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BACKGROUND: Biosimilar medicines are defined as biological products highly similar to an already licensed biological product (RP). The market entry of biosimilars is expected to reduce the costs of biological treatments. OBJECTIVE: This study aims to evaluate the range of differences between the prices of biosimilars and the corresponding RP for biologicals approved in four countries. METHOD: This is a cross-national comparison of pricing of biosimilars in Argentina, Australia, Brazil, and Italy. The study examined online price databases provided by the national authorities of the investigated countries. Biosimilar price difference was calculated by subtracting the unit price of the biosimilar by the unit price of the RP, and then dividing it by the unit price of the RP. The results were presented as percentage. RESULTS: Brazil had the highest median price reduction (- 36.3%) in biosimilars price, followed by Italy (- 20.0%) and Argentina (- 18.6%). All the biosimilars in Italy were priced below the RP presenting a minimum reduction of 6.3%, while in Australia, most of the prices of biosimilars were equal to the RP. In Argentina, one infliximab-biosimilar displayed price above the RP (40.7%) while the lower priced brand had a reduction of 14.4%. Brazil had four biosimilars with prices above the respective RP, including isophane insulin (1), insulin glargine (1) and somatropin (2). CONCLUSION: The study revealed a marked dispersion in the price's differences between biosimilars and RP across the studied countries. Governments should evaluate whether their policies have been successful in improving affordability of biological therapies.
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Medicamentos Biossimilares , Medicamentos Biossimilares/economia , Itália , Argentina , Brasil , Austrália , Humanos , Custos de Medicamentos , Custos e Análise de CustoRESUMO
This study is aimed at describing tofacitinib and baricitinib users by characterizing their prescription and healthcare histories, drug and healthcare utilization patterns, and direct costs from a healthcare system perspective. This retrospective cohort study was performed using Tuscan administrative healthcare databases, which selected two groups of Janus kinase inhibitors (JAKi) incident users (index date) from 1st January 2018 to 31 December 2019 and from 1 January 2018 to 30 June 2019. We included patients ≥18 years old, at least 10 years of data, and six months of follow-up. In the first analysis, we describe mean time, standard deviation (SD), from the first-ever disease-modifying antirheumatic drug (DMARD) to the JAKi, and costs of healthcare facilities and drugs in the 5 years preceding the index date. In the second analysis, we assessed Emergency Department (ED) accesses and hospitalizations for any causes, visits, and costs in the follow-up. In the first analysis, 363 incident JAKi users were included (mean age 61.5, SD 13.6; females 80.7%, baricitinib 78.5%, tofacitinib 21.5%). The time to the first JAKi was 7.2 years (SD 3.3). The mean costs from the fifth to the second year before JAKi increased from 4325 (0; 24,265) to 5259 (0; 41,630) per patient/year, driven by hospitalizations. We included 221 incident JAKi users in the second analysis. We observed 109 ED accesses, 39 hospitalizations, and 64 visits. Injury and poisoning (18.3%) and skin (13.8%) caused ED accesses, and cardiovascular (69.2%) and musculoskeletal (64.1%) caused hospitalizations. The mean costs were 4819 (607.5; 50,493) per patient, mostly due to JAKi. In conclusion, the JAKi introduction in therapy occurred in compliance with RA guidelines and the increase in costs observed could be due to a possible selective prescription.
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The coronavirus disease 2019 (COVID-19) pandemic that hit the world in 2020 triggered a massive dissemination of information (an "infodemic") about the disease that was channeled through the print, broadcast, web, and social media. This infodemic also included sensational and distorted information about drugs that likely first influenced opinion leaders and people particularly active on social media and then other people, thus affecting choices by individual patients everywhere. In particular, information has spread about some drugs approved for other indications (chloroquine, hydroxychloroquine, nonsteroidal anti-inflammatory drugs, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, favipiravir, and umifenovir) that could have led to inappropriate and therefore hazardous use. In this article, we analyze the rationale behind the claims for use of these drugs in COVID-19, the communication about their effects on the disease, the consequences of this communication on people's behavior, and the responses of some influential regulatory authorities in an attempt to minimize the actual or potential risks arising from this behavior. Finally, we discuss the role of pharmacovigilance stakeholders in emergency management and possible strategies to deal with other similar crises in the future.
