). Requests must include diagnosis, neurologist involvement where applicable, age appropriateness, confirmation that interferon beta-1a will not be used concurrently with other disease-modifying therapies for MS, and dosing consistent with policy limits.

Affected codes: HCPCS Q3028 (where applicable) and drug-specific billing codes.
Diagnosis must be one of: clinically isolated syndrome, relapsing-remitting MS, or secondary progressive MS.
Prescriber: prescribed by or in consultation with a neurologist.
Age limits: Rebif ≥ 2 years; Avonex ≥ 18 years.
Dosing limits: Avonex ≤ 30 mcg/week (1 syringe/autoinjector/week); Rebif ≤ 44 mcg three times/week (1 syringe/autoinjector three times/week).

Prior Authorization

Prior Authorization and Approval Duration

Prior authorization decisions include specified approval durations. Note the updated initial and continued approval durations by line of business.

Background

Interferon beta-1a is an amino acid glycoprotein indicated for relapsing forms of multiple sclerosis (including clinically isolated syndrome, relapsing‑remitting MS, and active secondary progressive MS) and is used as a disease‑modifying therapy to reduce relapse frequency and disease activity.

Key Definitions

Interferon beta-1a (definition)

DefinitionInterferon beta-1a is an amino acid glycoprotein used as a disease-modifying therapy for relapsing forms of multiple sclerosis (includes clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS).

Brand names coveredAvonex, Rebif

Indicated populationAdults with relapsing forms of MS (clinically isolated syndrome, relapsing‑remitting, active secondary progressive).

HCPCS Q3028

HCPCS codeQ3028

DescriptionInjection, interferon beta-1a, 1 mcg for subcutaneous use

Policy Summary

Payermhn

PolicyInterferon Beta-1a (Avonex, Rebif)

Policy CodePolicy CP.PHAR.255

Change TypeDocumentation relaxation and approval-duration updates

Effective Date09.01.16

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis, neurologist involvement, age criteria, no concurrent DMTs, and dosing within specified limits.

SourceLink

On This Page

Approval duration (Continued Therapy): Medicaid/HIM/ICHRA — 12 months; Commercial — 6 months or to member's renewal date, whichever is longer.
2Q2026 update: for Medicaid and HIM, initial approval duration extended from 6 to 12 months for this maintenance medication; ICHRA added to lines of business.

Denial Risk

Concurrent Therapy Restriction

Interferon beta-1a must not be prescribed concurrently with other disease-modifying therapies for MS; requests indicating concurrent DMT use may be denied.

See Appendix D for list of disease-modifying therapies considered concurrent therapies.

Documentation Required

Submission Requirements

Providers must submit supporting documentation with authorization requests to demonstrate the member meets all approval criteria.

Include office chart notes, lab results, and other relevant clinical information.
Documentation should show diagnosis, prescriber/consultation with neurologist, age, dosing, and prior therapy status or continuity when applicable.

Documentation Required

Documentation Changes (2Q2025)

Documentation requirements were relaxed in 2Q2025: baseline relapse counts, Expanded Disability Status Scale (EDSS) scores, and specific measures of positive response are no longer required.

Continued therapy HIM and Medicaid approval duration simplified to 12 months as of 2Q2025.
Providers should still submit clinical information demonstrating continued medical benefit (e.g., clinician assessment of response).

Denial Risk

Denial Triggers

Requests for non‑FDA approved indications or for primary progressive MS are not authorized by this policy unless supported by the applicable off‑label use policy or evidence of coverage documents; such requests may be denied.

Off‑label policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace/ICHRA), CP.PMN.53 (Medicaid).
Primary progressive MS is excluded from coverage under this policy.

Note

Coverage Document and Legal Compliance

This clinical policy is a guide to medical necessity used to assist coverage decisions and benefit administration; it is not a guarantee of payment and is subject to the terms, conditions, exclusions, and limitations of the member's coverage documents and applicable law.

Coverage decisions are subject to the member's evidence of coverage, certificate of coverage, policy, contract of insurance, and state or federal requirements.
The Health Plan may change, amend, or withdraw this policy; providers remain responsible for exercising independent medical judgment.

Note

Provider Reminder

Important reminder about policy development and use: the policy was developed by licensed clinicians using current evidence and is intended as a medical necessity guide; providers retain responsibility for clinical care and decision-making.

The Health Plan makes no representations or accepts liability for external sources used in policy development.
Unauthorized copying or distribution of this policy is prohibited; providers, members, and representatives are bound by contract terms when providing services or submitting claims.

Listed as the HCPCS code for interferon beta-1a in the clinical policy coding section.