CurrentCentenePolicy CP PHAR.537

Ponesimod (Ponvory) for relapsing forms of multiple sclerosis

Defines Centene medical necessity and prior authorization criteria for ponesimod (Ponvory) in adults with relapsing forms of multiple sclerosis and related coverage rules across lines of business.

Policy Summary

PayerCentene

PolicyPonesimod (Ponvory) for relapsing forms of multiple sclerosis

Policy CodePolicy CP PHAR.537

Change TypeRevision and clarification (step therapy exception for IL HIM)

Effective DateJun 1, 2021

Next Review Date

Key ActionObtain prior authorization and submit chart notes showing diagnosis, prior DMT trials or contraindications, neurologist involvement, and dosing within titration/maintenance limits.

SourceLink

POLICY UPDATE CHANGES

Removed requirements for documentation of baseline relapses/EDSS and specific measures of positive response; removed notation that Extavia is preferred interferon beta-1b for Medicaid; modified continued therapy approval duration wording to 12 months.

For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.

12 monthsapproval duration for continued therapy

20 mg/daymaximum maintenance dose

14-daytitration schedule for initiation

Adults ≥18age requirement

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Coverage Criteria for Ponesimod (Ponvory)

Initial Therapy

Covered when ALL of the following are met for Initial Approval (Multiple Sclerosis):

Initial Approval - MS

Diagnosis specifics: a) Clinically isolated syndrome (when member is contraindicated to both or has clinically significant adverse effects to an interferon‑beta agent or glatiramer) OR b) Relapsing‑remitting MS with failure of all of the following at up to maximally indicated doses unless contraindicated or intolerant: (i) dimethyl fumarate, (ii) teriflunomide, (iii) fingolimod, and (iv) an interferon‑beta agent or glatiramer OR c) Secondary progressive MS
Prescriber: Prescribed by or in consultation with a neurologist
Age ≥ 18 years
Concomitant therapy: Not prescribed concurrently with other disease‑modifying therapies for MS
See Appendix D for list of DMTs
Dosing limits: Initiation follows 14‑day titration schedule and maintenance dose does not exceed 20 mg/day (1 tablet/day)

Step therapy - RRMS: For relapsing‑remitting MS, failure of dimethyl fumarate, teriflunomide, fingolimod, and an interferon‑beta agent or glatiramer at maximally indicated doses is required unless contraindicated or intolerant

Illinois HIM exception for step therapy applies per IL HB 5395

Continuation Therapy

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

Continued Therapy: Member is currently receiving medication via Centene benefit or previously met initial approval criteria; member is responding positively to therapy; ponesimod is not used concurrently with other MS DMTs; if request is for dose increase the new dose does not exceed 20 mg/day (1 tablet/day)

Approval duration: 12 months

Requests for ponesimod will not be authorized when the member’s diagnosis is primary progressive multiple sclerosis. This diagnosis is listed among the conditions for which coverage is not authorized and will result in denial of the request.

Use of ponesimod for indications that are not FDA‑approved is not authorized under this policy unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP PMN.53 (Medicaid) or other relevant evidence of coverage documents.

Drug and Dosing Codes / Key Dosing Limits

Drug identifiermixed

Ponvory

Ponesimod (brand name provided in policy)

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

Maximum daily dose20 mg/day (maximum maintenance dose)

inv-07: Titration duration — 14-day titration schedule

Titration duration14-day titration schedule for treatment initiation (per dosing regimen Days 1–14)

Provider Requirements, Prior Authorization, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must document the diagnosis, prior DMT trials or contraindications, neurologist involvement, age, and that Ponvory is not used concurrently with other MS disease‑modifying therapies. Provider must submit supporting documentation (office chart notes, lab results, or other clinical information) that the member meets all approval criteria.

Prior authorization required for Ponvory and other MS disease‑modifying therapies (see policy).
Submit office chart notes, lab results, or other clinical information to support the request.

