An updated systematic review on spinal muscular atrophy patients treated with nusinersen, onasemnogene abeparvovec (at least 24 months), risdiplam (at least 12 months) or combination therapies.

OBJECTIVE: This systematic review provides an update on outcomes for patients with spinal muscular atrophy (SMA) type 1 to 4 treated with approved therapeutics, including the most recent, risdiplam, for an observation period of up to 48 months. METHODS: A systematic literature search was conducted in July 2023 in four databases. Selected publications were assessed for internal validity and risk of bias by two authors and relevant data were extracted into standardised tables. Results were summarised narratively as substantial heterogeneity of studies prevents meaningful quantitative analysis. RESULTS: Twenty observational studies and one RCT were included in the analysis, fifteen studies on nusinersen, one on onasemnogene abeparvovec and two on risdiplam. Evidence supports the effectiveness of the therapies in motor function improvement for up to 48 months of follow-up in the SMA types specified in their respective indications. Better results were observed with earlier treatment initiation and higher baseline function. Whilst motor improvement was consistently observed, regardless of SMA type or treatment used, we noted no significant improvements in respiratory and nutritional outcomes. Quality of life endpoints were rarely investigated. Adverse events were common but seldom classified as treatment-related except for post-lumbar puncture syndrome, which was frequently reported across nusinersen studies. CONCLUSION: The treatment of SMA with the new therapies changes the disease phenotype with changes in motor function far exceeding any improvement in respiratory and nutritional function. Questions persist on long-term efficacy, potential regressions, impact on quality of life and social functioning, therapy duration, and discontinuation indicators.

Robot-assisted surgery in thoracic and visceral indications: an updated systematic review.

BACKGROUND: In surgical advancements, robot-assisted surgery (RAS) holds several promises like shorter hospital stays, reduced complications, and improved technical capabilities over standard care. Despite extensive evidence, the actual patient benefits of RAS remain unclear. Thus, our systematic review aimed to assess the effectiveness and safety of RAS in visceral and thoracic surgery compared to laparoscopic or open surgery. METHODS: We performed a systematic literature search in two databases (Medline via Ovid and The Cochrane Library) in April 2023. The search was restricted to 14 predefined thoracic and visceral procedures and randomized controlled trials (RCTs). Synthesis of data on critical outcomes followed the Grading of Recommendations, Assessment, Development, and Evaluation methodology, and the risk of bias was evaluated using the Cochrane Collaboration's Tool Version 1. RESULTS: For five out of 14 procedures, no evidence could be identified. A total of 20 RCTs and five follow-up publications met the inclusion criteria. Overall, most studies had either not reported or measured patient-relevant endpoints. The majority of outcomes showed comparable results between study groups. However, RAS demonstrated potential advantages in specific endpoints (e.g., blood loss), yet these findings relied on a limited number of low-quality studies. Statistically significant RAS benefits were also noted in some outcomes for certain indications-recurrence, quality of life, transfusions, and hospitalisation. Safety outcomes were improved for patients undergoing robot-assisted gastrectomy, as well as rectal and liver resection. Regarding operation time, results were contradicting. CONCLUSION: In summary, conclusive assertions on RAS superiority are impeded by inconsistent and insufficient low-quality evidence across various outcomes and procedures. While RAS may offer potential advantages in some surgical areas, healthcare decisions should also take into account the limited quality of evidence, financial implications, and environmental factors. Furthermore, considerations should extend to the ergonomic aspects for maintaining a healthy surgical environment.

Mapping horizon scanning systems for medical devices: similarities, differences, and lessons learned.

