Economic evaluation of third-line neratinib plus capecitabine versus lapatinib plus capecitabine with HER2+ metastatic breast cancer.

Background: Breast cancer (BC) is one of the most common malignant tumors in women. In addition, human epidermal growth factor receptor 2-positive (HER2+) BC is overexpressed in 25% of BC patients, resulting in the predicament of poor prognosis. Although first- and second-line treatments have been established, optimum third-line treatment is still mired in controversies for HER2+ metastatic BC (mBC). Therefore, this study analyzes the cost-effectiveness of neratinib plus capecitabine (N+C) and lapatinib plus capecitabine (L+C) over a 5-year time horizon from a payer perspective. Methods: A half-cycle corrected four-state Markov model was established to simulate the course of BC events and deaths in N+C and L+C armed patients. The data of this model were derived from NCT01808573 trail and other published literatures. One-way deterministic sensitivity analysis (DSA) was conducted to investigate the impact of variables and probabilistic sensitivity analysis (PSA) was performed based on second-order Monte Carlo simulation. In addition, subgroup analysis was performed to verify its cost-effectiveness in China. Result: The base-case results found that N+C was in dominant position in 82.70% of the generation scenarios, providing an improvement of 0.17 quality-adjusted life-years (QALYs) and a reduction of $1,861.28 compared with L+C. The ICER was $-1,3294.86/QALY, which did not exceed the willingness to pay (WTP) threshold, while in subgroup, the ICER decreased to $-2,448.17/QALY. Conclusion: This analysis indicated that the combination of neratinib plus capecitabine is likely to be cost-effective in comparison with lapatinib plus capecitabine in patients with HER2+ mBC who continues to progress during or after second-line HER2-targeted therapy. So neratinib plus capecitabine can become a third-line treatment option.

Análise das solicitações de medicamentos não padronizados de um hospital universitário terciário / Analysis of requests for non-standard medicines from a tertiary university hospital

Introdução: O uso extensivo de medicamentos não padronizados causa aumento de custos em saúde, além de potencial redução de segurança e uso racional de medicamentos. A Comissão de Farmácia e Terapêutica orienta a prescrição de medicamentos, por meio da avaliação e seleção de medicamentos a serem incluídos no formulário de medicamentos padronizados, com base nas melhores evidências científicas disponíveis e no perfil dos pacientes locais, promovendo o uso racional de medicamentos. O objetivo deste trabalho foi analisar as solicitações de fornecimento de medicamentos não padronizados na instituição. Métodos: Trata-se de um estudo observacional e descritivo onde foram analisadas as solicitações de medicamentos não padronizados realizadas entre fevereiro de 2016 e dezembro de 2021, identificando os medicamentos envolvidos e seus respectivos custos. Resultados: Foram realizadas 203 solicitações no período, sendo 174 incluídas no estudo. Os medicamentos que tiveram mais solicitações foram o rituximabe (41), a imunoglobulina humana (31), o sucralfato (23), a nitazoxanida (12) e o eltrombopague (7). As solicitações com maior custo foram as de imunoglobulina humana (US$ 799,702.38), rituximabe (US$ 717,320.26), eltrombopague (US$ 281,062.50), ruxolitinibe (US$ 167,867.46) e bortezomibe (US$ 149,033.52). As principais clínicas que solicitaram medicamentos não padronizado foram a neurologia (47), a hematologia (30), as moléstias infecciosas e parasitárias (17), e a anestesiologia (12). As solicitações de maior custo foram realizadas pela neurologia (US$ 145,519.08), hematologia (US$ 120,980.25), transplante de medula óssea (US$ 51,635.11) e dermatologia (US$ 44,813.40). Conclusão: O estudo demonstrou que há um fluxo estruturado de solicitação de medicamentos não padronizados na instituição, sendo uma importante ferramenta de gerenciamento dessas solicitações, evitando a aquisição desnecessária de itens que não compõem o elenco terapêutico do hospital.