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Infecções por Coronavirus , Uso de Medicamentos/tendências , Disseminação de Informação , Pandemias , Pneumonia Viral , Saúde Pública , Atitude Frente a Saúde , Betacoronavirus , COVID-19 , Infecções por Coronavirus/classificação , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/psicologia , Humanos , Disseminação de Informação/ética , Disseminação de Informação/métodos , Conduta do Tratamento Medicamentoso/ética , Conduta do Tratamento Medicamentoso/normas , Farmacovigilância , Pneumonia Viral/tratamento farmacológico , Pneumonia Viral/epidemiologia , Pneumonia Viral/psicologia , Saúde Pública/métodos , Saúde Pública/normas , SARS-CoV-2 , Mídias Sociais/ética , Mídias Sociais/normas , Medicina Social/ética , Medicina Social/normas , Tratamento Farmacológico da COVID-19RESUMO
INTRODUCTION: Adverse drug events (ADEs) may represent an important item of expenditure for healthcare systems and their prevention could be associated with a relevant cost saving. OBJECTIVE: The objective of this study was to simulate the annual economic burden for ADEs in Tuscany (Italy) and the potential cost savings related to avoidable ADEs. METHODS: A systematic review was performed, according to the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) and Meta-analysis Of Observational Studies in Epidemiology (MOOSE) statements, on observational studies published from 2006 to 2016 in MEDLINE and EMBASE, focusing on direct costs of ADEs in the inpatient setting from high-income countries. The mean probability of preventable ADEs was estimated over the included studies. The mean ADE cost was calculated by means of Monte Carlo simulation. We then extrapolated the spontaneous reports of ADEs in Tuscany, Italy in 2016 from the Italian National Pharmacovigilance Network (Rete Nazionale di Farmacovigilanza), and we assumed the same costs and preventability probability for these as obtained in the systematic review. Finally, we simulated the possible costs of ADEs and preventable ADEs in Tuscany. Three sensitivity analyses were also performed to test the robustness of the results. RESULTS: Of 11,936 articles initially selected, 12 observational studies were included. The estimated mean [± standard deviation (SD)] ADE cost was 2471.46 (± 1214.13). The mean (± SD) probability of preventable ADEs was 45% (± 21). The Tuscan expenditure for ADEs was 3,406,280.63 per million inhabitants (95% confidence interval (CI) 1,732,910.44-5,079,664.61) and the potential cost saving was 1,532,760.25 per million inhabitants (95% CI 779,776.1-2,285,750.60). Sensitivity analyses confirmed the robustness of the results. CONCLUSIONS: The present simulation showed that ADEs could have a relevant economic impact on the Tuscan healthcare system. In this setting, the prevention of ADEs would result in important cost savings. These results could be likely extended to other healthcare systems.
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Redução de Custos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/economia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Gastos em Saúde , Modelos Econômicos , Humanos , Itália , Método de Monte Carlo , Farmacovigilância , ProbabilidadeRESUMO
Statins, or 3-hydroxy-3-methyl-glutaryl coenzyme A reductase inhibitors, such as lovastatin, atorvastatin, simvastatin, pravastatin, fluvastatin, rosuvastatin and pitavastatin, are cholesterol-lowering drugs used in clinical practice to prevent coronary heart disease. These drugs are generally well tolerated and have been rarely associated with severe adverse effects (e.g. rhabdomyolysis). Over the years, case series and data from national registries of spontaneous adverse drug reaction reports have demonstrated the occurrence of neuropsychiatric reactions associated with statin treatment. They include behavioural alterations (severe irritability, homicidal impulses, threats to others, road rage, depression and violence, paranoia, alienation, antisocial behaviour); cognitive and memory impairments; sleep disturbance (frequent awakenings, shorter sleep duration, early morning awakenings, nightmares, sleepwalking, night terrors); and sexual dysfunction (impotence and decreased libido). Studies designed to investigate specific neuropsychiatric endpoints have yielded conflicting results. Several mechanisms, mainly related to inhibition of cholesterol biosynthesis, have been proposed to explain the detrimental effects of statins on the central nervous system. Approaches to prevent and manage such adverse effects may include drug discontinuation and introduction of dietary restrictions; maintenance of statin treatment for some weeks with close patient monitoring; switching to a different statin; dose reduction; use of ω-3 fatty acids or coenzyme Q10 supplements; and treatment with psychotropic drugs. The available information suggests that neuropsychiatric effects associated with statins are rare events that likely occur in sensitive patients. Additional data are required, and further clinical studies are needed.