CurrentPremera BluecrossPolicy 5.01.565

Pharmacotherapy of Multiple Sclerosis (drug-specific coverage criteria)

Defines medical necessity criteria, quantity limits, prescriber and age requirements, benefit management (medical vs pharmacy), documentation and coding for disease-modifying therapies for relapsing forms of multiple sclerosis for Premera Blue Cross plans; contains multiple drug-specific criteria and program/plan-specific variations.

Policy Summary

PayerPremera Bluecross

PolicyPharmacotherapy of Multiple Sclerosis (drug-specific coverage criteria)

Policy CodePolicy 5.01.565

Change TypePeriodic administrative, criteria and product updates (2024-2026)

Effective DateJun 1, 2026

Next Review Date

Key ActionMedications listed in policy require pre-approval by the health plan per the drug-specific criteria and quantity limits; check member formulary and plan-specific section distinctions for applicability.

SourceLink

POLICY UPDATE CHANGES

2026 Update: Reviewed prescribing information for all drugs listed in policy. No changes to policy statements.

2025 Update: Added prescriber and age requirements for multiple products; moved several high-cost drugs to a different policy (5.01.644); updated Section structure and quantity limits.

2024 Updates: Multiple revisions including adding new products (Tascenso ODT, Tyruko, Briumvi), separate Metallic formulary criteria, and removal of certain prior trial requirements for many products in Metallic formulary.

Added generic cladribine to the policy with the same criteria as Mavenclad (cladribine).

06/01/26 formatting update removed references to Section 1/2/3 organization and removed non-formulary exception references.

MultipleDrugs listed/covered with criteria

2Cladribine treatment courses allowed

12Standard initial authorization (months)

NumerousHCPCS code edits over policy lifetime

2026-05-12Most recent review date (approved)

Coverage Summary

This policy (No. 5.01.565) defines drug-specific medical necessity criteria for disease-modifying therapies for relapsing forms of multiple sclerosis (RMS) for Premera Blue Cross plans, including coverage indications, quantity and dose limits, prescriber and age requirements, benefit management distinctions (medical vs pharmacy), documentation and coding requirements. Effective date is 2026-06-01 with last review approved 2026-05-12. The policy includes multiple product-specific criteria and program/plan variations and has been periodically updated (most recently an administrative formatting update in 06/01/26).

Coverage stance: mixed. Standard initial and re-authorization approval durations are up to 12 months (re-authorization generally up to 12 months for all drugs except generic cladribine/Mavenclad, which have special reauthorization limits after two treatment courses).

Key thresholds & quick facts

EDSS requirement (most drugs)Expanded Disability Status Score (EDSS) < 6 for most therapies

EDSS exception (Mayzent)Mayzent (siponimod) requires EDSS < 7

Age limitsKesimpta: age ≥ 18; Generic fingolimod/Gilenya/Tascenso: age ≥ 10

Cladribine treatment coursesGeneric cladribine and Mavenclad limited to 2 treatment courses

Standard initial authorizationInitial approval up to 12 months for all listed drugs

Benefit management (medical vs pharmacy)Avonex, Betaseron, Copaxone, generic glatiramer, Glatopa, Kesimpta, Plegridy, and Rebif managed through both medical and pharmacy benefits; all other medications managed through pharmacy benefit

Concurrent therapy ruleNot to be used concurrently with other MS disease-modifying drugs (applies across products)

Medical-Necessity Criteria

Investigational / Other uses

Investigational when:

Investigational uses: Any use of the medications listed that is outside the product's FDA dosage and administration prescribing information is considered investigational

Coding

HCPCS J-codes / miscellaneous codes listedHCPCS

J1595	Injection, glatiramer acetate, 20 mg (use to report: Glatopa and Copaxone)
J1826	Injection, interferon beta-1a (Avonex), 30 mcg
J1830	Injection interferon beta-1b (Betaseron), 0.25 mg
J3590	Unclassified biologics (use to report: Kesimpta and Plegridy)
Q3027	Injection, interferon beta-1a (Avonex), 1 mcg for intramuscular use
Q3028	Injection, interferon beta-1a (Rebif), 1 mcg for subcutaneous use

HCPCS / J-codes mentioned historically (added/removed/moved)HCPCS

J0202	HCPCS code added previously then removed/moved
J2323	HCPCS code removed/moved
J2329	HCPCS code added historically (coding update 07/01/23)
J2350	HCPCS code added 01/01/18 then removed/moved
Q5134	HCPCS code added then removed/moved (added 04/01/24)
J3590	HCPCS code used for certain therapies; Briumvi and Tyruko and Ocrevus Zunovo referenced in J3590 parenthetical historically
Q3028	HCPCS code added 10/01/22

Provider Actions & Operational Notes

Prior Authorization

Prior authorization required per policy

Medications listed in policy require pre-approval by the health plan per the drug-specific criteria and quantity limits; check the member formulary and plan-specific section distinctions for applicability.

Documentation Required

Documentation to support medical necessity

Submit office visit notes that include the diagnosis, relevant history, physical evaluation, and medication history to demonstrate that medical necessity criteria are met.

