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. METHODS: Eighteen member organisations of the European Network of Health Technology Assessment (EUnetHTA) participated in the development of the model. Different versions of the model were developed and piloted in this collaboration and adjusted accordingly based on feedback on the content and feasibility of the model. RESULTS: The final model deviates from the traditional HTA Core Model® used for assessing other types of technologies. This is due to the limited scope (strong focus on RE), the timing of the assessment (just after market authorisation), and strict timelines (e.g. 90 days) required for performing the assessment. The number of domains and assessment elements was limited and it was decided that the primary information sources should preferably be a submission file provided by the marketing authorisation holder and the European Public Assessment Report. CONCLUSIONS: The HTA Core Model® for Rapid REA (version 3.0) was developed to produce standardised transparent RE information of pharmaceuticals. Further piloting can provide input for possible improvements, such as further refining the assessment elements and new methodological guidance on relevant areas.

Insight into recent reforms and initiatives in Austria: implications for key stakeholders.

Pharmaceutical expenditure continued to rise steadily in Austria during the 1990s and early 2000s despite a variety of reforms. However, recent reforms and initiatives have moderated the growth rate. These initiatives include transparent pricing of new drugs and generics, greater restrictions on the prescribing of new drugs and voluntary price reductions. Alongside this, there have also been initiatives to enhance rational and efficient prescribing. The lack of published data makes it difficult to fully analyze the impact of individual reforms. In addition, some reforms have only recently been introduced. Despite this, implications can be drawn for key stakeholder groups in the future. This includes pharmaceutical companies continuing to need to demonstrate substantially added benefit for their new drug to command average European prices. Otherwise, premiums will be restricted to a maximum 10% above the price of current standards. In addition, companies will need to continue to lower the price of their brands in interchangeable classes as standards become available as generics. The alternative will be prescribing restrictions. Further reforms will be needed in Austria to meet government growth targets for pharmaceutical expenditure of only 3-4% per annum, while continuing to fund new innovative drugs and increased volumes with greater prevalence of chronic diseases. Possible future measures and their implications for key stakeholder groups will also be discussed.

Simultaneous PIV/OH-PLIF, Rayleigh thermometry/OH-PLIF and stereo PIV measurements in a low-swirl flame.

The diagnostic techniques for simultaneous velocity and relative OH distribution, simultaneous temperature and relative OH distribution, and three component velocity mapping are described. The data extracted from the measurements include statistical moments for inflow fluid dynamics, temperature, conditional velocities, and scalar flux. The work is a first step in the development of a detailed large eddy simulation (LES) validation database for a turbulent, premixed flame. The low-swirl burner used in this investigation has many of the necessary attributes for LES model validation, including a simplified interior geometry; it operates well into the thin reaction zone for turbulent premixed flames, and flame stabilization is based entirely on the flow field and not on hardware or pilot flames.