Facilitators and Barriers of Incremental Innovation by Fixed Dose Combinations in Cardiovascular Diseases.

Despite the availability of affordable pharmaceuticals treating cardiovascular diseases (CVDs), many of the risk factors remain poorly controlled. Fixed-dose combinations (FDCs), a form of incremental innovation, have already demonstrated improvements over combinations of single medicines in adherence and hard clinical endpoints. Nevertheless, there are many barriers related to the wider use of FDCs in CVDs. Our aim was to identify these barriers and explore system-level facilitators from a multi-stakeholder perspective. Identified barriers include (i) hurdles in evidence generation for manufacturers, (ii) limited acceptance of adherence as an endpoint by clinical guideline developers and policymakers, (iii) limited options for a price premium for incremental innovation for healthcare payers, (iv) limited availability of real-world evidence, and (v) methodological issues to measure improved adherence. Initiatives to standardize and link healthcare databases in European countries, movements towards improved patient centricity in healthcare, and extended value assessment provide opportunities to capture the benefits of FDCs. Still, there is an emerging need to facilitate the generalizability of sporadic clinical evidence across different FDCs and to improve adherence measures. Finally, healthcare payers need to be convinced to pay a fair premium price for the added value of FDCs to incentivize incremental innovation in CVD treatment.

Cost-Effectiveness of Bariatric Surgery in Patients Living with Obesity and Type 2 Diabetes.

Aims: The favourable effects of bariatric surgeries on body weight reduction and glucose control have been demonstrated in several studies. Additionally, the cost-effectiveness of bariatric surgeries has been confirmed in several analyses. The aim of the current analysis was to demonstrate the cost-effectiveness of bariatric surgeries in obese patients with type 2 diabetes in Hungary compared to conventional diabetes treatments based on economic modelling of published clinical trial results. Materials and Methods: Patients entered the simulation model at the age of 45 with body mass index (BMI) ≥ 30 kg/m2 and type 2 diabetes. The model was performed from the public payer's perspective, comparing sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) procedures to conventional care of diabetes. The results were provided separately for three BMI categories. Results: The base-case analysis demonstrated that both surgery types were dominant; i.e., they saved 17 064 to 24 384 Euro public payer expenditures and resulted in improved health outcomes (1.36 to 1.50 quality-adjusted life years gain (QALY)) in the three BMI categories. Bariatric surgeries extended the life expectancy and the disease-free survival times of all the investigated diabetes complications. All the scenario analyses confirmed the robustness of the base-case analysis, such that bariatric surgeries remained dominant compared to conventional diabetes treatments. Conclusion: The results of this cost-effectiveness analysis highlight the importance of bariatric surgeries as alternatives to conventional diabetes treatments in the obese population. Therefore, it is strongly recommended that a wider population has access to these surgeries in Hungary.

Incremental cost of premature birth - a public health care payer perspective from Hungary.

BACKGROUND: Preterm birth remains a significant burden to families, health systems and societies. The aim was to quantify the incremental prematurity-related public health expenditure in Hungary and to estimate the potential impact of a decrease in the prevalence of prematurity on the public payer's spending. METHODS: Over a 6-year time horizon, public financing data of inpatient, outpatient and pharmaceutical care for children born at ≥ 25 weeks of gestation in 2009/2010 were retrieved from the Hungarian National Health Insurance Fund database. In descriptive analysis, the public payer's spending was given as cost/capita. The impact of a decrease in prematurity prevalence was specified as the total budget impact. An exchange rate of 294 Hungarian forint/Euro was applied. RESULTS: A total of 93,124 children (including 8.6% who were premature babies) were included in the analysis. A strong negative relationship was shown between gestational age and per capita cost. The 6-year cost of care for the cohort born at 26 weeks of gestation (28,470 Euro per capita) was 24 times higher than that for the cohort born at 40 weeks. First-year inpatient spending accounted for the largest proportion of total health care spending across all gestational ages. All investigated prematurity complications (retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, intraventricular cerebral bleeding and leukomalacia) resulted in additional significant incremental spending. If 70% of pregnancies ending with preterm birth could be prolonged by 1 week, the savings would be almost 7.0 million Euros in the first 6 years of life. CONCLUSION: This comprehensive analysis of prematurity-related health care spending confirmed that premature infants have much higher costs for care than those born at term in Hungary. These quantitative outcomes can provide essential inputs for the cost-effectiveness analysis of medical technologies and public health interventions that can decrease the prevalence of premature birth. TRIAL REGISTRATION: Not applicable.