Background

This policy provides drug-specific medical necessity criteria for disease-modifying therapies for relapsing forms of multiple sclerosis, specifying Expanded Disability Status Score (EDSS) thresholds (most products require EDSS < 6, with product-specific exceptions such as Mayzent EDSS < 7), prescriber and prior-trial requirements, product-specific dose and quantity limits, benefit management determinations (which agents are managed through medical vs pharmacy benefits), and required documentation to support medical necessity (e.g., office visit notes with diagnosis, history, physical exam, and medication history).

Definition: EDSS — Expanded Disability Status Score: a numeric scale used to quantify disability in multiple sclerosis.

Evidence

Definitions / FAQ

Revision History

06/01/26revisedLatest

06/01/26 formatting update: removed references to Section 1/2/3 organization and removed non-formulary exception references (administrative; not material to clinical policy statements).

05/01/26added

05/01/26 interim review approved April 13, 2026: Added generic cladribine to the policy with the same criteria as Mavenclad (cladribine). (marked material in brief).

03/01/26clarified

Policy Summary

PayerPremera Bluecross

PolicyPharmacotherapy of Multiple Sclerosis (drug-specific coverage criteria)

Policy CodePolicy 5.01.565

Change TypePeriodic administrative, criteria and product updates (2024-2026)

Effective DateJun 1, 2026

Next Review Date

SourceLink

On This Page

Billing Rule

Benefit management (medical vs pharmacy)

Avonex, Betaseron, Copaxone, generic glatiramer, Glatopa, Kesimpta, Plegridy, and Rebif are managed through both the medical and pharmacy benefit; all other medications listed in this policy are managed through the pharmacy benefit.

Step Therapy

Product-specific prior trials required

Certain brand products require trial and inadequate response or intolerance to specified generic equivalents or other agents first. Examples: Aubagio requires prior failure of generic teriflunomide; Tecfidera requires trial of generic dimethyl fumarate; Bafiertam and Vumerity require prior trial of dimethyl fumarate; Ponvory requires trials of generic fingolimod and generic dimethyl fumarate.

Documentation Required

Follow FDA prescribing information

Medications listed are subject to the product's FDA dosage and administration prescribing information; providers must follow those directions.

Prior Authorization

Non-formulary exception authorizations duration

Non-formulary exception review authorizations for all drugs listed may be approved for up to 12 months.

Billing Rule

Site of service review for certain drugs

Site of service review was added for certain infusion/biologic agents (example: Ocrevus effective March 5, 2020) and other agents (e.g., Briumvi, Tyruko) were later added; providers should follow site-of-service requirements and coding in the policy.

J3590

03/01/26 Annual Review approved Feb 9, 2026: No changes to policy statements; clarified quantity limits for multiple listed MS therapies (administrative/clarifying).

01/01/26administrative

01/01/26 interim review approved Dec 22, 2025: Removed reference to Preferred formulary (Formulary ID: 6064; Rx Plan G3) as no longer available; clarified Section 2 applies to plans with the High Cost Low Value (HCLV) drug list and clarified product-specific quantity limits (administrative).

01/01/26clarified

01/01/26 update: Removed reference to Preferred formulary as no longer available (administrative).

2026clarified

2026 Update: Reviewed prescribing information for all drugs listed in policy. No changes to policy statements (non-material).

2025revised

2025 Update: Many administrative and coverage-detail revisions across plan sections — added prescriber requirements to numerous drugs, added age requirements to generic fingolimod/Gilenya/Tascenso ODT and Kesimpta, moved several high-cost drugs to a different policy (5.01.644), and updated section structure and quantity limits. (material change noted).

05/01/25revised

05/01/25 interim reviews and formatting: updated policy section structure (Section 1/2/3) and clarified quantity limits and plan applicability (administrative).

04/01/25clarified

04/01/25 Interim Review: Updated Ponvory coverage to require trial with generic fingolimod and generic dimethyl fumarate first (coverage-detail change; material to Ponvory criteria).

02/01/25revised

02/01/25 Annual Review approved Jan 14, 2025: Removed Extavia from market, clarified non-formulary exception authorization durations up to 12 months, added prescriber requirements to numerous products and added age requirements to fingolimod products and Kesimpta; moved several agents between policies and removed/updated several HCPCS codes (administrative and material coverage-detail changes).

2024revised

2024 Updates: Added new products (Tascenso ODT), Tyruko, Briumvi, Ocrevus Zunovo; added separate Metallic formulary criteria and made multiple changes to prior trial, prescriber, and age requirements across sections (material).

03/01/24 - 04/01/24added

03/01/24–04/01/24 Interim Reviews: Added Tyruko and Briumvi to site-of-service requirements; 04/01/24 added HCPCS code Q5134 (later removed/moved) — administrative coding adjustments.

2023revised

2023 Update: Added generic fingolimod and generic teriflunomide; required trials of generics before brand products in several cases; added Briumvi and updated HCPCS J3590 parenthetical (coverage-detail changes).

2022revised

2022 Update: Added Tascenso ODT (fingolimod) with identical coverage criteria as Gilenya (administrative/coverage addition).

2019-2021 (selected)revised

2019–2021 updates: Added Mavenclad and Mayzent criteria (2019); removed 'first-line' wording (2021); added multiple agents and site-of-service requirements over time (administrative and coverage-detail).

2018 and earlier (history)added

Historical: initial policy creation and periodic annual reviews with additions/removals of agents and coding updates since 2016 (administrative/contextual).