Transcription
Prior Authorization CriteriaFilgrastimPolicy Number: C2437-ACRITERIA EFFECTIVE DATES:ORIGINAL EFFECTIVE DATE6/2012J CODELAST REVIEWED DATE6/17/2020TYPE OF CRITERIANEXT REVIEW DATE6/17/2021LAST P&TAPPROVAL/VERSIONRxPAQ3 202020200722C2437-AJ1442-Inj, filgrastim (g-csf),excludes biosimilars, 1 mcgQ5101-Inj, filgrastim-sndz,biosimilar, (zarxio), 1 mcgJ1447-Inj, tbo-filgrastim, 1mcgQ5110-Inj, filgrastim-aafi,biosimilar, (nivestym), 1 mcgPRODUCTS AFFECTED:Neupogen (filgrastim); Zarxio (filgrastim-sndz); Nivestym (filgrastim-aafi); Granix (tbo-filgrastim)DRUG CLASS:Granulocyte Colony-Stimulating Factors (G-CSF)ROUTE OF ADMINISTRATION:Intravenous or SubcutaneousPLACE OF SERVICE:Specialty Pharmacy or Buy and BillThe recommendation is that medications in this policy will be for pharmacy benefit coverage and theIV infusion products administered in a place of service that is a non-hospital facility-based location(i.e., home infusion provider, provider’s office, free-standing ambulatory infusion center) and the PreFilled Syringe product for self-administeredAVAILABLE DOSAGE FORMS:Neupogen (filgrastim) 300mcg/mL vial, 300mcg/0.5mL prefilled syringe, 480mcg/1.6mL vial,480mcg/0.8mL prefilled syringe Zarxio (filgrastim-sndz) 300mcg/0.5mL prefilled syringe,480mcg/0.8mL prefilled syringe Nivestym (filgrastim-aafi) 300mcg/0.5mL prefilled syringe,480mcg/0.8mL prefilled syringe Granix (tbo- filgrastim) 300mcg/0.5mL prefilled syringe,480mcg/0.8mL prefilled syringeFDA-APPROVED USES:ALL PRODUCTS: Myelosuppressive chemotherapy recipients with nonmyeloid malignancies: Todecrease the incidence of infection (neutropenic fever) in members with nonmyeloid malignanciesreceiving myelosuppressive chemotherapy associated with a significant incidence of severeneutropenia with feverNEUPOGEN ONLY: Increase survival in members acutely exposed to myelosuppressive doses ofradiation (Hematopoietic Syndrome of Acute Radiation Syndrome)NEUPOGEN/ZARXIO/NIVESTYM ONLY:Molina Healthcare, Inc. confidential and proprietary 2020This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed, or printed without written permission fromMolina Healthcare. This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliatedwith Molina Healthcare.Page 1 of 7
Prior Authorization CriteriaAcute myeloid leukemia following induction or consolidation chemotherapy: To reduce the time toneutrophil recovery and the duration of fever, following induction or consolidation chemotherapy inadults with acute myeloid leukemia (AML)Bone marrow transplantation: To reduce the duration of neutropenia and neutropenia-related events(e.g., neutropenic fever) in members with nonmyeloid malignancies receiving myeloablativechemotherapy followed by bone marrow transplantation.Peripheral blood progenitor cell collection and therapy: Mobilization of autologous hematopoieticprogenitor cells into the peripheral blood for apheresis collectionSevere chronic neutropenia: Long-term administration to reduce the incidence and duration ofneutropenic complications (e.g., fever, infections, oropharyngeal ulcers) in symptomaticmemberswith congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia.COMPENDIAL APPROVED OFF-LABELED USES:NoneCOVERAGE CRITERIA: INITIAL AUTHORIZATIONDIAGNOSIS:see FDA-approved uses aboveREQUIRED MEDICAL INFORMATION:IF THIS IS A NON-FORMULARY/NON-PREFERRED PRODUCT FOR INITIAL OR CONTINUATIONOF THERAPY REQUEST: Documentation of trial/failure of or intolerance to a majority (not more than 3)of the preferred formulary BIOLOGIC/PDL alternatives for the given diagnosis. If yes, please submitdocumentation including medication(s) tried, dates of trial(s) and reason for treatment failure(s)BIOSIMILAR DRUGS are preferred when requested as a physician administered drug and/orpharmacy formulary product per applicable state regulations and there is a lack of datademonstrating clinical superiority of reference drugs over the FDA approved biosimilar drugs. Areference medication is approved under the following conditions:1. Treatment with at least two (2) associated biosimilar drug(s) has been ineffective, not tolerated,or is contraindicated (i.e. an allergic reaction to a specific inactive ingredient in the preferredbiologic product or biosimilar OR an adverse reaction to a specific inactive ingredient in thepreferred biologic product or biosimilar OR therapeutic success while taking a