ModifiedCentenePolicy CP.PHAR.255

Interferon Beta-1a (Avonex, Rebif)

Covers medical necessity and authorization criteria for interferon beta-1a (Avonex, Rebif) for treatment of relapsing forms of multiple sclerosis for Centene-affiliated health plans across listed lines of business.

Policy Summary

PayerCentene

PolicyInterferon Beta-1a (Avonex, Rebif)

Policy CodePolicy CP.PHAR.255

Change TypeOperational updates to authorization duration and documentation requirements

Effective DateSep 1, 2016

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, prescriber/consultation, age limits, non-concurrent DMT use, and dosing within specified maximums.

SourceLink

POLICY UPDATE CHANGES

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

Modified HIM and Medicaid continued approval duration wording to a flat 12 months.

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

Removed requirements for documentation of baseline relapses/EDSS and specific measures of positive response.

Modified Medicaid/HIM continued approval duration language to a flat '12 months' regardless of total prior treatment duration.

HCPCS code Q3028 specified as injection, interferon beta-1a, 1 mcg for subcutaneous use.

2formulations (Avonex, Rebif)

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covered MS diagnoses

12 moMedicaid/HIM/ICHRA approval

6 moCommercial approval

Q3028HCPCS code listed

Coverage Criteria for Interferon Beta-1a

Initial Therapy

Covered when ALL of the following are met

Initial Approval - Multiple Sclerosis: 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: either (a) Rebif: ≥ 2 years, or (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: (a) Avonex: 30 mcg per week (1 syringe/autoinjector per week), OR (b) Rebif: 44 mcg three times per week (1 syringe/autoinjector three times per week).

See Appendix D for list of DMTs

Continuation Therapy

Covered when ALL of the following are met

Continued Therapy - Multiple Sclerosis: 1. Member meets one of the following: (a) Currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) Currently receiving medication and enrolled in a state/product with 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, the new dose does not exceed: (a) Avonex: 30 mcg per week (1 syringe/autoinjector per week), OR (b) Rebif: 44 mcg three times per week (1 syringe/autoinjector three times per week).

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

Coverage is not authorized for members with a diagnosis of primary progressive multiple sclerosis (primary progressive MS).

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety in accordance with the applicable off‑label use or formulary/non‑formulary policies. Refer to the off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (HIM/ICHRA), and CP.PMN.53 (Medicaid), and to the relevant no‑coverage or non‑formulary policies for the appropriate line of business as described in the policy.

When state Medicaid coverage provisions conflict with this clinical policy, state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for specific coverage requirements.

Explicitly not authorized: primary progressive multiple sclerosis (primary progressive MS) is listed as a diagnosis for which coverage of interferon beta‑1a is not authorized.

Coding and Dosing

HCPCS Codes referencedHCPCS

J1826	Injection, interferon beta-1a, 30 mcg.
Q3027	Injection, interferon beta-1a, 1 mcg for intramuscular use.
Q3028	Injection, interferon beta-1a, 1 mcg for subcutaneous use.

HCPCS CodesHCPCS

Q3028

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

Maximum dosing limits

Avonex maximum dose30 mcg per week (1 syringe/autoinjector per week)

Rebif maximum dose44 mcg three times per week (1 syringe/autoinjector each administration)

Rebif target weekly/monthly dosingTargeted dose achieved TIW (three times weekly) — either 22 mcg or 44 mcg per administration (44 mcg TIW = 132 mcg/week)

HCPCS Q3028 definition

HCPCS Q3028Injection, interferon beta-1a, 1 mcg for subcutaneous use.

Use contextCode describes interferon beta-1a product administered subcutaneously (Rebif formulation).

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for interferon beta-1a (Avonex, Rebif). Requests must include documentation that the member meets all approval criteria, including diagnosis, prescriber/consultation requirements, age criteria, and confirmation that therapy is not concurrent with other MS disease-modifying therapies.

Prescribed by or in consultation with a neurologist is required.
Age limits: Rebif ≥ 2 years; Avonex ≥ 18 years.
Interferon beta-1a must not be used concurrently with other DMTs for MS (see Appendix D).

Prior Authorization

Prior Authorization Duration and LOB Update

Approval durations vary by line of business. For continued therapy, Medicaid, HIM, and ICHRA initial/continued approval has been updated to 12 months. Commercial approval is 6 months or to the member's renewal date, whichever is longer.

Medicaid/HIM/ICHRA: 12 months (initial/continued per 2Q2026 update).

