Can Drug Price Controls Help Patients Get a Better Deal? A SWOT Analysis

@#Introduction: Due to the increasing rate of drug prices and overall healthcare inflation, stakeholders from the pharmaceutical industry and non-governmental organisations (NGOs) are voicing their concerns about the possible reciprocal effects in the long run. Drug price controls (DPCs) regulation is crucial to ensure affordability and indirectly reduce congestion in public healthcare facilities. This study aims to identify the SWOT analysis of the DPCs in Malaysia and how it will impact the drug supply chain. Methods: The study adopted a subjective environmental scanning method and a SWOT analysis tool to examine the Malaysian pharmaceutical DPCs in the healthcare supply chain (HSC) ecosystem through both intrinsic and extrinsic perspectives. Results: The immediate effect of DPCs would be beneficial, especially to the patients and the government. Balancing the right amount of control and liberalization of the market is seen to be the biggest factor contributing to the policy’s effect on the drug supply chain. The main concern would be the long-term effect as mixed results are coming from a group of countries that had implemented a similar policy. Conclusion: Notwithstanding the qualitative methodology of the paper, the findings could provide a better understanding of the price of drugs in Malaysia’s HSC and serve as a foundation for future studies. This paper proposes a new way to diversify the DPCs economy by entering the HSC chain industry.

Cannabidiol para la epilepsia resistente a fármacos en Argentina: evaluación de tecnología sanitaria / Cannabidiol for drug-resistant epilepsy in Argentina: health technology assessment

INTRODUCCIÓN: El cannabidiol (CBD), un derivado de la planta de cannabis, está autorizado como especialidad medicinal para su comercialización en Argentina y otros países con el fin de tratar la epilepsia resistente a fármacos. Se encuentran en estudio otras potenciales indicaciones. MÉTODOS: Se realizó una evaluación de tecnología sanitaria para la Comisión Nacional de Evaluación de Tecnologías de Salud (CONETEC) sobre CBD para epilepsia resistente a fármacos en Argentina. RESULTADOS: Se describen aspectos legales, regulatorios y económicos, las evidencias disponibles sobre eficacia y seguridad en epilepsia y el impacto presupuestario. DISCUSIÓN: La evaluación pone de manifiesto una serie de desafíos para el sistema de salud argentino, relacionados con el mercado del CBD para la epilepsia en el país, su tamaño, los distintos actores y su comportamiento. Se indaga acerca de la estructura de costos, los márgenes de ganancia, y se mencionan algunas estrategias que fueron puestas en práctica por la industria farmacéutica en Argentina y otros países. Se discute el impacto de la competencia en los precios y se describen potenciales herramientas del Estado para la regulación como el uso de precios de referencia internacionales, la evaluación de tecnologías sanitarias y las compras mancomunadas, así como la articulación con productores nacionales y actores internacionales.

INTRODUCTION: Cannabidiol (CBD), a derivative of the cannabis plant, is authorized as a medicinal product for sale in Argentina and other countries for the treatment of drug-resistant epilepsy. Other potential indications are under study. METHODS: A health technology assessment was conducted for CONETEC (National Commission for Health Technology Assessment), analyzing CBD for drug-resistant epilepsy in Argentina. RESULTS: Legal, regulatory and economic aspects are described as well as the available evidence on efficacy and safety in epilepsy, and the budget impact. DISCUSSION: The assessment highlights a series of challenges for the Argentine health system, related to the CBD market for epilepsy, its size, the different actors, and their behavior. Inquiries are made about cost structure and profit margins, mentioning some strategies that were put into practice by the pharmaceutical industry in Argentina and other countries. The impact of competition on prices is discussed, and potential State tools for price regulation like the use of international reference prices, health technology assessment and joint purchases, as well as articulation with national producers and international actors are described.

Drug prices in Latin American countries: the case of rheumatoid arthritis Biosimilars

Abstract Background: The objective of this paper is to analyze the prices of biological drugs in the treatment of Rheumatoid Arthritis (RA) in three Latin American countries (Brazil, Colombia and Mexico), as well as in Spain and the United States of America (US), from the point of market entry of biosimilars. Methods: We analyzed products authorized for commercialization in the last 20 years, in Brazil, Colombia, and Mexico, comparing them to the United States of America (USA) and Spain. For this analysis, we sought the prices and registries of drugs marketed between 1999 and October 1, 2019, in the regulatory agencies' databases. The pricing between countries was based on purchasing power parity (PPP). Results: The US authorized the commercialization of 13 distinct biologicals and four biosimilars in the period. Spain and Brazil marketed 14 biopharmaceuticals for RA, ten original, four biosimilars. Colombia and Mexico have authorized three biosimilars in addition to the ten biological ones. For biological drug prices, the US is the most expensive country. Spain's price behavior seems intermediate when compared to the three LA countries. Brazil has the highest LA prices, followed by Mexico and Colombia, which has the lowest prices. Spain has the lowest values in PPP, compared to LA countries, while the US has the highest prices. Conclusions: The economic effort that LA countries make to access these medicines is much higher than the US and Spain. The use of the PPP ensured a better understanding of the actual access to these inputs in the countries analyzed.(AU)

