Availability and financing of CAR-T cell therapies: A cross-country comparative analysis.

Chimeric antigen receptor T-cell therapies (CAR-T therapies) are a type of advanced therapy medicinal product (ATMP) that belong to a new generation of personalised cancer immunotherapies. This paper compares the approval, availability and financing of CAR-T cell therapies in ten countries. It also examines the implementation of this type of ATMP within the health care system, describing the organizational elements of CAR-T therapy delivery and the challenges of ensuring equitable access to all those in need, taking a more systems-oriented view. It finds that the availability of CAR-T therapies varies across countries, reflecting the heterogeneity in the organization and financing of specialised care, particularly oncology care. Countries have been cautious in designing reimbursement models for CAR-T cell therapies, establishing limited managed entry arrangements under public payers, either based on outcomes or as an evidence development scheme to allow for the study of real-world therapeutic efficacy. The delivery model of CAR-T therapies is concentrated around existing experienced cancer centres and highlights the need for high networking and referral capacity. Some countries have transparent and systematic eligibility criteria to help ensure more equitable access to therapies. Overall, as with other pharmaceuticals, there is limited transparency in pricing, eligibility criteria and budgeting decisions in this therapeutic area.

How did the COVID-19 pandemic affect inpatient care for children in Germany? An exploratory analysis based on national hospital discharge data.

BACKGROUND: The delivery of health services around the world faced considerable disruptions during the COVID-19 pandemic. While this has been discussed for a number of conditions in the adult population, related patterns have been studied less for children. In light of the detrimental effects of the pandemic, particularly for children and young people under the age of 18, it is pivotal to explore this issue further. METHODS: Based on complete national hospital discharge data available via the German National Institute for the Reimbursement of Hospitals (InEK) data browser, we compare the top 30 diagnoses for which children were hospitalised in 2019, 2020, 2021 and 2022. We analyse the development of monthly admissions between January 2019 and December 2022 for three tracers of variable time-sensitivity: acute lymphoblastic leukaemia (ALL), appendicitis/appendectomy and tonsillectomy/adenoidectomy. RESULTS: Compared to 2019, total admissions were approximately 20% lower in 2020 and 2021, and 13% lower in 2022. The composition of the most frequent principal diagnoses remained similar across years, although changes in rank were observed. Decreases were observed in 2020 for respiratory and gastrointestinal infections, with cases increasing again in 2021. The number of ALL admissions showed an upward trend and a periodicity prima vista unrelated to pandemic factors. Appendicitis admissions decreased by about 9% in 2020 and a further 8% in 2021 and 4% in 2022, while tonsillectomies/adenoidectomies decreased by more than 40% in 2020 and a further 32% in 2021 before increasing in 2022; for these tracers, monthly changes are in line with pandemic waves. CONCLUSIONS: Hospital care for critical and urgent conditions among patients under the age of 18 was largely upheld in Germany during the COVID-19 pandemic, potentially at the expense of elective treatments. There is an alignment between observed variations in hospitalisations and pandemic mitigation measures, possibly also reflecting changes in demand. This study highlights the need for comprehensive, intersectoral data that would be necessary to better understand changing demand, unmet need/foregone care and shifts from inpatient to outpatient care, as well as their link to patient outcomes and health care efficiency.

Giant cell tumor of the patellar tendon sheath in childhood: case report.

The aim of this study was to report a rare case of a giant cell tumor of the patellar tendon sheath. This indicates the diagnostic procedures and treatment options for giant cell tumors of the patellar tendon. This study reported a case of a 13-year-old male patient with a giant cell tumor of the tendon sheath. In our case, open arthrotomy was performed with complete surgical excision of the lesion. Histopathological examination revealed a giant cell tumor. At the last follow-up, 2 years after surgery, no complications were reported. The giant cell tumor of the patellar tendon sheath is an uncommon benign tumor. It mimics common knee symptoms. A differential diagnosis is definitely a challenge. Available operation approaches have demonstrated similar results, which lead to symptom relief and a low recurrence rate.

Benefit Assessment and Reimbursement of Digital Health Applications: Concepts for Setting Up a New System for Public Coverage.

In Germany, some digital health applications (DiHA) became reimbursable through the statutory health insurance system with the adoption of the Digital Healthcare Act in 2019. Approaches and concepts for the German care context were developed in an iterative process, based on existing concepts from international experience. A DiHA categorization was developed that could be used as a basis to enable the creation of a reimbursed DiHA repository, and to derive evidence requirements for coverage and reimbursement for each DiHA. The results provide an overview of a possible classification of DiHA as well as approaches to assessment and evaluation. The structure of remuneration and pricing in connection with the formation of groups is demonstrated.

Innovation, value and reimbursement in radiation and complex surgical oncology: Time to rethink.

