Budget impact and cost per responder analysis of upadacitinib for the treatment of moderate to severe atopic dermatitis from the perspective of the social security and the private sector in Argentina.

OBJECTIVES: Our study assessed the budget impact and cost per responder of upadacitinib15mg and 30 mg for moderate to severe atopic dermatitis (MS-AD) treatment from social security and private health sector perspective in Argentina. METHODS: A budget impact model was adapted to depict clinical and economic aspects of treatment over a 5-years horizon time. Scenario analyses and deterministic sensitivity analyses were performed. A 16-weeks cost per responder model was adapted based on a network meta-analysis. Primary analyses assessed the cost per Eczema Area and Severity Index 50, 75 and 90 at week 16. RESULTS: The inclusion of upadacitinib 15 mg and 30 mg in the biological treatment mix for MS-AD was associated with an average budget saving per-member per-month ofU$S0.062 (social security) and U$S0.064 (private sector). Percentage of patients with access to treatment, acquisition cost of upadacitinib 30 mg and prevalence of MS-AD were the most influential parameters in the budget impact results. At week 16, upadacitinib 30 mg was associated with the lowest number needed to treat and the lowest cost per responder for all outcomes. CONCLUSION: The introduction of upadacitinib in MS-AD treatment was associated with modest savings for the social security and private payer budget in Argentina.

Improving Affordability in Dermatology: Cost Savings in Mark Cuban Cost Plus Drug Company Versus GoodRx.

Unlabelled: This observational cost analysis was conducted to assess the efficacy of the Mark Cuban Cost Plus Drug Company (CostPlus) relative to GoodRx and found that CostPlus has significant potential to improve the financial burden of prescription medications within dermatology.

Direct medical costs of polyarthritis in a pediatric hospital in Mexico.

BACKGROUND: Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease in children. The polyarticular course (polyarthritis) represents 63-66% of patients with JIA. The aim was to determine the direct medical costs (DMC) of JIA of the polyarthritis type in pediatric patients of a tertiary hospital in Mexico. METHODS: An analysis of the disease costs was developed from the perspective of the Instituto de Seguridad Social del Estado de México y Municipios Maternal and Child Hospital (HMI). The time horizon was 12 years. All patients diagnosed with JIA with polyarticular course treated by the pediatric rheumatology service of the HMI from January to September 2022 and with an active clinical record were included. Different costing techniques were used. The cost components were consultations, medications, hospitalization, and office and laboratory studies. The costs are reported in USD 2021. RESULTS: Twenty-six records of patients with polyarticular arthritis from the HMI were analyzed, with a mean of 4,555.2 USD (standard deviation [SD] = 1,456.7) and a median of 3,828 USD (SD = 1,492) in the first 10 years of treatment. The components of DMC were medications (82.7%), office and laboratory studies (8.4%), hospitalization (8.0%), and consultations (1.8%). Biological disease-modifying drugs (bDMARDs) accounted for 95.3% of the drug component cost. CONCLUSION: The cost of bDMARDs represented the most critical cost of polyarticular JIA, reflected in the 2nd year of treatment. Including generic bDMARDs and reviewing purchase prices by health institutions in Mexico is necessary.

INTRODUCCIÓN: La Artritis Idiopática Juvenil (AIJ) constituye la enfermedad reumática más común en la edad pediátrica. El curso poliarticular (poliartritis) representa entre el 63-66% de los pacientes con AIJ. El objetivo fue determinar los costos médicos directos (CMD) de la AIJ del tipo poliatritis en pacientes pediátricos de un hospital de tercer nivel en México. MÉTODOS: Se desarrolló un análisis de costos de la enfermedad desde la perspectiva del Hospital Materno Infantil del ISSEMyM (HMI). El horizonte temporal fue de 12 años. Se incluyeron a todos los pacientes con diagnóstico de AIJ con curso poliarticular atendidos por el servicio de Reumatología Pediátrica del HMI de enero a septiembre de 2022 que contaban con expediente clínico activo. Se emplearon diferentes técnicas de costeo. Los componentes de costos fueron: consultas, medicamentos, hospitalización, estudio de gabinete y laboratorio. Los costos están reportados en USD 2021. RESULTADOS: Se analizaron 26 expedientes de pacientes con artritis poliarticular del HMI los cuales presentaron una media de 4,555.2 USD (D.E. = 1,456.7) y una mediana de 3,828 USD (D.E. = 1,492) en los primeros diez años de tratamiento. Los componentes de CMD fueron: medicamentos (82.7%), estudios de gabinete y laboratorio (8.4%), hospitalización (8.0%) y consultas (1.8%). Los medicamentos biológicos modificadores de la enfermedad (MBME) representaron el 95.3% del costo del componente de medicamentos. CONCLUSIÓN: El costo de los MBME representó el costo más importante de la AJI poliarticular, este se reflejó a partir del segundo año de tratamiento. Resulta necesaria la inclusión de MBME enfermedad genéricos y la revisión de los precios de compra por parte de las instituciones de salud en México.

