Overcoming Barriers in Hospital-Based Health Technology Assessment (HB-HTA): International Expert Panel Consensus.

The purpose of this article is to investigate the common facilitators and barriers associated with the implementation of hospital-based health technology assessment (HB-HTA) across diverse hospital settings in seven countries. Through a two-round Delphi study, insights were gathered from a panel of 15 HTA specialists from France, Hungary, Italy, Kazakhstan, Poland, Switzerland, and Ukraine. Experts initially conducted a comprehensive review of the HB-HTA implementation in their respective countries, identifying the barriers and facilitators through descriptive analysis. Subsequently, panel experts ranked these identified barriers and facilitators on a seven-point Likert scale. A median agreement score ≥ 6 and interquartile range (IQR) ≤ 1 was accepted as reaching a consensus. Out of the 12 statements categorized as external and internal barriers and facilitators, the expert panel reached consensus on six statements (two barriers and four facilitators). The external barrier, which achieved consensus, was the lack of the formal recognition of the role of HB-HTA in national or regional legislations. The internal barrier reaching consensus was the limited availability of human resources dedicated to HB-HTA. This qualitative study indicates that HB-HTA still has progress to make before being formally accepted and integrated across most countries, although by building on the facilitating factors we identified there may be an opportunity for the implementation of internationally developed strategies to strengthen HB-HTA practices.

Evidence-based public policy making for medicines across countries: findings and implications for the future.

Aim: Global expenditure on medicines is rising up to 6% per year driven by increasing prevalence of non-communicable diseases (NCDs) and new premium priced medicines for cancer, orphan diseases and other complex areas. This is difficult to sustain without reforms. Methods: Extensive narrative review of published papers and contextualizing the findings to provide future guidance. Results: New models are being introduced to improve the managed entry of new medicines including managed entry agreements, fair pricing approaches and monitoring prescribing against agreed guidance. Multiple measures have also successfully been introduced to improve the prescribing of established medicines. This includes encouraging greater prescribing of generics and biosimilars versus originators and patented medicines in a class to conserve resources without compromising care. In addition, reducing inappropriate antibiotic utilization. Typically, multiple measures are the most effective. Conclusion: Multiple measures will be needed to attain and retain universal healthcare.

Potential approaches for the pricing of cancer medicines across Europe to enhance the sustainability of healthcare systems and the implications.

Introduction: There are growing concerns among European health authorities regarding increasing prices for new cancer medicines, prices not necessarily linked to health gain and the implications for the sustainability of their healthcare systems.Areas covered: Narrative discussion principally among payers and their advisers regarding potential approaches to the pricing of new cancer medicines.Expert opinion: A number of potential pricing approaches are discussed including minimum effectiveness levels for new cancer medicines, managed entry agreements, multicriteria decision analyses (MCDAs), differential/tiered pricing, fair pricing models, amortization models as well as de-linkage models. We are likely to see a growth in alternative pricing deliberations in view of ongoing challenges. These include the considerable number of new oncology medicines in development including new gene therapies, new oncology medicines being launched with uncertainty regarding their value, and continued high prices coupled with the extent of confidential discounts for reimbursement. However, balanced against the need for new cancer medicines. This will lead to greater scrutiny over the prices of patent oncology medicines as more standard medicines lose their patent, calls for greater transparency as well as new models including amortization models. We will be monitoring these developments.

Practical Implications From European Hospital Pharmacists on Prospective Risk Assessment for Medicine Shortages.

Objective: This study aimed to obtain a comprehensive overview on the perception, attitudes, and experience of European pharmacists with prospective risk assessment procedures in everyday practice, as well as to identify challenges and solutions. This is a follow-up study to the surveys on prospective risk assessment previously carried out within the COST Action 15105 among pharmacists across Europe. Methodology: In-depth interviews were performed using an interview guide comprising 25 questions. Interviews were transcribed ad verbatim and imported into NVivo 10 for framework analysis. In NVivo, the interviews were coded through assigning text segments to a responding code from a coding tree, covering the full content of the interviews. Coded text segments were then charted into a matrix, and analyzed by interpreting all text segments per code. Results: In total, 18 interviews were conducted. From the framework analysis, 6 codes and 12 sub-codes emerged. Overall, despite citing specific issues pertaining to its implementation, the interviewees considered multi-stakeholder and multi-disciplinary prospective risk assessment to be essential. While healthcare professionals reported being aware of the importance of risk assessment, they cited insufficient knowledge and skills to be a major obstacle in everyday practice. They also reported inadequate IT support since a paper-based system is still widely in use, thereby complicating data extraction to carry out prospective risk assessment. Conclusion: While prospective risk assessment was found to be valuable, interviewees also found it to be a resource-intensive and time-consuming process. Due to resource constraints, it may not be possible or desirable to conduct prospective risk assessment for every shortage. However, for critical-essential drugs, it is crucial to have a ready-to-use substitute based on risk assessment. Moreover, potential risks of substitutes on patient health should be identified before a shortage occurs and the substitute is dispensed as an alternative.

