Utilisation Trend of Long-Acting Insulin Analogues including Biosimilars across Europe: Findings and Implications
Jazyk angličtina Země Spojené státy americké Médium electronic-ecollection
Typ dokumentu časopisecké články
PubMed
34676266
PubMed Central
PMC8526244
DOI
10.1155/2021/9996193
Knihovny.cz E-zdroje
- MeSH
- analýza nákladů a výnosů trendy MeSH
- biosimilární léčivé přípravky ekonomika terapeutické užití MeSH
- diabetes mellitus diagnóza farmakoterapie ekonomika MeSH
- dlouhodobě působící inzulin ekonomika terapeutické užití MeSH
- hypoglykemika ekonomika terapeutické užití MeSH
- inzulin glargin ekonomika terapeutické užití MeSH
- lidé MeSH
- vzdělávání pacientů jako téma metody MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Evropa MeSH
- Názvy látek
- biosimilární léčivé přípravky MeSH
- dlouhodobě působící inzulin MeSH
- hypoglykemika MeSH
- inzulin glargin MeSH
BACKGROUND: Diabetes mellitus rates and associated costs continue to rise across Europe enhancing health authority focus on its management. The risk of complications is enhanced by poor glycaemic control, with long-acting insulin analogues developed to reduce hypoglycaemia and improve patient convenience. There are concerns though with their considerably higher costs, but moderated by reductions in complications and associated costs. Biosimilars can help further reduce costs. However, to date, price reductions for biosimilar insulin glargine appear limited. In addition, the originator company has switched promotional efforts to more concentrated patented formulations to reduce the impact of biosimilars. There are also concerns with different devices between the manufacturers. As a result, there is a need to assess current utilisation rates for insulins, especially long-acting insulin analogues and biosimilars, and the rationale for patterns seen, among multiple European countries to provide future direction. Methodology. Health authority databases are examined to assess utilisation and expenditure patterns for insulins, including biosimilar insulin glargine. Explanations for patterns seen were provided by senior-level personnel. RESULTS: Typically increasing use of long-acting insulin analogues across Europe including both Western and Central and Eastern European countries reflects perceived patient benefits despite higher prices. However, activities by the originator company to switch patients to more concentrated insulin glargine coupled with lowering prices towards biosimilars have limited biosimilar uptake, with biosimilars not currently launched in a minority of European countries. A number of activities were identified to address this. Enhancing the attractiveness of the biosimilar insulin market is essential to encourage other biosimilar manufacturers to enter the market as more long-acting insulin analogues lose their patents to benefit all key stakeholder groups. CONCLUSIONS: There are concerns with the availability and use of insulin glargine biosimilars among European countries despite lower costs. This can be addressed.
Chair of Epidemiology and Preventive Medicine Medical College Jagiellonian University Krakow Poland
Dachverband der Österreichischen Sozialversicherungen Kundmanngasse 21 AT 1030 Vienna Austria
Department of Global Health Economics and Policy University of Kragujevac Kragujevac Serbia
Department of Global Public Health Karolinska Institutet Stockholm Sweden
Department of Health Policy and Health Economics Eotvos Lorand University Budapest Hungary
Department of Health Services Management University of Malta Valletta Malta
Department of Pharmacology College of Pharmacy Hawler Medical University Erbil Iraq
Department of Pharmacy Faculty of Medicine University of Medicine Tirana Albania
Drug Department Catalan Health Service Gran Via de les Corts Catalanes 08007 Barcelona Spain
Faculty of Pharmacy UBT Higher Education Institute Pristina Kosovo
Health Insurance Institute Miklosiceva 24 SI 1507 Ljubljana Slovenia
HTA Consulting Starowiślna Str 17 3 31 038 Krakow Poland
Independent Consultant Riga Latvia
Institute of Comparative Economic Studies Faculty of Economics Hosei University Tokyo Tokyo Japan
Istituto di Ricerche Farmacologiche 'Mario Negri' IRCCS Milan Italy
Medicines Committee Oslo University Hospitals Oslo Norway
National Organization for the Provision of Healthcare Services Athens Greece
NEPI Nätverk för läkemedelsepidemiologi Stockholm Sweden
Pharmacy Services Greater Glasgow and Clyde Glasgow UK
Public Health Scotland Gyle Square 1 South Gyle Crescent Edinburgh UK
School of Pharmaceutical Sciences Universiti Sains Malaysia Penang Malaysia
State Agency of Medicines Nooruse 1 50411 Tartu Estonia
State Institute for Drug Control Prague Czech Republic
Wissenschaftliches Institut der AOK Rosenthaler Straße 31 10178 Berlin Germany
Zobrazit více v PubMed
IQVIA. The Global Use of Medicine in 2019 and Outlook to 2023 - Forecasts and Areas to Watch . 2019. https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/the-global-use-of-medicine-in-2019-and-outlook-to-2023.pdf .
Jakovljevic M., Jakab M., Gerdtham U., et al. Comparative financing analysis and political economy of noncommunicable diseases. Journal of Medical Economics . 2019;22(8):722–727. doi: 10.1080/13696998.2019.1600523. PubMed DOI
Odone A., Azzopardi-Muscat N. Health and the effect of universal health coverage in Italy. The Lancet Public health. . 2019;4(12):e597–e598. doi: 10.1016/S2468-2667(19)30206-3. PubMed DOI
OECD. Health at a Glance: Europe 2020 State of Health in the EU Cycle . https://www.oecd-ilibrary.org/docserver/82129230-en.pdf?expires=1612384979&id=id&accname=guest&checksum=E9AD44E432E325AC9EEBEB236EAE5851 .
European Commission. Defining value in “value based healthcare”. Report of the expert panel on effective ways of investing in health (EXPH) . 2019 https://ec.europa.eu/health/sites/health/files/expert_panel/docs/024_defining-value-vbhc_en.pdf .