Projected Cost Savings With Optimal Medication Adherence in Patients With Cardiovascular Disease Requiring Lipid-Lowering Therapy: A Multinational Economic Evaluation Study.

BACKGROUND: Poor adherence to chronic cardiovascular treatments can impede targeted clinical outcomes. This study estimates the potential benefits of improving adherence among patients with cardiovascular disease requiring secondary prevention in Mexico, Thailand, and China. METHODS AND RESULTS: We performed Markov model simulation for patients with cardiovascular disease in 3 countries from health care and societal perspectives over a lifetime horizon. Two scenarios were compared: (1) optimal adherence based on a meta-analysis of 51 randomized controlled trials and (2) status quo. The association between adherence and cardiovascular disease outcomes derives from a dose-response meta-analysis of 4 051 338 patients. Outcomes include the accumulated number of cardiovascular events and associated costs in 2022 US dollars, life years, and quality-adjusted life years. Optimal adherence could prevent 42 (95% credible interval [CrI], 29-56) cardiovascular events in Mexico, 34 (95% CrI, 24-50) in Thailand, and 63 (95% CrI, 43-89) in China per 1000 patients over a lifetime. Incremental effectiveness per patient was 0.60 (95% CrI, 0.47-0.74) life-years in Mexico, 0.68 (95% CrI, 0.37-0.94) quality-adjusted life years in Thailand, and 0.93 (95% CrI, 0.44-1.27) quality-adjusted life years in China. Cost savings from societal perspective amounted to $412 (95% CrI, $211-$723), $316 (95% CrI, $187-$541), and $700 (95% CrI, $355-$1144) per patient for Mexico, Thailand, and China, respectively. Findings remained cost saving in deterministic and probabilistic sensitivity analyses. CONCLUSIONS: Achieving optimal adherence in patients with cardiovascular disease requiring lipid-lowering therapy saves costs and improves health outcomes in Mexico, Thailand, and China. These findings support national health care systems implementing strategies to improve adherence in these countries.

Identification of public and private expenditure on medicines using the SHA 2011 methodology

Medicines are frequently used in most health services. They are a high-cost component with high-price dynamics. Analyzing the financial burden of this component is a priority in terms of equity, sustainability, and efficient use of resources. This document supports the standardized measurement of expenditure on medicines by the two most relevant actors: governments and households. By documenting their funding of medicines, policy priorities can be established to better meet treatment needs in each society.

Budget impact analysis of cabergoline for medical treatment of Cushing's disease in Brazil.

Objective: The aim of this study was to estimate the budget impact of adding cabergoline to the Brazilian Unified Health System (SUS) formulary for the treatment of patients with Cushing's disease (CD) who do not achieve disease control after transsphenoidal surgery. Materials and methods: We conducted a budget impact analysis (BIA) from the perspective of the Brazilian SUS over a 5-year time horizon. We compared two scenarios: ketoconazole (Scenario 1) versus including cabergoline as a treatment option (Scenario 2). All analyses were conducted using Microsoft Excel. Uncertainty was explored in univariate sensitivity analyses. Results: The total costs were BRL $25,596,729 for Scenario 1 and BRL $32,469,169 for Scenario 2. The budget impact of adding cabergoline to the formulary for CD treatment within the SUS would be BRL $6,091,036 over 5 years. On univariate analyses, variations in the rates of surgical failure and CD recurrence had the greatest potential to affect the final costs associated with cabergoline. Conclusions: The estimated budget impact of adding cabergoline to the formulary for CD treatment within the Brazilian SUS would be about BRL $6 million. While cost savings cannot be expected, the budget impact of adding cabergoline would be lower than that of adding other treatment options for CD.

Efficient use of mepolizumab in children: An analysis of the economically justifiable price in Colombia.

