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Colony Stimulating Factors: Fulphila (pegfilgrastim-jmdb)(Subcutaneous)Document Number: MODA-0370Last Review Date: 12/03/2019Date of Origin: 07/03/2018Dates Reviewed: 07/2018, 09/2018, 12/2018, 03/2019, 06/2019, 09/2019, 12/2019I.Length of AuthorizationCoverage will be provided for four months and may be renewed.II.Dosing LimitsA. Quantity Limit (max daily dose) [NDC Unit]: Fulphila 6 mg prefilled syringe: 1 syringe per 14 daysB. Max Units (per dose and over time) [HCPCS Unit]: III.12 billable units weekly x 2 doses for Acute Radiation Exposure12 billable units per 14 days for all other indicationsInitial Approval CriteriaNeulasta and Udenyca are the preferred long-acting granulocyte colony-stimulating factorproducts. Patients must have failed, or have a contraindication, or intolerance to Neulasta ANDUdenyca prior to consideration of any other long-acting G-CSF product.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 febrileneutropenia* of 20% or greater §; OR Patient is undergoing myelosuppressive chemotherapy with an expected incidence of febrileneutropenia* of 10% or greater § AND one or more of the following co-morbidities: Age 65 receiving full dose intensityHistory of recurrent febrile neutropenia from chemotherapyExtensive prior exposure to chemotherapyPrevious exposure of pelvis, or other areas of large amounts of bone marrow, to radiationPersistent neutropenia (ANC 1000/mm3)Bone marrow involvement with tumorPatient has a condition that can potentially increase the risk of serious infection (i.e.HIV/AIDS with low CD4 counts)Moda Health Plan, Inc. Medical Necessity CriteriaPage 1/5
Recent surgery and/or open woundsPoor performance statusRenal dysfunction (creatinine clearance 50)Liver dysfunction (elevated bilirubin 2.0)Chronic immunosuppression in the post-transplant setting including organ transplantNote: dose-dense therapy, in general, requires growth factor support to maintain doseintensity and schedule. In the palliative setting, consideration should be given to dosereduction or change in regimenPatient who experienced a neutropenic complication from a prior cycle of the samechemotherapy § ‡Note: dose-dense therapy, in general, requires growth factor support to maintain doseintensity and schedule. In the palliative setting, consideration should be given to dosereduction or change in regimenPatients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome ofAcute 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 chemotherapyregimens can be found in the NCCN Myeloid Growth Factors Clinical Practice Guideline atNCCN.orgIV.Renewal CriteriaSame as initial prior authorization policy criteria.V.Dosage/AdministrationIndicationDoseAll 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 mgDosed no more frequently than every 14 days.Acute Radiation Exposure6 mg subcutaneously weekly x 2 doses (Use weight based dosing forpediatrics weighing 45 kg)Moda Health Plan, Inc. Medical Necessity CriteriaPage 2/5
*Do not administer within 14 days before and 24 hours after administration of cytotoxic chemotherapyVI.Billing Code/Availability InformationHCPCS code: Q5108 – Injection, pegfilgrastim-jmdb, biosimilar, (Fulphila), 0.5 mg: 1 billable unit 0.5mgNDC: Fulphila 6 mg prefilled single-dose syringe: 67457-0833-xxVII.References1. Fulphila [package insert]. Zurich, Switzerland; Mylan GmbH; May 2019. Accessed October2019.2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCNCompendium ) pegfilgrastim. National Comprehensive Cancer Network, 2019. The NCCNCompendium is a derivative work of the NCCN Guidelines . NATIONALCOMPREHENSIVE CANCER NETWORK , NCCN , and NCCN GUIDELINES aretrademarks owned by the National Comprehensive Cancer Network, Inc. To view the mostrecent and complete version of the Compendium, go online to NCCN.org. Accessed October2019.3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCNCompendium ) Hematopoietic Growth Factors. Version 2.2019. National ComprehensiveCancer Network, 2019. The NCCN Compendium is a derivative work of the NCCNGuidelines . NATIONAL COMPREHENSIVE CANCER NETWORK , NCCN , and NCCNGUIDELINES are trademarks owned by the National Comprehensive Cancer Network,Inc. To view the most recent and complete version of the Compendium, go online toNCCN.org. Accessed October 2019.4. Russel N, Mesters R, Schubert J, et al. A phase 2 pilot study of pegfilgrastim and filgrastimfor mobilizing peripheral blood progenitor cells in patients with non-Hodgkin’s lymphomareceiving chemotherapy. Haematologica March 200893:405-412;doi:10.3324/haematol.112875. Isidori A, Tani M, Bonifazi F, et al. Phase II study of a single pegfilgrastim injection as anadjunct to chemotherapy to mobilize stem cells into the peripheral blood of pretreatedlymphoma patients. Haematologica January 200590:225-2316. Jagasia MH, Greer JP, Morgan DS, et al. Pegfilgrastim after high-dose chemotherapy andautologous 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 bloodprogenitor cell mobilization results in similar yields of CD34 progenitors in patients withmultiple myeloma." Transfusion 46.2 (2006): 180-185.8. Staber, P. B., et al. "Fixed-dose single administration of Pegfilgrastim vs daily Filgrastim inpatients with haematological malignancies undergoing autologous peripheral blood stem celltransplantation." Bone marrow transplantation 35.9 (2005): 889-893.Moda Health Plan, Inc. Medical Necessity CriteriaPage 3/5