Study on the Price and Affordability of Rare Disease Drug s in Chin a / 中国药房

OBJECTIVE：To evaluate the price and affordability of rare disease drugs in China and provide the suggestions for the improvement of rare disease drug affordability in order to provide reference for the relevant decision-making of government departments. METHODS ：According to the List of the First Batch of Rare Diseasesand Diagnosis and Treatment Guideline for Rare Diseases（2019 edition），rare disease drugs were selected. The median price ratio （MPR）was used to evaluate the drug price level ， and the ratio of the annual drug costs to the annual disposable income of urban or rural residents was used to evaluate the affordability，and the impact of price management policieson drug prices and affordability. RESULTS and CONCLUSIONS ：A total of 71 kinds of rare disease drugs were included ，and the median MPR of them was 0.83；among them ，the median MPR of the original drugs was 1.13，and the median MPR of the generic drugs was 0.37. The annual cost of 71 rare disease drugs was 0.001-178.43 times the average annual income of urban residents ，and 0.003-456.57 times the average annual income of rural residents. There were 21 and 28 drugs whose annual cost exceeded the annual income of urban and rural residents.After the implementation of national medical insurance negotiation or volume based procurement of 14 drugs，the median MPR of these drugs decreased from 1.71 to 0.46. For urban residents ，the number of unaffordable drugs had been reduced from 8 to 0；for rural residents，it had been reduced from 10 to 5. In summary ，the price level of orphan drugs in China was slightly lower than international reference price ，but the price level of original drugs was higher than the international reference price ，and the cost of some drugs far exceeded the residents ’ability to pay. It is suggested that the government should strengthen the price management of original drugs ，promote the substitution of high-quality generic drugs for original drugs ，and improve the payment system for high-value rare disease drugs.

New Price Conversion Method of Anti-cancer Drugs under the Buy-and-gift Strategy Based on Survival Data / 中国药房

OBJECTIVE：To provid e a more accurate calculation method for the determination of drug negotiation base price ， pharmacoeconomic calculation and budget impact analysis and calculation in the process of medical insurance access with buy-and-gift strategy. METHODS ：By the model method and literature research ，understanding the existing price conversion methods of the anti-cancer drugs that currently implement the buy-and-gift strategy ，a new method of drug price conversion was explored on the basis of the survival data of patients in different disease states ，and the core idea and calculation process of the algorithm were analyzed by an example. RESULTS ：The new algorithm was combined with the survival data of patients under different disease states. Its calculation process mainly included obtaining the actual duration of medication use per unit cycle and the theoretical amount of medication ，determining the aid model for anti-cancer drugs under buy-and-gift strategy ，converting the actual price. The simulation calculation was carried out under the one-step drug donation mode ，periodic drug donation mode and preferential installment drug donation mode. CONCLUSIONS ：The conversion method of anti-cancer drug price under buy-and-gift strategy based on survival data makes up for the shortcoming that the existing calculation methods are difficult to reflect the actual price of anti-cancer drugs ，and provides a new calculation method for calculating the actual reference price of anti-cancer drugs for medical insurance access.

Reflections And Perspectives On Biosimilars In Brazil

Objective: Biological agents are among the medicines with the highest revenue in the world market. Biosimilars are copies of biological products introduced into the market to offer clinical efficacy like the originator or reference product at lower prices. This study aimed to verify the characteristics and price differences between biological medicines registered and marketed in Brazil until the end of 2019. Methods: All records were collected by November 2019 on the website of the National Health Surveillance Agency (Anvisa). The list of the Chamber of Regulation of the Medicines Market (CMED) consulted for the price analysis, has an economic classificatory criterion with eight ranges. Categorization, according to the date/period of authorization for marketing, was also made. Results: At Anvisa site, there are 144 drugs present in 277 products distributed in three regulatory categories: new, biological, and similar. Approximately 73% of drugs have been approved in the past five years. Three classes represent 77.9% of all drugs-antineoplastics and immunomodulatory agents (38.6%), blood and blood organ forming (20.7%), and alimentary tract and metabolism (18.6%). Of the 178 products listed in the CMED, 26 (14.6%) have prices above 10,000 reais. Conclusion: The prices of original products, for most of the inputs, are lower than those of biosimilars, reversing the international logic.