Introduction: Widespread use of non-formulary drugs (NFD) increases cost and may reduce safety and rational use of medicines. The Pharmacy and Therapeutics Committee provides guidance on drug prescription by evaluating and selecting medications to be included in a hospital's formulary based on best scientific evidence available and local patients' profile, promoting rational use of medicines. The objective of this study was to assess non-formulary drugs prescriptions at a tertiary hospital. Methods: This was a retrospective study. NFD prescribed and its associated costs were assessed through NFD request forms received from February 2016 to December 2021. Results: A total of 203 NFD request forms were received, from which 174 were included in this study. The most frequently prescribed NFD included rituximab (n = 41), immunoglobulin (31), sucralfate (23), nitazoxanide (12), and eltrombopag (7), with the highest costs being with immunoglobulin (US$ 799,702.38), rituximab (US$ 717,320.26), eltrombopag (US$ 281,062.50), ruxolitinib (US$ 167,867.46), and bortezomib (US$ 149,033.52). The most frequent requesting specialties were neurology (n = 47), hematology (30), infectious disease (17) and anesthesiology (12), and highest costs requests were from neurology (US$ 145,519.08), hematology (US$ 120,980.25), bone marrow transplant unit (US$ 51,635.11), and dermatology (US$ 44,813.40). Conclusion: This study showed that a structured request flow for NFD prescription is a critical procedure in order to better manage drug prescription within the hospital, promoting rational use of medicines and preventing unnecessary spending with drugs for which the clinical indication may be covered by a drug already in the hospital's formulary.

The Effect of Biosimilar Prescription Targets for Erythropoiesis-Stimulating Agents on the Prescribing Behavior of Physicians in Germany.

OBJECTIVES: This study aimed to aid decision makers by analyzing the impact of introducing biosimilar prescription targets on physician prescribing behavior in the prescription of biologic erythropoiesis-stimulating agents in Germany. METHODS: We combined secondary data of regional level biosimilar prescription targets and secondary data of routinely collected claims data of dispensed prescriptions by physicians operating within the statutory health insurance system in ambulatory care across 7 German regions from 2009 to 2015. Two-way fixed-effects regression analysis was used to identify the average treatment effect of introducing biosimilar prescription targets at the physician level. The main outcome of interest was the share of biosimilar prescriptions on all prescriptions within the substance group. We compared 6 regions that introduced biosimilar prescription targets with 1 region without any prescription target policy. RESULTS: Introducing biosimilar prescription targets increased the average share of biosimilars between 6 percentage points (P < .05) in Hamburg and up to 20 percentage points (P < .001) in Saxony-Anhalt. Stratification of specialists by prescription volume and adoption status indicated heterogeneous effects. We identified similar but higher effects for high-volume prescribers. Disentangling of effects with regard to the composition of biosimilar share suggested that the increase in biosimilar share was driven by increased biosimilar use accompanied by a nonsignificant decrease in original biologics prescriptions. CONCLUSIONS: Prescription targets to alter physician prescribing behavior meet their intended goals by increasing biosimilar share. Physicians partly responded to the policy by decreasing overall prescriptions of the target substance. Prescription targets might be a useful tool, but decision makers need to consider all aspects of potential responses.

Análise de preços praticados nas aquisições de medicamentos pelos consórcios de saúde em comparação com as instituições municipais para o período de 2017 a 2018 / Analysis of practical prices in the acquisition of medicines by the health consortia compared to municipal institutions in the period from 2017 to 2018

Objetivo: Identificar se as aquisições de medicamentos realizadas pelos Consórcios de Saúde foram mais eficientes, em termos econômicos, que as compras realizadas individualmente pelas Instituições Municipais, para os anos de 2017 e 2018. Métodos: Análise descritiva da amostra, empregando as medidas de tendência central, análise econômica e cálculo do percentual econômico. Resultados: Os valores obtidos mostraram eficiência nas compras dos consórcios, refletidos na maior quantidade adquirida e no menor preço praticado, para a maioria dos itens analisados no período de referência. Conclusão: As compras pelos Consórcios de Saúde proporcionaram mais economia em comparação com as compras realizadas pelas Instituições Municipais, mostrando-se como uma opção para obter economicidade dos recursos destinados à saúde.

Objective: To identify whether the drug purchases made by the Health Consortia were more efficient, in economic terms, than the purchases made individually by the Municipal Institutions, for the years 2017 and 2018. Methods: Descriptive analysis of the sample, using the trend measures central, economic analysis and calculation of the economic percentage. Results: The values obtained showed efficiency in consortium purchases, reflected in the greater quantity acquired and the lower price practiced, for most of the items analyzed in the reference period. Conclusion: Purchases by Health Consortia provided more savings compared to purchases made by Municipal Institutions, proving to be an option to obtain economic resources for health.

