Cost-effectiveness of atezolizumab plus chemotherapy for advanced/recurrent endometrial cancer.

OBJECTIVE: This study assessed the cost-effectiveness of atezolizumab in combination with chemotherapy for patients with advanced or recurrent endometrial cancer (EC) from the U.S. payer's perspective. METHODS: A cost-effectiveness study was conducted using a Markov model based on ENGOT-en7/MaNGO/AtTEnd clinical trials. The population consisted of patients with EC, stratified by mismatch repair-deficient (dMMR) and mismatch repair-proficient (pMMR) subgroups. The model simulated patients receiving either atezolizumab plus chemotherapy or chemotherapy alone. Cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER) were calculated using a Willingness-to-Pay (WTP) threshold of $150,000/QALY. Sensitivity analyses were performed. RESULTS: Adding atezolizumab to chemotherapy in dMMR EC resulted in an incremental gain of 3.31 QALYs but at an additional cost of $855,042, leading to an ICER of $258,391.07/QALY compared to chemotherapy alone. In pMMR EC, there was a gain of 0.50 QALYs with an additional cost of $140,502, resulting in an ICER of $279,239.72/QALY. The overall ICER for EC was $216,459.34/QALY. Scenario analysis indicated that administering atezolizumab for a maximum of 2 years improved cost-effectiveness in dMMR EC, with an ICER of $70,695.96/QALY falling within the predetermined WTP threshold. CONCLUSION: For patients with advanced or recurrent EC, the combination of atezolizumab and chemotherapy may not prove cost-effective. However, administering atezolizumab for a limited period of maximum 2 years could improve cost-effectiveness in dMMR EC.

Cost-effectiveness of pembrolizumab plus chemotherapy for advanced endometrial cancer.

OBJECTIVE: To assess the cost-effectiveness of pembrolizumab in combination with chemotherapy compared to chemotherapy alone, based on the results of the NRG-GY018 trial, in patients with advanced or recurrent endometrial cancer (EC), stratified by mismatch repair-deficient (dMMR) and mismatch repair-proficient (pMMR) subgroups. METHODS: A Markov model was used to simulate patients receiving either pembrolizumab plus chemotherapy or chemotherapy alone. Lifetime costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER) were calculated using a willingness-to-pay (WTP) threshold of $150,000/QALY. Univariate and probabilistic sensitivity analyses were conducted to assess the robustness of our findings. RESULTS: The addition of pembrolizumab to chemotherapy led to an incremental gain of 4.05 QALYs at an additional cost of $167,224, resulting in an ICER of $41,305.09/QALY compared to chemotherapy alone in dMMR EC. Additionally, there were 0.93 additional QALYs at an additional cost of $83,661, which resulted in an ICER of $90,284.80/QALY in pMMR EC. Sensitivity analyses indicated that the cost of pembrolizumab, utility of progressed disease, and utility of progression-free survival had the greatest impact on the results. Probabilistic sensitivity analysis showed that pembrolizumab was considered cost-effective at a 100% probability at a WTP threshold of $150,000 per QALY. CONCLUSION: Pembrolizumab, when combined with chemotherapy, was found to be cost-effective compared to chemotherapy alone both for patients with advanced or recurrent dMMR and pMMR EC from the perspective of a payer in the United States.

Economic impact of a clinical pharmacist in the orthopaedic sector: a review of the literature.

OBJECTIVES: This review of the literature aimed to evaluate the economic impact of a clinical pharmacist in the orthopaedic sector. METHODS: The review followed the PRISMA recommendations. A bibliographic search was conducted on 23 June 2023 using PubMed, Cochrane Library and Web of Science. All articles in French or English with economic data on clinical pharmacy activities in orthopaedics were included. Articles not mentioning the term 'orthopaedics' and those published prior to 1990 were excluded. Data from the studies were compiled in an Excel table. A bias analysis using the ROBINS-I Cochrane tool was performed. The methodology of the studies was compared and weighted using the CHEERS and STROBE checklists. RESULTS: Among 529 articles initially identified, 10 were included in the review. The cost-benefit ratio of a clinical pharmacist in orthopaedics ranged from 0.47:1 to 28:1. The maximum savings reached US$73 410 /year in the American study and €1 42 356 /year in the French study. For three studies, the cost of a clinical pharmacist was not evaluated. Eight studies showed a positive economic impact. The Dutch study showed a balance and the Danish study showed a negative economic impact of €3442/month. CONCLUSIONS: This literature review has shown an economic benefit of a clinical pharmacist in the orthopaedic sector despite several biases and methodological limitations. The two studies that did not confirm this benefit only evaluated a limited number of expected benefits. Nevertheless, the economic impact of the clinical pharmacist in the orthopaedic sector seems positive and undervalued.