non-preferredbiologic product or biosimilar and therapeutic failure while taking the preferred biologic productor biosimilar documented by patient diary or medical charted notes)[DOCUMENTATION REQUIRED-Document when the preferred biologic product or biosimilarwas tried and the length of the trial period. Provide specific clinical documentation oftherapeutic failure on the preferred biologic product or biosimilar whenever possible. Describethe medical problem caused by the preferred referenced biologic. Vague and non-descriptivesymptoms are not adequate rationale (e.g., stomachache)]A. FEBRIL NEUTROPENIA PROPHYLAXIS IN NON-MYELOID MALIGNANCIES:1. Documented diagnosis of non-myeloid malignancyAND2. Documentation that filgrastim is being used following myelosuppressive chemotherapy[Documentation of current chemotherapy regimen, any previous chemotherapy regimens,and anticipated treatment plan]AND3. (a) Member has a risk of febrile neutropenia (FN) of greater than 20% based on currentMolina Healthcare, Inc. confidential and proprietary 2020This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed, or printed without written permission fromMolina Healthcare. This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliatedwith Molina Healthcare.Page 2 of 7
Prior Authorization Criteriachemotherapy regimen (as listed in current ASCO and NCCN guidelines for myeloid growthfactors [See Appendix]OR(b) Member has a risk of febrile neutropenia of 10‐20% based on chemotherapy regimen,and at least ONE of the following risk factors apply:(i) Prior chemotherapy or radiation therapy(ii) Persistent neutropenia (defined as neutrophil count less than 500 neutrophils/mcLor less than 1,000 neutrophils/mcL and a predicted decline to less than or equal to500 neutrophils/mcL over next 48 hours)(iii) Bone marrow involvement by tumor(iv) Recent surgery and/or open wounds(v) Liver dysfunction (bilirubin greater than 2.0 mg/dL)(vi) Renal dysfunction (creatinine clearance less than 50 mL/min)(vii) Age greater than 65 receiving full chemotherapy dose intensityOR(c) Previous neutropenic fever complication from a prior cycle of similar chemotherapyOR(d) The member is receiving a dose‐dense chemotherapy regimenB. FEBRILE NEUTROPENIA PROPHYLAXIS IN ACUTE MYELOID LEUKEMIA (AML):1. Documentation that member is receiving either induction chemotherapy ORconsolidation chemotherapyC. FEBRIL NEUTROPENIA PROPHYLAXIS FOLLOWING HEMATOPOETIC STEM CELLTRANSPLANT (HSCT):1. Documented diagnosis of non-myeloid malignancyAND2. Documentation member is undergoing or must have had a hematopoietic stem cell transplant(HSCT) (e.g. bone marrow transplant, peripheral‐blood progenitor cell (PBPC) transplant) fora non‐myeloid malignancyD. PERIPHERAL BLOOD PROGENITOR CELL COLLECTION:1. Prescriber attests that member is in need of filgrastim therapy for the mobilization ofautologous hematopoietic progenitor cells into the peripheral blood for collection byleukapheresis and will be initiated before leukapheresis (e.g., prescribed for 6 to 7 days withleukapheresis on days 5, 6 and 7)E. FEBRILE NEUTROPENIA PROPHYLAXIS DURING RADIATION THERAPY:1. Documentation member is s receiving radiation therapy alone AND prolonged delayssecondary to neutropenia are expected.AND2. Member will not be receiving concomitant chemotherapyNOTE: ASCO guidelines state that CSFs should be avoided in patients receivingconcomitant chemotherapy and radiation therapy, particularly involving the mediastinum. TheNCCN guidelines for myeloid growth factors (version 02.2020) state the prophylactic use ofCSFs in patients given concurrent chemotherapy and radiation is not recommended.F. CHRONIC NEUTROPENIA:1. Documentation of a diagnosis of congenital, cyclic, or idiopathic neutropeniaAND2. Prescriber attests that member is symptomatic (e.g. fever, infections, oropharyngeal ulcers)G. TREATMENT OF FEBRILE NEUTROPENIA:1. Documentation member has a diagnosis of febrile neutropenia [documentation of labMolina Healthcare, Inc. confidential and proprietary 2020This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed, or printed without written permission fromMolina Healthcare. This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliatedwith Molina Healthcare.Page 3 of 7
