Asset Publisher
Rytelo® (imetelstat)
Policy Number: VP-0761
Intravenous
Last Review Date: 07/02/2024
Date of Origin: 07/02/2024
Dates Reviewed: 07/2024
FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill. |
- Length of Authorization 1
- Coverage will be provided for 6 months and may be renewed.
- Dosing Limits
A. Quantity Limit (max daily dose) [NDC Unit]:
- Rytelo 47 mg powder in a single-dose vial: 3 vials every 4 weeks
- Rytelo 188 mg powder in a single-dose vial: 5 vials every 4 weeks
B. Max Units (per dose and over time) [HCPCS Unit]:
- 940 billable units every 4 weeks
- Initial Approval Criteria 1
Coverage is provided in the following conditions:
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- Patient is at least 18 years of age; AND
Myelodysplastic Syndrome (MDS)
- Patient has IPSS symptomatic low- to intermediate-1-risk disease; AND
- Patient is relapsed or refractory to ESA therapy or is ESA ineligible (i.e., EPO>500 mU/mL); AND
- Patient is red blood cell (RBC) transfusion dependent, defined as requiring at least 4 RBC units transfused over an 8-week period
(Note: Patients with a deletion (5q) cytogenetic mutation, or who have previously received treatment with lenalidomide or a hypomethylating agent (e.g., azacitidine, decitabine, etc.), will be reviewed on a case-by-case basis.)
† FDA Approved Indications; ‡ Compendia Recommended Indication(s); Ф Orphan Drug
- Renewal Criteria 1,5-8,12
- Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
- Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe thrombocytopenia, neutropenia, and severe infusion-related reactions, etc.; AND
Myelodysplastic Syndromes (MDS)
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- For first renewal: Patient has achieved a reduction in RBC transfusion burden after at least 24 weeks, (6 doses), from baseline; OR
- For subsequent renewals: Patient is experiencing disease response as evidenced by a decrease in the number of RBC transfusions from baseline
- Dosage/Administration 1,12
Indication |
Dose |
Myelodysplastic Syndromes (MDS) |
The recommended dosage of Rytelo is 7.1 mg/kg administered as an intravenous infusion over 2 hours every 4 weeks.
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- Billing Code/Availability Information
HCPCS Code:
- J0870 – Injection, imetelstat, 1 mg; 1 billable unit = 1 mg (Effective on 01/01/2025)
- J9999 – Not otherwise classified, antineoplastic drugs (Discontinue use on 01/01/2025)
NDC(s):
- Rytelo 47 mg powder in a single-dose vial: 82959-0112-xx
- Rytelo 188 mg powder in a single-dose vial: 82959-0111-xx
- References
- Rytelo [package insert]. Foster City, CA; Geron, Inc: June 2024. Accessed June 2024.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) imetelstat. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed June 2024.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Myelodysplastic Syndromes. Version 1.2024. National Comprehensive Cancer Network, 2024. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed June 2024.
- Zeidan AM, Platzbecker U, Santini V, et al. IMerge: Results from a phase 3, randomized, double-blind, placebo-controlled study of imetelstat in patients (pts) with heavily transfusion dependent (TD) non-del(5q) lower-risk myelodysplastic syndromes (LR-MDS) relapsed/refractory (R/R) to erythropoiesis stimulating agents (ESA). Meeting Abstract: 2023 ASCO Annual Meeting I. Journal of Clinical Oncology Volume 41, Number 16_suppl June 2023.
Appendix 1 – Covered Diagnosis Codes
ICD-10 |
ICD-10 Description |
C93.10 |
Chronic myelomonocytic leukemia not having achieved remission |
D46.0 |
Refractory anemia without ring sideroblasts, so stated |
D46.1 |
Refractory anemia with ring sideroblasts |
D46.20 |
Refractory anemia with excess of blasts, unspecified |
D46.21 |
Refractory anemia with excess of blasts 1 |
D46.4 |
Refractory anemia, unspecified |
D46.9 |
Myelodysplastic syndrome, unspecified |
D46.A |
Refractory cytopenia with multilineage dysplasia |
D46.B |
Refractory cytopenia with multilineage dysplasia and ring sideroblasts |
D46.Z |
Other myelodysplastic syndromes |
Appendix 2 – Centers for Medicare and Medicaid Services (CMS)
The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.
Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A
Medicare Part B Administrative Contractor (MAC) Jurisdictions |
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Jurisdiction |
Applicable State/US Territory |
Contractor |
E (1) |
CA, HI, NV, AS, GU, CNMI |
Noridian Healthcare Solutions, LLC |
F (2 & 3) |
AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ |
Noridian Healthcare Solutions, LLC |
5 |
KS, NE, IA, MO |
Wisconsin Physicians Service Insurance Corp (WPS) |
6 |
MN, WI, IL |
National Government Services, Inc. (NGS) |
H (4 & 7) |
LA, AR, MS, TX, OK, CO, NM |
Novitas Solutions, Inc. |
8 |
MI, IN |
Wisconsin Physicians Service Insurance Corp (WPS) |
N (9) |
FL, PR, VI |
First Coast Service Options, Inc. |
J (10) |
TN, GA, AL |
Palmetto GBA |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA |
L (12) |
DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA) |
Novitas Solutions, Inc. |
K (13 & 14) |
NY, CT, MA, RI, VT, ME, NH |
National Government Services, Inc. (NGS) |
15 |
KY, OH |
CGS Administrators, LLC |