ICD-10 — MDS subtypes (lower-risk only)
| Code | For |
|---|
D46.0 | RA, no sideroblasts |
D46.1 | MDS-RS (refractory anemia w/ ring sideroblasts) |
D46.20/.21 | RAEB-1 (lower-risk subset only) |
D46.22 | RAEB-2 (verify lower-risk by IPSS-R) |
D46.A | Refractory cytopenia w/ multilineage dysplasia |
D46.C/D46.4 | Other / unspecified RA (lower-risk only) |
D46.9 | MDS unspecified (avoid as primary) |
Z79.890 + Z51.81 | Transfusion dependence + therapeutic transfusion encounter |
D64.9 | AVOID — will deny |
PA needs IPSS-R + transfusion log + ESA history. Submit BMA w/ cytogenetics, blast %, EPO if ineligibility cited.
Indication checklist (all 4 required)
- Adult — pediatric off-label
- Lower-risk MDS — IPSS low/int-1 OR IPSS-R very-low/low/intermediate
- Transfusion-dependent — ≥ 4 RBC units / 8 wk preceding
- ESA-failed / loss-of-response / ineligible — document agent, dates, response, EPO > 500 mU/mL if ineligibility
Payer requirements (May 2026)
| Payer | PA | Key criteria |
|---|
| UnitedHealthcare | Yes | IPSS-R + transfusion log + ESA history; heme/onc Rx |
| Aetna (CPB 1063) | Yes | Mirrors FDA label; Hgb < 11; reauth at 6 & 12 mo |
| BCBS plans | Yes | Some require luspatercept step on top of ESA — appeal w/ label |
| Medicare (orig.) | No | Coverage per FDA label; no NCD |
Reauth needs response evidence: ≥ 50% transfusion reduction or 8 wk transfusion independence per NCCN.
Medicare reimbursement (Q2 2026)
| Field | Value |
|---|
| ASP+6% per mg | $58.169 (per 1 mg unit) |
| 497 mg dose (70 kg) | $28,910 (497 u) |
| 568 mg dose (80 kg) | $33,040 (568 u) |
| 639 mg dose (90 kg) | $37,170 (639 u) |
| Annual (70 kg, 13 doses) | ~$375,830 |
Patient assistance — REACH4RYTELO
- REACH4RYTELO HUB: 1-844-RYTELO1 (1-844-798-3561)
- Hours: M–F 8 AM–8 PM ET
- Enrollment fax: 1-888-224-2518
- Copay program: $0 per infusion commercial; $9,450/yr drug cap + $1,200/yr admin (excludes Medicare/Medicaid/federal)
- PAP: free drug uninsured/underinsured (~≤ 500% FPL)
- Foundations: PAN, HealthWell, CancerCare, PAF (Medicare patients)
- Web: rytelohcp.com / rytelo.com
W&P (no Boxed): Thrombocytopenia and neutropenia (most common dose-limiting,
per IMerge); infusion reactions; hepatotoxicity (monitor LFTs); embryo-fetal toxicity. CBC schedule:
weekly cycles 1–2 → pre-dose cycles 3–6 → as indicated. Hold and reduce per FDA dose-mod table.