Jakovljevic M., Matter-Walstra K., Sugahara T., et al. Cost-effectiveness and resource allocation (CERA) 18 years of evolution: maturity of adulthood and promise beyond tomorrow. Cost effectiveness and resource allocation. . 2020;18(1) doi: 10.1186/s12962-020-00210-2. PubMed DOI PMC
Chan J. C. N., Lim L. L., Wareham N. J., et al. The Lancet Commission on diabetes: using data to transform diabetes care and patient lives. Lancet . 2021;396(10267):2019–2082. doi: 10.1016/S0140-6736(20)32374-6. PubMed DOI
Liu J., Ren Z.-H., Qiang H., et al. Trends in the incidence of diabetes mellitus: results from the Global Burden of Disease Study 2017 and implications for diabetes mellitus prevention. BMC Public Health . 2020;20(1):p. 1415. doi: 10.1186/s12889-020-09502-x. PubMed DOI PMC
Ceriello A., deValk H. W., Guerci B., et al. The burden of type 2 diabetes in Europe: current and future aspects of insulin treatment from patient and healthcare spending perspectives. Diabetes research and clinical practice . 2020;161:p. 108053. doi: 10.1016/j.diabres.2020.108053. PubMed DOI
Basu S., Yudkin J. S., Kehlenbrink S., et al. Estimation of global insulin use for type 2 diabetes, 2018-30: a microsimulation analysis. The lancet Diabetes & endocrinology. . 2019;7(1):25–33. doi: 10.1016/S2213-8587(18)30303-6. PubMed DOI
Sharma M., Nazareth I., Petersen I. Trends in incidence, prevalence and prescribing in type 2 diabetes mellitus between 2000 and 2013 in primary care: a retrospective cohort study. BMJ Open . 2016;6(1, article e010210) doi: 10.1136/bmjopen-2015-010210. PubMed DOI PMC
A P V., Kamath L., Shankar S. Knowledge, attitude and practice of insulin use of diabetic patients in India. Pharmacology and Clinical Pharmacy Research. . 2020;5(1):23–32. doi: 10.15416/pcpr.v5i1.26564. DOI
Heller S. R., Peyrot M., Oates S. K., Taylor A. D. Hypoglycemia in patient with type 2 diabetes treated with insulin: it can happen. BMJ Open Diabetes Research & Care . 2020;8(1):p. e001194. doi: 10.1136/bmjdrc-2020-001194. PubMed DOI PMC
Bommer C., Sagalova V., Heesemann E., et al. Global economic burden of diabetes in adults: projections from 2015 to 2030. Diabetes Care . 2018;41(5):963–970. doi: 10.2337/dc17-1962. PubMed DOI
Jakovljevic M., Timofeyev Y., Ranabhat C. L., et al. Real GDP growth rates and healthcare spending – comparison between the G7 and the EM7 countries. Globalization and Health . 2020;16(1):p. 64. doi: 10.1186/s12992-020-00590-3. PubMed DOI PMC
Jakovljevic M., Sugahara T., Timofeyev Y., Rancic N. Predictors of (in)efficiencies of healthcare expenditure among the leading Asian economies - comparison of OECD and non-OECD nations. Risk management and healthcare policy. . 2020;Volume 13:2261–2280. doi: 10.2147/RMHP.S266386. PubMed DOI PMC
Amiel S. A., Aschner P., Childs B., et al. Hypoglycaemia, cardiovascular disease, and mortality in diabetes: epidemiology, pathogenesis, and management. The lancet Diabetes & endocrinology . 2019;7(5):385–396. doi: 10.1016/s2213-8587(18)30315-2. PubMed DOI
Kalra S. Hypoglycaemia in diabetes. Journal Of Pakistan Medical Association . 2014;64(9):1090–1093. PubMed
Pathan M. F., Fariduddin M., Nazimuddin K., et al. The incidence of hypoglycemia among insulin-treated patients with type 1 or type 2 diabetes: Bangladeshi cohort of international operations-hypoglycemia assessment tool study. Indian Journal of Endocrinology and Metabolism . 2018;22(3):379–386. doi: 10.4103/ijem.IJEM_545_17. PubMed DOI PMC
Khunti K., Alsifri S., Aronson R., et al. Rates and predictors of hypoglycaemia in 27 585 people from 24 countries with insulin-treated type 1 and type 2 diabetes: the global HAT study. Diabetes, obesity & metabolism. . 2016;18(9):907–915. doi: 10.1111/dom.12689. PubMed DOI PMC
Hussein Z., Kamaruddin N. A., Chan S. P., et al. Hypoglycemia awareness among insulin-treated patients with diabetes in Malaysia: a cohort subanalysis of the HAT study. Diabetes research and clinical practice. . 2017;133:40–49. doi: 10.1016/j.diabres.2017.08.007. PubMed DOI
Abusnana S., Beshyah S. A., al-Mutawa N., et al. Hypoglycaemia among insulin-treated patients with diabetes: evaluation of the United Arab Emirates cohort of the International Operations-Hypoglycaemia Assessment Tool study. Sultan Qaboos University Medical Journal [SQUMJ] . 2019;18(4):447–e454. doi: 10.18295/squmj.2018.18.04.004. PubMed DOI PMC
Munro N., Barnett A. H. Incidence, worry and discussion about dosing irregularities and self-treated hypoglycaemia amongst HCPs and patients with type 2 diabetes: results from the UK cohort of the Global Attitudes of Patient and Physicians (GAPP2) survey. International journal of clinical practice. . 2014;68(6):692–699. doi: 10.1111/ijcp.12388. PubMed DOI
