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Colony Stimulating Factors: Leukine® (sargramostim) (Subcutaneous/Intravenous)
Policy Number: VP-0237
Last Review Date: 03/31/2023
Date of Origin: 10/17/2008
Dates Reviewed: 06/2009, 12/2009, 06/2010, 07/2010, 09/2010, 12/2010, 03/2011, 06/2011, 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 04/2019, 04/2020, 04/2021, 04/2022, 04/2023
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. |
I. Length of Authorization
High Risk Neuroblastoma:
- When used in combination with dinutuximab, coverage will be provided for five months and may not be renewed.
- When used in combination with naxitamab, coverage will be provided for six months and may be renewed.
All other indications: Coverage will be provided for six months and may be renewed.
II. Dosing Limits
- Quantity Limit (max daily dose) [NDC Unit]:
- Leukine 250 mcg vial: 28 vials per 14 days
- Max Units (per dose and over time) [HCPCS Unit]:
- 15 billable units per day (acute radiation syndrome)
- 10 billable units per day on days 1 through 14 of cycles 1, 3 and 5 (cycle length is 24 days) for a maximum of 5 cycles only (high-risk neuroblastoma in combination with dinutuximab)
- 10 billable units per day for 10 days of each 28-day cycle for six cycles followed by subsequent cycles every 8 weeks thereafter (high-risk neuroblastoma in combination with naxitamab)
- 10 billable units per day (all other indications)
III. Initial Approval Criteria1-11
The patient has another FDA labeled or guideline supported (at highest level of evidence) indication. |
Coverage is provided in the following conditions:
Myeloid reconstitution after autologous or allogeneic bone marrow transplant (BMT) †
Peripheral Blood Progenitor Cell (PBPC) mobilization and transplant †
Acute Myeloid Leukemia (AML) following induction or consolidation chemotherapy † Ф
Bone Marrow Transplantation (BMT) failure or Engraftment Delay † Ф
Treatment of chemotherapy-induced febrile neutropenia ‡
- Used for the treatment of chemotherapy induced febrile neutropenia in patients who have not received prophylactic therapy with a granulocyte colony stimulating factor; AND
- Patient has one or more of the following risk factors for developing infection-related complications:
-
- Sepsis Syndrome
- Age greater than 65 years
- Absolute neutrophil count [ANC] less than 100/mcL
- Duration of neutropenia expected to be greater than 10 days
- Pneumonia or other clinically documented infections
- Invasive fungal infection
- Hospitalization at the time of fever
- Prior episode of febrile neutropenia
-
Patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome [H-ARS]) † Ф
High-Risk Neuroblastoma † 12,13
- Used in combination with GD2-binding monoclonal antibodies (i.e., naxitamab, dinutuximab, etc.) for the treatment of high-risk neuroblastoma
† FDA-labeled indication(s); ‡ Compendia recommended indication(s); Ф Orphan Drug
IV. Renewal Criteria 1,12,13
High-Risk Neuroblastoma
- Use in combination with dinutuximab may not be renewed.
- Used in combination with naxitamab; AND
- Patient continues to meet 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 hypersensitivity reactions, severe effusions and capillary leak syndrome, severe supraventricular arrythmias, etc.
All Other Indications
- Refer to initial prior authorization criteria.
V. Dosage/Administration1-13
Indication |
Dose |
Acute Exposure to Myelosuppressive Doses of Radiation |
• 7 mcg/kg in adult and pediatric patients weighing greater than 40 kg • 10 mcg/kg in pediatric patients weighing 15 kg to 40 kg • 12 mcg/kg in pediatric patients weighing less than 15 kg
|
High-Risk Neuroblastoma |
In combinations with naxitamab 250 mcg/m2 subcutaneously daily for 5 doses starting 5 days prior to the day 1 of naxitamab infusion followed by sargramostim 500 mcg/m2 subcutaneously daily on days 1, 2, 3, 4, and 5 repeated each cycle in combination with naxitamab. Note: Treatment cycles are repeated every 4 weeks until complete or partial response, followed by 5 additional cycles (every 4 weeks). Subsequent cycles may be repeated every 8 weeks. Discontinue (naxitamab and GM-CSF) with disease progression or unacceptable toxicity. In combination with dinutuximab 250 mcg/m2 daily on days 1 through 14 of cycles 1, 3 and 5 (cycle length is 24 days) for a maximum of 5 cycles only. |
All other indications |
250 mcg/m2 daily for up to 14 days |
VI. Billing Code/Availability Information
HCPCS Code:
- J2820 – Injection, sargramostim (GM-CSF), 50 mcg: 1 billable unit = 50 mcg
NDC:
- Leukine 250 mcg single-dose vial: 00024-5843-xx
VII. References
- Leukine [package insert]. Lexington, MA; Partner Therapeutics, Inc.; May 2022. Accessed February 2023.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) sargramostim. National Comprehensive Cancer Network, 2023. 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 February 2023.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Hematopoietic Growth Factors. Version 3.2022. National Comprehensive Cancer Network, 2023. 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 February 2023.
- Arora M, Burns LJ, Barker JN, et al. Randomized comparison of granulocyte colony-stimulating factor versus granulocyte-macrophage colony-stimulating factor plus intensive chemotherapy for peripheral blood stem cell mobilization and autologous transplantation in multiple myeloma. Biol Blood Marrow Transplant. 2004;10(6):395-404.