OBJECTIVES: This article presents the mapping of horizons scanning systems (HSS) for medical devices, conducted by the Medical Devices Working Group of the International Horizon Scanning Initiative (IHSI MDWG). It provides an overview of the identified HSS, highlights similarities and differences between the systems, and lessons learned. METHODS: Potentially relevant HSS were identified through literature searches, scan of an overview of EuroScan members, and input from the IHSI MDWG members. Structured information was collected from organizations that confirmed having an HSS for medical devices. RESULTS: Sixteen initiatives could be identified, of which 11 are currently ongoing. The purposes of the HSS range from raising awareness of trends and new developments to managing informed decisions on innovative health services in hospitals. The time-horizon is most often 3 years up to a few months before market entry. Three models of identification of new technologies crystallized: a reactive (stakeholders outside HSS inform), a pro-active (actively searching multifold sources), and a hybrid model. Prioritization is often conducted by separate committees via scoring or debate. The outputs focus either on in-depth information of single technologies or on a class of technologies or on technologies in specific disease areas. CONCLUSIONS: The identified HSS share the common experience that horizon scanning (HS) for medical devices is a resource-intensive exercise that requires a dedicated and skilled team. Insights into the identified HSS and their experiences will be used in the continued work of the IHSI MDWG on its proposal for an IHSI HSS for medical devices.

Digital Health Applications (DiHA): Approaches to develop a reimbursement process for the statutory health insurance in Austria.

Purpose: To elaborate a concept for implementing digital health applications (DiHA), including prioritisation criteria (PC) for the Austrian context and an overview of available prioritised DiHAs. Methods: Based on European DiHA-listings and input by Austrian experts, a categorised meta-directory of DiHAs was created. PC were developed to reflect, inter alia, the provisions of the Austrian General Insurance Act, and were applied to the meta-directory to identify DiHAs potentially relevant for the Austrian statutory health insurance. An iterative process with expert involvement was used to tailor an existing reimbursement framework to the Austrian setting. Results: The meta-directory comprised 132 DiHAs. Developed PC focused on plausibility (German language) and legal aspects (treatment/monitoring of chronic conditions), while other criteria (e.g. interoperability standards) were considered optional. After applying the PC, 38 DiHAs were potentially relevant in the Austrian setting. Of these, only seven supported current health record integration. Most of the prioritised DiHAs reported on CE marking (29/38) and data protection (35/38), while reporting on risk class (10/38) and technical algorithms (0/38) was sparse. For DiHA reimbursement, a four-step process is proposed: identification (ideally based on needs assessment); filtering based on PC; review of technical, regulatory and evidentiary requirements; and health technology assessment. Conclusion: The proposed concept can offer guidance for policy makers (e.g., on prioritising available DiHAs) and may further foster scientific debate with regard to DiHA implementation. Further discussion on how to fully incorporate regulatory, technical, and evidentiary criteria is needed. Attention should be given to national implementation requirements, re-assessment criteria, and appropriate remuneration schemes.

Wearable cardioverter defibrillator for preventing sudden cardiac death in patients at risk: An updated systematic review of comparative effectiveness and safety.

Objectives: To synthesise the available evidence of wearable cardioverter defibrillator (WCD) therapy as an add-on measure to optimal medical therapy (OMT) or as a replacement of hospital stay. Methods: An update systematic review (SR) of comparative effectiveness and safety of WCD therapy was conducted. We included randomised controlled trials (RCT), prospective comparative studies and prospective uncontrolled studies with at least 100 patients. A narrative synthesis of the evidence was conducted. Results: One RCT (n = 2348) and further eleven observational studies (n = 5345) fulfilled our inclusion criteria. In the only available RCT, the use of the WCD was not statistically associated with a clinical benefit on arrhythmic mortality in post-myocardial infarction (MI) patients with an ejection fraction of ≤35%. The compliance with WCD therapy was low in the RCT and high in observational studies, with ten observational studies reporting on a daily wear time between 20 and 23.5 h. The range of percentage of patients receiving at least one appropriate shock was 1-4.8% and the rate of first shock success was reported to be 100% in three studies. Serious adverse events (SAEs) such as inappropriate shocks occurred rarely, with between 0% and 2% of patients being inappropriately shocked within ten observational studies. In one of the observational studies, two patients (2%) were allergic to nickel developing skin rash and false alarms occurred in 58 patients (57%) in this study. Another registry study (n = 448) reported milder AEs, such as dermatitis and pressure marks, occurring in 0.9% and 0.2% of enrolled patients, respectively. Conclusion: The only available RCT failed to show superiority of add-on use of WCD in post MI patients. Observational evidence shows that the compliance with WCD is good, but the evidence is afflicted with selection bias and the inclusion of diverse mixed patient populations diluting the ability to draw indication-specific conclusions on the utility of the device. More comparative data is needed to justify continuing or expanding use of WCD therapy.