Efeito das "promessas terapêuticas" sobre os preços de medicamentos em tempos de pandemia / Effect of "therapeutic promises" on drug prices in times of pandemic

Objetivo: Analisar o preço real de aquisição de medicamentos anunciados como promessas terapêuticas para tratamento da COVID-19 no Brasil. Métodos: Identificaram-se os medicamentos que estão sendo estudados e/ou noticiados como promissores e, posteriormente, analisaram-se os custos de aquisição desses medicamentos por uma drogaria do interior do estado de Minas Gerais, entre janeiro e junho de 2020. Resultados: Sete (87,5%) medicamentos apresentaram aumento do valor de compra no período estudado. Dexametasona e ivermectina apresentaram elevação de mais de 200% no preço. A menor elevação foi o polivitamínico, 5,44%. A hidroxicloroquina foi o único medicamento (12,5%) que não sofreu variação no preço e só foi adquirida nos três primeiros meses do ano de 2020. Conclusão: O preço de aquisição da maioria dos medicamentos anunciados como "promessas terapêuticas" para tratamento da Covid-19 no Brasil sofreu aumento significativo no período da pandemia.

Objective: To analyze the real purchase price of drugs announced as therapeutic promises for the treatment of Coronavirus disease in Brazil. Methods: The drugs that are being studied and/or announced as promising were identified and, subsequently, the costs of purchasing these drugs by a drugstore in the countryside of the state of Minas Gerais were analyzed between January and June 2020. Results: A total of seven (87.5%) drugs showed an increase in the purchase price in the period studied. Dexamethasone and ivermectin showed an increase of more than 200% in price. The lowest increase was the multivitamin, 5.44%. Hydroxychloroquine was the only drug (12.5%) that did not change its price and was only purchased in the first three months of 2020. Conclusion: The purchase price of the vast majority of drugs announced as "therapeutic promises" for the treatment of Covid-19 in Brazil suffered a significant increase during the pandemic period.

Cost comparison of commonly used antidepressant drugs with drug price control order in India

Background: Price of a drug is an important factor for compliance to the treatment. So, to overcome the high prices of drugs, National Pharmaceutical Pricing Authority (NPPA) under government of India has issued Drug Price Control Order (DPCO) list containing commonly used drugs. Pharmaceutical companies can be punished if they keep their prices higher than the ceiling price mentioned in the DPCO. To find out the price variations of commonly used antidepressant drugs included in DPCO list of 29th April 2019.Methods: A list of all oral antidepressant drugs included in DPCO of 29th April 2019 and available in Indian market was procured from medguide India. Analysis of number of total brands following as well as not following DPCO ceiling price was done.Results: Author found 17 formulations of four antidepressant drugs included in DPCO. Total 556 brands found out of which 84.6% were following the DPCO and 15.4% of brands prices were higher than the ceiling price of DPCO.Conclusions: Though large number of companies are following the DPCO but still strict regulation is needed to further increase the compliance of guidelines.

Availability of biological cancer drugs under research: registration and price in Brazil, Colombia, and Mexico / Disponibilidade de medicamentos biológicos contra o câncer: registro e preço no Brasil, Colômbia e México

Abstract This study seeks to understand biological cancer drug availability through registration and prices of the biological agents used for cancer therapy and authorized for sale in the last 5 years in Brazil, Colombia, and Mexico, comparing the data to those for the United States of America (USA) and Spain. The regulatory agencies' websites were assessed for drugs registered between January 1, 2014, and February 20, 2019. Drug prices were sought in the clerical databases. Prices were also compared using purchasing power parity (PPP). The comparison between the purchasing power (PP) of the three Latin American countries is hampered by market heterogeneity and uncertainty in the data. There is no registration synchronization. The average difference between the launch time in the USA and in the other countries is 1.6 to 2.6 years. The USA has the lowest PPP values, compared to the Latin American countries studied, but higher prices. Differences in registration time reveal issues in drug access in the Latin American countries studied or a lack of equity between countries. The economic effort that these countries make to have access to these supplies is much higher than that of the USA and Spain.

Resumo Este estudo busca entender a disponibilidade de medicamentos contra o câncer biológico por meio do registro e preços dos agentes biológicos utilizados na terapia do câncer e autorizados para venda nos últimos cinco anos no Brasil, Colômbia e México, comparando os dados com os dos Estados Unidos da América (EUA) e Espanha. Os sites das agências reguladoras foram consultados para medicamentos registrados entre 1º de janeiro de 2014 e 20 de fevereiro de 2019. Os preços dos medicamentos foram procurados nas bases de dados administrativas. Os preços também foram comparados usando a paridade do poder de compra (PPP). A comparação entre o poder de compra (PP) dos três países da América Latina é dificultada pela heterogeneidade de mercado e incerteza nos dados. Não há sincronização de registro. A diferença média entre o tempo de lançamento nos EUA e nos outros países é de 1,6 a 2,6 anos. Os EUA têm os menores valores de PPP, em comparação com os países latino-americanos estudados, mas preços mais altos. As diferenças no tempo de registro revelam problemas no acesso a medicamentos nos países latino- americanos estudados ou falta de equidade entre os países. O esforço econômico que esses países fazem para ter acesso a esses suprimentos é muito maior do que o dos EUA e da Espanha.

