Incorporações de medicamentos para doenças raras no Brasil: é possível acesso integral a estes pacientes?

Biglia, Luiza Vasconcelos; Mendes, Samara Jamile; Lima, Tácio de Mendonça; Aguiar, Patrícia Melo

doi:10.1590/1413-812320212611.26722020

Cited by 9 publications

(4 citation statements)

References 12 publications

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“…The rst ten years of Conitec's operation featured growth in terms of patient and public involvement as evidenced by the number of public consultations conducted and contributions received over the years; in addition, 13% of recommendations changed after the public consultation, and the signi cant participation of patients and their families was strongly associated with changes in preliminary recommendations regarding the adoption of technologies into the SUS. Previous investigations, which featured shorter follow-up times or analysed speci c subgroups, found the frequency of change in recommendations following a public consultation to 18.8% in the case of medicines up to June 2016 (13), 8% in the case of medicines, products and procedures by 2018 (2) and 19% in the case of rare diseases by June 2019 (14).…”

Section: Discussionmentioning

confidence: 97%

Does patient and public involvement impact public health decision-making? A 10-year retrospective analysis of public consultation in Brazil

Lopes

Novaes

Soárez

2023

Preprint

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Background: The aim of this work is to characterize the processes associated with patient and public involvement (PPI) in the form of public consultations (PC) during the first 10 years of operation of the National Committee for Health Technology Incorporation in the Unified Health System (Conitec) of Brazil and to identify factors associated with changes in Conitec’s recommendations following these PC. Methods: This cross-sectional study analysed all processes related to the adoption of technology that took place in Brazil between 2012 and 2021 based on technical reports and self-reported information collected from PC participants. A multiple logistic regression model identified factors associated with changes in Conitec’s recommendations following PC. Results: A total of 479 technical reports were published, of which 83% (n=400) were submitted to PC. Demands were made mainly by applicants from the state (n=262; 55%), regarding the adoption of medicines (n=367; 77%), in which context neoplasms and infectious diseases were the most frequent indications (n=66; 14% for each). A total of 264 (55%) processes resulted in a final recommendation in favour of introducing the technology. Over the period of 10 years, 196,483 contributions were received in response to PC. The largest volume of contributions was made by patients and their families or representatives (n=99,082; 50.4%), females (122,895; 67%), white individuals (129,165; 70.8%) and individuals between the ages of 25 and 59 years (145,364; 79.9%). Alteration of the preliminary recommendation occurred in 13% (n=53) of the PC, with a higher proportion of recommendations being altered from 2017 onwards. Increased participation by patients had a significant impact on the alteration of the preliminary recommendation (Odds Ratio 3.87, 95% CI 1.33-13.35, p=0.02). Conclusions: It is necessary to develop PPI mechanisms that are more dialogical and less vulnerable to political contexts with the aim of establishing a more equitable and accountable health system.

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Section: Discussionmentioning

confidence: 97%

Does patient and public involvement impact public health decision-making? A 10-year retrospective analysis of public consultation in Brazil

Lopes

Novaes

Soárez

2023

Preprint

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“…It is understood that no matter how much a country invests in health care, it is not possible to incorporate every intervention for the entire populace. Hence, debating more effective ways, in addition to the cost‐effectiveness methodology and the BIA in order to evaluate new technologies is of utmost importance 33 . Standard health technology assessment methods may not fully capture the social value of some health technologies.…”

Section: Discussionmentioning

confidence: 99%

“…Hence, debating more effective ways, in addition to the costeffectiveness methodology and the BIA in order to evaluate new technologies is of utmost importance. 33 Standard health technology assessment methods may not fully capture the social value of some health technologies. To this end, more research is needed to validate the extent of the deviation between the social value and the efficiency perspective when deciding on reimbursement for health technologies.…”

Section: Study Limitationsmentioning

confidence: 99%

Cost‐effectiveness analysis of epidural morphine/ropivacaine treatment in patients with cancer pain

