DOCSLIB.ORG

Clinical Medication Policy

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Clinical Medication Policy CLINICAL MEDICATION POLICY Policy Name: Granulocyte Colony Stimulating Factors (G-CSFs: Neupogen®, Granix®, Neulasta ®, Zarxio ®) Policy Number: MP-006-MC-ALL Responsible Departments: Medical Management; Clinical Pharmacy Provider Notice Date: 12/15/2018; 12/15/2017; 04/01/2017 Issue Date: 01/15/2019 Original Effective Date: 01/15/2019; 01/15/2018; 05/01/2017 Annual Approval Date: 11/14/2019 Revision Date: 11/14/2018; 11/08/2017 Products: Pennsylvania Medicare Assured Application: All participating and nonparticipating hospitals and providers Page Number(s): 1 of 29 DISCLAIMER Gateway HealthSM (Gateway) clinical medication policy is intended to serve only as a general reference resource regarding coverage for the services described. This policy does not constitute medical advice and is not intended to govern or otherwise influence medical decisions. POLICY STATEMENT Gateway Health℠ may provide coverage under the medical benefits of the Company’s Medicare products for medically necessary Granulocyte Colony Stimulating Factors (Neupogen, Granix). This policy is designed to address medical necessity guidelines that are appropriate for the majority of individuals with a particular disease, illness or condition. Each person’s unique clinical circumstances warrant individual consideration, based upon review of applicable medical records. DEFINITIONS Filgrastim – A recombinant granulocyte colony stimulating factor (rG-CSF). Colony Stimulating Factors (CSFs) – CSFs are naturally occurring cytokine glycoproteins classified as immunomodulators. They serve as growth factors specifically for myeloid hematopoietic cells Policy No. MP-006-MC-ALL Page 1 of 29 Granulocyte Colony Stimulating Factor – G-CSF specifically modulates neutrophils and their precursors, regulating their production within the bone marrow and affecting neutrophil progenitor proliferation, differentiation and selected end-cell functional activation. Neutropenia – A hematological disorder characterized by an abnormally low number of neutrophil granulocytes. Febrile Neutropenia – A condition in which there is a temperature of approximately 38.5° (greater than 101°F) or greater, sustained for more than one hour, and developing concurrently with absolute neutropenia of less than 500 cells/µL. PROCEDURES 1. Medical Necessity Criteria A. The following G-CSFs are preferred: 1) Granix (tbo-filgrastim) B. All other G-CSFs are considered non-preferred and require documentation of failure with one of the preferred G-CSFs in addition to meeting the criteria outlined below: 1) Neupogen (filgrastim) 2) Neulasta (pegfilgrastim) 3) Fulphila (pegfilgrastim-jmdb_ 4) Zarxio (filgrastim-sndz) 5) Leukine (sargramostim) For all requests for Granulocyte Colony Stimulating Factors all of the following criteria must be met: All requests must be prescribed by, or in consultation with, an oncologist or hematologist The requested dose and frequency is in accordance with FDA-approved labeling, nationally recognized compendia, and/or evidence-based practice guidelines C. Coverage may be provided with a diagnosis of primary prophylaxis of febrile neutropenia (FN) and the following criteria are met: 1) Request must be for Neupogen (filgrastim), Zarxio (filgrastim-sndz), Neulasta (pegfilgrastim), Fulphila (pegfilgrastim-jmdb), or Granix (tbo-filgrastim) 2) Must also meet at least one of the following: i. Must have a solid tumor or non-myeloid malignancy and be receiving myelosuppressive chemotherapy which has a greater than 20% risk of FN, as indicated in current American Society of Clinical Oncology and National Comprehensive Cancer Network guidelines for myeloid growth factors; ii. Must have a solid tumor or non-myeloid malignancy and be receiving nonmyelosuppressive