The Current Situation Regarding Long-Acting Insulin Analogues Including Biosimilars Among African, Asian, European, and South American Countries; Findings and Implications for the Future.

Autor:	Godman B; Department of Pharmacoepidemiology, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom.; Division of Public Health Pharmacy and Management, School of Pharmacy, Sefako Makgatho Health Sciences University, Pretoria, South Africa.; School of Pharmaceutical Sciences, Universiti Sains Malaysia, George Town, Malaysia., Haque M; Unit of Pharmacology, Faculty of Medicine and Defence Health, Universiti Pertahanan Nasional Malaysia (National Defence University of Malaysia), Kuala Lumpur, Malaysia., Leong T; Essential Drugs Programme, South African National Department of Health, Pretoria, South Africa., Allocati E; Center for Health Regulatory Policies, Istituto di Ricerche Farmacologiche 'Mario Negri' IRCCS, Milan, Italy., Kumar S; Department of Periodontology and Implantology, Karnavati University, Gandhinagar, India., Islam S; Department of Microbiology, Jahangirnagar University, Dhaka, Bangladesh., Charan J; Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, India., Akter F; Department of Endocrinology, Chittagong Medical College, Chittagong, Bangladesh., Kurdi A; Department of Pharmacoepidemiology, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom.; Division of Public Health Pharmacy and Management, School of Pharmacy, Sefako Makgatho Health Sciences University, Pretoria, South Africa.; Department of Pharmacology, College of Pharmacy, Hawler Medical University, Erbil, Iraq., Vassalo C; Facultad de Ciencias Médicas, Universidad Nacional del Litoral, Santa Fe, Argentina., Bakar MA; Department of Endocrinology and Metabolism, Chattogram Maa-O-Shishu Hospital Medical College, Chattogram, Bangladesh., Rahim SA; Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders General Hospital, Dhaka, Bangladesh., Sultana N; Department of Endocrinology and Metabolism, Bangabandhu Sheik Mujib Medical University Hospital, Dhaka, Bangladesh., Deeba F; Department of Obstetrics and Gynaecology, Bangabandhu Sheik Mujib Medical University, Dhaka, Bangladesh., Khan MAH; Shaheed Suhrawardy Medical College Hospital, Dhaka, Bangladesh., Alam ABMM; Shaheed Suhrawardy Medical College Hospital, Dhaka, Bangladesh., Jahan I; Department of Physiology, Eastern Medical College, Cumilla, Bangladesh., Kamal ZM; National Institute of Mental Health (NIMH), Dhaka, Bangladesh., Hasin H; Clinical Fellow, Epsom and St Helier University Hospitals NHS Trust, Surrey, United Kingdom., Munzur-E-Murshid; Women's Integrated Sexual Health (WISH) 2 Access Choice Together Innovate Ownership Now (ACTION) Project, Handicap International, Kurigram, Bangladesh., Nahar S; Department of Microbiology, Jahangirnagar University, Dhaka, Bangladesh., Haque M; Human Resource Department, Square Toiletries Limited, Rupayan Center, Dhaka, Bangladesh., Dutta S; Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, India., Abhayanand JP; Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, India., Kaur RJ; Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, India., Rwegerera GM; Department of Medicine, Sir Ketumile Masire Teaching Hospital, Gaborone, Botswana.; Faculty of Medicine, University of Botswana, Gaborone, Botswana., do Nascimento RCRM; Department of Pharmacy, Postgraduate Program in Pharmaceutical Sciences (CiPharma), School of Pharmacy, Federal University of Ouro Preto, Ouro Preto, Brazil., Dias Godói IP; Institute of Health and Biological Studies, Universidade Federal do Sul e Sudeste do Pará, Cidade Universitária, Marabá, Brazil.; Group (CNPq) for Epidemiological, Economic and Pharmacological Studies of Arboviruses (EEPIFARBO), Universidade Federal do Sul e Sudeste do Pará, Marabá, Brazil., Irfan M; Faculdade de Odontologia, Universidade Federal de Pelotas, Pelotas, Brazil., Amu AA; Pharmacy Department, Eswatini Medical Christian University, Mbabane, Eswatini., Matowa P; Pharmacy Department, Eswatini Medical Christian University, Mbabane, Eswatini., Acolatse J; Cape Coast Teaching Hospital (CCTH), Cape Coast, Ghana., Incoom R; Cape Coast Teaching Hospital (CCTH), Cape Coast, Ghana., Sefah IA; Pharmacy Department, Keta Municipal Hospital, Ghana Health Service, Keta-Dzelukope, Ghana.; Pharmacy Practise Department of Pharmacy Practise, School of Pharmacy, University of Health and Allied