Prospective Risk Assessment of Medicine Shortages in Europe and Israel: Findings and Implications.

INTRODUCTION: While medicine shortages are complex, their mitigation is more of a challenge. Prospective risk assessment as a means to mitigate possible shortages, has yet to be applied equally across healthcare settings. The aims of this study have been to: 1) gain insight into risk-prevention against possible medicine shortages among healthcare experts; 2) review existing strategies for minimizing patient-health risks through applied risk assessment; and 3) learn from experiences related to application in practice. METHODOLOGY: A semi-structured questionnaire focusing on medicine shortages was distributed electronically to members of the European Cooperation in Science and Technology (COST) Action 15105 (28 member countries) and to hospital pharmacists of the European Association of Hospital Pharmacists (EAHP) (including associated healthcare professionals). Their answers were subjected to both qualitative and quantitative analysis (Microsoft Office Excel 2010 and IBM SPSS Statistics®) with descriptive statistics based on the distribution of responses. Their proportional difference was tested by the chi-square test and Fisher's exact test for independence. Differences in the observed ordinal variables were tested by the Mann-Whitney or Kruskal-Wallis test. The qualitative data were tabulated and recombined with the quantitative data to observe, uncover and interpret meanings and patterns. RESULTS: The participants (61.7%) are aware of the use of risk assessment procedures as a coping strategy for medicine shortages, and named the particular risk assessment procedure they are familiar with failure mode and effect analysis (FMEA) (26.4%), root cause analysis (RCA) (23.5%), the healthcare FMEA (HFMEA) (14.7%), and the hazard analysis and critical control point (HACCP) (14.7%). Only 29.4% report risk assessment as integrated into mitigation strategy protocols. Risk assessment is typically conducted within multidisciplinary teams (35.3%). Whereas 14.7% participants were aware of legislation stipulating risk assessment implementation in shortages, 88.2% claimed not to have reported their findings to their respective official institutions. 85.3% consider risk assessment a useful mitigation strategy. CONCLUSION: The study indicates a lack of systematically organized tools used to prospectively analyze clinical as well as operationalized risk stemming from medicine shortages in healthcare. There is also a lack of legal instruments and sufficient data confirming the necessity and usefulness of risk assessment in mitigating medicine shortages in Europe.

Poland: Health System Review.

This analysis of the Polish health system reviews recent developments in organization and governance, health financing, health care provision, health reforms and health system performance. In late 2017, the Polish government committed to increase the share of public expenditures on health to 6% of GDP by 2024. If the GDP continues to grow in the years to come, this will present an opportunity to tackle mounting health challenges such as socioeconomic inequalities in health, high rates of obesity, rising burden of mental disorders and population ageing that put strain on health care resources. It is also an opportunity to tackle certain longstanding imbalances in the health sector, including overreliance on acute hospital care compared with other types of care, including ambulatory care and long-term care; shortages of human resources; the negligible role of health promotion and disease prevention vis-a-vis curative care; and poor financial situation in the hospital sector. Finally, the additional resources are much needed to implement important ongoing reforms, including the reform of primary care. The resources have to be spent wisely and waste should be minimized. The introduction, in 2016, of a special system (IOWISZ) of assessing investments in the health sector that require public financing (including from the EU funds) as well as the work undertaken by the Polish health technology assessment (HTA) agency (AOTMiT), which evaluates health technologies and publicly-financed health policy programmes as well as sets prices of goods and services, should help ensure that these goals are achieved. Recent reforms, such as the ongoing reform of primary care that seeks to improve coordination of care and the introduction of the hospital network, go in the right direction; however, a number of longstanding unresolved problems, such as hospital indebtedness, need to be tackled.

Proposal for a regulation on health technology assessment in Europe - opinions of policy makers, payers and academics from the field of HTA.

