ModifiedmhnPolicy CP.PHAR.537

Ponesimod (Ponvory) for relapsing forms of multiple sclerosis

Defines medical necessity, prior authorization, dosing, and continuation criteria for ponesimod (Ponvory) when used to treat relapsing forms of multiple sclerosis in adults under Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyPonesimod (Ponvory) for relapsing forms of multiple sclerosis

Policy CodePolicy CP.PHAR.537

Change Type2Q 2025 administrative and coverage updates (documentation removal, IL step therapy bypass, continued therapy set to 12 months)

Effective DateJun 1, 2021

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation showing member meets initial approval criteria for relapsing forms of MS.

SourceLink

POLICY UPDATE CHANGES

Removed requirements for documentation of baseline relapses/expanded disability status score and specific measures of positive response.

Removed notation that Extavia is the preferred interferon beta-1b product for the Medicaid line of business.

Modified continued therapy approval duration to a uniform 12 months.

Added step therapy bypass for Illinois HIM per IL HB 5395.

12 monthscontinued therapy approval duration

20 mg/daymaximum maintenance dose

≥18minimum age for coverage

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state legislation prompting bypass

2Q 2025annual review reference

Coverage and Medical Necessity Criteria

Initial Therapy

Covered when ALL of the following are met for Multiple Sclerosis (initial approval):

MS initial approval

Prescriber and age: 2. Prescribed by or in consultation with a neurologist; 3. Age ≥ 18 years.
Concomitant therapy and dosing: 4. Ponvory is not prescribed concurrently with other disease modifying therapies for MS; 5. Request meets dosing requirements: initiation follows the 14-day titration schedule and does not exceed 1 tablet/day; maintenance dose does not exceed 20 mg/day and 1 tablet/day.

Continuation Therapy

Covered when ALL of the following are met for Continued Therapy:

MS continued therapy: 1. Member meets one of: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. Ponvory is not prescribed concurrently with other disease modifying therapies for MS; 4. If request is for a dose increase, new dose does not exceed 20 mg/day and 1 tablet/day.

Approval duration: 12 months.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety consistent with applicable off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage. This policy also explicitly excludes coverage for primary progressive multiple sclerosis.

Per the 2Q 2025 annual review, the policy language was updated to reflect that Extavia (interferon beta-1b) is no longer noted as the preferred interferon beta-1b product for the Medicaid line of business because it is no longer available on the market. This notation was removed from the policy to align with current market availability.

Coverage for primary progressive multiple sclerosis is specifically excluded by this policy and is considered not authorized. Requests for this diagnosis should be denied unless there is an alternative, applicable policy or explicit coverage authority.

Dosage and Coding Reference

inv-06: Maximum daily dose — 20 mg/day

Maximum maintenance dose20 mg/day (maximum dose per MS dosing regimen)

Maximum tablets per day1 tablet per day (maintenance)

Initiation/titration14-day titration schedule with maintenance starting Day 15 at 20 mg PO QD

Provider Requirements, Prior Authorization, and Operational Notes

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must demonstrate that the member meets the initial approval criteria for relapsing forms of multiple sclerosis and submit supporting clinical documentation.

Prior authorization required for initiation and continuation of Ponvory and other disease-modifying therapies for MS.
Providers must show member meets Initial Approval Criteria for relapsing MS (see criteria section).

Prior Authorization

Prior Authorization Duration

Continued therapy approvals are processed via prior authorization and, when approved, are authorized for a 12-month duration.

Continued therapy approval duration: 12 months.
PA processes remain in place for continuation requests.

Key Definitions

inv-17: Relapsing forms of MS definition

Definition (FDA indication)Relapsing forms of MS include clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.

Age groupAdults (FDA-indicated population)

Context — disease-modifying therapiesPonesimod (Ponvory) is listed among MS disease-modifying therapies in Appendix D.

Clinical Background

Ponesimod (Ponvory) is a sphingosine‑1‑phosphate (S1P) receptor modulator approved for the treatment of relapsing forms of multiple sclerosis in adults, which includes clinically isolated syndrome, relapsing‑remitting MS, and active secondary progressive MS. As a disease‑modifying therapy, ponesimod is intended to reduce relapse risk and slow disease activity; treatment initiation follows a defined titration schedule and the maintenance dose must not exceed 20 mg/day. The policy reflects updated administrative changes from the 2Q 2025 review, including removal of certain documentation requirements and confirmation of continued therapy approval durations.

Policy Summary

Payermhn

PolicyPonesimod (Ponvory) for relapsing forms of multiple sclerosis

Policy CodePolicy CP.PHAR.537

Change Type2Q 2025 administrative and coverage updates (documentation removal, IL step therapy bypass, continued therapy set to 12 months)

Effective DateJun 1, 2021

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation showing member meets initial approval criteria for relapsing forms of MS.

SourceLink

On This Page

Step Therapy

IL Step Therapy Bypass for HIM Members

For Illinois Health Insurance Marketplace (HIM) members, step therapy requirements do not apply per IL HB 5395 as of 1/1/2026; include this bypass when processing Illinois HIM requests.

Step therapy bypass applies only to Illinois HIM members per IL HB 5395 (effective 1/1/2026).
Document member plan/state when submitting PA to ensure bypass is applied appropriately.

Step Therapy

Step Therapy for Relapsing‑Remitting MS

Step therapy applies for relapsing‑remitting MS: member must have failed all listed first-line disease-modifying therapies at maximally indicated doses unless contraindicated or clinically significant adverse effects occurred.

Required failures (unless contraindicated or intolerant): dimethyl fumarate, teriflunomide, fingolimod, and an interferon‑beta agent or glatiramer.
Prior authorization may be required for these DMTs; Betaseron noted as preferred interferon beta‑1b for Commercial and HIM lines in source (market availability may change).

Documentation Required

Provider must submit clinical documentation supporting that the member meets all approval criteria.

Acceptable documentation includes office chart notes, laboratory results, and other relevant clinical information.
Per 2Q 2025 review, requirements for baseline relapses, EDSS, and specific measures of positive response have been removed and are not required.

Denial Risk

Triggers for Denial

Denial may be issued if required documentation is missing or if the diagnosis is excluded under this policy (e.g., primary progressive MS).

Missing or incomplete clinical documentation supporting approval criteria can result in denial.
Coverage is not authorized for primary progressive MS and other excluded indications as listed in the policy.

Note

Medicaid Precedence Reminder

State Medicaid provisions take precedence when they conflict with this clinical policy; follow the applicable state Medicaid manual.

For Medicaid members, if state Medicaid coverage provisions conflict with this policy, state provisions supersede.
Consult the state Medicaid manual for state‑specific coverage rules.