CurrentCignaPolicy N/A

Mayzent (siponimod) prior authorization for multiple sclerosis

Defines prior authorization requirements, medical necessity criteria, covered indications, exclusions, prescriber specialization, approval durations, and appendix of other MS disease-modifying therapies for Mayzent (siponimod) for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyMayzent (siponimod) prior authorization for multiple sclerosis

Policy CodePolicy N/A

Change TypeReview Date updated (no criteria changes)

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and ensure Mayzent is prescribed by or in consultation with a neurologist or MS specialist; document objective evidence of benefit for continuation beyond 1 year.

POLICY UPDATE CHANGES

Review Date updated to 07/23/2025 with Early Annual Revision noted; no criteria changes stated in history.

1Approval Duration (years)

2Covered Indication Categories

2Primary Exclusions

Coverage Summary

Overview: This policy defines prior authorization requirements and medical necessity criteria for Mayzent (siponimod) for relapsing forms of multiple sclerosis. The coverage stance is covered with criteria for FDA‑approved relapsing MS indications. Status: CURRENT. Effective/last review date: 07/23/2025.

Medical-Necessity Criteria

FDA-Approved Indication

Approve for the duration noted below if the patient meets ONE of the following (A or B):

ANY of the following

A) Initial Therapy - Approve for 1 year
- Patient has a relapsing form of multiple sclerosis
  Examples 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) Currently Receiving Mayzent ≥ 1 Year - Approve for 1 year
- Patient has a relapsing form of multiple sclerosis
  Examples include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease.
- At least one of:
  - Patient experienced a beneficial clinical response when assessed by at least one objective measure
    Examples include stabilization or reduced worsening in MRI activity (absence or decrease in gadolinium enhancing lesions, decrease in new/enlarging T2 lesions); stabilization or reduced worsening on EDSS; achievement of NEDA-3 or NEDA-4; improvement on FSIQ-RMS; reduction/absence of relapses; improvement/maintenance on 6-minute walk test or 12-Item MS Walking Scale; improvement on MSFC; attenuation of brain volume loss.
  - Patient 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 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 (Not Medically Necessary)

Mayzent is considered not medically necessary for ANY other use(s) including the following:

ALL of the following

Current use with other disease-modifying agents used for multiple sclerosis
Combination therapy with other MS disease-modifying agents is considered not medically necessary; additional data required for safety/efficacy. See Appendix for examples.
Non-relapsing forms of multiple sclerosis
Efficacy of Mayzent has not been established in patients with non-relapsing forms of the disease (example: primary progressive multiple sclerosis).

Provider Actions & Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is recommended/required for prescription benefit coverage of Mayzent. Approvals are provided for the duration noted (typically 1 year).

Approval duration: 1 year

Documentation Required

Prescriber Specialty Requirement

Mayzent must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis for both initial and continuation approvals.

Documentation Required

Objective Evidence for Continuation

For patients currently receiving Mayzent for ≥ 1 year, documentation of treatment benefit is required via at least one objective measure or clinical symptom stabilization/improvement.

Magnetic resonance imaging (MRI) findings (e.g., absence or decrease in gadolinium-enhancing lesions; decrease in new/enlarging T2 lesions)
Expanded Disability Status Scale (EDSS) stabilization or reduced worsening
Achievement of No Evidence of Disease Activity (NEDA-3 or NEDA-4)
Reduction or absence of relapses
Improvement or maintenance on functional tests (e.g., six-minute walk test, 12-Item MS Walking Scale, MSFC, FSIQ-RMS)
Attenuation of brain volume loss or other objective measures

Denial Risk

Combination Therapy Exclusion

Claims for Mayzent used in combination with other disease-modifying agents for multiple sclerosis are considered not medically necessary and may be denied. See the Appendix for examples of other MS disease-modifying agents.

Denial Risk

Non-Relapsing MS Exclusion

Use of Mayzent for non-relapsing forms of multiple sclerosis (for example, primary progressive MS) is considered not medically necessary and may be denied.

Background & Evidence

Mayzent (siponimod) is an oral sphingosine 1‑phosphate (S1P) receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease in adults.

Key safety concerns from the prescribing information and policy include decreases in heart rate at initiation with recommended first‑dose 6‑hour monitoring in certain patients with preexisting cardiac conditions (additional monitoring may be required), and multiple class and product warnings/precautions such as infections, progressive multifocal leukoencephalopathy, macular edema, bradyarrhythmias and atrioventricular conduction delays, respiratory effects, liver injury, cutaneous malignancies, increased blood pressure, and posterior reversible encephalopathy syndrome.

Source	Reference
Prescribing information	Mayzent tablets [prescribing information], Novartis; June 2024
Guideline consensus	MS Coalition consensus on disease-modifying therapies, Sept 2019

Relapsing forms of multiple sclerosis: Includes clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease (examples cited in the policy).

Non‑relapsing forms of multiple sclerosis: Includes primary progressive multiple sclerosis; Mayzent efficacy has not been established for non‑relapsing forms and use in these cases is considered not medically necessary.

Revision History

07/23/2025policy_reviewLatest

Review Date updated to 07/23/2025 with Early Annual Revision noted; no criteria changes (not material).

10/09/2024annual_revision

Annual Revision; Ocrevus Zunovo was added to the Appendix; no criteria changes.

11/08/2023annual_revision

Annual Revision; No criteria changes.

08/10/2023update

Update, Summary of Changes: No criteria changes; Appendix updated to add Briumvi and Tascenso ODT; noted Aubagio available as generic.

Aubagio (teriflunomide)	oral
Avonex (interferon beta-1a)	intramuscular injection
Bafiertam (monomethyl fumarate)	oral
Betaseron (interferon beta-1b)	subcutaneous injection
Briumvi (ublituximab-xiiy)	intravenous infusion
Copaxone (glatiramer acetate)	subcutaneous injection
Gilenya (fingolimod)	oral
Glatopa (glatiramer acetate)	subcutaneous injection
Kesimpta (ofatumumab)	subcutaneous injection
Lemtrada (alemtuzumab)	intravenous infusion

OpenPayer