Subcutaneous implantable cardioverter-defibrillator: a systematic review of comparative effectiveness and safety.

This systematic review evaluated the clinical effectiveness and safety of subcutaneous implantable cardioverter-defibrillator (S-ICD) in patients at an increased risk of sudden cardiac death and with an ICD indication for primary or secondary prevention. A systematic literature search was conducted in four databases (Medline via Ovid, Embase, the Cochrane Library, and HTA-INAHTA). Randomized controlled trials (RCTs) and controlled observational studies with ≥100 S-ICD patients and a low to moderate risk of bias were eligible for inclusion. The studies' quality and the available evidence's strength were assessed using the Cochrane risk of bias tool, the ROBINS-I tool, and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. One RCT, a post hoc analysis of the RCT (n = 849) and four controlled observational studies (n = 7149) were included. The quality of the available evidence was graded as low to very low, except for the primary composite endpoint of the RCT, which was rated as moderate quality. After 4 years, the RCT showed that S-ICD was non-inferior to TV-ICD regarding the composite endpoint of inappropriate shocks and device-related complications (68 [15.1%] vs. 68 [15.7%], hazard ratio [HR] 0.99, 95% confidence interval [CI] [0.71, 1.39], non-inferiority margin 1.45, P = 0.001). The RCT and two observational studies reported statistically significantly fewer lead complications in S-ICD patients (after 4 years: 1.4% vs. 6.6%, HR 0.24, 95% CI [0.10, 0.54]; after 3 years: 0.3% vs. 2.3%, P = 0.03; and after 5 years: 0.8% vs. 11.5%, P = 0.03). Identified evidence about appropriate and inappropriate shocks was inconclusive: The RCT detected statistically significantly more appropriate shocks in patients with S-ICD (83 [19.2%] vs. 57 [11.5%], HR 1.52, 95% CI [1.08, 2.12], P = 0.02), whereas one observational study showed a statistically significantly lower rate in the S-ICD group (9.9%, 95% CI [7.0, 13.9], vs. 13.9%, 95% CI [10.8, 17.8], P = 0.003). Regarding inappropriate shocks, one observational study reported statistically significantly higher rates in the S-ICD cohort (11.9% vs. 7.5%, P = 0.007), whereas the RCT and two other observational studies did not detect a statistically significant difference between the treatment groups (P > 0.05). None of the included studies showed a statistically significant difference in overall mortality and shock efficacy between patients with S-ICD and TV-ICD (P > 0.05). The available evidence is insufficient to show the superiority of S-ICD compared with TV-ICD, hindering the widespread use of the technology. Results of the recently completed ATLAS trial are to be awaited, and the anticipated role of the S-ICD needs to be clearly formulated.

Clinical effectiveness and safety of self-expandable implantable bulking agents for faecal incontinence: a systematic review.