Public financing of human insulins in Brazil: 2009-2017 / Financiamento público de insulinas humanas no Brasil: 2009-2017

ABSTRACT: Background: From 2006 to 2017, the Brazilian federal government provided free of charge traditional insulins for diabetes treatment. This involved public tendering by the Department of Health Logistics of the Ministry of Health (DLOG-MOH) and the reimbursement after direct contracting for supply with commercial private retailers (Brazilian Popular Pharmacy Program - PFPB). Objective: We aim to describe the budget of the Brazilian federal government committed to for the acquisition of insulin, as well as corresponding prices and treatment availability from 2009 to 2017. Methods: Insulin volume and expenditure data were obtained in official administrative databases and in the Electronic System of the Information Service to Citizens. Data were analyzed according to the total provision by the federal government, DLOG-MOH and PFPB. Moreover, data were presented according to insulin type. Volumes were calculated in number of defined daily doses (DDD)/1,000 inhabitants/day. Results: Budgetary commitments due to insulin over nine years amounted to U$1,027 billion in 2017, with an approximate average of U$114.1 million per year. DLOG-MOH was the main insulin provider, despite the increase in PFPB provision along period. DLOG-MOH and PFBP together provided an average of 6.08 DDD/1000 inhabitants/day for nine years. Average prices in PFPB were higher than those in the DLOG series, with a downward trend over the years, narrowing to 2.7 times in 2017, when compared to 2009. Conclusions: Brazil evidenced a moderately sustainable and effective, albeit imperfect, policy for public provision of traditional insulins in the period preceding mandatory free supply of insulin analogues. Future studies must address treatment availability and financial sustainability in the new scenario.

RESUMO: Introdução: Entre 2006 e 2017, o governo federal forneceu gratuitamente insulinas tradicionais para o tratamento de diabetes por meio de licitação pública pelo Departamento de Logística em Saúde do Ministério da Saúde (DLOG-MOH) e reembolso a drogarias privadas credenciadas pelo Programa Farmácia Popular do Brasil (PFPB) após contratação direta para fornecimento. Objetivo: Descrever o orçamento federal brasileiro empenhado pela aquisição de insulinas, bem como preços e disponibilidade de tratamento correspondentes entre 2009 e 2017. Métodos: Dados de despesas e volume de insulina foram obtidos em registros administrativos oficiais e mediante solicitação ao Sistema Eletrônico do Serviço de Informações ao Cidadão. Os dados foram analisados de acordo com a provisão total do governo federal e segundo aquisições via DLOG-MOH e PFPB e tipo de insulina. Os volumes de insulina foram calculados em número de doses diárias definidas (DDD)/1.000 habitantes/dia. Resultados: Em nove anos, o orçamento empenhado com a insulina totalizou US$ 1.027 bilhões em 2017, média de US$ 114,1 milhões/ano. O DLOG-MOH foi o principal fornecedor de insulina apesar do crescimento do PFPB durante o período. O DLOG-MOH e o PFPB disponibilizaram em média 6,08 DDD/1.000 habitantes/dia durante o período analisado. Os preços médios no PFPB foram maiores que os do DOG-MOH ao longo do período, com tendência de queda ao longo dos anos, estreitando-se para 2,7 vezes em 2017 em comparação a 2009. Conclusão: O Brasil evidenciou uma política de fornecimento gratuito de insulina moderadamente sustentável e eficaz, ainda que imperfeita, no período que antecedeu o fornecimento obrigatório de análogos. Recomendam-se estudos futuros para avaliar a disponibilidade de tratamento e a sustentabilidade do financiamento nesse novo cenário.

O custo da extensão da vigência de patentes de medicamentos para o Sistema Único de Saúde / The cost to the Brazilian Unified National Health System of the extension of drug patent terms / El coste para el Sistema Único de Salud de Brasil de la extensión de la vigencia de patentes de medicamentos

Resumo: O parágrafo único do art. 40 da Lei de Propriedade Industrial brasileira estabelece a extensão de vigência de patentes pela mora do exame, ao menos, até dez anos a partir da concessão. Pensado como exceção, esse dispositivo tornou-se a regra no caso das patentes farmacêuticas, prolongando o prazo de exclusividade de exploração de medicamentos. Isso impacta o consumo privado e o orçamento do Sistema Único de Saúde (SUS). Este trabalho investiga o custo, para o SUS, da extensão de vigência de nove medicamentos, por ser proibida a compra de versões genéricas ou biossimilares. Foram analisados três grupos: (a) quatro já em extensão; (b) três que, com a concessão das patentes, terão extensão; e (c) dois com patentes mailbox que estão em domínio público, mas que podem ter a extensão garantida judicialmente. A partir de valores unitários e quantidades totais de compra pelo Departamento de Logística em Saúde do Ministério da Saúde (DLOG), foi estimado um gasto total de R$ 10,6 bilhões com os nove medicamentos entre 2014 a 2018. Assim, foi projetado o gasto total nos respectivos períodos de extensão: R$ 6,8 bilhões. Uma busca de mercado por preços de alternativas genéricas retornou uma redução potencial de R$ 1,2 bilhão para o gasto do DLOG com apenas quatro medicamentos. Por fim, com base nas reduções mínimas, médias e máximas do mercado, foi encontrada uma economia potencial de até R$ 3,9 bilhões no gasto do DLOG com a compra dos nove medicamentos, se não houvesse o dispositivo de extensão de vigência.