Alva M. L., Gray A., Mihaylova B., Leal J., Holman R. R. The impact of diabetes-related complications on healthcare costs: new results from the UKPDS (UKPDS 84) Diabetic medicine. . 2015;32(4):459–466. doi: 10.1111/dme.12647. PubMed DOI
Papazafiropoulou A., Tentolouris N., Soldatos R. P., et al. Mortality in diabetic and nondiabetic patients after amputations performed from 1996 to 2005 in a tertiary hospital population: a 3-year follow-up study. Journal of Diabetes and its Complications . 2009;23(1):7–11. doi: 10.1016/j.jdiacomp.2007.11.008. PubMed DOI
Narres M., Kvitkina T., Claessen H., et al. Incidence of lower extremity amputations in the diabetic compared with the non-diabetic population: a systematic review. PLoS One . 2017;12(8, article e0182081) doi: 10.1371/journal.pone.0182081. PubMed DOI PMC
Rys P., Wojciechowski P., Rogoz-Sitek A., et al. Systematic review and meta-analysis of randomized clinical trials comparing efficacy and safety outcomes of insulin glargine with NPH insulin, premixed insulin preparations or with insulin detemir in type 2 diabetes mellitus. Acta diabetologica . 2015;52(4):649–662. doi: 10.1007/s00592-014-0698-4. PubMed DOI PMC
McGovern A., Tippu Z., Hinton W., Munro N., Whyte M., de Lusignan S. Comparison of medication adherence and persistence in type 2 diabetes: a systematic review and meta-analysis. Diabetes, obesity & metabolism. . 2018;20(4):1040–1043. doi: 10.1111/dom.13160. PubMed DOI
Pedersen-Bjergaard U., Kristensen P. L., Beck-Nielsen H., et al. Effect of insulin analogues on risk of severe hypoglycaemia in patients with type 1 diabetes prone to recurrent severe hypoglycaemia (HypoAna trial): a prospective, randomised, open-label, blinded-endpoint crossover trial. The lancet Diabetes & endocrinology. . 2014;2(7):553–561. doi: 10.1016/S2213-8587(14)70073-7. PubMed DOI
Semlitsch T., Engler J., Siebenhofer A., Jeitler K., Berghold A., Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. The Cochrane database of systematic reviews . 2020;11:p. Cd005613. PubMed PMC
Almeida P., Silva T. B. C., de Assis Acurcio F., et al. Quality of life of patients with type 1 diabetes mellitus using insulin analog glargine compared with NPH insulin: a systematic review and policy implications. The patient. . 2018;11(4):377–389. doi: 10.1007/s40271-017-0291-3. PubMed DOI PMC
Hemmingsen B., Metzendorf M. I., Richter B. (Ultra-)long-acting insulin analogues for people with type 1 diabetes mellitus. The Cochrane database of systematic reviews . 2021;3:p. Cd013498. PubMed PMC
Caires de Souza A. L., Acurcio F. A., Guerra Júnior A. A., Rezende Macedo do Nascimento R. C., Godman B., Diniz L. M. Insulin glargine in a Brazilian state: should the government disinvest? An assessment based on a systematic review. Applied health economics and health policy. . 2014;12(1):19–32. doi: 10.1007/s40258-013-0073-6. PubMed DOI
Tricco A. C., Ashoor H. M., Antony J., et al. Comparative efficacy and safety of ultra-long-acting, long-acting, intermediate-acting, and biosimilar insulins for type 1 diabetes mellitus: a systematic review and network meta-analysis. Journal of General Internal Medicine . 2021;36(8):2414–2426. doi: 10.1007/s11606-021-06642-7. PubMed DOI PMC
Ewen M., Joosse H. J., Beran D., Laing R. Insulin prices, availability and affordability in 13 low-income and middle-income countries. BMJ global health. . 2019;4(3, article e001410) doi: 10.1136/bmjgh-2019-001410. PubMed DOI PMC
Beran D., Ewen M., Laing R. Constraints and challenges in access to insulin: a global perspective. The lancet Diabetes & endocrinology. . 2016;4(3):275–285. doi: 10.1016/S2213-8587(15)00521-5. PubMed DOI
Haque M., Islam S., Kamal Z. M., et al. Ongoing efforts to improve the management of patients with diabetes in Bangladesh and the implications. Hospital practice. . 2021:1–7. doi: 10.1080/21548331.2021.1906083. PubMed DOI
Zion Market Research. Insulin glargine market: by type (pre-filled syringe and single dose vial), by application (type 1 diabetes and type 2 diabetes), by distribution channel (hospital pharmacy, online sales, retail pharmacy and other distribution channels): global industry perspective, comprehensive analysis and forecast . 2019. pp. 2018–2025. https://www.zionmarketresearch.com/report/insulin-glargin-market .
Research and Markets. $24 billion insulin markets - global intelligence database 2012-2018 & 2019-2023 . 2019. https://www.globenewswire.com/news-release/2019/05/29/1856512/0/en/24-Billion-Insulin-Markets-Global-Intelligence-Database-2012-2018-2019-2023.html .
PMLive. Levemir . http://www.pmlive.com/top_pharma_list/pharmaceutical_products/levemir .