Step Therapy

Step Therapy for Relapsing‑Remitting MS

For relapsing‑remitting multiple sclerosis (RRMS), step therapy requirements must be documented: failure of or contraindication to all of the following agents at up to maximally indicated doses is required unless there are clinically significant adverse effects or contraindications: dimethyl fumarate, teriflunomide, fingolimod, and an interferon‑beta agent or glatiramer acetate. Note: Illinois HIM requests are exempt from these step therapy requirements per IL HB 5395 effective 01/01/2026.

Background on Ponesimod

Ponesimod (Ponvory) is a sphingosine 1‑phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis, which includes clinically isolated syndrome, relapsing‑remitting MS, and active secondary progressive MS in adults. The prescribing regimen includes a 14‑day titration schedule with a maintenance dose not to exceed 20 mg/day (one tablet daily).

Definitions and Terms

inv-14: Relapsing forms of multiple sclerosis — definition (CIS, RRMS, active SPMS)

Included diagnosesClinically isolated syndrome (CIS), relapsing‑remitting MS (RRMS), and active secondary progressive MS (SPMS)

inv-15: Disease‑modifying therapies — list of referenced agents used to modify MS disease course

Interferons and glatiramerInterferon beta‑1a and beta‑1b (Avonex, Rebif, Betaseron/Extavia, Plegridy) and glatiramer acetate (Copaxone, Glatopa)

Oral fumarates and derivativesDimethyl fumarate (Tecfidera), diroximel fumarate (Vumerity), monomethyl fumarate (Bafiertam)

Sphingosine‑1‑phosphate modulatorsFingolimod (Gilenya), siponimod (Mayzent), ozanimod (Zeposia), ponesimod (Ponvory)

Other oral agentsTeriflunomide (Aubagio), cladribine (Mavenclad)

Policy Summary

PayerCentene

PolicyPonesimod (Ponvory) for relapsing forms of multiple sclerosis

Policy CodePolicy CP PHAR.537

Change TypeRevision and clarification (step therapy exception for IL HIM)

Effective DateJun 1, 2021

Next Review Date

Key ActionObtain prior authorization and submit chart notes showing diagnosis, prior DMT trials or contraindications, neurologist involvement, and dosing within titration/maintenance limits.

SourceLink

On This Page

Required prior DMTs: dimethyl fumarate; teriflunomide; fingolimod; an interferon‑beta agent (Avonex, Betaseron/Extavia, Rebif, Plegridy) OR glatiramer (Copaxone, Glatopa).
Illinois HIM exemption: IL HB 5395 — step therapy requirements do not apply for Illinois HIM as of 1/1/2026.

Documentation Required

Required Documentation

Provider must submit office chart notes, lab results, or other clinical information supporting that the member meets all approval criteria, including documentation of prior DMT trials, adverse effects or contraindications, neurologist consultation/prescription, age, and dosing/titration plan.

Include evidence of trials and dates/doses of prior DMTs or documentation of contraindications/adverse effects.
Confirm prescription by or in consultation with a neurologist.
Provide dosing information and adherence to titration schedule.

Denial Risk

Excluded Diagnoses and Indications

Requests will be denied if the diagnosis is primary progressive MS. Requests for non‑FDA approved indications not addressed in this policy will be denied unless sufficient documentation of efficacy and safety is provided per the applicable off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents.

Primary progressive MS is excluded from coverage under this policy.
Non‑FDA indications require robust off‑label justification per payer off‑label policies.

Denial Risk

Step Therapy Denial Risk

There is a denial risk if step therapy failure requirements for RRMS are not documented. Ensure documentation shows failure, intolerance, or contraindication to the specified prior DMTs to avoid denial.

Failure/intolerance/contraindication to dimethyl fumarate, teriflunomide, fingolimod, and an interferon‑beta agent or glatiramer must be documented.
If documentation is incomplete or absent, the request may be denied.

Monoclonal antibodies and infusion therapiesAlemtuzumab (Lemtrada), mitoxantrone (Novantrone), natalizumab (Tysabri), ocrelizumab (Ocrevus and biosimilars), ofatumumab (Kesimpta), ublituximab (Briumvi)