- Berghmans T, Paesmans M, Lafitte JJ, et al. Therapeutic use of granulocyte and granulocyte-macrophage colony-stimulating factors in febrile neutropenic cancer patients. A systematic review of the literature with meta-analysis. Support Care Cancer. 2002;10(3):181-188.
- Dubois RW, Pinto LA, Bernal M, et al. Benefits of GM-CSF versus placebo or G-CSF in reducing chemotherapy-induced complications: A systematic review of the literature. Support Cancer Ther. 2004;2(1):34-41.
- Nemunaitis J, Rosenfeld CS, Ash R, et al. Phase III randomized, double-blind placebo-controlled trial of rhGM-CSF following allogeneic bone marrow transplantation. Bone Marrow Transplant. 1995;15(6):949-954.
- Nemunaitis J, Singer JW, Buckner CD, et al. Use of recombinant human granulocyte-macrophage colony-stimulating factor in graft failure after bone marrow transplantation. Blood. 1990;76(1):245-253.
- Nemunaitis J, Buckner CD, Appelbaum FR et al. Phase I/II trial of recombinant human granulocyte-macrophage colony-stimulating factor following allogeneic bone marrow transplantation. Blood. 1991;77:2065-71.
- Nemunaitis J, Rabinowe SN, Singer JW et al. Recombinant granulocyte-macrophage colony-stimulating factor after autologous bone marrow transplantation for lymphoid cancer. N Engl J Med. 1991;324:1773-8.
- Rabinowe SN, Neuberg D, Bierman PJ et al. Long-term follow-up of a phase III study of recombinant human granulocyte-macrophage colony-stimulating factor after autologous bone marrow transplantation for lymphoid malignancies. Blood. 1993;81:1903-8.
- Rowe JN, Andersen JW, Mazza JJ et al. A randomized placebo-controlled phase III study of granulocyte-macrophage colony-stimulating factor in adult patients (> 55 to 70 years of age) with acute myelogenous leukemia: a study of the Eastern Cooperative Oncology Group (E1490). Blood. 1995;86:457-62.
- Danyelza [package insert]. New York, NY; Y-mAbs Therapeutics, Inc. ; November 2020. Accessed December 2020.
- Unituxin [package insert]. Silver Spring, MD; United Therapeutics Corp; September 2020. Accessed December 2020.
Appendix 1 – Covered Diagnosis Codes
ICD-10 |
ICD-10 Description |
C74.90 |
Malignant neoplasm of unspecified part of unspecified adrenal gland |
C92.00 |
Myeloid leukemia not having achieved remission |
C92.02 |
Myeloid leukemia in relapse |
C92.50 |
Acute myelomonocytic leukemia not having achieved remission |
C92.52 |
Acute myelomonocytic leukemia in relapse |
C92.60 |
Acute myeloid leukemia with 11q23-abnormality not having achieved remission |
C92.62 |
Acute myeloid leukemia with 11q23-abnormality in relapse |
C92.A0 |
Acute myeloid leukemia with multilineage dysplasia not having achieved remission |
C92.A2 |
Acute myeloid leukemia with multilineage dysplasia in relapse |
C93.00 |
Acute monoblastic/monocytic leukemia not having achieved remission |
C93.02 |
Acute monoblastic/monocytic leukemia in relapse |
D61.81 |
Pancytopenia |
D70.1 |
Agranulocytosis secondary to cancer chemotherapy |
D70.9 |
Neutropenia, unspecified |
T45.1X5A |
Adverse effect of antineoplastic and immunosuppressive drugs initial encounter |
T45.1X5D |
Adverse effect of antineoplastic and immunosuppressive drugs subsequent encounter |
T45.1X5S |
Adverse effect of antineoplastic and immunosuppressive drugs sequela |
T66.XXXA |
Radiation sickness, unspecified, initial encounter |
T66.XXXD |
Radiation sickness, unspecified, subsequent encounter |
T66.XXXS |
Radiation sickness, unspecified, sequela |
W88.1 |
Exposure to radioactive isotopes |
W88.8 |
Exposure to other ionizing radiation |
Z41.8 |
Encounter for other procedures for purposes other than remedying health state |
Z48.290 |
Encounter for aftercare following bone marrow transplant |
Z51.11 |
Encounter for antineoplastic chemotherapy |
Z51.12 |
Encounter for antineoplastic immunotherapy |
Z51.89 |
Encounter for other specified aftercare |
Z52.001 |
Unspecified donor, stem cells |
Z52.011 |
Autologous donor, stem cells |
Z52.091 |
Other blood donor, stem cells |
Z76.89 |
Persons encountering health services in other specified circumstances |
Z94.81 |
Bone marrow transplant status |
Z94.84 |
Stem cells transplant status |
Appendix 2 – Centers for Medicare and Medicaid Services (CMS)
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 Determination (NCD), Local Coverage Articles (LCAs), and Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/ search.aspx. Additional indications may be covered at the discretion of the health plan.
Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCA/LCD): N/A
Medicare Part B Administrative Contractor (MAC) Jurisdictions |
||
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, LLC |
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA, LLC |
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 |