Cost-minimization analysis of teledermatology versus conventional care in the Brazilian National Health System.

Aims: Cost-minimization analysis (CMA) comparing the teledermatology service of the State of Santa Catarina, Brazil with the provision of conventional care, from the societal perspective. Patients & methods: All costs related to direct patient care were considered in calculation of outpatient costs. The evaluation was performed using the parameters avoided referrals and profile of hospitalizations. The economic analysis was developed through a decision tree. Results: Totally, 40% of 79,411 tests performed could be managed in primary care, avoiding commuting and expanding the patients' access. The CMA showed the teledermatology service had a cost per patient of US$196.04, and the conventional care of US$245.66. Conclusion: In this scenario, teledermatology proved to be a cost-saving alternative to conventional care, reducing commuting costs.

Lay abstract Diagnosis and treatment of skin diseases through teledermatology avoid patient referrals, improves accessibility to specialized care, as well as the skin care provided by physicians. This study compared the costs of the teledermatology service of the State of Santa Catarina, Brazil with the costs of the provision of conventional care, to check which of them was more efficient. All costs related to direct patient care were considered in the calculation of costs. Totally, 40% of 79,411 dermatological tests performed could be locally managed in primary care, avoiding commuting, and expanding the patients' access to care. The teledermatology service had a cost per patient of US$196.04, compared with the cost of conventional care of US$245.66. In this evaluation, teledermatology proved to be cheaper than conventional care, reducing commuting costs.

Integrative Review of Managed Entry Agreements: Chances and Limitations.

BACKGROUND AND OBJECTIVE: Managed entry agreements (MEAs) consist of a set of instruments to reduce the uncertainty and the budget impact of new high-priced medicines; however, there are concerns. There is a need to critically appraise MEAs with their planned introduction in Brazil. Accordingly, the objective of this article is to identify and appraise key attributes and concerns with MEAs among payers and their advisers, with the findings providing critical considerations for Brazil and other high- and middle-income countries. METHODS: An integrative review approach was adopted. This involved a review of MEAs across countries. The review question was 'What are the health technology MEAs that have been applied around the world?' This review was supplemented with studies not retrieved in the search known to the senior-level co-authors including key South American markets. It also involved senior-level decision makers and advisers providing guidance on the potential advantages and disadvantages of MEAs and ways forward. RESULTS: Twenty-five studies were included in the review. Most MEAs included medicines (96.8%), focused on financial arrangements (43%) and included mostly antineoplastic medicines. Most countries kept key information confidential including discounts or had not published such data. Few details were found in the literature regarding South America. Our findings and inputs resulted in both advantages including reimbursement and disadvantages including concerns with data collection for outcome-based schemes. CONCLUSIONS: We are likely to see a growth in MEAs with the continual launch of new high-priced and often complex treatments, coupled with increasing demands on resources. Whilst outcome-based MEAs could be an important tool to improve access to new innovative medicines, there are critical issues to address. Comparing knowledge, experiences, and practices across countries is crucial to guide high- and middle-income countries when designing their future MEAs.

Funding and Service Organization to Achieve Universal Health Coverage for Medicines: An Economic Evaluation of the Best Investment and Service Organization for the Brazilian Scenario.

BACKGROUND: There are many health benefits since 31 years after the foundation of the National Health Service (NHS) in Brazil, especially the increase in life expectancy. However, family-income inequalities, insufficient funding, and suboptimal private sector-public sector collaboration are still areas for improvement. The efforts of Brazil to achieve universal health coverage (UHC) for medicines have resulted in increased public financing of medicines and their availability, reducing avoidable hospitalization and mortality. However, lack of access to medicines still remains. Due to historical reasons, pharmaceutical service organization in developing countries may have important differences from high-income countries. In some cases, developing countries finance and promote medicine access by using the public infrastructure of health care/medical units as dispensing sites and cover all costs of medicines dispensed. In contrast, many high-income countries use private community pharmacies and cover the costs of medicines dispensed plus a fee, which includes all logistic costs. In this study, we will undertake an economic evaluation to understand the funding needs of the Brazilian NHS to reduce inequalities in access to medicines through adopting a pharmaceutical service organization similar to that seen in many high-income countries with hiring/accrediting private pharmacies. METHODS: We performed an economic evaluation of a model to provide access to medicines within public funds based on a decision tree model with two alternative scenarios public pharmacies (NHS, state-owned facilities) versus private pharmacies (NHS, agreements). The analysis assumed the perspective of the NHS. We identified the types of resources consumed, the amount, and costs in both scenarios. We also performed a budget impact forecast to estimate the incremental funding required to reduce inequalities in access to essential medicines in Brazil. FINDINGS: The model without rebates for medicines estimated an incremental cost of US$3.1 billion in purchasing power parity (PPP) but with an increase in the average availability of medicines from 65% to 90% for citizens across the country irrespective of family income. This amount places the NHS in a very good position to negotiate extensive rebates without the need for external reference pricing for government purchases. Forecast scenarios above 35% rebates place the alternative of hiring private pharmacies as dominant. Higher rebate rates are feasible and may lead to savings of more than US$1.3 billion per year (30%). The impact of incremental funding is related to medicine access improvement of 25% in the second year when paying by dispensing fee. The estimate of the incremental budget in five years would be US$4.8 billion PPP. We have yet to explore the potential reduction in hospital and outpatient costs, as well as in lawsuits, with increased availability with the yearly expenses for these at US$9 billion and US$1.4 billion PPP respectively in 2017. INTERPRETATION: The results of the economic evaluation demonstrate potential savings for the NHS and society. Achieving UHC for medicines reduces household expenses with health costs, health litigation, outpatient care, hospitalization, and mortality. An optimal private sector-public sector collaboration model with private community pharmacy accreditation is economically dominant with a feasible medicine price negotiation. The results show the potential to improve access to medicines by 25% for all income classes. This is most beneficial to the poorest families, whose medicines account for 76% of their total health expenses, with potential savings of lives and public resources.

