Budget Saving Potential of Pegfilgrastim Biosimilar for the Treatment of Chemotherapy-Induced Febrile Neutropenia, in Italy
DOI:
https://doi.org/10.7175/fe.v23i1.1516Keywords:
Biosimilars, Budget Impact Analysis, Cost saving, Febrile neutropenia, Granulocyte colony stimulating factor (G-CSF)Abstract
INTRODUCTION: Current Italian guidelines recommend prophylaxis with granulocyte colony-stimulating factors (G-CSFs) to reduce the risk of chemotherapy-induced febrile neutropenia (FN). The availability of G-CSF biosimilars represents an opportunity for savings in the Italian National Healthcare Service (NHS) delivery of care.
OBJECTIVE: To assess the cost saving potential associated with the introduction of pegfilgrastim biosimilars to local formularies, compared to the current G-CSF standard practice in Italy.
METHODS: A budget impact model was developed to compare the current standard practice of long-acting (LA) and short-acting (SA) G-CSFs use, with a future scenario in which the market share of LA G-CSFs grows due to the more advantageous administration schedule and price of pegfilgrastim biosimilar. The analysis included G-CSF treatment schedules, drug acquisition costs and costs of patient management including hospitalization and ambulatory care.
RESULTS: The introduction of pegfilgrastim biosimilar resulted in cumulative 3-year cost savings of € 59,650 and € 41,539 for FN prophylaxis in a potential cohort of 1000 patients with solid tumors and lymphomas, respectively.
CONCLUSIONS: The results indicate that the introduction of pegfilgrastim biosimilar is potentially associated with substantial cost savings for the Italian healthcare system.
References
Aapro M, Boccia R, Leonard R, et al. Refining the role of pegfilgrastim (a long-acting G-CSF) for prevention of chemotherapy-induced febrile neutropenia: consensus guidance recommendations. Support Care Cancer 2017;25:3295-304; https://doi.org/10.1016/s0959-8049(17)30619-6
Klastersky J, de Naurois J, Rolston K, et al. Management of febrile neutropaenia: ESMO clinical practice guidelines. Ann Oncol 2016;27:111-8; https://doi.org/10.1093/annonc/mdw325
Wang L, Baser O, Kutikova L, et al. The impact of primary prophylaxis with granulocyte colony-stimulating factors on febrile neutropenia during chemotherapy: a systematic review and Meta-analysis of randomized controlled trials. Support Care Cancer 2015;23:3131-3140; https://doi.org/10.1007/s00520-015-2686-9
Pettengell R, Schwenkglenks M, Leonard R, et al. Neutropenia occurrence and predictors of reduced chemotherapy delivery: results from the INC-EU prospective observational European neutropenia study. Support Care Cancer 2008;16:1299-1309; https://doi.org/10.1007/s00520-008-0430-4
Bennett CL, Djulbegovic B, Norris LB, et al. Colony-stimulating factors for febrile neutropenia during cancer therapy. New Engl J Med 2013;368:1131-39; https://doi.org/10.1056/NEJMct1210890
Aapro MS, Bohlius J, Cameron DA, et al. 2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours. Eur J Cancer 2011;47:8-32; https://doi.org/10.1016/j.ejca.2010.10.013
LG AIOM, Gestione della tossicità ematopoietica in oncologia, Edizione 2019.
