Postlaunch evidence generation practices among health technology assessment bodies in Europe.

Objectives: The term Postlaunch Evidence Generation (PLEG) refers to evidence generated after the launch or licensing of a health technology. The aim of this paper is to provide an overview of the implementation of these practices in the European Union in order to explore cross-border cooperation opportunities.

Methods: In December 2019, a survey composed of nine closed-ended questions with multiple choice answers about the PLEG practices in each country was sent to all twenty-five dedicated work package (WP5B) partners of the European Network of Health Technology Assessment (EUnetHTA) Joint Action 3.

Early Dialogues for Pharmaceutical Products in European Network for Health Technology Assessment Joint Action 3: What Was Done and Where to Go in the Future.

Objectives: The aim of this article is to describe the process, results, and experiences of European Network for Health Technology Assessment (EUnetHTA) Joint Action 3's (JA3) Early Dialogue (ED) activities and to highlight opportunities for improving the processes.

Methods: A descriptive analysis of the steps of the EUnetHTA ED process and evaluation of the data from the EDs conducted by EU health technology assessment (HTA) bodies, published guidelines, and documents, as well as internal statistics.

Results: In JA3, an Early Dialogues Working Party (EDWP) was established, responsible for developing and improving processes and providing advice to pharmaceutical companies, supported by the ED Secretariat.

Development and Pilot Test of the Registry Evaluation and Quality Standards Tool: An Information Technology-Based Tool to Support and Review Registries.

Objectives: Health technology assessment (HTA) bodies are increasingly making use of real-world evidence and data. High-quality registries could be an asset for this; nevertheless, there is a lack of specified standards to assess the quality of data in the registry, or the registry itself. The European Network for Health Technology Assessment Joint Action 3 led the work to develop a tool for the evaluation of clinical registries: the "Registry Evaluation and Quality Standards Tool" (REQueST).

Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines.

The understanding of the benefit risk profile, and relative effectiveness of a new medicinal product, are initially established in a circumscribed patient population through clinical trials. There may be uncertainties associated with the new medicinal product that cannot be, or do not need to be resolved before launch. Postlicensing or postlaunch evidence generation (PLEG) is a term for evidence generated after the licensure or launch of a medicinal product to address these remaining uncertainties.

Cost-effectiveness analysis of memantine for moderate-to-severe Alzheimer's disease in the Netherlands.

Objective: The purpose of this study was to estimate the cost-effectiveness of memantine relative to standard care in patients with moderate-to-severe Alzheimer's disease in the Netherlands.

Methods: A country-adapted five-year Markov model simulated disease progression through a series of states, defined by dependency and disease severity. Transition probabilities were derived from trials, with utility and epidemiological data obtained from a longitudinal Dutch cohort.

Modeling stroke management: a qualitative review of cost-effectiveness analyses.

Objective: To review recent economic analyses and determine if means of improving methodology used in modeling stroke management may exist.

Study Design And Setting: The Medline database was searched for pharmacoeconomic models of treatments or interventions in acute, non-transitory ischemic stroke. Search terms were: stroke, cost, cost-effectiveness, cost analysis, stroke management, model, modeling, and economic.

Cost-effectiveness of memantine compared with standard care in moderate-to-severe Alzheimer disease in Canada.

Objective: To conduct a cost-effectiveness analysis comparing the addition of memantine to standard care (that is, without acetylcholinesterase inhibitors) with standard care alone in moderate-to-severe Alzheimer disease (AD) in Canada.

Methods: A 2-year Markov model estimated clinical effects in terms of quality-adjusted life years (QALYs) and time in complete dependence as well as societal costs in four 6-month cycles. Health states were defined by AD severity assessed with the Mini-Mental State Examination (moderate = 10 to 19; severe < 10), by level of dependence in activities of daily living, and by death.

New assessment of dependency in demented patients: impact on the quality of life in informal caregivers.

Unlabelled: A qualitative tool was recently developed for evaluation of dependency in a demented population. This tool assesses the impact of cognitive impairment on functional status, taking into account disability in both the basic and the instrumental activities of daily living. The purpose of the present paper was to study the impact of dependency on informal caregivers who assist demented patients at home, with this new useful tool.

Cost-effectiveness of memantine in community-based Alzheimer's disease patients: An adaptation in Spain.

Several clinical trials have demonstrated the efficacy and safety of the NMDA antagonist memantine in moderately severe to severe Alzheimer's disease (AD) patients. A 28-week pharmacoeconomic study conducted in the US also showed a reduction of total healthcare costs and informal care compared to placebo. Long-term implications of memantine treatment were modelled in the UK and Finland and revealed reductions in dependency, institutionalization and costs.

Characteristics and health status change over 6 months in people with moderately severe to severe Alzheimer's disease in the U.K.

Background And Objectives: Until recently, attention and treatment strategies have focused mainly on patients in the early phases of Alzheimer's disease (AD). The objectives of this study were to collect information on moderately severe and severe AD patients (Mini-mental State Examination score < 15) in terms of epidemiological, clinical and economic characteristics and disease change in the later stages of AD, and to compare this specific AD population over 6 months with those in the earlier stages.

Methods: This descriptive analysis recruited institutionalized patients and patients living within the community from the city of London and the South-East region of the U.

Cost effectiveness of memantine in Alzheimer's disease: an analysis based on a probabilistic Markov model from a UK perspective.

Background: Clinical trials with memantine, an uncompetitive moderate-affinity NMDA antagonist, have shown improved clinical outcomes, increased independence and a trend towards delayed institutionalisation in patients with moderately severe-to-severe Alzheimer's disease. In a randomised double-blind, placebo-controlled, 28-week study conducted in the US, reductions in resource utilisation and total healthcare costs were noted with memantine relative to placebo. While these findings suggest that, compared with placebo, memantine provides cost savings, further analyses may help to quantify potential economic gains over a longer treatment period.