Development of hospital pharmacy services at transition of care points: a scoping review.

BACKGROUND: Several hospital pharmacy services exist, which take place at different interfaces of patient care. Although they are an important tool for improving medication safety, they are not yet sufficiently implemented in hospitals around the world. OBJECTIVE: This scoping review aims to summarise different hospital pharmacy services at transition of care (TOC) points in order to identify development trends and practice patterns in high-income countries over the past decade. METHODS: A literature search of four databases (PubMed, PubPharm, Cochrane Library (Ovid) and ScienceDirect) since 2011 was conducted. A detailed search strategy was developed and refined with the help of a research librarian. Title, abstract and full-text selection was carried out by two researchers independently. The study was reported in accordance with the PRISMA-ScR items to ensure quality standard reporting. Only studies originating from developed countries and published in the English language were included. The data obtained were extracted and summarised using a data extraction form developed to meet the research aims of the study. RESULTS: Of the 5456 search results, 65 studies met the inclusion criteria. These originated from Europe (n=29), North America/Canada (n=28), Australia (n=7) and Asia (n=1). Individual TOC services such as medication reconciliation and medication review on admission and at discharge were the main focus of published literature practice patterns between 2011 and 2016, after which a more holistic TOC service started to emerge that follows patients across all TOC points during their hospital stay. Facilitators and barriers were consistently dependent on resources and infrastructure. Clinical and economic outcomes show a mixed picture. CONCLUSION: During the past decade pharmaceutical services have developed more holistic TOC services. Large-scale high-quality studies are needed to reliably determine clinical and economic benefit.

Budget impact analysis: comparing the costs of nusinersen and risdiplam in the treatment of type 3 spinal muscular atrophy patients.

OBJECTIVES: The aim of the budget impact analysis (BIA) was to determine the economic impact of introducing risdiplam in the treatment of type 3 spinal muscular atrophy (SMA) patients in a rare diseases reference centre on a 3-year time horizon, as compared with nusinersen. METHODS: Public databases were used to estimate the target population. Two market scenarios were assessed over a 3-year time horizon: with nusinersen and with the introduction of risdiplam. Drug acquisition and administration costs were considered. BIA is calculated as the difference between scenarios with nusinersen - scenario with risdiplam. RESULTS: The introduction of risdiplam would generate a 3-year saving of €3411.50. There could be a saving in the administration of risdiplam in the treatment of patients under the age of 2 with a weight of 5 kg (€26 382.08). CONCLUSION: The BIA shows the overlapping costs of these therapies, although the oral administration of risdiplam could be a decisive factor for the therapeutical switch from nusinersen.

Creating an evidence-based economic model for prefilled parenteral medication delivery in the hospital setting.

OBJECTIVES: Prefilled syringes (PFS) may offer clinical and economic advantages over conventional parenteral medication delivery methods (vials and ampoules). The benefits of converting from vials and ampoules to PFS have been explained in previous drug-specific economic models; however, these models have limited generalisability to different drugs, healthcare settings and other countries. Our study aims to (1) present a comprehensive economic model to assess the impact of switching from vials to PFS delivery; and (2) illustrate through two case studies the model's utility by highlighting important features of shifting from vials to PFS. METHODS: The economic model estimates the potential benefit of switching to PFS associated with four key outcomes: preventable adverse drug events (pADE), preparation time, unused drugs, and cost of supplies. Model reference values were derived from existing peer-reviewed literature sources. The user inputs specific information related to the department, drug, and dose of interest and can change reference values. Two hypothetical case studies are presented to showcase model utility. The first concerns a cardiac intensive care unit in the United Kingdom administering 30 doses of 1 mg/10 mL atropine/day. The second concerns a coronavirus (COVID-19) intensive care unit in France that administers 30 doses of 10 mg/25 mL ephedrine/day. RESULTS: Total cost savings per hospital per year, associated with reductions in pADEs, unused drugs, drug cost and cost of supplies were £34 829 for the atropine example and €104 570 for the ephedrine example. Annual preparation time decreased by 371 and 234 hours in the atropine and ephedrine examples, respectively. CONCLUSIONS: The model provides a generalisable framework with customisable inputs, giving hospitals a comprehensive view of the clinical and economic value of adopting PFS. Despite increased costs per dose with PFS, the hypothetical case studies showed notable reductions in medication preparation time and a net budget savings owing to fewer pADEs and reduced drug wastage.