Analysis of practical prices in the acquisition of medicines by the health consortia compared to municipal institutions in the period from 2017 to 2018

Objective: To identify whether the drug purchases made by the Health Consortia were more efficient, in economic terms, than the purchases made individually by the Municipal Institutions, for the years 2017 and 2018. Methods: Descriptive analysis of the sample, using the trend measures central, economic analysis and calculation of the economic percentage. Results: The values obtained showed efficiency in consortium purchases, reflected in the greater quantity acquired and the lower price practiced, for most of the items analyzed in the reference period. Conclusions: Purchases by Health Consortia provided more savings compared to purchases made by Municipal Institutions, proving to be an option to obtain economic resources for health.

Continuing trends in U.S. brand-name and generic drug competition.

OBJECTIVE: To provide updated evidence in a series of analyses of U.S. trends over the past two decades in key financial metrics for branded drugs: market exclusivity periods (MEPs, the time between launch and first generic entry) for new molecular entities (NMEs); the probability, timing and number of patent challenges under Paragraph IV of the Hatch-Waxman Act; and the intensity of generic penetration. METHODS: As previously, we used IQVIA National Sales Perspectives U.S. data to calculate MEPs for the 356 NMEs experiencing initial generic entry from 1995 through 2019, the number of generic competitors for twelve months afterward (by prior sales level), and generic shares. We calculated the probability, timing and number of Paragraph IV challengers using Abbreviated New Drug Application (ANDA) approval letters, the FDA website, public information searches, and ParagraphFour.com. RESULTS: For NMEs experiencing initial generic entry in 2017-19, the MEP was 13.0 years for drugs with sales greater than $250 million in 2008 dollars the year before generic entry (NMEs>$250 million), 14.1 years overall. One year later, brands' average unit share was 18% for NMEs>$250 million, 23% overall. Ninety-three percent of NMEs>$250 million experiencing initial generic entry faced at least one Paragraph IV challenge (2019, three-year rolling average), an average of 6.0 years after brand launch (81% and 6.3 years for all NMEs). NMEs faced an average of 6.8 and 8.9 Paragraph IV challengers per NME, for all and NMEs>$250 million, respectively (2017-19 figures). LIMITATIONS: All analyses were restricted to NMEs experiencing generic entry. CONCLUSION: The average 2017-19 MEP of 13.0 years for NMEs>$250 million has changed relatively little over the past decade and remains lower than for all NMEs (14.1 years). Paragraph IV challenges are more frequent and occur earlier for NMEs>$250 million. Generic share erosion remains high for both NME types.

Pricing and Reimbursement Pathways of New Orphan Drugs in South Korea: A Longitudinal Comparison.

This study aimed to analyze four current pathways affecting the listing and post-listing prices of new orphan drugs (ODs) in South Korea. These mechanisms were: (1) essential OD, (2) pharmacoeconomic evaluation (PE) waiver OD, (3) weighted average price OD, and (4) PE OD. We analyzed the ratio of the listing price of 48 new ODs to the average adjusted price (AAP) of seven advanced countries and examined the change in the post-listing price. Descriptive statistics were used to analyze the listing and post-listing price changes. The mean and median ratios of the listing price of total new OD to AAP were calculated to be 69.4% and 65.4%, respectively. Essential OD showed the highest mean (93.8%) and median (80.8%) ratios. The mean cumulative price discount rate of the new OD was 7.2% in the third year and 5.7% in the fifth year. The rarity of diseases impacts the listing price of OD, but the political effects of the benefits of OD on the post-listing price of these drugs could not be verified. Further research should be conducted to develop measures that facilitate the practical sharing of budget risks and increase patient access to new ODs.

The efficacy, safety and cost-effectiveness of hydroxychloroquine, sulfasalazine, methotrexate triple therapy in preventing relapse among patients with rheumatoid arthritis achieving clinical remission or low disease activity: the study protocol of a randomized controlled clinical Trial (ESCoRT study).

