Eligibility for Low-Dose Rivaroxaban Based on the COMPASS Trial: Insights from the Veterans Affairs Healthcare System.

INTRODUCTION: Low-dose rivaroxaban reduced major adverse cardiac and limb events among patients with stable atherosclerotic vascular disease (ASCVD) in the COMPASS trial. The objective of our study was to evaluate the eligibility and budgetary impact of the COMPASS trial in a real-world population. METHODS: The VA administrative and clinical databases were utilized to conduct a cross-sectional study to identify patients eligible for low-dose rivaroxaban receiving care at all 141 facilities between October 1, 2014 and September 30, 2015. Proportion of patients with stable ASCVD eligible for low-dose rivaroxaban and prevalence of multiple risk enrichment criteria among eligible patients. Pharmaceutical budgetary impact using VA pharmacy pricing. Chi-squared and Student's t tests were used to compare patients eligible versus ineligible patients. RESULTS: From an initial cohort of 1,248,214 patients with ASCVD, 488,495 patients (39.1%) met trial eligibility criteria. Eligible patients were older (74.2 vs 64.5 years) with higher proportion of hypertension (84.1% vs 82.1%) and diabetes (46.2% vs 32.9) compared with ineligible patients (p < 0.001 for all comparisons). A median of 38.7% (IQR 4.6%) of total ASCVD patients per facility were rivaroxaban eligible. Estimated annual VA pharmacy budgetary impact would range from $0.47 billion to $1.88 billion for 25% to 100% treatment penetration. Annual facility level pharmaceutical budgetary impact would be a median of $12.3 million (IQR $8.0-$16.3 million) for treatment of all eligible patients. Among eligible patients, age greater than 65 years was the most common risk enrichment factor (86.9%). Prevalence of eligible patients with multiple enrichment factors varied from 34.2% (one factor) to 6.2% (four or more). CONCLUSION: Over one third of patients with stable ASCVD may qualify for low-dose rivaroxaban within the VA. Additional studies are needed to understand eligibility in other populations and a formal cost-effectiveness analysis is warranted.

Budget impact analysis of darolutamide for treatment of nonmetastatic castration-resistant prostate cancer.

BACKGROUND: Darolutamide, a structurally distinct androgen receptor inhibitor approved for the treatment of men with nonmetastatic castration-resistant prostate cancer (nmCRPC), has been shown to increase metastasis-free survival among men with nmCRPC compared with placebo. This treatment has a novel chemical structure that may also have safety, tolerability, and efficacy advantages for men with nmCRPC. OBJECTIVE: To estimate the projected budget impact of including darolutamide on a U.S. payer formulary as a treatment option for men with nmCRPC. METHODS: A budget impact model was developed to evaluate darolutamide for nmCRPC for a hypothetical 1-million-member plan over a 5-year period. Costs (drug acquisition, drug administration, and treatment-related adverse events [AEs]) were estimated for 2 scenarios: with and without darolutamide treatment for nmCRPC. The budget impact of darolutamide was calculated as the difference in costs for these 2 scenarios. An analysis for high-risk nmCRPC also was conducted. The model included treatments recommended by the National Comprehensive Cancer Network (e.g., apalutamide and enzalutamide) and potential comparators that are used but are not specifically indicated for nmCRPC. All treatments were assumed to be administered in combination with a weighted average androgen deprivation therapy comparator (consisting of luteinizing hormone-releasing hormone [LHRH] agonists, LHRH antagonists, and first-generation antiandrogens). Market share estimates were derived from interviews with physicians treating men with nmCRPC. The model includes grade 3-4 AEs, and the rates were obtained from clinical trial data. Costs were taken from publicly available sources and varied in a one-way sensitivity analysis. RESULTS: For a plan with 1 million lives, there were approximately 90 incident cases of nmCRPC (46 high risk) each year, with 332 (109 high risk) treatment-eligible cases by year 5. Darolutamide's market share increased from 3.6% in year 1 to 18% in year 5. Given the utilization of other agents, introducing darolutamide along with other targeted therapies was predicted to increase the total budget by $158,640 ($0.0132 per member per month [PMPM]) in year 1, which decreased over time to a cost savings of $149,240 ($0.0124 PMPM) by year 5. The scenario with darolutamide showed reduced AE costs each year. Similar results were observed for the high-risk nmCRPC population. CONCLUSIONS: Adding darolutamide to a U.S. payer formulary for the treatment of nmCRPC can result in a manageable increase in the budget that is partly offset by AE costs in the first 4 years, followed by a cost savings by year 5. DISCLOSURES: This study was conducted by RTI Health Solutions under the direction of Bayer U.S. and was funded by Bayer U.S., which was involved in the design of the study; collection, analysis, and interpretation of the data; writing of the report; and the decision to submit the report for publication. Miles and Purser (and/or their institutions) are employees of RTI Health Solutions and received research funding from Bayer U.S. to develop the budget impact model. Appukkuttan and Farej are employees of Bayer U.S. Wen was an employee of Bayer U.S. at the time of the study. This study was presented as a poster at the AMCP Virtual Learning Event, April 20-24, 2020.

A novel method for predicting the budget impact of innovative medicines: validation study for oncolytics.