Vieira,

de Barros,

Price

et al. 2023

Pain Practice

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BackgroundCancer pain is one of the main causes of human suffering, which can generate disabilities and compromise quality of life, giving rise to several psychosocial and economic consequences.AimsThis quantitative study sought to perform a cost‐effectiveness pharmacoeconomic analysis to assess the impact of implanting epidural morphine associated with ropivacaine treatment in gastrointestinal cancer patients with pain that is difficult clinical control, compared with conventional oral treatment.Materials and MethodsThe study population consisted of 24 patients with gastrointestinal neoplasia who underwent treatment for cancer pain that was difficult to clinically control. 12 patients each were recruited into the control and intervention groups, respectively. While patients in the control group were administered drug treatment orally, patients in the intervention group underwent a surgical procedure for subcutaneous implantation of a catheter that allowed epidural administration of morphine and ropivacaine. For pain assessment, the Visual Analogue Scale was applied. Data analysis had a descriptive character of costs, taking into account the costs for the year 2021. The study perspective was the Brazilian public healthcare provider, referred to as the Unified Health System (Sistema Único de—SUS in Portuguese). Costs were computed over the time horizon corresponding to the duration of treatment, from the first medical consultation (when the treatment was defined) to the end (end of treatment, disease progression, or death). Treatment duration was divided into three phases (first 60 days, support with palliative care, and end‐of‐life care). To assess the robustness of the economic analysis, sensitivity analyses were performed, considering the effectiveness of pain reduction on the Visual Analogue Scale, and a comparison of results using the median prices of pharmaceutical components used in the study.ResultsThe mean age of patients was 59.3 years. The results from the cost‐effectiveness analysis showed the epidural morphine/ropivacaine treatment to be more effective with regard to pain reduction on the pain scale, particularly for end‐of‐life care, when compared to the conventional oral treatment, however, at a significantly higher cost.DiscussionFrom the accomplishment of this research, it was observed that the application of the pain assessment scale is a way to better interpret and understand the patient's pain, facilitating care planning and decision‐making by health professionals, as well as monitoring the effectiveness of the proposed new treatment.ConclusionTo present a better cost‐effectiveness ratio, a reduction in the cost of the new epidural technology or an increase in the value of the existing oral intervention would be required. However, the latter is not feasible and unlikely to occur. A value judgement to decide whether the incremental benefit associated with the use of the new intervention is worth the extra cost will have to be made by the healthcare provider. Interventions that can relieve cancer pain symptoms should be investigated continuously, in search of evidence to support clinical practice and promote better quality of life for patients.

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“…In addition, 13% of recommendations changed after the public consultation, and the significant participation of patients and their families was strongly associated with changes in preliminary recommendations regarding the adoption of technologies into the SUS. Previous investigations, which featured shorter follow-up times or analysed specific subgroups, found the frequency of change in recommendations following a public consultation to 18.8% in the case of medicines up to June 2016 [ 14 ], 8% in the case of medicines, products and procedures by 2018 [ 5 ], and 19% in the case of rare diseases by June 2019 [ 15 ].…”

Section: Discussionmentioning

confidence: 99%

Does patient and public involvement impact public health decision-making? A 10 year retrospective analysis of public consultation in Brazil

Lopes

Novaes

Soárez

2023

Health Res Policy Sys

View full text Add to dashboard Cite

Background The aim of this work is to characterize the processes associated with patient and public involvement (PPI) in the form of public consultations (PC) during the first 10 years of operation of the National Committee for Health Technology Incorporation in the Unified Health System (Conitec) of Brazil, and to identify factors associated with changes in Conitec’s recommendations following these PC. Methods This cross-sectional study analysed all processes related to the adoption of technologies that took place in Brazil between 2012 and 2021 based on technical reports and self-reported information collected from PC participants. A multiple logistic regression model identified factors associated with changes in Conitec’s recommendations following PC. Results A total of 479 technical reports were published, of which 83% (n = 400) were submitted to PC. Demands were made mainly by applicants from the government (n = 262; 55%), regarding the adoption of medicines (n = 366; 76%), in which context neoplasms and infectious diseases were the most frequent indications (n = 66; 14% for each). A total of 264 (55%) processes resulted in a final recommendation in favour of introducing the technology. Over the period of 10 years, 196 483 contributions were received in response to PC. The largest volume of contributions was made by patients and their families or representatives (n = 99 082; 50%), females (122 895; 67%), white individuals (129 165; 71%) and individuals between the ages of 25 and 59 years (145 364; 80%). Alteration of the preliminary recommendation occurred in 13% (n = 53) of the PC, with a higher proportion of recommendations being altered from 2017 onwards. Increased participation by patients had a significant impact on the alteration of the preliminary recommendation (odds ratio 3.87, 95% CI 1.33–13.35, p = 0.02). Conclusions Increased engagement of patients and their families and caregivers in PC was associated with changing the preliminary recommendation of Conitec about the adoption of technologies into the public health system in Brazil.

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Incorporações de medicamentos para doenças raras no Brasil: é possível acesso integral a estes pacientes?

Cited by 9 publications

References 12 publications

Does patient and public involvement impact public health decision-making? A 10-year retrospective analysis of public consultation in Brazil

Does patient and public involvement impact public health decision-making? A 10-year retrospective analysis of public consultation in Brazil

Cost‐effectiveness analysis of epidural morphine/ropivacaine treatment in patients with cancer pain

Does patient and public involvement impact public health decision-making? A 10 year retrospective analysis of public consultation in Brazil

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