CurrentViva HealthPolicy IC-0781

Ryoncil (remestemcel-L-rknd) intravenous therapy for steroid-refractory acute graft-versus-host disease

Defines prior authorization, dosing, renewal, and coverage criteria for Ryoncil (remestemcel-L-rknd) for treatment of acute graft-versus-host disease (aGVHD) following allogeneic stem cell transplant for Viva Health members.

Policy Summary

PayerViva Health

PolicyRyoncil (remestemcel-L-rknd) intravenous therapy for steroid-refractory acute graft-versus-host disease

Policy CodePolicy IC-0781

Change TypeNo material changes

Effective Date

Next Review DateNov 4, 2025

Key ActionSubmit required supporting clinical documentation via the PA web portal or fax to establish medical necessity for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 monthsminimum patient age

8-16typical dosing (doses)

J3402HCPCS

1 monthinitial PA validity

D89.810diagnosis code

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Initial Approval

Covered when ALL of the following are met:

Universal criteria: Patient is at least 2 months of age; submission of supporting clinical documentation is provided via PA web portal or fax; patient is post-allogeneic stem cell transplant; patient does not have skin-only aGVHD involvement or evidence of encephalopathy, diffuse alveolar hemorrhage, or other active pulmonary disease; patient does not have known hypersensitivity to dimethyl sulfoxide (DMSO) or porcine and bovine proteins.

Documentation must be provided via PA portal or fax

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.

Age ≥12 additional requirement: For patients 12 years and older, patient has had an inadequate response to an adequate trial of, or a contraindication or intolerance to, ruxolitinib.

Applies only to patients ≥12 years

Renewal Criteria

Renewal granted when ALL of the following are met:

Continued eligibility: Patient continues to meet the universal and indication‑specific criteria from Initial Approval and there is absence of unacceptable toxicity from the drug (examples include severe infusion‑related reactions or hypersensitivity).

Demonstrated clinical response options: 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 one evaluable organ with worsening in another) OR is experiencing an aGVHD recurrence after achieving a complete response.

Partial or mixed response => patient will require 4 additional weekly doses; recurrence after complete response => patient will require 8 additional twice‑weekly doses.

Coverage is excluded for patients with skin-only aGVHD involvement. Coverage is also not provided for patients with evidence of encephalopathy, diffuse alveolar hemorrhage, or other active pulmonary disease. Additionally, patients with known hypersensitivity to dimethyl sulfoxide (DMSO) or porcine and bovine proteins are contraindicated for therapy under this policy. These exclusions apply to initial authorization and are drawn from the indication-specific requirements for Ryoncil in aGVHD.

Prior authorization may not be renewed if a patient achieves a complete response (resolution of aGVHD in all involved organs) or has no response to initial treatment. Exceptions to non-renewal will be considered on a case-by-case basis and require submission of supporting clinical documentation for review.

Continuation and response-based treatment

Continuation Therapy

citations':['6','2'],

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ERROR_REPAIR_PLACEHOLDER

Billing and coding

Covered HCPCS CodesHCPCSCovered

J3402

Injection, remestemcel-l-rknd, per therapeutic dose; 1 billable unit = 1 therapeutic dose

Covered Diagnosis Codes (ICD-10)ICD-10Covered

D89.810

Acute graft-versus-host disease

inv-08: Response assessment timing

Assessment timingAssess response 28 ± 2 days after the first dose

PurposeGuides decision for continuation, repeat, or cessation of therapy based on Day 28 response

Related actionsIf partial or mixed response → administer 4 additional weekly infusions; if complete response → no further treatment; if recurrence after CR → repeat twice weekly for 4 weeks

Prior authorization, documentation, and step requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorization will be provided for 1 month and may be renewed monthly thereafter. Requests must include all required clinical documentation to support medical necessity.

Initial authorization duration: 1 month
Renewals: May be renewed every month
Submit requests via the PA web portal or by fax

Step Therapy

Step Therapy Requirement for Patients ≥ 12 Years

For patients aged 12 years and older, a trial of ruxolitinib with inadequate response, or documented contraindication or intolerance to ruxolitinib, is required prior to initiation of Ryoncil.