Cheng A. Y. Y., Wong J., Freemantle N., Acharya S. H., Ekinci E. The safety and efficacy of second-generation basal insulin analogues in adults with type 2 diabetes at risk of hypoglycemia and use in other special populations: a narrative review. Diabetes therapy. . 2020;11(11):2555–2593. doi: 10.1007/s13300-020-00925-8. PubMed DOI PMC
Thalange N., Gundgaard J., Parekh W., Tutkunkardas D. Cost analysis of insulin degludec in comparison with insulin detemir in treatment of children and adolescents with type 1 diabetes in the UK. BMJ open diabetes research & care. . 2019;7(1, article e000664) doi: 10.1136/bmjdrc-2019-000664. PubMed DOI PMC
Evans M., Moes R. G. J., Pedersen K. S., Gundgaard J., Pieber T. R. Cost-effectiveness of insulin degludec versus insulin glargine U300 in the Netherlands: evidence from a randomised controlled trial. Advances in Therapy . 2020;37(5):2413–2426. doi: 10.1007/s12325-020-01332-y. PubMed DOI PMC
Russel-Szymczyk M., Valov V., Savova A., Manova M. Cost-effectiveness of insulin degludec versus insulin glargine U100 in adults with type 1 and type 2 diabetes mellitus in Bulgaria. BMC endocrine disorders . 2019;19(1):p. 132. doi: 10.1186/s12902-019-0460-6. PubMed DOI PMC
Permsuwan U., Thavorn K., Dilokthornsakul P., Saokaew S., Chaiyakunapruk N. Cost-effectiveness of insulin detemir versus insulin glargine for Thai type 2 diabetes from a payer's perspective. Journal of Medical Economics . 2017;20(9):991–999. doi: 10.1080/13696998.2017.1347792. PubMed DOI
Beran D., Lazo-Porras M., Mba C. M., Mbanya J. C. A global perspective on the issue of access to insulin. Diabetologia . 2021;64(5):954–962. doi: 10.1007/s00125-020-05375-2. PubMed DOI PMC
Shafie A. A., Ng C. H. Cost-effectiveness of insulin glargine and insulin detemir in the basal regimen for naïve insulin patients with type 2 diabetes mellitus (T2DM) in Malaysia. ClinicoEconomics and outcomes research. . 2020;Volume 12:333–343. doi: 10.2147/CEOR.S244884. PubMed DOI PMC
Jendle J., Ericsson Å., Ekman B., et al. Real-world cost-effectiveness of insulin degludec in type 1 and type 2 diabetes mellitus from a Swedish 1-year and long-term perspective. Journal of Medical Economics . 2020;23(11):1311–1320. doi: 10.1080/13696998.2020.1805454. PubMed DOI
Lee T. Y., Kuo S., Yang C. Y., Ou H. T. Cost-effectiveness of long-acting insulin analoguesvsintermediate/long‐acting human insulin for type 1 diabetes: a population-based cohort followed over 10 years. British journal of clinical pharmacology. . 2020;86(5):852–860. doi: 10.1111/bcp.14188. PubMed DOI PMC
Alemayehu B., Speiser J., Bloudek L., Sarnes E. Costs associated with long-acting insulin analogues in patients with diabetes. The American journal of managed care . 2018;24 PubMed
Gururaj Setty S., Crasto W., Jarvis J., Khunti K., Davies M. J. New insulins and newer insulin regimens: a review of their role in improving glycaemic control in patients with diabetes. Postgraduate Medical Journal . 2016;92(1085):152–164. doi: 10.1136/postgradmedj-2015-133716. PubMed DOI
Jensen T. B., Kim S. C., Jimenez-Solem E., Bartels D., Christensen H. R., Andersen J. T. Shift from adalimumab originator to biosimilars in Denmark. JAMA Internal Medicine. . 2020;180(6):902–903. doi: 10.1001/jamainternmed.2020.0338. PubMed DOI PMC
Matusewicz W., Godman B., Pedersen H. B., et al. Improving the managed introduction of new medicines: sharing experiences to aid authorities across Europe. Expert review of pharmacoeconomics & outcomes research. . 2015;15(5):755–758. doi: 10.1586/14737167.2015.1085803. PubMed DOI
Davio K. After biosimilar deals, UK spending on adalimumab will drop by 75% . 2018. https://www.centerforbiosimilars.com/news/after-biosimilar-deals-uk-spending-on-adalimumab-will-drop-by-75 .
Moorkens E., Godman B., Huys I., et al. The expiry of Humira® market exclusivity and the entry of adalimumab biosimilars in Europe: an overview of pricing and national policy measures. Frontiers in pharmacology . 2021;11 doi: 10.3389/fphar.2020.591134. PubMed DOI PMC
Godman B. Biosimilars are becoming indispensable in the management of multiple diseases although concerns still exist. Bangladesh Journal of Medical Science. . 2020;20(1):5–10.
Yamada T., Kamata R., Ishinohachi K., et al. Biosimilar vs originator insulins: systematic review and meta-analysis. Diabetes, obesity & metabolism. . 2018;20(7):1787–1792. doi: 10.1111/dom.13291. PubMed DOI
Altman J. J., Chevalier N., Delemer B., Travert F., Benabbad I. LY2963016 insulin glargine: the first biosimilar insulin approved in the European Union. Presse Médicale . 2018;47(10):854–866. doi: 10.1016/j.lpm.2018.06.004. PubMed DOI
Blevins T. C., Barve A., Sun B., et al. Efficacy and safety of MYL-1501D versus insulin glargine in patients with type 2 diabetes after 24 weeks: results of the phase III INSTRIDE 2 study. Diabetes, obesity & metabolism. . 2019;21(1):129–135. doi: 10.1111/dom.13495. PubMed DOI
Blevins T. C., Barve A., Raiter Y., et al. Efficacy and safety of MYL-1501D versus insulin glargine in people with type 1 diabetes mellitus: results of the INSTRIDE 3 phase 3 switch study. Diabetes, obesity & metabolism. . 2020;22(3):365–372. doi: 10.1111/dom.13904. PubMed DOI PMC
Hoy S. M. MYL1501D insulin glargine: a review in diabetes mellitus. BioDrugs . 2020;34(2):245–251. doi: 10.1007/s40259-020-00418-x. PubMed DOI PMC
Greater Glasgow. Greater Glasgow and Clyde. Clyde. Medicines Update - Semglee® – preferred brand of insulin glargine . 2020. http://ggcprescribing.org.uk/blog/alternatives-insulin-glargine-post-tc/
Greener M. Why isn’t the NHS making the most of biosimilar insulin? Prescriber . 2019;30(8):21–24.