Systematic Literature Review of Economic Evaluations of Treatment Alternatives in Chronic Lymphocytic Leukemia.

BACKGROUND: Economic evaluations are widely used to predict the economic impact of new treatment alternatives. Comprehensive economic reviews in the field of chronic lymphocytic leukemia (CLL) are warranted to supplement the existing analyses focused on specific therapeutic areas. METHODS: A systematic literature review was conducted based on literature searches in Medline and EMBASE to summarize the published health economics models related to all types of CLL therapies. Narrative synthesis of relevant studies was performed focusing on compared treatments, patient populations, modelling approaches and key findings. RESULTS: We included 29 studies, the majority of which were published between 2016 and 2018, when data from large clinical trials in CLL became available. Treatment regimens were compared in 25 cases, while the remaining four studies considered treatment strategies with more complex patient pathways. Based on the review results, Markov modelling with a simple structure of three health states (progression-free, progressed, death) can be considered as the traditional basis to simulate cost effectiveness. However, more recent studies added further complexity, including additional health states for different therapies (e.g. best supportive care or stem cell transplantation), for progression-free state (e.g. by differentiating between with or without treatment), or for response status (i.e. partial response and complete response). CONCLUSIONS: As personalized medicine is increasingly gaining recognition, we expect that future economic evaluations will also incorporate new solutions, which are necessary to capture a larger number of genetic and molecular markers and more complex patient pathways with individual patient-level allocation of treatment options and thus economic assessments.

Patient and Caregiver Experience Decision Factors in Treatment Decision Making: Results of a Systematic Literature Review of Multiple Myeloma Decision Aids.

OBJECTIVES: Decision-aids (DAs) may facilitate shared decision-making for patients and caregivers, by providing evidence-based information to assist healthcare professionals, patients, and caregivers in making choices about aspects of care, and/or highlighting decision factors to discuss with the potential of altering the treatment decision. These decision factors may not be well integrated in DAs. METHODS: A systematic literature review was conducted in the field of multiple myeloma (MM) on peer-reviewed publications, extended with a gray literature search. Data on whether and how patient and caregiver experience elements, other than survival and physical quality of life, were mentioned as decision factors in the identified MM DAs were extracted and analyzed qualitatively. RESULTS: Seventy MM DAs were found and analyzed; 51% of DAs mentioned any patient non-routinely assessed experience decision factors and only 17% mentioned any caregiver-related information. One hundred and forty potential decision factors were extracted, deduplicated and categorized into the following categories: 1) financial, 2) mode of administration / transportation issues, 3) personal beliefs and values, 4) emotional and social quality of life, 5) other medical information, 6) availability of social support, 7) caregiver burden. None of the DAs presented a comprehensive framework on all seven categories of decision factors being consider when mapping patient and caregiver experience value elements in MM. CONCLUSIONS: Based on available DAs, we recommend a set of patient and caregiver experience decision factors that have the potential to affect treatment choices of patients with MM, which should be included in DAs, including MM clinical guidelines.

Systematic literature review of health economic models developed for multiple myeloma to support future analyses.

