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.

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

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.

OpenPayer