BACKGROUND: Tumor necrosis factor α inhibitors (TNFi) is effective for rheumatoid arthritis (RA) patients who fail to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs). Because of high cost, the discontinuation is common but often lead to disease relapse. The study aims to investigate, if the combination therapy of csDMARDs is more effective in reducing disease relapse than methotrexate (MTX) monotherapy, and more cost-effective than continuing TNFi and MTX. METHODS: It will be a two-stage trial. In the first stage, all RA patients who failed to csDMARDs treatment [disease activity score 28 (DAS28)-CRP > 3.2] will receive MTX plus TNFi for no more than 12 weeks. Patients achieving DAS28-CRP < 3.2 during the first stage will be randomized into three groups at 1:1:1 ratio: (A) add hydroxychloroquine (HCQ) and sulfasalazine (SSZ) for the first 12 weeks and then remove TNFi but continue other treatments for the next 48 weeks; (B) maintain TNFi + MTX for 60 weeks; and (C) maintain TNFi + MTX for the first 12 weeks and then remove TNFi but continue MTX monotherapy for the next 48 weeks. The primary outcome will be disease relapse (DAS28-CRP increases by at least 0.6 and > 3.2). Secondary outcomes will include the incremental cost per reducing 1 case of relapse; patient reported intolerance to the treatment; adverse events; change of mean disease activity measured by DAS28, clinical disease activity index (CDAI) and simplified disease activity index (SDAI); the proportion of modified Sharp score increase < 0.3; ultrasound-detected remission in hands; Health Assessment Questionnaire Disability Index (HAQ-DI) and health related quality of life [the five-level EuroQol-5D (EQ-5D-5L) and short form-6D (SF-6D)]. DISCUSSION: The aim of this trail will be to seek effective treatment options of preventing relapse of RA. The results of the current study may provide an instructive recommendation for more economical application of TNFi treatment in RA. Trial registration NCT, NCT02320630. Registered on 16 December 2014. https://register.clinicaltrials.gov/prs/app/action/LoginUser?ts=3&cx=-jg9qo2 .

Cost-effectiveness of paclitaxel, doxorubicin, cyclophosphamide and trastuzumab versus docetaxel, cisplatin and trastuzumab in new adjuvant therapy of breast cancer in china.

BACKGROUND: Breast cancer is the most common cancer among women in China. Amplification of the Human epidermal growth factor receptor type 2 (HER2) gene is present and overexpressed in 18-20% of breast cancers and historically has been associated with inferior disease-related outcomes. There has been increasing interest in de-escalation of therapy for low-risk disease. This study analyzes the cost-effectiveness of Doxorubicin/ Cyclophosphamide/ Paclitaxel/ Trastuzumab (AC-TH) and Docetaxel/Carboplatin/Trastuzumab(TCH) from payer perspective over a 5 year time horizon. METHODS: A half-cycle corrected Markov model was built to simulate the process of breast cancer events and death occurred in both AC-TH and TCH armed patients. Cost data came from studies based on a Chinese hospital. One-way sensitivity analyses as well as second-order Monte Carlo and probabilistic sensitivity analyses were performed.The transition probabilities and utilities were extracted from published literature, and deterministic sensitivity analyses were conducted. RESULTS: We identified 41 breast cancer patients at Hangzhou First People's Hospital, among whom 15 (60%) had a partial response for AC-TH treatment and 13 (81.25%) had a partial response for TCH treatment.No cardiac toxicity was observed. Hematologic grade 3 or 4 toxicities were observed in 1 of 28 patients.Nonhematologic grade 3 or 4 toxicities with a reverse pattern were observed in 6 of 29 patients. The mean QALY gain per patient compared with TCH was 0.25 with AC-TH, while the incremental costs were $US13,142. The incremental cost-effectiveness ratio (ICER) of AC-TH versus TCH was $US 52,565 per QALY gained. CONCLUSIONS: This study concluded that TCH neoadjuvant chemotherapy was feasible and active in HER2-overexpressing breast cancer patients in terms of the pathological complete response, complete response, and partial response rates and manageable toxicities.

Changing Pharmaceutical Industry Interaction in US Family Medicine Residencies: A CERA Study.

BACKGROUND: Pharmaceutical interaction in US residencies is common. This study explores the extent and type of learner interactions in US family medicine residencies with the pharmaceutical industry and compares interactions from 2008, 2013, and 2019. METHODS: We surveyed program directors of 628 family medicine residencies with 8 questions using the 2019 Council of Academic Family Medicine Educational Research Alliance Survey and compared the responses to 2008 and 2013 results. RESULTS: The survey response rate was 39%; 81% of responding residencies did not allow food or gifts, 86% did not allow drug samples, 84% did not allow industry to interact with medical students or residents, and 81% did not allow industry-sponsored residency activities. These numbers were statistically significantly higher than both 2008 and 2013. In 2019, 151 responding programs (64%) were pharma-free, that is, they answered "No" to all 4 questions about interactions. Pharma-free residencies were increased in 2019 compared with 26% in 2008% and 49% in 2013. University-based family medicine programs were more likely to be pharma-free. Only 21% of responding programs had a formal curriculum that explores the interaction between physicians and the pharmaceutical industry. Factors cited for decreasing interaction included: institutional policy, ethical concerns, faculty input, and local response to national legislation. CONCLUSIONS: Interaction between trainees in US family medicine residencies and the pharmaceutical industry continued to decrease. A changing national legislative landscape combined with institutional policies and concerns about industry influence on prescribing habits may be important factors driving the limiting of interactions.

