CurrentCignaPolicy IP0732

Graft-Versus-Host Disease - Ryoncil

Defines Cigna's prior authorization, coverage criteria, dosing, and coding for Ryoncil (remestemcel‑L) for treatment of steroid‑refractory acute GVHD in pediatric patients; applies to health benefit plans administered by Cigna Companies.

Policy Summary

PayerCigna

PolicyGraft-Versus-Host Disease - Ryoncil

Policy CodePolicy IP0732

Change TypeNew policycoding updates

Effective Dateas written

Next Review Date

Key ActionObtain prior authorization and document steroid‑refractory acute GVHD diagnosis, appropriate prescriber specialty, and requested dosing per policy.

SourceLink

POLICY UPDATE CHANGES

Added HCPCS J3402 for remestemcel‑l‑rknd effective 10/1/2025.

Updated description for J3590 to include note that code is effective until 09/30/2025.

New policy created for Ryoncil with effective/creation date 05/15/2025.

2 months to <18 yearsage range for FDA‑approved indication

up to 12maximum approved infusions

2 × 10^6 cells/kgrecommended dose

J3402HCPCS code added

Coverage Criteria for Ryoncil (remestemcel‑L)

Policy Summary

PayerCigna

PolicyGraft-Versus-Host Disease - Ryoncil

Policy CodePolicy IP0732

Change TypeNew policycoding updates

Effective Dateas written

Next Review Date

Key ActionObtain prior authorization and document steroid‑refractory acute GVHD diagnosis, appropriate prescriber specialty, and requested dosing per policy.

SourceLink

On This Page

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inv-01: Initial FDA‑Approved Coverage

Approve for up to twelve infusions per episode if the patient meets ALL of the following (A, B, and C):

FDA-approved pediatric indication: A) Patient is ≥ 2 months of age and < 18 years of age; AND B) Patient has steroid-refractory acute graft-versus-host disease; AND C) The medication is prescribed by or in consultation with a hematologist, oncologist, transplant specialist physician, or a physician associated with a transplant center.

Approvals provided for duration noted; extended approvals allowed if criteria continue to be met.

inv-02: Dosing Criteria

Dosing. Approve if the requested dosing meets BOTH of the following (A and B):

Dosing requirements: A) 2 × 10^6 mesenchymal stromal cells/kg body weight given by intravenous infusion; AND B) Infusions are administered twice weekly for 4 weeks, then once weekly for up to 4 additional weeks for a total of up to 12 infusions per episode.2 × 10^6 cells/kg; up to 12 infusions

Deliver infusions at least 3 days apart; evaluate response approximately Day 28 (28 ± 2 days) and adjust per Day 28 response as described in dosing guidance.

Ryoncil (remestemcel‑L) is covered only for the FDA‑approved pediatric indication: treatment of steroid‑refractory acute graft‑versus‑host disease in patients who are ≥ 2 months and < 18 years of age and when prescribed by or in consultation with a hematologist, oncologist, transplant specialist, or a physician associated with a transplant center. Ryoncil for any other use is considered not medically necessary. This policy will be updated if new published data become available.

Use of Ryoncil outside the specified FDA‑approved pediatric population and indication is not covered. Specifically, use of Ryoncil for indications other than steroid‑refractory acute graft‑versus‑host disease in pediatric patients (≥ 2 months to < 18 years) is not medically necessary under this policy.

Regimen	Details
Remestemcel-L (Ryoncil) dosing regimen
2 × 10^6 mesenchymal stromal cells/kg per IV infusion; administer twice weekly for 4 weeks (8 infusions), then once weekly for up to 4 additional weeks for a total of up to 12 infusions per episode. Deliver infusions at least 3 days apart; evaluate response ~Day 28 (28 ± 2 days) and adjust further treatment based on Day 28 response (no further treatment if complete response; once weekly x4 weeks for partial/mixed response; consider alternatives for no response; repeat twice weekly x4 weeks for recurrence after complete response).