PURPOSE: The purpose of this systematic review is to evaluate whether self-expandable implantable vs non-self-expandable injectable bulking agents (second-line therapies) are equal/superior in terms of effectiveness (severity, quality of life [QoL]) and safety (adverse events) for faecal incontinence (FI). METHODS: A systematic review was conducted, and five databases were searched (Medline via Ovid, Embase, Cochrane Library, University of York Centre for Reviews and Dissemination, and International Network of Agencies for Health Technology database). In-/exclusion criteria were predefined according to the PICOS scheme. The Institute of Health Economics risk of bias (RoB) tool assessed studies' internal validity. According to the Grading of Recommendations, Assessment, Development and Evaluation approach, the strength of evidence for safety outcomes was rated. A qualitative synthesis of the evidence was used to analyse the data. RESULTS: The evidence consists of eight prospective single-arm, before-after studies (166 patients) fulfilling the inclusion criteria for assessing clinical effectiveness and safety of implantable bulking agents. FI severity statistically significantly improved in five of seven studies rated by the Cleveland Clinic FI Score and in three of five studies measured by the Vaizey score. Statistically significant improved disease-related QoL was found in one of five studies measured by the FI QoL Score and in one of two studies rated by the American Medical Systems score. Procedure-related adverse events occurred in 16 of 166 patients (i.e., intraoperative complications, anal discomfort and pain). Device-related adverse events occurred in 48 of 166 patients, including prostheses' dislodgement and removed/extruded prostheses. Studies were judged with moderate/high RoB. The strength of evidence for safety was judged to be very low. CONCLUSION: Implantable bulking agents might be an effective and safe minimally invasive option in FI treatment if conservative therapies fail. FI severity significantly improved, however, effects on QoL need to be explored in further studies. Due to the uncontrolled nature of the case series, comparative studies need to be awaited.

EUnetHTA's contribution to the new legal framework for health technology assessment cooperation in Europe.

The history of the European cooperation on health technology assessment (HTA) has reached an important milestone with the adoption of the European HTA Regulation (HTA R) 2021/2282 in Dec 2021 (1). Its publication in the Official Journal of the European Union means a lot to those of us who wish to give HTA a stronger role in supporting health policy in favor of sustainable healthcare systems in Europe. The HTA R was prepared well by the European Commission with an impact assessment on policy options for enhanced EU cooperation on HTA (2) in 2017, followed by 3 years of negotiations with Member States. Now the ratified document stipulates that the European Cooperation on HTA will be based on a legal mandate and no longer stay a voluntary project-based initiative. It also means sustainability, since a permanent Secretariat at the European Commission will be set-up under the HTA R.

Mid- and long-term (at least 12 months) follow-up of patients with spinal muscular atrophy (SMA) treated with nusinersen, onasemnogene abeparvovec, risdiplam or combination therapies: A systematic review of real-world study data.

OBJECTIVES: This systematic review aimed to assess mid- and long-term (at least 12 months) real-world study data from all types of spinal muscular atrophy (SMA) patients treated with any of the approved drugs or combination therapies. METHODS: A systematic literature search was carried out in five databases. Two authors selected the studies based on pre-defined selection criteria and independently graded the risk of bias at study level. RESULTS: Five hundred forty-six records were identified in the literature search and 22 studies (in 26 publications) were included in the analysis. Nusinersen, onasemnogene abeparvovec and combination therapies improved motor endpoints in SMA type 1 patients. SMA type 2 to type 4 patients treated with nusinersen showed stabilisation or small improvements in motor endpoints with some deterioration observed. Quality of life endpoints, such as respiratory and nutritional support were poorly reported on. Drug-related adverse events occurred rarely in all types of SMA patients with all assessed drugs. Mid- and long-term studies on risdiplam could not be identified. CONCLUSIONS: The large quantity of missing data and heterogeneity of studies hinder comparability. Although stability and further improvement on the long-term is still uncertain, the results from the included evidence, as well as from pivotal trials show a striking contrast to the natural progression of the disease.

European Network for Health Technology Assessment's Response to COVID-19: Rapid Collaborative Reviews on Diagnostic Tests and Rolling and Rapid Collaborative Reviews on Therapeutics.