Evaluation of drug cost savings related to clinical trials from the perspective of a university hospital.

OBJECTIVES: Clinical trials are an opportunity for patients to access innovative therapy, but patient inclusion in clinical trials can also result in cost savings for hospitals. Our objective was to evaluate the economic impact of clinical trials drug cost savings in a French academic institution from the perspectives of both the French Health Insurance (FHI) and hospitals. METHODS: A retrospective, observational, cost saving analysis was performed on all the clinical trials initiated in our university hospital between 2015 and 2020. Only trials involving an investigational medicinal product were considered. Drug cost savings were defined as the best standard of care, defined in the protocol, whose cost was covered by a sponsor. RESULTS: Of the 646 trials undertaken during the 6 years analysed, 21% (212/646) led to cost savings, mostly driven by the industrial sponsor (92%, €6 984 283/€7 591 612) for a total of €7 591 612 (91% from the FHI's perspective (€6 959 115/€7 591 612)). Oncology trials generated 79.1% (€6 004 966/€7 591 612) of global cost savings, mostly driven by onco-haematology (33.1%, €1 983 146/€6 004 966), onco-pneumology (29.2%, €1 754 333/€6 004 966) and onco-dermatology (23.5%, €1 409 553/€6 004 966) followed by hepatogastroenterology trials (6.9%, €413 113/€6 004 966). Of the 162 drugs, the top 15 generated 75.3% (€5 715 479/€7 591 612) of savings and were grouped together: 12 antineoplastic agents (six per os and six intravenous) and three per os antiviral for hepatitis C. CONCLUSIONS: With ever-changing prices and new innovative treatments, such cost avoidance must be regularly evaluated. We provided objective evidence that clinical trials could achieve potential cost savings for the FHI and hospitals, in addition to the potential benefit to patients of having access to innovative investigational medicinal products.

Automation of parenteral nutrition: impact on process and cost analysis.

OBJECTIVES: On the basis of its safety and accuracy, automation is recommended for parenteral nutrition (PN). The aim of this study was to highlight the changes in practices related to the automation of PN and to perform a cost study comparing manual vs automated production costs. METHODS: We conducted a micro-costing study using 1 year of manual production data for adult, neonatal and paediatric PN bagsat a hospital. We used the data to estimate the costs of automating the production process for adult, neonatal and paediatric bags. RESULTS: Major modification to the PN production process resulted in: rationalisation of raw materials, computerisation and optimisation of human needs. Switching from a manual to an automated process reduced the cost of neonatal/paediatric custom bags (€130.73 vs €124.58) and semi-custom bags (€172.08 vs €166.86); but increased the cost of adult bags (€93.06 vs €127.92). CONCLUSIONS: The changes resulting from the automation and revision of the production process globally increased annual expenditures by approximately 9.7%. However, automation minimised the risk of misproduction, bag contamination, and led to a more secure production process that reduced risks incurred by the teams. In view of the gain in patient and staff safety (linked to the use of an automated compounding device) the moderate economic impact (<10%) should not deter the automation of PN production circuits.

The role of clinical trials in the sustainability of the Italian national health service cancer drug expenditure.

OBJECTIVE: Clinical trials offer new and potentially more effective therapeutic options for cancer patients and a potential cost-saving opportunity, especially considering that trial drugs are provided free-of-charge. The aim of this study was to analyse drug-related cost savings in clinical trials in a cancer institute over a 3 year period. The cost savings relate to the pharmaceutical expenditure of our centre, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori". METHODS: We conducted a retrospective analysis of patients taking part in interventional clinical cancer trials approved by a local independent Ethics Committee between 1 January 2018 and 31 December 2020. The standard of care (SOC) was identified as the standard treatment that would have been offered to a patient if he/she had not been enrolled in the study. The sum of SOC costs of all patients represents the potential cost avoidance during the study period. Results were stratified by year, trial promoter, trial phase and tumour type. The same approach was used to perform a secondary analysis of compassionate use programmes. RESULT: In the 3 year analysis, 1,257 patients were treated with experimental therapies in 244 clinical trials, of which 157 were profit and 87 academic. Results showed an overall cost savings of €13,266,518, more than 50% of which (€7,035,009) was related to phase III studies. Profit clinical trials generated €9,069,764 (68.4%) of the drug cost savings compared with €4,196,754 (31.6%) of academic studies. The stratification for tumour type was €3,552,592 (26.8%) genitourinary cancer, €3,268,074 (24.6%) melanoma, €2,574,127 (19.4%) haematological malignancies, €2,330,791 (17.6%) lung cancer, €728,149 (5.5%) gastrointestinal cancer, €557,608 (4.2%) rare tumours and €255,178 (1.9%) breast cancer. The secondary analysis on compassionate use included 122 patients involved in 28 different access programmes and revealed cost savings of €1,649,550. CONCLUSION: The results of our analysis point to the benefits of participating in and planning clinical trials for the public healthcare sector.

