Analiza trenda potrošnje lekova protiv gojaznosti i statusa na listama lekova koji se refundiraju – perspektiva odabranih evropskih zemalja
Sažetak
Gojaznost je hronična, kompleksna bolest koja se ponovo javlja (relaps) i utiče na zdravstvene sisteme i ekonomiju širom sveta. Cilj nam je da analiziramo trendove potrošnje lekova protiv gojaznosti, kao i status refundacije tih lekova na listama lekova fondova zdravstvenog osiguranja (FZO) u odabranim evropskim zemljama. Za analizu trenda potrošnje korišćena je metodologija DDD/1000 stanovnika/dan, gde su korišćeni podaci iz zvaničnih nacionalnih izveštaja o potrošnji. Za analizu statusa refundacije za 5 lekova protiv gojaznosti (orlistat, semaglutid, liraglutid, naltrekson/bupropion, setmelanotid), pregledani su sajtovi nacionalnih FZO u 22 evropske zemlje. Analiza trenda je otkrila fluktuacije za skoro sve lekove protiv gojaznosti (najveći pad zabeležen za orlistat u Srbiji, a najveći porast za liraglutid u Hrvatskoj). Novi lekovi protiv gojaznosti pokazuju trend rasta upotrebe u skoro svim zemljama. U dve od tri evropske zemlje lekove protiv gojaznosti ne pokriva FZO. Slovenija i Danska refundiraju troškove većine lekova protiv gojaznosti. Holandija je jedina zemlja u kojoj trošak setmelanotida plaća FZO. Naši rezultati naglašavaju važnost davanja prioriteta uvođenju i implementaciji novih strategija i modela šema refundacije u globalnim i nacionalnim politikama usmerenim protiv gojaznosti.
Reference
Bray GA, Kim KK, Wilding JPH; World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Obes Rev. 2017;18(7):715-723.
WHO acceleration plan to stop obesity [Internet]. [cited 2024 Apr 10]. Available from: https://iris.who.int/bitstream/handle/10665/370281/9789240075634-eng.pdf?sequence=1.
Nacionalni vodič dobre kliničke prakse Lečenje gojaznosti [Internet]. [cited 2024 Mar 04]. Available from: https://www.zdravlje.gov.rs/view_file.php?file_id=2406&cache=sr.
A healthy lifestyle - WHO recommendations [Internet]. [cited 2024 Apr 10]. Available from: https://www.who.int/europe/news-room/fact-sheets/item/a-healthy-lifestyle---who-recommendations.
Health service delivery framework for prevention and management of obesity. Geneva: World Health Organization; 2023.
World Obesity Atlas 2024 [Internet]. [cited 2024 Apr 01]. Available from: https://s3-eu-west-1.amazonaws.com/wof-files/WOF_Obesity_Atlas_2024.pdf.
World Obesity Federation [Internet], The economic impact of overweight & obesity in 2020 and 2060, 2nd edition with estimates in 161 countries [cited 2024 Mar 01]. Available from: https://data.worldobesity.org/publications/WOF-Economic-Impacts-2-V2.pdf.
World Obesity Atlas 2023 [Internet]. [cited 2024 Apr 01]. Available from:https://s3-eu-west-1.amazonaws.com/wof-files/World_Obesity_Atlas_2023_Report.pdf.
Squadrito F, Rottura M, Irrera N, Minutoli L, Bitto A, Barbieri MA, et al. Anti-obesity drug therapy in clinical practice: Evidence of a poor prescriptive attitude. Biomed Pharmacother. 2020 Aug;128:110320.
Health service delivery framework for prevention and management of obesity. Geneva: World Health Organization; 2023.
Divino V, Ramasamy A, Anupindi VR, Eriksen KT, Olsen AH, DeKoven M, Meincke HH. Complication-specific direct medical costs by body mass index for 13 obesity-related complications: a retrospective database study. J Manag Care Spec Pharm. 2021;27(2):210-22.
