ModifiedCentenePolicy CP.PHAR.252

Glatiramer Acetate (Copaxone, Glatopa)

Defines medical necessity, authorization criteria, dosing limits, and coverage exclusions for glatiramer acetate (Copaxone, Glatopa) for members in Centene lines of business (Commercial, HIM, Medicaid). Applies to prescribers and reviewers processing prior authorization requests.

Policy Summary

PayerCentene

PolicyGlatiramer Acetate (Copaxone, Glatopa)

Policy CodePolicy CP.PHAR.252

Change TypeCriteria and operational updates (generic redirection, continued approval duration, safety warning)

Effective DateSep 1, 2016

Next Review Date

Key ActionSubmit prior authorization with clinical documentation showing covered indication, prescriber specialty, age, prior medication history, and dosing; document contraindication to generic glatiramer to request brand Copaxone.

SourceLink

POLICY UPDATE CHANGES

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

Updated Appendix C to include boxed warning for anaphylactic reactions and contraindication to known hypersensitivity to glatiramer acetate or mannitol.

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

Added generic redirection (requirement to use generic glatiramer including Glatopa before brand Copaxone unless contraindicated or adverse effects).

Revised policy/criteria section to also include generic glatiramer.

≥18Minimum age for therapy per policy

6 mo

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Coverage Criteria for Glatiramer Acetate

Initial Therapy (Multiple Sclerosis)

Covered when ALL of the following are met:

Initial MS criteria: 1. Diagnosis of one of the following: clinically isolated syndrome; relapsing‑remitting multiple sclerosis; or secondary progressive multiple sclerosis.; 2. Prescribed by or in consultation with a neurologist; 3. Age ≥ 18 years; 4. If request is for brand Copaxone, member must use generic glatiramer (including Glatopa) unless contraindicated or clinically significant adverse effects are experienced; 5. Glatiramer is not prescribed concurrently with other disease‑modifying therapies for MS; 6. Dose does not exceed one of the following: 20 mg per day OR 40 mg three times per week.

Initial approval duration: Medicaid/HIM 6 months; Commercial 6 months or to the member's renewal date.

Continuation Therapy (Multiple Sclerosis)

Covered when ALL of the following are met:

Continued therapy criteria: 1. Member currently receiving medication via Centene benefit or member has previously met initial approval criteria OR member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. If request is for brand Copaxone, member must use generic glatiramer (including Glatopa) unless contraindicated or clinically significant adverse effects are experienced; 4. Glatiramer is not prescribed concurrently with other disease‑modifying therapies for MS; 5. If request is for a dose increase, the new dose does not exceed one of the following: 20 mg per day OR 40 mg three times per week.

Continued approval duration: Medicaid/HIM 12 months; Commercial 6 months or to the member's renewal date (commercial may vary).

Other Diagnoses/Indications

Covered when ONE of the following is met:

Other indications: 1. If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, follow the formulary/no‑coverage or non‑formulary policy for the relevant line of business (see CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16 as applicable); 2. If the requested use (diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53).

Refer to the listed line‑of‑business policies for coverage determination.

Continued Therapy

Continued therapy approval duration for HIM and Medicaid

Continued therapy duration: Continued approval duration for HIM and Medicaid is 12 months.12 months

This replaces prior wording that referenced total treatment received and re‑authorizations; continued approvals are now a flat 12 months.

Coverage under this policy does not extend to primary progressive MS. Requests for indications that are not FDA‑approved and are not otherwise addressed in this policy require sufficient documentation of efficacy and safety per the applicable off‑label use policy for the member's line of business (see CP.CPA.09, HIM.PA.154, CP.PMN.53).

When reviewing Medicaid requests, note that state Medicaid coverage provisions take precedence over the clinical policy when there is a conflict; reviewers should follow the applicable state Medicaid manual for any differing coverage rules.

Glatiramer must not be used concurrently with other disease‑modifying therapies for MS; concurrent use is listed as not authorized. Requests for the branded product Copaxone require prior documentation of contraindication or clinically significant adverse effects to generic glatiramer (including Glatopa) before brand use is approved. The policy enforces FDA‑approved dosing limits: maximum dosing is 20 mg per day or 40 mg three times per week.

Prior authorization reviewers no longer require documentation of baseline relapses, Expanded Disability Status Scale (EDSS) scores, or specific objective measures of positive response for continued therapy approvals; these prior documentation triggers have been removed. Continued therapy still requires evidence that the member is responding positively to therapy and otherwise meets the continuation criteria in the policy.

Coding and Dosing

HCPCS CodesHCPCS

J1595

Injection, glatiramer acetate, 20 mg

Prior authorization affected codesmixed

affected codes

Codes affected by prior authorization updates (specific CPT/HCPCS/NDC codes not present in these chunks)

Maximum dosing — FDA‑approved dosing regimens

FDA‑approved dosing regimens20 mg subcutaneously once daily (QD) or 40 mg subcutaneously three times weekly (TIW)

Maximum dosing limitDo not exceed 20 mg per day or 40 mg three times per week

Route of administrationSubcutaneous (SC) injection

Indication tied to dosingDosing regimen applies to relapsing forms of multiple sclerosis

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Approval Durations

Prior authorization is required for glatiramer acetate (including brand Copaxone and generics such as Glatopa). Initial approvals are limited to a maximum of 6 months for Medicaid/HIM and 6 months (or to the member's renewal date, whichever is longer) for Commercial. Continued therapy approvals are 12 months for HIM and Medicaid; commercial continued approvals follow standard commercial policy timing.

Medicaid/HIM: 6 months initial approval; continued therapy: 12 months
Commercial: 6 months initial approval or to member renewal date, whichever is longer

Documentation Required

Documentation Requirements

Provider must submit clinical documentation (e.g., office chart notes, lab results, other clinical information) supporting that the member meets all approval criteria. Requests that lack documentation of a covered indication or required supporting clinical documentation will be denied/not medically necessary.

Background

Glatiramer acetate (Copaxone, Glatopa) is a disease‑modifying therapy indicated for relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease in adults. It is administered subcutaneously in FDA‑approved regimens of 20 mg once daily or 40 mg three times weekly. Contraindications include known hypersensitivity to glatiramer acetate or mannitol; anaphylactic reactions are described in the product safety information.

Definitions

Relapsing forms of multiple sclerosis definition

DefinitionRelapsing forms of multiple sclerosis include clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease

PopulationAdults (per FDA indications)

Exclusions notePrimary progressive MS is not a covered indication under this policy unless addressed by off‑label policies