BACKGROUND: High budget impact (BI) estimates of new drugs have led to decision-making challenges potentially resulting in restrictions in patient access. However, current BI predictions are rather inaccurate and short term. We therefore developed a new approach for BI prediction. Here, we describe the validation of our BI prediction approach using oncology drugs as a case study. METHODS: We used Dutch population-level data to estimate BI where BI is defined as list price multiplied by volume. We included drugs in the antineoplastic agents ATC category which the European Medicines Agency (EMA) considered a New Active Substance and received EMA marketing authorization (MA) between 2000 and 2017. A mixed-effects model was used for prediction and included tumor site, orphan, first in class or conditional approval designation as covariates. Data from 2000 to 2012 were the training set. BI was predicted monthly from 0 to 45 months after MA. Cross-validation was performed using a rolling forecasting origin with e^|Ln(observed BI/predicted BI)| as outcome. RESULTS: The training set and validation set included 25 and 44 products, respectively. Mean error, composed of all validation outcomes, was 2.94 (median 1.57). Errors are higher with less available data and at more future predictions. Highest errors occur without any prior data. From 10 months onward, error remains constant. CONCLUSIONS: The validation shows that the method can relatively accurately predict BI. For payers or policymakers, this approach can yield a valuable addition to current BI predictions due to its ease of use, independence of indications and ability to update predictions to the most recent data.

Cervical cancer prevention in Indonesia: An updated clinical impact, cost-effectiveness and budget impact analysis.

INTRODUCTION: The clinical and economic impact of cervical cancer consistently become a serious burden for all countries, including Indonesia. The implementation of HPV vaccination policy for a big country such as Indonesia requires a strong commitment from several decision-makers. The aim of this study was to provide a comprehensive description on cost-effectiveness and the budget-impact of HPV vaccination policy in Indonesia. METHOD: A cohort Markov model was used to evaluate the cost and the clinical impact of HPV vaccination for 10 years old girls in Indonesia. The researchers consider two doses of all three available HPV vaccines adjusted with the HPV infection profilewith 95% vaccination coverage to estimate the national cervical cancer incidence and mortality. The Budget impact analysis explores three different scenarios covering (1) Two districts per year expansion, (2) oneprovince per year expansion and (3) achieving the National Immunization Program in 2024. RESULTS: Upon fully vaccinating almost 2.3 million 10-year-old girls, 34,723; 43,414; and 51,522 cervical cancer cases were prevented by Quadrivalent, Bivalent and Nonavalent vaccines, consecutively. Furthermore, the highest (591 cases) and lowest (399 cases) mortality were prevented by Nonavalent and Quadrivalent vaccines, respectively. Most of the vaccines were considerably cost-effective and only the Bivalent vaccine with the GAVI/UNICEF price which will be considered a cost-saving strategy.To provide national coverage of HPV vaccination in Indonesia, the government has to provide an annual budget of about US$49 million and US$22 million using the government contract price and GAVI/UNICEF price, respectively. CONCLUSION: HPV vaccination shows a cost-effective strategy and the budget required to provide this policy is considerably affordable for Indonesia.

Budget Impact of Enzalutamide for Nonmetastatic Castration-Resistant Prostate Cancer.

BACKGROUND: Prostate cancer is the most common cancer and second-leading cause of cancer death among men in the United States. Prostate cancer poses a large economic burden, which increases with progression from localized to metastatic disease. Newly approved treatments for non-metastatic castration-resistant prostate cancer (nmCRPC) delay disease progression and reduce the risk of metastatic disease. Quantifying the potential budget impact of these new treatments is of interest to health care decision makers. OBJECTIVE: To estimate the budget impact of enzalutamide for the treatment of patients with nmCRPC in the United States over a 3-year time horizon. METHODS: An Excel-based model was developed to estimate the budget impact to a U.S. health plan of enzalutamide, a second-generation antiandrogen, as an add-on to androgen deprivation therapy (ADT) for the treatment of high-risk nmCRPC patients (prostate-specific antigen doubling time of ≤ 10 months). Comparators include apalutamide + ADT, bicalutamide + ADT, and ADT only. The analysis includes treatment costs for nmCRPC and for treatment after progression to metastatic castration-resistant prostate cancer (mCRPC). The treated population size was estimated from epidemiological data and literature. Dosing, duration of therapy, and adverse event rates were based on package inserts and pivotal studies. RED BOOK, Centers for Medicare & Medicaid Services fee schedules, and literature were used to obtain costs of drugs, adverse events, and health care visits. Market shares were estimated for each comparator before and after enzalutamide adoption. A 1-way sensitivity analysis was performed to quantify the impact of parameter uncertainty. RESULTS: In a hypothetical 1-million-member plan with 3% annual growth, it was estimated that there would be approximately 19 eligible incident nmCRPC patients in year 1, increasing to 20 eligible incident patients in year 3. With an assumed market share of approximately 6% for enzalutamide in year 1, the budget impact would be $106,074 ($0.009 per member per month [PMPM]). With a 26% enzalutamide share in year 3, the budget impact would be $632,729 ($0.048 PMPM). Cumulative budget impact to the health plan over 3 years is estimated to be $1,082,095 ($0.028 PMPM). The increased cost of the treatment regimen is partly offset by reduced postprogression costs. CONCLUSIONS: Treatment of nmCRPC patients with enzalutamide has a modest budget impact that is partly offset by delaying progression to mCRPC. DISCLOSURES: This research was sponsored by Astellas Pharma and Pfizer, the codevelopers of enzalutamide. All authors contributed to the development of the manuscript and maintained control over the final content. Schultz is employed by Astellas Pharma and owns stock in Gilead Sciences and Shire. O'Day and Sugarman are employees of Xcenda, which received consultancy fees from Astellas Pharma. Ramaswamy is employed by Pfizer. A synopsis of the current study was presented in poster format at the AMCP Managed Care & Specialty Pharmacy Annual Meeting 2019, in San Diego, CA, on March 25-28, 2019.

