RESUMO

Background: Most cancer drugs enter the US market first. US Food and Drug Administration (FDA) approvals of new cancer drugs may influence regulatory decisions in other settings. The study examined whether characteristics of available evidence at FDA approval influenced time-to-marketing authorisation (MA) in Brazil, and price differences between the two countries. Methods: All new FDA-approved cancer drugs from 2010 to 2019 were matched to drugs with MA and prices approved in Brazil by December 2020. Characteristics of main studies, availability of randomised controlled trials (RCTs), overall survival (OS) benefit, added therapeutic benefit, and prices were compared. Findings: Fifty-six FDA-approved cancer drugs with matching indications received a MA at the Brazilian Health Regulatory Agency (Anvisa) after a median of 522 days following US approval (IQR: 351-932). Earlier authorisation in Brazil was associated with availability of RCT (median: 506 vs 760 days, p = 0.031) and evidence of OS benefit (390 vs 543 days, p = 0.019) at FDA approval. At Brazilian marketing authorisation, a greater proportion of cancer drugs had main RCTs (75% vs 60.7%) and OS benefit (42.9% vs 21.4%) than that in the US. Twenty-eight (50%) drugs did not demonstrate added therapeutic benefit over drugs for the same indication in Brazil. Median approved prices of new cancer drugs were 12.9% lower in Brazil compared to the US (adjusted by Purchasing Power Parity). However, for drugs with added therapeutic benefit median prices were 5.9% higher in Brazil compared to the US, while 17.9% lower for those without added benefit. Interpretation: High-quality clinical evidence accelerated the availability of cancer medicines in Brazil. The combination of marketing and pricing authorisation in Brazil may favour the approval of cancer drugs with better supporting evidence, and more meaningful clinical benefit albeit with variable degree of success in achieving lower prices compared to the US. Funding: None.

Assuntos

RESUMO

OBJECTIVES: To describe changes in the private market for selected originators, branded generics ('similares'), and generic products during the 10 years following passage of the Brazilian Generics Law. METHODS: We analyzed longitudinal data collected by IQVIA® on quarterly sales by wholesalers to retail pharmacies in Brazil from 1998 through 2010, grouped by originators, branded generics, and generic products in three therapeutic classes (antibiotics, antidiabetics, and antihypertensives). Outcomes included market share (proportion of the total private market volume), sales volume per capita, prices and number of manufacturers by group. RESULTS: In the private market share, generics became dominant in each therapeutic class but the speed of uptake varied. Originators consistently lost most market share while branded generics varied over time. By the end of the study period, generics were the most sold product type in all classes, followed by branded generics. The number of generic manufacturers increased in all classes, while branded generics increased just after the policy but then decreased slowly through the end of 2010. For approximately 50% of the antibiotics analyzed, branded generics and generics had lower prices than originators. For antidiabetics, branded generic and generic prices were quite similar during the period analyzed. Price trends for the various subclasses of antihypertensive exhibited very different patterns over time. CONCLUSION: Sales of branded generics and originators decreased substantially in the three therapeutic classes analysed following the introduction of the generics policy in Brazil, but the time to market dominance of generics varied by class.

RESUMO

OBJECTIVES: New antidiabetic medications such as insulin analogues and thiazolidinediones have been introduced over the last decade. This study compares the uptake of new agents in three emerging pharmaceutical markets: Brazil, China, and Thailand. METHODS: Using longitudinal IMS Health sales data, we calculated the quarterly percentage market share for types of insulins and oral hypoglycemic agents from 2002 through 2012 in each country. New oral hypoglycemic agents included: alpha-glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, and non-sulfonylurea secretagogues. RESULTS: While China had the highest use of insulin cartridges and pens (85.6% in 2010), Brazil was the earliest adopter of insulin analogues and had the greatest use of these products overall (44.6% of the insulin market) in 2010, which then decreased by almost half by 2012. Together, sulfonylureas and metformin dominated the markets in Brazil and Thailand (~89% and ~96% respectively) over the 10-year period. Between 2002 and 2012, there was a shift in use from sulfonylureas to metformin; the market share of newer agents remained 10% or less in both countries. In China, however, market share of new oral agents grew rapidly from 13.1% to 44.4%. While metformin use was relatively stable in China (one-third of the market), sulfonylureas declined substantially over the 10-year period (41.5% to 20.8%). CONCLUSION: Given large cost differentials between newer and older insulins and among oral hypoglycemic agents, it is important to evaluate uptake of newer products over time. Uptake patterns differed in the study countries, likely due to different medicines policy approaches. Future research should evaluate how trends in use of antidiabetic products align with national clinical practice guidelines and pharmaceutical policies, as well as the impacts of different patterns of use on cost and clinical outcomes.