chemotherapy which has 10-20% risk of FN, and be considered to be at high risk for chemotherapy-induced FN or infection due to at least one of the following: 1. Age greater than 65 years; 2. Poor performance status; 3. Previous episode of FN; 4. Extensive prior treatment including large radiation ports 5. Previous chemotherapy or radiation therapy 6. Preexisting neutropenia 7. Cytopenias due to bone marrow involvement by tumor Policy No. MP-006-MC-ALL Page 2 of 29 8. Poor nutritional status 9. Presence of open wounds or active infections 10. Recent surgery 11. Advanced cancer 12. Cardiovascular disease 13. Mucositis 14. Poor renal function 15. Liver dysfunction, most notably elevated bilirubin iii. Must be receiving a dose-dense chemotherapy regimen for the treatment of node- positive breast cancer, small-cell lung cancer, or diffuse aggressive non-Hodgkin’s Lymphoma. D. Coverage may be provided with a diagnosis of secondary prophylaxis of febrile neutropenia and the following criteria are met: 1) Request must be for Neupogen (filgrastim), Zarxio (filgrastim-sndz), Neulasta (pegfilgrastim), or Granix (tbo-filgrastim) 2) Member must have a documented episode of neutropenia from a prior cycle of chemotherapy for which primary prophylaxis was not received and a reduction in dose may compromise treatment outcome. E. Coverage may be provided for the mobilization of progenitor cells into peripheral blood for collection by leukophoresis and the following criteria is met: 1) Request must be for Neupogen (filgrastim), Leukine (sargramostim), or Zarxio (filgrastim-sndz). F. Coverage may be provided to reduce the duration of severe neutropenia following autologous stem-cell transplantation and the following criteria is met: 1) Request must be for Neupogen (filgrastim) or Zarxio (filgrastim-sndz) G. Coverage may be provided to reduce time to neutrophil recovery and duration of fever in adult patients with acute myeloid leukemia receiving induction or consolidation therapy and the following criteria is met: 1) Request must be for Neupogen (filgrastim) or Zarxio (filgrastim-sndz). H. Coverage may be provided with a diagnosis of congenital, cyclic, or idiopathic neutropenia and the following criteria are met: 1) Request must be for Neupogen (filgrastim) or Zarxio (filgrastim-sndz) 2) Must have experienced an infection requiring antibiotic treatment during the previous 12 months 3) For congenital or idiopathic neutropenia must have at least three documented episodes of severe chronic neutropenia (ANC <500/uL) during a 6 month period 4) For cyclic neutropenia must have documentation of 5 consecutive days of severe neutropenia (ANC <500/uL) per cycle. I. Coverage may be provided to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) and the following criteria is met: 1) Request must be for Leukine (sargramostim), Neupogen (filgrastim) or Neulasta (pegfilgrastim). Policy No. MP-006-MC-ALL Page 3 of 29 J. Coverage may be provided for myeloid recovery following bone marrow transplant and the following criteria are met: 1) Request must be for Leukine (sargramostim) 2) Must meet one of the following criteria: i. Must have undergone allogenic bone marrow transplant from HLA-matched related donor ii. Must have undergone autologous bone marrow transplant for non-Hodgkin’s lymphoma, acute lymphoblastic leukemia, or Hodgkin’s disease iii. Must have failed or delayed engraftment post bone marrow transplant as defined below: 1. Delay in engraftment: ANC ≤ 100 cells/mm3 by day 28 posttransplantation OR ANC ≤ 100 cells/mm3 by day 21 posttransplantation with evidence of active infection 2. Engraftment failure: average of ANC ≥ 500 cells/mm3 for at least one week followed by loss of engraftment with ANC < 500 cells/mm3 for at least one week beyond day 21 post transplantation 2. When the administration of G-CSF is not covered The administration