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Approve when patient meets age, diagnosis, prescriber specialty, and dosing regimen criteria. Requests for doses outside the dosing documented in this policy will be reviewed case‑by‑case by a clinician (Medical Director or Pharmacist).

Prior authorization is required for medical benefit coverage of Ryoncil.
Approvals are for the duration noted in the policy; extended approvals allowed if patient continues to meet Criteria and Dosing.
Requests for non‑standard dosing considered case‑by‑case by a clinician.

Step Therapy

Prior Therapy Requirement

Prior therapy requirement: Ryoncil is indicated only for patients with steroid‑refractory acute graft‑versus‑host disease. The patient must have failed first‑line corticosteroid therapy (steroid‑refractory). Consideration of alternative therapies (for steroid‑refractory acute GVHD) per guideline context includes ruxolitinib as the NCCN category 1 recommended agent and other category 2A options (e.g., alemtuzumab, alpha‑1 antitrypsin, ATG, basiliximab, calcineurin inhibitors, etanercept, extracorporeal photopheresis, infliximab, mTOR inhibitors, mycophenolate mofetil, pentostatin, tocilizumab, vedolizumab).

Patient must meet steroid‑refractory acute GVHD requirement (failure of first‑line corticosteroids) before Ryoncil is approved.
Alternative agents per NCCN include ruxolitinib (category 1) and other category 2A therapies.

Documentation Required

Prescriber and Approval Documentation

Prescriber and approval documentation: Because of required specialized skills for evaluation, diagnosis, monitoring of adverse events, and long‑term efficacy, Ryoncil must be prescribed by or in consultation with a hematologist, oncologist, transplant specialist physician, or a physician associated with a transplant center. Documentation of the consulting specialist (if applicable), the covered diagnosis (steroid‑refractory acute GVHD), and the requested dosing regimen (2 × 10^6 MSC/kg IV per infusion; twice weekly ×4 weeks then once weekly up to 4 additional weeks; up to 12 infusions) must be included with the authorization request.

Medication must be prescribed by or in consultation with a hematologist, oncologist, transplant specialist, or physician associated with a transplant center.
Include documentation of steroid‑refractory acute GVHD diagnosis and prior corticosteroid therapy failure.
Include requested dosing regimen and infusion schedule when submitting authorization request.

Denial Risk

Denial Triggers

Denial triggers — Claims or authorization requests lacking a covered diagnosis, lacking required prescriber/consultation documentation, not meeting the steroid‑refractory requirement, or requesting doses/regimens outside the policy without clinical justification will be denied. Prior authorization is required; claims submitted without prior authorization and without covered codes will be denied as not covered.

Claims submitted without covered diagnosis or procedure codes under this policy will be denied.
Requests that do not document steroid‑refractory status (failure of first‑line corticosteroids) will be denied.
Prior authorization required; lack of required prior authorization may result in claim denial.

Clinical Background

Acute graft‑versus‑host disease (acute GVHD) is an immune‑mediated complication that occurs after allogeneic hematopoietic stem cell transplantation when donor T cells mount an inflammatory response against recipient tissues, potentially causing systemic inflammation and end‑organ damage. It affects a substantial proportion of transplant recipients and can be severe; when patients fail first‑line corticosteroid therapy they are considered to have steroid‑refractory acute GVHD, the setting for which Ryoncil is indicated in pediatric patients. Management decisions should account for disease severity, prior therapies, and available evidence when considering second‑line options.

OpenPayer

Graft-Versus-Host Disease - Ryoncil

Coverage Criteria for Ryoncil (remestemcel‑L)

Recommended and Approved Regimens

Billing and Coding

Provider Actions and Requirements

Line of Therapy and Positioning

Definitions

Clinical Background

J3402	Injection, remestemcel-l-rknd, per therapeutic dose (Code effective 10/1/2025).
J3590	Unclassified biological (Code effective until 09/30/2025).