Greater Glasgow. Clyde. Medicines Update - Prescribing medicines by brand . 2020. http://www.ggcprescribing.org.uk/blog/prescribing-medicines-brand/
Lothian Formulary. 6.1.1 Insulins . 2020. https://www.ljf.scot.nhs.uk/LothianJointFormularies/Adult/6.0/6.1/6.1.1/Pages/default.aspx .
WHO. WHO launches first-ever insulin prequalification programme to expand access to life-saving treatment for diabetes . 2019. https://www.who.int/news/item/13-11-2019-who-launches-first-ever-insulin-prequalification-programme-to-expand-access-to-life-saving-treatment-for-diabetes .
Gotham D., Barber M. J., Hill A. Production costs and potential prices for biosimilars of human insulin and insulin analogues. BMJ global health. . 2018;3(5, article e000850) doi: 10.1136/bmjgh-2018-000850. PubMed DOI PMC
Chapman S. R., Fitzpatrick R. W., Aladul M. I. Knowledge, attitude and practice of healthcare professionals towards infliximab and insulin glargine biosimilars: result of a UK web-based survey. BMJ Open . 2017;7(6, article e016730) doi: 10.1136/bmjopen-2017-016730. PubMed DOI PMC
Agirrezabal I., Sánchez-Iriso E., Mandar K., Cabasés J. M. Real-world budget impact of the adoption of insulin glargine biosimilars in primary care in England (2015-2018) Diabetes Care . 2020;43(8):1767–1773. doi: 10.2337/dc19-2395. PubMed DOI
Standl E., Owen D. R. New long-acting basal insulins: does benefit outweigh cost? Diabetes Care . 2016;39(Supplement 2):S172–S179. doi: 10.2337/dcS15-3011. PubMed DOI
Escalada J., Bonnet F., Wu J., et al. Reduced hypoglycemia risk in type 2 diabetes patients switched to/initiating insulin glargine 300 vs 100 U/ml: a European real-world study. Advances in Therapy . 2020;37(9):3863–3877. doi: 10.1007/s12325-020-01436-5. PubMed DOI PMC
Díez-Fernández A., Cavero-Redondo I., Moreno-Fernández J., Pozuelo-Carrascosa D. P., Garrido-Miguel M., Martínez-Vizcaíno V. Effectiveness of insulin glargine U-300 versus insulin glargine U-100 on nocturnal hypoglycemia and glycemic control in type 1 and type 2 diabetes: a systematic review and meta-analysis. Acta diabetologica. . 2019;56(3):355–364. doi: 10.1007/s00592-018-1258-0. PubMed DOI
Bolli G. B., Riddle M. C., Bergenstal R. M., et al. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naïve people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3) Diabetes, obesity & metabolism. . 2015;17(4):386–394. doi: 10.1111/dom.12438. PubMed DOI PMC
Abitbol A., Brown R. E., Jiandani D., Sauriol L., Aronson R. Real-world health outcomes of insulin glargine 300 U/mL vs insulin glargine 100 U/mL in adults with type 1 and type 2 diabetes in the Canadian LMC Diabetes Patient Registry: the REALITY Study. Canadian journal of diabetes . 2019;43(7) doi: 10.1016/j.jcjd.2019.04.012. PubMed DOI
Ritzel R., Roussel R., Giaccari A., Vora J., Brulle-Wohlhueter C., Yki-Järvinen H. Better glycaemic control and less hypoglycaemia with insulin glargine 300 U/mL vs glargine 100 U/mL: 1-year patient-level meta-analysis of the EDITION clinical studies in people with type 2 diabetes. Diabetes, obesity & metabolism. . 2018;20(3):541–548. doi: 10.1111/dom.13105. PubMed DOI PMC
Vargas-Uricoechea H. Efficacy and Safety of Insulin Glargine 300 U/mL versus 100 U/mL in Diabetes Mellitus: A Comprehensive Review of the Literature. Journal of diabetes research. . 2018;2018, article 2052101:1–28. doi: 10.1155/2018/2052101. PubMed DOI PMC
Keramatian K., Chakrabarty T., Yatham L. N. Long-acting injectable second-generation/atypical antipsychotics for the management of bipolar disorder: a systematic review. CNS Drugs . 2019;33(5):431–456. doi: 10.1007/s40263-019-00629-z. PubMed DOI
Olagunju A. T., Clark S. R., Baune B. T. Long-acting atypical antipsychotics in schizophrenia: a systematic review and meta-analyses of effects on functional outcome. The Australian and New Zealand journal of psychiatry. . 2019;53(6):509–527. doi: 10.1177/0004867419837358. PubMed DOI
Godman B., Persson M., Miranda J., et al. Can authorities take advantage of the availability of generic atypical antipsychotic drugs? Findings from Sweden and potential implications. Journal of Pharmaceutical Health Services Research . 2013;4(3):139–150. doi: 10.1111/jphs.12025. DOI
McCabe H., Godman B., Kurdi A., et al. Prescribing trends of inhaler treatments for asthma and chronic obstructive pulmonary disease within a resource-constrained environment in the Scottish national health service: findings and implications. Expert review of respiratory medicine. . 2019;13(7):679–689. doi: 10.1080/17476348.2019.1624528. PubMed DOI
Alkhafaji A. A., Trinquart L., Baron G., Desvarieux M., Ravaud P. Impact of evergreening on patients and health insurance: a meta analysis and reimbursement cost analysis of citalopram/escitalopram antidepressants. BMC medicine . 2012;10(1) doi: 10.1186/1741-7015-10-142. PubMed DOI PMC
Vernaz N., Haller G., Girardin F., et al. Patented drug extension strategies on healthcare spending: a cost-evaluation analysis. PLoS Medicine . 2013;10(6, article e1001460) doi: 10.1371/journal.pmed.1001460. PubMed DOI PMC
Godman B., Kurdi A., McCabe H., et al. Ongoing initiatives within the Scottish national health service to affect the prescribing of selective serotonin reuptake inhibitors and their influence. Journal of comparative effectiveness research. . 2019;8(7):535–547. doi: 10.2217/cer-2018-0132. PubMed DOI
Godman B., Kurdi A., McCabe H., et al. Ongoing activities to influence the prescribing of proton pump inhibitors within the Scottish national health service: their effect and implications. Generics and Biosimilars Initiative Journal. . 2018;7(4):142–151. doi: 10.5639/gabij.2018.0704.030. DOI
Godman B., Wilcock M., Martin A., et al. Generic pregabalin; current situation and implications for health authorities, generics and biosimilars manufacturers in the future. GaBI Journal. . 2015;4(3):125–135. doi: 10.5639/gabij.2015.0403.028. DOI
Scottish Medicines Consortium. Insulin glargine 300 units/mL solution for injection in a pre-filled pen (Toujeo®) 2015. https://www.scottishmedicines.org.uk/media/1860/insulin_glargine__toujeo_solostar__abbreviated_final_july_2015_for_website.pdf .