Crawford J, Armitage J, Balducci L, et al. Myeloid growth factors. J Natl Compr Canc Netw 2013;11:1266-90; https://doi.org/10.6004/jnccn.2013.0148
Lyman GH, Dale DC, Culakova E, et al. The impact of the granulocyte colony-stimulating factor on chemotherapy dose intensity and cancer survival: a systematic review and meta-analysis of randomized controlled trials. Ann Oncol 2013;24:2475-84; https://doi.org/10.1093/annonc/mdt226
Kuderer NM, Dale DC, Crawford J, et al. Impact of primary prophylaxis with granulocyte colony-stimulating factor on febrile neutropenia and mortality in adult cancer patients receiving chemotherapy: a systematic review. J Clin Oncol 2007;25:3158-67; https://doi.org/10.1200/JCO.2006.08.8823
Lyman GH, Barron RL, Natoli JL, et al. Systematic review of efficacy of dose-dense versus non-dose-dense chemotherapy in breast cancer, non-Hodgkin lymphoma, and non-small cell lung cancer. Crit Rev Oncol Hematol 2012;81:296-308; https://doi.org/10.1016/j.critrevonc.2011.04.010
Cornes P, Gascon P, Chan S, et al. Systematic review and meta-analysis of short- versus long-acting granulocyte colony-stimulating factors for reduction of chemotherapy-induced febrile neutropenia. Adv Ther 2018;35:1816-29; https://doi.org/10.1007/s12325-018-0798-6
Mitchell S, Li X, Woods M, et al. Comparative effectiveness of granulocyte colony-stimulating factors to prevent febrile neutropenia and related complications in cancer patients in clinical practice: a systematic review. J Oncol Pharm Pract 2016;22:702-716; https://doi.org/10.1177/1078155215625459
Botteri E, Krendyukov A, Curigliano G. Comparing granulocyte colony-stimulating factor filgrastim and pegfilgrastim to its biosimilars in terms of efficacy and safety: a meta-analysis of randomised clinical trials in breast cancer patients. Eur J Cancer 2018;89:49-55; https://doi.org/10.1016/j.ejca.2017.10.034
Fagnani D, Isa L, Verga MF, et al. Granulocyte colony-stimulating factors used in clinical practice: PoloNord registry-based cohort Italian study. Tumori 2014;100:491-498; https://doi.org/10.1700/1660.18158
Rosti G, Lebboroni M, Cerchiari A, et al. Analisi di budget impact sull’utilizzo di pegfilgrastim nella profilassi della neutropenia febbrile in Italia. Farmeconomia e percorsi terapeutici 2011;12:119-127
Trotta F, Mayer F, Mecozzi A, et al. Impact of guidance on the prescription patterns of G-CSFs for the prevention of febrile neutropenia following anticancer chemotherapy: A population-based utilization study in the Lazio region. BioDrugs 2017;31:117-124; https://doi.org/10.1007/s40259-017-0214-9
Cornes P, Gascon P, Vulto AG, et al. Biosimilar Pegflgrastim: Improving Access and Optimising Practice to Supportive Care that Enables Cure. BioDrugs 2020;34:255-263; https://doi.org/10.1007/s40259-020-00411-4
Wang W, Li E, Campbell K, et al. Economic Analysis on Adoption of Biosimilar Granulocyte Colony-Stimulating Factors in Patients with Nonmyeloid Cancer at Risk of Febrile Neutropenia Within the Oncology Care Model Framework. JCO Oncology Practice 2021;17:1139-1149; https://doi.org/10.1200/OP.20.00994
Tilleul PR, Rodgers-Gray BS, Edwards JO. Introduction of biosimilar pegfilgrastim in France: Economic analysis of switching from originator. J Oncol Pharm Practice 2020;0:1-12; https://doi.org/10.1177/1078155220962208
Ravasio R, Antonuzzo L, Danova, et al. Budget impact analysis of pegfilgrastim biosimilar in the treatment of febrile neutropenia in Italy. AboutOpen 2020;7:04-08; https://doi.org/10.33393/abtpn.2020.2030