The development process of economic evaluation guidelines in low- and middle-income countries: a systematic review.

OBJECTIVES: To review the development of economic evaluation guidelines (EEGs) in low- and middle-income countries (LMICs), with the goal of assisting those developing EEGs in LMICs. METHODS: We conducted a systematic search in MEDLINE (Ovid), PubMed, EconLit, Embase (Ovid), the Cochrane Library, and the gray literature until March 2021. We extracted data on the methods used in the EEG development process, the responsible party engaged, and the development team's composition. We conducted a quality assessment, using the Appraisal of Guidelines for Research and Evaluation-Health Systems tool, and then carried out a relative comparison. RESULTS: Fourteen EEGs and nine studies were identified. In ten countries, the Ministry of Health was responsible for handling the development process. The majority of LMICs who developed EEGs did not explicitly report the discipline of those involved in the process. The developers of EEGs followed four main steps: conducting a review on national guidelines, organizing workshops, and getting support from international experts or from organizations. One-third of the identified EEGs failed to engage multisectoral or multidisciplinary developers, and approximately 14 percent did not follow or report any recommended step. CONCLUSIONS: This study identified a scarcity of published information related to the development process and the suboptimal quality of included studies. It provides relevant material to support international organizations and developers of guidelines in LMICs in developing EEGs that fit their national context. In addition, this paper recommends a transparent approach to the design of guidelines and to reporting on the methods for developing them.

Disposição a pagar e Método de Valoração Contingente na avaliação econômica de serviços farmacêuticos / Willingness to pay and Contingent Valuation Method in the economic evaluation of pharmacy services

Objetivo: Sintetizar os principais pontos abordados em investigações de Disposição a Pagar (DAP) por serviços farmacêuticos, com foco no Método de Valoração Contingente (MVC). Métodos: Foi realizada uma revisão não sistemática com recuperação e análise de manuscritos publicados até novembro de 2020. A busca por estudos ocorreu nas bases MEDLINE, LILACS e SciELO. Resultados: Foram discutidos os fundamentos teóricos e processos metodológicos da análise, apresentando o MVC como principal perspectiva de abordagem. Enquanto delineamento do questionário, é sugerida uma estrutura que apresente, sequencialmente, os elementos: "conhecimento do participante sobre a intervenção", "apresentação da intervenção", "cenário hipotético", "pergunta DAP", "estado de saúde percebido" e "informações socioeconômicas". No mais, é enfatizada a importância da execução de etapas de validação, tanto do instrumento quanto da avaliação. Conclusão: Avaliar a preferência declarada da população por serviços farmacêuticos é uma estratégia ainda limitada. Se realizado adequadamente, esse tipo de investigação pode auxiliar gestores e tomadores de decisão no processo de implementação de novas tecnologias de cuidado.

Objective: To synthesize key points addressed in investigations of Willingness to Pay (WTP) for pharmaceutical care services, focusing on the Contingent Valuation Method (CVM). Methods: We performed a non-systematic review with recovery and analysis of manuscript published until November 2020. Three databases were majorly searched, including MEDLINE, LILACS and SciELO. Results: The theoretical foundations and methodological process were discussed, presenting the CVM as the main perspective. For questionnaire design, is suggested a structure that sequentially presents the elements: "participant knowledge on intervention", "intervention presentation", "hypothetical scenario", "WTP question", "perceived health status", and "socioeconomic information". In addition, we emphasize the importance of executing validation steps for the instrument of measurement as well as the evaluation process. Conclusion: Assessing the population's declared preference for pharmaceutical services is still a limited strategy. If carried out properly, this type of investigation can help managers and decision makers in the process of implementing technologies of care.