A budget impact analysis of a magnetic sphincter augmentation device for the treatment of medication-refractory mechanical gastroesophageal reflux disease: a United States payer perspective.

BACKGROUND: Medication-refractory gastroesophageal reflux disease (GERD) is sometimes treated with laparoscopic Nissen fundoplication (LNF); however, this is a non-reversible procedure associated with important side effects and the need for repeat surgery. Removable magnetic sphincter augmentation (MSA) devices are an alternative, effective, and safe treatment option for such patients who have some lower esophageal sphincter function. The objective of this study was to assess the economic impact of introducing MSA technology (i.e., LINX Reflux Management System) into current practice from a US-payer perspective. METHODS: An economic budget impact model was developed over a 1-year time horizon that compared current treatment of GERD patients who are medically managed (but refractory) or receiving LNF to future treatment of GERD patients that included a mix of patients treated with medical management only, LNF, or MSA. Resources included within the analyses were index procedures (inpatient and outpatient use), reoperations (revisions and removals), readmissions, healthcare visits, diagnostic tests, procedures, and medications. Medicare payment rates were typically used to inform unit costs. RESULTS: Assuming a hypothetical commercial insurance population of 1 million members, the base-case analysis estimated a net cost savings of $111,367 with introduction of the MSA. This translates to a savings of $0.01 per member per month. Results were largely driven by avoided inpatient procedures with use of the MSA device. Alternative analyses exploring the potential impact of increasing surgical volumes predicted that results would remain cost saving if the proportion of MSA market share taken from LNF was ≥ 90%. CONCLUSIONS: This study predicts that the introduction of the MSA device would lead to favorable budget impact results for the treatment of medication-refractory mechanical GERD for commercial payers. Future analyses will benefit from inclusion of middle-ground treatments as well as longer time horizons.

RDQA - Relatório Detalhado do Quadrimestre Anterior da Secretaria de Saúde do Estado do Tocantins [1º Quadrimestre de 2020] / RDQA - Detailed Report for the Previous Quadrimester of the Tocantins State Health Department [1st Quadrimester of 2020]

O Relatório Detalhado do Quadrimestre Anterior (RDQA) apresentam os resultados alcançados com a execução da PAS a cada quadrimestre e orientam eventuais redirecionamentos. Eles têm a função de comprovar a aplicação de todos os recursos do Fundo de Saúde. É instrumento indissociável do Plano e de suas respectivas Programações, sendo a principal ferramenta para subsidiar o processo de monitoramento e avaliação da gestão. Tem seu modelo padronizado pela Resolução nº 459 do Conselho Nacional de Saúde - CNS, de 10 de outubro de 2012, publicada no DOU de 21/12/2012, conforme dispõe o Parágrafo 4º do Artigo 36 da Lei Complementar nº 141/2012. A Programação Anual de Saúde (PAS) é a referência de execução das ações e serviços públicos em saúde, cujo processo de sua gestão é demonstrado no Relatório de Gestão: a cada quadrimestre no RDQA e ao final do exercício no Relatório Anual de Gestão (RAG).

The Detailed Report for the Previous Quadrimester (RDQA) presents the results achieved with the execution of the PAS every four months and guides any redirections. They have the function of proving the application of all the resources of the Health Fund. It is an inseparable instrument of the Plan and its respective Programs, being the main tool to support the process of monitoring and evaluation of management. Its model is standardized by Resolution No. 459 of the National Health Council - CNS, of October 10, 2012, published in the DOU of 12/21/2012, as provided in Paragraph 4 of Article 36 of Complementary Law No. 141/2012. The Annual Health Program (PAS) is the benchmark for executing public health actions and services, whose management process is demonstrated in the Management Report: every four months in the RDQA and at the end of the year in the Annual Management Report (RAG) ).

El Informe Detallado del Cuatrimestre Anterior (RDQA) presenta los resultados obtenidos con la ejecución del PAS cada cuatro meses y orienta las redirecciones. Tienen la función de acreditar la aplicación de todos los recursos del Fondo de Salud, instrumento inseparable del Plan y sus respectivos Programas, siendo la principal herramienta de apoyo al proceso de seguimiento y evaluación de la gestión. Su modelo se encuentra estandarizado por la Resolución No. 459 del Consejo Nacional de Salud - CNS, de 10 de octubre de 2012, publicada en el DOU de 21/12/2012, según lo dispuesto en el numeral 4 del artículo 36 de la Ley Complementaria No. 141/2012. El Programa Anual de Salud (PAS) es el referente para la ejecución de acciones y servicios de salud pública, cuyo proceso de gestión se demuestra en el Informe de Gestión: cuatrimestral en el RDQA y al final del año en el Informe Anual de Gestión (RAG) ).

Le rapport détaillé du quadrimestre précédent (RDQA) présente les résultats obtenus avec l'exécution du PAS tous les quatre mois et guide les éventuelles réorientations. Ils ont pour fonction de prouver l'application de toutes les ressources du Fonds de la Santé, instrument indissociable du Plan et de ses Programmes respectifs, étant le principal outil d'appui au processus de suivi et d'évaluation de la gestion. Son modèle est normalisé par la résolution n ° 459 du Conseil national de la santé - CNS du 10 octobre 2012, publiée au DOU du 21/12/2012, comme prévu au paragraphe 4 de l'article 36 de la loi complémentaire n ° 141/2012. Le Programme Annuel de Santé (PAS) est la référence pour la mise en œuvre d'actions et de services de santé publique, dont le processus de gestion est démontré dans le rapport de gestion: tous les quatre mois dans le RDQA et en fin d'année dans le rapport annuel de gestion (RAG) ).