Abstract: The sole paragraph of Article 40 of the Brazilian Industrial Property Law determines the extension of the patent term in case of delayed prosecution, guaranteeing 10 years of protection from grant. Originally conceived as an exception, this provision became the rule in the case of drug patents, prolonging period of exclusive exploitation. This situation impacts both the out-of-pocket spending by families and the budget of the Brazilian Unified National Health System (SUS). This study explores the cost to SUS of extending the patent term for nine drugs, which delays the launch of generic or biosimilar alternatives. Three groups were analyzed: (a) four patents already extended; (b) three that will be extended if granted; and (c) two drugs with mailbox patents that are in the public domain, but that may have the extension granted by court order. Based on the unit values and the total amounts of purchases by the Logistics Department of the Ministry of Health (DLOG), a total expenditure of BRL 10.6 billion on the nine drugs from 2014 to 2018 was estimated. The total projected expenditure for the respective extension periods was thus BRL 6.8 billion. A market price search for generic alternatives yielded potential savings of BRL 1.2 billion in expenditures by DLOG on four drugs alone. Finally, based on the minimum, average, and maximum market price reductions, potential savings of up to BRL 3.9 billion were estimated for DLOG on the purchase of the nine medicines, if the patent terms were not extended.

Resumen: El párrafo único del art. 40 de la Ley de Propiedad Industrial brasileña establece la extensión de la vigencia de patentes, debido al retraso de su examen, garantizando al menos 10 años a partir de su concesión. Concebido como excepcional, este recurso se convirtió en una regla en el caso de las patentes farmacéuticas, prolongando el plazo de exclusividad de explotación de medicamentos. Esto impacta en el consumo privado y el presupuesto del Sistema Único de Salud de Brasil (SUS). Este trabajo investiga el coste para el SUS de la extensión de vigencia de nueve medicamentos, por estar prohibida la compra de versiones genéricas o biosimilares. Se analizaron tres grupos: (a) cuatro ya en extensión; (b) tres que, si fueran concedidas las patentes, tendrán extensión; y (c) dos con patentes mailbox que son de dominio público, pero pueden contar con una extensión garantizada judicialmente. A partir de valores unitarios, y cantidades totales de compra por parte del Departamento de Logística en Salud del Ministerio de la Salud (DLOG), se estimó un gasto total de BRL 10,6 billones con los nueve medicamentos de 2014 a 2018. De este modo, se proyectó el gasto total en los respectivos períodos de extensión: BRL 6,8 billones. Una búsqueda de mercado con precios de alternativas genéricas arrojó una reducción potencial de BRL 1,2 billón para el gasto del DLOG, con solo cuatro medicamentos. Finalmente, basándose en las reducciones mínimas, medias y máximas del mercado, se encontró un ahorro potencial de hasta BRL 3,9 billones en el gasto del DLOG con la compra de los nueve medicamentos, si no existiera un recurso de extensión de la vigencia.

Study on the Effects of the Deregulation of Drug Price Control on Drug Price / 中国药房

OBJECTIVE：To study the effects of the deregulation of drug price control on drug price ，and to provide reference for policy formulation. METHODS ：The quarterly price data of 46 875 chemical and biological products （measured by fixed Laspeyres index ）were collected from 788 sample hospitals from the database of National Medical Economic Information Network during Jan. 2012 to Jun. 2017. Based on the interrupted time series model ，changes in the prices of overall situation of chemicals and biological products ，as well as the sub-group ，ie. low-cost drugs ，original and imitated drugs were analyzed after the government’s policies of canceling the price limit control and strengthening the price monitoring （including Notice on Printing and Distributing the Opinions on the Supply and Guarantee of Commonly Used Low-cost Drugs in 2014，Notice on Printing and Distributing the Opinions on Promoting the Reform of Drug Prices in 2015，etc.），returning to market competition ；the effects of canceling the price limit control on drug price were put forward. RESULTS & CONCLUSIONS ：After government deregulation for maximum retail price limit of commonly used low-priced drugs ，the price of low-priced drugs increased substantially （β3＝1.11×10－2， P＝0.008）. After the total abolition of drug price control ，there was no significant change in the overall chemical and biological products（β3＝－1.85×10－3，P＝0.175）and sub-group （low-cost drugs ：β3＝1.10×10－3，P＝0.066；original drugs ：β3＝－7.20×10－4， P＝0.549；generic drugs ：β3＝6.78×10－4，P＝0.784）drug prices. Within two years after government deregulation policy in 2015， drug prices and the drug market had remained stable. It can be seen that it is feasible for canceling the government ’s pricing and opening the price control in the mature market so as to make the price formulation return to the market ，combined with the government strengthening the price monitoring.