INTRODUCTION: Asthma imposes a crucial economic burden on health systems, especially with the incorporation of new drugs. Recently, mepolizumab has been approved to prevent exacerbations in patients with eosinophilic asthma. This study explores the economically justifiable price of mepolizumab for preventing exacerbations in children with severe asthma. MATERIALS AND METHODS: A model was developed using the microsimulation to estimate the quality-adjusted costs and life years of two interventions: mepolizumab versus not applying standard treatment without mepolizumab. This analysis was made during a time horizon of 50 years and from a third-payer perspective. RESULTS: Mepolizumab was cost-effective using a WTP of U$ 19,992 per QALY, but not at a WTP of U$ 4828, U$ 5128 per QALY. The economically justifiable cost for mepolizumab in Colombia is between $33 and $350 per dose, for WTP of U$ 4828, and U$ 5128 respectively. At the current price of Mepolizumab, U$ 780 per dose, only using a WTP higher than U$ 10,300 per QALY mepolizumab will be the best alternative to no mepolizumab. CONCLUSION: Our study shows that the economically justifiable cost for mepolizumab in Colombia is between $33 and $350 per dose, for WTP of 4828 and 5180 respectively. This result should encourage more studies in the region that optimize decision-making processes when incorporating this drug into the health plans of each country.

Parathyroidectomy reduces the costs of medication in patients with secondary hyperparathyroidism.

INTRODUCTION: Subtotal Parathyroidectomy (S-PTx) and total Parathyroidectomy with immediate Autograft (PTx-AG) are well-established techniques for the treatment of refractory Secondary Hyperparathyroidism (SHPT), with comparable improvements in patients' quality of life and survival. However, the long-term costs after these operations may impact the choice of surgical technique. The objective of the study is to analyze the impact of surgical treatment on medication costs and whether there is any difference between medication use after each procedure, considering impacts on the health system. MATERIAL AND METHODS: Prospective and randomized study in patients with severe SHPT undergoing S-PTx and PTx-AG. Analysis of prescribed medication costs in the month before the postoperative period at 1-, 3-, 6-, 12-, and 18 months. Costs were estimated according to government payment system values. The medications of 65 patients after PTx-AG were compared with those of 24 patients after S-PTx. A comparison of the total costs of the period between 38 men and 51 women was also made. RESULTS: There were 89 evaluable cases. Surgery reduced medication costs after 12 months. The median of total drug costs in the analyzed period was R$ 8,375.00 per patient. There was no difference in costs per patient in the S-PTx group compared to the PTx-AG group. The median total costs were R$ 11,063.0 for men and R$ 7,651.0 for women (p = 0.0078). CONCLUSIONS: The type of parathyroidectomy did not impact costs after surgery. In the first year after surgery, the use of calcium and calcitriol was more significant than the use of other medications. In the following months, the use of sevelamer is responsible for the highest costs. Men have higher costs in outpatient follow-up after surgery.

[Twenty years since the publication of medication price regulation in Brazil: time to update?] / Vinte anos da publicação da regulamentação de preços de medicamentos no Brasil: momento de atualizar?

Criteria for setting medication prices in Brazil are set forth in CMED Resolution n. 2/2004 of the (Medicines Market Regulation Chamber). The stipulated prices influence the private and public markets, which makes it challenging to review pricing policies due to the need to harmonize social and economic interests. A proposal for reviewing this Resolution was made available through the SEAE Public Consultation n. 2/2021 of the Competition and Competitiveness Advocacy Secretariat/Brazilian Ministry of Economy; however, so far without publication of the consolidated results. Recent recommendations from the World Health Organization regarding the adoption of different thresholds for setting medication prices are adopted in this Resolution, although it was published 20 years ago. To interpret and describe the alignment, possible advances and setbacks between the legal texts related to medication price regulation, we conducted an analytical-descriptive and exploratory documentary research. As a result, the list of reference countries for international price verification and the thresholds for internal and external price referencing were maintained. The normative omissions of the Resolution remain in the Public Consultation, such as the absence of criteria for pricing radiopharmaceuticals, advanced therapies and medication without international and comparator prices in the Brazilian market, to revise prices and transpose provisional to definitive prices. A critical point was the creation of a 35% bonus above the stipulated price for medication that present additional clinical benefit without, however, defining clear contours as to the acceptable scientific evidence to prove such benefit. In short, few advances were noticed in the Public Consultation.

