Economic evaluations of colorectal cancer screening: A systematic review and quality assessment.

Colorectal Cancer (CRC) is the third most common type of cancer worldwide and ranks second in mortality. Screening programs for early detection and treatment have been implemented in several countries. Economic evaluations are an important tool to support decision-making about reimbursement and coverage decisions in health systems and, therefore, to support efficient resource allocation. The article aims to review the up-to-date evidence on economic evaluations of CRC screening strategies. MEDLINE, EMBASE, Web of Science, SCOPUS, SciELO, Lilacs, CRD databases, and lists of references were reviewed to identify relevant literature regarding full economic evaluations of CRC screening in asymptomatic average-risk individuals over 40 years old. Searches were conducted with no restriction to language, setting, or date. Qualitative syntheses described CRC screening strategies and comparators (baseline context), study designs, key parameter inputs and incremental cost-effectiveness ratios. Seventy-nine articles were included. Most of the studies were from high-income countries and a third-party payer perspective. Markov models were predominantly used, although microsimulation has been increasingly adopted in the last 15 years. The authors found 88 different screening strategies for CRC, which differed in the type of technique, the interval of screening, and the strategy, i.e., isolated or combined. The annual fecal immunochemical test was the most predominant screening strategy. All studies reported cost-effective results in their scenarios compared to no screening scenarios. One-quarter of the publications reported cost-saving results. It is still necessary to develop future economic evaluations in Low- and Middle-Income Countries (LMICs), which account for the high burden of disease.

Economic evaluations of colorectal cancer screening: A systematic review and quality assessment

Abstract Colorectal Cancer (CRC) is the third most common type of cancer worldwide and ranks second in mortality. Screening programs for early detection and treatment have been implemented in several countries. Economic evaluations are an important tool to support decision-making about reimbursement and coverage decisions in health systems and, therefore, to support efficient resource allocation. The article aims to review the up-to-date evidence on economic evaluations of CRC screening strategies. MEDLINE, EMBASE, Web of Science, SCOPUS, SciELO, Lilacs, CRD databases, and lists of references were reviewed to identify relevant literature regarding full economic evaluations of CRC screening in asymptomatic average-risk individuals over 40 years old. Searches were conducted with no restriction to language, setting, or date. Qualitative syntheses described CRC screening strategies and comparators (baseline context), study designs, key parameter inputs and incremental cost-effectiveness ratios. Seventy-nine articles were included. Most of the studies were from high-income countries and a third-party payer perspective. Markov models were predominantly used, although microsimulation has been increasingly adopted in the last 15 years. The authors found 88 different screening strategies for CRC, which differed in the type of technique, the interval of screening, and the strategy, i.e., isolated or combined. The annual fecal immunochemical test was the most predominant screening strategy. All studies reported cost-effective results in their scenarios compared to no screening scenarios. One-quarter of the publications reported cost-saving results. It is still necessary to develop future economic evaluations in Low- and Middle-Income Countries (LMICs), which account for the high burden of disease.

Patient and public involvement in health technology decision-making processes in Brazil.

OBJECTIVE: The study aims to characterize and discuss the processes of patient and public involvement (PPI) in the Brazilian Health Regulatory Agency (Anvisa), the National Committee for Health Technology Incorporation (Conitec), and the National Agency for Supplementary Health (ANS) in Brazil. METHODS: This is an exploratory, descriptive, and comparative study, conducted by analyzing the public documents and regulation of the three institutions. RESULTS: The mechanisms for PPI included public consultations, public hearings, participation in advisory committees, and health technology evaluation requests. Anvisa conducted 187 public consultations between 1999 and 2018, gathering 10,699 contributions. In total, 76 (41%) public consultations did not present information about the contributions received. Conitec carried out 234 public consultations and received 53,174 contributions between 2011 and 2018. It was identified that 70 (23%) recommendations from Conitec did not go through public consultation, and 26 (8%) recommendations changed after public consultation. Recommendation changes seemed to have occurred especially in cases with a greater number of contributions in the public consultation process. ANS conducted eight public consultations regarding the list of health procedures and events covered by health insurances between 2000 and 2018, and it received 31,498 contributions. For three public consultations, there was no information about the number of contributions received. CONCLUSIONS: There are regulatory advances and institutional activity supporting PPI in highly technical decision-making processes in Brazil, although heterogeneously among the analyzed institutions. The power of PPI to influence health technology deliberative processes still requires in-depth studies, including the characterization of stakeholders and the legitimacy of decisions.

Health technology assessment of biosimilars worldwide: a scoping review.