Drug price control order: the impact on pharmacoeconomics

Background: The objective of the present study was to analyze the prices of metformin, losartan, atorvastatin, paracetamol and aspirin for the doses which are included in the list of Drug Price Control Order (DPCO) 2013.Methods: Current index medical specialties India, 37th year, April-July 2015 issue was used for analysis. The retail prices of the drugs in INR were tabulated in Microsoft Office Excel 2013. The prices of the above listed drugs were compared with prices of DPCO 2013 for the same doses of drugs. The analysis of drugs costing more than the prices listed in the DPCO with the margin of the difference in percentage was carried out.Results: Out of 25 brands of metformin 500 mg tablet, 11 (44%) brands had price higher than listed in DPCO 2013. Similarly, prices for losartan 25 mg and 50 mg tablets, 8 (25%) out of 32 and 11 (31.42%) out of 35 were higher respectively. For atorvastatin 5 mg and 10 mg tablets, 2 (9.52%) out of 21 and 8 (13.55%) out of 59 brands had higher prices. For paracetamol 500 mg tablet, 12 (63.15%) out of 19 brands were priced higher than DPCO list. For aspirin 100 mg tablet and 325 mg tablet, 3 (100%) out of 3 brands and 1 (100%) out of 1 brand had higher prices.Conclusions: Many of the brand formulations have higher prices than the DPCO 2013 issued by government of India. The clinicians prescribing these drugs should be aware of these brand formulations to reduce the cost of the drug therapy.

Regulação contemporânea de preços de medicamentos no Brasil - uma análise crítica / Contemporary regulation of drug prices in Brazil - a critical analysis

RESUMO A regulação de preços visa garantir sustentabilidade à assistência farmacêutica. Com o objetivo de discutir criticamente o tema, elaborou-se um ensaio sustentado em análise documental (2000-2017) da regulação econômica da indústria farmacêutica brasileira na Câmara de Regulação de Medicamentos (CMED), periódicos, teses e publicações do Legislativo e indústria farmacêutica. Vigorando há 15 anos, a Lei nº 10.742/2003 instituiu um modelo de teto de preços, compreendendo estabelecimento de preços máximos para medicamentos e reajustes anuais por fórmula definida em lei. Modelo, implementação e fórmula são alvos de crítica. A fórmula vincula reajustes ao Índice Nacional de Preços ao Consumidor Amplo - IPCA (inflação), agregando índices de custos de produção, concorrência e produtividade setoriais. A longevidade do modelo, sem realinhamento periódico dos tetos aos preços de mercado recomendado na literatura especializada, tem gerado preços máximos descolados da realidade, que aumentam a assimetria de informação e podem respaldar futuros aumentos abusivos. A priorização da eficiência do mercado em detrimento do combate à assimetria de informações no modelo regulatório tem reduzido a força dos consumidores no debate. O atual modelo avançou em relação às políticas de preços liberados, mas seu aperfeiçoamento pressupõe a apropriação do tema e crescente participação de consumidores e profissionais de saúde no processo regulatório.

ABSTRACT Price regulation aims to ensure sustainability of pharmaceutical care. Aiming to critically discuss the regulation of pharmaceutical prices in Brazil, we elaborated an essay based on document analysis (2000-2017) of the pharmaceutical economic regulation found at the Medication Regulation Chamber (CMED), journals, theses, and publications of the Legislature and pharmaceutical industry. For 15 years, Act no. 10.742/2003 has established a price ceiling model, comprising maximum prices for medicines and annual readjustments according to a formula defined in law. Model, implementation and formula have all been criticized. The formula links adjustments to the IPCA (general inflation index), adding indexes for production costs, competition, and productivity. The longevity of the model, without regular realignment of the ceiling to actual market prices, as recommended in specialized literature, generates price ceilings detached from reality, which deepen information asymmetries and may support abusive price increases in the future. Prioritization of market efficiency over reduction of information asymmetry in the regulatory model has reduced the strength of consumers in the debate. The current regulatory model has advanced in relation to previous liberalized pricing policies, but further improvement depends on the appropriation of the theme and increasing participation of consumers and health professionals in the regulatory process.

