The costs of medicines pose a growing burden on healthcare systems worldwide. A comprehensive understanding of current procurement processes provides strong support for the development of effective ...policies. This study examined Brazilian Federal Government pharmaceutical procurement data provided by the Integrated System for the Administration of General Services (SIASG) database, from 2006 to 2013. Medicine purchases were aggregated by volume and expenditure for each year. Data on expenditure were adjusted for inflation using the Extended National Consumer Price Index (IPCA) for December 31, 2013. Lorenz distribution curves were used to study the cumulative proportion of purchased therapeutic classes. Expenditure variance analysis was performed to determine the impact of each factor, price and/or volume, on total expenditure variation. Annual expenditure on medicines increased 2.72 times, while the purchased volume of drugs increased 1.99 times. A limited number of therapeutic classes dominated expenditure each year. Drugs for infectious diseases drove the increase in expenditures from 2006 to 2009 but were replaced by antineoplastic and immunomodulating agents beginning in 2010. Immunosuppressants (L04), accounted for one third of purchases since 2010, showing the most substantial growth in expenditures during the period (250-fold increase). The overwhelming price-related increase in expenditures caused by these medicines is bound to have a relevant impact on the sustainability of the pharmaceutical supply system. We observed increasing trends in expenditures, especially in specific therapeutic classes. We propose the development and implementation of better medicine procurement systems, and strategies to allow for monitoring of product price, effectiveness, and safety. This must be done with ongoing assessment of pharmaceutical innovations, therapeutic value and budget impact.
The organisation and systematisation of health actions and services are essential to ensure patient safety and the effectiveness and efficiency of cancer care. The objective of this study was to ...analyse the structure of cancer care envisaged in Brazilian norms, describe the types of accreditations of cancer services and their geographic distribution, and determine the planning and evaluation parameters used to qualify the health units that provide cancer care in Brazil.
This observational study identified the current organisation of cancer care and other health services that are accredited by Brazil's national health system (SUS) for cancer treatment as of February 2017. The following information was collected from the current norms and the National Registry of Health Establishments: geographic location, type of accreditation, type of care, and hospital classification according to annual data of the number of cancer surgeries. The adequacy of the number of licensed units relative to population size was assessed. The analysis considered the facilitative or restrictive nature of policies based on the available rules and resources.
The analysis of the norms indicated that these documents serve as structuring rules and resources for developing and implementing cancer care policies in Brazil. A total of 299 high-complexity oncology services were identified in facilities located in 173 (3.1%) municipalities. In some states, there were no authorised services in radiotherapy, paediatric oncology and/or haematology-oncology. There was a significant deficit in accredited oncology services.
The parameters that have been used to assess the need for accredited cancer services in Brazil are widely questioned because the best basis of calculation is the incidence of cancer or disease burden rather than population size. The results indicate that the availability of cancer services is insufficient and the organisation of the cancer care network needs to be improved in Brazil.
Background Breast cancer is the most common cancer among women in Brazil and the country's public health care system is the main care provider. Timely treatment can increase the chance of cure, ...prevent metastasis and improve quality of life. Effective public procurement of antineoplastic agents can therefore improve access to drug therapy. This study investigates patterns in the procurement of selected antineoplastic agents used for treating breast cancer by public bodies and avoidable expenditure on these drugs between January 2013 and December 2019. Methods We selected antineoplastic agents used for adjuvant or preoperative chemotherapy listed in the 2018 Breast Cancer Diagnosis and Treatment Guidelines and included in category L of the WHO Anatomical Therapeutic Chemical classification system. We analyzed regular purchases of antineoplastic agents registered in the Integrated General Services Administration System (SIASG), considering purchased quantity, unit price, date of purchase and procuring entity. Prices were inflation-adjusted to July 2019 based on the National Consumer Price Index. Results A total of 10 antineoplastic agents were selected. Trastuzumab and tamoxifen accounted for the largest share of total spending and largest volume of purchases, respectively. The Ministry of Education was the largest purchaser in volume terms of all the drugs studied, except trastuzumab 440 mg, where the category "Other Institutions" accounted for most purchases, and vinorelbine 20 mg, where the Ministry of Health made most purchases. The category "Other Institutions" accounted for the largest share of total spending. Total avoidable expenditure was R$99,130,645. Prices paid for medicines and avoidable expenditure were highest in the Ministry of Defense. Conclusions The differences observed in the performance of different categories of buyers as to amounts purchased and prices practiced for antineoplastic agents could be reduced by employing strategies to expand the centralization of purchases, resulting in expanded access to breast cancer medicines in the public sector. Keywords: Pharmaceutical services, Drug costs, Antineoplastic agents, Federal government, Breast neoplasms
We analyzed uncertainties and complexities of the Zika virus outbreak in Brazil, and we discuss risk reduction for future emergencies. We present the public health situation in Brazil and concurrent ...determinants of the epidemic and the knowledge gaps that persist despite building evidence from research, making public health decisions difficult. Brazil has adopted active measures, but producing desired outcomes may be uncertain because of partial or unavailable information. Reducing population group vulnerabilities and acting on environmental issues are medium- to long-term measures. Simultaneously dealing with information gaps, uncontrolled disease spread, and vulnerabilities is a new risk scenario and must be approached decisively to face emerging biothreats.
