A systematic review of economic evaluations of the use of memantine alone or combined with donepezil for moderate to severe Alzheimer’s disease

Objective: To synthesize the available evidence and state of the art of economic evaluations which evaluate the use of memantine, whether alone or combined with donepezil, for moderate to severe Alzheimer’s disease (AD), focusing on the analytical decision models built. Method: The electronic databases MEDLINE, EMBASE, NHS EED, CEA Registry and LILACS were searched for references. After duplicates were removed, two independent reviewers evaluated the titles and abstracts and subsequently the full texts. The Drummond M. tool was used to evaluate the quality of the studies. Results: After the application of the eligibility criteria, twelve complete economic evaluations were included. One evaluation was a clinical trial, two involved simulations and nine used Markov models. The main outcome measure adopted was dominated by cost per quality adjusted life year (QALY). The use of memantine was considered cost-effective and dominant in eight studies; while in a single study, its use was dominated when compared to donepezil for moderate AD. Sensitivity analyzes were systematically performed, with robust results. The quality assessment indicated that the methodological quality of the studies was good. Conclusion: Although there is some controversy regarding the benefits derived from the use of memantine, whether combined or not with donepezil, the evidence collected suggests that it is cost-effective in the countries where the studies were performed. However, local economic studies need to be performed, given the significant variability derived from the different parameters adopted in the evaluations

The regulatory, evaluation, pricing and reimbursement pathway for medicines in the UK: combining innovation and access

The United Kingdom has universal healthcare systems, the National Health System (NHS), in its four nations, with healthcare services provided free of charge at the point of delivery. Approximately 10.5% of the UK population has voluntary supplementary private health insurance. While the provision of inpatient medicines is free of charge, medicines provided in the outpatient setting have a dispensing fee in some of the nations, such as the case of England (co-payment). The UK marketing authorisation process is called product licensing and is overseen by the Medicines and Healthcare Products Regulatory Agency (MHRA). There are different licensing routes based on the intended market for launch. MHRA also offers early access schemes and pathways for products targeting unmet medical needs and promising technologies, that aim to accelerate and facilitate market and patient access to products in the UK. These schemes include the option for companies to engage early with regulators and other system partners such as health technology assessment (HTA) agencies. As soon as the technology is authorised, it is available at a list price. Prices for medicines are regulated in legislation and in schemes agreed between the industry association and the Department of Health and Social Care (DHSC). The prices for the NHS are negotiated between the government and the companies. Routine funding decisions in the NHS are guided by HTA evaluations informed by agencies such as the National Institute for Health and Care Excellence (NICE) in England, the Scottish Medicines Consortium (SMC) in Scotland, and the All Wales Medicines Strategy Group (AWMSG) in Wales. Many medicines and other technologies are subject to price negotiations in the NHS, sometimes with confidential price agreements. The NHS in England is legally mandated to routinely fund technologies recommended by NICE that have been evaluated by some of its programmes. The other UK nations have similar arrangements or recognise decisions made in England. The role and contribution of NICE and other HTA agencies in ensuring value for money and evidence-based decision making is well recognised worldwide

Custo-efetividade do uso da tomografia de emissão de pósitrons na detecção de recorrência do câncer diferenciado de tireoide/Cost-effectiveness of the use of positron emission tomography in the detection of recurrence of differentiated thyroid cancer

The positron emission tomography (18FDG-PET/CT) was recently introduced in Brazilian health care for many oncology indications but accompanied by higher costs. In our study we performed a cost-effectiveness analysis of the addition of PET/CT to the conventional diagnostic work-up to detect recurrent differentiated thyroid cancers. The analytical decision model represented a hypothetical cohort of adults, thyroid cancer patients with high risk by initial stratification, submitted to total thyroidectomy and ablation with I131. The addition of PET/CT was applied to subjects with negative results on I131scintigraphy. The model was designed from the perspective of the Brazilian public health care system, with a time horizon of 10 years. Effectiveness was measured by the additional recurrent cases detected. Only direct medical costs were considered. Costs and benefits were discounted by 5%. Univariate deterministic and probabilistic sensitivity analyzes were performed to explore the uncertainties. The PET/CT diagnosed 13 additional cases compared to conventional strategy (1,888 vs 1,875) by a cost of R$477,633.05 per case detected. The parameters of greatest impact in the sensitivity analysis were the accuracy of conventional tests, cost of PET/CT and the discount rate. The costs of adding PET/CT seems significant and its introduction is not cost-effective on the Brazilian perspective

Guidelines for utility measurement for economic analysis: The Brazilian policy

Introduction Health-related quality of life is expressed in utilities, also referred to as utility estimates or parameters. Considerations about the source and type of utility values are especially important in a modeling context, where the lack of transparency, including the lack of a hierarchy for utility data sources, is a major issue to any estimation and can potentially compromise model reliability. Objectives This document aims to present the first version of the Brazilian guidelines for utility measurement to support economic analysis. Methods A virtual workshop and a modified Delphi panel with 10 health technology specialists followed a rapid evaluation of 110 technical documents and indexed publications. The recommendations are based on the proposition that has received the most votes, although contentious issues are addressed in the suggestion or discussion. The rationale for the final decision is included in the text. Results The consensus includes 50 recommendations with the following topics: Transparency and Reliability, Model Design, Conditions Under Which Generic Questionnaires Are Not Sensible or Valid, Utility Evidence Hierarchy, Utility Data Searching, Modeling Utility Values, Extrapolating Quality Adjusted Life-Years for Models With Lifetime Horizons, Caregiver Utility, Utility Data Synthesis, Quality/Certainty of the Evidence, and Utility Estimates in End-of-Life Conditions. Conclusions The goal of this project is to create unified national standards for using utility metrics in economic analysis in Brazil. This set of recommendations is not obligatory, but it is meant to serve as a guide and lead to the development of better and more transparent economic models in the country