CurrentCignaPolicy N/A

Multiple Sclerosis (Injectable) - Glatiramer Products Prior Authorization Policy

Prior authorization requirements for coverage of injectable glatiramer products (Copaxone, Glatopa, and generic glatiramer acetate) for treatment of relapsing forms of multiple sclerosis under Cigna benefit plans.

Policy Summary

PayerCigna

PolicyMultiple Sclerosis (Injectable) - Glatiramer Products Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation showing the patient meets criteria and that medication is prescribed by or in consultation with a neurologist or MS specialist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearapproval duration for initial or continuing therapy

relapsing formsindication covered

NMNconcurrent use excluded

requiredspecialist prescribing

Coverage Criteria for Glatiramer Acetate

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FDA-Approved Indication

Covered when ONE of the following is met

Main approval paths: Either A) Initial Therapy OR B) Continuing Therapy for current users

A) Initial Therapy (approve 1 year): i) Patient has a relapsing form of multiple sclerosis; AND ii) Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis

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

B) Patient currently receiving glatiramer ≥ 1 year (approve 1 year): i) Patient has a relapsing form of multiple sclerosis; AND ii) Patient meets ONE of the following: a) experienced a beneficial clinical response when assessed by at least one objective measure (examples provided) OR b) experienced stabilization, slowed progression, or improvement in at least one symptom such as motor function, fatigue, vision, bowel/bladder function, spasticity, walking/gait, or pain/numbness/tingling sensation; AND iii) Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis

Objective measure examples: MRI (absence/decrease in gadolinium-enhancing lesions or new/enlarging T2 lesions), EDSS stabilization or reduced worsening, NEDA-3/NEDA-4, MSFC, 6-minute walk, 12-item MS Walking Scale, FSIQ-RMS, reduction/absence of relapses, attenuation of brain volume loss

Concurrent administration of glatiramer acetate products with other disease-modifying agents for multiple sclerosis is considered not medically necessary. The policy specifies that these agents are not indicated for combination use and that additional data are required to determine safety and additive efficacy. In addition, use of Copaxone, Glatopa, or generic glatiramer acetate for non-relapsing forms of multiple sclerosis (for example, primary progressive MS) is not covered because efficacy has not been established for these populations.

Use of glatiramer acetate in combination with other disease-modifying multiple sclerosis agents is explicitly listed as not medically necessary; the policy notes that these therapies are not indicated for combination and cites the need for additional data to support safety and benefit. The policy also excludes glatiramer acetate for non-relapsing forms of MS, stating that efficacy has not been established in those cases (primary progressive MS is listed as an example).

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required for Copaxone and Glatopa (all strengths). Initial and continuation approvals are provided for 1 year when criteria are met. Because of the specialized skills required for evaluation, Copaxone/Glatopa must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis.

Applies to: Copaxone® (glatiramer acetate injection 20 mg/mL and 40 mg/mL) and Glatopa® (glatiramer acetate injection 20 mg/mL and 40 mg/mL).
All approvals (initial and continuation) are for 1 year when criteria are met.

Documentation Required

Required Documentation

Providers must submit documentation that demonstrates the patient meets the applicable benefit plan criteria and the policy’s medical necessity criteria. Documentation should include evidence of the covered diagnosis (relapsing form of multiple sclerosis), documentation of prior benefit plan determinations where applicable, and objective measures of clinical response or stability when requesting continuation therapy.

Required clinical documentation: diagnosis supporting relapsing form of MS (examples: clinically isolated syndrome, relapsing–remitting MS, active secondary progressive MS).
For continuation requests: objective evidence of benefit or stabilization (e.g., MRI findings, relapse history, EDSS/MSFC scores, NEDA metrics, functional testing, or documented symptom improvement).
Medication must be prescribed by or in consultation with a neurologist or MS specialist.

Step Therapy

Step therapy / Appendix Context

Step therapy context: other disease-modifying therapies (DMTs) for multiple sclerosis are listed in the Appendix. The policy does not mandate a specific sequencing of DMTs in the main criteria, but the Appendix provides examples of alternative DMT agents and their modes of administration which may be considered when selecting therapy.

See Appendix for other DMTs (examples include: Aubagio, Avonex, Bafiertam, Betaseron, Briumvi, Gilenya, Kesimpta, Lemtrada, Mavenclad, Mayzent, Ocrevus, Plegridy, Rebif, Tecfidera, Tysabri, Zeposia, etc.).
Concurrent use with other DMTs is considered not medically necessary; agents are not indicated for combination use (see Conditions Not Covered).

Background

Glatiramer acetate products (Copaxone, Glatopa, and generics) are indicated for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. Multiple sclerosis is a chronic, inflammatory, demyelinating autoimmune disease of the central nervous system with variable clinical courses; disability is commonly assessed using measures such as the EDSS. The policy emphasizes that glatiramer acetate is approved for relapsing disease and that use in non-relapsing forms (for example, primary progressive MS) is considered not medically necessary because efficacy has not been established.

Definitions

Relapsing forms of MS — definition and examples

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.

Adult indicationGlatiramer acetate (Copaxone, Glatopa, generic) is indicated for treatment of relapsing forms of MS in adults.

EDSS — Expanded Disability Status Scale

DefinitionExpanded Disability Status Scale (EDSS) is an ordinal scale ranging from 0 to 10 used to grade disability in multiple sclerosis; higher scores indicate greater disability.

Primary useCommonly used to grade deterioration of mobility and overall neurologic disability in MS.

ContextEDSS is referenced in disease course descriptions and objective measures of disability and treatment response in MS management.

Copaxone (glatiramer acetate) 20 mg/mL	subcutaneous injection — Teva, generic
Copaxone (glatiramer acetate) 40 mg/mL	subcutaneous injection — Teva, generic
Glatopa (glatiramer acetate) 20 mg/mL	subcutaneous injection — Sandoz
Glatopa (glatiramer acetate) 40 mg/mL	subcutaneous injection — Sandoz

OpenPayer

Multiple Sclerosis (Injectable) - Glatiramer Products Prior Authorization Policy

Coverage Criteria for Glatiramer Acetate

Covered Product Coding

Provider Requirements and Authorization

Background

Definitions