Os critérios para definir os preços de medicamentos no Brasil estão previstos na Resolução CMED nº 2/2004 da Câmara de Regulação do Mercado de Medicamentos. Os preços estipulados influenciam o mercado privado e público, o que torna desafiador a revisão de políticas de preços devido a necessidade de harmonizar interesses sociais e econômicos. Uma proposta de revisão dessa Resolução foi disponibilizada por meio da Consulta Pública SEAE nº 2/2021 da Secretaria de Advocacia da Concorrência e Competitividade/Ministério da Economia, porém, até o momento sem publicação dos resultados consolidados até o momento. Recomendações recentes da Organização Mundial da Saúde em relação à adoção de diferentes limiares para definição de preços de medicamentos são adotadas nessa Resolução, embora essa tenha sido publicada há 20 anos. Com o objetivo de interpretar e descrever o alinhamento e os possíveis avanços e retrocessos nos textos legais relacionados à regulação de preços de medicamentos, foi utilizado o método da pesquisa documental analítica-descritiva, de cunho exploratório. Como resultado, foram mantidas a lista de países referência para conferência de preço internacional e os limiares de referenciamento interno e externo de preços. As omissões normativas da Resolução permanecem na Consulta Pública, como a ausência de critérios para precificar radiofármacos, terapias avançadas e medicamentos sem preço internacional, e sem comparadores no mercado brasileiro para revisar preços e transpor preço provisório para definitivo. Um ponto crítico foi a criação de bônus de 35% acima do preço estipulado para medicamentos que apresentem benefício clínico adicional sem, contudo, definir contornos claros quanto às evidências científicas aceitáveis para a comprovação desse benefício. Em suma, poucos avanços foram percebidos na Consulta Pública.

Los criterios para definir los precios de los medicamentos en Brasil están establecidos en la Resolución CMED nº 2/2004 de la Cámara de Regulación del Mercado de Medicamentos. Los precios estipulados influyen en el mercado público y privado, lo que dificulta la revisión de las políticas de precios debido a la necesidad de armonizar los intereses sociales y económicos. Una propuesta para revisar esta Resolución se puso a disposición mediante la Consulta Pública SEAE nº 2/2021 de la Secretaría de Competencia y Promoción de la Competitividad/Ministerio de Economía, sin embargo, hasta el momento no se han publicado los resultados consolidados. En esta Resolución se adoptan recomendaciones recientes de la Organización Mundial de la Salud sobre la adopción de diferentes umbrales para fijar los precios de los medicamentos, aunque fue publicada hace 20 años. Con el objetivo de interpretar y describir el alineamiento, posibles avances y retrocesos, entre los textos legales relacionados con la regulación de precios de medicamentos, se utilizó el método de investigación documental analítica-descriptiva, de carácter exploratorio. Como resultado, se mantuvieron la lista de países de referencia para la verificación de precio internacional y los umbrales para la referenciación interna y externa de precios. Quedan en Consulta Pública las omisiones normativas de la Resolución, como la ausencia de criterios de fijación de precios de radiofármacos, terapias avanzadas y medicamentos sin precio internacional y comparadores en el mercado brasileño, para revisar precios y transponer el precio provisional al definitivo. Un punto crítico fue la creación de una bonificación del 35% sobre el precio estipulado para los medicamentos que presenten un beneficio clínico adicional sin definir, sin embargo, contornos claros sobre las evidencias científicas aceptables para demostrar dicho beneficio. En definitiva, se percibieron pocos avances en la Consulta Pública.

Medicamentos de alto costo: el difícil equilibrio entre los derechos individuales y los derechos colectivos / High-cost medicines: the difficult balance between individual and collective rights

[RESUMEN]. Los medicamentos son bienes especiales que cubren necesidades de salud de la población. En las últimas décadas, la industria farmacéutica modificó su estrategia de investigación y desarrollo, y migró su interés desde la exploración de fármacos destinados a enfermedades crónicas padecidas por gran parte de la población hacia la búsqueda de medicamentos para pocas personas que tienen enfermedades raras. Esta falta de masividad en los consumidores se traduce en una oferta selectiva de pocos productos dirigidos a ciertas patologías que tienen un precio muy elevado, lo cual hace difícil tanto el acceso de los pacientes como el brindar cobertura desde los financiadores de la salud. En este artículo se recorre la temática de los medicamentos de alto precio y se incorpora al debate el contexto sanitario, cultural, jurídico, político y económico que la rodea. Se hace hincapié en las diferencias existentes entre los distintos fármacos en términos de eficacia para cambiar el curso natural de las enfermedades para los cuales son indicados, en la construcción del precio al cual estos medicamentos se venden en el mercado, en las consecuencias que tiene ese precio para los financiadores de la salud, y en la relación costo-oportunidad de tener que pagar por ellos en desmedro de otros recursos considerados esenciales. Por último, se reflexiona sobre los derechos legítimos de cada individuo a reclamar el acceso a medicamentos de alto precio por considerarlos fundamentales para recuperar su salud, y de cómo garantizar esa cobertura puede afectar los derechos colectivos de la población, y se aportan ejemplos concretos que ilustran esta situación.