Sciences, Volta Region, Ghana., Acharya J; Department of Dentistry, SP Medical College, Bikaner, India., Opanga S; Department of Pharmaceutics and Pharmacy Practise, School of Pharmacy, University of Nairobi, Nairobi, Kenya., Njeri LW; Department of Pharmacy, Kenyatta National Hospital, Nairobi, Kenya., Kimonge D; Department of Pharmaceutics and Pharmacy Practise, School of Pharmacy, University of Nairobi, Nairobi, Kenya., Kwon HY; Division of Biology and Public Health, Mokwon University, Daejeon, South Korea., Bae S; College of Pharmacy, Ewha Woman's University, Seoul, South Korea., Khuan KKP; Friends' Pharmacy Pekan Sg Besi 42G, Kuala Lumpur, Malaysia., Abubakar AR; Department of Pharmacology and Therapeutics, Faculty of Pharmaceutical Sciences, Bayero University, Kano, Nigeria., Sani IH; Unit of Pharmacology, College of Health Sciences, Yusuf Maitama Sule University (YUMSUK), Kano, Nigeria., Khan TA; National Institute of Health, Islamabad, Pakistan., Hussain S; National Institute of Health, Islamabad, Pakistan., Saleem Z; Department of Pharmacy Practise, Faculty of Pharmacy, The University of Lahore, Lahore, Pakistan., Malande OO; Department of Child Health and Paediatrics, Egerton University, Nakuru, Kenya.; East Africa Centre for Vaccines and Immunisation (ECAVI), Kampala, Uganda., Piloya-Were T; Paediatric Endocrinologist, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda., Gambogi R; National Resources Fund (FNR), Montevideo, Uruguay., Hernandez Ortiz C; National Resources Fund (FNR), Montevideo, Uruguay., Alutuli L; University Teaching Hospital Group, Department of Pharmacy, Lusaka, Zambia., Kalungia AC; Department of Pharmacy, School of Health Sciences, University of Zambia, Lusaka, Zambia., Hoxha I; Department of Pharmacy, Faculty of Medicine, University of Medicine, Tirana, Albania., Marković-Peković V; Department of Social Pharmacy, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina., Tubic B; Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina, Banja Luka, Bosnia and Herzegovina.; Department of Medicinal Chemistry, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina., Petrova G; Department of Social Pharmacy and Pharmacoeconomics, Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria., Tachkov K; Department of Social Pharmacy and Pharmacoeconomics, Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria., Laius O; State Agency of Medicines, Tartu, Estonia., Harsanyi A; Department of Health Policy and Health Economics, Eotvos Lorand University, Budapest, Hungary., Inotai A; Syreon Research Institute, Budapest, Hungary.; Center of Health Technology Assessment, Semmelweis University, Budapest, Hungary., Jakupi A; Faculty of Pharmacy, UBT Higher Education Institute, Pristina, Kosovo., Henkuzens S; Independent Researcher, Riga, Latvia., Garuoliene K; Department of Pharmacy, Faculty of Medicine, Institute of Biomedical Sciences, Vilnius University, Vilnius, Lithuania., Gulbinovič J; Department of Pathology, Forensic Medicine and Pharmacology, Faculty of Medicine, Institute of Biomedical Sciences, Vilnius University, Vilnius, Lithuania., Wladysiuk M; Chair of Epidemiology and Preventive Medicine Jagiellonian University, Medical College, Kraków, Poland.; HTA Consulting, Kraków, Poland., Rutkowski J; HTA Consulting, Kraków, Poland., Mardare I; Faculty of Medicine, Public Health and Management Department, 'Carol Davila' University of Medicine and Pharmacy Bucharest, Bucharest, Romania., Fürst J; Health Insurance Institute, Ljubljana, Slovenia., McTaggart S; Public Health Scotland, Edinburgh, United Kingdom., MacBride-Stewart S; Pharmacy Services, Greater Glasgow and Clyde (NHS GGC), Glasgow, United Kingdom., Pontes C; Drug Department, Catalan Health Service, Barcelona, Spain.; Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Barcelona, Spain., Zara C; Drug Department, Catalan Health Service, Barcelona, Spain., Tagoe ET; Department of Management Science, Business School, University of Strathclyde, Glasgow, United Kingdom., Banzi R; Center for Health Regulatory Policies, Istituto di Ricerche Farmacologiche 'Mario Negri' IRCCS, Milan, Italy., Wale J; Independent Consumer Advocate, Brunswick, VIC, Australia., Jakovljevic M; Department of Global Health Economics and Policy, University of Kragujevac, Kragujevac, Serbia.; Faculty of Economics, Institute of Comparative Economic Studies, Hosei University Tokyo, Tokyo, Japan.
