CurrentCignaPolicy IP0253

Vumerity (diroximel fumarate) coverage

Prior authorization and coverage criteria for Vumerity (diroximel fumarate) for treatment of relapsing forms of multiple sclerosis for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyVumerity (diroximel fumarate) coverage

Policy CodePolicy IP0253

Change TypeMaterial changes to prescribing and continuation criteria

Effective Date

Next Review Date

Key ActionObtain prior authorization and document specialist consultation and objective evidence of benefit when requesting coverage.

SourceLink

POLICY UPDATE CHANGES

Added a specialist prescribing requirement.

Added criteria for patients currently receiving Vumerity for ≥ 1 year.

Added a definition for documentation.

Removed Employer Plans preferred product requirements.

Ocrevus Zunovo was added to the Appendix.

Prior authauthorization requirement

1 yrtypical approval length

Relapsing MSFDA-approved indication

Non-relapsing MSexplicit exclusions

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Coverage Criteria for Vumerity (diroximel fumarate)

FDA-Approved Indication - Initial and Continuation Therapy

Approve for Multiple Sclerosis when ONE of the following is met (A or B):

A: Initial Therapy

Initial criteria: i. Patient has a relapsing form of multiple sclerosis; AND ii. Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis; AND iii. Preferred product criteria is met for the product(s) as listed for Individual and Family Plans (trial/intolerance to dimethyl fumarate).
Examples of relapsing forms include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease.

B: Currently Receiving Vumerity for ≥ 1 Year

Continuation criteria: i. Patient has a relapsing form of multiple sclerosis; AND ii. Patient meets one of: (a) experienced a beneficial clinical response assessed by at least one objective measure (examples: MRI activity reduction, EDSS stabilization/improvement, NEDA-3/4 achievement, reduction in relapses, improvements on validated functional measures) OR (b) experienced stabilization/slowed progression or improvement in at least one symptom (motor, fatigue, vision, bowel/bladder, spasticity, walking/gait, pain/numbness/tingling); AND iii. Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis.

Coverage for Vumerity (diroximel fumarate) excludes its use in combination with other disease-modifying therapies for multiple sclerosis. Concurrent use with other disease-modifying agents used for multiple sclerosis is not covered, because these agents are not indicated for combined use and additional data are needed to establish safety and added efficacy. Additionally, use of Vumerity for non-relapsing forms of multiple sclerosis is not covered; the efficacy of Vumerity has not been established in non-relapsing MS (for example, primary progressive multiple sclerosis).

Vumerity is considered not medically necessary for any indication other than the specified relapsing forms of multiple sclerosis and the scenarios listed in this policy. This includes, but is not limited to, concurrent use with other disease-modifying MS agents and treatment of non-relapsing forms of MS, for which efficacy has not been established.

Coding & Approval Duration

Covered CPT Codesmixed

No codes listed

inv-05: Approval duration

Approval duration1 year

Authorization frequencyApprovals are provided for the duration noted (1 year)

Applies toInitial therapy and patients currently receiving Vumerity for ≥ 1 year

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vumerity. All approvals are provided for 1 year. Because of the specialized skills required for evaluation and diagnosis and monitoring of patients treated with Vumerity, the medication must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., a neurologist or an MS specialist).

Approvals are provided for 1 year.
Medication must be prescribed by or in consultation with a neurologist or physician who specializes in multiple sclerosis.

Step Therapy

Preferred Product / Step Therapy

For members in Individual & Family Plans, step therapy applies: the patient must have tried dimethyl fumarate (generic for Tecfidera) and, according to the prescriber, had inadequate efficacy or significant intolerance to dimethyl fumarate before Vumerity will be approved.

Affected product: Vumerity (diroximel fumarate)

Background

Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating autoimmune disease of the central nervous system that typically follows a pattern of relapses and remissions for most patients. Relapsing forms of MS include clinically isolated syndrome, relapsing‑remitting disease, and active secondary progressive disease. Vumerity is indicated for treatment of adults with relapsing forms of MS; its efficacy has not been established for non‑relapsing forms of the disease.

Definitions

inv-11: Relapsing forms of MS

Clinically isolated syndrome (CIS)The first clinical presentation of inflammatory demyelination that may represent MS but does not yet meet diagnostic criteria.

Relapsing remitting MS (RRMS)MS characterized by clearly defined relapses with full or partial recovery (remissions) between attacks.

Active secondary progressive MS (active SPMS)Secondary progressive MS with evidence of disease activity (clinical relapses or MRI activity) and continuing worsening of neurologic function.

Relapsing forms of MS (summary)Includes clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease — patients may be further characterized as active vs not active and worsening vs stable.

Documentation Required

Documentation Requirements

Provider documentation must support the medical necessity of Vumerity. Documentation should include diagnosis of a relapsing form of multiple sclerosis, evidence of specialist consultation or that the prescriber is a neurologist/MS specialist, and objective evidence of clinical response or intolerance when applicable. A definition for documentation has been added to policy guidance; include relevant supporting materials in the prior authorization request.

Required: covered diagnosis of a relapsing form of multiple sclerosis (examples: clinically isolated syndrome, relapsing remitting disease, active secondary progressive disease).
Required: evidence the medication is prescribed by or in consultation with a neurologist or MS specialist.
For continuation (patient currently receiving Vumerity ≥ 1 year): documentation of beneficial clinical response by at least one objective measure, or other supporting clinical information.
Include any prescriber notes, prior therapy history (e.g., trial and intolerance/efficacy of dimethyl fumarate), and objective test results as applicable.