Economic evaluation guidelines in low- and middle-income countries: a systematic review.

OBJECTIVES: To systematically identify the latest versions of official economic evaluation guidelines (EEGs) in low- and middle-income countries (LMICs) and explore similarities and differences in their content. METHODS: We conducted a systematic search in MEDLINE (Ovid), PubMed, EconLit, Embase (Ovid), the Cochrane Library, and the gray literature. Using a predefined checklist, we extracted the key features of economic evaluation and the general characteristics of EEGs. We conducted a comparative analysis, including a summary of similarities and differences across EEGs. RESULTS: Thirteen EEGs were identified, three pertaining to lower-middle-income countries (Bhutan, Egypt, and Indonesia), nine to upper-middle-income countries (Brazil, China, Colombia, Cuba, Malaysia, Mexico, Russian Federation, South Africa, and Thailand), in addition to Mercosur, and none to low-income countries. The majority (n = 12) considered cost-utility analysis and health-related quality-of-life outcome. Half of the EEGs recommended the societal perspective, whereas the other half recommended the healthcare perspective. Equity considerations were required in ten EEGs. Most EEGs (n = 11) required the incremental cost-effectiveness ratio and recommended sensitivity analysis, as well as the presentation of a budget impact analysis (n = 10). Seven of the identified EEGs were mandatory for pharmacoeconomics submission. Methodological gaps, contradictions, and heterogeneity in terminologies used were identified within the guidelines. CONCLUSION: As the importance of health technology assessment is increasing in LMICs, this systematic review could help researchers explore key aspects of existing EEGs in LMICs and explore differences among them. It could also support international organizations in guiding LMICs to develop their own EEGs and improve the methodological framework of existing ones.

Comparative analysis of kidney transplant costs related to recovery of renal function after the procedure / Análise comparativa dos custos do transplante renal relacionados à recuperação da função renal após o procedimento

Abstract Introduction: The number of kidney transplants (KTx) is increasing in Brazil and, consequently, the costs of this procedure increase the country's health budget. We retrospectively evaluated the data of kidney transplant procedures until hospital discharge, according to kidney function recovery after the procedure. Methods: Retrospective analysis of the non-sensitized, 1st KTx from deceased donors performed between Jan/2010 to Dec/2017. Results: Out of the 1300 KTx from deceased donors performed in this period, 730 patients were studied and divided into 3 groups: Immediate Renal Function (IRF) - decrease in serum creatinine ≥ 10% on two consecutive days; Delayed Graft Function (DGF) - decrease in serum creatinine <10% on two consecutive days, without the need for dialysis, and Dialysis (D) - need for dialysis during the first week. Patients in group D stayed longer in the hospital compared to DGF and IRF (21, 11 and 8 days respectively, p < 0.001). More D patients (21%) were admitted to the ICU and performed a greater number of laboratory tests (p < 0.001) and renal biopsies (p < 0.001), in addition to receiving a higher amount of immunosuppressants. Total hospital costs were higher in group D and DGF compared to IRF (U$ 7.021,48; U$ 3.603,42 and U$ 2.642,37 respectively, p < 0.001). Conclusion: The costs of the transplant procedure is impacted by the recovery of kidney function after the transplant. The reimbursement for each of these different kidney function outcomes should be individualized in order to cover their real costs.

Resumo Introdução: O número de transplantes renais (KTx, do inglês kidney transplant) está aumentando no Brasil e, consequentemente, os custos deste procedimento aumentam o orçamento de saúde do país. Avaliamos retrospectivamente dados dos procedimentos de transplantes renais até a alta hospitalar, de acordo com a recuperação da função renal após o procedimento. Métodos: Análise retrospectiva dos 1º KTx de doadores falecidos, não sensibilizados, realizados entre Jan/2010 a Dez/2017. Resultados: Dos 1300 KTx de doadores falecidos realizados neste período, 730 pacientes foram estudados e divididos em 3 grupos: Função Renal Imediata (FRI) - diminuição na creatinina sérica ≥ 10% em dois dias consecutivos; Função Retardada do Enxerto (FRE) - diminuição na creatinina sérica <10% em dois dias consecutivos, sem necessidade de diálise, e Diálise (D) - necessidade de diálise durante a primeira semana. Pacientes no grupo D permaneceram mais tempo no hospital em comparação com FRE e FRI (21, 11 e 8 dias dias respectivamente, p < 0,001). Mais pacientes do grupo D (21%) foram admitidos na UTI e realizaram um maior número de testes laboratoriais (p < 0,001) e biópsias renais (p < 0,001), além de receberem uma quantidade maior de imunossupressores. Os custos hospitalares totais foram mais elevados nos grupos D e FRE em comparação com FRI (U$ 7.021,48; U$ 3.603,42 e U$ 2.642,37 respectivamente, p < 0,001). Conclusão: Os custos do procedimento de transplante são impactados pela recuperação da função renal após o transplante. O reembolso para cada um desses diferentes desfechos da função renal deve ser individualizado a fim de cobrir seus custos reais.

