CurrentNeighborhood Health Plan of Rhode IslandPolicy 1842-A

fingolimod (Gilenya, Tascenso ODT) for relapsing multiple sclerosis

Covers fingolimod products for treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome and active secondary progressive disease, for members meeting the approval criteria and without exclusions to therapy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policyfingolimod (Gilenya, Tascenso ODT) for relapsing multiple sclerosis

Policy CodePolicy 1842-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization for up to 12 months and ensure the medication is prescribed by or in consultation with a neurologist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical prior authorization duration

>=10minimum covered age

neurologistprescriber specialty required

othernon-covered indications

Coverage Criteria for Fingolimod

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FDA indication: Patient has a relapsing form of multiple sclerosis (including clinically isolated syndrome, relapsing‑remitting disease, or active secondary progressive disease)age >= 10 years

FDA‑approved age is 10 years and older

Prescriber: Medication is prescribed by or in consultation with a neurologist

Authorization duration: Authorization may be granted for 12 months for initial therapy for relapsing MS or clinically isolated syndrome, or for continuation if the member is experiencing disease stability or improvement12 months

Fingolimod (including branded and generic formulations) is covered only for the FDA‑approved relapsing forms of multiple sclerosis — which include clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease — in patients aged 10 years and older. All other indications beyond these FDA‑approved relapsing forms of MS are considered experimental/investigational and not medically necessary.

inv-12: Relapsing forms of multiple sclerosis — definition listing clinically isolated syndrome, relapsing‑remitting, active secondary progressive disease

Clinically isolated syndrome (CIS)Included as a relapsing form of multiple sclerosis per FDA indication

Relapsing‑remitting multiple sclerosis (RRMS)Explicitly listed as a relapsing form of multiple sclerosis per FDA indication

Active secondary progressive multiple sclerosis (active SPMS)Included as a relapsing form of multiple sclerosis per FDA indication

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Duration and Indications

Prior authorization may be granted for up to 12 months for members diagnosed with relapsing forms of multiple sclerosis (including relapsing-remitting and secondary progressive disease with ongoing relapses) and for clinically isolated syndrome. Continuation authorizations of 12 months may be granted for members who are experiencing disease stability or improvement while receiving the requested medication.

Documentation Required

Prescriber Specialty Requirement

This medication must be prescribed by or in consultation with a neurologist.

Denial Risk

Non‑covered Indications — Risk of Denial

Use of the requested medication for indications other than FDA‑approved relapsing forms of multiple sclerosis (to include clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease) is considered experimental/investigational and may be denied.

Denial Risk

Concomitant Disease‑Modifying Therapy

Concurrent use of the requested medication with other disease‑modifying multiple sclerosis agents is not permitted and may result in denial. (Note: Ampyra and Nuedexta are not disease‑modifying and are not included in this restriction.)

Background

Fingolimod (brand and generic) is indicated for the treatment of relapsing forms of multiple sclerosis, specifically including clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease, for patients aged 10 years and older. This policy applies to those fingolimod products referenced and governs prior authorization, coverage criteria, and exclusions for the indicated relapsing MS populations.

Definitions

inv-12: Relapsing forms of multiple sclerosis — definition entry (CIS, RRMS, active SPMS)

CISClinically isolated syndrome is included in the FDA‑approved relapsing forms of MS

RRMSRelapsing‑remitting disease is included in the FDA‑approved relapsing forms of MS

Active SPMSActive secondary progressive disease is included in the FDA‑approved relapsing forms of MS