CurrentEmblemHealthPolicy N/A

Ryoncil (remestemcel-L-rknd) intravenous infusion — Coverage Criteria

Medical coverage criteria for Ryoncil (remestemcel-L-rknd) IV infusion for treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in pediatric patients; governs prior authorization, renewal, coding, and documentation requirements for EmblemHealth members.

Policy Summary

PayerEmblemHealth

PolicyRyoncil (remestemcel-L-rknd) intravenous infusion — Coverage Criteria

Policy CodePolicy N/A

Change TypeAdministrative — no material clinical changes

Effective DateApr 30, 2025

Next Review DateApr 30, 2025

Key ActionObtain prior authorization; initial coverage provided for 1 month with documentation demonstrating the member meets the coverage criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 monthsmin age

16max doses

1 monthauth length

D89.810ICD-10

Coverage Criteria for Ryoncil (remestemcel-L-rknd)

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Universal eligibility: Patient is at least 2 months of ageage >= 2 months

Indication: Diagnosis of acute graft-versus-host disease (aGVHD)

Steroid-refractory requirement: Patient has steroid-refractory disease defined as progression within 3 days, or no improvement within 7 days of consecutive treatment with 2 mg/kg/day methylprednisolone or equivalent

Organ involvement exclusions: No skin-only involvement and no evidence of encephalopathy, diffuse alveolar hemorrhage, or other active pulmonary disease

Hypersensitivity exclusions: No known hypersensitivity to dimethyl sulfoxide (DMSO) or porcine and bovine proteins

Transplant status: Patient is post-allogeneic stem cell transplant (symptoms of aGVHD typically appear within 100 days)

Renewal Therapy Criteria

Renewal covered when ALL of the following are met

Continue baseline criteria: Patient continues to meet the universal and indication-specific criteria identified in Initial Criteria

Toxicity: Absence of unacceptable toxicity from the drug (examples include severe infusion‑related reactions or hypersensitivity)

Renewal dosing options: Either patient will require 4 additional weekly doses OR patient will require 8 additional twice‑weekly doses

Response requirement for renewal: Patient has experienced at minimum a partial response (organ improvement of at least 1 stage without worsening in any other organ) OR a mixed response (improvement in at least 1 evaluable organ with worsening in another); patients with complete response or no response will be reviewed on a case‑by‑case basis and are not routinely eligible for renewal

Coverage for Ryoncil excludes patients with skin-only aGVHD involvement and excludes those with evidence of encephalopathy, diffuse alveolar hemorrhage, or other active pulmonary disease. These organ-involvement exclusions must be documented in the clinical record and will be applied when determining medical necessity for treatment.

For renewal requests, members must continue to meet the initial eligibility criteria and have absence of unacceptable toxicity (for example, severe infusion-related or hypersensitivity reactions). Renewal dosing options are limited to either four additional weekly doses or eight additional twice-weekly doses as specified. Importantly, patients who have achieved a complete response (CR) or who have no response are not routinely eligible for renewal; such cases will be reviewed on a case-by-case basis.

Regimen	Initial dosing	Renewal dosing (if renewal criteria met)	Max total doses / notes
Ryoncil (remestemcel-L-rknd) intravenous infusion for steroid-refractory acute graft-versus-host disease (aGVHD) in pediatric patients post-allogeneic stem cell transplant	Up to 225 million MSC administered twice weekly for 4 weeks (initial course)	If renewal criteria met: either 4 additional weekly doses OR 8 additional twice-weekly doses (patient must meet renewal criteria including partial or mixed response and absence of unacceptable toxicity)	Maximum dosing described as 225 million MSC twice weekly for 4 weeks (initial) with possible additional doses per renewal — up to 16 total doses for the initial 4-week course; renewal dosing defined separately