[ABSTRACT]. Medicines are special goods that cover the health needs of the population. In recent decades, the pharmaceutical industry has changed its research and development strategy, shifting its focus from the exploration of medicines for chronic diseases affecting a large part of the population to the search for drugs for rare diseases that affect a small number of people. This lack of a mass consumer base is reflected in a selective offer of a few very high-cost products aimed at certain diseases, which hinders both patient access and financial coverage. This article reviews the issue of high-cost medicines, including its cultural, legal, political, economic, and health aspects. It emphasizes the differences between various medicines in terms of their efficacy in changing the natural course of diseases, their market price, the consequences of their cost for healthcare funders, and the cost-opportunity ratio of having to pay for them at the expense of other essential resources. Finally, the article reflects on the legitimate rights of each individual to claim access to high-cost medicines when they are considered essential to recover a person’s health, and on how guaranteeing such coverage can affect the collective rights of the population. Concrete examples that illustrate this situation are provided.

[RESUMO]. Medicamentos são bens especiais que atendem às necessidades de saúde da população. Nas últimas décadas, a indústria farmacêutica mudou sua estratégia de pesquisa e desenvolvimento, deixando de explorar medicamentos para doenças crônicas que afetam grande parte da população e passando a buscar medicamentos para poucas pessoas com doenças raras. Esse número limitado de consumidores se reflete em uma oferta seletiva de poucos produtos de preço elevado para determinadas doenças, dificultando o acesso dos pacientes e a obtenção de cobertura dos agentes financiadores da saúde. Neste artigo, analisa-se a questão dos medicamentos de alto custo e incorpora-se ao debate o contexto sanitário, cultural, jurídico, político e econômico. São enfatizados os seguintes aspectos: diferenças entre os diferentes medicamentos em termos da eficácia em mudar o curso natural das doenças para as quais são indicados; determinação do preço pelo qual esses medicamentos são vendidos no mercado; consequências desse preço para os agentes financiadores da saúde; e a relação custo-oportunidade de ter de pagar por esses medicamentos em detrimento de outros recursos considerados essenciais. Por fim, reflete-se sobre os direitos legítimos de cada indivíduo de reivindicar acesso a medicamentos de alto custo, por considerá-los essenciais para recuperar a própria saúde, e como a garantia dessa cobertura pode afetar os direitos coletivos da população; também são fornecidos exemplos concretos que ilustram essa situação.

Drug Pricing Stewardship from Mark Cuban's Cost Plus Generic Drug Program.

IMPORTANCE: The exceedingly high US spending per capita on prescription medications is mediated, at least in part, by the inefficiencies of existing generic pharmaceutical distribution and reimbursement systems; yet, the extent of potential savings and areas for targeted interventions for generic drug prescribers remains underexplored. OBJECTIVE: We aimed to analyze 2021 Medicare Part D spending on generic drugs in comparison with pricing of a low-cost generic drug program, the Mark Cuban Cost Plus Drug Company (MCCPDC), to gauge the extent of achievable potential savings. DESIGN, SETTING, AND PARTICIPANTS: In this retrospective, observational study, we performed a systematic analysis of potential Medicare Part D savings when using MCCPDC generic pricing. The 2023 MCCPDC data, as of August 2023, were obtained from the provider's publicly available database. The 2021 Medicare Part D data and prescriber datasets were obtained from the US Centers for Medicare and Medicaid Services. MAIN OUTCOMES AND MEASURES: Outcomes included total prescription volume, proportion of drugs with savings, total US dollar Medicare savings, and average weighted price reduction per unit drug. Results were stratified by medical and surgical subspecialties to identify areas for targeted interventions. Subspecialty-wise contribution to total savings versus contribution to total prescription volume was characterized. RESULTS: Total estimated Medicare Part D savings were $8.6 billion using 90-day MCCPDC pricing, with surgical drugs accounting for over $900 million. Nearly 80% of the examined drugs were more price effective through MCCPDC using 90-day supply. Commonly prescribed drugs in cardiology, psychiatry, neurology, transplant surgery, and urology demonstrated the highest estimated absolute savings. The most disproportionate savings relative to prescription volume were observed for drugs in oncology, gynecology, infectious disease, transplant surgery, and colorectal surgery. CONCLUSIONS AND RELEVANCE: This study underscores the significant potential for Medicare Part D savings through strategies that address the systemic overpayment for generic medications. We identified key areas for reform as well as specific medical and surgical subspecialties where targeted interventions could yield substantial savings.

Frequency of use and annual costs of biological therapy for psoriasis in Colombia in 2019.