Cost comparison of antihypertensive drugs available in India with Drugs Prices Control Order price list

Background: DPCO (Drugs Prices Control Order) price list is issued by NPPA (National Pharmaceutical Pricing Authority) each year to guide the pharmaceuticals companies for controlling the prices in India. Some drugs cost more than the DPCO list. As antihypertensive drugs are taken lifelong once diagnosis is made, price variation and costing above prescribed price cause a huge economic burden on such patients. This study was undertaken to know the number of antihypertensive drugs brands with price above the recommended DPCO price list 2017.Methods: Authors have collected the data from website medguideindia.com, CIMS (current index of medical specialties), Drug Today, and compared the listed antihypertensive drugs of various available brands in India with DPCO price list 2017. Data was entered in Microsoft excel 2010. Percentage of selling price above the DPCO price list was calculated for each drug.Results: The data of 30 formulations of 16 antihypertensive drugs was analysed. The total number of available brands of all formulations was 1365 out of which only 831 (60.88%) brands were found to have price <DPCO recommended list. 534 (39.12%) brands had price more than the recommended limit. The minimum violation of price limit was found in case of metoprolol 25mg (6.66%) and maximum price violation was observed with spironolactone 25mg and sodium nitroprusside inj 10mg/ml.Conclusions: Reassessment and monitoring for implementation of DPCO price list should be done as still large number of brands are not following the regulations and are violating the limit set by NPPA/DPCO.

Analysis of the impacts of drug price markup reform on hospitalization expenses of tertiary public hospitals in Sichuan province / 中华医院管理杂志

Objective To analyze the impact of canceling drug price markup policy on hospitalization expenses of urban public hospitals in Sichuan province and provide decision-making basis. Methods Data of hospitalization expenses of the top 50 diseases among inpatients discharged in 2016 and 2017 were collected, totaling 2 732 022 inpatient cases. Based on hospitalization expenses, these disease were divided into seven categories ( A-G) using dynamic clustering analysis, which represent respectively dominant diseases of different expense makeups, to compare such indicators as hospitalization expenses and composition ratios of these diseases before (2016) and after the reform (2017). Results The study found drastic changes among the medical expenses of different categories of dominant diseases. For example, per-hospitalization cost of categories E ( featuring high drug and examination expenses ) and G ( featuring balanced expenses distribution) diseases decreased since the reform, while the other categories rose instead. The proportion of drugs of different disease categories decreased to various extents. For example, category A ( high drug ratio of 5.60% ) and category E (5.15% ) diseases of which were found with the sharpest drop. Proportion of service expenses, on the other hand, rose to different extents. For example, the proportion of service expenses of all disease categories increased to varying degrees, among which category E (3.46% ), category F (3.37% ) and category D (3.36% ) accounted for the largest share of increase.Conclusions The reform is moving the cost structure of dominant diseases in Sichuan towards a rational level, yet with significant differences among disease categories. The authorities should target various categories to adjust their reimbursement policies, minimize financial burden on patients, strengthen their supervision on drug use and medical behavior, prevent such misbehaviors as the inducing demands and transferring drug markups.

Evaluation of essential medicines accessibility in liaoning province / 中国药学杂志

OBJECTIVE: To assess the accessibility of essential medicines in medical institutions at all levels in Liaoning province, and provide reference for the improvement of related policies. METHODS: The WHO/HAI standardized approach adjusted based on China′s national conditions was adopted. The availability, median price ratio (MPR) and disease burden per capita income were used as evaluation indicators and methods. RESULTS: ① Fifty-two percent (52%) of the surveyed drugs′ availability is lower than the international general standard (50%); there was a significant difference in the availability of sample drugs at all levels of medical institutions. The specific performance was primary (27.3%) 0.05). ③In rural and urban areas, seventy-seven percent(77%) and ninety-two percent(92%) of essential medicines each have a course of treatment cost that is less than the WHO referenced standard, respectively. CONCLUSION: Under the premise that the affordability of essential medicines is good, the availability of primary medical institutions is the lowest among surveyed institutions. In order to ensure the fairness and accessibility of essential medicines, it is suggested to strengthen the supply of essential drugs for primary-level medical institutions.

Application of DrugAbacus Method in Pricing Antitumor Drugs / 中国药学杂志

OBJECTIVE: China is still in its infancy in assessing the value of anti-tumor drugs, lacking a mature drug value assessment system. To provide reference for the establishment of a pharmacoeconomic model based on value assessment in China, and provide valuable reference for clinicians and patients to choose treatment options, Through the analysis and discussion of the DrugAbacus interactive calculator. METHODS: The value components and data sources of the DrugAbacus interactive calculator were analyzed by literature search, data query, etc., and the price of the anti-tumor drugs was evaluated according to the baseline values. RESULTS: The actual price of anti-cancer drug afinitor is higher than the recommended price when used to treat kidney cancer, pancreatic cancer and breast cancer. When the anti-tumor drug avastin is used in the treatment of colon cancer, the actual price is not much different from the recommended price. Halaven's suggested price is always higher than the actual price, that is, the price of the drug is at least reasonable or even low, and Ixempra's price is high, so using the drug Halaven can save more money than using the drug Ixempra. CONCLUSION: The DrugAbacus method provides a complex analysis of the factors that should be considered in drug pricing. Although there are limitations, this method reflects to a large extent the evaluation of the value of innovative drugs in society, which can provide reference for drug pricing in China.

