PP262—Can authorities take full advantage of the availability of generic atypical antipsychotic drugs? implications for the future

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Utilisation of the ESMO-MCBS in practice of HTA

It is highly appreciated that the European Society of Medical Oncology has developed a system to assess new oncologic compounds according to their value to patients. Consequently, offering decision-support to those who either want to use the new cancer therapies in clinical practice but cannot keep up-to-date with all therapy options or, alternatively, to those who have to decide whether or not to fund new oncology medicines or exclude from reimbursement due to their low value. This is particularly important with ever-rising prices for new oncology medicines which have increased up to ten fold in recent years

Systemic Measures and Legislative and Organizational Frameworks Aimed at Preventing or Mitigating Drug Shortages in 28 European and Western Asian Countries

Drug shortages have been identified as a public health problem in an increasing number of countries. This can negatively impact on the quality and efficiency of patient care, as well as contribute to increases in the cost of treatment and the workload of health care providers. Shortages also raise ethical and political issues. The scientific evidence on drug shortages is still scarce, but many lessons can be drawn from cross-country analyses. The objective of this study was to characterize, compare, and evaluate the current systemic measures and legislative and organizational frameworks aimed at preventing or mitigating drug shortages within health care systems across a range of European and Western Asian countries. The study design was retrospective, cross-sectional, descriptive, and observational. Information was gathered through a survey distributed among senior personnel from ministries of health, state medicines agencies, local health authorities, other health or pharmaceutical pricing and reimbursement authorities, health insurance companies and academic institutions, with knowledge of the pharmaceutical markets in the 28 countries studied. Our study found that formal definitions of drug shortages currently exist in only a few countries. The characteristics of drug shortages, including their assortment, duration, frequency, and dynamics, were found to be variable and sometimes difficult to assess. Numerous information hubs were identified. Providing public access to information on drug shortages to the maximum possible extent is a prerequisite for performing more advanced studies on the problem and identifying solutions. Imposing public service obligations, providing the formal possibility to prescribe unlicensed medicines, and temporary bans on parallel exports are widespread measures. A positive finding of our study was the identification of numerous bottom-up initiatives and organizational frameworks aimed at preventing or mitigating drug shortages. The experiences and lessons drawn from these initiatives should be carefully evaluated, monitored, and presented to a wider international audience for careful appraisal. To be able to find solutions to the problem of drug shortages, there is an urgent need to develop a set of agreed definitions for drug shortages, as well as methodologies for their evaluation and monitoring. This is being progressed

Can authorities appreciably enhance the prescribing of oral generic risperidone to conserve resources? : findings from across Europe and their implications

Generic atypical antipsychotic drugs offer health authorities opportunities for considerable savings. However, schizophrenia and bipolar disorders are complex diseases that require tailored treatments. Consequently, generally there have been limited demand-side measures by health authorities to encourage the preferential prescribing of generics. This is unlike the situation with hypertension, hypercholaesterolaemia or acid-related stomach disorders.The objectives of this study were to compare the effect of the limited demand-side measures in Western European countries and regions on the subsequent prescribing of risperidone following generics; to utilise the findings to provide future guidance to health authorities; and where possible, to investigate the utilisation of generic versus originator risperidone and the prices for generic risperidone. Principally, this was a segmented regression analysis of retrospective time-series data of the effect of the various initiatives in Belgium, Ireland, Scotland and Sweden following the introduction of generic risperidone. The study included patients prescribed at least one atypical antipsychotic drug up to 20 months before and up to 20 months after generic risperidone. In addition, retrospective observational studies were carried out in Austria and Spain (Catalonia) from 2005 to 2011 as well as one English primary care organisation (Bury Primary Care Trust (PCT)). There was a consistent steady reduction in risperidone as a percentage of total selected atypical antipsychotic utilisation following generics. A similar pattern was seen in Austria and Spain, with stable utilisation in one English PCT. However, there was considerable variation in the utilisation of generic risperidone, ranging from 98% of total risperidone in Scotland to only 14% in Ireland. Similarly, the price of generic risperidone varied considerably. In Scotland, generic risperidone was only 16% of pre-patent loss prices versus 72% in Ireland. Consistent findings of no increased prescribing of risperidone post generics with limited specific demand-side measures suggests no 'spillover' effect from one class to another encouraging the preferential prescribing of generic atypical antipsychotic drugs. This is exacerbated by the complexity of the disease area and differences in the side-effects between treatments. There appeared to be no clinical issues with generic risperidone, and prices inversely reflected measures to enhance their utilisation

Adherence to quality criteria improves concordance between transient elastography and ElastPQ for liver stiffness assessment-A multicenter retrospective study

BACKGROUND: Assessment of liver stiffness provides important diagnostic and prognostic information in patients with chronic liver disease. AIMS: To investigate whether the use of quality criteria (i) improves the concordance between transient elastography (TE) and a novel point shear wave elastography technique (ElastPQ®) and (ii) impacts on the performance of ElastPQ® for liver fibrosis staging using TE as the reference standard. METHODS: In this multicenter retrospective study, data of patients undergoing liver stiffness measurements (LSM) in five European centers were collected. TE was performed with FibroScan® (Echosens, France) and ElastPQ® with EPIQ® or Affiniti® systems (Philips, The Netherlands). The agreement between TE and ElastPQ® LSMs was assessed with Lin's concordance correlation coefficient (CCC). Diagnostic performance of ElastPQ® was assessed by the area under receiver operating characteristic (AUROC) curves. RESULTS: Overall, 664 patients were included: mean age: 54.8(13.5) years, main etiologies: viral hepatitis (83.1%) and NAFLD (7.5%). CCC increased significantly when LSMs with ElastPQ® were obtained with IQR/M ≤ 30% (p < 0.001). The diagnostic performance of ElastPQ® for fibrosis staging also increased if LSM values were obtained with IQR/M ≤ 30%. CONCLUSION: Quality criteria should be followed when using ElastPQ® for LSM, since the concordance with TE fibrosis staging was better at an ElastPQ® IQR/M ≤ 30

Systemic Solutions, Legislati ve And Organizational Frameworks Aimed To Prevent Or Mitigate Drug Shortages In European Countries

Objectives: The shortages of medicines have become an issue in many countries. This negatively impacts on the quality and efficiency of the care of patients. The scientific evidence regarding drug shortages in terms of their extent and rationale is still scarce. The goal of this study was to characterize, compare and evaluate potential solutions and legislative frameworks which exist within health care systems across a range of European countries, aimed at preventing or mitigating drug shortages. Methods: The survey was distributed among national health authority and health insurance company experts knowledgeable of the European pharmaceutical markets. It included questions pertaining to: 1) general characteristics of drug shortages; 2) alertness on drug shortages and description of information systems; 3) public service obligations; 4) regulations associated with the problem of drug shortages. Results: The findings are based on feedback from 16 European countries. In the majority of countries formal definitions of drug shortages currently don’t exist. Shortages have occurred in all countries throughout the last decade and have typically been increasing. The types of medicines experiencing shortages are generally well recognized, however the frequency and duration of shortages are varied and unpredictable. The notification-related obligations of Marketing Authorization Holders in cases which could lead to drug shortages exist in almost all countries. At least one institution per country is involved in national reporting system but access to information is often limited to the public. In the majority of countries, there exist formal obligations associated with supplying medicines to cover patients’ needs so as not to compromise patient care. A few countries have attempted to limit parallel exports to cope with drug shortages. Conclusions: Drug shortages have become an increasingly important public health problem. Its characteristics varies across the European countries. Several lessons can be drawn based on a collective international experience.status: publishe