BACKGROUND: Evidence describing the types and annual costs of biological treatments for psoriasis in Latin America is scarce. This study aimed to estimate the frequency of use and costs of biologic therapy for psoriasis in Colombia in 2019. METHODS: This secondary data analysis uses the International Classification of Diseases terms associated with psoriasis, excluding those related to psoriatic arthritis, based on data from the registry of the Colombian Ministry of Health. We estimated the prevalence of psoriasis per 100,000 inhabitants; then, we retrieved the frequency of use of biologic therapy in patients with psoriasis and estimated the cost per year of each and overall therapies in 2019 in US dollars (USD). RESULTS: There were 100,823 patients with psoriasis in Colombia in 2019, which amounts to a prevalence of 0.2% in the general population. Of those patients, 4.9% received biologic therapy, most frequently males (60%). The most commonly used biological therapies for psoriasis in Colombia in 2019 were ustekinumab (35.2%), with an annual cost per patient of $12,880 USD; adalimumab (26%), with a yearly cost per patient of $7130 USD; and secukinumab (19.8%), with an annual cost per patient of $6825 USD. CONCLUSION: This is the first study to describe the use and cost of biological therapy for psoriasis in Colombia. It provides valuable cost-awareness information for the Colombian health system.

Clinical Benefit and Revenues of Drugs Affected by Rare Pediatric Disease Priority Review Vouchers, 2017-2023.

OBJECTIVE: To determine the clinical benefit of drugs that earned or redeemed rare pediatric disease priority review vouchers (PRVs) from 2017 through 2023, and the revenues generated by such drugs. STUDY DESIGN: In this cohort study, Federal Register documents, publicly available health technology agency (HTA) assessments, and financial filings were used to identify drugs that were issued or redeemed using a rare pediatric disease PRV from 2017 through 2023, and to assess their added therapeutic benefit and drug-specific global revenues. RESULTS: Among the 36 drugs whose approval resulted in issuance of a rare pediatric PRV, therapeutic benefit ratings were available for 17 (47%), with 9 (53%) rated as high by at least 1 organization. Mean annual global revenues were $363 million (year 1), $621 million (year 2), and $850 million (year 3). The median annual list price for drugs issued a voucher was $788,705. Vouchers were then redeemed for 15 different drugs; out of 13 drugs with therapeutic benefit ratings, 4 (31%) were high value. CONCLUSIONS: Drugs that treat rare pediatric diseases generate similar revenues compared with other brand drugs, and drugs with high therapeutic benefit tend to generate more revenue than those with low therapeutic benefit. Drugs that earned the rare pediatric disease PRV for their manufacturer generate significant revenues and the voucher may not be necessary to incentivize drug development in the rare pediatric disease space.

Patient-Level Savings on Generic Drugs Through the Mark Cuban Cost Plus Drug Company.

This economic evaluation estimates the out-of-pocket cost savings patients could achieve if generic drugs were purchased directly from the Mark Cuban Cost Plus Drug Company rather than using their health insurance.

[Judicialization of high priced medications in Argentina: quali-quantitative study]. / Judicialización de medicamentos de alto precio en Argentina: estudio cuali-cuantitativo.

INTRODUCTION: The economic consequences of mandatory coverage, through judicial means, of high-priced medications constitutes a growing problem, which merits knowing its local characteristics to provide possible solutions. OBJECTIVE: To identify medications, diseases involved, economic impact and contextual factors of the judicialization of high-priced medications in the Argentine Health System(MEP). METHODS: Quali-quantitative descriptive study that retrospectively analyzed legal protection resources by MEP from three national and provincial databases from January 2017 to December 2020, evaluating the existing relationship between lawsuits with regulatory approval, inclusion in benefit packages and relationship with journalistic articles for the three most frequently prosecuted drugs. RESULTS: 405 lawsuits were included, mainly from the Ministry of National Health. The three most prosecuted medications were nusinersen (21.7%), palbociclib (5.9%) and agalsidase-alfa (4.7%). Only 69.4% of medications were approved for marketing in Argentina at the time of the protection; 45.7% were incorporated into the Single Reimbursement System, and 16.8% had a report from the National Commission for the Evaluation of Health Technologies and Clinical Excellence (CONETEC), which was negative in 87.1% of cases. The average time from request to provision of the medication was 150 days. A temporal correlation was observed between the appearance of the MEP in the national graphic press and the appeals occurrence. CONCLUSIONS: Judicialization focused on very highpriced medications for rare or oncological diseases. The rulings were mostly in favor of the plaintiff, and access times to the medication took a long time. The mass media anticipated the judicial processes.

