CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Fingolimod (Gilenya, generics, Tascenso ODT) for relapsing multiple sclerosis — Coverage Criteria

Covers FDA-approved use of fingolimod products for treatment of relapsing forms of multiple sclerosis (including clinically isolated syndrome) in patients aged 10 years and older when approval criteria are met; applies to prescribers affiliated with Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyFingolimod (Gilenya, generics, Tascenso ODT) for relapsing multiple sclerosis — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization for up to 12 months and ensure prescription is from or in consultation with a neurologist; do not prescribe with other disease‑modifying MS therapies.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration (initial and renewal)

>=10minimum covered patient age

relapsing MScovered indications

not coveredother indications

Coverage Criteria for Fingolimod

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inv-01: Covered indications and authorization duration

Covered when ALL of the following are met:

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

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

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Authorization duration: Initial and continuation authorizations may be granted for 12 months when criteria are met; continuation requires documented disease stability or improvement.12 months

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Concomitant therapy: Member is not receiving concomitant disease‑modifying multiple sclerosis agents while using the requested medication.no concomitant DMTs

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All indications other than the FDA‑approved relapsing forms of multiple sclerosis (including clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease) are considered experimental/investigational and not medically necessary.

Use of fingolimod for non‑FDA approved indications is considered not medically necessary and may be denied.

Provider Requirements and Authorization Details

Prior Authorization

12‑month authorization period

Authorization of 12 months may be granted for initial treatment of relapsing forms of multiple sclerosis, including relapsing‑remitting and secondary progressive disease with ongoing relapses.

Initial authorization period: 12 months

Prior Authorization

12‑month authorization period — clinically isolated syndrome

Authorization of 12 months may be granted for treatment of clinically isolated syndrome.

Initial authorization period: 12 months

Documentation Required

Prescriber specialty and documentation

Prescription must be written by or in consultation with a neurologist. Documentation of specialist involvement (e.g., consult note or co‑signature) should be available on request.

Prescriber: neurologist or in consultation with neurologist
Document consultation or specialist involvement

Denial Risk

Non‑FDA indications and concomitant therapy — denial risk

Use of this medication for indications other than the FDA‑approved relapsing forms of multiple sclerosis (including clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease) is considered experimental/investigational and not medically necessary and will be denied. Additionally, members must not use the requested medication concomitantly with other disease‑modifying multiple sclerosis agents.

Non‑FDA indications: denial (experimental/investigational)
No concomitant DMTs allowed (Ampyra and Nuedexta are not disease‑modifying)

Background

Fingolimod is indicated to treat relapsing forms of multiple sclerosis — including clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease — in patients aged 10 years and older. The policy covers use for these FDA‑approved relapsing MS indications when authorization criteria are met; uses outside these indications are considered experimental and not covered.

Definitions

Relapsing forms of MS

DefinitionRelapsing forms of multiple sclerosis include clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease as specified in the FDA‑approved indication.

Age thresholdIndication applies to patients 10 years of age and older (age >= 10 years).

Scope of FDA approvalCovers treatment of relapsing forms of MS per FDA labeling; other indications are considered experimental/investigational and not medically necessary.

Authorization implicationContinuation authorization contingent on meeting coverage criteria (e.g., prescriber specialty, no concomitant DMTs) and documentation of stability or improvement — authorizations may be granted for 12 months when criteria are met.