CurrentCignaPolicy N/A

Multiple Sclerosis (Oral - Fumarate) - Dimethyl Fumarate Prior Authorization Policy

Defines prior authorization requirements, clinical criteria for medical necessity, coverage duration, and exclusions for dimethyl fumarate (Tecfidera and generics) for treatment of relapsing forms of multiple sclerosis under Cigna-administered plans.

Policy Summary

PayerCigna

PolicyMultiple Sclerosis (Oral - Fumarate) - Dimethyl Fumarate Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAppendix maintenancename updated

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended; ensure dimethyl fumarate is prescribed by or in consultation with a neurologist and document disease course and objective evidence of benefit for continuing therapy.

SourceLink

POLICY UPDATE CHANGES

Policy name changed to add 'Oral - Fumarate'.

History notes show multiple appendix updates and annual reviews with no criteria changes.

1Covered Indication (relapsing MS)

1Approval Duration (years per authorization)

NeurologistRequired Provider Type (prescribe or consult)

2Primary Exclusions (combination therapy, non-relapsing MS)

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Coverage Summary

This policy defines prior authorization requirements, clinical criteria for medical necessity, coverage duration, and exclusions for dimethyl fumarate (Tecfidera and generics) when used to treat relapsing forms of multiple sclerosis under Cigna-administered plans. Approvals require prescribing by or consultation with a neurologist or a physician who specializes in MS and are provided for specified durations. Safety considerations include reports of progressive multifocal leukoencephalopathy (PML) in patients treated with dimethyl fumarate.

Policy metadata

StatusCURRENT

SubjectDimethyl fumarate (Tecfidera) prior authorization for relapsing multiple sclerosis

Covered indication count1 (Covered Indication: relapsing MS)

Approval duration1 year per authorization

Last review date2025-07-23

Medical Necessity Criteria

Provider specialty requirement

Dimethyl fumarate must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis

Applies to both initial and continuing approvals.

Not Medically Necessary / Exclusions

Not medically necessary (Exclusions)

Tecfidera (dimethyl fumarate) is considered not medically necessary for ANY other use(s) including the following:

ANY of the following

Concurrent use with other disease-modifying agents used for multiple sclerosis
Combination therapy not indicated; examples provided in Appendix.
Non-relapsing forms of multiple sclerosis
Example: primary progressive multiple sclerosis; efficacy not established.

Coding

Product(s) coveredNDC|mixedCovered

Tecfidera

dimethyl fumarate delayed-release capsules - Biogen, generic

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is recommended for prescription benefit coverage of dimethyl fumarate. Approvals are provided for a specified duration (1 year) and require the medication to be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis.

Documentation Required

Document disease course and response

For continuing therapy, document that the patient has a relapsing form of multiple sclerosis, the duration of prior therapy (patient has been receiving dimethyl fumarate for ≥ 1 year), and objective evidence of benefit or clinical response. Examples of objective measures include MRI findings (absence or decrease in gadolinium‑enhancing lesions, decreased number of new or enlarging T2 lesions), stabilization or reduced worsening on EDSS score, achievement of NEDA-3 or NEDA-4, improvement on FSIQ‑RMS, reduction or absence of relapses, improvement or maintenance on the six‑minute walk test or 12‑Item MS Walking Scale, improvement on MSFC score, or attenuation of brain volume loss. Examples of symptom improvement/stabilization include motor function, fatigue, vision, bowel/bladder function, spasticity, walking/gait, and pain/numbness/tingling.

Background, Evidence & Definitions

Dimethyl fumarate is indicated for the treatment of patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive MS in adults. Progressive multifocal leukoencephalopathy has occurred in patients with MS treated with dimethyl fumarate, including a fatal case; monitoring and specialist involvement are required per the policy.

Source	Reference
Prescribing information	Tecfidera delayed-release capsules, Biogen; March 2024
Guideline	Multiple Sclerosis Coalition consensus paper, September 2019

Relapsing forms of multiple sclerosis (definition)

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

Revision History

07/23/2025name_changeLatest

Policy name changed to add "Oral - Fumarate"; Extavia was removed from the Appendix (early annual revision).

11/08/2023appendix_update

Ocrevus Zunovo was added to the Appendix.

08/10/2023appendix_update

No criteria changes; Appendix additions included Briumvi and Tascenso ODT; Aubagio noted as available as a generic. This revision was non-material to clinical criteria.