INTRODUCTION: In January 2018 the European Commission published a Proposal for a Regulation on Health Technology Assessment (HTA): 'Proposal for a Regulation on health technology assessment and amending Directive 2011/24/EU'. A number of stakeholders, including some Member States, welcomed this initiative as it was considered to improve collaboration, reduce duplication and improve efficiency. There were however a number of concerns including its legal basis, the establishment of a single managing authority, the preservation of national jurisdiction over HTA decision-making and the voluntary/mandatory uptake of joint assessments by Member States. Areas covered: This paper presents the consolidated views and considerations on the original Proposal as set by the European Commission of a number of policy makers, payers, experts from pricing and reimbursement authorities and academics from across Europe. Expert commentary: The Proposal has since been extensively discussed at Council and while good progress has been achieved, there are still divergent positions. The European Parliament gave a number of recommendations for amendments. If the Proposal is approved, it is important that a balanced, improved outcome is achieved for all stakeholders. If not approved, the extensive contribution and progress attained should be sustained and preserved, and the best alternative solutions found.

Poland: health system review

This analysis of the Polish health system reviews recent developments in organization and governance, health financing, health care provision, health reforms and health system performance. In late 2017, the Polish governmentcommitted to increase the share of public expenditures on health to 6% of GDP by 2024. If the GDP continues to grow in the years to come, this will present an opportunity to tackle mounting health challenges such as socioeconomicinequalities in health, high rates of obesity, rising burden of mental disorders and population ageing that put strain on health care resources. It is also an opportunity to tackle certain longstanding imbalances in the health sector, including overreliance on acute hospital care compared with other types of care, including ambulatory care and long-term care; shortages of human resources; the negligible role of health promotion and disease prevention vis-à-vis curative care; and poor financial situation in the hospital sector.Finally, the additional resources are much needed to implement important ongoing reforms, including the reform of primary care. The resources have to be spent wisely and waste should be minimized.The introduction, in 2016, of a special system (IOWISZ) of assessing investments in the health sector that require public financing (including from the EU funds) as well as the work undertaken by the Polish health technology assessment (HTA) agency (AOTMiT), which evaluates health technologies and publicly financed health policy programmes as well as sets prices of goods and services, should help ensure that these goals are achieved. Recent reforms, such as the ongoing reform of primary care that seeks to improvecoordination of care and the introduction of the hospital network, go in the right direction; however, a number of longstanding unresolved problems, such as hospital indebtedness, need to be tackled.

Barriers for Access to New Medicines: Searching for the Balance Between Rising Costs and Limited Budgets.

Introduction: There is continued unmet medical need for new medicines across countries especially for cancer, immunological diseases, and orphan diseases. However, there are growing challenges with funding new medicines at ever increasing prices along with funding increased medicine volumes with the growth in both infectious diseases and non-communicable diseases across countries. This has resulted in the development of new models to better manage the entry of new medicines, new financial models being postulated to finance new medicines as well as strategies to improve prescribing efficiency. However, more needs to be done. Consequently, the primary aim of this paper is to consider potential ways to optimize the use of new medicines balancing rising costs with increasing budgetary pressures to stimulate debate especially from a payer perspective. Methods: A narrative review of pharmaceutical policies and implications, as well as possible developments, based on key publications and initiatives known to the co-authors principally from a health authority perspective. Results: A number of initiatives and approaches have been identified including new models to better manage the entry of new medicines based on three pillars (pre-, peri-, and post-launch activities). Within this, we see the growing role of horizon scanning activities starting up to 36 months before launch, managed entry agreements and post launch follow-up. It is also likely there will be greater scrutiny over the effectiveness and value of new cancer medicines given ever increasing prices. This could include establishing minimum effectiveness targets for premium pricing along with re-evaluating prices as more medicines for cancer lose their patent. There will also be a greater involvement of patients especially with orphan diseases. New initiatives could include a greater role of multicriteria decision analysis, as well as looking at the potential for de-linking research and development from commercial activities to enhance affordability. Conclusion: There are a number of ongoing activities across countries to try and fund new valued medicines whilst attaining or maintaining universal healthcare. Such activities will grow with increasing resource pressures and continued unmet need.

Antibiotic consumption and antimicrobial resistance in Poland; findings and implications.