OBJECTIVES: In spring 2020, The European network for Health Technology Assessment (EUnetHTA) decided to join forces to produce best evidence to inform health policy in the COVID-19 pandemic. The objective of this paper is to describe the process and output of the coordinated and collaborative activities of EUnetHTA. METHODS: Relevant published and internal documents were retrieved for a descriptive analysis of EUnetHTA processes, methods, and outputs related to EUnetHTA's response to the pandemic. RESULTS: Process: In April 2020, a COVID-19 task force was set up and a survey collected pressing health policy questions across Europe. Two coordinating agencies for diagnostic tests and therapeutics were assigned. A process for prioritization and selection was set up for therapeutics, as well as explicit starting and stopping rules. Methodology: To increase a timely response, it was agreed that the rapid collaborative reviews (rapid CRs) would not require the consultation of manufacturers and the involvement of external experts, but would not differ in the methods and conduct of the systematic search, review, and synthesis of all available evidence, nor in the requirement for reviewing by EUnetHTA partners. Final reports: The joint effort resulted in the production of two rapid CRs on diagnostic tests, nineteen collaborative rolling reviews on therapeutics, three of which later moved to rapid CRs. CONCLUSIONS: During COVID-19 pandemic, the EUnetHTA partners proved capable of prompt collaboration, which allowed speeding up the production and release of high-quality EUnetHTA outputs, while the relationships with the other European institutions facilitated their quick dissemination.

Reimbursement decisions for medical services in Austria: an analysis of influencing factors for the hospital individual services catalogue between 2008 and 2020.

OBJECTIVES: To (1) describe the (evidence-based) reimbursement process of hospital individual services, (2) evaluate the accordance between evidence-based recommendations and reimbursement decision of individual services and (3) elaborate potential aspects that play a role in the decision-making process in Austria. METHOD: The reimbursement process is described based on selected relevant sources such as official documents. Evidence-based recommendations and subsequent reimbursement decisions for the annual maintenance of the hospital individual service catalogue in Austria between 2008 and 2020 were analysed using a mixed methods approach, encompassing descriptive statistics and a focus group with Austrian decision makers. RESULTS: 118 evidence-based recommendations were analysed. There were 93 (78.8%) negative and 25 (21.2%) positive evidence-based recommendations. In total, 107 out of 118 evidence-based recommendations (90.1%) did not lead to a deviating reimbursement decision. We identified six aspects that may have played a role in the decision-making process for the annual maintenance of the hospital individual service catalogue, with clinical evidence being the most notable. Further aspects included quality assurance/organisational aspects (i.e., structural quality assurance), costs (if comparable to already existing medical services, not: cost-effectiveness), procedural aspects (e.g., if certain criteria for adoption have not been met formally through the proposals), "other countries" (i.e., taking into account how other countries decided) and situational aspects (such as the COVID-19 pandemic). CONCLUSIONS: There is good accordance between evidence-based recommendations and reimbursement decisions regarding hospital individual services in Austria. Beyond clinical evidence, organisational aspects seem to be considered often with regard to quality assurance but costs do not appear to play a major role. The Austrian system has mechanisms in place that can restrict widespread adoption of novel hospital individual services with uncertain clinical benefits. Future studies could investigate how well these mechanisms work and how they compare to other health systems in Europe.

Real-world experience with anti-PD-1/PD-L1 monotherapy in patients with non-small cell lung cancer : A retrospective Austrian multicenter study.

