CurrentCignaPolicy N/A

Bafiertam Prior Authorization Policy

Defines prior authorization requirements, covered indications, and exclusions for Bafiertam (monomethyl fumarate delayed-release capsules) for treatment of relapsing forms of multiple sclerosis for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyBafiertam Prior Authorization Policy

Policy CodePolicy N/A

Change Typeclarified

Effective DateJul 23, 2025

Next Review Date

Key ActionPrior authorization is required; approvals are for 1 year and Bafiertam must be prescribed by or in consultation with an MS specialist.

SourceLink

POLICY UPDATE CHANGES

Policy name was changed to add 'Oral - Fumarate' (07/23/2025).

1Covered Indications

2Prescriber requirement & duration

2Not-covered categories

Coverage Summary

Covered with criteria: Bafiertam (monomethyl fumarate) is covered for the FDA‑approved indication of relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive MS; policy requires prior authorization and specialist prescribing/consultation.

FDA-Approved Indication - Multiple Sclerosis

Bafiertam is covered as medically necessary for relapsing forms of multiple sclerosis when the following criteria are met for FDA-approved indication(s):

ANY of the following

A) Initial Therapy
- Patient has a relapsing form of multiple sclerosis
  Examples of relapsing forms of multiple sclerosis include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease.
- Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis
B) Patient is Currently Receiving Bafiertam for ≥ 1 Year
- Patient has a relapsing form of multiple sclerosis
  Examples of relapsing forms of multiple sclerosis include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease.
- Clinical benefit
  - Patient experienced a beneficial clinical response when assessed by at least one objective measure
    Examples include stabilization or reduced worsening in MRI (absence or a decrease in gadolinium enhancing lesions, decrease in the number of new or enlarging T2 lesions); stabilization or reduced worsening on the Expanded Disability Status Scale (EDSS) score; achievement in criteria for No Evidence of Disease Activity-3 (NEDA-3) or NEDA-4; improvement on the FSIQ-RMS scale; reduction or absence of relapses; improvement or maintenance on the six-minute walk test or 12-Item MS Walking Scale; improvement on the Multiple Sclerosis Functional Composite (MSFC) score; attenuation of brain volume loss.
  - Patient experienced stabilization, slowed progression, or improvement in at least one symptom
    Examples: motor function, fatigue, vision, bowel/bladder function, spasticity, walking/gait, or pain/numbness/tingling sensation
- Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis

Conditions Not Covered

Bafiertam is considered not medically necessary for any other use(s) including:

ALL of the following

Concurrent use with other disease-modifying agents used for multiple sclerosis
Appendix provides examples; combination use not indicated and requires additional data
Non-relapsing forms of multiple sclerosis (e.g., primary progressive multiple sclerosis)
Efficacy not established in non-relapsing forms

Prescriber & Approval Rules

Prescriber Requirement and Approval Duration

Operational coverage rules

ALL of the following

Prescription must be by or in consultation with a neurologist or physician specialized in MS
Because of specialized skills required for evaluation and monitoring, approval requires prescription by or consultation with an MS specialist.
Approvals are provided for 1 year1 year

Key Thresholds

Duration of prior Bafiertam therapy to qualify for continuation≥ 1 Year

Approval duration1 year

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required for Bafiertam for prescription benefit coverage. All approvals are provided for 1 year. Bafiertam must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis.

Prior authorization required for prescription benefit coverage
Approvals provided for 1 year
Prescribed by or in consultation with an MS specialist (neurologist or physician who specializes in MS)

Documentation Required

Document clinical benefit for continuation

For patients currently receiving Bafiertam ≥ 1 year, the provider must document clinical benefit using at least one objective measure or by demonstrating symptom stabilization, slowed progression, or improvement.

MRI changes (absence or decrease in gadolinium-enhancing lesions; decrease in new or enlarging T2 lesions)
Expanded Disability Status Scale (EDSS) stabilization or reduced worsening
Achievement of NEDA-3 or NEDA-4
Relapse reduction or absence of relapses
Functional tests (six-minute walk test, 12-Item MS Walking Scale, Multiple Sclerosis Functional Composite [MSFC])
Fatigue improvement (FSIQ-RMS) or other symptom stabilization/improvement (motor, vision, bowel/bladder, spasticity, walking/gait, pain/numbness/tingling)

Denial Risk

Use outside covered indications

Claims for Bafiertam billed for conditions not covered under this policy will be considered not medically necessary and denied. Examples include use in non-relapsing forms of multiple sclerosis (e.g., primary progressive MS) and concurrent use with other disease-modifying agents for MS.

Non-relapsing forms of MS (e.g., primary progressive MS) — not covered
Concurrent use with other disease-modifying multiple sclerosis agents — not covered

Clinical Evidence & References

Prescribing information: Bafiertam delayed‑release capsules prescribing information, Banner Life Sciences; September 2024.

Guideline: MS Coalition consensus on disease‑modifying therapies, updated September 2019.

Safety/context note: Progressive multifocal leukoencephalopathy has occurred with Tecfidera (dimethyl fumarate), the prodrug of Bafiertam; the policy references MS treatment guidance (MS Coalition consensus) and requires specialist prescribing and monitoring consistent with guideline recommendations.

Definitions

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

Scope: Defines prior authorization requirements, covered indications, and exclusions for Bafiertam (monomethyl fumarate delayed‑release capsules) for treatment of relapsing forms of multiple sclerosis for Cigna‑administered health benefit plans; approvals require prescribing by or in consultation with a physician who specializes in MS and are provided for 1 year.

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