Confidentiality agreements: a challenge in market regulation.

BACKGROUND: Sustainability and the ability to maintain the right to health, with the guarantee of access to quality medicines and health services, have been a great challenge for countries with universal health systems. The great technological advances bring with it an expressive increase in the expenditures of the health systems, especially those directed towards the acquisition of high-cost drugs, which are still under patent protection, have a high cost and, in some cases, present uncertainties about their effectiveness and safety. As a way of maintaining the proper functioning of the systems and guaranteeing access to these medicines, some countries started to negotiate discounts with manufacturing companies. Pricing agreements have been adopted by developed countries with the objective of reducing their spending on high-cost medicines and, although they represent an opportunity for better negotiation with the industries, they violate the principle of transparency that regulates the world market. However, the existence of confidentiality agreements has meant that the declared prices are not the actual prices, unfairly harming the countries that use these price lists as beacons in their systems. METHODS: Representatives of health, judicial, legislative, patient organizations and academics from eight countries in Latin America and South Korea participated in a meeting in September 2017 in Chile to discuss price confidentiality agreements and the impact on public health policies. During the meeting, participants were presented with a hypothetical case to subsidize the discussion on the topic. Divided into groups, participants should propose recommendations for the problem by pointing out the pros and cons if each proposed recommendation was adopted. The groups were then confronted by a simulated jury and finally issued a single and final recommendation for the problem. RESULTS: The topic was widely discussed and recommendations were raised by the participants. Among them, it is worth noting the elaboration of norms that regulate the negotiations of prices between the countries bringing transparency and harmony in the adopted conducts. In addition, the possible consequences and potential impacts of confidentiality on drug prices and inputs, such as information asymmetry and inequity of access between countries, were pointed out. CONCLUSION: Despite there are efforts to make price negotiations more transparent, there is still no well-established standardization that promotes a well-functioning market. Confidentiality agreements hamper the fairness of access to essential health products.

Who should pay for the continuity of post-trial health care treatments?

BACKGROUND: The bioethical debate in the world on who should pay for the continuity of post-trials treatment of patients that have medical indication remains obscure and introduces uncertainties to the patients involved in the trials. The continuity of post-trial treatment was only incorporated in the 2000s by the Helsinki Declaration. The Universal Declaration on Bioethics and Human Rights, published in 2006, points out that post-trial continuity may present a broader scope than just the availability of the investigated medicine. In the latest version of this Declaration, in 2013, it was stated that "prior to the start of the clinical trial, funders, researchers and governments of the countries participating in the research should provide post-trial access for all participants who still require an intervention that was identified as beneficial. This information should also be disclosed to participants during the informed consent process". However, a systematic review on the registration of phase III and IV clinical trials, from the clinical trials website, demonstrated that the understanding of the various guidelines and resolutions is conflicting, generating edges in the post-trial setting. For the health authorities of countries where clinical trials take place, the uncertainties about the continuity of the treatments generate gaps in care and legal proceedings against health systems, which are forced to pay for the treatments, even if they are not included in the list of medicines available to the population. METHODS: Fifty-one representatives from the health, judicial, legislative, patient and academic organizations of eight countries of Latin American and South Korea took part in a meeting in Chile, in 2017, to discuss the responsibility of the treatment continuation after clinical trials. From a hypothetical case of development of a new drug and its studies of efficacy and safety, the participants, divided in groups, proposed recommendations for the problem and pointed out the pros and cons of adopting each recommendation. The groups were, afterwards, confronted by a simulated jury and, finally, issued a final recommendation for the problem. Then, an analysis was made on the content of the recommendations and the pros and cons in adopting conservative or liberal positions, besides the possible impacts of a restrictive regulation regarding the conduction of clinical trials, pointed out by the groups, before and after the simulated jury. RESULTS: The theme was widely discussed and about 12 recommendations were proposed by the participants. The main ones took into account aspects related to patients' rights, economic factors and the development of new technologies, above the position of industry and research institutes, as well as the legislation in force in each country. CONCLUSION: The countries of Latin America and South Korea, currently, do not have laws that address patients' rights, moreover, there is no definition on who should be responsible for post-trial treatments. It is suggested that the World Health Organization issue a resolution recommending that all associated countries determine that the pharmaceutical and medical device industries, or those that sponsored it, should continue to provide treatment to all patients who participated in clinical trials and have medical indication to the continuity.