Background: The problem of inappropriate use of antibiotics and the resulting growth in antimicrobial resistance (AMR) has implications for Poland and the world. The objective of this paper was to compare and contrast antibiotic resistance and antibiotic utilisation in Poland in recent years versus other European countries, including agreed quality indicators, alongside current AMR patterns and ongoing policies and initiatives in Poland to influence and improve antibiotic prescribing. Methods: A quantitative ten-year analysis (2007-2016) of the use of antibiotics based on European Centre for Disease Prevention and Control (ECDC) data combined with a literature review on AMR rates and antimicrobial stewardship initiatives. Results: The system of monitoring AMR and appropriate strategies to address AMR rates remain underdeveloped in Poland. The role of microbiological diagnostics and efforts to prevent infections is currently underestimated by physicians. Overall, Poland had one of the highest rates of total consumption of antibiotics in the analysed European countries. Total consumption of antibacterials for systemic use and relative consumption of beta-lactamase sensitive penicillins were characterized by small but statistically significant average annual increases between 2007 and 2016 (from 22.2 DIDs to 23.9 DIDs and from 0.8 to 1.3%, respectively). Conclusions: The integrated activities around appropriate antibiotic prescribing in the pre- and post-graduate training of physicians and dentists seem to be particularly important, as well as changes in policies on prescribing antibiotics within ambulatory care. AMR and appropriate prescribing of antibiotics should be the focus of health policy actions in Poland.

Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation.

Medicines receiving a conditional marketing authorization through Medicines Adaptive Pathways to Patients (MAPPs) will be a challenge for payers. The "introduction" of MAPPs is already seen by the European Medicines Agency (EMA) as a fait accompli, with payers not consulted or involved. However, once medicines are approved through MAPPs, they will be evaluated for funding by payers through different activities. These include Health Technology Assessment (HTA) with often immature clinical data and high uncertainty, financial considerations, and negotiations through different types of agreements, which can require monitoring post launch. Payers have experience with new medicines approved through conditional approval, and the fact that MAPPs present additional challenges is a concern from their perspective. There may be some activities where payers can collaborate. The final decisions on whether to reimburse a new medicine via MAPPs will have more variation than for medicines licensed via conventional processes. This is due not only to increasing uncertainty associated with medicines authorized through MAPPs but also differences in legal frameworks between member states. Moreover, if the financial and side-effect burden from the period of conditional approval until granting full marketing authorization is shifted to the post-authorization phase, payers may have to bear such burdens. Collection of robust data during routine clinical use is challenging along with high prices for new medicines during data collection. This paper presents the concept of MAPPs and possible challenges. Concerns and potential ways forward are discussed and a number of recommendations are presented from the perspective of payers.

The Implementation of Managed Entry Agreements in Central and Eastern Europe: Findings and Implications.

BACKGROUND: Managed entry agreements (MEAs) are a set of instruments to facilitate access to new medicines. This study surveyed the implementation of MEAs in Central and Eastern Europe (CEE) where limited comparative information is currently available. METHOD: We conducted a survey on the implementation of MEAs in CEE between January and March 2017. RESULTS: Sixteen countries participated in this study. Across five countries with available data on the number of different MEA instruments implemented, the most common MEAs implemented were confidential discounts (n = 495, 73%), followed by paybacks (n = 92, 14%), price-volume agreements (n = 37, 5%), free doses (n = 25, 4%), bundle and other agreements (n = 19, 3%), and payment by result (n = 10, >1%). Across seven countries with data on MEAs by therapeutic group, the highest number of brand names associated with one or more MEA instruments belonged to the Anatomical Therapeutic Chemical (ATC)-L group, antineoplastic and immunomodulating agents (n = 201, 31%). The second most frequent therapeutic group for MEA implementation was ATC-A, alimentary tract and metabolism (n = 87, 13%), followed by medicines for neurological conditions (n = 83, 13%). CONCLUSIONS: Experience in implementing MEAs varied substantially across the region and there is considerable scope for greater transparency, sharing experiences and mutual learning. European citizens, authorities and industry should ask themselves whether, within publicly funded health systems, confidential discounts can still be tolerated, particularly when it is not clear which country and party they are really benefiting. Furthermore, if MEAs are to improve access, countries should establish clear objectives for their implementation and a monitoring framework to measure their performance, as well as the burden of implementation.

The transparency of published health technology assessment-based recommendations on pharmaceutical reimbursement in Poland.