Kluge H. H. P., Wickramasinghe K., Rippin H. L., et al. Prevention and control of non-communicable diseases in the COVID-19 response. Lancet . 2020;395(10238):1678–1680. doi: 10.1016/S0140-6736(20)31067-9. PubMed DOI PMC
Ogunleye O. O., Basu D., Mueller D., et al. Response to the novel corona virus (COVID-19) pandemic across Africa: successes, challenges, and implications for the future. Frontiers in pharmacology . 2020;11(1205) doi: 10.3389/fphar.2020.01205. PubMed DOI PMC
Godman B., Hill A., Simoens S., et al. Pricing of oral generic cancer medicines in 25 European countries; findings and implications. Generics and Biosimilars Initiative Journal. . 2019;8(2):49–70. doi: 10.5639/gabij.2019.0802.007. DOI
Godman B., Shrank W., Andersen M., et al. Policies to enhance prescribing efficiency in Europe: findings and future implications. Frontiers in pharmacology. . 2011;1 doi: 10.3389/fphar.2010.00141. PubMed DOI PMC
Vončina L., Strizrep T., Godman B., et al. Influence of demand-side measures to enhance renin-angiotensin prescribing efficiency in Europe: implications for the future. Expert review of pharmacoeconomics & outcomes research. . 2011;11(4):469–479. doi: 10.1586/erp.11.42. PubMed DOI
Baumgart D. C., Misery L., Naeyaert S., Taylor P. C. Biological therapies in immune-mediated inflammatory diseases: can biosimilars reduce access inequities? Frontiers in pharmacology. . 2019;10:p. 279. doi: 10.3389/fphar.2019.00279. PubMed DOI PMC
Kostic M., Djakovic L., Sujic R., Godman B., Jankovic S. M. Inflammatory bowel diseases (Crohn´s disease and ulcerative colitis): cost of treatment in Serbia and the implications. Applied health economics and health policy. . 2017;15(1):85–93. doi: 10.1007/s40258-016-0272-z. PubMed DOI PMC
Péntek M., Lakatos P. L., Oorsprong T., et al. Access to biologicals in Crohn's disease in ten European countries. World Journal of Gastroenterology . 2017;23(34):6294–6305. doi: 10.3748/wjg.v23.i34.6294. PubMed DOI PMC
Putrik P., Ramiro S., Kvien T. K., et al. Inequities in access to biologic and synthetic DMARDs across 46 European countries. Annals of the rheumatic diseases. . 2014;73(1):198–206. doi: 10.1136/annrheumdis-2012-202603. PubMed DOI
Rencz F., Péntek M., Bortlik M., et al. Biological therapy in inflammatory bowel diseases: access in Central and Eastern Europe. World Journal of Gastroenterology . 2015;21(6):1728–1737. doi: 10.3748/wjg.v21.i6.1728. PubMed DOI PMC
Beran D., Laing R. O., Kaplan W., et al. A perspective on global access to insulin: a descriptive study of the market, trade flows and prices. Diabetic medicine. . 2019;36(6):726–733. doi: 10.1111/dme.13947. PubMed DOI PMC
Vogler S., Schneider P. Assessing data sources for medicine price studies. International journal of technology assessment in health care. . 2019;35(2):106–115. doi: 10.1017/S0266462319000138. PubMed DOI
Garuoliene K., Godman B., Gulbinovic J., Schiffers K., Wettermark B. Differences in utilization rates between commercial and administrative databases: implications for future health-economic and cross-national studies. Expert review of pharmacoeconomics & outcomes research. . 2016;16(2):149–152. doi: 10.1586/14737167.2016.1158649. PubMed DOI
WHO. WHO Collaborating Centre for Drug Statistics Methodology. ATC/ DDD Index . https://www.whocc.no/
WHO. WHO Collaborating Centre for Drug Statistics Methodology. Guidelines for ATC classification and DDD assignment . 2021. https://www.whocc.no/filearchive/publications/2021_guidelines_web.pdf .
Neville H., Trenaman S. C. Drug utilization research: methods and applications. The Canadian journal of hospital pharmacy . 2017;70(4):p. 325.
