vp-0409
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Colony Stimulating Factors: Udenyca™ (pegfilgrastim-cbqv) (Subcutaneous)

Policy Number: VP-0409

Last Review Date: 09/03/2019

Date of Origin: 12/04/2018

Dates Reviewed: 12/2018, 03/2019, 06/2019, 09/2019

 

I. Length of Authorization

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

II. Dosing Limits

  1. Quantity Limit (max daily dose) [Pharmacy Benefit]:
  • Udenyca 6 mg prefilled syringe: 1 syringe per 14 days
  1. Max Units (per dose and over time) [Medical Benefit]:
  • 12 billable units weekly x 2 doses for Acute Radiation Exposure
  • 12 billable units per 14 days for all other indications

III. Initial Approval Criteria

The patient has another FDA labeled or guideline supported (at highest level of evidence) indication.

 

Coverage is provided in the following conditions:

Prophylactic use in patients with non-myeloid malignancy †

  • Patient is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia* of 20% or greater §; OR
  • Patient is undergoing myelosuppressive chemotherapy with an expected incidence of febrile neutropenia* of 10% or greater § AND one or more of the following co-morbidities:
  • Age >65 receiving full dose intensity
  • History of recurrent febrile neutropenia from chemotherapy
  • Extensive prior exposure to chemotherapy
  • Previous exposure of pelvis, or other areas of large amounts of bone marrow, to  radiation
  • Persistent neutropenia (ANC ≤ 1000/mm3)
  • Bone marrow involvement with tumor
  • Patient has a condition that can potentially increase the risk of serious infection (i.e. HIV/AIDS with low CD4 counts)
  • Recent surgery and/or open wounds
  • Poor performance status
  • Renal dysfunction (creatinine clearance <50)
  • Liver dysfunction (elevated bilirubin >2.0)
  • Chronic immunosuppression in the post-transplant setting including organ transplant

Note: dose-dense therapy, in general, requires growth factor support to maintain dose intensity and schedule. In the palliative setting, consideration should be given to dose reduction or change in regimen

Patient who experienced a neutropenic complication from a prior cycle of the same chemotherapy § ‡

Note: dose-dense therapy, in general, requires growth factor support to maintain dose intensity and schedule. In the palliative setting, consideration should be given to dose reduction or change in regimen

Patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome) ‡

Bone marrow transplantation (BMT) failure or engraftment delay ‡

Peripheral blood progenitor cell (PBPC) mobilization and transplant ‡

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

*Febrile neutropenia is defined as:

  • a single temperature ≥38.3 °C orally or ≥38.0 °C over 1 h; AND
  • neutropenia <500 neutrophils/mcL or <1,000 neutrophils/mcL and a predicted decline to ≤500 neutrophils/mcL over the next 48 h

§Expected incidence of febrile neutropenia percentages for myelosuppressive chemotherapy regimens can be found in the NCCN Myeloid Growth Factors Clinical Practice Guideline at NCCN.org

IV. Renewal Criteria

Same as initial prior authorization policy criteria.

V. Dosage/Administration

Indication

Dose

All other indications*

  • <10 kg = 0.1 mg/kg
  • 10-20 kg = 1.5 mg
  • 21-30 kg = 2.5 mg
  • 31-44 kg = 4 mg
  • 45 kg and up = 6 mg

Dosed no more frequently than every 14 days.

Acute Radiation Exposure

6 mg subcutaneously weekly x 2 doses (Use weight based dosing for pediatrics weighing <45 kg)

*Do not administer within 14 days before and 24 hours after administration of cytotoxic chemotherapy

VI. Billing Code/Availability Information

HCPCS code:

  • Q5111 – Injection, Pegfilgrastim-cbqv, biosimilar, (udenyca), 0.5 mg; 1 billable unit = 0.5 mg

NDC:

  • Udenyca 6 mg prefilled single-dose syringe: 70114-0101-xx

VII. References

  1. Udenyca [package insert]. Redwood City, California; Coherus Biosciences; February 2019. Accessed July 2019.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) pegfilgrastim. National Comprehensive Cancer Network, 2019. 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 July 2019.
  3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Hematopoietic Growth Factors. Version 2.2019. National Comprehensive Cancer Network, 2019. 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 July 2019.
  4. Russel N, Mesters R, Schubert J, et al. A phase 2 pilot study of pegfilgrastim and filgrastim for mobilizing peripheral blood progenitor cells in patients with non-Hodgkin’s lymphoma receiving chemotherapy.  Haematologica March 200893:405-412;doi:10.3324/haematol.11287
  5. Isidori A, Tani M, Bonifazi F, et al. Phase II study of a single pegfilgrastim injection as an adjunct to chemotherapy to mobilize stem cells into the peripheral blood of pretreated lymphoma patients.  Haematologica January 200590:225-231
  6. Jagasia MH, Greer JP, Morgan DS, et al.  Pegfilgrastim after high-dose chemotherapy and autologous peripheral blood stem cell transplant: phase II study. Bone Marrow Transplant. 2005 Jun;35(12):1165-9.
  7. Bruns, Ingmar, et al. "A single dose of 6 or 12 mg of pegfilgrastim for peripheral blood progenitor cell mobilization results in similar yields of CD34+ progenitors in patients with multiple myeloma." Transfusion 46.2 (2006): 180-185.
  8. Staber, P. B., et al. "Fixed-dose single administration of Pegfilgrastim vs daily Filgrastim in patients with haematological malignancies undergoing autologous peripheral blood stem cell transplantation." Bone marrow transplantation 35.9 (2005): 889-893.
  9. Vanstraelen, Gaëtan, et al. "Pegfilgrastim compared with Filgrastim after autologous hematopoietic peripheral blood stem cell transplantation." Experimental hematology 34.3 (2006): 382-388.
  10. National Government Services, Inc. Local Coverage Article: Filgrastim, Pegfilgrastim, Tbo-filgrastim and biosimilars - Related to LCD L33394 (A52408). Centers for Medicare & Medicaid Services, Inc. Updated on 07/26/2019 with effective date 08/01/2019. Accessed August 2019.
  11. Wisconsin Physicians Service Insurance Corporation. Local Coverage Article: Human Granulocyte/Macrophage Colony Stimulating Factors Billing and Coding Guidelines (A56274). Centers for Medicare & Medicaid Services, Inc.  Updated on 03/19/2019 with effective date 03/19/2019. Accessed May 2019.
  12. CGS Administrators, LLC. Local Coverage Article: Neulasta® (pegfilgrastim) (A54826).  Centers for Medicare & Medicaid Services, Inc. Updated on 05/21/2019 with effective date 05/30/2019. Accessed August 2019.
  13. Palmetto GBA. Local Coverage Determination: White Cell Colony Stimulating Factors (L37176). Centers for Medicare & Medicaid Services, Inc. Updated on 07/19/2019 with effective date 08/01/2019. Accessed August 2019.
  14. First Coast Service Options, Inc. Local Coverage Determination (LCD): Pegfilgrastim (Neulasta®) (L33747).  Centers for Medicare & Medicaid Services, Inc. Updated on 01/25/2019 with effective date 01/01/2019.  Accessed August 2019.

Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

D61.810

Antineoplastic chemotherapy induced 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

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): 6, K

NCD/LCD Document (s): A52408

https://www.cms.gov/medicare-coverage-database/search/document-id-search-results.aspx?DocID=A52408&bc=gAAAAAAAAAAA&

Jurisdiction(s): 5,8

NCD/LCD Document (s): A56274

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A56274&bc=IAAAAAAAAAAA&SearchType=Advanced

Jurisdiction(s):  N

NCD/LCD Document (s): L33747

https://www.cms.gov/medicare-coverage-database/search/lcd-date-search.aspx?DocID=L33747&bc=gAAAAAAAAAAA

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