of G-CSF is not covered for conditions other than those listed above because the scientific evidence has not been established. Coverage may be provided for any non-FDA labeled indication if it is determined that the use is a medically accepted indication supported by nationally recognized pharmacy compendia or peer- reviewed medical literature for treatment of the diagnosis (es) for which it is prescribed. These requests will be reviewed on a case-by-case basis to determine medical necessity. When criteria are not met, the request will be forwarded to a Medical Director for review. The physician reviewer must override criteria when, in their professional judgment, the requested medication is medically necessary. 3. Post-payment Audit Statement The medical record must include documentation that reflects the medical necessity criteria and is subject to audit by Gateway Health℠ at any time pursuant to the terms of your provider agreement. Coverage Determination Gateway Health ℠ follows the coverage determinations made by CMS as outlined in either the national coverage determinations (NCD) or the state-specific local carrier determination (LCD). There is no specific NCD or Pennsylvania LCD (Novitas Solutions, Inc.) for G-CSF. For additional information, please see: http://www.novitas- solutions.com/webcenter/portal/MedicalPolicy_JL/?_afrLoop=237596175793895#!%40%40%3F_afrLoo p%3D237596175793895%26_adf.ctrl-state%3Dwnoa115p2_42 Policy No. MP-006-MC-ALL Page 4 of 29 GOVERNING BODIES APPROVAL Summary of FDA Approved Labeled Indications for G-CSF Products: Myelosuppressive Acute Bone Progenitor Sever Chemotherapy Myeloid Marrow Cell Chronic Leukemia Transplant Collection Neutropenia Neupogen® X X X X X Neulasta® X Granix® X Zarxio™ X X X X X CODING REQUIREMENTS Procedure Codes HCPCS Codes Description J1442 Injection, filgrastim (G-CSF), excludes
Load more

Recommended publications
  • Therapeutic Class Overview Colony Stimulating Factors
    Therapeutic Class Overview Colony Stimulating Factors Therapeutic Class Overview/Summary: This review will focus on the granulocyte colony stimulating factors (G-CSFs) and granulocyte- macrophage colony stimulating factors (GM-CSFs).1-5 Colony-stimulating factors (CSFs) fall under the naturally occurring glycoprotein cytokines, one of the main groups of immunomodulators.6 In general, these proteins are vital to the proliferation and differentiation of hematopoietic progenitor cells.6-8 The G- CSFs commercially available in the United States include pegfilgrastim (Neulasta®), filgrastim (Neupogen®), filgrastim-sndz (Zarxio®), and tbo-filgrastim (Granix®). While filgrastim-sndz and tbo- filgrastim are the same recombinant human G-CSF as filgrastim, only filgrastim-sndz is considered a biosimilar drug as it was approved through the biosimilar pathway. At the time tbo-filgrastim was approved, a regulatory pathway for biosimilar drugs had not yet been established in the United States and tbo-filgrastim was filed under its own Biologic License Application.9 Only one GM-CSF is currently available, sargramostim (Leukine). These agents are Food and Drug Administration (FDA)-approved for a variety of conditions relating to neutropenia or for the collection of hematopoietic progenitor cells for collection by leukapheresis.1-5 Due to the pathway taken, tbo-filgrastim does not share all of the same indications as filgrastim and these two products are not interchangeable. It is important to note that although filgrastim-sndz is a biosimilar product, and it was approved with all the same indications as filgrastim at the time, filgrastim has since received FDA-approval for an additional indication that filgrastim-sndz does not have, to increase survival in patients with acute exposure to myelosuppressive doses of radiation.1-3A complete list of indications for each agent can be found in Table 1.