This study examines the dynamics of the eculizumab patenting, orphan designation, and marketing authorization process in different countries and regulatory systems and analyzes drug revenues since ...its first marketing authorization.
A retrospective case study was conducted. Multiple information sources were used to: determine the status of eculizumab patents; examine the designation of orphan drug status by US, European, Japanese, and Brazilian regulatory authorities to determine registration status and approved clinical indications; estimate the prevalence of associated clinical conditions; investigate the history of the drug manufacturer, Alexion Pharmaceuticals, Inc., and its financialized business model; and examine global eculizumab sales revenues since its first marketing authorization.
Our search yielded 32 patent families divided into 98 applications. The first patent granted was filed in 1995 by Alexion Pharmaceuticals, Inc. in the US. Eculizumab has always been as an orphan drug, except in the Brazilian regulatory agency. All clinical indications approved thus far refer to rare diseases (e.g., paroxysmal nocturnal hemoglobinuria syndrome, atypical hemolytic-uremic syndrome, refractory and generalized myasthenia gravis, and neuromyelitis optica spectrum disorder). Alexion's revenues amounted to more than US$25 billion between 2007 and 2019, showing a growing trend. Eculizumab led sales from the beginning, being the only product in the company's portfolio until 2015. In 2019, the drug accounted for 79.1% of all revenues.
Our findings show that a strategy focused on obtaining orphan drug designation, expanding therapeutic indications and the geographic range of marketing approvals, extending monopoly periods, and prioritizing public procurement niches has enhanced revenues and helped the company achieve leadership in a highly specific and profitable market.
This study examined the purchases of eculizumab, a high-cost monoclonal antibody used in the treatment of rare diseases by Brazilian federal agencies, in terms of purchased quantities, expenditures, ...and prices.
Eculizumab purchases made between March 2007 and December 2018 were analyzed, using secondary data extracted from the Federal Government Purchasing System (SIASG in Portuguese). The following aspects were assessed: number of purchases, purchased quantities, number of daily doses defined per 1,000 inhabitants per year, annual expenditures, and prices. The prices were adjusted by the National Broad Consumer Price Index for December 2018. Linear regression was used for trend analysis.
All acquisitions by federal agencies were made by the Brazilian Ministry of Health. The purchases began in 2009 with tender waiver to comply with legal demand. There was an increasing trend in the number of purchases and quantities acquired over time. Two hundred and eighty-three purchases were made, totaling 116,792 units purchased, 28.2% of them in 2018. The adjusted total expenses summed more than R$ 2.44 billion. After market approval by the Brazilian Health Regulatory Agency, the weighted average price fell approximately 35%, to values under the Medicines Market Chamber of Regulation established prices.
Eculizumab represented extremely significant expenditures for the Brazilian Ministry of Health during the period. All purchases were made to meet demands from lawsuits, outside the competitive environment. The market approval of eculizumab promoted an important price reduction. This study indicates the relevance of licensing and the need for permanent monitoring and auditing of drug purchases to meet legal demands.
This study maps and analyzes patient flows for breast cancer chemotherapy in order to identify the potential implications for organization of pharmaceutical services in the cancer care network. An ...ecological study design sought to correlate the place of residence with place of care for breast cancer patients. All chemotherapy procedures financed by Brazil's Unified Health System (SUS) and performed from January to December 2013 were included. Flows were mapped using TerraView® software. A total of 1 347 803 outpatient chemotherapy procedures were delivered by 243 cancer care units located in 156 municipalities. Seventeen cities concentrated approximately 50.0 % of the procedures. A total of 8 538 origin-destination flows were generated and 49.2% of procedures were performed in services located outside the municipality in which the patient resided. Context challenges, related to inequality of access to chemotherapy and hindrances in planning and management of pharmaceutical services, were discussed.
This paper analyzes the Minister of Health's (MoH) procurement of medicines for hepatitis C from 2005 to 2015. Data sources were the Integrated General Services Administration (SIASG), to estimate ...annual expenditure for selected medicines of the MoH Clinical Protocols and Therapeutic Guidelines (PCDT) for Hepatitis C. All presentations and strengths recorded on SIASG were included. The unit prices were estimated based on the purchase with the highest volume each year. There was a 159.5 fold increase in expenditure of the selected medicines from 2005 to 2006, because procurement of those medicines became centralized. In 2007 there was 730% increase in spending due to the incorporation of pegainterferons alfa 2a and 2b. In 2012 the purchase of only two new direct-acting antivirals (DAA) accounted for 99% of total annual expenditure. In 2015 the adoption of a new DAA led to an increase of 230% (R$945 million) in MoH spending. The significant increase of MoH expenditure on medicines for hepatitis C from 2005 to 2015 was due to the increase of volumes purchased as well as the incorporation of alfapeginterferon and new DAAs. Ensuring universal access to treatment for hepatitis C will depend on the implementation of strategies that strengthen the MoH's bargaining power in price reduction negotiations with the manufacturers of monopoly medicines.
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