ModifiedCignaPolicy IP0257

Glatiramer Products

Defines medical necessity and coverage criteria for Copaxone, Glatopa, and generic glatiramer acetate for treatment of relapsing forms of multiple sclerosis for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyGlatiramer Products

Policy CodePolicy IP0257

Change TypeModified — coding, continuity criteria, and documentation definition added

Effective DateDec 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization using HCPCS J1595 and supply required documentation including specialist consultation to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

Added a specialist prescribing requirement.

Added criteria for patient currently receiving glatiramer for ≥ 1 year.

Added HCPCS coding table including J1595 (injection, glatiramer acetate, 20 mg).

Added a definition for documentation.

Updated the preferred product multi-source brand language to current standards.

Ocrevus Zunovo was added to the Appendix.

3branded/generic products listed

1 yearapproval duration

J1595HCPCS code listed

Relapsing formsindication limited to

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Coverage Criteria for Glatiramer Products

Initial Therapy (Employer Group)

Covered when ALL of the following are met:

Initial Therapy (Employer): i. Documentation the patient has a relapsing form of multiple sclerosis; ii. Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis; iii. Preferred product criteria is met for the product(s) as listed in the below table(s).approve for 1 year

Examples of relapsing forms include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease.

Continuation Therapy (Employer Group)

Covered when ALL of the following are met:

Continuation Therapy (Employer): i. Documentation the patient has a relapsing form of multiple sclerosis; ii. Patient meets one of: (a) patient experienced a beneficial clinical response when assessed by at least one objective measure (examples: MRI lesion reduction, stabilization on EDSS, NEDA-3/4, relapse reduction, MSFC improvement, etc.) OR (b) patient experienced stabilization, slowed progression, or improvement in at least one symptom (motor function, fatigue, vision, bowel/bladder function, spasticity, walking/gait, or pain/numbness/tingling); iii. Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis.approve for 1 year

Continuation applies when patient has been receiving glatiramer ≥ 1 year.

Initial Therapy (Individual & Family Plans)

Covered when ALL of the following are met:

Initial Therapy (Individual/Family): i. Documentation the patient has a relapsing form of multiple sclerosis; ii. Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis; iii. Preferred product criteria is met for the product(s) as listed in the below table(s).approve for 1 year

Examples of relapsing forms include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease.

Continuation Therapy (Individual & Family)

Covered when ALL of the following are met:

Continuation Therapy (Individual/Family): i. Documentation the patient has a relapsing form of multiple sclerosis; ii. Patient meets one of: (a) patient experienced a beneficial clinical response when assessed by at least one objective measure (examples: MRI lesion reduction, stabilization on EDSS, NEDA-3/4, relapse reduction, MSFC improvement, etc.) OR (b) patient experienced stabilization, slowed progression, or improvement in at least one symptom (motor function, fatigue, vision, bowel/bladder function, spasticity, walking/gait, or pain/numbness/tingling); iii. Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis.approve for 1 year

Continuation applies when patient has been receiving glatiramer ≥ 1 year.

Copaxone / Generic Trial Requirement

Coverage for Copaxone requires prior steps:

Copaxone coverage prerequisite: i. Documented trial of the bioequivalent generic glatiramer acetate; AND ii. Patient cannot take the generic due to a formulation difference in the inactive ingredient(s) (for example, differences in dyes, fillers, preservatives) which, per the prescriber, would result in a significant allergy or serious adverse reaction.document exception to generic-first

Applies to employer and individual plans as stated.

Currently Receiving Glatiramer for ≥ 1 Year

Policy includes new continuation criteria for patients currently receiving glatiramer for ≥ 1 year.

Continuation for current users: Patient has been receiving glatiramer for >= 1 year and meets documentation and specialist prescribing requirements as defined in policy.>=1 year

A specialist prescribing requirement and a definition for documentation were added in the revision.

The policy specifies that concurrent use with other disease‑modifying agents for multiple sclerosis is not covered because these products are not indicated for combination use and additional data are required to demonstrate safety and additive efficacy. Examples of excluded combinations are listed in the policy appendix. This exclusion is operationalized as an experimental/investigational and not‑covered condition and may lead to denial of requests for combination therapy.

The revision updated the policy’s preferred‑product and multi‑source brand language to current standards. Providers should be aware that these changes may reflect plan‑specific preferred‑product or step‑edit behavior described in the policy appendix and criteria tables; follow the plan’s step therapy and product preference guidance when requesting coverage.

Use of glatiramer products for non‑relapsing forms of multiple sclerosis (for example, primary progressive MS) is identified as having unestablished efficacy and is considered not medically necessary/experimental under this policy. Requests to treat non‑relapsing MS with glatiramer agents may be denied per the policy’s conditions‑not‑covered language.

The policy ties medical necessity determinations to the HCPCS billing code. Use of HCPCS J1595 (Injection, glatiramer acetate, 20 mg) without meeting the applicable medical necessity criteria in this policy is explicitly stated as not medically necessary and may result in denial of coverage.

Billing and HCPCS Codes

Considered Medically Necessary HCPCS CodesHCPCSCovered

J1595

Injection, glatiramer acetate, 20 mg

Covered HCPCS CodesHCPCSCovered

J1595

Injection, glatiramer acetate, 20 mg

Provider Responsibilities, Prior Authorization, and Documentation

Prior Authorization

Prior authorization and coding

Prior authorization may be required; coverage applies when medical necessity criteria are met and HCPCS J1595 is the listed billing code for glatiramer acetate 20 mg injection.

Prior Authorization

Prior authorization required for J1595

Prior authorization is required for HCPCS J1595 (Injection, glatiramer acetate, 20 mg) and will be approved only when the policy’s medical necessity criteria are met.

Step Therapy

Generic-first requirement (Copaxone)

For employer and individual plans, a documented trial of the bioequivalent generic glatiramer acetate is required before coverage of Copaxone unless the prescriber documents that a formulation difference in inactive ingredients would cause a significant allergy or serious adverse reaction.

Clinical Background

Multiple sclerosis is a chronic inflammatory, demyelinating autoimmune disease of the central nervous system with heterogeneous clinical courses. Approximately 85–90% of patients present with relapsing disease; glatiramer products are indicated for relapsing forms of MS including clinically isolated syndrome, relapsing‑remitting MS, and active secondary progressive MS. Disability and progression are commonly evaluated using objective measures such as MRI lesion burden and the EDSS.

Key Definitions

Relapsing forms of multiple sclerosis — inv-22

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

ExamplesClinically isolated syndrome; relapsing‑remitting MS; active secondary progressive MS.

Typical onset/epidemiologyApproximately 85%–90% of patients present with a relapsing pattern at onset.

Clinical context noteRelapsing presentations may be characterized further by disease activity (active vs not active) and by worsening vs stable status.

Documentation — inv-23

Definition addedA definition for "documentation" was added to the policy; providers must supply the specified documentation as defined in the policy when requesting coverage or continuation.