Gupta S., Wang H., Skolnik N., et al. Treatment dosing patterns and clinical outcomes for patients with type 2 diabetes starting or switching to treatment with insulin glargine (300 units per milliliter) in a real-world setting: a retrospective observational study. Advances in Therapy . 2018;35(1):43–55. doi: 10.1007/s12325-017-0651-3. PubMed DOI PMC
Moon J. C., Godman B., Petzold M., et al. Different initiatives across Europe to enhance losartan utilization post generics: impact and implications. Frontiers in pharmacology. . 2014;5 doi: 10.3389/fphar.2014.00219. PubMed DOI PMC
Godman B., Petzold M., Bennett K., et al. Can authorities appreciably enhance the prescribing of oral generic risperidone to conserve resources? Findings from across Europe and their implications. Medicine . 2014;12(1) doi: 10.1186/1741-7015-12-98. PubMed DOI PMC
Godman B., Shrank W., Andersen M., et al. Comparing policies to enhance prescribing efficiency in Europe through increasing generic utilization: changes seen and global implications. Expert review of pharmacoeconomics & outcomes research. . 2010;10(6):707–722. doi: 10.1586/erp.10.72. PubMed DOI
Godman B., Bishop I., Finlayson A. E., Campbell S., Kwon H. Y., Bennie M. Reforms and initiatives in Scotland in recent years to encourage the prescribing of generic drugs, their influence and implications for other countries. Expert review of pharmacoeconomics & outcomes research. . 2013;13(4):469–482. doi: 10.1586/14737167.2013.820956. PubMed DOI
Tubic B., Markovic-Pekovic V., Jungić S., Allocati E., Godman B. Availability and accessibility of monoclonal antibodies in Bosnia and Herzegovina: findings and implications. Medicine Access@Point of Care. . 2021;5:p. 239920262110276. doi: 10.1177/23992026211027692. PubMed DOI PMC
Vella Bonanno P., Ermisch M., Godman B., et al. Adaptive pathways: possible next steps for payers in preparation for their potential implementation. Frontiers in pharmacology . 2017;8:p. 497. doi: 10.3389/fphar.2017.00497. PubMed DOI PMC
Ferrario A., Arāja D., Bochenek T., et al. The implementation of managed entry agreements in Central and Eastern Europe: findings and implications. PharmacoEconomics . 2017;35(12):1271–1285. doi: 10.1007/s40273-017-0559-4. PubMed DOI PMC
Bochenek T., Abilova V., Alkan A., et al. Systemic Measures and Legislative and Organizational Frameworks Aimed at Preventing or Mitigating Drug Shortages in 28 European and Western Asian Countries. Frontiers in pharmacology. . 2018;8 doi: 10.3389/fphar.2017.00942. PubMed DOI PMC
Pontes C., Zara C., Torrent-Farnell J., et al. Time to review authorisation and funding for new cancer medicines in Europe? Inferences from the case of olaratumab. Applied health economics and health policy. . 2020;18(1):5–16. doi: 10.1007/s40258-019-00527-x. PubMed DOI
Godman B., Haque M., Kumar S., et al. Current utilization patterns for long-acting insulin analogues including biosimilars among selected Asian countries and the implications for the future. Current medical research and opinion. . 2021:1–17. doi: 10.1080/03007995.2021.1946024. PubMed DOI
Haque M., Kumar S., Charan J., et al. Utilisation, availability and price changes of medicines and protection equipment for COVID-19 Among Selected Regions in India: findings and implications. Frontiers in pharmacology . 2021;11(1822) doi: 10.3389/fphar.2020.582154. PubMed DOI PMC
Godman B., Haque M., Islam S., et al. Rapid assessment of price instability and paucity of Medicines and protection for COVID-19 across Asia: findings and public health implications for the future. Frontiers in Public Health . 2020;8(744) doi: 10.3389/fpubh.2020.585832. PubMed DOI PMC
Gad M., Salem A., Oortwijn W., Hill R., Godman B. Mapping of current obstacles for rationalizing use of medicines (CORUM) in Europe: current situation and potential solutions. Frontiers in pharmacology . 2020;11(144) doi: 10.3389/fphar.2020.00144. PubMed DOI PMC
NHS Scotland. Quality Prescribing for Diabetes - A Guide for Improvement 2018 - 2021 . 2018. https://www.therapeutics.scot.nhs.uk/wp-content/uploads/2018/03/Strategy-Diabetes-Quality-Prescribing-for-Diabetes-2018.pdf .
Leporowski A., Godman B., Kurdi A., et al. Ongoing activities to optimize the quality and efficiency of lipid-lowering agents in the Scottish national health service: influence and implications. Expert review of pharmacoeconomics & outcomes research. . 2018;18(6):655–666. doi: 10.1080/14737167.2018.1501558. PubMed DOI
Godman B., Persson M., Miranda J., et al. Changes in the utilization of venlafaxine after the introduction of generics in Sweden. Applied health economics and health policy. . 2013;11(4):383–393. doi: 10.1007/s40258-013-0037-x. PubMed DOI
Godman B., Wettermark B., Miranda J., Bennie M., Martin A., Malmstrom R. E. Influence of multiple initiatives in Sweden to enhance ARB prescribing efficiency following generic losartan; findings and implications for other countries. International journal of clinical practice. . 2013;67(9):853–862. doi: 10.1111/ijcp.12130. PubMed DOI
Garuoliene K., Godman B., Gulbinovic J., Wettermark B., Haycox A. European countries with small populations can obtain low prices for drugs: Lithuania as a case history. Expert review of pharmacoeconomics & outcomes research. . 2011;11(3):343–349. doi: 10.1586/erp.11.24. PubMed DOI
Godman B., Wettermark B., van Woerkom M., et al. Multiple policies to enhance prescribing efficiency for established medicines in Europe with a particular focus on demand-side measures: findings and future implications. Frontiers in pharmacology. . 2014;5 doi: 10.3389/fphar.2014.00106. PubMed DOI PMC
Marković-Peković V., Škrbić R., Petrović A., et al. Polypharmacy among the elderly in the Republic of Srpska: extent and implications for the future. Expert review of pharmacoeconomics & outcomes research. . 2016;16(5):609–618. doi: 10.1586/14737167.2016.1115347. PubMed DOI
IQVIA. The Impact of Biosimilar Competition in Europe . 2019. https://ec.europa.eu/docsroom/documents/38461 .