OBJECTIVE: As real-world data regarding immunotherapy for non-small cell lung cancer are lacking for Austria, we conducted a retrospective study in six hospitals to present data from real-world practice. METHODS: Patients with metastatic non-small cell lung cancer were stratified into two groups, either patients with first-line pembrolizumab monotherapy (cohort 1) or patients with second-line nivolumab, pembrolizumab or atezolizumab monotherapy (cohort 2). Primary outcome measures were objective response rate and overall survival. A matched-pair analysis was performed to compare overall survival to patients from the Tyrolean Lung Cancer Project as a historical control group. RESULTS: In total, 89 patients were identified, 42 patients in cohort 1 and 47 patients in cohort 2. The objective response rates were 43.3% and 31.4%, respectively. The median overall survival was 17.0 months (95% CI 11.7-21.5 months) in cohort 1 and 18.7 months (95% CI 9.5-23.4 months) in cohort 2. Treatment-related adverse events grades 3 and 4 were reported in 11.2% of patients. The matched-pair analysis showed a median overall survival of 15.2 months (95% CI 7.6-20.4 months) for first-line pembrolizumab monotherapy compared to 9.8 months (95% CI 7.8-11.6 months) for the historical control (p = 0.43). In cohort 2, a median overall survival of 20.3 months (95% CI 6.9-26.2 months) for second-line immunotherapy compared to 5.4 months (95% CI 3.2-11.7 months) for the historical control (p = 0.18) was shown. CONCLUSION: The results are comparable with other real-world studies and, when matched to historical controls, support the improvement in outcomes made possible by these agents.

[Technology assessment of digital health applications for reimbursement decisions]. / Technologiebewertung digitaler Gesundheitsanwendungen für Refundierungsentscheidungen.

BACKGROUND: For most digital health applications (DiGA) only limited evidence of benefit is available. Currently available assessment frameworks do not cover all domains of a full health technology assessment (HTA). Additionally, technology-specific aspects are required for the evaluation of DiGA. This work aimed to analyze the available assessment frameworks and design an evaluation process for DiGA. METHODS: By a systematic literature search six assessment frameworks for DiGA were selected and analyzed. A hand search for strategies on DiGA of selected countries was conducted. RESULTS: Of the analyzed assessment frameworks four described study designs. One assessment framework proposed a risk classification of DiGA. Aspects of artificial intelligence were assessed by one assessment framework. The analyzed countries have differing strategies for reimbursement of DiGA. CONCLUSION: Assessment frameworks for DiGA are very heterogeneous. There are efforts to find regulations for DiGA on a national level. When evaluating DiGA, a staged approach considering risk classes with subsequent evaluation of relevant HTA aspects is recommended.

Health technology assessment applied to emergency preparedness: a new perspective.

Emergency preparedness is a continuous quality improvement process through which roles and responsibilities are defined to effectively anticipate, respond to, and recover from the impact of emergencies. This process results in documented plans that provide a backbone structure for developing the core capacities to address health threats. Nevertheless, several barriers can impair an effective preparedness planning, as it needs a 360° perspective to address each component according to the best evidence and practice. Preparedness planning shares common principles with health technology assessment (HTA) as both encompass a multidisciplinary and multistakeholder approach, follow an iterative cycle, adopt a 360° perspective on the impact of intervention measures, and conclude with decision-making support. Our "Perspective" illustrates how each HTA domain can address different component(s) of a preparedness plan that can indeed be seen as a container of multiple HTAs, which can then be used to populate the entire plan itself. This approach can allow one to overcome preparedness barriers, providing an independent, systematic, and robust tool to address the components and ensuring a comprehensive evaluation of their value in the mitigation of the impact of emergencies.

Extracorporeal Cytokine Adsorption Therapy As a Preventive Measure in Cardiac Surgery and As a Therapeutic Add-On Treatment in Sepsis: An Updated Systematic Review of Comparative Efficacy and Safety.