A systematic review of pharmaceutical price mark-up practice and its implementation.

Pharmaceutical products, apart from being essential for medical treatment, are of high value and heavily regulated to ensure the prices are controlled. This systematic review was conducted to identify pharmaceutical pricing mark-up control measures, specifically in the wholesale and retail sectors. The search method comprised the following databases: PubMed, Science Direct, Springer Link, ProQuest, and EBSCOhost and Google Scholar. The results were filtered systematically from the inception of the aforementioned databases until 23 April 2021. Eligible studies were those focusing on the implementation of pharmaceutical pricing strategies that involve a) mark-ups of medicine, and b) pharmaceutical cost control measures. A total of 13 studies were included in this review: seven covered European countries, four covered Asian countries, one covered the USA and one covered Canada. The main points of discussion in the qualitative synthesis were the implementation of medicine mark-ups, price mark-up regulatory strategies and the outcomes of these regulatory strategies. Our findings suggest that Western countries have a lower mark-up margin, around 4% to 25% of the original purchased price, compared to Asian countries, up to 50%.

Extending the hierarchical decision matrix to incorporate a dominance ranking score for economic systematic reviews.

As the base of clinical evidence grows, it is increasingly common to conduct economic evaluations in addition to clinical evaluations of effectiveness in order to inform health policies. For economic systematic reviews there is currently no agreed-upon quantitative method to obtain a pooled economic effect size. With no suitable quantitative method available, the hierarchical decision matrix stands out as a tool that enables a visual summary of different types of economic studies, but there are limitations with the hierarchical decision matrix. We extended the hierarchical decision matrix with a weighted scoring system (termed dominance ranking score) to allow for useful information of a study design to be incorporated. •The scoring system of the dominance ranking score incorporates weighting factors that are based on sample size and effect size of a study.•The dominance ranking score enables a more differentiating analysis of dominance levels.•For systematic reviews that include partial economic studies, both the hierarchical decision matrix and the dominance ranking score assist to indicate the level of economic potential for a particular intervention, which facilitates the conduct of subsequent full economic studies.

Immune checkpoint inhibitors of the PD-1/PD-L1-axis in non-small cell lung cancer: promise, controversies and ambiguities in the novel treatment paradigm.

Immune checkpoint inhibitors (ICIs) have received much attention not least for melanoma since the award of the Nobel prize in 2018. Here, we review the current state of knowledge about the use of these monoclonal antibodies (mAbs) in non-small cell lung cancer (NSCLC). These drugs have generally been conditionally approved on limited early data and there are few long-term follow-up data from randomized clinical trials. The effect observed for NSCLC thus far is, on average, moderately better than that obtained with chemotherapy. Severe side-effects are more common than might have been expected. The drugs themselves are expensive and are associated with time-consuming histopathologic testing even though the predictive value of these tests can be discussed. In addition, monitoring for side-effects involves increased workload and budgetary expense for clinical chemistry laboratories. Here, we review and summarize the current knowledge, controversies and ambiguities of ICIs for the treatment of NSCLC.

Pharmacare in Canada: The paediatric perspective.

Canada's drug insurance system is one of the most expensive in the world, yet millions of Canadians still struggle to access necessary medications. As a result, provincial, territorial, and federal governments are considering public pharmacare policy proposals to ensure that all Canadians can access the medications they need. Pharmacare policies offer an opportunity to prioritize children and youth, whose unique drug needs have long been neglected. Prescription drug use is common in this population, with approximately half of Canadian children and youth requiring at least one prescription in any given year. Drug use remains concentrated, however, among those with complex, chronic, and serious diseases. Children and youth rely heavily on compounded and off-label prescription drugs, which impacts safety, efficacy, palatability, and cost. Reimbursement decision-making bodies do not appropriately value the unique benefits of paediatric drugs, including child-friendly formulations, improved quality of life for children and families, and cost-savings outside the healthcare system. Regardless of the pharmacare model ultimately implemented, ensuring universal, comprehensive, and portable prescription drug coverage for all children and youth is essential. To accomplish this, paediatric drug experts should develop a national, evidence-informed formulary of paediatric drugs. Health Canada should also improve processes to make commercial paediatric drugs and child-friendly formulations more available and accessible. The federal government must also support paediatric drug research and development to this end.