9. Vanstraelen, Gaëtan, et al. "Pegfilgrastim compared with Filgrastim after autologoushematopoietic peripheral blood stem cell transplantation." Experimental hematology 34.3(2006): 382-388.10. First Coast Service Options, Inc. Local Coverage Determination (LCD): Pegfilgrastim(Neulasta ) (L33747). Centers for Medicare & Medicaid Services, Inc. Updated on01/25/2019 with effective date 01/01/2019. Accessed October 2019.11. Palmetto GBA. Local Coverage Determination: White Cell Colony Stimulating Factors(L37176). Centers for Medicare & Medicaid Services, Inc. Updated on 07/19/2019 witheffective date 08/01/2019. Accessed October 2019.12. National Government Services, Inc. Local Coverage Article: Filgrastim, Pegfilgrastim, Tbofilgrastim and biosimilars - Related to LCD L33394 (A52408). Centers for Medicare &Medicaid Services, Inc. Updated on 07/26/2019 with effective date 08/01/2019. AccessedOctober 2019.13. CGS Administrators, LLC. Local Coverage Article: Billing and Coding: Neulasta (pegfilgrastim) (A56829). Centers for Medicare & Medicaid Services, Inc. Updated on10/03/2019 with effective date 8/8/2019. Accessed October 2019.Appendix 1 – Covered Diagnosis CodesICD-10ICD-10 DescriptionD61.81PancytopeniaD70.1Agranulocytosis secondary to cancer chemotherapyD70.9Neutropenia, unspecifiedT45.1X5AAdverse effect of antineoplastic and immunosuppressive drugs initial encounterT45.1X5DAdverse effect of antineoplastic and immunosuppressive drugs subsequent encounterT45.1X5SAdverse effect of antineoplastic and immunosuppressive drugs sequelaT66.XXXARadiation sickness, unspecified, initial encounterT66.XXXDRadiation sickness, unspecified, subsequent encounterT66.XXXSRadiation sickness, unspecified, sequelaW88.1Exposure to radioactive isotopesW88.8Exposure to other ionizing radiationZ41.8Encounter for other procedures for purposes other than remedying health stateZ48.290Encounter for aftercare following bone marrow transplantZ51.11Encounter for antineoplastic chemotherapyZ51.12Encounter for antineoplastic immunotherapyZ51.89Encounter for other specified aftercareZ52.001Unspecified donor, stem cellsZ52.011Autologous donor, stem cellsZ52.091Other blood donor, stem cellsZ76.89Persons encountering health services in other specified circumstancesZ94.81Bone marrow transplant statusZ94.84Stem cells transplant statusModa Health Plan, Inc. Medical Necessity CriteriaPage 4/5
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 isrequired where applicable. They can be found at: h/advanced-search.aspx. Additional indications may be covered at the discretion ofthe health plan.Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD):Jurisdiction(s): NNCD/LCD Document (s): se/search/lcd-datesearch.aspx?DocID L33747&bc gAAAAAAAAAAAJurisdiction(s): J, MNCD/LCD Document (s): se/search/lcd-datesearch.aspx?DocID L37176&bc gAAAAAAAAAAAJurisdiction(s): 6, KNCD/LCD Document (s): se/search/document-id-searchresults.aspx?DocID A52408&bc gAAAAAAAAAAA&Jurisdiction(s): 15NCD/LCD Document (s): se/search/document-id-searchresults.aspx?DocID A56829&bc gAAAAAAAAAAA&Medicare Part B Administrative Contractor (MAC) JurisdictionsJurisdictionApplicable State/US TerritoryContractorE (1)CA, HI, NV, AS, GU, CNMIF (2 & 3)AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ Noridian Healthcare Solutions, LLC5KS, NE, IA, MOWisconsin Physicians Service Insurance Corp (WPS)6MN, WI, ILNational Government Services, Inc. (NGS)H (4 & 7)LA, AR, MS, TX, OK, CO, NMNovitas Solutions, Inc.8MI, INWisconsin Physicians Service Insurance Corp (WPS)N (9)FL, PR, VIFirst Coast Service Options, Inc.J (10)TN, GA, ALPalmetto GBA, LLCM (11)NC, SC, WV, VA (excluding below)Palmetto GBA, LLCDE, MD, PA, NJ, DC (includes Arlington &Novitas Solutions, Inc.L (12)Fairfax counties and the city of Alexandria in VA)Noridian Healthcare Solutions, LLCK (13 & 14) NY, CT, MA, RI, VT, ME, NHNational Government Services, Inc. (NGS)15CGS Administrators, LLCKY, OHModa Health Plan, Inc. Medical Necessity CriteriaPage 5/5
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 File Size: 213KB