OBJECTIVES: Evaluating whether there is a clinical benefit of using extracorporeal cytokine adsorption therapy in two indications. DESIGN: Systematic review. SETTING: Search on four databases, Medline, Embase, The Cochrane Library, and the European Network for Health Technology Assessment planned and ongoing projects database. PATIENTS: Patients with sepsis/septic shock; patients undergoing cardiac surgery. INTERVENTIONS: Cytokine adsorption. MEASUREMENTS AND MAIN RESULTS: Randomized controlled trials and prospective studies with concurrent control were eligible for the evidence synthesis. The quality of the individual studies and the strength of the available evidence were assessed using the Cochrane risk of bias tool and the Grading of Recommendations, Assessment, Development, and Evaluation approach, respectively. For the preventive treatment of extracorporeal cytokine adsorption therapy in patients undergoing cardiac surgery, we found very low-quality inconclusive evidence for mortality (five randomized controlled trials, n = 163), length of stay in the ICU (five randomized controlled trials, n = 163), and length of hospitalization (three randomized controlled trials, n = 101). Very low-quality inconclusive evidence was found for (serious) adverse events (four randomized controlled trials, n = 148). For the therapeutic treatment of extracorporeal cytokine adsorption therapy in patients with sepsis/septic shock, we found very low-quality inconclusive evidence for mortality up to 60-day follow-up (two randomized controlled trials, n = 117), organ function (two randomized controlled trials, n = 117) and length of stay in the ICU (one randomized controlled trial, n = 20). Very low-quality inconclusive evidence was found for (serious) adverse events (two randomized controlled trials, n = 117). CONCLUSIONS: Given the available evidence, the efficacy and safety of extracorporeal cytokine adsorption therapy in combination with standard care in the investigated indications was not established. We strongly recommend considering well-powered studies with patient-relevant endpoints instead of investing further research funds on studies that may not shed light on the clinical benefit of extracorporeal cytokine adsorption therapy.

Cancer care near the end-of-life in Austria: A retrospective data analysis.

OBJECTIVE: Since end-of-life care (EOL) is an internationally accepted indicator for the quality of oncological care we aimed to investigate the current EOL care situation for Austrian cancer patients especially concerning the place of death cancer treatment hospitalisation near death and palliative care. METHODS: A retrospective data analysis was carried out based on Austrian routine inpatient data of the years 2012 to 2016. Data including the date of death of adult patients with a main hospital discharge diagnosis of a neoplasm were included. All analyses were source-related and based on the place of residence. RESULTS: In total 80818 cancer patients have died between 2012 and 2016 of whom 53.4% died in the inpatient setting. Palliative care at the EOL (last hospitalisation) was present in 12.9% of patients whereby more than 50% were admitted two to 14 days before death. Considering cancer treatment at the EOL (30 days before death) 6.9% of cancer patients have received chemotherapy 1.7% radiation therapy and 0.75% were treated with a monoclonal antibody. CONCLUSION: In international comparison Austria appears to do well on quality indicators concerning ICU-admission and chemotherapy treatment average on hospital death and poorly on hospital admissions and timely referral for palliative care.

Evaluating options for decision making on costly hospital drugs in Austria.

OBJECTIVES: The aim of this study was to suggest options for a national and standardized process for the reimbursement of costly drugs provided in Austrian hospitals. METHODS: For answering the research questions, reimbursement processes of ten countries were investigated and the strengths and weaknesses of elaborated options of actions were analyzed, resulting in suggestions for solutions in the Austrian reimbursement processes for hospital drugs. RESULTS: Based on the information derived from the international analysis and the deliberation of the strengths and weaknesses on optional approaches, as well as, on the consideration of the existing reimbursement processes in Austria, three options to reorganize the current decentralized inpatient reimbursement process in Austria were suggested. The first option presents a process following the established processes of the decision making for outpatient drugs. The second option suggests stronger coordination of and cooperation across the existing processes of the nine regional "Pharmaceutical and Therapeutics Committees". The third option proposes to expand the already established reimbursement process for non-drug interventions. CONCLUSIONS: Evidence-based, transparent, fair and efficient resource allocations are needed for priority setting decisions. However, a decision process can be based on the best available evidence, can be fair and transparent, although it might be substantially more time-consuming. Thus, a pragmatic balance between quality, transparency and timeliness is crucial.