    [Show full text]
  • FULPHILA Safely and Effectively
    HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use FULPHILA safely and effectively. See full prescribing information for -----------------------WARNINGS AND PRECAUTIONS----------------------­ FULPHILA. • Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. (5.1) ™ FULPHILA (pegfilgrastim-jmdb) injection, for subcutaneous use • Acute respiratory distress syndrome (ARDS): Evaluate patients who Initial U.S. Approval: 2018 develop fever, lung infiltrates, or respiratory distress. Discontinue ™ ® Fulphila in patients with ARDS. (5.2) FULPHILA (pegfilgrastim-jmdb) is biosimilar* to NEULASTA • Serious allergic reactions, including anaphylaxis: Permanently (pegfilgrastim). (1) discontinue Fulphila in patients with serious allergic reactions. (5.3) • Fatal sickle cell crises: Have occurred. (5.4) ----------------------------INDICATIONS AND USAGE--------------------------- • Glomerulonephritis: Evaluate and consider dose-reduction or Fulphila is a leukocyte growth factor indicated to interruption of Fulphila if causality is likely. (5.5) • Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving ------------------------------ADVERSE REACTIONS------------------------------ myelosuppressive anti-cancer drugs associated with a clinically Most common adverse reactions (≥ 5% difference in incidence compared to significant incidence of febrile neutropenia.
    [Show full text]
  • Comparison Between Filgrastim and Lenograstim Plus Chemotherapy For
    Bone Marrow Transplantation (2010) 45, 277–281 & 2010 Macmillan Publishers Limited All rights reserved 0268-3369/10 $32.00 www.nature.com/bmt ORIGINAL ARTICLE Comparison between filgrastim and lenograstim plus chemotherapy for mobilization of PBPCs R Ria, T Gasparre, G Mangialardi, A Bruno, G Iodice, A Vacca and F Dammacco Department of Biomedical Sciences and Human Oncology, Section of Internal Medicine and Clinical Oncology, University of Bari Medical School, Bari, Italy Recombinant human (rHu) G-CSF has been widely used during transplantation.4 However, the use of G-CSF after to treat neutropenia and mobilize PBPCs for their autologous PBPC transplantation has been queried, as its autologous and allogeneic transplantation. It shortens further reduction in time to a safe neutrophil count5,6 does neutropenia and thus reduces the frequency of neutropenic not always imply fewer significant clinical events, such as fever. We compared the efficiency of glycosylated rHu infections, length of hospitalization, extrahematological and non-glycosylated Hu G-CSF in mobilizing hemato- toxicities or mortality.7,8 Even so, the ASCO guidelines still poietic progenitor cells (HPCs). In total, 86 patients were recommend the use of growth factors after autologous consecutively enrolled for mobilization with CY plus either PBPC transplantation.9 glycosylated or non-glycosylated G-CSF, and under- G-CSF induces the proliferation and differentiation of went leukapheresis. The HPC content of each collection, myeloid precursor cells, and also provides a functional toxicity, days of leukapheresis needed to reach the activity that influences chemotaxis, respiratory burst and minimum HPC target and days to recover WBC (X500 Ag expression of neutrophils.
    [Show full text]
  • Filgrastim Vs Pegfilgrastim: a Quality of Life Issue for Children
    FEATURE | Filgrastim vs pegfilgrastim Filgrastim vs pegfilgrastim: A quality of life issue for children Administration, safety, and efficacy are similar in both agents.H owever, the frequency of administration makes a significant difference for patients. KAREN E. MACDonaLD, BSN, RN, CPON; HAYLEY BEE, BSN, RN, CPN, CCRN; DARBY TOZER, BSN, RN; JEnnIFER E. TRAIN, BSN, RN ancer is diagnosed in 1.5 million people in the United States each year, and more than 12,000 cancer patients are younger C 1 than 21 years. Parents sit across the table from the medical team and learn about the side effects of treatment that their child may experience. The child will lose his or her hair, miss school, experience nausea and vomiting, and endure multiple laboratory and diagnostic tests. Families learn that their day-to-day life, once filled with school, work, soccer games, and other family- centered activities, will now consist of hospital admissions, doctor visits, and isolation to abate the possible side effects of treatment. In addition, parents will need to learn how to administer clinical care, such as subcutaneous injections of medications to improve the child’s immune system, at home. Neutrophils are a critical member of the phago- cytic system and provide a first-line defense against bacterial organisms.2 Neutropenia is defined as a reduction in circulating neutrophils to less than 1,500/µL.1 Chemotherapy-induced neutropenia is the primary treatment-related dose-limiting toxicity in children with can- cer. Severe neutropenia (neutrophils less than 500/µL) can occur as a result of chemotherapy treatment. Children who receive intensive che- motherapy have a 40% chance of developing 3 © THINKSTOCK © febrile neutropenia.
