CurrentCignaPolicy N/A

Mayzent (siponimod) prior authorization for multiple sclerosis

Defines Cigna's prior authorization requirements, coverage criteria, and limitations for Mayzent (siponimod) for treatment of relapsing forms of multiple sclerosis for covered members and prescribers.

Policy Summary

PayerCigna

PolicyMayzent (siponimod) prior authorization for multiple sclerosis

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateJul 23, 2025

Key ActionObtain prior authorization for Mayzent; approvals are issued for 1 year for initial and continuation therapy when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearapproval duration

Relapsing formscovered indications

Concomitant DMTs / non-relapsing MSnot medically necessary

6-hourfirst-dose monitoring

Coverage Criteria for Mayzent (siponimod)

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Overall: Approve if the patient meets ONE of the following: A) Initial Therapy OR B) Patient is Currently Receiving Mayzent ≥ 1 year.

Approvals are for 1 year.

A) Initial Therapy

A.i: Patient has a relapsing form of multiple sclerosis
Examples: clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease.
A.ii: 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 Mayzent for ≥ 1 Year

B.i: Patient has a relapsing form of multiple sclerosis
Examples: clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease.
B.ii: Patient meets ONE of the following: (a) experienced a beneficial clinical response when assessed by at least one objective measure OR (b) experienced stabilization, slowed progression, or improvement in at least one symptom (motor function, fatigue, vision, bowel/bladder function, spasticity, walking/gait, or pain/numbness/tingling).
Objective measure examples include: MRI (absence or decrease in gadolinium‑enhancing lesions; decrease in new or enlarging T2 lesions), stabilization or reduced worsening on EDSS, achieving NEDA‑3/NEDA‑4, improvement on FSIQ‑RMS, reduction/absence of relapses, improvement/maintenance on 6‑minute walk or 12‑Item MS Walking Scale, improvement on MSFC, and/or attenuation of brain volume loss.
B.iii: Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis

Use of Mayzent (siponimod) in combination with other disease‑modifying therapies for multiple sclerosis is not medically necessary. The policy states that these agents are not indicated for concurrent use and additional data are required to determine whether combination therapy is safe and provides added efficacy. (See Appendix for examples of disease‑modifying therapies.)

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization and Prescriber/Documentation Requirements

Prior authorization is required for Mayzent (siponimod). Approvals are provided for 1 year for both initial and continuation therapy when the criteria in this policy are met. Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with Mayzent, the medication must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis. Documentation must show the patient has a relapsing form of multiple sclerosis (examples include clinically isolated syndrome, relapsing–remitting disease, and active secondary progressive disease). Claims submitted without covered diagnosis or procedure codes, or requests that do not meet the policy criteria, will be denied as not covered.

Prior authorization required; approvals valid for 1 year for initial and continuation therapy
Medication must be prescribed by or in consultation with a neurologist or MS specialist
Documentation must demonstrate a relapsing form of multiple sclerosis
Claims lacking covered diagnosis/procedure codes or not meeting policy criteria will be denied

Denial Risk

Concomitant Therapy Restriction

Mayzent is considered not medically necessary for use in combination with other disease‑modifying therapies (DMTs) for multiple sclerosis. The policy appendix lists examples of other DMTs; concurrent use of Mayzent with these agents is not supported due to insufficient evidence on safety and additive efficacy. Requests for concomitant therapy with another listed DMT will be denied as not medically necessary.

Concomitant use with other disease‑modifying agents listed in Appendix is not medically necessary
See Appendix for examples of affected agents (e.g., fingolimod, ozanimod, ocrelizumab, cladribine, natalizumab, etc.)

Denial Risk

Denial Triggers and Documentation Risks

Claims or authorization requests that do not include a covered diagnosis or applicable procedure code, or that fail to meet the specific policy criteria (including prescriber type and documented relapsing disease), are subject to denial as not covered. Providers should ensure submitted documentation supports the criteria (diagnosis, objective measures of benefit for continuation where applicable, and prescriber specialty) to avoid denial.

Absence of covered diagnosis/procedure codes → denial as not covered
Requests not meeting policy criteria (including documentation, prescriber, or concomitant therapy rules) → denial as not covered

Background

Mayzent (siponimod) is a sphingosine 1‑phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis. Multiple sclerosis is a chronic inflammatory demyelinating disease with relapsing and progressive courses; relapsing forms include clinically isolated syndrome, relapsing‑remitting MS, and active secondary progressive MS. This policy requires prior authorization for Mayzent and defines coverage only for the relapsing MS populations for which benefit has been demonstrated; uses outside those indications are considered not medically necessary.

Definitions

inv-09: Relapsing forms of multiple sclerosis — includes clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease.

DefinitionRelapsing forms of multiple sclerosis include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease.

Scope (patients)Applies to adults with relapsing forms of multiple sclerosis as defined above.

Examples of relapsing formsClinically isolated syndrome; relapsing remitting MS; active secondary progressive MS.

Context in coverage criteriaRequired element for approval: patient must have a relapsing form of MS for initial or continued Mayzent therapy.

Source drug indicationMayzent (siponimod) is indicated for treatment of relapsing forms of multiple sclerosis.