Ten-year kidney transplant survival of cyclosporine- or tacrolimus-treated patients in Brazil

Gomes, Rosângela Maria; Júnior, Augusto Afonso Guerra; Lemos, Larissa de Araújo; Costa, Juliana de Oliveira; Almeida, Alessandra Maciel; Álvares, Juliana; Filho, Charles Simão; Cherchiglia, Mariângela Leal; Andrade, Eli Iôla Gurgel; Godman, Brian; Acúrcio, Francisco de Assis

doi:10.1080/17512433.2016.1190270

Cited by 16 publications

(29 citation statements)

References 41 publications

(45 reference statements)

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“…Such concerns have not proved to be the case in long term follow-up of these patients [100][101][102][103][104][105][106]. Long term follow-up of patients in public healthcare databases have also demonstrated significantly improved long-term graft survival in kidney transplant patients prescribed cyclosporine versus tacrolimus despite current beliefs [107]. These issues and concerns have resulted in the development of new models, especially among European countries, to better manage the entry of new medicines, which also includes potential new models for valuing new medicines for orphan diseases given current concerns [3][4][5][6]66,108].…”

Section: Ongoing Developments Impacting On the Role Of Hta To Improvementioning

confidence: 99%

“…As mentioned, this has included assessing rates of infection and cancer with the use of biological medicines to treat immunological diseases such as rheumatoid arthritis and psoriasis [100][101][102][103][104][105][106], as well as assessing long-term graft survival in kidney transplant patients prescribed either cyclosporine or tacrolimus [107]. Other examples including assessing the appropriateness of prescribing, as well as the effectiveness and safety of new oral anti-coagulants such as dabigatran given early concerns [3,[154][155][156] as well as the use and potential risks associated with medicines for weight loss [157].…”

Section: Post-launch Activitiesmentioning

confidence: 99%

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Role of Health Technology Assessment in Pharmaceutical Market Access in Developed Countries

Kahveci¹,

Oortwijn²,

Godman³

et al. 2018

Pharmaceutical Market Access in Developed Markets2018

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Section: Ongoing Developments Impacting On the Role Of Hta To Improvementioning

confidence: 99%

Section: Post-launch Activitiesmentioning

confidence: 99%

Role of Health Technology Assessment in Pharmaceutical Market Access in Developed Countries

Kahveci¹,

Oortwijn²,

Godman³

et al. 2018

Pharmaceutical Market Access in Developed Markets2018

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“…It is noteworthy that older technologies can sometimes have worse evidence as seen in the review of older medicines that had been superseded by newer more effective medicines in France (28). However, this may not always be the case as seen with tacrolimus versus cyclosporine and insulin glargine versus NPH insulins in Brazil (20,21). Overall though, older funded technologies may be prioritized for HTpA to assess their continued funding.…”

Section: Development Of the Second Version Of The Guideline After Thementioning

confidence: 99%

“…However, this does not always happen in practice as seen by the continued use of tacrolimus for kidney transplantation despite real world evidence supporting greater effectiveness with cyclosporine at substantially higher costs (21). .…”

Section:  Medical Advocatesmentioning

confidence: 99%

Health Technology Performance Assessment: Real-World Evidence for Public Healthcare Sustainability

