CurrentBlue Cross Blue Shield - IowaPolicy 05.05.89

Ryoncil (remestemcel‑L‑rknd) for steroid‑refractory acute graft‑versus‑host disease

This policy describes benefit application, coverage criteria, and billing for Ryoncil (remestemcel‑L‑rknd) for treatment of steroid‑refractory acute graft‑versus‑host disease (SR‑aGvHD) in pediatric patients, and applies to members covered under Blue Cross Blue Shield - Iowa contracts.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyRyoncil (remestemcel‑L‑rknd) for steroid‑refractory acute graft‑versus‑host disease

Policy CodePolicy 05.05.89

Change TypeNo material change

Effective DateJul 25, 2025

Next Review Date

Key ActionObtain prior authorization and document prior adequate systemic corticosteroid therapy (methylprednisolone 2 mg/kg/day or equivalent) consistent with the steroid‑refractory timing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

pediatric (>=2 mo)age group specified for FDA indication

2 monthsinitial authorization duration

8max infusions (initial)

4reauthorization limit (partial)

J3402, C9339, J3590

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Coverage Criteria for Ryoncil (remestemcel‑L‑rknd)

Initial therapy (acute GvHD)

Covered when ALL of the following are met

Initial authorization for acute GvHD: Member is a pediatric patient (age ≥ 2 months); disease is steroid‑refractory — defined as progression within 3 days or no improvement within 7 consecutive days of treatment with methylprednisolone 2 mg/kg/day or equivalent; authorization duration 2 months (maximum 8 infusions)2 months; max 8 infusions

Pediatric ≥ 2 months per FDA indication

Continuation / Reauthorization

Reauthorization/continued treatment — authorization may be granted when either of the following is met

Reauthorization criteria: A. Partial or mixed response: improvement in symptoms with no evidence of unacceptable toxicity while on the current regimen (maximum of 4 infusions)partial response: max 4 infusions

Reauthorization criteria: B. Recurrence after complete response: member (including new members) must meet all original coverage requirements for continuation of therapy (maximum of 8 infusions)recurrence after CR: max 8 infusions

Ryoncil (remestemcel‑L‑rknd) is considered not medically necessary for members who do not meet the coverage criteria set forth above.

Use of Ryoncil for indications or patient populations not meeting the specified criteria is considered not medically necessary.

Candidate Population

Transplant population

Candidate population for therapy

Eligible candidates: Pediatric patients aged 2 months and older with steroid‑refractory acute GvHD>= 2 months

Matches FDA indication

Provider Actions, Documentation & Billing

Prior Authorization

Prior authorization and reporting codes for Ryoncil

Prior authorization may be granted for Ryoncil (remestemcel‑L‑rknd) for steroid‑refractory acute graft‑versus‑host disease in pediatric patients who meet the coverage criteria. Report services using the listed HCPCS/CPT or unclassified biologic codes as appropriate (see coding section).

Authorization may be granted for up to 2 months (maximum 8 infusions) for initial therapy.
Reauthorization limits: partial/mixed response — maximum 4 infusions; recurrence after complete response — maximum 8 infusions.

Step Therapy

Corticosteroid requirement (steroid‑refractory definition)

Authorization requires prior adequate systemic corticosteroid therapy, defined as methylprednisolone 2 mg/kg/day (or equivalent), with steroid‑refractory disease defined as progression within 3 days or no improvement within 7 consecutive days of that corticosteroid therapy.

Steroid‑refractory timing: progressed within 3 days OR did not improve within 7 consecutive days of methylprednisolone 2 mg/kg/day (or equivalent).

Billing and Coding

Covered HCPCS (specific)HCPCSCovered

J3402

Injection, remestemcel-l-rknd, per therapeutic dose (effective 10/1/2025)

Covered HCPCS (unclassified)HCPCSCovered

C9339

Unclassified drugs or biologicals

Covered HCPCS (unclassified)HCPCSCovered

J3590

Unclassified biologics

Post‑Transplant Coverage Details

Ryoncil infusions for SR‑aGvHD — continuation and reauthorization limits

Initial authorization duration and infusion maximumAuthorization of 2 months (maximum 8 infusions) for treatment of acute GvHD when pediatric and steroid‑refractory criteria are met

Partial or mixed response (continuation)Reauthorization may be granted for partial or mixed response with symptom improvement and no unacceptable toxicity — maximum of 4 infusions

Recurrence after complete response (reauthorization)Reauthorization allowed for recurrence after complete response if all original coverage requirements are met — maximum of 8 infusions

Definitions

Steroid‑refractory (SR) — definition and requirements

Definition of steroid‑refractory (SR)Disease that progressed within 3 days or did not improve within 7 consecutive days of treatment with methylprednisolone 2 mg/kg/day or equivalent.

Required prior therapySystemic corticosteroid therapy (methylprednisolone 2 mg/kg/day or equivalent) must have been used with timing consistent with the SR definition before authorization.

Eligible patient populationPediatric patients (meets FDA indication) with acute graft versus host disease meeting the SR definition.

Evaluation Requirements and Documentation

Documentation Required

Evaluation requirements — document prior corticosteroid therapy and timing

Documentation must include evidence of prior adequate corticosteroid therapy (methylprednisolone 2 mg/kg/day or equivalent) and timing consistent with the steroid‑refractory definition to support authorization.

Record the corticosteroid dose, start date, and clinical course demonstrating progression within 3 days or lack of improvement within 7 consecutive days.
Include clinical notes showing pediatric age and applicable infusion counts if requesting continuation or reauthorization.

Background

Ryoncil (remestemcel‑L‑rknd) is indicated for the treatment of steroid‑refractory acute graft‑versus‑host disease (SR‑aGvHD) in pediatric patients aged 2 months and older. Authorization for initial therapy may be granted for up to 2 months (maximum of 8 infusions), with reauthorization limited by response criteria (partial response: maximum of 4 infusions; recurrence after complete response: up to a maximum of 8 infusions).