Avaliação da economia gerada por meio das intervenções farmacêuticas realizadas em um hospital universitário terciário de grande porte / Evaluation of cost savings generated through pharmaceutical inverventions performed in a large tertiary university hospital

Introdução: A farmácia clínica tem como objetivo garantir uma farmacoterapia adequada ao paciente. A avaliação de prescrição é uma das principais atividades do farmacêutico clínico, o que pode resultar em intervenções e economia para a instituição, além de promover o uso racional e seguro de medicamentos. O objetivo deste estudo foi avaliar a economia gerada por meio das intervenções realizadas pelos farmacêuticos clínicos durante o processo de avaliação farmacêutica de prescrição. Métodos: Estudo transversal, observacional e analítico, onde foi analisada a economia gerada através das intervenções realizadas pelos farmacêuticos no período entre janeiro e julho de 2017. Resultados: Foram realizadas 3.033 intervenções no período do estudo e 943 foram incluídas. O valor da economia gerada foi de R$ 72.648,39 (US$ 23.134,95), sendo as intervenções mais frequentes relacionadas à adequação de apresentação (847) e forma farmacêutica (44). Dentre os medicamentos cujas intervenções farmacêuticas resultaram em maior economia, estão a anfotericina B lipossomal (R$ 18.919,75), a daptomicina (R$ 8.575,00), o valganciclovir (R$ 7.452,00) e a anidulafungina (R$ 7.422,35). Algumas intervenções não resultaram em economia direta do tratamento medicamentoso, como ocorreu com a risperidona comprimido (− R$ 264,04) e o sulfametoxazol+trimetoprima comprimido (− R$ 208,62), que foram substituídos por solução oral para administração por sondas. Conclusão: O estudo demonstrou que a atuação do farmacêutico clínico resultou na efetivação de intervenções relacionadas à adequação de dose, correção de diluição, alteração de apresentação, substituição de forma farmacêutica, adequação de tempo de tratamento e a adesão aos protocolos institucionais. Essas intervenções refletiram diretamente na redução de custo dos tratamentos, otimizando recursos e gerando economia ao serviço de saúde. (AU)

Introduction: Clinical pharmacy aims to ensure appropriate pharmacotherapy for patients. Prescription evaluation is one of the main activities of the clinical pharmacist and can result in interventions and cost savings for the institution, in addition to promoting the rational and safe use of medications. The objective of this study was to evaluate cost savings generated through interventions performed by clinical pharmacists during the process of prescription evaluation. Methods: This cross-sectional, observational, analytical study analyzed cost savings generated through interventions performed by pharmacists from January to July 2017. Results: A total of 3,033 interventions were performed during the study period, of which 943 were included. Cost savings amounted to R$ 72,648.39 (US$ 23,134.95), and the most frequent interventions were related to the adequacy of presentation (847) and dosage form (44). The medications whose pharmaceutical interventions resulted in the greatest cost savings are liposomal amphotericin B (R$ 18,919.75), daptomycin (R$ 8,575.00), valganciclovir (R$ 7,452.00), and anidulafungin (R$ 7,422.35). Some interventions did not result in direct cost savings, such as treatment with risperidone tablet (− R$ 264.04) and trimethoprim-sulfamethoxazole tablet (− R$ 208.62), which were replaced by oral solution for tube administration. Conclusion: The study demonstrated that the performance of clinical pharmacists resulted in the implementation of interventions related to dose adjustment, dilution correction, change of presentation, replacement of dosage form, adjustment of treatment duration, and adherence to institutional protocols. These interventions directly resulted in the reduction of treatment costs, optimizing resources and generating cost savings for the health system. (AU)

Assessment of the adherence to and costs of the prophylaxis protocol for venous thromboembolism