Introducción: Las consecuencias económicas de la cobertura obligatoria, vía judicial, de medicamentos de alto precio constituye un problema creciente, que amerita conocer sus características locales para aportar posibles soluciones. OBJETIVO: Identificar medicamentos, enfermedades, impacto económico y factores contextuales de la judicialización de medicamentos de alto precio (MEP) Argentina. Métodos: Estudio descriptivo cuali-cuantitativo que analizó retrospectivamente recursos de amparos legales por MEP de tres bases de datos nacionales y provinciales durante 4 años, evaluando relación existente entre amparos con aprobación regulatoria, inclusión de los MEP al paquete de beneficios y relación con notas periodísticas. RESULTADOS: Se incluyeron 405 amparos provenientes principalmente del Ministerio de Salud Nacional. Los tres medicamentos más judicializados fueron nusinersen (21.7%), palbociclib (5.9%) y agalsidasa-alfa (4.7%). Solo el 69.4% de los medicamentos se encontraban aprobados para la comercialización en Argentina al momento del amparo; el 45.7% se encontraban incorporados al Sistema Único de Reintegros y el 16.8% contaban con informe de la Comisión Nacional de Evaluación de Tecnologías Sanitarias y Excelencia Clínica (CONETEC), negativa en el 87.1% de casos. El tiempo promedio desde la solicitud hasta la provisión del medicamento fue de 150 días. Se observó una correlación temporal entre la aparición del MEP en la prensa nacional gráfica y la presentación de amparos de dicho MEP. CONCLUSIONES: La judicialización se concentró en medicamentos de altísimo precio para enfermedades poco frecuentes u oncológicas. Los fallos fueron mayoritariamente a favor del demandante, siendo los tiempos de acceso al medicamento prolongados. Los medios de comunicación anticiparon los procesos judiciales.

Spending on nucleos(t)ide analogues for hepatitis B in medicaid beneficiaries: 2012-2021.

INTRODUCTION AND OBJECTIVES: Treatment of chronic hepatitis B (CHB) with nucelos(t)ide analogues (NA) can improve outcomes, but NA treatment is expensive for insurance plans. MATERIALS AND METHODS: The Centers for Medicare & Medicaid Services database was assessed from 2012 to 2021 to assess the use of NA for CHB in patients on Medicaid. Data extracted included the number of claims, units, and costs of each agent stratified by originator and generic. RESULTS: Over the study period, 1.9 billion USD was spent on NA, with spending peaking in 2016 at $289 million US, which has subsequently decreased. Lower expenditures since 2016 have been associated with increased use of generics. The use of generic tenofovir or entecavir led to savings of $669 million US over the study period. CONCLUSIONS: Increased generic use has significantly reduced expenditures for NA drugs; policy shifts towards generic drug use may help with sustainability.

Costo en el cuidado de enfermería a personas con úlcera vascular venosa / Cost of nursing care for patients with venous vascular ulcer / Custo dos cuidados de enfermagem as pessoas com úlcera vascular venosa

Introducción: El cuidado de las úlceras vasculares venosas se ha considerado un problema de salud pública por su alta incidencia e impacto social y económico que genera. Objetivo: Determinar los costos directos del cuidado de enfermería en personas con úlcera vascular venosa atendidas por un prestador de servicios de salud en la ciudad de Bogotá. Materiales y métodos: Estudio observacional, descriptivo, retrospectivo, realizado entre el 1 enero de 2019 y el 31 de enero de 2020; el cual se basó, en la revisión de historias clínicas de personas con úlcera vascular venosa. La muestra estuvo conformada por 52 historias clínicas, seleccionadas mediante un instrumento de valoración de enfermería. Las variables que se analizaron fueron la edad y el sexo, utilizando estadística descriptiva y el análisis del costo. Resultados: El sexo predominante fue el femenino (69,24%) y la edad promedio de 64 años. El costo directo fue de 70.109.504.76 COP y la estimación promedio 1.348.259 COP, valor que incluyó el costo de apósitos, elastocompresión, limpieza y consulta. Conclusión: Los costos en el cuidado de las úlceras vasculares venosas están inmersos en los paquetes de atención, que incluyen los costos de curación y consulta; sin embargo, no son explícitos para enfermería.

Introduction: The venous vascular ulcers care has become a public health problem due to its high incidence and the social and economic impact it causes. Objective: To determine the direct costs of nursing care of people with venous vascular ulcers treated at a health service provider facility in Bogota, Colombia. Materials and methods: Observational, descriptive, retrospective study carried out between January 1, 2019 and January 31, 2020, which focused on the review of medical records of patients with venous vascular ulcer. The sample included 52 medical records that were selected through a nursing assessment instrument. The variables of age and gender were analyzed through descriptive statistics and cost analysis. Results: Female was the predominant gender (69.24%) and the average age was 64 years. The direct cost was $70.109.504.76 COP, whereas the average estimate was $1.348.259 COP, which included the cost of dressings, elastocompression, cleaning, and consultation. Conclusion: The costs of venous vascular ulcers care are included in the care packages, which include costs of healing and consultation. Nevertheless, they are not explicit for nursing.