RDQA 2º Quadrimestre de 2020 Relatório Detalhado do Quadrimestre Anterior da Secretaria de Saúde do Estado do Tocantins / RDQA 2nd Quadrimester of 2020 Detailed Report of the Previous Quadrimester of the State Health Department of Tocantins

O Relatório Detalhado do Quadrimestre Anterior (RDQA) apresentam os resultados alcançados com a execução da PAS a cada quadrimestre e orientam eventuais redirecionamentos. Eles têm a função de comprovar a aplicação de todos os recursos do Fundo de Saúde. É instrumento indissociável do Plano e de suas respectivas Programações, sendo a principal ferramenta para subsidiar o processo de monitoramento e avaliação da gestão. Tem seu modelo padronizado pela Resolução nº 459 do Conselho Nacional de Saúde - CNS, de 10 de outubro de 2012, publicada no DOU de 21/12/2012, conforme dispõe o Parágrafo 4º do Artigo 36 da Lei Complementar nº 141/2012. A Programação Anual de Saúde (PAS) é a referência de execução das ações e serviços públicos em saúde, cujo processo de sua gestão é demonstrado no Relatório de Gestão: a cada quadrimestre no RDQA e ao final do exercício no Relatório Anual de Gestão (RAG).

The Detailed Report for the Previous Quadrimester (RDQA) presents the results achieved with the execution of the PAS every four months and guides any redirections. They have the function of proving the application of all the resources of the Health Fund. It is an inseparable instrument of the Plan and its respective Programs, being the main tool to support the process of monitoring and evaluation of management. Its model is standardized by Resolution No. 459 of the National Health Council - CNS, of October 10, 2012, published in the DOU of 12/21/2012, as provided in Paragraph 4 of Article 36 of Complementary Law No. 141/2012. The Annual Health Program (PAS) is the benchmark for executing public health actions and services, whose management process is demonstrated in the Management Report: every four months in the RDQA and at the end of the year in the Annual Management Report (RAG) ).

El Informe Detallado del Cuatrimestre Anterior (RDQA) presenta los resultados obtenidos con la ejecución del PAS cada cuatro meses y orienta las redirecciones. Tienen la función de acreditar la aplicación de todos los recursos del Fondo de Salud, instrumento inseparable del Plan y sus respectivos Programas, siendo la principal herramienta de apoyo al proceso de seguimiento y evaluación de la gestión. Su modelo se encuentra estandarizado por la Resolución No. 459 del Consejo Nacional de Salud - CNS, de 10 de octubre de 2012, publicada en el DOU de 21/12/2012, según lo dispuesto en el numeral 4 del artículo 36 de la Ley Complementaria No. 141/2012. El Programa Anual de Salud (PAS) es el referente para la ejecución de acciones y servicios de salud pública, cuyo proceso de gestión se demuestra en el Informe de Gestión: cuatrimestral en el RDQA y al final del año en el Informe Anual de Gestión (RAG) ).

Le rapport détaillé du quadrimestre précédent (RDQA) présente les résultats obtenus avec l'exécution du PAS tous les quatre mois et guide les éventuelles réorientations. Ils ont pour fonction de prouver l'application de toutes les ressources du Fonds de la Santé, instrument indissociable du Plan et de ses Programmes respectifs, étant le principal outil d'appui au processus de suivi et d'évaluation de la gestion. Son modèle est normalisé par la résolution n ° 459 du Conseil national de la santé - CNS du 10 octobre 2012, publiée au DOU du 21/12/2012, comme prévu au paragraphe 4 de l'article 36 de la loi complémentaire n ° 141/2012. Le Programme Annuel de Santé (PAS) est la référence pour la mise en œuvre d'actions et de services de santé publique, dont le processus de gestion est démontré dans le rapport de gestion: tous les quatre mois dans le RDQA et en fin d'année dans le rapport annuel de gestion (RAG) ).

Financiamento público, preparação olímpica e aplicação de recursos: o caso da confederação brasileira de handebol / Public funding, olympic preparation and resources application: the case of the brazilian handball confederation

RESUMO Esse estudo, de caráter documental, teve como objetivo investigar o volume e a aplicação de recursos públicos federais da CBHb no período entre 2008 e 2016, em relação as funções estabelecidas às entidades de administração do esporte, pelo Sistema Brasileiro do Desporto. Identificou-se as principais receitas da entidade e coletou-se documentos e prestações de contas (e.g. e-SIC, ME e COB) contendo os valores dos repasses e suas aplicações. Considerou-se apenas os valores executados pela entidade. No período, a CBHb executou R$ 129,6 milhões, que, embora segmentados, teve como a principal fonte os repasses de empresas estatais (41%). Em sua maioria, os recursos apresentaram interrupções e expressivas variações, mas que ao longo do período sofreram um aumento expressivo, justificado pela necessidade de impulsionar a preparação olímpica. Os dados apontaram para uma sobreposição no uso das políticas de financiamento quanto sua aplicação no esporte de elite e suas áreas de atuação. Identificou-se a ausência de uma política estruturada que garanta a oferta de atividades esportivas nas esferas educacionais e de participação que, consequentemente, alimentam o esporte de elite. Além disso, as políticas desenvolvidas se caracterizaram como ações que embora retardem o abandono do esporte, tendem a não estimular a renovação esportiva.