    [Show full text]
  • G-CSF Protects Motoneurons Against Axotomy-Induced Apoptotic Death In
    Henriques et al. BMC Neuroscience 2010, 11:25 http://www.biomedcentral.com/1471-2202/11/25 RESEARCH ARTICLE Open Access G-CSF protects motoneurons against axotomy- induced apoptotic death in neonatal mice Alexandre Henriques1,2,3, Claudia Pitzer1*, Luc Dupuis2,3, Armin Schneider1* Abstract Background: Granulocyte colony stimulating factor (G-CSF) is a growth factor essential for generation of neutrophilic granulocytes. Apart from this hematopoietic function, we have recently uncovered potent neuroprotective and regenerative properties of G-CSF in the central nervous system (CNS). The G-CSF receptor and G-CSF itself are expressed in a motoneurons, G-CSF protects motoneurons, and improves outcome in the SOD1(G93A) transgenic mouse model for amyotrophic lateral sclerosis (ALS). In vitro, G-CSF acts anti- apoptotically on motoneuronal cells. Due to the pleiotrophic effects of G-CSF and the complexity of the SOD1 transgenic ALS models it was however not possible to clearly distinguish between directly mediated anti- apoptotic and indirectly protective effects on motoneurons. Here we studied whether G-CSF is able to protect motoneurons from purely apoptotic cell death induced by a monocausal paradigm, neonatal sciatic nerve axotomy. Results: We performed sciatic nerve axotomy in neonatal mice overexpressing G-CSF in the CNS and found that G-CSF transgenic mice displayed significantly higher numbers of surviving lumbar motoneurons 4 days following axotomy than their littermate controls. Also, surviving motoneurons in G-CSF overexpressing animals were larger, suggesting additional trophic effects of this growth factor. Conclusions: In this model of pure apoptotic cell death the protective effects of G-CSF indicate direct actions of G-CSF on motoneurons in vivo.
    [Show full text]
  • ©Ferrata Storti Foundation
    Stem Cell Transplantation • Research Paper Single-dose pegfilgrastim for the mobilization of allogeneic CD34+ peripheral blood progenitor cells in healthy family and unrelated donors Frank Kroschinsky Background and Objectives. Short-term treatment with granulocyte colony-stimulating Kristina Hölig factor (G-CSF) has been established as the standard regimen for mobilizing allogeneic Kirsten Poppe-Thiede peripheral blood progenitor cells (PBPC) from healthy donors. The pegylated form of fil- Kristin Zimmer grastim (pegfilgrastim) has a longer elimination half-life because of decreased serum Rainer Ordemann clearance and might be a convenient alternative for stem cell mobilization. Matthias Blechschmidt Uta Oelschlaegel Design and Methods. Twenty-five family (n=15) or unrelated (n=10) healthy donors received a single-dose of 12 mg pegfilgrastim for mobilization of allogeneic PBPC. Martin Bornhauser + Gabi Rall Donors with inadequate mobilization (blood CD34 cells ≤5/µL on day 3 or ≤20/µL on Claudia Rutt day 4) were given additional daily doses of 10 µg/kg conventional filgrastim. Gerhard Ehninger Leukapheresis was planned to start on day 5. Results. All harvests were completed successfully. In 20 out of 25 donors (80 %) only a single apheresis was necessary. Additional non-pegylated filgrastim had to be given to only one 74-year old family donor. The maximum concentration of circulating CD34+ + cells occurred on day 5 (median 67/µL, range 10-385/µL). The median yield of CD34 cells was 9.3 (range 3.2-39.1) 106/kg of the recipient´s body weight. The median × 8 number of T cells in the apheresis products was 3.9 (range 2.7-10.8)×10 /kg.
