Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
-
Several evidence-based interventions exist for people who misuse opioids, but there is limited guidance on optimal intervention selection. Economic evaluations using simulation modeling can guide the allocation of resources and help tackle the opioid crisis. This study reviews methods employed by economic evaluations using computer simulations to investigate the health and economic effects of interventions meant to address opioid misuse. ⋯ Future economic evaluations should consider synergies between interventions and examine combinations of interventions to inform optimal policy response. They should also more consistently conduct model validation and assess the value of further research.
-
Given the potential of real-world evidence (RWE) to inform understanding of the risk-benefit profile of next-generation sequencing (NGS)-based testing, we undertook a study to describe the current landscape of whether and how payers use RWE as part of their coverage decision making and potential solutions for overcoming barriers. ⋯ We provide numerous suggestions to overcome the data, methodologic, infrastructure, and policy challenges constraining greater integration of RWE in assessments of NGS.
-
Common health state valuation methodology, such as time tradeoff (TTO) and standard gamble (SG), is typically applied under several descriptively invalid assumptions, for example, related to linear quality-adjusted life years (QALYs) or expected utility (EU) theory. Hence, the current use of results from health state valuation exercises may lead to biased QALY weights, which may in turn affect decisions based on economic evaluations using such weights. Methods have been proposed to correct responses for the biases associated with different health state valuation techniques. In this article we outline the relevance of prospect theory (PT), which has become the dominant descriptive alternative to EU, for health state valuations and economic evaluations. ⋯ Suggestions for research addressing these issues are provided. Nonetheless, if validly corrected health state valuations become available, we argue in favor of using these in economic evaluations.
-
To compare US Food and Drug Administration (FDA) and European Medicines Agency (EMA) labeling for evidence based on patient-reported outcomes (PROs) of new oncology treatments approved by both agencies. ⋯ During this time period, the FDA and the EMA used different evidentiary standards to assess PRO data from oncology studies, with the EMA more likely to accept data from open-label studies and broad concepts such as health-related quality of life. An understanding of the key differences between the agencies may guide sponsor PRO strategy when pursuing labeling. Patient-focused proximal concepts are more likely than distal concepts to receive positive reviews.
-
Review
Cost of Tuberculosis Diagnosis and Treatment in Patients with HIV: A Systematic Literature Review.
To summarize the costs of tuberculosis (TB) diagnosis and treatment in human immunodeficiency virus (HIV)-infected patients and to assess the methodological quality of these studies. ⋯ Our findings point to the need of generation of more standardized methods for cost data collection to generate more robust estimates and thus, support decision-making process.