ABSTRACT The purpose of this documentary study was to investigate the amount and allocation of public funding directed to the CBHb in the period between 2008 and 2016, in relation to the functions established to sports federations, by the Brazilian System of Sports. The main revenues of the entity were identified, and documents and accounts (e.g. e-SIC, ME e BOC) that contained the amounts of the onlendings were collected. Were considered only the values executed by the entity. In the period, CBHb executed R $ 129.6 million, which, although segmented, had as its main source the resources coming from state-owned companies (41%). For the most part, resources presented interruptions and significant variations in their onlendings, however, over the period, they suffered a significant increase, justified by the need to boost the Olympic preparation. The data pointed to an overlap in the use of financing policies regarding its application in elite sport and its areas of activity. It was identified the absence of a structured policy that guarantees the provision of sports activities in other spheres that, consequently, feed the elite sport. The policies developed have been characterized as actions that, although delaying the abandonment of sports, tend not to stimulate sports renewal.

Budget Impact of Dabrafenib and Trametinib in Combination as Adjuvant Treatment of BRAF V600E/K Mutation-Positive Melanoma from a U.S. Commercial Payer Perspective.

BACKGROUND: Before the approval of dabrafenib and trametinib in combination, there were no approved therapies in the adjuvant setting that target the RAS/RAF/MEK/ERK pathway. OBJECTIVE: To evaluate the budget impact of dabrafenib and trametinib in combination for adjuvant treatment of patients with BRAF V600 mutation-positive resected Stage IIIA, IIIB, or IIIC melanoma from a U.S. commercial payer perspective using data from the COMBI-AD trial, as well as other sources. METHODS: The budget impact of dabrafenib and trametinib in combination for patients with BRAF V600E/K mutation-positive, resected Stage IIIA, IIIB, or IIIC melanoma was evaluated from the perspective of a hypothetical population of 1 million members with demographic characteristics consistent with those of a commercially insured U.S. insurance plan (i.e., adults aged less than 65 years) using an economic model developed in Microsoft Excel. The model compared melanoma-related health care costs over a 3-year projection period under 2 scenarios: (1) a reference scenario in which dabrafenib and trametinib are assumed to be unavailable for adjuvant therapy and (2) a new scenario in which the combination is assumed to be available. Treatments potentially displaced by dabrafenib and trametinib were assumed to include observation, high-dose interferon alpha-2b, ipilimumab, and nivolumab. Costs considered in the model include those of adjuvant therapies and treatment of locoregional and distant recurrences. The numbers of patients eligible for treatment with dabrafenib and trametinib were based on data from cancer registries, published sources, and assumptions. Treatment mixes under the reference and new scenarios were based on market research data, clinical expert opinion, and assumptions. Probabilities of recurrence and death were based on data from the COMBI-AD trial and an indirect treatment comparison. Medication costs were based on wholesale acquisition cost prices. Costs of distant recurrence were from a health insurance claims study. RESULTS: In a hypothetical population of 1 million commercially insured members, 48 patients were estimated to become eligible for treatment with dabrafenib and trametinib in combination over the 3-year projection period; in the new scenario, 10 patients were projected to receive such treatment. Cumulative costs of melanoma-related care were estimated to be $6.3 million in the reference scenario and $6.9 million in the new scenario. The budget impact of dabrafenib and trametinib in combination was an increase of $549 thousand overall and 1.5 cents per member per month. CONCLUSIONS: For a hypothetical U.S. commercial health plan of 1 million members, the budget impact of dabrafenib and trametinib in combination as adjuvant treatment for melanoma is likely to be relatively modest and within the range of published estimates for oncology therapies. These results may assist payers in making coverage decisions regarding the use of adjuvant dabrafenib and trametinib in melanoma. DISCLOSURES: Funding for this research was provided to Policy Analysis Inc. (PAI) by Novartis Pharmaceuticals. Stellato, Moynahan, and Delea are employed by PAI. Ndife, Koruth, Mishra, and Gunda are employed by Novartis. Ghate was employed by Novartis at the time of this study and is shareholder in Novartis, Provectus Biopharmaceuticals, and Mannkind Corporation. Gerbasi was employed by PAI at the time of this study and is currently an employee, and stockholder, of Sage Therapeutics. Delea reports grant funding from Merck and research funding from Amgen, Novartis, Sanofi, Seattle Genetics, Takeda, Jazz, EMD Serono, and 21st Century Oncology, unrelated to this work.

Ordinance 3992/2017: challenges and advances for resource management in the Brazilian Unified Health System (SUS).

To advance in order to overcome the challenge of enabling greater autonomy in the use of financial resources in the Unified Health System (SUS), system managers agreed that transfers from the Union to other federated entities will be carried out through a financial investment account and a costing account. Over the past few years, states and municipalities managed more than 34,000 bank accounts dedicated to the Union's on-lendings, in which balance exceeded R$8 billion. However, from 2018, Ordinance 3,992/2017 unequivocally separated the budget flow from the financial flow, and the fund-to-fund transfers started to be carried out in only 11,190 bank accounts. Since then, managers have had financial autonomy in the management of financial resources received from the Union, if in accordance with the parameters established in their respective budget items at the end of each fiscal year.