Prior Authorization Criteria2.report is required]ANDPrescriber attests that member is concurrently receiving appropriate antibiotics, if memberis at high-risk for developing infection-associated complicationsH. HEPATITIS C TREATMENT RELATED NEUTROPENIA:1. Documented diagnosis of Hepatitis CAND2. Prescriber attests member is undergoing treatment with peginterferonAND3. Documentation of neutropenia (ANC 500 cells/mm3 after dose reduction of peginterferon)I. HIV RELATED NEUTROPENIA:1.Documented diagnosis of HIV infectionAND2.Documentation member has an ANC 1,000 (cells/mm3)J. FELTYS SYNDROME:1.Documented diagnosis for Felty’s syndromeAND2. Documentation of a history of recurrent or severe infectionsAND3. Member has tried and failed methotrexate (at maximum tolerated dose of up to 25mgweekly) or leflunomide if unable to tolerate methotrexate AND concurrent use ofanother DMARD for at least two monthsK. ACUTE RADIATION SYNDROME:1. Documentation that member has had suspected or confirmed acute exposure tomyelosuppressive doses of radiation [greater than 2 Grays (Gy)]DURATION OF APPROVAL:Initial Authorization: Up to 12 weeks or up to length of chemotherapy approval date- whichever isshorter,Continuation of Therapy: Up to 12 weeks or up to length of chemotherapy approval date-whicheveris shorterQUANTITY:SPECIALTY PHARMACY:Neupogen: 300 mcg vial: 14 doses per 28 daysNeupogen/Zarxio/Nivestym 300 mcg prefilled syringes: 14 doses per 28 days Neupogen 480 mcgvial: 14 doses per 28 daysNeupogen/Zarxio/Nivestym 480 mcg prefilled syringes: 14 doses per 28 daysBUY AND BILL:Felty's syndrome 1364 unitsMyelodysplastic syndrome 568 combined units per date of serviceNeutropenia related to renal transplantation 682 combined units per date of service 1136 combinedunits per date of service (diagnosis of acute exposure to myelosuppressive doses of radiation,agranulocytosis, consolidation chemotherapy in acute lymphocytic leukemia, consolidationchemotherapy in acute myeloid leukemia, cyclic neutropenia, diffuse large B-cell lymphoma, febrileneutropenia in non-myeloid malignancy, hairy cell leukemia, HIV members with drug-inducedneutropenia, HIV-induced neutropenia, idiopathic neutropenia, infectious complications followingesophagectomy, leukemic relapse after allogeneic stem cell transplantation, neonatal neutropenia,nonmyeloid malignancy members undergoing myeloablative chemotherapy followed by boneMolina Healthcare, Inc. confidential and proprietary 2020This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed, or printed without written permission fromMolina Healthcare. This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliatedwith Molina Healthcare.Page 4 of 7
Prior Authorization Criteriamarrow transplantation, or reduction of incidence of neonatal sepsis related to pre-eclampsia.)PRESCRIBER REQUIREMENTS:Prescribed by or in consultation with a board-certified hematologist, oncologist, or transplant specialistAGE RESTRICTIONS:One month of age and olderCONTINUATION OF THERAPY:A. FOR ALL INDICATIONS:1. Member is compliant with filgrastim therapy as verified by prescriber and fill historyAND2. Documentation of clinical benefits to support continuation of treatment including positiveresponse to therapy (i.e. member did not become neutropenic mid-cycle requiring GCFS) AND Documentation of regular lab monitoring (i.e. CBC and platelet counts)AND3. Documentation of disease CONTINUATION:All other uses of filgrastim and its biosimilars are considered experimental/investigational andtherefore, will follow Molina’s Off-Label policy. Use in routine infection prophylaxis (e.g. adjunctivetherapy to antibiotics in a member with uncomplicated febrile neutropenia, afebrile neutropenia).Continued use beyond 42 days with no response. Concurrent use with other CSF agents (Neulasta).Known hypersensitivity to filgrastim or any ingredient in the requested formulation. E. coli proteinhypersensitivity. Receiving chemotherapy with a risk of febrile neutropenia 20% and no significanthigh risk for complications. Filgrastim will be administered in the period between 24 hours before and24 hours after administration of cytotoxic chemotherapy. Used concurrently with myelosuppressivechemotherapy or radiation. Administered prior to or concurrent with chemotherapy for AML. Used toincrease the dose-intensity of cytotoxic chemotherapy beyond established dosing range for theseregimens. Used before and/or concurrently with chemotherapy for a “priming” effect. Use in acutepromyelocytic leukemia (APL).OTHER