CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tecfidera (dimethyl fumarate) — Coverage Criteria for Relapsing Forms of Multiple Sclerosis

Covers use of Tecfidera (dimethyl fumarate) for treatment of relapsing forms of multiple sclerosis and clinically isolated syndrome when approval criteria are met; affects members of Neighborhood Health Plan of Rhode Island and providers prescribing this medication.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTecfidera (dimethyl fumarate) — Coverage Criteria for Relapsing Forms of Multiple Sclerosis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescribe only by or in consultation with a neurologist and document no concomitant use of other disease‑modifying MS agents.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization length

Neurologistrequired prescriber specialty

Relapsing MSFDA-approved indication covered

Coverage and Medical Necessity Criteria

Initial and Renewal Coverage Criteria

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FDA indication: Member has a diagnosis of a relapsing form of multiple sclerosis (including clinically isolated syndrome, relapsing‑remitting disease, or active secondary progressive disease) in an adult.

based on FDA‑approved indication

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

Authorization period: Initial and renewal authorizations are for 12 months when approval criteria are met and member has no exclusions to the prescribed therapy.12 months

Renewal requires disease stability or improvement while on therapy.

Concomitant therapy: Member is not using the requested medication concomitantly with other disease‑modifying multiple sclerosis agents.

Ampyra and Nuedexta are not disease‑modifying agents (allowed if applicable).

Prescriber Requirements and Authorization Details

Documentation Required

Prescriber and concomitant therapy documentation

This medication must be prescribed by or in consultation with a neurologist. The prescriber must document that the member is not receiving the requested medication concomitantly with any other disease‑modifying multiple sclerosis (DMT) agents.

Prescriber: neurologist or documented consultation
Documentation: confirm no concomitant use with other disease‑modifying MS agents

Prior Authorization

Authorization duration — relapsing MS

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) when approval criteria are met.

Authorization duration: up to 12 months for relapsing MS

Prior Authorization

Authorization duration — clinically isolated syndrome

Authorization may be granted for up to 12 months for members treated for clinically isolated syndrome when approval criteria are met.

Authorization duration: up to 12 months for clinically isolated syndrome

Denial Risk

Prohibition on concomitant disease‑modifying therapies

Members must not use Tecfidera concomitantly with other disease‑modifying multiple sclerosis agents. (Note: Ampyra and Nuedexta are not disease‑modifying agents and are not included in this prohibition.)

Concomitant DMTs prohibited: any other disease‑modifying MS agent
Exceptions noted: Ampyra and Nuedexta are not DMTs

Key Definitions

Relapsing forms of MS — FDA definition

DefinitionRelapsing forms of multiple sclerosis include clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease (FDA‑approved indication).

Age groupAdults (FDA‑approved population).

Coverage implicationOnly FDA‑approved relapsing forms of MS are covered; all other indications are experimental/investigational and not medically necessary.

Source languageStated exactly in FDA‑approved indication for Tecfidera: 'relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease.'

Background

Tecfidera (dimethyl fumarate) is FDA‑approved for the treatment of relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease. The approval supports coverage when the medication is used for these indications and in accordance with policy criteria; uses outside this FDA‑approved indication are considered experimental/investigational and not medically necessary.