    [Show full text]
  • NEULASTA (Pegfilgrastim)
    HIGHLIGHTS OF PRESCRIBING INFORMATION Injection: 6 mg/0.6 mL solution in a single-dose prefilled syringe These highlights do not include all the information needed to use co-packaged with the on-body injector for Neulasta. (3) NEULASTA safely and effectively. See full prescribing information for NEULASTA. -------------------------------CONTRAINDICATIONS ---------------------------­ Patients with a history of serious allergic reactions to human granulocyte NEULASTA® (pegfilgrastim) injection, for subcutaneous use colony-stimulating factors such as pegfilgrastim or filgrastim. (4) Initial U.S. Approval: 2002 -----------------------WARNINGS AND PRECAUTIONS-----------------------­ ----------------------------RECENT MAJOR CHANGES-------------------------­ Fatal splenic rupture: Evaluate patients who report left upper abdominal Warnings and Precautions, Aortitis (5.11) 0 6 / 2 0 1 8 or shoulder pain for an enlarged spleen or splenic rupture. (5.1) W a r n i n g s a n d P r e c a u t i o n s , N u c l e a r I m a g i n g ( 5 . 1 2 ) 06/2018 Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue ----------------------------INDICATIONS AND USAGE--------------------------- Neulasta in patients with ARDS. (5.2) Neulasta is a leukocyte growth factor indicated to Serious allergic reactions, including anaphylaxis: Permanently Decrease the incidence of infection, as manifested by febrile discontinue Neulasta in patients with serious allergic reactions. (5.3) neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically The on-body injector for Neulasta uses acrylic adhesive. For patients significant incidence of febrile neutropenia. (1.1) who have reactions to acrylic adhesives, use of this product may result in a significant reaction.
    [Show full text]
  • NEUPOGEN® (Filgrastim) DESCRIPTION Filgrastim Is a Human Granulocyte Colony-Stimulating Factor (G-CSF)‚ Produced by Recombinant DNA Technology
    NEUPOGEN® (Filgrastim) DESCRIPTION Filgrastim is a human granulocyte colony-stimulating factor (G-CSF)‚ produced by recombinant DNA technology. NEUPOGEN® is the Amgen Inc. trademark for filgrastim‚ which has been selected as the name for recombinant methionyl human granulocyte colony-stimulating factor (r-metHuG-CSF). NEUPOGEN® is a 175 amino acid protein manufactured by recombinant DNA technology.1 NEUPOGEN® is produced by Escherichia coli (E coli) bacteria into which has been inserted the human granulocyte colony-stimulating factor gene. NEUPOGEN® has a molecular weight of 18‚800 daltons. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis‚ except for the addition of an N-terminal methionine necessary for expression in E coli. Because NEUPOGEN® is produced in E coli‚ the product is nonglycosylated and thus differs from G-CSF isolated from a human cell. NEUPOGEN is a sterile‚ clear‚ colorless‚ preservative-free liquid for parenteral administration containing filgrastim at a specific activity of 1.0 ± 0.6 x 108 U/mg (as measured by a cell mitogenesis assay). The product is available in single-use vials and prefilled syringes. The single-use vials contain either 300 mcg or 480 mcg filgrastim at a fill volume of 1.0 mL or 1.6 mL, respectively. The single-use prefilled syringes contain either 300 mcg or 480 mcg filgrastim at a fill volume of 0.5 mL or 0.8 mL, respectively. See table below for product composition of each single-use vial or prefilled syringe. 300 mcg/ 480 mcg/ 300 mcg/ 480 mcg/ 1.0 mL Vial 1.6 mL Vial 0.5 mL Syringe 0.8 mL Syringe filgrastim 300 mcg 480 mcg 300 mcg 480 mcg Acetate 0.59 mg 0.94 mg 0.295 mg 0.472 mg Sorbitol 50.0 mg 80.0 mg 25.0 mg 40.0 mg Polysorbate 80 0.04 mg 0.064 mg 0.02 mg 0.032 mg Sodium 0.035 mg 0.056 mg 0.0175 mg 0.028 mg Water for Injection USP q.s.
