CurrentCignaPolicy N/A

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

Prior authorization policy for prescription benefit coverage of Vumerity (diroximel fumarate delayed-release capsules) for treatment of relapsing forms of multiple sclerosis in adults, including initial and continuation criteria, duration of approvals, contraindications (not medically necessary uses), and prescriber specialty requirements. Applies to Cigna-administered health benefit plans where applicable.

Policy Summary

PayerCigna

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

Policy CodePolicy N/A

Change TypeAppendix updates; name revision

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization is required for Vumerity and medication must be prescribed by or in consultation with a neurologist or MS specialist; approvals are typically for 1 year.

POLICY UPDATE CHANGES

Policy name was changed to add 'Oral - Fumarate' and Appendix modifications were made (additions/removals of listed agents).

History notes indicate 08/10/2023 update had no criteria changes and multiple administrative Appendix updates occurred on various dates.

1Approval duration (years)

Initial or ContinuedCovered scenarios

2Not covered categories

Coverage Summary & Indications

Scope: Prior authorization policy for prescription benefit coverage of Vumerity (diroximel fumarate delayed-release capsules) for the treatment of relapsing forms of multiple sclerosis in adults, including initial and continuation criteria, duration of approvals (typically 1 year), prescriber specialty requirements, and contraindicated/non-covered uses. (Applies to Cigna-administered health benefit plans where applicable.)

Background: Vumerity is indicated for the treatment of adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive MS. The policy aligns coverage with the FDA indication and requires that Vumerity be prescribed by or in consultation with a neurologist or physician who specializes in MS to ensure appropriate evaluation and monitoring. The policy references safety concerns similar to dimethyl fumarate — specifically the risk of progressive multifocal leukoencephalopathy — and incorporates specialist prescribing/monitoring due to required adverse event and efficacy monitoring.

Conditions Not Covered (Not Medically Necessary)

Vumerity is considered not medically necessary for any other uses including but not limited to:

Conditions Not Covered

Concurrent use with other disease-modifying agents used for multiple sclerosis
These agents are not indicated for use in combination (see Appendix). Additional data are required to determine if combination use is safe and provides added efficacy.
Non-relapsing forms of multiple sclerosis
The efficacy of Vumerity has not been established in patients with non-relapsing forms of multiple sclerosis (example: primary progressive multiple sclerosis).

Prior Authorization & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Vumerity (diroximel fumarate) requests must be reviewed and approved before benefit coverage is provided. All approvals are provided for the duration noted in the policy (typically 1 year).

Approvals typically issued for 1 year

Documentation Required

Specialist Prescribing/Consultation Required

Prescribing or consultation by a specialist is required. Vumerity must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis. This requirement applies to both initial and continuation approvals.

Applies to initial and continuation therapy

Documentation Required

Continuation Therapy — Objective Response Documentation

For continuation (patients receiving Vumerity ≥ 1 year), documentation of beneficial clinical response is required. Evidence must include either at least one objective measure of response (for example, MRI stability or improvement, reduced/new lesion counts, EDSS stabilization/improvement, achievement of NEDA-3/NEDA-4, MSFC improvement, reduced relapses, or attenuation of brain volume loss) or documented stabilization, slowed progression, or improvement in at least one clinical symptom (eg, motor function, fatigue, vision, bowel/bladder, spasticity, walking/gait, pain/numbness/tingling).

Objective measures: MRI (absence/decrease in gadolinium-enhancing lesions, decrease in new/enlarging T2 lesions), EDSS, NEDA-3/NEDA-4, MSFC, 6-minute walk/12-Item MS Walking Scale, FSIQ-RMS
Symptom measures: documented stabilization, slowed progression, or improvement in motor function, fatigue, vision, bowel/bladder, spasticity, walking/gait, or sensory symptoms

Denial Risk

Not Covered Indications — Denial Risk

Not-covered indications may lead to claim denials. Requests for concurrent use of Vumerity with other disease-modifying multiple sclerosis agents or use for non‑relapsing forms of multiple sclerosis (eg, primary progressive MS) are considered not medically necessary and may be denied.

Concurrent use with other disease-modifying agents for MS (combinations not indicated)
Non-relapsing forms of MS (example: primary progressive MS)

Evidence & References

Evidence:

• Prescribing information: Vumerity delayed-release capsules prescribing information (Biogen), September 2024.

• Guideline consensus: Multiple Sclerosis Coalition consensus (September 2019) on the use of disease-modifying therapies in MS.

Safety notes: Progressive multifocal leukoencephalopathy has occurred in patients treated with dimethyl fumarate, which shares the same active metabolite as Vumerity; the policy references this safety concern and requires specialist prescribing and monitoring for adverse events and efficacy.

Definitions & Scope

Definitions:

• Relapsing forms of multiple sclerosis: Includes clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease. This term is the indication for Vumerity in adults, and the policy requires that treatment be prescribed by or in consultation with a neurologist or physician who specializes in MS for both initial and continuation approvals.

Scope summary: Prior authorization policy for prescription benefit coverage of Vumerity (diroximel fumarate delayed-release capsules) for treatment of relapsing forms of multiple sclerosis in adults, including initial and continuation criteria, duration of approvals, contraindications (not medically necessary uses), and prescriber specialty requirements.

Policy Revision History

07/23/2025policy_revisionLatest

Policy name updated to include 'Oral - Fumarate'; Appendix modified with additions and removals (e.g., Ocrevus Zunovo added earlier; Extavia removed). Changes marked non-material.

10/09/2024appendix_update

Appendix updated to add Ocrevus Zunovo. Changes marked non-material.

08/10/2023administrative_update

Administrative history note: 08/10/2023 update had no criteria changes; Appendix additions included Briumvi and Tascenso ODT; Aubagio noted as available as a generic. Changes marked non-material.