Harsanyi A., Csanadi M., Marky K., Vincziczki A. Z., Kalo Z., Inotai A. Influence of biosimilar infliximab launch on the utilization pattern of biological medicines: the case of Hungary. Expert review of pharmacoeconomics & outcomes research. . 2020;20(6):653–659. PubMed
Kawalec P., Stawowczyk E., Tesar T., et al. Pricing and Reimbursement of Biosimilars in Central and Eastern European Countries. Frontiers in pharmacology. . 2017;8:p. 288. doi: 10.3389/fphar.2017.00288. PubMed DOI PMC
Bertolani A., Jommi C. Local policies on biosimilars: are they designed to optimize use of liberated resources? Generics and Biosimilars Journal (GaBI). . 2020;9(4):163–170. doi: 10.5639/gabij.2020.0904.027. DOI
Godman B., Allocati E., Moorkens E., Kwon H.-Y. Can local policies on biosimilars optimize the use of freed resources – experiences from Italy. Generics and Biosimilars Initiative Journal (GABI). . 2020;9(4):183–187. doi: 10.5639/gabij.2020.0904.029. DOI
Ferner R. E., Lenney W., Marriott J. F. Controversy over generic substitution. BMJ . 2010;340(jun01 1):p. c2548. doi: 10.1136/bmj.c2548. PubMed DOI
IQVIA. Country Scorecards for Biosimilar Sustainability . 2020. https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/country-scorecards-for-biosimilar-sustainability/iqvia-institute-scorecards-appendix-orb2520.pdf?la=en .
Singh V. Top biosimilar companies with approved and pipeline products in the US and EU . 2019. https://pharmashots.com/24011/top-biosimilar-companies-with-approved-and-pipeline-products-in-the-us-and-eu/
Schreiber S. A., Russmann A. Long-term efficacy of insulin glargine therapy with an educational programme in type 1 diabetes patients in clinical practice. Current medical research and opinion. . 2007;23(12):3131–3136. doi: 10.1185/030079907X242827. PubMed DOI
Woerkom M., Piepenbrink H., Godman B., et al. Ongoing measures to enhance the efficiency of prescribing of proton pump inhibitors and statins in The Netherlands: influence and future implications. Journal of comparative effectiveness research. . 2012;1(6):527–538. doi: 10.2217/cer.12.52. PubMed DOI
Dylst P., Simoens S. Does the market share of generic medicines influence the price level?: a European analysis. PharmacoEconomics . 2011;29(10):875–882. doi: 10.2165/11585970-000000000-00000. PubMed DOI
Hesse U., Godman B., Petzold M., Martin A., Malmstrom R. E. Impact of delisting ARBs, apart from losartan, on ARB utilisation patterns in Denmark: implications for other countries. Applied health economics and health policy. . 2013;11(6):677–685. doi: 10.1007/s40258-013-0059-4. PubMed DOI
Fürst J., Čižman M., Mrak J., et al. The influence of a sustained multifaceted approach to improve antibiotic prescribing in Slovenia during the past decade: findings and implications. Expert review of anti-infective therapy. . 2015;13(2):279–289. doi: 10.1586/14787210.2015.990381. PubMed DOI
Godman B., Sakshaug S., Berg C., Wettermark B., Haycox A. Combination of prescribing restrictions and policies to engineer low prices to reduce reimbursement costs. Expert review of pharmacoeconomics & outcomes research. . 2011;11(1):121–129. doi: 10.1586/erp.10.87. PubMed DOI
Wettermark B., Godman B., Neovius M., Hedberg N., Mellgren T. O., Kahan T. Initial effects of a reimbursement restriction to improve the cost- effectiveness of antihypertensive treatment. Health Policy . 2010;94(3):221–229. doi: 10.1016/j.healthpol.2009.09.014. PubMed DOI
Eatwell E., Swierczyna A. Emerging voluntary cooperation between European healthcare systems: are we facing a new future? Medicine Access@Point of Care . 2019;3:p. 239920261985231. doi: 10.1177/2399202619852317. DOI
O’Mahony J. F. Beneluxa: what are the prospects for collective bargaining on pharmaceutical prices given diverse health technology assessment processes? PharmacoEconomics . 2019;37(5):627–630. doi: 10.1007/s40273-019-00781-w. PubMed DOI
WHO. WHO Guideline on Country Pharmaceutical Pricing Policies . second. Geneva: World Health Organization; 2020. https://apps.who.int/iris/bitstream/handle/10665/335692/9789240011878-eng.pdf . PubMed
Singh S. Biocon’s Malaysia insulin glargine manufacturing facility receives EU GMP certification . 2019. https://indiamedtoday.com/biocons-malaysia-insulin-glargine-manufacturing-facility-receives-eu-gmp-certification/
Opanga S., Njeri L. W., Kimonge D., Godman B., Oluka M. Assessing utilisation and expenditure on long-acting insulin analogues in Kenya; findings and implications for the future. Scholars Academic Journal of Pharmacy . 2021;10(4):63–70.
Department of Health Republic of South Africa. National Essential Medicines List Committee (NEMLC) - Tertiary and Quaternary Level Essential Medicines List Reviewed Items . 2021. https://www.knowledgehub.org.za/system/files/elibdownloads/2021-04/Tertiary%20and%20Quaternary%20Level%20Essential%20Medicine%20Recommendations_April%202021.pdf .
Beran D., Ewen M., Lipska K., Hirsch I. B., Yudkin J. S. Availability and affordability of essential medicines: implications for global diabetes treatment. Current diabetes reports. . 2018;18(8) doi: 10.1007/s11892-018-1019-z. PubMed DOI
Godman B., Fadare J., Kwon H. Y., et al. Evidence-based public policy making for medicines across countries: findings and implications for the future. Journal of comparative effectiveness research. . 2021;10(12):1019–1052. doi: 10.2217/cer-2020-0273. PubMed DOI