Budget Impact of Switching to Biosimilar Trastuzumab (CT-P6) for the Treatment of Breast Cancer and Gastric Cancer in 28 European Countries.

BACKGROUND: As the economic burden of treating cancer patients has been soaring in European countries, performing a budget impact analysis is becoming one of the requirements for payers' application dossiers. OBJECTIVE: The objective of this study was to estimate the budgetary impact of introducing the biosimilar trastuzumab (CT-P6) from the payer's perspective and to determine the number of additional patients who could be treated with resulting savings in 28 European countries. METHODS: A budget impact model was developed to analyze the financial impact of switching from originator trastuzumab to biosimilar CT-P6 in the treatment of early and metastatic breast cancer and metastatic gastric cancer with a time horizon of 1-5 years. Budgetary savings and the number of patients potentially affected were measured based on epidemiological and sales volume data. The base-case analysis assumed that the price of CT-P6 is 70% of the originator price, the switching rate of originator to CT-P6 in the first year is 20%, and the annual growth in the switching rate for each subsequent year is 5%. RESULTS: For analyses using the base-case scenario following CT-P6 introduction, the total estimated budgetary savings over a 5-year period (depending on the scenario) ranged from €1.13 billion to €2.27 billion based on epidemiological data, or from €0.91 billion to €1.82 billion based on sales volume data. In the first year only, the projected budgetary savings ranged from €58 million to €136 million, and the number of additional patients who could be treated using the savings ranged from 3503 to 7078 by sensitivity analysis. CONCLUSIONS: The conducted budget impact analysis assessing a switch from originator trastuzumab to biosimilar CT-P6 in 28 European countries indicates that budget savings could be between €0.91 billion and €2.27 billion over the next 5 years. These savings could be used to help improve patient access to local biologics in their respective countries while simultaneously strengthening the overall public health landscape across the European Union.

Equity analysis of resource distribution for the Popular Pharmacy Program.

OBJECTIVE: To analyze the regional allocation of the resources from the Brazilian Popular Pharmacy Program, taking into account the relative availability of the program and the potential needs of the region. METHODS: Data from the National Health Survey of the Annual Report of Social Information and the administrative database of the program were used to create a non-parametric indicator of coverage using multiple data envelopment analysis technique. This indicator considers the relative availability of the program, taking into account equal access to equal needs (equity based on regional needs). The analysis of this indicator shows if the regions that most need pharmaceutical assistance are those that receive more resources from the Brazilian Popular Pharmacy Program. RESULTS: The states belonging to the richest regions of the country, Southeast and South, present wider relative coverage of the Brazilian Popular Pharmacy Program compared to poorer localities. In addition, the inequalities observed between locations are better explained by inefficiency in the transfer of resources to the basic component of pharmaceutical care than by the Brazilian Popular Pharmacy Program itself. According to the model, a 43.76% increase in the transfer to the basic component of pharmaceutical care would be required in order to improve equity, whereas the increase required by the Brazilian Popular Pharmacy Program is equivalent to 22.71%. CONCLUSIONS: Although the Brazilian Popular Pharmacy Program seeks to reduce the socioeconomic inequalities observed in access to pharmaceutical care, which integrates health care services, regional disparities in access to medicine persist. These regional differences are attributed mostly to allocation failures and problems in managing the conventional pharmaceutical care cycle provided through SUS pharmacies.

Budget impact of netupitant/palonosetron for the prevention of chemotherapy-induced nausea and vomiting.

Background: Chemotherapy-induced nausea and vomiting (CINV) are among the most common and debilitating side-effects patients experience during chemotherapy, and are associated with considerable acute care use and healthcare cost. It is estimated that 70-80% of CINV could be prevented through appropriate use of CINV prophylaxis; however, suboptimal CINV compliance and control remains an issue in clinical practice. Netupitant/palonosetron (NEPA) is a fixed combination of serotonin-3 (5-HT3) and neurokinin-1 (NK1) receptor antagonists (RAs), respectively, indicated for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC). Phase 3 clinical trials showed a significantly higher complete response rate in both acute and delayed CINV in chemotherapy-naïve patients receiving NEPA compared to patients receiving palonosetron. Objective: The objective of this study was to estimate the budgetary impact of adding NEPA to a US payer or practice formulary for CINV prophylaxis. Methods: A model was developed to estimate the impact of adding NEPA to the formulary of a hypothetical US payer with 1.15 million members, including 150,000 (13%) Medicare beneficiaries. The model compared the annual total costs of CINV-related events and CINV prophylaxis in two scenarios: base year (no NEPA) and comparator year (10% and 5% NEPA usage in HEC and MEC patients, respectively). A univariate sensitivity analysis was conducted to explore the effect of variability in model parameters on the budget impact. Results: A total of 2,021 patients were eligible to receive CINV prophylaxis. With NEPA, CINV prophylaxis costs increased by 0.7% ($3,493,630 vs $3,518,760) while medical costs associated with CINV events decreased by 3.9% ($15,118,639 vs $14,532,442), resulting in a net cost saving of $561,067 (3.0%) for the health plan ($18,612,269 vs $18,051,202), or $0.04 per member per month. This was equivalent to saving $5,011 per patient moved to NEPA. Among all 5-HT3 RA + NK1 RA regimens, NEPA was associated with the lowest CINV-related costs, leading to the lowest total cost of care. Conclusions: Adding NEPA to a payer or practice formulary results in a net decrease in the total budget due to a substantial reduction in CINV event-related resource utilization and medical costs, and an increase in pharmacy costs <1%, saving over $5,000 per patient.