Okunogbe A, Nugent R, Spencer G, Ralston J, Wilding J. Economic impacts of overweight and obesity: current and future estimates for eight countries. BMJ Glob Health. 2021 Oct;6(10):e006351.
Download medicine data. European public assessment reports (EPAR) [Internet]. EMA [cited 2024 Jan 10]. Available from: https://www.ema.europa.eu/en/medicines/download-medicine-data.
FDA Approves New Medication for Chronic Weight Management [Internet]. [cited 2024 Mar 10]. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-new-medication-chronic-weight-management.
Pedersen SD, Manjoo P, Wharton S. Canadian Adult Obesity Clinical Practice Guidelines: Pharmacotherapy in Obesity Management [Internet]. [cited 2024 Mar 10]. Available from: https://obesitycanada.ca/guidelines/pharmacotherapy.
Chakhtoura M, Haber R, Ghezzawi M, Rhayem C, Tcheroyan R, Mantzoros CS. Pharmacotherapy of obesity: an update on the available medications and drugs under investigation. EClinicalMedicine. 2023 Mar 20;58:101882.
Promet i potrošnja lekova 2007-2022 [Internet]. Agencija za lekove i medicinska sredstva Srbije [cited 2024 Feb 01]. Available from: https://www.alims.gov.rs/o-agenciji/publikacije/.
Izvješća o potrošnji lijekova [Internet]. Agencija za ljekove i medicinske proizvode Hrvatske [cited 2024 Feb 01]. Available from:https://www.halmed.hr/Promet-proizvodnja-i-inspekcija/Promet/Potrosnja-lijekova/Izvjesca-o-prometu-lijekova/.
Sakshaug S, editor. Drug Consumption in Norway 2007-2011 (Legemiddelforbruket i Norge 2007-2011). Oslo: Norwegian Institute of Public Health, March 2012.
Sakshaug S, editor. Drug Consumption in Norway 2008-2012 (Legemiddelforbruket i Norge 2008-2012). Oslo: Norwegian Institute of Public Health, legemiddelstatistikk, 2013:1.
Sakshaug S, editor. Drug Consumption in Norway 2011-2015 (Legemiddelforbruket i Norge 2011-2015). Oslo: Norwegian Institute of Public Health, legemiddelstatistikk, 2016:1.
Sakshaug S, editor. Legemiddelforbruket i Norge 2013–2017 [Drug Consumption in Norway 2013–2017]. Legemiddelstatistikk 2018:1. Oslo: Folkehelseinstituttet, 2018.
Danise LS, editor. Drug Consumption in Norway 2017-2021 - Data from Norwegian Drug Wholesales Statistics and the Norwegian Prescription Database, 2017-2021. Oslo: Folkehelseinstituttet, 2022.
Danise LS, editor. Drug Consumption in Norway 2018-2022 - Data from Norwegian Drug Wholesales Statistics, 2018-2022. Oslo: Folkehelseinstituttet, 2023.
Estonian State Agency of Medicines, Latvian State Agency of Medicines, Lithuanian State Medicines Control Agency. Baltic Statistics on Medicines 2010–2012. Tartu, Estonia, 2013.
Latvian State Agency of Medicines, Estonian State Agency of Medicines, Lithuanian State Medicines Control Agency Baltic Statistics on Medicines 2013–2015. Riga, Latvia, 2016.
Lithuanian State Medicines Control Agency, Latvian State Agency of Medicine, Estonian State Agency of Medicines. Baltic Statistics on Medicines 2016–2018. Vilnius, Lithuania, 2019.
Sammul M, Linask E, Uusküla M, Laius O, editors. Statistical Yearbook of the State Agency of Medicines 2020. Tartu, Estonia, 2020.
Sammul M, Sepp J, Laius O, editors. Statistical Yearbook of the State Agency of Medicines 2021. Tartu, Estonia, 2021.
Sepp J, Sammul M, Uusküla M, editors. Statistical Yearbook of the State Agency of Medicines 2022. Tartu, Estonia, 2022.
