CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

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

Covers authorization criteria and prescribing requirements for Tecfidera (dimethyl fumarate) for relapsing forms of multiple sclerosis and clinically isolated syndrome for members of Neighborhood Health Plan of Rhode Island when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

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

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for up to 12 months and document that 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 monthsauthorization period

neurologistprescriber required

relapsing MSFDA-covered indication

clinically isolated syndromecovered

Coverage Criteria for Tecfidera (dimethyl fumarate)

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Initial and continuation therapy criteria

Covered when ALL of the following are met:

FDA‑approved indication: Patient has a diagnosis of a relapsing form of multiple sclerosis (including clinically isolated syndrome, relapsing‑remitting disease, or active secondary progressive disease) or a compendial use; all other indications are considered experimental/investigational and not medically necessary.

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

Authorization period — initial therapy: Authorization requested is for up to 12 months for members diagnosed with a relapsing form of multiple sclerosis (including relapsing‑remitting and secondary progressive disease with relapse) or for clinically isolated syndrome.12 months

Authorization period — continuation of therapy: For continuation, authorization may be granted for 12 months when the member is experiencing disease stability or improvement while receiving Tecfidera.12 months

Concomitant therapy: Tecfidera is not to be used concomitantly with other disease‑modifying multiple sclerosis agents.

All indications for Tecfidera (dimethyl fumarate) that are not FDA‑approved or otherwise listed as compendial uses in this policy are excluded from coverage and considered experimental/investigational. Concurrent use of Tecfidera with other disease‑modifying multiple sclerosis agents is also excluded and not permitted.

Use of Tecfidera for any indication other than the FDA‑approved relapsing forms of multiple sclerosis (including clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease) or recognized compendial uses is considered not medically necessary and may be denied.

Provider Requirements and Authorization Details

Documentation Required

Required prescriber and diagnosis documentation

This medication must be prescribed by or in consultation with a neurologist. Documentation must support the diagnosis (e.g., clinical notes, MRI findings, history of relapses) and be provided with the prior authorization request to verify the member meets the indication for treatment.

Prescriber: Neurologist or consultation with a neurologist must be documented
Diagnosis support: clinical notes, MRI reports, history of relapses or other objective evidence to confirm relapsing forms of MS or clinically isolated syndrome

Prior Authorization

Prior authorization duration and indication details

Authorization may be granted for up to 12 months for members meeting the indication criteria. Include the specific approved indication in the request (relapsing forms of MS or clinically isolated syndrome). For continuation of therapy, authorization of 12 months may be granted for members demonstrating disease stability or improvement while receiving Tecfidera.

Approval period: up to 12 months
Indications: relapsing forms of MS (including relapsing‑remitting and active secondary progressive) or clinically isolated syndrome
Continuation: 12‑month approvals may be granted when there is documented stability or improvement

Denial Risk

Non‑approved indications

Tecfidera is approved only for FDA‑labeled relapsing forms of multiple sclerosis (including clinically isolated syndrome). Use for other indications is considered experimental/investigational and may result in denial of the request.

Covered indication: relapsing forms of MS (clinically isolated syndrome, relapsing‑remitting, active secondary progressive)
Not covered: any non‑FDA approved indications

Denial Risk

Concomitant disease‑modifying therapy exclusion

Members must not be on another disease‑modifying multiple sclerosis (DMT) agent concurrently. If a prior DMT was used, documentation must show the agent was discontinued prior to initiating Tecfidera or the rationale for switching. Note: Ampyra and Nuedexta are not considered disease‑modifying agents and do not conflict with this requirement.

No concurrent DMTs: concurrent use with other disease‑modifying MS agents will trigger denial
Documentation: evidence of discontinuation of prior DMT or clinical rationale for switching must be provided
Clarification: Ampyra and Nuedexta are not DMTs and do not count as concurrent DMTs

OpenPayer

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

Coverage Criteria for Tecfidera (dimethyl fumarate)

Provider Requirements and Authorization Details

Key Definitions

Background