AIMS: The goal of this study was to review the economic evaluations of health technologies in multiple myeloma (MM) and provide guidance and recommendations for future health economic analyses. MATERIALS AND METHODS: A systemic literature review (SLR) was conducted on original economic assessment studies and structured review papers focusing on the studies in MM. The search was limited to English language papers published from 1 January 2000 onwards. Publications not applying any type of modelling methodology to describe disease progression and patient pathways over a specific time horizon were excluded. RESULTS: A total of 2,643 publications were initially identified, of which 148 were eligible to be included in the full-text review phase. From these, 49 publications were included in the final analysis. Most published health economic analyses supported by models came from high-income countries. Evaluations from middle-income countries were rarely published. Diagnostic technologies were rarely modelled and integrated care had not been modelled. Very few models investigated MM treatments from a societal perspective and there was a relative lack of evaluations regarding minimal residual disease (MRD). LIMITATIONS: Limitations of the publications included differences between trial populations and modelled populations, justification of methods, lack of confounder analyses, and small trial populations. Limitations of our study included the infeasibility of comparing MM economic evaluations due to the significant variance in modelled therapeutic lines and indications, and the relative scarcity of published economic evaluations from non-high-income countries. CONCLUSIONS: As published economic models lacked many of the elements of the complex and heterogeneous patient pathways in MM and they focused on single decision problems, a thorough, open-source economic whole disease modelling framework is needed to assess the economic value of a wide range of technologies across countries with various income levels with a more detailed view on MM, by including patient-centric and societal aspects.

Beyond medicines' barriers: exploring the true cost of multiple myeloma.

AIM: The goal of this research was to quantify and qualify all the costs associated with multiple myeloma (MM) from a healthcare and societal perspective and to highlight certain costs that are often underestimated. MATERIALS AND METHODS: The study used a mixed methods approach that consisted of three phases: a systemic literature review (SLR), a virtual roundtable discussion based on the results of the SLR, and an online survey. RESULTS: In total, 4321 records were identified by literature and snowball searches. After applying the eligibility criteria, 49 articles were included in the narrative summary. As combination treatments have become the mainstay of MM treatment, drug costs have become the most important component of the total healthcare costs. Collected evidence suggests that optimizing treatment pathways, besides prolonging patient survival and maintaining quality of life, has the potential to generate cost savings for all stakeholders (payers and patients). Improved patient access to new therapies that can improve outcomes may reduce the "financial toxicity" of MM by decreasing patients' and caregivers' productivity loss due to better prognosis and it also has the potential of reducing patients' direct health care payments. LIMITATIONS: Heterogeneity of research objectives of included studies, costing methods, and applied measurement units limited the comparability of cost data between studies. Data for more than half of the world's population, including China, Russia, the Middle East, and Africa were not investigated. CONCLUSION: While treatment costs are burdensome for healthcare systems, it is only one of several items that make up the True Cost of MM. Understanding these burdens is one way to argue for optimized treatment pathways and improve patient outcomes by tearing down access barriers.

Improved survival of non-small cell lung cancer patients after introducing patient navigation: A retrospective cohort study with propensity score weighted historic control.

OnkoNetwork is a patient navigation program established in the Moritz Kaposi General Hospital to improve the timeliness and completeness of cancer investigations and treatment. The H2020 SELFIE consortium selected OnkoNetwork as a promising integrated care initiative in Hungary and conducted a multicriteria decision analysis based on health, patient experience, and cost outcomes. In this paper, a more detailed analysis of clinical impacts is provided in the largest subgroup, non-small cell lung cancer (NSCLC) patients. A retrospective cohort study was conducted, enrolling new cancer suspect patients with subsequently confirmed NSCLC in two annual periods, before and after OnkoNetwork implementation (control and intervention cohorts, respectively). To control for selection bias and confounding, baseline balance was improved via propensity score weighting. Overall survival was analyzed in univariate and multivariate weighted Cox regression models and the effect was further characterized in a counterfactual analysis. Our analysis included 123 intervention and 173 control NSCLC patients from early to advanced stage, with significant between-cohort baseline differences. The propensity score-based weighting resulted in good baseline balance. A large survival benefit was observed in the intervention cohort, and intervention was an independent predictor of longer survival in a multivariate analysis when all baseline characteristics were included (HR = 0.63, p = 0.039). When post-baseline variables were included in the model, belonging to the intervention cohort was not an independent predictor of survival, but the survival benefit was explained by slightly better stage distribution and ECOG status at treatment initiation, together with trends for broader use of PET-CT and higher resectability rate. In conclusion, patient navigation is a valuable tool to improve cancer outcomes by facilitating more timely and complete cancer diagnostics. Contradictory evidence in the literature may be explained by common sources of bias, including the wait-time paradox and adjustment to intermediate outcomes.