Consumer willingness to pay for a hypothetical Zika vaccine in Brazil and the implications.

ABSTRACT  Background: Zika virus is a newly emerging infection, associated with increasingly large outbreaks especially in tropical countries such as Brazil. A future Zika vaccine can contribute to decreasing the number of cases and associated complications. Information about consumers' willingness to pay (WTP) for a hypothetical Zika vaccine can help price setting discussions in the future in Brazil, starting with the private market. METHODS: A cross-sectional study conducted among residents of Minas Gerais, Brazil, regarding their WTP for a hypothetical Zika Vaccine. The mean effective protection was 80%, with the possibility of some local and systemic side- effects. RESULTS: 517 people were interviewed. However, 28 would not be vaccinated even if the vaccine was free. Most of the resultant interviewees (489) were female (58.2%), had completed high school (49.7%), were employed (71.2%), had private health insurance (52.7%), and did not have Zika (96.9%). The median individual maximum WTP for this hypothetical Zika vaccine (one dose) was US$31.34 (BRL100.00). CONCLUSION: Such discussions regarding WTP can contribute to decision-making about prices once a Zika vaccine becomes available in Brazil alongside other ongoing programs to control the virus.

Infrastructure evaluation of Pharmaceutical Services in the National Health System of Minas Gerais. / Avaliação da infraestrutura da Assistência Farmacêutica no Sistema Único de Saúde em Minas Gerais.

OBJECTIVES: To characterize the infrastructure of public pharmacies in Minas Gerais, comparing municipalities that have received the RFM program to the ones that haven't, in order to verify if the State's Economic Incentives implied in improvement of local Pharmaceutical Services (PS). METHODS: A cross-sectional, exploratory, evaluative study in a representative sample of the municipalities of Minas Gerais. Face-to-face interviews were conducted with users, physicians, and drug dispensers, as well as observation of pharmacy facilities and telephone interviews with municipal officials from the PS. 104 municipalities were selected, of which 41.3% had adopted the RFM. Data were collected from July 2014 to May 2015. RESULTS: Municipalities adept to the RFM presented significantly higher rates of legal documentation, more comfort for users and staff, better storage conditions of medicine and competence to conduct clinical activities. CONCLUSION: The higher state investment in the PS organization for municipalities adept to the RFM developed better infrastructure that have been approved by health professionals and the users of the National Health System.

Avaliação da infraestrutura da Assistência Farmacêutica no Sistema Único de Saúde em Minas Gerais / Infrastructure evaluation of Pharmaceutical Services in the National Health System of Minas Gerais

Resumo Em 2008, o estado de Minas Gerais criou o Programa Rede Farmácia de Minas (RFM), uma estratégia para garantir infraestrutura adequada das farmácias. O objetivo deste artigo é caracterizar a infraestrutura da Assistência Farmacêutica (AF) de Minas Gerais, comparando municípios contemplados ou não pela RFM, no intuito de verificar se os gastos estaduais implicaram em melhoria das AF municipais. Estudo transversal de avaliação da AF de Minas Gerais. Foram realizadas entrevistas presenciais e telefônicas com usuários, médicos, responsáveis pela AF e dispensadores de medicamentos, além de observação das instalações. Foram selecionados 104 municípios, dos quais 41,3% haviam adotado a RFM. Os dados foram coletados de julho de 2014 a maio de 2015. Municípios com RFM apresentaram taxas significativamente maiores de regularização da documentação legal, maior conforto para os usuários e funcionários, melhores condições de armazenamento de medicamento e realização de atividades clínicas. O maior volume de investimentos estadual na AF dos municípios com RFM gerou melhores condições de infraestrutura que foram avaliadas positivamente tanto por profissionais de saúde como pelos usuários do SUS.