Pharmaceutical procurement among public sector procurers in CARICOM.

OBJECTIVE: To examine multiple aspects of the medicines in CARICOM procurement markets, including manufacturer headquarters location, regulatory history, and type (innovator versus generic); the proportion of World Health Organization (WHO) essential medicines; and the most expensive medicines procured. METHODS: An analysis of procurement information from selected CARICOM procurers. Four public sector procurement lists were obtained based on public availability or sharing of data from public sector procurers. Analyses were based on parameters available or deduced from these data. RESULTS: The majority of products come from manufacturers headquartered in North America and Europe (63%-67%). The percentage of medicines procured from generic companies is 60%-87%; and 25%-50% of medicines procured are on the WHO Essential Medicines List. Wide price variations exist in the most expensive medicines purchased. CONCLUSIONS: The analysis identifies vulnerabilities and opportunities in the procurement situation of CARICOM states, particularly related to quality and rational use of medicines. This analysis represents a baseline that governments and other stakeholders can use in the future.

El copago farmacéutico en España tras la reforma del año 2012 desde la perspectiva del usuario. ¿Evidencias de inequidad? / Pharmaceutical copayment in Spain after the 2012 reform from the user's perspective. Evidence of inequity?

Objetivo: Identificar cuáles son las características que se asocian con aquella parte de la población que manifiesta no poder comprar todos los medicamentos recetados por un médico de la sanidad pública, relacionándolas con los criterios que definen el sistema de copago farmacéutico fijado por el Real Decreto 16/2012, con la finalidad de orientar cambios que eliminen posibles inequidades. Método: Estudio de asociación y relación causal entre la dificultad para comprar medicamentos recetados por la sanidad publica que manifiestan los usuarios a través de la encuesta Barómetro Sanitario y un conjunto de variables que reflejan la capacidad económica, el nivel de necesidad de servicios de salud y que, a su vez, forman parte de los criterios de copago, mediante técnicas de análisis de correspondencias múltiples y de regresión. Resultados: Tras el análisis de las oleadas correspondientes a los años 2013-2017 se ha encontrado evidencia a favor de la hipótesis de que los usuarios más pobres, los activos y los de peor salud manifiestan mayores dificultades para acceder a los medicamentos que les han sido recetados por un médico de la sanidad pública. Conclusiones: Los resultados son compatibles con la hipótesis de que el copago actual es percibido como una barrera de acceso a medicamentos necesarios por parte de algunos sectores de la población. Aunque del trabajo pueden derivarse ciertas acciones dirigidas a reducir dicha barrera, es necesario realizar más investigación que tenga en cuenta la opinión de los usuarios. (AU)

Objective: Identify what are the characteristics of the part of the population that says they cannot buy all the medicines prescribed by a public health doctor, relating them to the criteria that define the pharmaceutical co-payment system established by Royal Decree 16/2012, with the purpose of guiding changes that eliminate possible inequities. Method: Association study and causal relationship between the difficulty to buy prescription drugs that users expressed through the survey called Health Barometer and a set of variables that reflect the degree of need for health services and the economic capacity, that is also part of the co-payment criteria, using multiple correspondence and regression analysis techniques. Results: After the analysis of the data corresponding to the years 2013-2017, evidence has been found in favour of the hypothesis that the poorest users, as well as the working ones and those with worst health show greater difficulties in accessing the medicines which have been prescribed by a public health doctor and, consequently, changes are proposed in the copayment system aimed at eliminating or, at least, reducing such differences. Conclusions: The results obtained are compatible with the hypothesis that the current copayment is perceived as a barrier to access necessary medicines by some sectors of the population. Although certain actions aimed at reducing this barrier can be derived from the work, more research that considers the opinion of the users is needed. (AU)

