CurrentCountyCarePolicy 5106.CC

Ryoncil (remestemcel-L-rknd) Coverage Criteria

Customize your policy alerts

Sign up for countycare Policy 5106.CC alerts

Get alerted when Policy 5106.CC changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

This guideline governs prior authorization for Ryoncil under the Health Plan's medical benefit for eligible pediatric members with acute graft-versus-host disease after allogeneic hematopoietic stem cell transplantation.

Policy Summary

PayerCountyCare

PolicyRyoncil (remestemcel-L-rknd) Coverage Criteria

Policy CodePolicy 5106.CC

Change TypeNo material clinical or coverage changes

Effective DateMarch 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization for Ryoncil under the Health Plan's medical benefit before treatment.

SourceLink

POLICY UPDATE CHANGES

The policy history identifies January 2026 as the introduction of a new guideline.

2 months–17 yearsEligible member age range

8 infusionsInitial course approved

6 monthsInitial authorization duration

Grades B–DRequired aGvHD severity range

J3402

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentCountyCarePolicy 5106.CC

Ryoncil (remestemcel-L-rknd) Coverage Criteria

Customize your policy alerts

Sign up for countycare Policy 5106.CC alerts

Get alerted when Policy 5106.CC changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerCountyCare

PolicyRyoncil (remestemcel-L-rknd) Coverage Criteria

Policy CodePolicy 5106.CC

Change TypeNo material clinical or coverage changes

Effective DateMarch 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization for Ryoncil under the Health Plan's medical benefit before treatment.

SourceLink

POLICY UPDATE CHANGES

The policy history identifies January 2026 as the introduction of a new guideline.

2 months–17 yearsEligible member age range

8 infusionsInitial course approved

6 monthsInitial authorization duration

Grades B–DRequired aGvHD severity range

J3402

Applicable HCPCS code

MedicaidApplicable line of business

Coverage Criteria

Initial Therapy

Covered when ALL of the following initial therapy criteria are met:

ALL of the following

Member is 2 months to 17 years old.
Ryoncil is prescribed by or in consultation with an oncologist, hematologist, or transplant specialist.
Member has a diagnosis of acute graft versus host disease (aGvHD) following an allogeneic hematopoietic stem cell transplantation (HSCT).
Chart documentation supports grade B to D severity aGvHD, per the International Bone Marrow Transplant Registry (IBMTR) grading scale (see Appendix 1).
- Inadequate response is defined as use of methylprednisolone or equivalent at 2 mg/kg/day with disease progression within 3 days or no improvement within 7 days of consecutive treatment.
Ryoncil is prescribed at a dose within the manufacturer's dosing guidelines, based on diagnosis, weight, and other applicable factors, listed in the FDA-approved labeling.
Provider documentation or attestation supports the additional requirements described below.

Reauthorization Therapy

For reauthorization, the request must meet ALL applicable criteria below.

ALL of the following

ONE of the following response criteria
- Recent chart note documentation shows the member experienced a partial response to the prior 8 infusions of Ryoncil. Partial response is defined as organ improvement of at least one stage without worsening in any other organ.
- Recent chart note documentation shows the member experienced a mixed response to the prior 8 infusions of Ryoncil. Mixed response is defined as improvement of at least one evaluable organ with worsening in another organ, as per the International Blood and Marrow Transplantation Registry Severity Index Criteria grading system (see Appendix 1).
Ryoncil is prescribed at a dose within the manufacturer's dosing guidelines, based on diagnosis, weight, and other applicable factors, listed in the FDA-approved labeling.

Provider documentation or attestation must confirm that the member does not have a known hypersensitivity to dimethyl sulfoxide (DMSO) or to murine, porcine, or bovine proteins.

Provider documentation or attestation must confirm that the member has not received any second-line therapy to treat aGvHD, such as mycophenolate mofetil, etanercept, sirolimus, extracorporeal photopheresis, brentuximab, or anti-thymocyte globulin.

Members with no response to prior Ryoncil injections will not be eligible for reauthorization.

Coding and Clinical Eligibility Details

Covered HCPCS CodesHCPCSCovered

J3402

Injection, remestemcel-l-rknd, per therapeutic dose

Member age

Minimum age2 months

Maximum age17 years old

Eligible age range2 months to 17 years old

Systemic steroid inadequate response

SteroidMethylprednisolone or equivalent

Dose2 mg/kg/day

Inadequate response timingDisease progression within 3 days or no improvement within 7 days of consecutive treatment

Provider Actions and Authorization Requirements

Prior Authorization

Medical-Benefit Prior Authorization Required

Prior authorization is required under the Health Plan's medical benefit for Ryoncil® (remestemcel-L-rknd). The request applies to all practitioners involved in providing the drug and is reviewed for medical necessity using FDA criteria.

