The economic evaluation of medical products and services is increasingly prioritised by healthcare decision makers and plays a key role in informing funding allocation decisions. It is well known that there are a number of methodological difficulties in the health technology assessment of medical devices, particularly in the provision of efficacy evidence. By contrasting devices with pharmaceuticals, the way in which the differing systems of innovation mould the UK's industry landscape is described and substantiated with market statistics. In recognition of the challenges faced by industry, as well as the growing need for cost-effective allocation of National Health Service (NHS) resources, the National Institute for Health and Care Excellence (NICE) led the development of the Medical Technologies Evaluation Programme (MTEP), which launched in 2009/2010. The review of the UK's medical devices market supports the programme's three principal aims: to simplify access to evaluation, speed up the process, and increase evaluative capacity for devices within NICE. However, an analysis of the output of MTEP's first 3 years suggests that it has some way to go to meet each of these aims.

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OBJECTIVES: During the last decade, with the arrival of new innovative vaccines, there was a huge increase in the number of papers on economic evaluation of vaccination programmes. Our study had a 3-fold objective: 1) Appraise available methodological papers dealing with specificities of vaccines in term of health economics; 2) Illustrate the impact of each issue in term of decision-making process with concrete examples; and 3) Identify futures challenges. METHODS: A comprehensive literature search was conducted to identify methodological papers dealing with specificities of economic evaluations of vaccines. Each issue was illustrated with concrete examples of cost-effectiveness analyses recently performed for HPV vaccines, or pneumococcal diseases. RESULTS: Except guidelines issued in 2008 by the WHO and a few general papers, most of methodological papers focused on modelling techniques and showed a trend in using more and more sophisticated methods (e.g. calibration). Several papers highlighted the need for having strong dynamic transmission models of infectious diseases to evaluate appropriately the cost-effectiveness of vaccination programmes. Other papers focused on the issue of discounting, and showed the extreme impact of discounting for some vaccines given this long-term assessment, possibly warranting an alternative method of discounting for vaccines. Fewer papers highlighted the different type of clinical evidence compared with curative pharmaceutical drugs, in particular the need to model immunological responses into clinical endpoints of disease and short-term efficacy into long-term effectiveness. Although there is an increasing level of expertise in the field, other important issues such as the choice of realistic assumptions (coverage rates or vaccine prices) and the inclusion of externalities (i.e. changes in the epidemiology of the infection) are not well analysed. CONCLUSIONS: It is important for decision makers to keep in mind the above vaccine specificities when they assess the cost-effectiveness of new vaccination programmes in order to provide relevant conclusions.

The objective of this study was to analyze recent HTA decisions in Taiwan and Korea, and determine the influence on the outcome by HTA decision in Australia and the UK. METHODS: This study examined 30 high-cost drugs that were FDA and EMA approved from 2011-2014. Two-thirds of the sample were oncology drugs, while the remaining one-third included drugs treating multiple sclerosis, chronic hepatitis C and type 2 diabetes. The HTA decisions of these products in Taiwan and Korea were analyzed as well as in their frequently referenced countries, Australia and the UK. RESULTS: Of the 30 products studied, 24 products were assessed by PBAC in Australia and 15 products were evaluated by NICE in the UK, while only 9 products received HIRA assessments in Korea and 5 products were assessed by the CDE in Taiwan. The difference in favorable HTA outcomes among these countries was even greater. Only 2 products received positive HTA decisions in Taiwan and Korea, while 8 and 11 products were recommended in Australia and the UK respectively. Among the 8 products evaluated by HIRA, and previously assessed by PBAC and NICE, 6 products received the same decisions as PBAC and / or NICE. The correlation coefficient between HIRA and PBAC decisions was 0.75. Similarly, all 5 products assessed by the CDE received similar evaluations to those of PBAC and / or NICE, and the correlation coefficient between CDE and PBAC decisions was 1. CONCLUSIONS: Access to medicine in Asia, even in wealthy countries like Taiwan and Korea, still largely lags behind Western countries like Australia and the UK. In Taiwan and Korea, where pharmacoeconomic assessment is a key component in the HTA evaluation, HTA decisions may be greatly influenced by the HTA outcomes in countries like Australia and the UK where pharmacoeconomic evaluation is well-established.

provision of diagnostic services at the drugstores (p<0,05, c2-test) were established. The highest PC quality (51% -high, medium and low, 49% -unsatisfactory) was estimated for dispense of OTC-drugs. The PC quality of prescription drugs assistance and diagnostic services were unsatisfactory. The PC quality during dispense of OTC-drugs was significantly correlated with undergraduate study on OTC-drugs PC (rOTC1 ¼ 0.76) and professional development on the issues of PC during the postgraduate training of pharmacists (rOTC2 ¼ 0.65). CONCLUSIONS: Overall PC quality in Ukraine is compromised significantly by the fact that national PC system is focused mostly on OTC-drugs whereas appropriate assistance during dispense of prescription drugs and the provision of diagnostic services is lacking. The opportunity to address this issue in pharmacy educational programs as well as regulatory guidelines should be carefully considered.