Sullivan SD, Mauskopf JA, Augustovski F, et al. Budget impact analysis principles of good practice: report of the ISPOR 2012 Budget Impact Analysis Good Practice II Task Force. Value Health 2014;17:5-14; https://doi.org/10.1016/j.jval.2013.08.2291
Almenar-Cubells D, Mayans J, Juan O, et al. Pegfilgrastim and daily granulocyte colony-stimulating Factor: Patterns of use and Neutropenia-related outcomes in cancer patients in Spain-results of the LEARN study. Eur J Cancer Care (Engl) 2009;18:280-286; https://doi.org/10.1111/j.1365-2354.2008.00959.x
PELGRAZ Summary of Product Characteristics. Available at https://www.ema.europa.eu/en/documents/product-information/pelgraz-epar-product-information_en.pdf (last accessed October 2018)
Green M, Koelbl H, Baselga J, et al. A randomized double-blind multicenter phase III study offixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol 2003;14:29-35; https://doi.org/10.1093/annonc/mdg019
Grigg A, Solal-Celigny P, Hoskin P, et al. Open-label, randomized study of pegfilgrastim vs. daily filgrastim as an adjunct to chemotherapy in elderly patients with non-Hodgkin’s lymphoma. Leuk Lymphoma 2003;44:1503-1508; https://doi.org/10.1080/1042819031000103953
Romieu G, Clemens M, Mahlberg R, et al. Pegfilgrastim supports delivery of FEC-100 chemotherapy in elderly patients with high-risk breast cancer: A randomized Phase 2 trial. Crit Rev Oncol Hematol 2007;64:64-72; https://doi.org/10.1016/j.critrevonc.2006.12.007
Almenar Cubells D, Bosch Roig C, Jiménez Orozco E, et al. Effectiveness of daily versus non‐daily granulocyte colony‐stimulating factors in patients with solid tumours undergoing chemotherapy: A multivariate analysis of data from current practice. Eur J Cancer Care (Engl) 2013;22:400-412; https://doi.org/10.1111/ecc.12043
Bondarenko I, Gladkov OA, Elsaesser R, et al. Efficacy and safety of lipegfilgrastim versus pegfilgrastim: a randomized, multicenter, active-control phase 3 trial in patients with breast cancer receiving doxorubicin/docetaxel chemotherapy. BMC cancer 2013;13:386; https://doi.org/10.1186/1471-2407-13-386
Chan A, Leng XZ, Chiang JY, et al. Comparison Of Daily Filgrastim And Pegfilgrastim To Prevent Febrile Neutropenia In Asian Lymphoma Patients. Asia Pac J Clin Oncol 2010;7:75-81; https://doi.org/10.1111/J.1743-7563.2010.01355.X
Bozzoli V, Tisi MC, Maiolo E, et al. Four doses of Unpegylated versus one dose of pegylated Filgrastim as supportive therapy IN R-CHOP-14 for elderly patients with Diffuse Large B-cell lymphoma. Br J Haematol 2015;169:787-794; https://doi.org/10.1111/bjh.13358
Link H, Illerhaus G, Martens UM, et al. Efficacy and safety of lipegfilgrastim versus pegfilgrastim in elderly patients with aggressive B cell non-Hodgkin lymphoma (B-NHL): results of the randomized, open-label, non-inferiority AVOID neutropenia study. Support Care Cancer 2021;29:2519-2527; https://doi.org/10.1007/s00520-020-05711-7
Lazzaro C, Bordonaro R, Cognetti F, et al. An Italian cost-effectiveness analysis OF paclitaxel albumin (nab-paclitaxel) versus conventional paclitaxel for metastatic breast cancer patients: The COSTANza study. Clinicoecon Outcomes Res 2013;5:125–135; https://doi.org/10.2147/ceor.s41850
Remunerazione prestazioni di assistenza ospedaliera per acuti, assistenza ospedaliera di riabilitazione e di lungodegenza postacuzie e di assistenza specialistica ambulatoriale. Decreto 10/2012 e pubblicato in GU Serie Generale n.23 del 28-1-2013
IMS Data. IMS MAT data on G-CSF up to September 2020.