Pharmaceutical procurement among public sector procurers in CARICOM / Compras farmacéuticas por parte de organismos del sector público de CARICOM / Aquisição de produtos farmacêuticos por compradores do setor público da CARICOM

ABSTRACT Objective. To examine multiple aspects of the medicines in CARICOM procurement markets, including manufacturer headquarters location, regulatory history, and type (innovator versus generic); the proportion of World Health Organization (WHO) essential medicines; and the most expensive medicines procured. Methods. An analysis of procurement information from selected CARICOM procurers. Four public sector procurement lists were obtained based on public availability or sharing of data from public sector procurers. Analyses were based on parameters available or deduced from these data. Results. The majority of products come from manufacturers headquartered in North America and Europe (63%-67%). The percentage of medicines procured from generic companies is 60%-87%; and 25%-50% of medicines procured are on the WHO Essential Medicines List. Wide price variations exist in the most expensive medicines purchased. Conclusions. The analysis identifies vulnerabilities and opportunities in the procurement situation of CARICOM states, particularly related to quality and rational use of medicines. This analysis represents a baseline that governments and other stakeholders can use in the future.

RESUMEN Objetivo. Revisar los múltiples aspectos de los medicamentos en los mercados de compras y los proveedores de CARICOM, como la ubicación de la sede del fabricante, el historial de regulación, el tipo (patentado versus genérico); la proporción de medicamentos esenciales de la Organización Mundial de la Salud (OMS); y los medicamentos comprados más caros. Métodos. Se analizó información sobre la compra por parte de determinados organismos de CARICOM. La información procedía de cuatro listas de organismos del sector público que realizan las compras, que se consiguieron en función de su disponibilidad pública o de los datos distribuidos por los organismos del sector público que realizan las compras. Los análisis estaban basados en los parámetros disponibles o derivados de estos datos. Resultados. La mayoría de los productos proviene de fabricantes radicados en América del Norte y Europa (entre 63% y 67%). El porcentaje de medicamentos que se compra de empresas genéricas oscila entre 60% y 87%; y de 25% a 50% de los medicamentos que se compran están en la Lista de Medicamentos Esenciales de la OMS. Hay una gran divergencia de precios entre los medicamentos comprados más caros. Conclusiones. En el análisis se han encontrado vulnerabilidades y oportunidades con respecto a la situación de las compras de medicamentos de los Estados de CARICOM, especialmente en cuanto a la calidad y al uso racional de los medicamentos. Este análisis representa una línea de base que los gobiernos u otros interesados directos pueden utilizar en el futuro.

RESUMO Objetivo. Examinar vários aspectos relacionados aos mercados e fornecedores de produtos farmacêuticos da CARICOM, incluindo a localização da sede do laboratório fabricante, histórico regulatório e tipo de produtos (inovadores versus genéricos); proporção de medicamentos adquiridos que constam da relação de medicamentos essenciais da Organização Mundial da Saúde (OMS); e medicamentos mais caros comprados. Métodos. Foi realizada uma análise de informação sobre compras feitas por compradores selecionados da CARICOM. Quatro listas de compras do setor público foram obtidas com informação de acesso público ou compartilhada pelos compradores. As análises foram feitas com base em parâmetros disponíveis ou inferidos a partir dos dados. Resultados. A maioria dos produtos farmacêuticos é proveniente de laboratórios com sedes na América do Norte e Europa (63%-67%). Do total, 60%-87% dos medicamentos adquiridos são de laboratórios de produtos genéricos e 25%-50% constam da relação de medicamentos essenciais da OMS. Existe uma ampla variação nos preços dos medicamentos mais caros comprados. Conclusões. Foram identificadas fragilidades e oportunidades na situação de compras dos países da CARICOM, em particular relacionadas à qualidade dos produtos e ao uso racional dos medicamentos. Esta análise serve de referência a ser usada futuramente pelos governos e outras partes interessadas.