BACKGROUND: The appropriate access to public information is very important for healthcare system stakeholders. The goal of this study was to examine how the execution of the formally existing right to public information on the HTA-based recommendations on reimbursement of new health technologies from public funds has been changing in Poland. METHODS: All recommendations published within two predefined equal periods of time between 2013 and 2015 were analyzed. The gathered data was subjected to statistical analysis. RESULTS: The frequency and intensity of censoring the published HTA-based recommendations on the pharmaceutical reimbursement has diminished. The text readability and clarity of message has improved, although the degree of decisiveness of the recommendations has dropped. CONCLUSION: The positive changes in the public communication policy should be continued. The transparency of the HTA-based recommendations should be increased further in some areas in the future.

Perceptions and Attitudes of Egyptian Health Professionals and Policy-Makers towards Pharmaceutical Sales Representatives and Other Promotional Activities.

BACKGROUND: Pharmaceutical promotion activities in low and middle-income countries are often neither regulated nor monitored. While Egypt has the highest population and per capita use of medicines in the Arab world, we know very little about pharmaceutical companies promotional activities in the country. AIM: To explore and analyze the perceptions of physicians towards promotional and marketing activities of pharmaceutical companies among physicians and pharmacists in Egypt. METHODOLOGY: Perspectives of different healthcare system stakeholders were explored through semi-structured, in-depth interviews conducted in 2014 in Cairo, Egypt. Interviewees were chosen via purposive sampling and snowball technique. Each interview was recorded and transcribed. Then qualitative, thematic analysis was conducted with the help of NVIVO software. FINDINGS: The majority of physicians and pharmacists acknowledged exposure to pharmaceutical promotion. It was commonly believed that interaction with the pharmaceutical industry is necessary and both associated risks and benefits were acknowledged. The interviewed physicians considered themselves competent enough to minimize risks and maximize benefits to their prescribing habits. Views diverged on the extent and magnitude of the risks and benefits of pharmaceutical promotion, especially in regard to the influence on patients' health. CONCLUSIONS: Pharmaceutical promotion in Egypt is intensely directed at prescribers and dispensers. Physicians, pharmacists and policymakers expressed little skepticism to the influence of promotion towards their individual prescribing. Raising awareness of the pitfalls of pharmaceutical promotion is necessary, especially among the less experienced physicians.

[The role of the cytostatic drugs unit in rationalization of hospital drugs management--the case study and the analysis of drug utilization]. / Znaczenie pracowni leków cytostatycznych w racjonalizacji szpitalnej gospodarki lekami--studium przypadku i analiza uzytkowania leków.

UNLABELLED: Until recently, the cytostatic drugs were being prepared at the Polish hospitals by the nursing staff on hospital wards, however according to the Pharmaceutical Law, preparation of cytostatic drugs, as a pharmaceutical service, should be performed by the pharmacists, who possess appropriate qualifications and experience in working within aseptic conditions and who are trained in professional handling with harmful substances. The aim of this paper has been to assess the impact, which establishment of the cytostatic drugs unit at the hospital pharmacy of the big oncologic hospital, located in southern Poland, had on the overall costs of cytostatic drugs utilization. MATERIAL AND METHODS: The analysis of drugs consumption, as well as determining the size of losses of particular active substances, prepared by the cytostatic drugs unit, have been based on statistical reports, provided by the hospital pharmacy. In order to calculate the level of consumption and losses of active substances in the chemotherapy ward, in framework of the previous modality of function, the estimations have been done, taking into consideration the same needs of particular patients, as those included within reports provided by the pharmacy. The actual prices of drugs from year 2012 have been applied in the assessment of costs of drug utilization. The calculations have been done with Excel and SPSS v.21 software. The methods of descriptive statistics and the comparison of groups, using the Student's t-test for dependent samples have been applied. RESULTS: Due to functioning of the centralized modality of cytostatic drugs preparation within the specialized unit, the decline of overall cytostatic drug consumption, amounting to 9.73% has been observed. The reduction in losses, on stage of preparation of drugs, has been achieved and the share of these losses within overall consumption of drugs has dropped by 77.28%. The dissolution of cytostatic drugs in the cytostatic drugs unit, instead of the chemotherapy ward, allows the hospital to achieve the yearly savings, exceeding PLN 572,276.07. CONCLUSIONS: Establisment of the cytostatic drugs unit, at the hospital pharmacy of the specialist oncologic hospital, not only allowed for increasing quality of pharmacotherapy, but also for substantial savings, when compared with the previously used method of dissolving and preparing cytostatic drugs by the nurses, instantly at the chemotherapy wards.