    [Show full text]
  • Colony Stimulating Factors – Medicare Advantage Policy Guideline
    UnitedHealthcare® Medicare Advantage Policy Guideline Colony Stimulating Factors Guideline Number: MPG214.06 Approval Date: December 9, 2020 Terms and Conditions Table of Contents Page Related Medicare Advantage Policy Guidelines Policy Summary ............................................................................. 1 • Self-Administered Drug(s) (SAD) Applicable Codes .......................................................................... 3 • Stem Cell Transplantation (Formerly 110.8.1) (NCD Definitions ...................................................................................... 3 110.23) References ..................................................................................... 4 Guideline History/Revision Information ....................................... 6 Related Medicare Advantage Reimbursement Policies Purpose .......................................................................................... 7 • Medically Unlikely Edits Policy, Professional Terms and Conditions ................................................................... 8 • National Drug Code (NDC) Requirement Policy, Professional and Facility • Procedure to Modifier Policy, Professional Related Medicare Advantage Coverage Summary • Medications/Drugs (Outpatient/Part B) Policy Summary See Purpose Overview White blood cell growth factors, also known as granulocyte colony stimulating factors (G-CSF), are administered to enhance recovery of blood related functions in neutropenia (low white blood count) including febrile neutropenia (FN). G-CSFs
    [Show full text]
  • Pegfilgrastim: More Cost Effective and Equally Efficacious Option As Compared to Filgrastim in Autologous Stem Cell Transplant
    Indian J Hematol Blood Transfus (Jan-Mar 2019) 35(1):66–71 https://doi.org/10.1007/s12288-018-0966-5 ORIGINAL ARTICLE Pegfilgrastim: More Cost Effective and Equally Efficacious Option as Compared to Filgrastim in Autologous Stem Cell Transplant 1 1 1 1 1 V. Sheth • A. Gore • R. Jain • A. Ghanekar • T. Saikia Received: 11 October 2017 / Accepted: 7 May 2018 / Published online: 17 May 2018 Ó Indian Society of Hematology and Blood Transfusion 2018 Abstract Use of growth factor after high-dose (p = 0.184).The average cost savings per person in terms of chemotherapy (HDC) and autologous peripheral blood number of days of hospitalization and number of days of stem cell (PBSC) support is current standard in reducing total parental nutrition was 582 Rs (p = 0.512) and 6003 Rs days of neutropenia. This retrospective study aims to (p = 0.018) respectively in favour of PEG arm. PEG is compare the efficacy of two standard growth factors, peg- similar to FIL in hematological reconstitution, however it filgrastim (PEG) and filgrastim (FIL) after HDC. We col- is more cost effective alternative after HDC and PBSC. lected data on 195 consecutive adult patients who received an autotransplant (myeloma, lymphoma and others) Keywords Pegfilgrastim Á Filgrastim Á Autologous stem between January 2004 and December 2014 at two tertiary cell transplantation care centres. The primary end point was the duration of neutropenia in terms of days to reach an ANC [ 0.5 9 109/L. Filgrastim was given to 110 patients Introduction and PEG was given to 85 patients. Time to engraftment, defined as the time to reach an ANC of 0.5 9 109/L on 2 High-dose chemotherapy (HDC) with autologous stem cell consecutive days after the day of auto-SCT, was 12.6 days support (SCT) is the current standard of care in relapsed with FIL compared with 12.1 days with PEG group lymphomas and myeloma.