Sepp J, Sammul M, Uusküla M, editors. Statistical Yearbook of the State Agency of Medicines 2023. Tartu, Estonia, 2023.
Latvia utilization data for the period 2019-2023 [Internet]. [cited 2024 Mar 15]. Available from: https://www.zva.gov.lv/en/publications-and-statistics/statistics-medicines-consumption-ddd.
Finland utilization dana for the period 2018-2021 [Internet]. [cited 2024 Mar 15]. Available from: http://raportit.nam.fi/raportit/kulutus/laakekulutus_e.pdf.
Kim HJ, Fay MP, Feuer EJ, Midthune DN. Permutation tests for joinpoint regression with applications to cancer rates. Stat Med. 2000;19:335-351. Erratum in: Stat Med 2001;20(4):655.
Joinpoint Regression Program, Version 5.0.2 - May 2023. Statistical Methodology and Applications Branch, Surveillance Research Program, National Cancer Institute.
Tomic T, Henman M, Tadic I, Antic Stankovic J, Santric Milicevic M, Maksimovic N, Odalovic M. Antimicrobial utilization and resistance in Pseudomonas aeruginosa using segmented regression analysis: a comparative study between Serbia and eight European Countries. Int J Clin Pharm. 2023 Aug;45(4):989-998.
Belgium reimbursement list of drugs [Internet]. [cited 2024 Apr 01]. Available from: https://www.inami.fgov.be/fr/themes/soins-de-sante-cout-et-remboursement/les-prestations-de-sante-que-vous-rembourse-votre-mutualite/medicaments/remboursement-d-un-medicament/specialites-pharmaceutiques-remboursables/specialites-pharmaceutiques-remboursables-listes-et-fichiers-de-reference.
Bulgaria reimbursement list of drugs [Internet]. [cited 2024 Apr 01]. Available from: https://portal.ncpr.bg/registers/pages/register/list-medicament.xhtml.
Croatia reimbursement list of drugs [Internet]. [cited 2024 Apr 01]. Available from:https://hzzo.hr/zdravstvena-zastita/lijekovi/objavljene-liste-lijekova.
Czech Republic reimbursement list of drugs [Internet]. [cited 2024 Apr 01]. Available from: https://www.sukl.eu/sukl/list-of-reimbursed-medicinal-products-valid-as-of-1-4-2024.
Denmark reimbursement list of drugs [Internet]. [cited 2024 Apr 01]. Available from: https://www.medicinpriser.dk/Default.aspx.
Estonia reimbursement list of drugs [Internet]. [cited 2024 Apr 01]. Available from: https://www.tervisekassa.ee/partnerile/ravimitest/soodusravimid.
Finland reimbursement list of drugs [Internet]. [cited 2024 Apr 01]. Available from: https://www.hila.fi/en/notices/reimbursable-authorized-medicinal-products-and-their-prices/reimbursable-authorized-medicinal-products-and-their-prices-2024/.
France reimbursement list of drugs [Internet]. [cited 2024 Apr 01]. Available from: http://www.codage.ext.cnamts.fr/codif/bdm_it/index.php?p_site=AMELI.
Ireland reimbursement list of drugs [Internet]. [cited 2024 Apr 01]. Available from: https://www.hse.ie/eng/staff/pcrs/items/.
Italy reimbursement list of drugs [Internet]. [cited 2024 Apr 01]. Available from: https://www.aifa.gov.it/en/liste-farmaci-a-h.
Latvia reimbursement list of drugs [Internet]. [cited 2024 Apr 01]. Available from: https://www.vmnvd.gov.lv/lv/kompensejamo-zalu-saraksti.
Lithuania reimbursement list of drugs [Internet]. [cited 2024 Apr 01]. Available from: https://kainynas.vlk.lt/webapp/index.html.
Montenegro reimbursement list of drugs [Internet]. [cited 2024 Apr 01]. Available from: https://fzocg.me/wp-content/uploads/2024/02/Lista-ljekova-januar-2024.-godine.pdf.
