ph-0237
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Colony Stimulating Factors: Leukine® (sargramostim)

Policy Number: PH-0237

 

Subcutaneous/Intravenous

 

Last Review Date: 04/01/2020

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

  1. Length of Authorization

Coverage will be provided for six months and may be renewed.

  1. Dosing Limits

A.  Quantity Limit (max daily dose) [NDC Unit]:

  • Leukine 250 mcg vial: 28 vials per 14 days
  • Leukine 500 mcg vial: 14 vials per 14 days

B.  Max Units (per dose and over time) [HCPCS Unit]:

  • 15 billable units per day (acute radiation syndrome)
  • 10 billable units per day (all  other indications)
  1. 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 †

Bone Marrow Transplantation (BMT) failure or Engraftment Delay †

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 >65
      • Absolute neutrophil count [ANC] <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]) †

FDA-labeled indication(s); Compendia recommended indication(s)

  1. Renewal Criteria

Same as initial prior authorization policy criteria.

  1. Dosage/Administration1-11

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

  • Administer Leukine as soon as possible after suspected or confirmed exposure to radiation doses greater than 2 gray (Gy).

All other indications

250 mcg/m2 daily for up to 14 days

  1. Billing Code/Availability Information

HCPCS Code:

  • J2820 – Injection, sargramostim (GM-CSF), 50 mcg: 1 billable unit = 50 mcg

NDC:

  • Leukine 250 mcg vial– 00024-5843-xx
  • Leukine 500 mcg vial– 00024-5844-xx
  1. References
  1. Leukine [package insert]. Bridgewater, NJ; Sanofi-aventis U.S. LLC; March 2018.  Accessed March 2020.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) sargramostim. National Comprehensive Cancer Network, 2020. 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 March 2020.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. Palmetto GBA. Local Coverage Determination (LCD): White Cell Colony Stimulating Factors (L37176). Centers for Medicare & Medicaid Services, Inc. Updated on 10/04/2019 with effective date 10/10/2019. Accessed March 2020.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

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

C93.10

Chronic myelomonocytic leukemia, not having achieved remission

C94.00

Acute erythroid leukemia not having achieved remission

C94.02

Acute erythroid leukemia in relapse

C94.20

Acute megakaryoblastic leukemia not having achieved remission

C94.22

Acute megakaryoblastic 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) 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/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD):

Jurisdiction(s):  J, M

NCD/LCD Document (s): L37176

https://www.cms.gov/medicare-coverage-database/search/lcd-date-search.aspx?DocID=L37176&bc=gAAAAAAAAAAA

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

 

 

 

LEUKINE® (sargramostim) Prior Auth Criteria
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