Health system financing paradigm in the state of São Paulo: a regional analysis.

OBJECTIVE: To analyze the allocation of financial resources in the Brazilian Unified Health System (SUS) in the state of São Paulo by level of care, health region, source of funds and level of government. METHODS: This is an exploratory study based on 2014 data extracted from the Public Health Budget Database, presented in absolute terms, relative terms and per capita . RESULTS: In 2014, R$52.1 bi were spent on public health, 58.0% having corresponded to the expenditures of the municipalities and 42.0% to those of the state government. Regional per capita spending varied from R$561.75 to R$824.85. As for the per capita spending on primary health care, which represented 37.5% of the municipalities' total expenditure, the lowest value was found in the city of São Paulo and the highest, in Araçatuba. Campinas had the highest per capita expenditure on medium and high complexity care, while Presidente Prudente had the lowest. The highest regional percentage of the current net revenue spent on health was verified in Registro, and the lowest, in the city of São Paulo. CONCLUSIONS: The paradigm of the health sector's financing in São Paulo revealed that the expenditure on primary health care, level elected by health policy as strategic because it depends on coordination and integral health care in the attention networks, was not considered a priority in relation to the expenditure with the medium and high complexity, exposing the iniquities in the state's regions.

Ordinance 3992/2017: challenges and advances for resource management in the Brazilian Unified Health System (SUS) / Portaria 3992/2017: desafios e avanços para gestão dos recursos no Sistema Único de Saúde

ABSTRACT To advance in order to overcome the challenge of enabling greater autonomy in the use of financial resources in the Unified Health System (SUS), system managers agreed that transfers from the Union to other federated entities will be carried out through a financial investment account and a costing account. Over the past few years, states and municipalities managed more than 34,000 bank accounts dedicated to the Union's on-lendings, in which balance exceeded R$8 billion. However, from 2018, Ordinance 3,992/2017 unequivocally separated the budget flow from the financial flow, and the fund-to-fund transfers started to be carried out in only 11,190 bank accounts. Since then, managers have had financial autonomy in the management of financial resources received from the Union, if in accordance with the parameters established in their respective budget items at the end of each fiscal year.

RESUMO A fim de avançar na superação do desafio de viabilizar maior autonomia na utilização dos recursos financeiros no Sistema Único de Saúde, os gestores do sistema pactuaram que as transferências da União aos demais entes federados passam a ser realizadas por meio de uma conta financeira de investimento e uma conta de custeio. Ao longo dos últimos anos, estados e municípios chegaram a gerenciar mais de 34 mil contas bancárias dedicadas somente aos repasses da União, nas quais foram acumulados saldos acima de R$8 bilhões. Entretanto, a partir de 2018, a Portaria 3.992/2017 separou de forma inequívoca o fluxo orçamentário do fluxo financeiro e as transferências fundo a fundo passaram a ser realizadas em apenas 11.190 contas bancárias. Desde então, os gestores passaram a ter autonomia financeira na gestão dos recursos financeiros recebidos da União, desde que obedecidos os parâmetros estabelecidos em suas respectivas peças orçamentárias ao final de cada exercício.

Equity analysis of resource distribution for the Popular Pharmacy Program / Análise de equidade da distribuição de recursos do Programa Farmácia Popular

ABSTRACT OBJECTIVE To analyze the regional allocation of the resources from the Brazilian Popular Pharmacy Program, taking into account the relative availability of the program and the potential needs of the region. METHODS Data from the National Health Survey of the Annual Report of Social Information and the administrative database of the program were used to create a non-parametric indicator of coverage using multiple data envelopment analysis technique. This indicator considers the relative availability of the program, taking into account equal access to equal needs (equity based on regional needs). The analysis of this indicator shows if the regions that most need pharmaceutical assistance are those that receive more resources from the Brazilian Popular Pharmacy Program. RESULTS The states belonging to the richest regions of the country, Southeast and South, present wider relative coverage of the Brazilian Popular Pharmacy Program compared to poorer localities. In addition, the inequalities observed between locations are better explained by inefficiency in the transfer of resources to the basic component of pharmaceutical care than by the Brazilian Popular Pharmacy Program itself. According to the model, a 43.76% increase in the transfer to the basic component of pharmaceutical care would be required in order to improve equity, whereas the increase required by the Brazilian Popular Pharmacy Program is equivalent to 22.71%. CONCLUSIONS Although the Brazilian Popular Pharmacy Program seeks to reduce the socioeconomic inequalities observed in access to pharmaceutical care, which integrates health care services, regional disparities in access to medicine persist. These regional differences are attributed mostly to allocation failures and problems in managing the conventional pharmaceutical care cycle provided through SUS pharmacies.

