Companion diagnostics are used to aid clinical decision making to identify patients who are most likely to respond to treatment. They are becoming increasingly important as more new pharmaceuticals receive licensed indications that require the use of a companion diagnostic to identify the appropriate patient subgroup for treatment. These pharmaceuticals have proven benefit in the treatment of s...

BACKGROUND In the field of health technology assessment (HTA), there are several approaches that can be used for ethical analysis. However, there is a scarcity of literature that critically evaluates and compares the strength and weaknesses of these approaches when they are applied in practice. In this paper, we analyse the applicability of some selected approaches for addressing ethical issues...

OBJECTIVES To evaluate the national regulatory, health technology assessment (HTA), and reimbursement pathways for public health care in Australia, Canada, England, and Scotland, to compare initial Canadian national HTA recommendations with the initial decisions of the other HTA agencies, and to identify factors for differing national HTA recommendations between the four HTA agencies. METHODS...

BACKGROUND Recent changes to the regulatory landscape of pharmaceuticals may sometimes require reimbursement authorities to issue guidance on technologies that have a less mature evidence base. Decision makers need to be aware of risks associated with such health technology assessment (HTA) decisions and the potential to manage this risk through managed entry agreements (MEAs). OBJECTIVE This...

The Central and Eastern European Society of Technology Assessment in Health Care was founded in Krakow, Poland in 2003. On October 8th and 9th, the 7th symposium took place titled 'HTA for Crisis'. This meeting was attended by over 250 decision makers, evidence-based specialists, healthcare managers, commercial company personnel and experts. The symposium was principally divided into four main ...

Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Briggs A H, Gray A M. Handling uncertainty when performing economic evaluation of healthcare interventions. Health Technology Assessment 1999; 3(2): 1-134 Authors' objectives 1. To perform a...

The Organisation of European Cancer Institutes OECI working group on Health Economics and Cost Benefit in Oncology suggests four actions that are needed to improve alignment and integration between clinicians, researchers, and Health Technology Assessment (HTA) experts and agencies: 1) HTA expertise is necessary close to or within the comprehensive cancer centres (CCC); 2) HTA expertise should ...

EGFR: Epidermal Growth Factor Receptor; EGFR M+: Epidermal Growth Factor Receptor Activating Mutation Positive; EMA: European Medicines Agency; ICER: Incremental Cost Effectiveness Ratio; HTA: Health Technology Assessment; NCPE: National Centre for Pharmacoeconomics; NICE: National Institute of Health and Care Excellence; NSCLC: Non Small Cell Lung Cancer; OS: Overall Survival; PEA: Pharmaco-Ec...

Early benefit assessment in Germany under the legislative framework of AMNOG (Arzneimittelmarktneuordnungsgesetz) requires direct comparisons of the new drug with appropriate comparators determined by the Federal Joint Committee (G-BA). In case no head-to-head studies are available for direct comparisons, the submission of indirect comparisons is permitted to assess the additional benefit of th...