The impact of quality-of-life data in relative effectiveness assessments of new anti-cancer drugs in European countries.

Purpose: The aim of this study is to investigate the role of health-related quality-of-life (QoL) data in relative effectiveness assessments (REAs) of new anti-cancer drugs across European jurisdictions, during health technology assessment procedures.

Methods: Comparative analysis of guidelines and publicly available REAs in six European jurisdictions of anti-cancer drugs approved by EMA between 2011 and 2013.

Results: Fourteen anti-cancer drugs were included, adding up to 79 REAs.

[HTA goes Europe: European collaboration on joint assessment and methodological issues becomes reality].

Introduction: The standardisation of European HTA and thus the reduction of redundancies require clearly defined processes and methods. The HTA Core Model®, a tool developed by the European Network EUnetHTA, is intended to ensure the transparent production of standardised and high-quality assessments in international collaboration.

Methods: The present paper describes the experience with already published EUnetHTA assessments as well as possibilities for national/local adaptations of these assessments.

Can a Joint Assessment Provide Relevant Information for National/Local Relative Effectiveness Assessments? An In-Depth Comparison of Pazopanib Assessments.

Background: In many European jurisdictions, relative effectiveness assessments (REAs) of pharmaceuticals are performed during the reimbursement decision-making process. International collaboration in the production of these assessments may prevent the duplication of information in various jurisdictions. A first pilot of a joint REA (pazopanib for the treatment of renal cell carcinoma) was published in 2011.

Which factors may determine the necessary and feasible type of effectiveness evidence? A mixed methods approach to develop an instrument to help coverage decision-makers.

Objectives: Reimbursement decisions require evidence of effectiveness and, in general, a blinded randomised controlled trial (RCT) is the preferred study design to provide it. However, there are situations where a cohort study, or even patient series, can be deemed acceptable. The aim of this study was to develop an instrument that first examines which study characteristics of a blinded RCT are necessary, and then, if particular characteristics are considered necessary, examines whether these characteristics are feasible.

Comparing the hta core model with a national health technology assessment report.

Objectives: The HTA Core Model is a framework for producing health technology assessments (HTAs) in a structured format. The Model splits the content of a HTA into assessment elements. The objective is to explore the adaptability of these assessment elements in national report production in a pilot case study comparing a national HTA report and the HTA Core Model.

Piloting international production of rapid relative effectiveness assessments of pharmaceuticals.

Background: This article describes the lessons learned from an international pilot assessment using the first version of the HTA Core Model® and Guidelines for rapid Relative Effectiveness Assessment (REA) of pharmaceuticals based on input from three different perspectives: the assessors, the users (health technology assessment organisations) and the marketing authorisation holder.

Methods: A pilot assessment was performed of pazopanib for the treatment of advanced or metastatic renal cell carcinoma for which 54 individuals from 22 EUnetHTA member organisations from 16 European countries gave their contribution. The work was divided in eight domain teams.

Standardized reporting for rapid relative effectiveness assessments of pharmaceuticals.

Objectives: Many European countries perform rapid assessments of the relative effectiveness (RE) of pharmaceuticals as part of the reimbursement decision making process. Increased sharing of information on RE across countries may save costs and reduce duplication of work. The objective of this article is to describe the development of a tool for rapid assessment of RE of new pharmaceuticals that enter the market, the HTA Core Model® for Rapid Relative Effectiveness Assessment (REA) of Pharmaceuticals.

Developing the HTA core model for the online environment.

Background: A framework for collaborative production and sharing of HTA information, the HTA Core Model, was originally developed within EUnetHTA in 2006-08. In this paper, we describe the further development of the Model to allow implementation and utilization of the Model online. The aim was to capture a generic HTA process that would allow effective use of the HTA Core Model and resulting HTA information while at the same time not interfering with HTA agencies' internal processes.

European collaboration on relative effectiveness assessments: What is needed to be successful?

Objective: The objective of this study is to identify the possible barriers and critical success factors for the implementation of European collaboration in the field of relative effectiveness assessment (REA) of drugs.

Methods: Data were gathered through semi-structured interviews with representatives from eight European health technology assessment (HTA) organisations involved in assessment of drugs for coverage decision-making (AAZ, AIFA, AHTAPol, HAS, HVB, IQWIG, NICE and ZiN).

Results: Potential barriers identified mainly relate to methodology, resources and challenges with implementation in the respective national processes (e.

['Fitting' evidence preferable when evaluating effectiveness of interventions].

The Dutch Health Care Insurance Board (CVZ) and the Institute for Medical Technology Assessment have developed a questionnaire to help assessors to formulate an answer to the question of which evidence fits best when evaluating the effectiveness of interventions by medical specialists. The Feasible Information Trajectory (FIT) questionnaire is based on the idea that the clinical setting defines the attainable study characteristics and thus possibly available evidence. The FIT questionnaire focuses on study characteristics (randomization, blinding and control groups) and not on study type (e.

Relative effectiveness assessment of pharmaceuticals: similarities and differences in 29 jurisdictions.

Objective: Assessment of the effectiveness compared with alternative treatment(s) plays an important role in many jurisdictions in determining the reimbursement status of pharmaceuticals. This type of assessment is often referred to as a relative effectiveness assessment (REA) and is carried out by many jurisdictions. Increased sharing of information across jurisdictions may save costs and reduce duplication.