Decision makers who undertake health technology assessments such as those conducted by NICE, deliberatively consider a new technologies cost per QALY, alongside other criteria (such as, equity, whether treatment is lifesaving and patient experience, etc) which are not captured in incremental cost-effectiveness ratios alone. The intention to implement an explicit value based pricing scheme in the United Kingdom in 2014 has sparked a debate regarding which elements should be included in the assessment of value and how they should be combined and traded-off against each other. Of importance is consideration to how values should be derived to determine how different criteria should trade-off each other. This debate is timely given that even where price is considered to be fixed during the re-imbursement process (such as the current NICE process) such systems could be seen implicitly determining value based price and may influence pricing decisions. Using an example presented in a recent review or multi-criteria decision making (Thokala 2011) we compare four mechanisms by which different elements of value could be explicitly and deterministically traded-off in order to provide an overall estimate of a value based price.The mechanisms are:conventional cost per QALY; MCDA; adjusted QALY approach; adjusted threshold approach; and a net benefit approach. Hypothetical criteria incorporated into the decision making process include equity, innovation, patient compliance and the quality of evidence.Using these examples, we show that these methods are clearly related in that they ultimately require estimates of monetary value to be placed on each dimension of value, but may place different emphasis on the weightings given to specific elements and the potential interactions between different elements. The mechanism in which these monetary values are derived, must importantly reflect societies values in trading off additional criteria for overall health gains. OBJECTIVES:Under the concept of pharmaceutical branch development (2011-2020), social reimbursement system is going to be developed and implemented in Ukraine. That will demand a use of central health technology assessment (HTA) approach with appropriate instruments for its implementation. The aim of this publication was to develop an instrument for HTA prioritization in Ukraine by using qualitative approach. METHODS: A literature search was performed across PudMed, Medline, and Cochrane. EUR-ASSESS report was analyzed. Factors important for current health care decision making, data availability, and criteria important for prioritization in the other countries were reviewed by the experts and assessed on their applicability in Ukrainian health care setting. RESULTS: A list of criteria that should be a basis for HTA prioritization in Ukraine was developed. The criteria have different weight in accordance to their importance and data availability. These criteria are the following: burden of disease, current size of state financing for this health care branch, potential benef...
professionals and guideline developers; 6. Processing results and preparation of field tests: sorting, selection and reduction of instruments for domains and concepts by using the framework and criteria for feasibility and use in daily practice; 7. Implementation-and dissemination planning. Results A Conceptual framework based on the structure of clinical reasoning and International Classification of Functioning. An inventory of domains that are relevant for physiotherapy and feasibility criteria for the selection of instruments. A guide for the selection and reduction of recommended instruments in guidelines and use in daily practice. Conclusions The framework gives professionals and guideline developers the same structure and a clearer understanding about the selection of instruments for daily practice. It helps professionals to learn when to use which instrument for what patient.
A365for the FDA, EMA, Health Canada and Australia the Australian Therapeutic Goods Administration. The studies used to make regulatory decisions were then compared to the studies used in the reimbursement decisions of France, Scotland, Canada and Australia. Results: In all 15 cases reviewed the FDA, EMA and Health Canada used at least one of the same studies to come to their decision and in 13 of the cases Australia also used that same study. In 14 cases the FDA approved the drug before the other regulatory authorities; the longest time before another regulatory agency approved a drug was 15 months for rilpivirine. In six cases the FDA commissioned studies that other regulatory bodies and reimbursement agencies used later. All of the studies were interventional studies. Reimbursement agencies always used studies that were previously cited in regulatory documents. These agencies would also use studies intended for the regulatory approval of another drug as a source for information in a review. ConClusions: Reimbursement agencies and other regulatory agencies are influenced by the FDA in the studies they consider, as illustrated by at least six cases in which other agencies used studies commissioned by the FDA after approval. This influence is easier to see in the last five years, but may be older than that due to improvements in published reports.
The problem of managing the safe operation of hoisting machines with an expired service life is associated with solving extremely complex interrelated tasks through a set of organizational and technical measures aimed at establishing the actual risk and economic feasibility of further operation. The most important condition in this case is the conduct of an expert examination of industrial safety and technical diagnostics, the results of which make it possible to establish the real state of hoisting machines at the current time. The safety of hoisting machines, including after the expiration of the standard service life (assigned resource), is associated with design features, workmanship, installation quality, their operation modes and a number of other factors. However, for heavily loaded hoisting machines, the main technical obstacle to safe operation is metal fatigue The results of a statistical analysis of defects detected by expert diagnosis of self-propelled boom-type cranes that have fulfilled the standard operating period are presented. The largest number of defects is associated with the destruction and wear of structural elements, the occurrence of fatigue cracks and the violation of the operating conditions of the equipment. The greatest number of defects is found in the hydraulic system of cranes, elements of the cable-block system, less often in metal construction. To conduct a risk analysis of self-propelled jib cranes in conditions of insufficient information, a methodology for expert assessments is proposed. It allows you to evaluate the impact of potential defects of self-propelled jib cranes on the amount of economic damage to the crane itself and the transported load and on the magnitude of the traumatic impact on humans. Defects and damage to the metal structures of the cranes discovered during the examinations are the result of the following combination of reasons: low quality of the metal (mild steel); unsatisfactory design; unsatisfactory quality of manufacture and installation of individual elements; environmental aggressiveness; operation of cranes in an unintended mode, poor maintenance and repair Keywords: safety, propelled jib crane, defect, expert assessment, risk analysis, diagnosis.
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