    [Show full text]
  • Colony Stimulating Factors Medical Policy
    Medical benefit drug policies are a source for BCBSM and BCN medical policy information only. These documents are not to be used to determine benefits or reimbursement. Please reference the appropriate certificate or contract for benefit information. This policy may be updated and therefore subject to change. Effective Date: 08/12/2021 Colony Stimulating Factors (CSFs) Fulphila™ (pegfilgrastim-jmbd) Granix® (tbo-filgrastim) Leukine® (sargramostim) Neulasta® (pegfilgrastim) Neulasta On-Pro® (pegfilgrastim) Neupogen® (filgrastim) Nivestym™ (filgrastim-aafi) Nyvepria™ (pegfilgrastim-apgf) Udenyca™ (pegfilgrastim-cbqv) Zarxio® (filgrastim-sndz) ZiextenzoTM (pegfilgrastim-bmez) FDA approval: Various HCPCS: Fulphila – J3490, Granix – J1447, Leukine – J2820, Neupogen – J1442, Neulasta – J2505, Nivestym J3490, Nyvepria - Q5122, Udenyca – Q5111, Zarxio – J3490, Zietxenzo – Q5120, C9058 Benefit: Both Policy: Requests must be supported by submission of chart notes and patient specific documentation. A. Coverage of the requested drug is provided for FDA approved indications and when all the following are met: a. Primary prophylaxis of chemotherapy-induced febrile neutropenia is considered clinically appropriate when ALL of the following are met: i. The individual has a non-myeloid malignancy ii. Chemotherapy intent must include one of the following: 1. Curative intent (adjuvant treatment for early stage disease, for example) OR 2. Intent is survival prolongation, and the use of a different regimen or dose reduction would reduce the likelihood of
    [Show full text]
  • Pegfilgrastim
    Colony Stimulating Factors – Pegfilgrastim: Neulasta®; Fulphila™; Udenyca®; Ziextenzo™; Nyvepria™ (Subcutaneous) Document Number: IH-0234 Last Review Date: 01/01/2021 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, 06/2018, 09/2018, 12/2018, 03/2019, 06/2019, 09/2019, 12/2019, 02/2020, 06/2020, 07/2020, 09/2020, 01/2021 I. Length of Authorization1-5,10,11,12,13,14 • Bone marrow transplantation (BMT) failure or engraftment delay: Coverage will be provided for 1 dose only and may not be renewed. • Peripheral blood progenitor cell (PBPC) mobilization and transplant: Coverage will be provided for 1 dose only and may not be renewed. • All other indications: Coverage will be provided for four months and may be renewed unless otherwise specified. II. Dosing Limits A. Quantity Limit (max daily dose) [NDC Unit]: − Neulasta 6 mg prefilled syringe: 1 syringe per 14 days − Fulphila 6 mg prefilled syringe: 1 syringe per 14 days − Udenyca 6 mg prefilled syringe: 1 syringe per 14 days − Ziextenzo 6 mg prefilled syringe: 1 syringe per 14 days − Nyvepria 6 mg prefilled syringe: 1 syringe per 14 days B. Max Units (per dose and over time) [HCPCS Unit]: Neulasta Fulphila Udenyca Ziextenzo Nyvepria (J2505) (Q5108) (Q5111) (Q5120) (Q5122) Acute Radiation 1 billable 12 billable 12 billable 12 billable 12 billable Exposure unit weekly units weekly units weekly units weekly units weekly x 2 doses x 2 doses x 2 doses x 2 doses x 2 doses BMT failure or 1 billable 12 billable 12 billable 12 billable 12 billable engraftment delay/ unit x 1 units x 1 units x 1 units x 1 units x 1 PBPC mobilization and dose dose dose dose dose transplant Proprietary & Confidential © 2021 Magellan Health, Inc.
    [Show full text]