Farmaci Biologici E Biosimilari. Scenari terapeutici e stima del risparmio per il Sistema Sanitario italiano. Centro Studi IQVIA Italia. Available at https://assobiotec.federchimica.it/docs/default-source/default-document-library/(iqvia)_farmaci_biologici_e_biosimilari.pdf?sfvrsn=853ad623_0 (Last accessed March 2019)
Guidotti E, Vinci B, Attanasio F, et al. Effective tools to manage biosimilars prescription: The Italian experience. Health Policy and Technology 2021;10:45-51; https://doi:org/10.1016/j.hlpt.2020.10.011
Aapro M, Cornes P, Abraham I. Comparative cost-efficiency across the European G5 countries of various regimens of filgrastim, biosimilar filgrastim, and pegfilgrastim to reduce the incidence of chemotherapy-induced febrile neutropenia. J Oncol Pharm Pract 2012;18:171-179. https://doi.org/10.1177/1078155211407367
Sun D, Andayani TM, Altyar A, et al. Potential cost savings from chemotherapy-induced febrile neutropenia with biosimilar filgrastim and expanded access to targeted antineoplastic treatment across the European Union G5 countries: a simulation study. Clin Ther 2015;37:842-857. https://doi.org/10.1016/j.clinthera.2015.01.011
Pinto L, Liu Z, Doan Q, et al. Comparison of pegfilgrastim with filgrastim on febrile neutropenia, grade IV neutropenia and bone pain: a metaanalysis of randomized controlled trials. Curr Med Res Opin 2007;23:2283-2295; https://doi.org/10.1185/030079907X219599
Bond TC, Szabo E, Gabriel S, et al. Meta-analysis and indirect treatment comparison of lipegfilgrastim with pegfilgrastim and filgrastim for the reduction of chemotherapy-induced neutropenia-related events. J Oncol Pharm Pract 2018;24:412-423; https://doi.org/10.1177/1078155217714859
Molineux G. Pegfilgrastim: using pegylation technology to improve neutropenia support in cancer patients. Anticancer Drugs 2003;13:259-264; https://doi.org/10.1097/00001813-200304000-00002
Lambertini M, Ferreira AR, Del Mastro L, et al. Pegfilgrastim for the prevention of chemotherapy induced febrile neutropenia in patients with solid tumours. Expert Opin Biol Ther 2015;15:1799-1817; https://doi.org/10.1517/14712598.2015.1101063
Weycker D, Hackett J, Edelsberg JS, et al. Are shorter courses of filgrastim prophylaxis associated with increased risk of hospitalization? Ann Pharmacother 2006;40:402-7; https://doi.org/10.1345/aph.1G516
Gascón P, Aapro M, Ludwig H, et al. Treatment patterns and outcomes in the prophylaxis of chemotherapy-induced (febrile) neutropenia with biosimilar filgrastim (the MONITOR-GCSF study) Support Care Cancer 2016;24:911-925; https://doi.org/10.1007/s00520-015-2861-z
Aapro M, Ludwig H, Bokemeyer C, et al. Predictive modeling of the outcomes of chemotherapyinduced (febrile) neutropenia prophylaxis with biosimilar filgrastim (MONITOR-GCSF study). Ann Oncol 2016;27:2039-2045; https://doi.org/10.1093/annonc/mdw309
Tornero Molina J, Lopéz Robledillo JC, Ruiz NC. Potential Benefits of the Self Administration of Subcutaneous Methotrexate with Autoinjector Devices for Patients: A Review. Drug Healthc Patient Saf 2021;13:81-94; https://doi.org/10.2147/DHPS.S290771
Gandell D. Mode of injection and treatment adherence: results of a survey characterizing the perspectives of health care providers and US women 18-45 years old. Patient Prefer Adherence 2019;13:351-61; https://doi.org/10.2147/PPA.S187120
Cox D, Stone J. Managing self-injection difficulties in patients with relapsing-remitting multiple sclerosis. J Neurosci Nurs 2016;38,167-71; https://doi:10.1097/01376517-200606000-00005
Fraser C, Morgante L, Hadjimichael O, et al. A prospective study of adherence to glatiramer acetate in individuals with multiple sclerosis. J Neurosci Nurs 2004;36:120-129; https://doi.org/10.1097/01376517-200406000-00002
Bayas A. Improving adherence to injectable disease-modifying drugs in multiple sclerosis. Expert Opin Drug Deliv 2013;10:285-287; https://doi.org/10.1517/17425247.2013.763793
Published
How to Cite
Issue
Section
License
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal. The Publication Agreement can be downloaded here, and should be signed by the Authors and sent to the Publisher when the article has been accepted for publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (see The Effect of Open Access).
- Authors are permitted to post their work online after publication (the article must link to publisher version, in html format)
