Federal procurement of unlicensed medicines in Brazil; findings and implications

Teodoro, Cristiane Roberta dos Santos; Reis, André Luis de Almeida dos; Godman, Brian; Caetano, Rosângela; Osório-de-Castro, Claudia Garcia Serpa

doi:10.1080/14737167.2017.1311209

Cited by 9 publications

(7 citation statements)

References 16 publications

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“…In the analysis of federal purchases in the period 2004 to 2013, Teodoro et al [25] observed low, but growing rates of acquisition of medicines without commercialization approval in Brazil. These purchases were justified by judicial demand in 82% of the cases.…”

Section: Resultsmentioning

confidence: 99%

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Public procurement of medicines: scoping review of the scientific literature in South America

Soares

Nascimento

Chaves

et al. 2019

J of Pharm Policy and Pract

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Section: Resultsmentioning

confidence: 99%

“…Most articles in this category referred to Brazil (80.8%) [12, 13, 15, 17–25, 28–30, 32–37] but they also included Argentina [14], Guyana [16], Chile, Colombia [26, 27] and Ecuador [31].…”

Section: Resultsmentioning

confidence: 99%

Public procurement of medicines: scoping review of the scientific literature in South America

Soares

Nascimento

Chaves

et al. 2019

J of Pharm Policy and Pract

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“…However, in 2019 CONITEC concluded that eculizumab was not suitable to be incorporated into the public health system due to the high cost of this therapy [ 29 ]. For this reason, currently, in Brazil, the only way to access eculizumab is through judicialization, which in this country is a lengthy process and that delays the beginning of the treatment in months [ 30 ]. Despite these difficulties, the higher rates of eculizumab use in the present cohort (71%) possibly reflect on the structure of the transplant services in Brazil that is linked to university centers, which could accelerate the investigation of rare diseases.…”

Section: Discussionmentioning

confidence: 99%

Thrombotic microangiopathy after kidney transplantation: Analysis of the Brazilian Atypical Hemolytic Uremic Syndrome cohort

et al. 2021

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Background Atypical Hemolytic Uremic Syndrome (aHUS) is an ultra-rare disease that potentially leads to kidney graft failure due to ongoing Thrombotic Microangiopathy (TMA). The aim was evaluating the frequency of TMA after kidney transplantation in patients with aHUS in a Brazilian cohort stratified by the use of the specific complement-inhibitor eculizumab. Methods This was a multicenter retrospective cohort study including kidney transplant patients diagnosed with aHUS. We collected data from 118 transplant centers in Brazil concerning aHUS transplanted patients between 01/01/2007 and 12/31/2019. Patients were stratified into three groups: no use of eculizumab (No Eculizumab Group), use of eculizumab for treatment of after transplantation TMA (Therapeutic Group), and use of eculizumab for prophylaxis of aHUS recurrence (Prophylactic Group). Results Thirty-eight patients with aHUS who received kidney transplantation were enrolled in the study. Patients’ mean age was 30 years (24–40), and the majority of participants was women (63% of cases). In the No Eculizumab Group (n = 11), there was a 91% graft loss due to the TMA. The hazard ratio of TMA graft loss was 0.07 [0.01–0.55], p = 0.012 in the eculizumab Prophylactic Group and 0.04 [0.00–0.28], p = 0.002 in the eculizumab Therapeutic Group. Conclusion The TMA graft loss in the absence of a specific complement-inhibitor was higher among the Brazilian cohort of kidney transplant patients. This finding reinforces the need of eculizumab use for treatment of aHUS kidney transplant patients. Cost optimization analysis and the early access to C5 inhibitors are suggested, especially in low-medium income countries.

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“…The literature shows many examples of how litigation has been used as a strategy to access unlicensed drugs in Brazil [20][21][22] . Evidence suggests that pharmaceutical companies may use relationships with patient advocacy groups and health professionals to expand market share by litigation, eventually forcing the incorporation of the drug into the health system 23,24 .…”

Section: Discussionmentioning

confidence: 99%

The case of eculizumab: litigation and purchases by the Brazilian Ministry of Health

et al. 2020

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OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

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Federal procurement of unlicensed medicines in Brazil; findings and implications

Abstract: Overall a low rate of unlicensed medicine use. However there are concerns given the current regulations in Brazil and the recent increase in the use of unlicensed medicines with increased litigation.

Cited by 9 publications

References 16 publications

Public procurement of medicines: scoping review of the scientific literature in South America

Public procurement of medicines: scoping review of the scientific literature in South America

Thrombotic microangiopathy after kidney transplantation: Analysis of the Brazilian Atypical Hemolytic Uremic Syndrome cohort

The case of eculizumab: litigation and purchases by the Brazilian Ministry of Health

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