Acesso aos medicamentos: aplicação da seletividade constitucional no imposto sobre circulação de mercadorias e serviços / Access to medicines: application of constitutional selectivity in tax on circulation of goods and services

RESUMO O acesso aos medicamentos pode ser limitado pelos seus altos preços impactados pela tributação, especialmente pelo Imposto de Circulação de Mercadorias e Serviços (ICMS). O artigo problematiza a aplicação do princípio constitucional da seletividade no ICMS e sua repercussão na carga tributária dos medicamentos, com reflexo na capacidade de pagamento de medicamentos pelos cidadãos. O método foi de revisão de literatura, com base em documentos, em normas e no referencial teórico de Carrazza. O artigo está dividido em três seções: Caracterização do panorama geral dos tributos incidentes nos medicamentos; Imposto sobre Circulação de Mercadorias e Serviços e Princípio da seletividade como vetor da dignidade da pessoa humana. Identificaram-se alguns contrapontos doutrinários, trazendo, importantes debates sobre a aplicação da seletividade prevista na Constituição brasileira. Verificou-se existência de benefícios fiscais envolvendo os tributos federais aplicáveis sobre os medicamentos no sistema tributário nacional. Conclui-se que a não aplicação do princípio da seletividade no ICMS pode ensejar problemas, especialmente no abandono do tratamento e na ocorrência de gastos superiores ao que as famílias podem suportar, o que afronta o princípio da universalidade da saúde tornando difícil sua equidade.

ABSTRACT Access to medicines may be limited by their high prices impacted by taxation, especially the Tax on Circulation of Goods and Services (ICMS). This paper discusses the application of the principle of selectivity in the ICMS and its impacts on the tax burden of medicines, with a reflection on the ability of citizens to pay for medicines. The method was literature review, based on documents, norms and theoretical background of Carrazza. The article is divided into three sections: General overview of taxes on medicines; Tax on Circulation of Goods and Services and Principle of selectivity as a vector of human dignity. It was also sought to debate the doctrinal counterpoints, bringing important discussions on the application of selectivity foreseen in the Brazilian Constitution. It was possible to verify tax benefits involving the applicable federal taxes on medicines in the national tax system. It is concluded that the non-application of the principle of selectivity in the ICMS can cause problems, especially regarding the abandonment of treatment and in the occurrence of higher expenses than families can afford, which violates the principle of universality of health making its equity difficult.

Consumo de antihipertensivos en el Hospital Manuel Fajardo. 2013-2017 / Consumption of antihypertensive drugs in Manuel Fajardo Hospital. 2013-2017

Introducción: La Hipertensión Arterial es el factor de riesgo más frecuente de infarto agudo de miocardio, enfermedad cerebrovascular, insuficiencia cardíaca y otras afecciones. Objetivo: Caracterizar el consumo intrahospitalario de medicamentos antihipertensivos en el Hospital Clínico Quirúrgico Manuel Fajardo en el período comprendido entre 2013 y 2017. Material y Métodos: Se realizó un estudio observacional descriptivo, de corte transversal sobre el consumo intrahospitalario de antihipertensivos. El universo estuvo determinado por todos los antihipertensivos que tuvieron indicación facultativa intrahospitalaria en los años comprendidos. Resultados: Se consumió un total de 301 616 unidades de drogas antihipertensivas. El Enalapril fue el antihipertensivo más consumido con 126 306 unidades, representando 41.89 por ciento del consumo total de antihipertensivos en el período, siendo además el más empleado en todos los años del estudio. El mayor costo lo representó el Enalapril para un total de 31 576.50 CUP. Conclusiones: Los antihipertensivos más empleados fueron el Enalapril, la Clortalidona y el Amlodipino. El Enalapril fue el más consumido en todos los años estudiados, mientras que la Clortalidona estuvo entre los tres más empleados en todos esos años. En cuanto a la repercusión económica del consumo de los antihipertensivos más empleados, el Enalapril fue el más costoso, seguido por el Amlodipino(AU)

Introduction: Arterial hypertension is the most frequent risk factor associated with acute myocardial infarction, cerebrovascular disease, heart failure, and other conditions. Objective: To characterize the intra-hospital consumption of antihypertensive drugs at Manuel Fajardo Hospital throughout the period between 2013 and 2017. Material and Methods: An observational, descriptive, cross-sectional study of the intra-hospital consumption of antihypertensive drugs was carried out. The universe was determined by all the antihypertensive drugs that had intra-hospital medical prescription during the period studied. Results: A total of 301.616 units of antihypertensive drugs were used. Enalapril was the most consumed drug with 126.306 units, representing 41.89 percent of the total consumption of antihypertensive drugs during the period; also being the most used drug for the entire years of the study. The increased cost was represented by Enalapril for a total of 31.576.50 Cuban pesos (CUP). Conclusions: The most used antihypertensive drugs were Enalapril, Chlorthalidone and Amlodipine. Enalapril was the most consumed drug in all the years studied, whereas Chlorthalidone was one of the three most commonly used. Regarding economical repercussion of the most consumed antihypertensive drugs, Enalapril was the most expensive one, followed by Amlodipine(AU)