Guerra-Junior

Lemos

Godman

et al. 2017

Int J Technol Assess Health Care

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Objective: Health technology financing is often based on randomized controlled trials (RCTs), which are often the same ones used for licensing. Since they are designed to show the best possible results with typically Phase III studies conducted under ideal and highly controlled conditions to seek high internal validity and maximize the chance of demonstrating clinical benefit, they often do not reflect likely effectiveness in routine clinical care. Consequently, it is not surprising that technologies do not always perform in real life in the same way as controlled conditions. Since financing (and price paid) decisions can be made with overestimated results, health authorities need to ask whether health systems achieve the results they expect when they choose to pay for a technology. The optimal way to answer this question is to assess the performance of financed technologies in real world settings. Health technology performance assessment (HTpA) refers to the systematic evaluation of the properties, effects, and/or impact of a health intervention or health technology in the real world to provide information for investment/ disinvestment decisions and clinical guideline updates. The objective is to describe the development and principal aspects of the Guideline for HTpA commissioned by the Brazilian Ministry of Health. Method: Extensive literature review, refinement with experts across countries and public consultation. Results: A comprehensive guideline was developed, which has been adopted by the Brazilian government. Conclusion: We believe the guideline, with its particular focus on disinvestment, along with the creation of a specific program for HTpA, will allow the institutionalization and continuous improvement of the scientific methods to use real world evidence to optimize available resources not only in Brazil but across countries.Keywords: Technology Assessment, Biomedical; Observational studies; Health policy; Health Information Systems Policy implications: Real-world evidence is emerging as an important tool to aid decision-making regarding health technology financing. Over the last decade, countries have developed health and/ or administrative registries capable of providing quality data for assessing health results in real life. At the same time, budgetary constraints and the pressure to finance emerging high-priced technologies are making it inevitable for health authorities to start assessing whether patients and society are getting the results from financed technologies agreed upon during investment decisions. This paper presents the concept of Health Technology performance Assessment and the development of a guideline, commissioned by the Brazilian Ministry of Health, to implement such activity. We believe it is the first guideline to formally incorporate the use of real-world evidence for updating clinical guidelines, price renegotiation and disinvestment decisions.

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“…Kidney transplantation is considered the optimal choice for the treatment of patients with advanced renal failure due to improved quality of life and life expectancy versus renal dialysis, and it is also the most cost-effective option when compared to dialysis [1][2][3][4][5][6]. The Brazilian National Health System (Sistema Único de Saúde (SUS)) performs more than 95% of all kidney transplants in the country and guarantees access to immunosuppressants for transplant patients without co-payment [7,8].…”

Section: Introductionmentioning

confidence: 99%

Effectiveness of Maintenance Immunosuppression Therapies in a Matched-Pair Analysis Cohort of 16 Years of Renal Transplant in the Brazilian National Health System

Gomes

Barbosa

Godman

et al. 2020

IJERPH

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The maintenance of patients with renal transplant typically involves two or more drugs to prevent rejection and prolong graft survival. The calcineurin inhibitors (CNI) are the most commonly recommended medicines in combinations with others. While immunosuppressive treatment regimens are well established, there is insufficient long-term effectiveness data to help guide future management decisions. The study analyzes the effectiveness of treatment regimens containing CNI after renal transplantation during 16 years of follow-up with real-world data from the Brazilian National Health System (SUS). This was a retrospective study of 2318 SUS patients after renal transplantion. Patients were propensity score-matched (1:1) by sex, age, type and year of transplantation. Kaplan–Meier analysis was used to estimate the cumulative probabilities of survival. A Cox proportional hazard model was used to evaluate factors associated with progression to graft loss. Multivariable analysis, adjusted for diabetes mellitus and race/color, showed a greater risk of graft loss for patients using tacrolimus plus mycophenolate compared to patients treated with cyclosporine plus azathioprine. In conclusion, this Brazilian real-world study, with a long follow-up period using matched analysis for relevant clinical features and the representativeness of the sample, demonstrated improved long-term effectiveness for therapeutic regimens containing cyclosporine plus azathioprine. Consequently, we recommend that protocols and clinical guidelines for renal transplantation should consider the cyclosporine plus azathioprine regimen as a potential first line option, along with others.

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Ten-year kidney transplant survival of cyclosporine- or tacrolimus-treated patients in Brazil

Abstract: Among other factors, tacrolimus-based regimens were associated with worse graft survival.

Cited by 16 publications

References 41 publications

Role of Health Technology Assessment in Pharmaceutical Market Access in Developed Countries

Role of Health Technology Assessment in Pharmaceutical Market Access in Developed Countries

Health Technology Performance Assessment: Real-World Evidence for Public Healthcare Sustainability

Effectiveness of Maintenance Immunosuppression Therapies in a Matched-Pair Analysis Cohort of 16 Years of Renal Transplant in the Brazilian National Health System

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