Abstract In 2008 the state of Minas Gerais created the "Program Rede Farmácia de Minas" (RFM), a strategy to ensure adequate infrastructure of local public pharmacies, in order to improve the quality of medications use. Objectives To characterize the infrastructure of public pharmacies in Minas Gerais, comparing municipalities that have received the RFM program to the ones that haven't, in order to verify if the State's Economic Incentives implied in improvement of local Pharmaceutical Services (PS). Methods A cross-sectional, exploratory, evaluative study in a representative sample of the municipalities of Minas Gerais. Face-to-face interviews were conducted with users, physicians, and drug dispensers, as well as observation of pharmacy facilities and telephone interviews with municipal officials from the PS. 104 municipalities were selected, of which 41.3% had adopted the RFM. Data were collected from July 2014 to May 2015. Results Municipalities adept to the RFM presented significantly higher rates of legal documentation, more comfort for users and staff, better storage conditions of medicine and competence to conduct clinical activities. Conclusion The higher state investment in the PS organization for municipalities adept to the RFM developed better infrastructure that have been approved by health professionals and the users of the National Health System.

Economic evaluation of the Programs Rede Farmácia de Minas do SUS versus Farmácia Popular do Brasil. / Avaliação econômica dos Programas Rede Farmácia de Minas do SUS versus Farmácia Popular do Brasil.

We conducted an economic assessment of the Pharmaceutical Assistance - Rede Farmácia de Minas Gerais-RFMG and Farmácia Popular do Brasil-FPB to ascertain which of the two models stands out as the most efficient. To do this, a model, which consisted of a study of incurred costs in both programs, up to the dispensing of medicine to citizens, was developed. The uncertainties of the proposed model were tested using the Monte Carlo method. If the entire population initially estimated in the RFMG were attended in the FPB, there would be an additional cost of R$ 139,324,050.19. The sensitivity analysis appeared to be favorable to the RFMG. A total of 10000 simulations were carried out, resulting in a median value of R$ 114,053,709.99 for the RFMG and R$ 254,106,120.65 for the FPB. The current National Drug Policy emphasizes the need to strengthen pharmaceutical services beyond the mere acquisition and delivery of pharmaceutical products. The public healthcare service model, consistent with the principles and guidelines of the SUS, seems to be more appropriate in ensuring complete and universal quality healthcare services to the citizens. The economic study conducted reinforces this fact, as it appears to be a more efficient alternative of the direct use of resources in the public health network.

Avaliação econômica dos Programas Rede Farmácia de Minas do SUS versus Farmácia Popular do Brasil / Economic evaluation of the Programs Rede Farmácia de Minas do SUS versus Farmácia Popular do Brasil

Resumo A fim de esclarecer qual programa de assistência farmacêutica, Rede Farmácia de Minas Gerais RFMG ou Farmácia Popular do Brasil FPB, se apresenta como o mais eficiente sob a perspectiva do financiador público foi realizada uma avaliação econômica. O modelo desenvolvido consiste em um levantamento dos custos incorridos até a dispensação de medicamentos. A análise de Monte Carlo foi utilizada para estimar valores a partir das incertezas. Considerando que a população inicialmente estimada no RFMG fosse atendida em sua totalidade no PFPB, haveria um custo incremental de R$ 139.324.050,19. A análise de Monte Carlo mostrou-se favorável ao RFMG. Foram realizadas 10 mil simulações resultando no valor médio de R$ 114.053.709,99 para RFMG e de R$ 254.106.120,65 para o FPB. O Brasil apresenta uma formulação avançada de políticas públicas na saúde. A Política Nacional de Medicamentos enfatiza a necessidade de fortalecimento da assistência farmacêutica para além da mera aquisição. O modelo público, coerente com princípios e diretrizes do SUS, apresenta-se com condições mais adequadas para garantir assistência integral e universal de qualidade. A avaliação econômica reforça essa afirmativa, pois encontrou maior eficiência na alternativa de aplicação dos recursos diretamente na rede pública.

Abstract We conducted an economic assessment of the Pharmaceutical Assistance - Rede Farmácia de Minas Gerais-RFMG and Farmácia Popular do Brasil-FPB to ascertain which of the two models stands out as the most efficient. To do this, a model, which consisted of a study of incurred costs in both programs, up to the dispensing of medicine to citizens, was developed. The uncertainties of the proposed model were tested using the Monte Carlo method. If the entire population initially estimated in the RFMG were attended in the FPB, there would be an additional cost of R$ 139,324,050.19. The sensitivity analysis appeared to be favorable to the RFMG. A total of 10000 simulations were carried out, resulting in a median value of R$ 114,053,709.99 for the RFMG and R$ 254,106,120.65 for the FPB. The current National Drug Policy emphasizes the need to strengthen pharmaceutical services beyond the mere acquisition and delivery of pharmaceutical products. The public healthcare service model, consistent with the principles and guidelines of the SUS, seems to be more appropriate in ensuring complete and universal quality healthcare services to the citizens. The economic study conducted reinforces this fact, as it appears to be a more efficient alternative of the direct use of resources in the public health network.