SPECIAL CONSIDERATIONS:NoneBACKGROUND:NoneAPPENDIX:A biosimilar is highly similar version of a brand name biological drug that meets strict controls forstructural, pharmaceutical, and clinical consistency. A biosimilar manufacturer must demonstrate thatthere are no meaningful clinical differences (i.e., safety and efficacy) between the biosimilar and thereference product. Clinical performance is demonstrated through human pharmacokinetic (exposure) andpharmacodynamic (response) studies, an assessment of clinical immunogenicity, and, if needed,additional clinical studies.1As costs for biological specialty drugs continue to rise, the growing biosimilar market will benefit providersand patients by broadening biological treatment options and expanding access to these medications atlower costs. Molina Healthcare, Inc. continues to be committed to continually reevaluating Preferredstrategies and applying innovative cost-controls to ensure patients receive safe, effective, and qualityhealthcare. This commitment includes potentially creating a preference for biosimilars when value can beadded without compromising patient satisfaction and safety.1. Food and Drug Administration. Biosimilar and Interchangeable Products. Retrieved from ndinterchangeable-products. Accessed October 8, 2019.Molina Healthcare, Inc. confidential and proprietary 2020This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed, or printed without written permission fromMolina Healthcare. This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliatedwith Molina Healthcare.Page 5 of 7
Prior Authorization CriteriaHigh risk for chemotherapy induced FN infectious complications because of bone marrowcompromise OR co-morbidity with any of the following risk factors (not an all-inclusive list):Age 65 yearsPoor performance statusPrevious episodes of FNHistory of previous chemotherapy or radiation therapyCompletion of combined chemoradiotherapyBone marrow involvement by tumor producing cytopeniaPre-existing neutropeniaPoor nutritional statusPoor renal functionLiver dysfunction (i.e. elevated bilirubin)Presence of open wound(s) or active infectionRecent surgery (within the past 12 weeks)More advanced cancerOther serious co-morbiditiesMolina Healthcare, Inc. confidential and proprietary 2020This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed, or printed without written permission fromMolina Healthcare. This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliatedwith Molina Healthcare.Page 6 of 7
Prior Authorization CriteriaDocumentation Requirements:Molina Healthcare reserves the right to require that additional documentation be made available aspart of its coverage determination; quality improvement; and fraud; waste and abuse preventionprocesses. Documentation required may include, but is not limited to, member records, test resultsand credentials of the provider ordering or performing a drug or service. Molina Healthcare maydeny reimbursement or take additional appropriate action if the documentation provided does notsupport the initial determination that the drugs or services were medically necessary, notinvestigational or experimental, and otherwise within the scope of benefits afforded to the member,and/or the documentation demonstrates a pattern of billing or other practice that is inappropriate orexcessive.REFERENCES:1. Neupogen [package insert]. Thousand Oaks, CA; Amgen Inc; June 2016.2. Zarxio [prescribing information]. Princeton, NJ: Sandoz, Inc.; March 2015.3. Granix [prescribing information]. Sunnyvale, CA; Pharmacyclics, Inc.; November 20134. Referenced with permission from the NCCN Drugs & Biologics Compendium(NCCNCompendium ) filgrastim. National Comprehensive Cancer Network, 2017. TheNCCNCompendium is a derivative work of the NCCN Guidelines .NATIONALCOMPREHENSIVE CANCER NETWORK , NCCN , and NCCN GUIDELINES are trademarks owned by the National Comprehensive Cancer Network, Inc.” To view themost recent and complete version of the Compendium, go online to NCCN.org.Molina Healthcare, Inc. confidential and proprietary 2020This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed, or printed without written permission fromMolina Healthcare. This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliatedwith Molina Healthcare.Page 7 of 7
6/17/2021 . J CODE TYPE OF CRITERIA LAST P&T APPROVAL/VERSION J1442-Inj, filgrastim (g-csf)
