CurrentCignaPolicy IP0262

Mayzent (siponimod) coverage

Cigna coverage policy for Mayzent (siponimod) for treatment of relapsing forms of multiple sclerosis in adults, detailing medical necessity, documentation, and formulary/preferred product considerations affecting members of Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyMayzent (siponimod) coverage

Policy CodePolicy IP0262

Change TypeMaterial and non-material updates (specialist prescribing requirementrenewal/documentation criteriaminor editorial updates)

Effective DateDec 1, 2024

Next Review Date

Key ActionObtain prior authorization and ensure the prescription is by or in consultation with a neurologist or MS specialist; initial approval is for 1 year.

SourceLink

POLICY UPDATE CHANGES

Added a specialist prescribing requirement.

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

Added a definition for documentation.

Removed Employer Plans preferred product requirements.

Ocrevus Zunovo was added to the Appendix.

1 yearstandard approval duration

≥1 yearcontinuation criterion

6 hoursfirst-dose monitoring

relapsing formsindication scope

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Coverage Criteria for Mayzent (siponimod)

inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial Therapy: i. Documentation the patient has a relapsing form of multiple sclerosis (examples include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease). ii. Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis. iii. Preferred product criteria is met for the product(s) as listed in the table for Individual and Family Plans.approve for 1 year

Documentation required as noted.

inv-02: Continuation Therapy

Covered when ALL of the following are met:

Continuation Therapy (Currently Receiving ≥ 1 year): i. Documentation the patient has a relapsing form of multiple sclerosis. ii. Patient meets one of: (a) experienced a beneficial clinical response assessed by at least one objective measure (examples include stabilization or reduced worsening on MRI [absence or decrease in gadolinium-enhancing lesions or new/enlarging T2 lesions], stabilization on EDSS, achievement of NEDA-3/NEDA-4, reduction in relapses, improvement on MSFC or 6-minute walk, attenuation of brain volume loss, or improvement on FSIQ-RMS), OR (b) experienced stabilization, slowed progression, or improvement in at least one symptom such as motor function, fatigue, vision, bowel/bladder function, spasticity, walking/gait, or 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.approve for 1 year

Objective measures examples include MRI lesion activity, EDSS stabilization, NEDA criteria, relapse reduction, MSFC, 6-minute walk, FSIQ-RMS, and brain volume loss.

inv-03: Individual and Family Plans criteria

Coverage available when ONE of the following is met:

Individual & Family Plans Conditions: 1) Documentation of failure, contraindication, or intolerance to dimethyl fumarate (generic for Tecfidera); OR 2) Individual has active secondary progressive multiple sclerosis (SPMS); OR 3) Currently receiving Mayzent.

Receipt of sample product does not satisfy criteria.

Use of Mayzent in combination with other disease-modifying therapies for multiple sclerosis is not supported by the evidence and is explicitly listed as a condition not covered. Combination therapy with other MS disease-modifying agents is considered experimental or investigational because these products are not indicated for concurrent use and additional data are needed to establish safety and additive efficacy.

Use of Mayzent for non-relapsing forms of multiple sclerosis (for example, primary progressive MS) is not covered. The policy states the efficacy of Mayzent has not been established for non-relapsing MS, and such uses are considered experimental, investigational, or unproven.

Any indication or use of Mayzent that is not specifically listed in this policy is considered not medically necessary and is treated as experimental, investigational, or unproven. Examples explicitly called out include combination therapy with other disease-modifying MS agents and use in non-relapsing forms of MS.

Referenced Products, Codes, and Monitoring

Referenced products and comparatorsmixed

Mayzent	siponimod tablets (oral)
Tecfidera / dimethyl fumarate	comparison/preferred product referenced (oral)
Ocrevus Zunovo	ocrelizumab and hyaluronidase-ocsq (subcutaneous) - added to Appendix
Other listed MS disease-modifying agents	Appendix lists multiple MS agents and modes of administration

First-dose monitoring (inv-07)

First-dose monitoring duration6 hours when recommended (additional monitoring may be required; repeat monitoring after reinitiation if treatment interrupted ≥4 days)

Context for monitoringRecommended for certain patients with preexisting cardiac conditions due to decreases in heart rate on initiation

Reinitiation requirementIf therapy is interrupted for ≥4 consecutive daily doses, reinitiate with Day 1 titration and complete first-dose monitoring for patients for whom it is recommended

Prior Authorization, Documentation, and Plan Requirements

Prior Authorization

Prior authorization required; standard 1-year approval

Prior authorization is required for Mayzent; initial and renewal approvals are for 1 year when the patient has a relapsing form of multiple sclerosis, the medication is prescribed by or in consultation with a neurologist or MS specialist, and preferred product criteria (for Individual and Family Plans) are met. Renewal for patients currently receiving Mayzent ≥ 1 year requires documentation of benefit and specialist prescribing.

Initial approval: 1 year when ALL initial criteria are met (relapsing MS, specialist prescribing/consultation, IFP preferred product criteria).
Renewal/continuation: 1 year when patient is currently receiving Mayzent ≥ 1 year with documentation of benefit and specialist involvement.

Step Therapy

IFP step: one qualifying condition required

For Individual and Family Plans coverage is available when ONE of the listed conditions is met: failure/contraindication/intolerance to dimethyl fumarate (generic Tecfidera), the individual has active secondary progressive MS (SPMS), or the member is currently receiving Mayzent.

Background on Mayzent (siponimod)

Mayzent (siponimod) is a sphingosine 1-phosphate (S1P) receptor modulator approved for the treatment of relapsing forms of multiple sclerosis, which include clinically isolated syndrome, relapsing‑remitting MS, and active secondary progressive MS. It acts by modulating S1P receptors to reduce lymphocyte migration and neuroinflammation, addressing the relapsing inflammatory component of MS.

The policy covers Mayzent when patients meet the defined clinical criteria for relapsing disease and other requirements (for example, prescribing by or in consultation with a neurologist or MS specialist and documentation as noted). For patients currently receiving Mayzent, the policy includes renewal criteria requiring evidence of benefit and specialist involvement.

Definitions and Documentation

Relapsing forms of MS (inv-13)

Clinically isolated syndrome (CIS)Included as a relapsing form of multiple sclerosis

Relapsing-remitting multiple sclerosis (RRMS)Included as a relapsing form of multiple sclerosis

Active secondary progressive multiple sclerosis (active SPMS)Included as a relapsing form of multiple sclerosis

Documentation (inv-14)

Acceptable documentation typesChart notes, laboratory tests, claims records, and/or other relevant clinical information

When documentation is requiredDocumentation is required where noted in the coverage criteria or renewal requirements