Coding and Dosing Limits

Applicable Procedure CodesHCPCS

C9399	Unclassified drugs or biologicals
J3590	Unclassified biologics

Applicable NDCsNDC

73648-00111-XX	Ryoncil <12.5kg 1 x 3.8 ML
73648-0112-XX
73648-0113-XX	Ryoncil To <37.5kg 3 x 3.8 ML
73648-0114-XX	Ryoncil 37.5kg To <50kg 4 x 3.8 ML
73648-0115-XX	Ryoncil To <62.5kg 5 x 3.8 ML
73648-0116-XX	Ryoncil 62.5kg To <75kg 6 x 3.8 ML
73648-0118-XX	Ryoncil 75kg To <87.5kg 7 x 3.8 ML
73648-0118-XX	Ryoncil 87.5kg To <100kg 8 x 3.8 ML

Applicable ICD-10 DiagnosesICD-10Covered

D89.810

Acute Graft-Versus-Host Disease

Max total doses

Maximum total dosing regimen225 million MSC twice a week for 4 weeks (up to 16 total doses)

Dosing frequencyTwice weekly during the 4-week initial course

Maximum number of dosesUp to 16 total doses

HCPCS unit contextListed under Max Units (per dose and over time) [HCPCS Unit] in policy

Prior Authorization, Documentation, and Operational Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial coverage will be provided for 1 month. Maximum dosing per authorization: up to 225 million MSC twice weekly for up to 16 doses.

Prior authorization required
Initial authorization length: 1 month
Max dosing: up to 225 million MSC twice weekly for up to 16 doses

Denial Risk

Steroid-Refractory Requirement

Patient must have steroid-refractory acute graft-versus-host disease (aGVHD). Steroid-refractory is defined as disease that shows progression within 3 days, or no improvement within 7 days of consecutive treatment with methylprednisolone (or equivalent) at 2 mg/kg/day.

Steroid treatment: methylprednisolone 2 mg/kg/day or equivalent
Progression within 3 days OR no improvement within 7 days = steroid-refractory

Documentation Required

Required Clinical Documentation

The treating provider must submit clinical documentation demonstrating that the member meets coverage criteria. Documentation should include evidence of age, steroid-refractory status (including steroid dosing and response timeline), treatment history, organ involvement (no skin-only involvement; absence of encephalopathy or diffuse alveolar hemorrhage or other active pulmonary disease), confirmation of post-allogeneic stem cell transplant status, contraindications/hypersensitivities (e.g., DMSO or porcine/bovine proteins), dosing plan, and planned response assessments. Without this documentation, EmblemHealth will not be able to properly review the request.

Confirm member age (≥ 2 months)
Document steroid-refractory status with dates, dose (methylprednisolone 2 mg/kg/day or equivalent), and objective response or progression
Provide treatment history and indication of post-allogeneic stem cell transplant
Specify organ involvement and absence of excluded conditions (skin-only involvement, encephalopathy, diffuse alveolar hemorrhage, other active pulmonary disease)
List known hypersensitivities (DMSO, porcine/bovine proteins)
Provide proposed dosing regimen and plan for response assessment

Denial Risk

Missing Clinical Documentation

Requests that lack the submitted clinical evidence demonstrating the member meets the coverage criteria may be denied. Ensure all required documentation is included at time of prior authorization submission to avoid delays or denials.

Incomplete submissions may be denied
Include all required clinical evidence with the prior authorization request

Background and Clinical Context

Ryoncil (remestemcel-L-rknd) is an allogeneic bone marrow‑derived mesenchymal stromal cell therapy indicated for the treatment of steroid‑refractory acute graft‑versus‑host disease (aGVHD) in pediatric patients following allogeneic stem cell transplant. Symptoms of aGVHD typically present within the first 100 days after transplant. Steroid‑refractory disease is defined as progression within 3 days or no improvement within 7 days of consecutive treatment with high‑dose corticosteroids (methylprednisolone 2 mg/kg/day or equivalent).

Definitions

Steroid-refractory aGVHD definition

Steroid-refractory definition (clinical)Disease that shows progression within 3 days of consecutive treatment with 2 mg/kg/day methylprednisolone (or equivalent)

Steroid-refractory definition (alternative)No improvement within 7 days of consecutive treatment with 2 mg/kg/day methylprednisolone (or equivalent)

Required corticosteroid dose for definition2 mg/kg/day methylprednisolone or equivalent

Population contextDefinition applied to pediatric patients with acute graft-versus-host disease (aGVHD)