RESUMO

BACKGROUND: Several low and middle-income countries are implementing electronic health records (EHR). In the near future, EHRs could become an efficient tool to evaluate healthcare performance if appropriate indicators are developed. The aims of this study are: a) to develop quality of care indicators (QCIs) for type 2 diabetes (T2DM) in the Mexican Institute of Social Security (IMSS) health system; b) to determine the feasibility of constructing QCIs using the IMSS EHR data; and c) to evaluate the quality of care (QC) provided to IMSS patients with T2DM. METHODS: We used a three-stage mixed methods approach: a) development of QCIs following the RAND-UCLA method; b) EHR data extraction and construction of indicators; c) QC evaluation using EHR data from 25,130 T2DM patients who received care in 2009. RESULTS: We developed 18 QCIs, of which 14 were possible to construct using available EHR data. QCIs comprised both process of care and health outcomes. Several flaws in the EHR design and quality of data were identified. The indicators of process and outcomes of care suggested areas for improvement. For example, only 13.0% of patients were referred to an ophthalmologist; 3.9% received nutritional counseling; 63.2% of overweight/obese patients were prescribed metformin, and only 23% had HbA1c <7% (or plasma glucose≤130 mg/dl). CONCLUSIONS: EHR data can be used to evaluate QC. The results identified both strengths and weaknesses in the electronic information system as well as in the process and outcomes of T2DM care at IMSS. This information can be used to guide targeted interventions to improve QC.

Assuntos

RESUMO

OBJECTIVES: We sought to investigate, across different socioeconomic groups, the proportion of household medicine expenses that were paid by households and the proportion paid by the Brazilian national health system. METHODS: We carried out a survey in Porto Alegre, Brazil, that included 2988 individuals of all ages. We defined 2 expenditure variables: "out-of-pocket medicines value" (the sum of retail prices of all medicines used by family members within the previous 15 days and paid for out of pocket) and "free medicines value" (a similar definition for medicines obtained without charge). RESULTS: In 2003, the Brazilian national health system provided, free of charge, 78% of the monetary value of medicines reported (79% in the bottom wealth quintile and 32% in the top 2 quintiles). The mean out-of-pocket expense for medicines was 6 times greater among the top wealth quintiles compared with those in lower quintiles, but free medicines constituted a 3-times-greater proportion of potential expenditures for medicines among the bottom quintile than among the top 2 quintiles. CONCLUSIONS: Free provision of medicines seems to be saving substantial amounts of medicine expenditures for poor people in Brazil.

Assuntos

RESUMO

OBJECTIVES: To describe medicine utilization and access in a population covered by the Family Health Program (PSF) in Brazil. METHODS: Cross-sectional study with a random sample of 2988 individuals living in areas covered by 45 PSF clinics. Medicine utilization in the 15 days prior to the interview was assessed, as well as lack of access to medicines (proportion of people with medicines needed but not used), and lack of free access through the PSF (proportion of medicines used which had to be purchased). RESULTS: Overall, 54.5% (95% CI 50.6; 58.4) of individuals used at least one medicine in the 15-day period and 3.6% reported failing to use a needed medicine. Of all medicines used, 41.5% were paid for out-of-pocket (25.5% among the poorest families), and 51.0% were obtained for free from the PSF. Almost 90% of the medicines prescribed by PSF physicians were provided for free by the PSF. CONCLUSION: Although medicine access was high, individuals paid out-of-pocket for a substantial proportion of the medicines used. Lack of availability in PSF facilities and prescribing by non-PSF providers seem to contribute to the need for out-of-pocket purchases, and thus can be targeted for improvement through PSF policies.

Assuntos

RESUMO

BACKGROUND: Studies carried out in the community enable researchers to understand access to medicines, affordability, and barriers to use from the consumer's point of view, and may stimulate the development of adequate medicines policies. The aim of the present article was to describe methodological and analytical aspects of quantitative studies on medicine utilization carried out at the household level. METHODS: Systematic review of original papers with data collected in studies in which the household was a sampling unit, published between 1995 and 2008. The electronic review was carried out in Medline/Pubmed, Scielo and Lilacs. The reference lists of the papers identified were examined, as well as other publications by their authors. Studies on the utilization of specific pharmacological groups, or those including only respondents with a given disease were excluded. RESULTS: Out of 4852 papers initially identified in the literature search, 61 fulfilled our inclusion criteria. Most studies were carried out in Europe and North America and used a cross-sectional approach. More than 80% used face-to-face interviews for data collection, and the most frequently used recall period for assessing medicine utilization was 14-15 days. In 59% of the studies, interviewers were trained to request the packaging of the medicines reported by the subjects; medical prescriptions were requested less frequently (15% of the studies). CONCLUSION: These data will be useful for updating researchers on what methods their peers are currently using. Such information may help overcome challenges in the planning and analyses of future studies. Moreover, this publication may contribute to the improvement of the quality of medicine use data obtained in household surveys.

Assuntos

Assuntos