Jazyk:	angličtina
Zdroj:	Frontiers in public health [Front Public Health] 2021 Jun 24; Vol. 9, pp. 671961. Date of Electronic Publication: 2021 Jun 24 (Print Publication: 2021).
DOI:	10.3389/fpubh.2021.671961
Abstrakt:	Background: Diabetes mellitus rates continue to rise, which coupled with increasing costs of associated complications has appreciably increased global expenditure in recent years. The risk of complications are enhanced by poor glycaemic control including hypoglycaemia. Long-acting insulin analogues were developed to reduce hypoglycaemia and improve adherence. Their considerably higher costs though have impacted their funding and use. Biosimilars can help reduce medicine costs. However, their introduction has been affected by a number of factors. These include the originator company dropping its price as well as promoting patented higher strength 300 IU/ml insulin glargine. There can also be concerns with different devices between the manufacturers. Objective: To assess current utilisation rates for insulins, especially long-acting insulin analogues, and the rationale for patterns seen, across multiple countries to inform strategies to enhance future utilisation of long-acting insulin analogue biosimilars to benefit all key stakeholders. Our approach: Multiple approaches including assessing the utilisation, expenditure and prices of insulins, including biosimilar insulin glargine, across multiple continents and countries. Results: There was considerable variation in the use of long-acting insulin analogues as a percentage of all insulins prescribed and dispensed across countries and continents. This ranged from limited use of long-acting insulin analogues among African countries compared to routine funding and use across Europe in view of their perceived benefits. Increasing use was also seen among Asian countries including Bangladesh and India for similar reasons. However, concerns with costs and value limited their use across Africa, Brazil and Pakistan. There was though limited use of biosimilar insulin glargine 100 IU/ml compared with other recent biosimilars especially among European countries and Korea. This was principally driven by small price differences in reality between the originator and biosimilars coupled with increasing use of the patented 300 IU/ml formulation. A number of activities were identified to enhance future biosimilar use. These included only reimbursing biosimilar long-acting insulin analogues, introducing prescribing targets and increasing competition among manufacturers including stimulating local production. Conclusions: There are concerns with the availability and use of insulin glargine biosimilars despite lower costs. This can be addressed by multiple activities. Competing Interests: MW and JR work for HTA Consulting and MH works for Square Toiletries Limited. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2021 Godman, Haque, Leong, Allocati, Kumar, Islam, Charan, Akter, Kurdi, Vassalo, Bakar, Rahim, Sultana, Deeba, Khan, Alam, Jahan, Kamal, Hasin, Munzur-E-Murshid, Nahar, Haque, Dutta, Abhayanand, Kaur, Rwegerera, Nascimento, Dias Godói, Irfan, Amu, Matowa, Acolatse, Incoom, Sefah, Acharya, Opanga, Njeri, Kimonge, Kwon, Bae, Khuan, Abubakar, Sani, Khan, Hussain, Saleem, Malande, Piloya-Were, Gambogi, Hernandez Ortiz, Alutuli, Kalungia, Hoxha, Marković-Peković, Tubic, Petrova, Tachkov, Laius, Harsanyi, Inotai, Jakupi, Henkuzens, Garuoliene, Gulbinovič, Wladysiuk, Rutkowski, Mardare, Fürst, McTaggart, MacBride-Stewart, Pontes, Zara, Tagoe, Banzi, Wale and Jakovljevic.)
Databáze:	MEDLINE
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