Introdução: O atendimento às úlceras vasculares venosas tem sido considerado um problema de saúde pública devido à alta incidência e ao impacto social e econômico que gera. Objetivo: Determinar os custos diretos da assistência de enfermagem a pessoas com úlceras vasculares venosas atendidas por um serviço de saúde na cidade de Bogotá. Materiais e métodos: Estudo observacional, descritivo, retrospectivo, realizado entre 1º de janeiro de 2019 e 31 de janeiro de 2020; que se baseou na revisão de prontuários de pessoas com úlcera vascular venosa. A amostra foi composta por 52 prontuários, selecionados por meio de instrumento de avaliação de enfermagem. As variáveis analisadas foram idade e sexo, por meio de estatística descritiva e análise de custos. Resultados: O sexo predominante foi o feminino (69,24%) e a média de idade foi de 64 anos. O custo direto foi de 70.109.504,76 COP e a estimativa média foi de 1.348.259 COP, valor que incluiu o custo de curativos, elastocompressão, limpeza e consulta. Conclusão: Os custos no cuidado das úlceras vasculares venosas estão embutidos nos pacotes de cuidados, que incluem os custos de cura e consulta; entretanto, não são explícitos para a enfermagem.

A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy.

BACKGROUND: Biosimilar medicines are defined as biological products highly similar to an already licensed biological product (RP). The market entry of biosimilars is expected to reduce the costs of biological treatments. OBJECTIVE: This study aims to evaluate the range of differences between the prices of biosimilars and the corresponding RP for biologicals approved in four countries. METHOD: This is a cross-national comparison of pricing of biosimilars in Argentina, Australia, Brazil, and Italy. The study examined online price databases provided by the national authorities of the investigated countries. Biosimilar price difference was calculated by subtracting the unit price of the biosimilar by the unit price of the RP, and then dividing it by the unit price of the RP. The results were presented as percentage. RESULTS: Brazil had the highest median price reduction (- 36.3%) in biosimilars price, followed by Italy (- 20.0%) and Argentina (- 18.6%). All the biosimilars in Italy were priced below the RP presenting a minimum reduction of 6.3%, while in Australia, most of the prices of biosimilars were equal to the RP. In Argentina, one infliximab-biosimilar displayed price above the RP (40.7%) while the lower priced brand had a reduction of 14.4%. Brazil had four biosimilars with prices above the respective RP, including isophane insulin (1), insulin glargine (1) and somatropin (2). CONCLUSION: The study revealed a marked dispersion in the price's differences between biosimilars and RP across the studied countries. Governments should evaluate whether their policies have been successful in improving affordability of biological therapies.

Evaluation of Potential Urologic Prescription Drug Savings With Mark Cuban Cost Plus Drug Company.

INTRODUCTION: Mark Cuban Cost Plus Drug Company (MCCPDC) launched in 2022 with a goal to decrease prescription drug costs. Thus far, research has focused on possible savings if Medicare purchased its annual volume of drugs at MCCPDC prices. The aim of this study is to analyze if MCCPDC can offer savings directly to urologic patients compared with other mail-order pharmacies, local pharmacies, and with patients using health insurance. METHODS: Twelve drugs used to treat urological diseases available on MCCPDC were analyzed. Pricing data of 30-tab and 90-tab prescriptions from MCCPDC, other mail-order pharmacies, and local in-person pharmacies near our zip code 40508 (Lexington, Kentucky) were compiled. To compare if MCCPDC could offer savings to patients using health insurance to fill their prescriptions, out-of-pocket drug costs for patients from the 2020 and 2021 Medical Expenditure Panel Survey and the 2021 Medicare Part D spending data were extracted. RESULTS: Greater savings at MCCPDC were found at 90-tab prescriptions, but overall variability in prices existed. When comparing without health insurance, 9 of 12 drugs at MCCPDC were cheaper at 90 tabs with solifenacin and tadalafil saving $20 and $12 per prescription. When considering patients using insurance, abiraterone, sildenafil, and tadalafil offered savings on out-of-pocket costs at 30- and 90-tab prescriptions. CONCLUSIONS: MCCPDC may offer cheaper prices for patients filling urologic medications, especially at 90-tab prescriptions. This study is the first to show patients could save money using MCCPDC and has implications for physician counseling when prescribing common urologic drugs.