Requested drug: Ryoncil® (remestemcel-L-rknd)
Applies to all practitioners involved in providing the requested drug
Medical-benefit authorization is required

Billing Rule

Initial Course Limited to 8 Infusions

Only one initial course of Ryoncil will be approved, limited to 8 total infusions. Additional infusions require reauthorization and must satisfy the applicable continuation criteria.

Therapy Background

Ryoncil (remestemcel-L-rknd) is an allogeneic bone marrow-derived mesenchymal stromal cell therapy indicated for steroid-refractory acute graft-versus-host disease in pediatric patients 2 months of age and older. This policy addresses its use following allogeneic hematopoietic stem cell transplantation and applies to acute graft-versus-host disease with grade B to D severity.

Clinical Definitions

Inadequate response to systemic steroids

Required steroidMethylprednisolone or equivalent

Required dose2 mg/kg/day

Disease progressionWithin 3 days

No-improvement definitionNo improvement within 7 consecutive treatment days

Partial response

Organ responseImprovement in at least one organ

Magnitude of improvementAt least one stage

Initial Therapy

Initial Therapy Criteria

Initial therapy requires ALL criteria:

Initial Ryoncil course

Member and diagnosis
- Member is 2 months to 17 years old.
- Member has acute graft-versus-host disease (aGvHD) following an allogeneic hematopoietic stem cell transplantation (HSCT).
- Chart documentation supports grade B to D aGvHD severity under the International Bone Marrow Transplant Registry (IBMTR) grading scale.
Clinical treatment history
- ONE of

Reauthorization and Continuation

Reauthorization Criteria

Reauthorization requires ALL of the applicable criteria:

Continuation therapy

ONE applicable response scenario
- Partial or mixed response
  - Recent chart note documentation shows that the member experienced a partial or mixed response to the prior 8 infusions of Ryoncil.
  - Response definition
    Partial response: Organ improvement of at least one stage without worsening in any other organ.

Step Therapy Requirements

Step	Requirement	Exception
1	Trial of systemic steroids before initial Ryoncil therapy. Inadequate response means methylprednisolone or equivalent at 2 mg/kg/day with disease progression within 3 days or no improvement within 7 consecutive treatment days.	Systemic steroid trial is not required when the member has an intolerance or contraindication to systemic steroids.

Quantity Limits

Ryoncil quantity limit

DrugRyoncil

Initial course limit8 total infusions

Additional infusionsRequire reauthorization

Policy Summary

PayerCountyCare

PolicyRyoncil (remestemcel-L-rknd) Coverage Criteria

Policy CodePolicy 5106.CC

Change TypeNo material clinical or coverage changes

Effective DateMarch 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization for Ryoncil under the Health Plan's medical benefit before treatment.

SourceLink

On This Page

IBMTR grade B skin involvement

InvolvementSkin

StageStage 2

Extent of rash25% to 50%

IBMTR grade B liver involvement

InvolvementLiver

StageStage 1–2

Total bilirubin34–102 µmol/L

IBMTR grade B gastrointestinal involvement

InvolvementGastrointestinal

StageStage 1–2

Diarrhea volume550–1500

IBMTR grade C skin involvement

InvolvementSkin

StageStage 3

Extent of rashGreater than 50%

IBMTR grade C liver involvement

InvolvementLiver

StageStage 3

Total bilirubin103–255 µmol/L

IBMTR grade C gastrointestinal involvement

InvolvementGastrointestinal

StageStage 3

Diarrhea volumeGreater than 1500 mL/day

IBMTR grade D

Skin involvementStage 4 with bullae

Liver involvementStage 4 with total bilirubin greater than 255 µmol/L

Gastrointestinal involvementStage 4 with severe pain and ileus

Initial approval: one course
Quantity limit: 8 total infusions
Further infusions require reauthorization

Documentation Required

Initial Authorization Documentation

Submit documentation supporting each initial authorization criterion, including the member's age, diagnosis, disease severity, prior systemic-steroid treatment or contraindication, prescriber qualifications, and dosing within FDA-approved manufacturer guidelines.

