CurrentCignaPolicy N/A

PRIOR AUTHORIZATION POLICY

Cigna prior authorization policy for fingolimod (Gilenya and generic fingolimod capsules) governing coverage for relapsing forms of multiple sclerosis for patients ≥10 years old, including initial and continuation therapy criteria, exclusions (non-relapsing forms, concomitant DMT use), and appendix of other disease-modifying therapies.

Policy Summary

PayerCigna

PolicyPRIOR AUTHORIZATION POLICY

Policy CodePolicy N/A

Change TypeAge requirement addedname and appendix updates

Effective Date

Next Review DateJul 23, 2025

Key ActionPrior authorization is recommended/required for prescription benefit coverage of fingolimod; approvals are provided for the duration noted (1 year for initial and continuation approvals).

SourceLink

POLICY UPDATE CHANGES

Added requirement that the patient is ≥ 10 years of age for both Initial and Patients Currently Receiving Therapy.

Policy name was changed to add 'Oral - Sphingosine 1-Phosphate Receptor Modulator'.

Appendix updated: Briumvi and Tascenso ODT added as examples; Ocrevus Zunovo added; Extavia removed in later revision.

1Covered indication (MS - relapsing forms)

>=10 yearsMinimum age for coverage

1 yrApproval duration

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Coverage Summary

Cigna prior authorization policy for fingolimod (Gilenya and generic fingolimod capsules) covers treatment of relapsing forms of multiple sclerosis for patients aged ≥10 years. Coverage is covered with criteria and requires specialist prescribing or consultation. Approvals are provided for 1 year (initial and continuation). Primary exclusions include concurrent use with other disease-modifying therapies (no combination DMT use) and non-relapsing forms of MS.

Key thresholds and quick facts

Minimum age>= 10 years

Approval duration1 year

Covered indication count1 (relapsing forms of MS)

Initial Therapy Criteria

FDA-Approved Indication: Multiple Sclerosis

Approve for the duration noted below if the patient meets ONE of the following (A or B):

A) Initial Therapy

Patient has a relapsing form of multiple sclerosis
Examples of relapsing forms of multiple sclerosis include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease.
Patient is >= 10 years of age>= 10 years
Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis

Continuation Therapy Criteria

Unproven / Exclusions

Primary exclusions: Non-relapsing forms of multiple sclerosis (example: primary progressive MS) and concurrent use with other disease-modifying therapies (combination DMT use). No additional exclusions beyond those listed in the policy's conditions-not-covered section are specified in the brief.

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is recommended/required for prescription benefit coverage of fingolimod. All approvals are provided for the duration noted (1 year for initial and continuation approvals).

Approval duration = 1 year

Documentation Required

Specialist prescribing requirement

Medication must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis for both initial and continuation approvals.

Documentation Required

Objective evidence for continuation

Applicable Codes

Drug / HCPCS / NDC (not explicitly listed in document)NDC|HCPCS

No codes listed

Clinical Evidence & Safety

Evidence and safety summary: Key evidence sources include the Gilenya prescribing information (Novartis; June 2024) and the INFORMS trial reporting that fingolimod did not slow progression in primary progressive MS (Lancet 2016). Safety concerns noted in the background and prescribing information include first-dose bradycardia with monitoring requirements, increased infection risk, macular edema, pulmonary toxicity, elevated liver enzymes, and rare reports of progressive multifocal leukoencephalopathy (PML).

Background & Definitions

Fingolimod is a sphingosine 1-phosphate receptor modulator indicated for treatment of patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease in patients ≥ 10 years of age. Safety issues include first-dose bradycardia requiring observation/monitoring (often 6 hours and ECG monitoring in higher-risk patients), as well as risks of infections, macular edema, pulmonary toxicity, elevated liver enzymes, and rare cases of PML. The policy appendix lists examples of other disease-modifying therapies.

Relapsing forms of multiple sclerosis: Includes clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease.

Revision History

01/04/2023material_change

Selected Revision: For both Initial and Patients Currently Receiving Therapy, added requirement that the patient is ≥ 10 years of age (reflected in policy criteria).

11/08/2023appendix_update

Annual Revision: Appendix updated — Briumvi and Tascenso ODT added as examples of disease-modifying agents used for multiple sclerosis; no criteria changes.

10/09/2024appendix_update