ModifiedCignaPolicy IP0259

Multiple Sclerosis - Fingolimod

Covers medical necessity and coverage criteria for fingolimod products (Gilenya and generic fingolimod capsules) for treatment of relapsing forms of multiple sclerosis for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyMultiple Sclerosis - Fingolimod

Policy CodePolicy IP0259

Change TypeMaterial revision — added age and prescriber requirements, continuation criteria, and documentation definition

Effective Date12/01/2024

Next Review Date

Key ActionObtain prior authorization and document patient is ≥ 10 years old and that medication is prescribed by or in consultation with a neurologist or MS specialist.

SourceLink

POLICY UPDATE CHANGES

Added a requirement for a patient to be ≥ 10 years of age.

Added a specialist prescribing requirement.

Added criteria for patient Currently Receiving Fingolimod for ≥ 1 Year.

Added a definition for documentation.

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

Ocrevus Zunovo was added to the Appendix.

≥ 10 yearsminimum patient age for coverage

1 yearinitial approval duration

~30therapeutic products in appendix

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Coverage and Medical Necessity Criteria

inv-01: Initial Therapy - Employer Group

Covered when ALL of the following are met:

Initial Therapy (Employer Group): i. Documentation the patient has a relapsing form of multiple sclerosis; AND ii. Patient is ≥ 10 years of age; AND iii. Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis; AND iv. Preferred product criteria is met for the product(s) as listed in the below table(s).

Approve for 1 year.

inv-02: Continuation Therapy - Employer Group

Covered when ALL of the following are met:

Continuation Therapy (Employer Group): i. Documentation the patient has a relapsing form of multiple sclerosis; AND ii. Patient is ≥ 10 years of age; AND iii. Patient experienced a beneficial clinical response when assessed by at least one objective measure OR experienced stabilization, slowed progression, or improvement in at least one symptom; AND iv. Medication is prescribed by or in consultation with a neurologist or MS specialist.

Approve for 1 year.

inv-03: Initial Therapy - Individual and Family

Covered when ALL of the following are met:

Initial Therapy (Individual and Family): i. Documentation the patient has a relapsing form of multiple sclerosis; AND ii. Patient is ≥ 10 years of age; AND iii. Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis; AND iv. Preferred product criteria is met for the product(s) as listed in the below table(s).

Approve for 1 year.

inv-04: Continuation Therapy - Individual and Family

Covered when ALL of the following are met:

Continuation Therapy (Individual and Family): i. Documentation the patient has a relapsing form of multiple sclerosis; AND ii. Patient is ≥ 10 years of age; AND iii. Patient experienced a beneficial clinical response when assessed by at least one objective measure OR experienced stabilization, slowed progression, or improvement in at least one symptom; AND iv. Medication is prescribed by or in consultation with a neurologist or MS specialist.

Approve for 1 year.

inv-05: Newly added coverage criteria (summary)

Policy revisions added the following coverage-relevant requirements:

Age and prescriber: Patient must be ≥ 10 years of age AND the medication must be prescribed by a specialist.age >= 10

Both added in 12/01/2024 revision

Fingolimod continuation: Criteria for patients currently receiving fingolimod for ≥ 1 year were added to allow continuation under specified conditions.duration >= 1 year

See full policy for exact continuation conditions

Concurrent use of fingolimod with other disease-modifying agents for multiple sclerosis is explicitly listed as not covered; the policy states these agents are not indicated for combined use and additional data are required to establish safety and added efficacy. The document also cites that fingolimod did not slow progression in primary progressive MS, so use for non-relapsing forms of multiple sclerosis (for example, primary progressive MS) is considered experimental, investigational, or unproven and not covered.

There are no additional exclusions or special-case restrictions explicitly stated in the provided document fragment beyond the revisions noted on 12/01/2024 (for example, additions of age and specialist prescriber requirements).

Any use of fingolimod that is not listed in the medical necessity criteria is considered experimental, investigational, or unproven. The policy specifically identifies concurrent use with other disease-modifying MS agents and use for non‑relapsing forms of MS as examples of such non‑covered, investigational uses.

Within the provided fragments there are no explicit statements

Appendix: Product and Administration Codes

Appendix drug list with administration modesmixed

Aubagio	teriflunomide tablets — Oral
Avonex	interferon beta-1a intramuscular injection — Injection (self-administered)
Bafiertam	monomethyl fumarate delayed-release capsules — Oral
Betaseron	interferon beta-1b subcutaneous injection — Injection (self-administered)
Briumvi	ublituximab-xiij — Intravenous infusion
Copaxone	glatiramer acetate subcutaneous injection — Injection (self-administered)
Extavia	interferon beta-1b subcutaneous injection — Injection (self-administered)
Gilenya	fingolimod capsules — Oral
Glatopa	glatiramer acetate subcutaneous injection — Injection (self-administered)
Kesimpta	ofatumumab subcutaneous injection — Injection (self-administered)

1–10 of 24
1/3

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization
Prior Authorization and Brand vs Generic
Prior authorization may be required. For some plans (see Employer and Individual/Family plan language), approval of brand Gilenya 0.5 mg requires a documented trial of the bioequivalent generic fingolimod capsules unless the prescriber documents that the patient cannot take the generic because of a formulation difference in inactive ingredients that would cause a significant allergy or serious adverse reaction.
Brand Gilenya 0.5 mg may require trial of bioequivalent generic fingolimod capsules for approval.
Employer plans: documented trial of generic required unless clinically contraindicated due to inactive ingredient differences.
Individual/Family plans: documented trial of generic may be required; prescriber must document intolerance to inactive ingredient differences.

Documentation Required
Required Documentation
Documentation is required as noted in the criteria and the policy now includes a definition for documentation. Documentation may include, but is not limited to, chart notes, laboratory tests, claims records, and/or other information. Providers should supply relevant clinical information to support the request (e.g., diagnosis confirming a relapsing form of MS, prior therapy history, objective measures of clinical response when continuing therapy, and reason for brand use if applicable).

Clinical Background

Fingolimod is included in this policy as a therapy for relapsing forms of multiple sclerosis. The revision notes (12/01/2024) emphasize programmatic requirements — including a minimum patient age of ≥ 10 years and a specialist prescriber — and added continuation criteria for patients currently receiving fingolimod for ≥ 1 year. The policy background and conditions-not-covered text indicate fingolimod’s use is confined to relapsing forms of MS and that it did not demonstrate benefit in primary progressive (non‑relapsing) MS in the INFORMS trial; clinicians should also be aware of first‑dose monitoring and safety risks described elsewhere in the full policy when initiating therapy.

Terms and Eligibility Definitions

Relapsing forms of multiple sclerosis — clinical description

DefinitionRelapsing forms of multiple sclerosis include clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease; characterized by relapses and remissions and may be described as active or not active.

Typical onsetOnset of MS symptoms most often occurs between ages 20 and 40, though children and older adults can be affected.

Disease course notesApproximately 85–90% of patients have a relapsing pattern at onset; disease may transition to secondary progressive MS over time if untreated.

Clinical measurementDisability in MS is commonly graded using the Expanded Disability Status Scale (EDSS).

Documentation — definition and expectations

Policy change