Member is 2 months to 17 years old
Diagnosis of acute graft versus host disease (aGvHD) following allogeneic HSCT
Chart documentation supports grade B to D aGvHD under the IBMTR grading scale
Prescribed by or in consultation with an oncologist, hematologist, or transplant specialist
Tried systemic steroids with inadequate response, or has an intolerance or contraindication; inadequate response means methylprednisolone or equivalent at 2 mg/kg/day with disease progression within 3 days or no improvement within 7 consecutive days
Dose is within the manufacturer's FDA-approved labeling guidelines

Documentation Required

Partial or Mixed Response Documentation

For reauthorization after the initial 8 infusions, provide a recent chart note documenting either a partial or mixed response to prior Ryoncil and confirm that dosing remains within the manufacturer's FDA-approved guidelines.

Partial response: improvement of at least one organ stage without worsening in any other organ
Mixed response: improvement of at least one evaluable organ with worsening in another organ, according to the International Blood and Marrow Transplantation Registry Severity Index Criteria
Include recent chart-note documentation and the prescribed dose

Documentation Required

Recurrence After Complete Response

For reauthorization after a complete response, provide a recent chart note documenting that the member previously achieved a complete response to Ryoncil and now has a recurrence of graft versus host disease (GvHD). Confirm that dosing remains within the manufacturer's FDA-approved guidelines.

Document the prior complete response to Ryoncil
Document the current recurrence of GvHD
Include the prescribed dose within manufacturer and FDA-approved labeling guidelines

Denial Risk

Initial Criteria Not Met

The request should be denied or referred for medical review when the member is outside the covered age range, the prescriber does not meet the required specialist qualification, or the initial medical-necessity criteria are not met.

Member is younger than 2 months or older than 17 years
Prescription is not by or in consultation with an oncologist, hematologist, or transplant specialist
Any required initial criterion is not satisfied or documented

Denial Risk

Exclusion Conditions

Ryoncil is not covered initially when the member has already received second-line therapy for aGvHD or has a specified hypersensitivity.

No prior second-line therapy for aGvHD, including mycophenolate mofetil, etanercept, sirolimus, extracorporeal photopheresis, bretuximab, or anti-thymocyte globulin
No known hypersensitivity to dimethyl sulfoxide (DMSO) or to murine, porcine, or bovine proteins

Denial Risk

No Response: Reauthorization Not Eligible

Members with no response to prior Ryoncil injections are not eligible for reauthorization. Document treatment response when submitting any renewal request.

No response to prior Ryoncil injections results in ineligibility for reauthorization

Other organsNo worsening in any other organ

Mixed response

ImprovementAt least one evaluable organ improves

WorseningAnother organ worsens

Assessment standardInternational Blood and Marrow Transplantation Registry Severity Index criteria

IBMTR grades B–D

Grade BNo liver or gastrointestinal involvement with stage 2 skin involvement, or stage 1–2 liver or gastrointestinal involvement

Grade CStage 3 skin, liver, or gastrointestinal involvement

Grade DStage 4 skin, liver, or gastrointestinal involvement

Inadequate response to systemic steroids

Member has received methylprednisolone or an equivalent at 2 mg/kg/day.
Disease progressed within 3 days or showed no improvement within 7 consecutive treatment days.

Steroid intolerance or contraindication: Member has an intolerance or contraindication to systemic steroids.

Prescriber and dosing

Ryoncil is prescribed by or in consultation with an oncologist, hematologist, or transplant specialist.
Dose is within the manufacturer's dosing guidelines, based on diagnosis, weight, and other applicable factors, as listed in the FDA-approved labeling.

Required documentation or attestation

Member has not received second-line therapy to treat aGvHD, including mycophenolate mofetil, etanercept, sirolimus, extracorporeal photopheresis, bretuximab, or anti-thymocyte globulin.
Member has no known hypersensitivity to dimethyl sulfoxide (DMSO) or to murine, porcine, or bovine proteins.

Improvement of at least one evaluable organ with worsening in another organ according to the International Blood and Marrow Transplantation Registry Severity Index criteria grading system.

Recurrence after complete response

Recent chart note documentation shows that the member previously had a complete response to Ryoncil and now has a recurrence of graft-versus-host disease.

FDA-approved dosing: Ryoncil is prescribed at a dose within the manufacturer's dosing guidelines, based on diagnosis, weight, and other applicable factors, as listed in the FDA-approved labeling.