Prioritization of implementation barriers related to integrated care models in Central and Eastern European countries.

The importance of integrated care will increase in future health systems due to aging populations and patients with chronic multimorbidity, however, such complex healthcare interventions are often developed and implemented in higher income countries. For Central and Eastern European (CEE) countries it is important to investigate which integrated care models are transferable to their setting and facilitate the implementation of relevant models by identifying barriers to their implementation. This study investigates the relative importance of integrated care models and the most critical barriers for their implementation in CEE countries. Experts from Croatia, Hungary, Poland, Romania and Serbia were invited to complete an online survey within the SELFIE H2020 project. 81 respondents completed the survey. Although experts indicated that some integrated care models were already being implemented in CEE countries, the survey revealed a great need for further improvement in the integration of care, especially the managed care of oncology patients, coordinated palliative care of terminally ill patients, and nursing care of elderly with multimorbidity. Lack of long-term financial sustainability as well as of dedicated financing schemes were seen the most critical implementation barriers, followed by the lack of integration between health and social care providers and insufficient availability of human resources. These insights can guide future policy making on integrated care in CEE countries.

Capacity Building for Health Technology Assessment in Jordan: Institutionalization and Its Use in Pricing and Reimbursement Decisions.

OBJECTIVES: This study aimed to describe the process of the institutionalization of health technology assessment (HTA) in Jordan. In particular, this study presents local policy perspectives on capacity building for HTA and the progress made toward its use in pricing and reimbursement decisions. HTA CAPACITY BUILDING: University-based education and professional development training in pharmacoeconomics and pharmaceutical policy have been the starting points to create a receptive environment, necessary expertise, and local tools across many settings in Jordan. International collaboration with HTA supporting bodies helped to build connections and informed policy development on local levels through projects, meetings, and discussions. HTA INSTITUTIONALIZATION AND ITS USE IN PRICING AND REIMBURSEMENT DECISIONS: Institutionalizing HTA in the King Hussein Cancer Center and the Royal Medical Services was the driving factor for HTA implementation and practice advancement; nevertheless, process transparency and experience sharing through reports and publications are still limited. The Jordan Food and Drug Administration's pricing and formulary decisions require pharmacoeconomic consultation in selected cases according to the Jordanian Drug Law. Nevertheless, there is a lack of local methodological guidelines for conducting HTA. In addition, HTA practitioners and the regulatory scope of future HTA activities in Jordan cannot be determined yet. RECOMMENDATIONS AND FUTURE DIRECTIONS: Over the past 2 decades, Jordan has crossed a number of milestones and advanced further to implement HTA as a tool for evaluating health interventions. As a next step, legislation is needed to mandate the use of HTA and to enhance transparency in decision-making processes.

Barriers to Use Artificial Intelligence Methodologies in Health Technology Assessment in Central and East European Countries.

The aim of this paper is to identify the barriers that are specifically relevant to the use of Artificial Intelligence (AI)-based evidence in Central and Eastern European (CEE) Health Technology Assessment (HTA) systems. The study relied on two main parallel sources to identify barriers to use AI methodologies in HTA in CEE, including a scoping literature review and iterative focus group meetings with HTx team members. Most of the other selected articles discussed AI from a clinical perspective (n = 25), and the rest are from regulatory perspective (n = 13), and transfer of knowledge point of view (n = 3). Clinical areas studied are quite diverse-from pediatric, diabetes, diagnostic radiology, gynecology, oncology, surgery, psychiatry, cardiology, infection diseases, and oncology. Out of all 38 articles, 25 (66%) describe the AI method and the rest are more focused on the utilization barriers of different health care services and programs. The potential barriers could be classified as data related, methodological, technological, regulatory and policy related, and human factor related. Some of the barriers are quite similar, especially concerning the technologies. Studies focusing on the AI usage for HTA decision making are scarce. AI and augmented decision making tools are a novel science, and we are in the process of adapting it to existing needs. HTA as a process requires multiple steps, multiple evaluations which rely on heterogenous data. Therefore, the observed range of barriers come as a no surprise, and experts in the field need to give their opinion on the most important barriers in order to develop recommendations to overcome them and to disseminate the practical application of these tools.

