CurrentCignaPolicy IP0732

Graft-Versus-Host Disease - Ryoncil

Coverage policy for prior authorization, dosing, and medical necessity criteria for Ryoncil infusion therapy for pediatric patients with steroid-refractory acute graft-versus-host disease under Cigna-administered health plans.

Policy Summary

PayerCigna

PolicyGraft-Versus-Host Disease - Ryoncil

Policy CodePolicy IP0732

Change TypeNew policy (annual revision notedno criteria changes)

Effective Date05/15/2025

Next Review Date

Key ActionSubmit prior authorization showing the patient meets the listed clinical criteria and dosing (see criteria and dosing).

SourceLink

POLICY UPDATE CHANGES

New policy created with effective date 05/15/2025.

Annual revision on 04/01/2026 indicates no criteria changes.

≥2 months to <18yage range for FDA-approved coverage

up to 12maximum infusions per episode

2×10^6 cells/kgrecommended dose per infusion

28±2 daysresponse assessment timing

J3402HCPCS code for remestemcel-l-rknd

Policy Summary

PayerCigna

PolicyGraft-Versus-Host Disease - Ryoncil

Policy CodePolicy IP0732

Change TypeNew policy (annual revision notedno criteria changes)

Effective Date05/15/2025

Next Review Date

Key ActionSubmit prior authorization showing the patient meets the listed clinical criteria and dosing (see criteria and dosing).

SourceLink

On This Page

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Coverage Criteria for Ryoncil (remestemcel-L-rknd)

FDA-Approved Indication

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

FDA-Approved 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 the durations noted; extended approvals allowed if criteria continue to be met.

Dosing and Treatment Course

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

Dosing: 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.up to 12 infusions

Deliver infusions at least 3 days apart; evaluate for a response 28 ± 2 days after first dose and modify treatment based on Day 28 response (no further treatment for complete response; once weekly x4 additional infusions for partial or mixed response; consider alternative treatments for no response).

Ryoncil (remestemcel‑L‑rknd) is not covered for indications other than steroid‑refractory acute graft‑versus‑host disease as defined in this policy. Specifically, Ryoncil for any other use is considered not medically necessary and will not be approved under this coverage policy.

Criteria and approvals in this policy are limited to the FDA‑approved pediatric indication and the dosing regimen specified; requests for uses outside these parameters should be considered not medically necessary unless and until the policy is updated based on new published data.

Use of Ryoncil for indications outside of the FDA‑approved pediatric population and indication described in this policy is not medically necessary. The policy covers Ryoncil only for patients meeting all components of the FDA‑approved indication: age, diagnosis of steroid‑refractory acute graft‑versus‑host disease, and prescribing by or in consultation with an appropriate specialist.

Requests for Ryoncil to treat conditions other than steroid‑refractory acute GVHD in patients ≥ 2 months to < 18 years will be denied as not medically necessary unless future evidence or policy updates explicitly expand the covered indications.

Covered Regimens and Dosing Schedules

Regimen	Indication / Age Range	Dosing Details	Maximum Infusions per Episode
2 × 10^6 mesenchymal stromal cells/kg IV twice weekly for 4 weeks then once weekly up to 4 additional weeks
Steroid-refractory acute graft-versus-host disease; pediatric patients ≥ 2 months to < 18 years
Intravenous infusion of 2 × 10^6 mesenchymal stromal cells/kg: twice weekly for 4 consecutive weeks (infusions ≥3 days apart), then once weekly for up to 4 additional weeks; evaluate for response 28 ± 2 days after the first dose and adjust treatment per Day 28 response
Up to 12 infusions per episode

Coding and Billing

Covered HCPCS CodesHCPCSCovered

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

inv-06: Response assessment timing

Response assessment timingEvaluate for a response 28 ± 2 days after the first dose

Minimum interval between infusionsDeliver infusions at least 3 days apart

Initial dosing course lengthTwice weekly for 4 consecutive weeks (total of 8 infusions) before Day 28 assessment

Actions based on Day 28 responseNo further Ryoncil for complete response; weekly for 4 weeks for partial/mixed response; consider alternatives for no response

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization and Coding

Prior Authorization is required for benefit coverage of Ryoncil. Claims submitted without a covered diagnosis or without appropriate codes under this policy will be denied. Prior authorization must be obtained before benefits will be considered; approvals are recommended for patients who meet the policy's clinical Criteria and Dosing. Approvals are issued for the duration noted in the policy and may be extended if the patient continues to meet the Criteria and Dosing. Requests for doses outside the dosing described in this policy will be reviewed on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacist).

Prior authorization required for benefits to be considered; claims without covered diagnosis or appropriate codes will be denied.
Approvals are provided for the duration noted and may be extended if criteria continue to be met.
Dose requests outside policy dosing reviewed case-by-case by clinician.

Documentation Required

Prescriber and Dose Documentation

Line of Therapy

Second-line

Line of therapy: Indicated for steroid-refractory acute GVHD (i.e., after failure of first-line corticosteroids).

Considered second-line therapy following inadequate response to first-line systemic corticosteroids; NCCN lists ruxolitinib as preferred category 1 for steroid-refractory acute GVHD; Ryoncil not addressed in NCCN as of referenced version.

Definitions

inv-12: steroid-refractory acute GVHD

DefinitionSteroid-refractory acute GVHD: acute graft-versus-host disease that does not respond to first-line corticosteroids

Clinical contextAcute GVHD is a serious, potentially life‑threatening complication after allogeneic hematopoietic stem cell transplantation; ~20%–80% develop acute GVHD and ~50% of those may not respond to corticosteroids

Implication for therapyIndication for second-line therapies such as Ryoncil when patients fail first-line corticosteroids

Recommended evaluation timing (related)If treated with Ryoncil, evaluate response at 28 ± 2 days after first dose to guide further management

Background

Acute graft‑versus‑host disease (GVHD) is a complication following allogeneic hematopoietic stem cell transplantation in which donor immune cells attack recipient tissues; severe cases can be life‑threatening and may not respond to first‑line corticosteroids. Ryoncil is indicated in this policy for pediatric patients with steroid‑refractory acute GVHD, reflecting its role as a second‑line therapy when initial corticosteroid treatment has failed.

This policy provides coverage for up to 12 infusions per episode using the approved dosing schedule and requires that the medication be prescribed by or in consultation with a hematologist, oncologist, transplant specialist, or a physician associated with a transplant center to ensure appropriate management of this complex, high‑risk clinical condition.