OBJECTIVES: Evaluate adherence to the therapeutic prophylaxis protocol for venous thromboembolism (VTE) as well as the costs of this practice. METHODS: A descriptive and cross-sectional study was conducted at a State General Hospital in Brazil through reports of drug dispensions, prescriptions and risk stratification of patients. Adherence to the VTE prophylaxis protocol was monitored. The tests for VTE diagnosis measured the adherence to therapeutic prophylaxis treatment, and the purchase prices of the drugs went into the calculation of drug therapy costs. The level of adherence to prescriptions for VTE prophylaxis in the hospital was classified as "adherence", "non-adherence" and "justified non-adherence" when compared with the protocol. RESULTS: Protocol adherence was observed for 50 (30.9%) patients, and non-adherence was observed for 63 (38.9%) patients, generating an additional cost of $180.40/month. Justified non-adherence in 49 (30.2%) patients generated $514.71/month in savings due to a reduction in the number of daily administrations of unfractionated heparin while still providing an effective method for preventing VTE. Twenty-six patients stratified as having medium to high risk of VTE who did not receive prophylaxis were identified, generating $154.41 in savings. However, these data should be evaluated with caution since the risks and outcomes associated with not preventing VTE outweigh the economy achieved from not prescribing a drug when a patient needs it. The only case of VTE identified during the study period was related to justified non-adherence to the protocol. CONCLUSION: The protocol is based on scientific evidence that describes an effective therapy to prevent VTE. However, the protocol should be updated because the justifications for non-adherence are based on scientific evidence, and this justified non-adherence generates savings and yields effective disease prevention.

Indication-specific Drug Pricing - Simple in Theory, Complex in Reality.

Varying drug prices by indication could be an important value-based strategy in oncology, where multiple indications are becoming the rule. But will administrative costs offset any benefit? And legal and regulatory obstacles could get in the way.

Cost of Cancer Drugs: Something Has To Give.

The drugs often are more effective and have fewer side effects. The science-often just amazing. Medically, cancer treatment has never been in a better place. But are high prices making it unaffordable? Payers, providers, policymakers, and drugmakers themselves are wrestling with the issue. Meanwhile, many patients are being priced out of treatments that could save their lives.

Perfil de gastos com o tratamento da Artrite Reumatoide para pacientes do Sistema Único de Saúde em Minas Gerais, Brasil, de 2008 a 2013 / Profile of spending on the treatment of rheumatoid arthritis for patients of the Unified Health System in the state of Minas Gerais - 2008-2013

Resumo A artrite reumatoide (AR) é uma doença crônica que afeta cerca de 1% da população adulta. No estudo de coorte histórica de pacientes de Minas Gerais, registrados no Sistema de Informações Ambulatoriais (SIA), em 2008-2013, foram identificados 11.573 indivíduos. A perspectiva foi a do financiador público e os valores observados como gastos do Sistema Único de Saúde (SUS) foram ajustados pelo Índice Nacional de Preços ao Consumidor Amplo (IPCA), de dezembro de 2015. O Etanercept foi o tratamento mais caro. A análise múltipla mostrou uma relação negativa entre o aumento das despesas e idade, sexo feminino e diagnóstico de entrada na coorte, e relação positiva para as variáveis Índice de Desenvolvimento Humano Municipal (IDH-M) e o uso de medicamentos bloqueadores do fator de necrose tumoral (ANTI-TNF). Este estudo identificou os fatores que têm impacto sobre o gasto com o tratamento medicamentoso da AR. Também apontou que métodos que permitem extrair dados demográficos e de gastos de sistemas de informação administrativos podem ser ferramentas importantes na construção de estudos econômicos capazes de subsidiar as avaliações econômicas de saúde, especialmente do ponto de vista da gestão.

Abstract Rheumatoid arthritis (RA) is a chronic condition that affects about 1% of the adult population. In a historical cohort of Minas Gerais State, 11,573 RA patients registered in the Outpatient Information System (SIA) between 2008 and 2013 were identified. For this study we adopted the public funding body's perspective and the values were adjusted by the national inflation index (IPCA) of December 2015. Etanercept was the most expensive treatment. The mean cohort age was 52 years old and most of the patients were women. Multiple regression analysis indicated a negative association between higher expenditure and age, female sex, and diagnosis at entry in the cohort and positive association between high expenditure and the Human Development Index (HDI) of the municipality and use of tumor necrosis factor agents. This study identified the factors that have an impact on RA drug treatment expenditure. Also, we showed that methods that enable extracting demographic and expenditure data of administrative information systems may represent important tools in the construction of economic studies to subsidize economic health evaluations, especially from the standpoint of the managers.