A multi-criteria decision analysis (MCDA) tool for purchasing off-patent oncology medicines in Egypt.

BACKGROUND: Multi- criteria decision analysis (MCDA) can assist policymakers in objectively choosing between alternative therapeutic options based on multiple value attributes. Our aim was to create an MCDA tool for the national tenders of off-patent oncology medicines in Egypt. METHODS: An initial list of criteria was developed through a literature review complemented by local expert interviews. Price or cost-related criteria were excluded to abide by the national regulations of the tender process. Next, a workshop hosting diversified stakeholders representing different governmental bodies was held. Anonymous voting was used to rank and weigh the criteria as well as assigning scores. Price was added as a separate step to identify best option based on price per point. The tool was then tested on a national tender sample of off-patent oncology medicines to assess its performance, and it was readjusted accordingly in a second workshop. RESULTS: Seven non-price criteria were selected, including use in reference countries (23.49% weight), equivalence with the reference product (18.79%), manufacturing quality (15.53%), provision of pharmacovigilance services (12.94%), supply reliability (10.78%), previous use in local settings (9.8%) and macroeconomic benefit (8.67%). A medicine receives a score ranging from 0 to 100% of each criterion's weight. The aggregated score is calculated on a hundred-point scale. Based on participants' consensus, an overall score of 65 was set as a cut-off for passing the technical eligibility phase of the tendering process. Any product receiving a lower score would be disqualified from the tender. For qualified products, the lower price per point represents preferential option for the national tender. CONCLUSIONS: The created MCDA tool is capable of objectively comparing similar off-patent oncology medicines by considering multiple value attributes and providing reliable scoring functions for each.

Systematic review of real-world studies evaluating the impact of medication non-adherence to endocrine therapies on hard clinical endpoints in patients with non-metastatic breast cancer.

Breast cancer, one of the most common malignancies, is associated with significant economic and health burden both at the patient and societal level. Although medication non-adherence to endocrine breast cancer therapies is common, so far only limited systematic evidence has been available on its quantitative consequences, as previous systematic reviews focused mainly on factors contributing to medication non-adherence. The objective of this review was to explore the implications of medication non-adherence to endocrine therapies on hard clinical outcomes in breast cancer based on real-world studies. A systematic literature review was conducted on PubMed; empirical evidence on hard clinical endpoints (i.e., survival, disease-free survival, metastasis and recurrence) were extracted from uni- or multivariate statistical analyses from retrospective or prospective cohort studies. Of the 2,360 identified records, 12 studies met the inclusion criteria. Two studies identified significant positive association between medication non-adherence and the risk of distant metastasis, three articles between medication non-adherence and the recurrence of breast cancer, two studies between medication non-adherence- and non-persistence and of worse disease-free survival and eight articles between medication non-adherence and mortality. There was only one study where the positive association between medication adherence and survival did not apply to all subgroups. The strong evidence on the negative health consequences of non-adherence to breast cancer treatments indicates the need for the regular monitoring of medication adherence. Furthermore, explicit inclusion of adherence enhancing interventions into health policy agenda would be warranted to improve medication adherence also at a system level.

Patient and Payer Preferences for Additional Value Criteria.

Background: Defining the value of healthcare is an elusive target, and depends heavily on the decision context and stakeholders involved. Cost-utility analysis and the quality-adjusted life year (QALY) have become the method and value definition of choice for traditional value judgements in coverage and pricing decisions. Other criteria that may influence value are often not measured and therefore omitted from value assessments, or are only used to qualitatively contextualize assessments. The objective of this study was to engage two key stakeholders; patients and payers to elicit and rank the importance of additional value criteria, potentially assessed in Multiple Criteria Decision Analysis (MCDA). Methods: This study consisted of a focus group with cancer patients (n = 7), including follow-up questions through an electronic survey, and in-depth phone interviews with payers (n = 5). Results: For payers, value equated either with criteria that provided tangible benefits (from their perspective) such as new treatment options that respond to serious unmet need. For patients, population-level value equated to options that would potentially benefit them in the future and the value of hope. However, these criteria were seen by payers as difficult to measure and incorporate into objective decision making. Limitations: The findings from this study are primarily limited due to generalizability. Due to the small sample size, it was outside the scope of this study to calculate a weight for each criterion that could be used as part of a quantitative MCDA. Conclusion: MCDA, with particular attention to qualitative aspects, is an avenue to incorporate these additional criteria into value assessments, as well as provide an opportunity for reflecting the patient's preferences in assessing the value of a treatment.