Applies to patients ≥ 12 years
Document trial of ruxolitinib, or contraindication/intolerance

Documentation Required

Required Clinical Documentation

Submission of supporting clinical documentation is REQUIRED for all authorization requests. Provide pertinent medical records, chart notes, laboratory results, and confirmatory diagnostics that demonstrate the diagnosis and meet the medical necessity criteria. Include documentation of step-therapy attempts and clinical markers when applicable (for example, genetic and mutational testing). Records will be reviewed at time of submission.

Examples of required documentation: medical records, clinic notes, labs, imaging, and confirmatory diagnostics
Include documentation for diagnosis, step therapy, and relevant clinical markers (e.g., genetic/mutational testing)
Upload documentation via the PA web portal or send by fax

Denial Risk

Documentation Submission Required

Failure to submit the required supporting clinical documentation may result in denial of the request due to inability to establish medical necessity. Ensure all requested records are provided at time of submission to avoid processing delays or denials.

Missing documentation may result in denial
Provide complete records at initial submission to support approval

Step	Requirement	Applies to
{"text":"1","status":""},{"text":"Must have had an inadequate response to, or a contraindication or intolerance to, ruxolitinib prior to Ryoncil","status":""},{"text":"Patients ≥12 years of age","status":""}

Definitions and response categories

inv-14: Steroid-refractory aGVHD

DefinitionDisease that shows progression within 3 days, or no improvement within 7 days of consecutive treatment with 2 mg/kg/day methylprednisolone or equivalent

Clinical contextApplies to patients post-allogeneic stem cell transplant with aGVHD

Implication for coverageSteroid-refractory status is required for initial approval under this policy

inv-15: Partial response

CriterionOrgan improvement of at least 1 stage without worsening in any other organ

Action on Day 28If partial response at Day 28 → administer four additional weekly infusions (4 doses)

Renewal relevancePartial response meets one of the demonstrated response options required for renewal

inv-16: Complete response

DefinitionResolution of aGVHD in all involved organs

Action on Day 28Complete response → no further treatment; prior authorization generally will not be renewed if CR achieved unless exceptions reviewed case-by-case

Recurrence policyIf recurrence after complete response → repeat treatment twice weekly for 4 weeks (8 infusions)

inv-17: Mixed response

DefinitionImprovement in at least one evaluable organ with worsening in another

Action on Day 28If mixed response at Day 28 → administer four additional weekly infusions (4 doses)

Renewal relevanceMixed response qualifies as a demonstrated clinical response option for renewal

Clinical background

Acute graft-versus-host disease (aGVHD) is a complication that typically occurs after allogeneic stem cell transplant and most commonly presents within the first 100 days post-transplant. Ryoncil (remestemcel-L-rknd) is an intravenous mesenchymal stromal cell therapy indicated for steroid-refractory aGVHD. Steroid-refractory disease is defined as progression within 3 days or lack of improvement within 7 days of consecutive treatment with 2 mg/kg/day methylprednisolone (or equivalent). Treatment response is assessed around Day 28 ± 2 days and guides continuation: patients with at least a partial or mixed response may receive additional doses, while those with complete response or no response are generally not eligible for renewal except in case-by-case reviews.

Policy Summary

PayerViva Health

PolicyRyoncil (remestemcel-L-rknd) intravenous therapy for steroid-refractory acute graft-versus-host disease

Policy CodePolicy IC-0781

Change TypeNo material changes

Effective Date

Next Review DateNov 4, 2025

Key ActionSubmit required supporting clinical documentation via the PA web portal or fax to establish medical necessity for prior authorization.

SourceLink

On This Page

OpenPayer

Ryoncil (remestemcel-L-rknd) intravenous therapy for steroid-refractory acute graft-versus-host disease

Coverage criteria for Ryoncil (remestemcel-L-rknd)

Initial therapy and dosing

Continuation and response-based treatment

Billing and coding

Prior authorization, documentation, and step requirements

Step therapy requirements

Quantity and dosing limits

Administration and monitoring

Definitions and response categories

Clinical background