Monoclonal antibodies and Fc-fusion protein biologic medicines: A multinational cross-sectional investigation of accessibility and affordability in Asia Pacific regions between 2010 and 2020.

Autor:	Tong X; Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China., Li X; Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.; Laboratory of Data Discovery for Health (D4H), Hong Kong Science and Technology Park, Sha Tin, Hong Kong SAR, China., Pratt NL; Quality Use of Medicines and Pharmacy Research Centre, Clinical and Health Sciences, University of South Australia, Australia., Hillen JB; Quality Use of Medicines and Pharmacy Research Centre, Clinical and Health Sciences, University of South Australia, Australia., Stanford T; Quality Use of Medicines and Pharmacy Research Centre, Clinical and Health Sciences, University of South Australia, Australia., Ward M; Quality Use of Medicines and Pharmacy Research Centre, Clinical and Health Sciences, University of South Australia, Australia., Roughead EE; Quality Use of Medicines and Pharmacy Research Centre, Clinical and Health Sciences, University of South Australia, Australia., Lai EC; School of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, Taiwan., Shin JY; Department of Biohealth Regulatory Science, School of Pharmacy, Sungkyunkwan University, Seoul, South Korea.; Department of Clinical Research Design and Evaluation, Samsung Advanced Institute for Health Sciences & Technology, Sungkyunkwan University, Seoul, South Korea., Cheng FWT; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China., Peng K; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China., Lau CS; Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China., Leung WK; Department of Medicine, School of Clinical Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China., Wong ICK; Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.; Laboratory of Data Discovery for Health (D4H), Hong Kong Science and Technology Park, Sha Tin, Hong Kong SAR, China.; Research Department of Practice and Policy, School of Pharmacy, University College London, United Kingdom.
Jazyk:	angličtina
Zdroj:	The Lancet regional health. Western Pacific [Lancet Reg Health West Pac] 2022 Jun 24; Vol. 26, pp. 100506. Date of Electronic Publication: 2022 Jun 24 (Print Publication: 2022).
DOI:	10.1016/j.lanwpc.2022.100506
Abstrakt:	Background: Monoclonal antibody (mAb) and Fc-fusion protein (FcP) are highly effective therapeutic biologics. We aimed to analyse consumption and expenditure trends in 14 Asia-Pacific countries/regions (APAC) and three benchmark countries (the UK, Canada, and the US). Methods: We analysed 440 mAb and FcP biological products using the IQVIA-MIDAS global sales database. For each year between 2010 and 2020 inclusive, we used standard units (SU) sold per 1000 population and manufacture level price (standardised in 2019 US dollars) to evaluate consumption (accessibility) and expenditure (affordability). Changes of consumption and expenditure were estimated using compound annual growth rate (CAGR). Correlations between consumption, country's economic and health performance indicators were measured using Spearman correlation coefficient. Findings: Between 2010 and 2020, CAGRs of consumption in each region ranged from 7% to 34% and the CAGRs of expenditure ranged from 9% to 31%. The median consumption of biologics was extremely low in lower-middle-income economies (0·29 SU/1000 population) compared with upper-middle-income economies (1·20), high-income economies (40·94) and benchmark countries (109·55), although the median CAGRs of biologics consumption in lower-middle-income economies (31%) was greater than upper-middle-income (14%), high-income economies (13%) and benchmark countries (9%). Consumption was correlated with GDP per capita [Spearman's rank correlation coefficient (r) = 0·75, p < 0·001], health expenditure as a percentage of total (r = 0·83, p < 0·001) and medical doctors' density (r = 0·85, p < 0·001). Interpretation: There have been significant increases in mAb and FcP biologics consumption and expenditure, however accessibility of biological medicines remains unequal and is largely correlated with country's income level. Funding: This research was funded by NHMRC Project Grant GNT1157506 and GNT1196900; Enhanced Start-up Fund for new academic staff and Internal Research Fund, Department of Medicine, LKS Faculty of Medicine, University of Hong Kong. Competing Interests: XL received research grants from Food and Health Bureau of the Government of the Hong Kong SAR (HMRF, HKSAR), Research Grants Council Early Career Scheme (RGC/ECS, HKSAR), RGC Research Matching Grant Scheme, Janssen, Pfizer and internal funding from the University of Hong Kong; consultancy fee from Merck Sharp & Dohme and Pfizer, unrelated to this work. Nicole L Pratt received research grants from Australian Government. WKL received speaker fees from Ferring, Janssen and Takeda. He also participated Data Safety Advisory Board in Astra Zeneca and Pfizer. All outside the submitted work. CSL reports payment of speaker fees from AbbVie, Astra Zeneca, GSK, Janssen, Pfizer and Roche. He also has participation on Astra Zeneca Data Safety Advisory Board. All outside the submitted work. ICKW reports research funding outside the submitted work from Amgen, Bristol-Myers Squibb, Pfizer, Janssen, Bayer, GSK, Novartis, the Hong Kong RGC, and the Hong Kong Health and Medical Research Fund, National Institute for Health Research in England, European Commission, National Health and Medical Research Council in Australia, and also received speaker fees from Janssen and Medice the previous 3 years. He is also an independent non-executive director of Jacobson Medical in Hong Kong. All other authors have no reports on conflict of interest. (© 2022 The Authors.)
Databáze:	MEDLINE
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