Early palliative care associated with lower costs for adults with advanced cancer: evidence from Hungary.

OBJECTIVE: Palliative Care Consult Service (PCCS) programme was established in Hungary to provide palliative care to hospitalised patients with complex needs and to coordinate integrated care across providers. The aim of this study was to measure the association of PCCS with healthcare costs from payer's perspective. METHODS: Study population consisted of patients with metastatic cancer, who were admitted to the Clinical Centre of the University of Pécs between 2014 and 2016. Patients who did not die within 180 days from enrolment were excluded. Patients receiving services from PCCS team (intervention patients) were compared to patients receiving usual care (controls). The two populations were matched using propensity scores. Data were obtained from electronic medical records linked to claims data. RESULTS: For patients who were involved in PCCS at least 60 days before their death, the costs of care outside the acute hospital were higher. However, this was offset by savings in hospital costs so that the total healthcare cost was significantly reduced (p = 0.034). The proportion of patients who died in the hospital was lower in the PCCS group compared to the usual care group (66% vs. 85%, p = 0.022). CONCLUSION: Timely initiation of palliative care for hospitalised patients is associated with cost savings for the healthcare system.

Identifying Patient Access Barriers for Tumor Necrosis Factor Alpha Inhibitor Treatments in Rheumatoid Arthritis in Five Central Eastern European Countries.

INTRODUCTION: Although there is a significant utilization gap of biologic medicines in the EU, many studies estimate equity in patient access to biopharmaceuticals only based on their availability on the national list of reimbursed medicines. Hidden access barriers may facilitate financial sustainability of pharmaceuticals in less affluent EU countries; however, they have rarely been documented in scientific publications. Our objective was to explore these access barriers for tumor necrosis factor (TNF) alpha inhibitors in rheumatoid arthritis (RA) in five Central and Eastern European countries. METHODS: A detailed interview guide was developed based on multi-stakeholder workshops and a targeted literature review. In each participant country 3-3-3-3 interviews with payers, rheumatologists, patients/patient representatives, and industry representatives were conducted. Responses were aggregated at a country level and validated by primary investigators in each country. RESULTS: Limited number of RA centers and consequently significant travelling time and cost for patients in distant geographical areas, uneven budget allocation among centers, limited capacity of nurses, narrowed patient population in national financial protocols compared to international clinical guidelines in initiating or continuing biologics, high administrative burden in prescribing biologics and limited health literacy of patients were the most relevant barriers to timely patient access in at least three participant countries. CONCLUSION: Assessing only the availability of TNF alpha inhibitors on the national list of reimbursed medicines provides limited information about real-world patient access to these medicines. Revealing hidden access barriers may contribute to initiate policy actions which could reduce inequity in patient access.

Barriers and facilitators of exploiting the potential of value-added medicines.

INTRODUCTION: Pharmaceutical research and development (R&D) is costly and only a minority of patients can access innovative medicines due to affordability constraints. Value-added medicines (VAMs) can offer potential benefits at significantly lower R&D costs. AREAS COVERED: VAMs may address different health care needs and problems, including off-label use of medicines, poor patient adherence, problems related to polypharmacy, need for home and/or personalized health care services. However, several barriers prevent societies from maximizing the benefits of incremental innovation related to VAMs. Generic manufacturers have limited budget and experience to demonstrate the value of new VAMs. Current market exclusivity options do not efficiently exclude freeridership and do not guarantee a return on investment for VAM innovators. Value propositions of VAMs are limitedly consistent with current HTA frameworks, consequently, incremental innovation is not acknowledged, nor rewarded with differential pricing by payers. Moreover, VAMs are often perceived solely as generic medicines by prescribers. EXPERT OPINION: Current practices may need to be reconsidered to exploit the full societal benefit of VAMs, including more efficient policies to guarantee market exclusivity for incremental innovation, acknowledgment of a fair price premium based on a specific value framework and the acceptance of low-cost evidence generation methods.