RESUMO OBJETIVO Analisar a alocação regional dos recursos do Programa Farmácia Popular do Brasil, levando em conta a disponibilidade relativa do programa e as necessidades potenciais da região. MÉTODOS Os dados da Pesquisa Nacional de Saúde, da Relação Anual de Informações Sociais e da base administrativa do programa foram usados para criar um indicador não paramétrico de cobertura a partir da técnica de análise envoltória de dados múltipla. Esse indicador considera a disponibilidade relativa do programa, considerando a equidade de acesso para necessidades idênticas (equidade baseada nas necessidades regionais). A análise desse indicador mostra se as regiões que mais necessitam de assistência farmacêutica são aquelas que recebem mais recursos do Programa Farmácia Popular do Brasil. RESULTADOS Os estados pertencentes às regiões mais ricas do país, Sudeste e Sul, apresentam maior cobertura relativa do Programa Farmácia Popular do Brasil em relação às localidades mais pobres. Ademais, as desigualdades observadas entre os locais são melhor explicadas por ineficiência no repasse dos recursos para o componente básico da assistência farmacêutica do que pelo Programa Farmácia Popular do Brasil em si. Segundo o modelo, para melhorar a equidade, seria necessário um aumento de 43,76% nos repasses ao componente básico da assistência farmacêutica, enquanto o aumento requerido pelo Programa Farmácia Popular do Brasil equivale a 22,71%. CONCLUSÕES Apesar de o Programa Farmácia Popular do Brasil buscar atenuar as desigualdades socioeconômicas observadas no acesso à assistência farmacêutica, que integra os serviços de atenção à saúde, persistem as disparidades regionais no acesso a medicamentos. Essas diferenças regionais são atribuídas em maior parte a falhas na alocação e problemas na gestão do ciclo de assistência farmacêutica convencional prestada por meio das farmácias do SUS.

Health system financing paradigm in the state of São Paulo: a regional analysis / Paradigma de financiamento do SUS no estado de São Paulo: uma análise regional

ABSTRACT OBJECTIVE To analyze the allocation of financial resources in the Brazilian Unified Health System (SUS) in the state of São Paulo by level of care, health region, source of funds and level of government. METHODS This is an exploratory study based on 2014 data extracted from the Public Health Budget Database, presented in absolute terms, relative terms and per capita . RESULTS In 2014, R$52.1 bi were spent on public health, 58.0% having corresponded to the expenditures of the municipalities and 42.0% to those of the state government. Regional per capita spending varied from R$561.75 to R$824.85. As for the per capita spending on primary health care, which represented 37.5% of the municipalities' total expenditure, the lowest value was found in the city of São Paulo and the highest, in Araçatuba. Campinas had the highest per capita expenditure on medium and high complexity care, while Presidente Prudente had the lowest. The highest regional percentage of the current net revenue spent on health was verified in Registro, and the lowest, in the city of São Paulo. CONCLUSIONS The paradigm of the health sector's financing in São Paulo revealed that the expenditure on primary health care, level elected by health policy as strategic because it depends on coordination and integral health care in the attention networks, was not considered a priority in relation to the expenditure with the medium and high complexity, exposing the iniquities in the state's regions.

RESUMO OBJETIVO Analisar a alocação de recursos financeiros no Sistema Único de Saúde (SUS) no estado de São Paulo por nível de atenção, região de saúde, fonte de recursos e ente federado. MÉTODOS Trata-se de estudo exploratório circunscrito ao exercício de 2014. Os dados extraídos do Sistema de Informações sobre Orçamentos Públicos em Saúde estão apresentados em valores absolutos, relativos e per capita . RESULTADOS Em 2014 observou-se um gasto público com saúde de R$52,1 bi, sendo 58,0% relativos ao gasto dos municípios e 42,0% relativos ao gasto do governo do estado. O gasto regional per capita variou de R$561,75 a R$824,85. Já o gasto per capita com atenção primária à saúde, que representou 37,5% do gasto total dos municípios, foi menor na região da Grande São Paulo e maior em Araçatuba. A região de Campinas apresentou o maior gasto per capita com atenção de média e alta complexidade, enquanto Presidente Prudente teve o menor. O maior percentual regional da receita corrente líquida gasto com saúde foi verificado em Registro, e o menor na Grande São Paulo. CONCLUSÕES O paradigma de financiamento do setor da saúde em São Paulo revelou que o gasto com a atenção primária, nível eleito pela política de saúde como estratégico porque dele dependem a coordenação e o cuidado integral à saúde nas redes de atenção, não recebeu prioridade em relação ao gasto com a média e a alta complexidade, expondo as iniquidades nas regiões do estado.

One size fits all? Disentangling the effects of tobacco taxes, laws, and control spending on adult subgroups in the United States.

Background: To determine the relative impact of each of the 3 state-level tobacco control policies (cigarette taxation, tobacco control spending, and smoke-free air [SFA] laws) on adult smoking rate overall and separately for adult subgroups in the United States. Methods: A difference-in-differences analysis was conducted with generalized propensity scores. State-level policies were merged with the individual-level Behavioral Risk Factor Surveillance System in 1995-2009. Results: State cigarette taxation was the only policy that significantly impacted smoking among the general adult population, with a 1-standard deviation increase in taxes (i.e., $0.68 in constant 2014 dollars) lowering the adult smoking rate by about a quarter of a percentage point. The taxation impact was consistent, regardless of the presence of, or interactions with, other policies. Taxation was also the only policy that significantly reduced smoking for some adult subgroups, including females, non-Hispanic whites, adults aged 51 or older, and adults with more than a high school education. However, other adult subgroups responded to the other 2 types of policies, either by mediating the taxation effect or by reducing smoking independently. Specifically, tobacco control spending reduced smoking among young adults (ages 18-25 years) and Hispanics. SFA laws affected smoking among men, young adults, non-Hispanic blacks, and Hispanics. Conclusions: State cigarette taxation is the single most important policy for reducing smoking among the general adult population. However, adult subgroups' reactions to taxes are diverse and mediated by tobacco control spending and SFA laws.