Netherlands reimbursement list of drugs [Internet]. [cited 2024 Apr 01]. Available from: https://www.medicijnkosten.nl.
Norway reimbursement list of drugs [Internet]. [cited 2024 Apr 01]. Available from: https://www.legemiddelsok.no.
Poland reimbursement list of drugs [Internet]. [cited 2024 Apr 01]. Available from: https://www.gov.pl/web/zdrowie/obwieszczenie-ministra-zdrowia-z-dnia-18-marca-2024-r-w-sprawie-wykazu-refundowanych-lekow-srodkow-spozywczych-specjalnego-przeznaczenia-zywieniowego-oraz-wyrobow-medycznych.
Portugal Infomed [Internet]. [cited 2024 Apr 01]. Available from: https://extranet.infarmed.pt/INFOMED-fo/index.xhtml.
Serbia reimbursement list of drugs [Internet]. [cited 2024 Apr 05]. Available from: https://www.rfzo.rs/index.php/osiguranalica/lekovi-info/lekovi-actual.
Slovakia reimbursement list of drugs [Internet]. [cited 2024 Apr 05]. Available from: https://www.health.gov.sk/Clanok?zuuc-202404-lieky.
Slovenia reimbursement list of drugs [Internet]. [cited 2024 Apr 05]. Available from: http://www.cbz.si/zzzs/pao/bazazdr2.nsf/Search/$searchForm!SearchView&Seq=2.
Sweden reimbursement list of drugs [Internet]. [cited 2024 Apr 05]. Available from: https://www.tlv.se/beslut/sok-priser-och-beslut-i-databasen.html.
Switzerland reimbursement list of drugs [Internet]. [cited 2024 Apr 05]. Available from: https://www.spezialitätenliste.ch.
Onakpoya IJ, Heneghan CJ, Aronson JK. Post-marketing withdrawal of anti-obesity medicinal products because of adverse drug reactions: a systematic review. BMC Med. 2016;14(1):191.
European Public Assessment Report, Mysimba [Internet]. [cited 2024 Apr 01]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/mysimba.
Authorization details, Xenical [Internet]. [cited 2024 Apr 01]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/xenical.
Sandhu H, Xu W, Olivieri AV, Lübker C, Smith I, Antavalis V. Once-Weekly Subcutaneous Semaglutide 2.4 mg Injection is Cost-Effective for Weight Management in the United Kingdom. Adv Ther. 2023 Mar;40(3):1282-1291.
Kim N, Wang J, Burudpakdee C, Song Y, Ramasamy A, Xie Y, et al. Cost-effectiveness analysis of semaglutide 2.4 mg for the treatment of adult patients with overweight and obesity in the United States. J Manag Care Spec Pharm. 2022 Jul;28(7):740-752.
Saumoy M, Gandhi D, Buller S, Patel S, Schneider Y, Cote G, et al. Cost-effectiveness of endoscopic, surgical and pharmacological obesity therapies: a microsimulation and threshold analyses. Gut. 2023 Nov 24;72(12):2250-2259.
ICER Publishes Evidence Report on Treatments for Obesity Management [Internet]. [cited 2024 Apr 01]. Available from: https://icer.org/news-insights/press-releases/icer-publishes-evidence-report-on-treatments-for-obesity-management//
Gadde KM, Atkins KD. The limits and challenges of antiobesity pharmacotherapy. Expert Opin Pharmacother. 2020 Aug;21(11):1319-1328.
Dehghani F, Ali Ahmadi M, Hefner M, Kudchadkar G, Najam W, Nateqi M, et al. An algorithm for the use of anti-obesity medications. Nutr Diabetes. 2024 Apr 18;14(1):20.
Suissa K, Schneeweiss S, Kim DW, Patorno E. Prescribing trends and clinical characteristics of patients starting antiobesity drugs in the United States. Diabetes Obes Metab. 2021 Jul;23(7):1542-1551.
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