Cost-benefit analysis of pharmacist interventions over 36 months in a university hospital

ABSTRACT OBJECTIVE: To perform a cost-benefits analysis of a clinical pharmacy (CP) service implemented in a Neurology ward of a tertiary teaching hospital. METHODS: This is a cost-benefit analysis of a single arm, prospective cohort study performed at the adult Neurology Unit over 36 months, which has evaluated the results of a CP service from a hospital and Public Health System (PHS) perspective. The interventions were classified into 14 categories and the costs identified as direct medical costs. The results were analyzed by the total and marginal cost, the benefit-cost ratio (BCR) and the net benefit (NB). RESULTS: The total 334 patients were followed-up and the highest occurrence in 506 interventions was drug introduction (29.0%). The marginal cost for the hospital and avoided cost for PHS was US$182±32 and US$25,536±4,923 per year; and US$0.55 and US$76.4 per patient/year. The BCR and NB were 0.0, -US$26,105 (95%CI −31,850 − -10,610), -US$27,112 (95%CI −33,160-11,720) for the hospital and; 3.0 (95%CI 1.97-4.94), US$51,048 (95%CI 27,645-75,716) and, 4.6 (95%CI 2.24-10.05), US$91,496 (95%CI 34,700-168,050; p < 0.001) for the PHS, both considering adhered and total interventions, respectively. CONCLUSIONS: The CP service was not directly cost-benefit at the hospital perspective, but it presented savings for forecast cost related to the occurrence of preventable morbidities, measuring a good cost-benefit for the PHS.

Distinct models to assess the cost-effectiveness of EGFR-tyrosine kinase inhibitors for the treatment of metastatic non-small cell lung cancer in the context of the Brazilian Unified Health Care System / Diferentes modelos para avaliar a relação custo-efetividade de inibidores de tirosina quinase do EGFR no tratamento do câncer de pulmão não pequenas células metastático no contexto do Sistema Único de Saúde

ABSTRACT Objective: Lung cancer is an important health problem due to its high incidence and mortality. The treatment of metastatic disease improved after the molecular pathways of cancer came to be known. However, targeted therapy is unavailable to many patients treated within the Brazilian Sistema Único de Saúde (SUS, Unified Health Care System). Our objective was to assess the cost-effectiveness of erlotinib, gefitinib, and afatinib versus that of chemotherapy for the treatment of non-small cell lung cancer in the context of the SUS. Methods: Different analytical models were developed based on data in the literature. The outcomes were presented in quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs) per QALY gained. All costs related to treatment and supportive therapies were included in the models. Results: In one model, data from retrospective studies showed 2.01 life-years saved and a mean QALY gain of 1.169. The ICER per QALY gained ranged from R$48,451.29 (for gefitinib) to R$85,559.22 (for erlotinib). In another model, data from a meta-analysis showed −0.01 life-years saved and a mean QALY gain of 0.178. The ICER per QALY gained ranged from R$27,028.30 (for gefitinib) to R$75,203.26 (for erlotinib). Conclusions: There is no ideal analytical model for the SUS. However, targeted therapy with EGFR-tyrosine kinase inhibitors has been shown to be cost-effective in various scenarios. The adoption of drug price discounts will improve the cost-effectiveness of treatment.

RESUMO Objetivo: O câncer de pulmão é um importante problema de saúde pela sua alta incidência e mortalidade. O tratamento da doença metastática melhorou após o conhecimento de vias moleculares tumorais. Contudo, a terapia-alvo está indisponível para muitos pacientes do Sistema Único de Saúde (SUS). Nosso objetivo foi avaliar a relação custo-efetividade de erlotinibe, gefitinibe e afatinibe vs. quimioterapia no tratamento do câncer de pulmão não pequenas células no contexto do SUS. Métodos: Foram desenvolvidos modelos analíticos distintos baseados em dados da literatura. Os desfechos foram apresentados em quality-adjusted life years (QALY, anos de vida ajustados pela qualidade) e incremental cost-effectiveness ratio (ICER, relação custo-efetividade incremental). Todos os custos relacionados ao tratamento e terapias de suporte foram incluídos nos modelos. Resultados: No primeiro modelo, dados de estudos retrospectivos apontaram 2,01 anos de vida salvos e uma média de ganho de QALY de 1,169. O ICER variou entre R$ 48.451,29 (gefitinibe) e R$ 85.559,22 (erlotinibe). No segundo modelo, dados de uma meta-análise evidenciaram −0,01 ano de vida salvos e uma média de ganho de QALY de 0,178. O ICER foi de R$ 27.028,30 (gefitinibe) a R$ 75.203,26 (erlotinibe). Conclusões: Não existe um modelo analítico ideal para o SUS. Contudo, diferentes cenários disponíveis na literatura mostram que a terapia-alvo com o uso dessas drogas é custo-efetiva. A adoção de descontos nos preços dos medicamentos melhorará a relação custo-efetividade do tratamento.