BACKGROUND: Health technology assessment (HTA) should provide an assessment of a technology's effects on health and of the related social, economic, organisational and ethical issues. HTA reports on biosimilars can specifically assess their immunogenicity, their extrapolation to one or more conditions, and the risks of interchangeability and substitution. We aimed to complete a scoping review within the context of HTA organisations to synthesise HTA reports on biosimilars and to map the extension, scope and methodological practices. MAIN BODY: A scoping review methodology was applied. The sources for biosimilars HTA reports were database searches and grey literature from HTA organisation websites up to June 2019. HTA reports of biosimilars were classified as full HTA, mini-HTA or rapid reviews. Data were extracted and recorded on a calibrated predefined data form. We identified 70 HTA reports of biosimilars of 16 biologic products (65.71% in 2015-2018) produced by 13 HTA organisations from 10 countries; 2 full HTAs, 4 mini-HTAs and 64 rapid reviews met the inclusion criteria. Almost all the rapid reviews gave no information regarding any evidence synthesis method and approximately half of the rapid reviews did not appraise the risk of bias of primary studies or the overall quality of evidence. All full-HTAs and mini-HTAs addressed organisational, ethical, social and legal considerations, while these factors were assessed in less than half of the rapid reviews. The immunogenicity and extrapolation of one or more conditions were often considered. The majority of full-HTAs and mini-HTAs contained an assessment of switching and a discussion of an educational approach about biosimilars. No HTA report rejected the adoption/reimbursement of the biosimilar assessed. CONCLUSION: HTA of biosimilars are emerging in the context of HTA organisations and those that exist often duplicate reports of the same biosimilar. Most HTA reports of biosimilars do not conduct a systematic literature review or consider economic issues. No report has rejected the adoption/reimbursement of biosimilars. There is a need to standardise the minimum criteria for the development of HTA on biosimilars to ensure a better understanding and better decision-making.

Patient and public involvement in health technology decision-making processes in Brazil / Participação social na gestão de tecnologias em saúde em âmbito federal no Brasil

ABSTRACT OBJECTIVE The study aims to characterize and discuss the processes of patient and public involvement (PPI) in the Brazilian Health Regulatory Agency (Anvisa), the National Committee for Health Technology Incorporation (Conitec), and the National Agency for Supplementary Health (ANS) in Brazil. METHODS This is an exploratory, descriptive, and comparative study, conducted by analyzing the public documents and regulation of the three institutions. RESULTS The mechanisms for PPI included public consultations, public hearings, participation in advisory committees, and health technology evaluation requests. Anvisa conducted 187 public consultations between 1999 and 2018, gathering 10,699 contributions. In total, 76 (41%) public consultations did not present information about the contributions received. Conitec carried out 234 public consultations and received 53,174 contributions between 2011 and 2018. It was identified that 70 (23%) recommendations from Conitec did not go through public consultation, and 26 (8%) recommendations changed after public consultation. Recommendation changes seemed to have occurred especially in cases with a greater number of contributions in the public consultation process. ANS conducted eight public consultations regarding the list of health procedures and events covered by health insurances between 2000 and 2018, and it received 31,498 contributions. For three public consultations, there was no information about the number of contributions received. CONCLUSIONS There are regulatory advances and institutional activity supporting PPI in highly technical decision-making processes in Brazil, although heterogeneously among the analyzed institutions. The power of PPI to influence health technology deliberative processes still requires in-depth studies, including the characterization of stakeholders and the legitimacy of decisions.

RESUMO OBJETIVO Caracterizar e discutir os processos formais de participação social previstos e implementados pelas instituições Agência Nacional de Vigilância Sanitária (Anvisa), Comissão Nacional de Incorporação de Tecnologias no SUS (Conitec) e Agência Nacional de Saúde Suplementar (ANS). MÉTODOS Estudo exploratório, descritivo, comparativo, conduzido por meio de análise de documentos publicados até 2018 no sítio eletrônico e da legislação específica de cada instituição. RESULTADOS Os espaços de participação social identificados incluem a representação em colegiados e participação direta por meio de uma demanda inicial ou em consultas públicas, audiências públicas e ouvidorias. A Anvisa conduziu 187 consultas públicas entre 1999 e 2018, e contabilizou 10.699 contribuições. Em 76 (41%) consultas públicas não há informações sobre as contribuições recebidas. A Conitec conduziu 234 consultas públicas, e recebeu 53.174 contribuições entre 2011 e 2018. Identificou-se que 70 (23%) recomendações da Conitec foram emitidas sem consulta pública, e 26 (8%) recomendações preliminares foram alteradas após consulta pública. As alterações de recomendação aconteceram especialmente em casos com grande volume de contribuições. A ANS conduziu 8 consultas públicas sobre o rol de procedimentos e eventos em saúde entre 2000 e 2018, e recebeu pelo menos 31.498 contribuições. Em três consultas públicas não há informações sobre o número de contribuições recebidas. CONCLUSÕES Observa-se recente avanço normativo e de desempenho institucional em favor da participação social em espaços decisórios notadamente técnicos, embora de forma bastante heterogênea entre as instituições analisadas. O poder deliberativo da participação social de influenciar as decisões em saúde ainda necessita de estudo aprofundado, incluindo a caracterização dos participantes e a legitimidade das decisões subsequentes.