Implementation of palliative care consult Service in Hungary - integration barriers and facilitators.

BACKGROUND: The Palliative Care Consult Service (PCCS) programme was among the first initiations in Hungary to provide palliative care for patients admitted to hospital. The PCCS team provides palliative care for mainly cancer patients and their family members and manages the patient pathway after being discharged from the hospital. The service started in 2014 with 300-400 patient visits per year. The aim of this study is to give a comprehensive overview of the PCCS programme guided by a conceptual framework designed by SELFIE ("Sustainable intEgrated chronic care modeLs for multi-morbidity: delivery, FInancing, and performancE"), a Horizon2020 funded EU project and to identify the facilitators and barriers to its wider implementation. METHODS: PCCS has been selected by the SELFIE consortium for in-depth evaluation as one of the Hungarian integrated care models for persons with multi-morbidity. The qualitative analysis of the PCCS programme was based on available documents of the care provider and interviews with different stakeholders related to the programme. RESULTS: The integrated, multidisciplinary and patient-centred approach was well-received among the patients, family members and clinical departments, as verified by the increasing number of requests for consultations. As a result of the patient pathway management across providers (e.g. from inpatient care to homecare) a higher level of coordination could be achieved in the continuity of care for seriously-ill patients. The regulatory framework has only partially been established, policies to integrate care across organizations and sectors and adequate financial mechanism to support the enhancement and sustainability of the PCCS are still missing. CONCLUSIONS: The service integration of palliative care could be implemented successfully in an academic hospital in Hungary. However, the continuation and enhancement of the programme will require further evidence on the performance of the integrated model of palliative care and a more systematic approach particularly regarding the evaluation, financing and implementation process.

Benefits Of Timely Care In Pancreatic Cancer: A Systematic Review To Navigate Through The Contradictory Evidence.

The evidence base of policies that improve the timeliness of cancer care is under ongoing debate. Pancreatic cancer is frequently diagnosed in a stage when curative therapy is not feasible; hence, it is an important target for timelier healthcare interventions. The objectives of our research were to identify all clinical studies on pancreatic cancer care delays via a systematic literature review, to assess the study methodologies for possible biases, to conclude on the available evidence, and to formulate research recommendations on evidence gaps. Nineteen studies were identified and eight reported multivariate analyses. Although many sources of bias shifted the results towards negative or paradoxical findings, a statistically significant association of shorter delays with better clinical outcomes was demonstrated in the majority of studies reporting multivariate analyses. Noninferiority analyses were not published. Further efforts to provide timely care for pancreatic cancer patients are encouraged, and studies on the associations of delay with patient experience and healthcare resource utilization are warranted.

Patterns of alternative access: Unpacking the Slovak extraordinary drug reimbursement regime 2012-2016.

Many countries employ "alternative access schemes" (e.g. compassionate use, early access programs, off-label use) that seek to provide patients with access to drugs not included on a positive drug list. These schemes offer flexibility to policy-makers but often lack transparency and clear rules. This ambiguity allows for dynamic responses to weaknesses in the main drug approval and reimbursement systems, but also opportunistic use by the health professionals, industry or patients. Yet, most descriptions of these schemes focus on the de jure rather than the de facto situation, presenting a potentially misleading picture. We describe one such scheme in practice: the Slovak "extraordinary reimbursement regime" (ERR), using semi-structured interviews with 18 experts and a new dataset of ERR drugs. The ERR expanded rapidly, doubling between 2012 and 2016. It combined features of four reimbursement schemes: (1) a backdoor market access for expensive drugs; (2) a compassionate use scheme for investigational drugs combined with a "legacy drugs" scheme for older unlicensed drugs; (3) a disease-specific scheme for cancer and orphan drugs; and (4) a scheme for off-label and "off-indication" drugs. These four features reflect broader challenges facing the Slovak reimbursement system. We conclude that detailed study of the type, size and evolution over time of alternative access schemes can serve as indicators of health policy objectives neglected by standard reimbursement systems.