Background

Interferon beta‑1a (Avonex, Rebif) is a disease‑modifying therapy indicated for treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing‑remitting MS, and active secondary progressive MS. Avonex is administered intramuscularly and Rebif is administered subcutaneously three times weekly with an initial titration option for Rebif and possible titration for Avonex to reach the labeled doses.

Definitions and Dosing Notes

Relapsing forms of multiple sclerosis

DefinitionRelapsing forms of multiple sclerosis include clinically isolated syndrome (CIS), relapsing‑remitting MS (RRMS), and active secondary progressive MS (active SPMS).

FDA indication contextAvonex and Rebif are indicated for treatment of patients with relapsing forms of MS, including CIS, RRMS, and active secondary progressive disease.

Clinical relevancePolicy coverage and authorization criteria apply specifically to these relapsing forms of MS; primary progressive MS is excluded.

Titration and dosing

Rebif titrationInitial dose at 20% of prescribed dose three times weekly, increased over 4 weeks to the targeted dose of either 22 mcg or 44 mcg SC TIW.

Avonex titrationMay be titrated starting at 7.5 mcg for the first week, increased by 7.5 mcg each week for 3 weeks until the target of 30 mcg IM weekly is reached.

Policy Summary

PayerCentene

PolicyInterferon Beta-1a (Avonex, Rebif)

Policy CodePolicy CP.PHAR.255

Change TypeOperational updates to authorization duration and documentation requirements

Effective DateSep 1, 2016

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, prescriber/consultation, age limits, non-concurrent DMT use, and dosing within specified maximums.

SourceLink

On This Page

Commercial: 6 months or to member renewal date, whichever is longer.

Denial Risk

Documentation & Diagnosis Requirements — Denial Risk for Incomplete Requests

Documentation and Diagnosis Requirements: Requests lacking required documentation — including a valid diagnosis supported by clinical information, documentation of prescriber or neurologist consultation, age confirmation per product, and evidence that interferon beta-1a is not being used with another DMT — may be denied or returned as incomplete per policy.

Non‑FDA approved indications and primary progressive MS are not authorized unless allowed by applicable off‑label policies or evidence of coverage documents.
Handle incomplete requests per the plan's adjudication procedures.

Documentation Required

Required Clinical Documentation

Required Clinical Documentation: Providers must submit supporting clinical documentation such as office chart notes, laboratory results, or other clinical information demonstrating the member meets all approval criteria (diagnosis, prior history, response to therapy, dosing, prescriber/consultation).

Include office notes and relevant labs or imaging when available.
If requesting a dose increase, document new dose and ensure it does not exceed policy limits.

Documentation Required

Documentation Changes (Operational Update)

Documentation Changes: Per the 2Q2025 annual review, requirements for baseline relapses, Expanded Disability Status Scale (EDSS), and specific measures of positive response were removed. Operational handling of continued therapy durations for HIM/Medicaid was simplified to a 12-month continued approval.

Removed: baseline relapses/EDSS and specific positive response measures (effective 2Q2025).
Continued therapy durations for HIM/Medicaid updated to 12 months (see 2Q2025 and 2Q2026 updates).

Billing Rule

Concurrent Therapy Restriction

Concurrent Therapy Restriction: Interferon beta-1a must not be prescribed concurrently with other disease-modifying therapies for MS. Refer to Appendix D for the list of DMTs to avoid concurrent use.

See Appendix D for comprehensive list of disease-modifying therapies (e.g., glatiramer acetate, interferon beta-1b, fingolimod, ocrelizumab, ofatumumab, etc.).

Step Therapy

Template/Step Therapy Notes

Template and Step Therapy Notes: Template changes were applied to continued therapy and other indications during annual reviews (2Q2022–2Q2026). These updates are administrative and affect how continued therapy and other indications are documented and authorized; providers should follow the current template/criteria when submitting renewals.

Annual template updates were applied to other diagnoses/indications and continued therapy sections.
Providers should follow the most recent criteria and submission templates when requesting continued therapy.

Denial Risk

Denial Risk Related to Coverage Terms

Denial Risk Tied to Coverage Document Terms: Coverage decisions remain subject to the terms, conditions, exclusions, and limitations of the member's specific evidence of coverage. Even if medical necessity criteria are met, benefits are determined by the member's coverage document.

Coverage for off‑label uses requires adherence to the applicable off‑label policies and member's evidence of coverage.
Refer to state-specific addendums and the member's plan documents for continuity of care provisions.

Avonex maintenance30 mcg intramuscular once weekly after titration.

Administration frequencyRebif: subcutaneous three times weekly (TIW); Avonex: intramuscular once weekly.