BACKGROUND AND PURPOSE: Complex surgery and radiotherapy are the central pillars of loco-regional oncology treatment. This paper describes the reimbursement schemes used in radiation and complex surgical oncology, reports on literature and policy reviews. MATERIAL AND METHODS: A systematic review of the literature of the reimbursement models has been carried out separately for radiotherapy and complex cancer surgery based on PRISMA guidelines. Using searches of PubMed and grey literature, we identified articles from scientific journals and reports published since 2000 on provider payment or reimbursement systems currently used in radiation oncology and complex cancer surgery, also including policy models. RESULTS: Most European health systems reimburse radiotherapy using a budget-based, fee-for-service or fraction-based system; while few reimburse services according to an episode-based model. Also, the reimbursement models for cancer surgery are mostly restricted to differences embedded in the DRG system and adjustments applied to the fees, based on the complexity of each surgical procedure. There is an enormous variability in reimbursement across countries, resulting in different incentives and different amounts paid for the same therapeutic strategy. CONCLUSION: A reimbursement policy, based on the episode of care as the basic payment unit, is advocated for. Innovation should be tackled in a two-tier approach: one defining the common criteria for reimbursement of proven evidence-based interventions; another for financing emerging innovation with uncertain definitive value. Relevant clinical and economic data, also collected real-life, should support reimbursement systems that mirror the actual cost of evidence-based practice.

Innovation, value and reimbursement in radiation and complex surgical oncology: Time to rethink.

BACKGROUND AND PURPOSE: Complex surgery and radiotherapy are the central pillars of loco-regional oncology treatment. This paper describes the reimbursement schemes used in radiation and complex surgical oncology, reports on literature and policy reviews. MATERIAL AND METHODS: A systematic review of the literature of the reimbursement models has been carried out separately for radiotherapy and complex cancer surgery based on PRISMA guidelines. Using searches of PubMed and grey literature, we identified articles from scientific journals and reports published since 2000 on provider payment or reimbursement systems currently used in radiation oncology and complex cancer surgery, also including policy models. RESULTS: Most European health systems reimburse radiotherapy using a budget-based, fee-for-service or fraction-based system; while few reimburse services according to an episode-based model. Also, the reimbursement models for cancer surgery are mostly restricted to differences embedded in the DRG system and adjustments applied to the fees, based on the complexity of each surgical procedure. There is an enormous variability in reimbursement across countries, resulting in different incentives and different amounts paid for the same therapeutic strategy. CONCLUSION: A reimbursement policy, based on the episode of care as the basic payment unit, is advocated for. Innovation should be tackled in a two-tier approach: one defining the common criteria for reimbursement of proven evidence-based interventions; another for financing emerging innovation with uncertain definitive value. Relevant clinical and economic data, also collected real-life, should support reimbursement systems that mirror the actual cost of evidence-based practice.

Emerging electronic cigarette policies in European member states, Canada, and the United States.

BACKGROUND: Increased electronic cigarette (ECIG) use has motivated new regulations to address the changing landscape of tobacco use and promote public health. METHOD: This policy scan compares ECIG prevalence and regulations in the European Union (EU), Canada, and the United States (US) at the federal- and local-level to foster a policy dialogue around modern tobacco prevention and control regulations. RESULTS: Among young adults, 40 % in the US, 29 % in Canada, and 28 % in the EU report ever using an ECIG. Results from the policy scan find significant variation in approach to regulating ECIGs. EU member states are subject to the most stringent requirements regarding nicotine concentration regulations, and several member states have also opted to ban flavors and/or require plain packaging or out of sight retail sales. Among EU and US states, taxation is a popular strategy, though taxing strategies vary widely. Regarding youth use, US states have led the way for increasing the legal age of sale to 21 at the federal level, and in Canada recent federal regulations are innovative in their approach to banning advertising that may appeal to youth. CONCLUSION: Strategies to achieve public health goals related to ECIGs vary widely, with federalism playing an important role in policy innovation, offering opportunities to evaluate their effectiveness and inform future regulations.

Reimbursement Status and Recommendations Related to Orphan Drugs in European Countries.

Objective: To review the reimbursement recommendations issued by selected European health technology assessment agencies for orphan drugs and the reimbursement status of these drugs; to assess the relationship between the type of recommendation and reimbursement status. Methods: The list of orphan drugs to be included in the analysis was obtained from the European Medicines Agency and Orphanet. Seven European states were included in the analysis: Belgium, England, France, Germany, Poland, Scotland, and Spain. For all identified orphan drugs, relevant data on the reimbursement status and type of recommendation were collected for each country. The relationship between the type of recommendation and reimbursement status was evaluated separately for each considered country, using Cohen's kappa coefficient for the measurement of agreement; sub-analyses for oncology and metabolic drugs were performed. Results: Most reimbursement recommendations for orphan drugs were positive (71%), while approximately 17% were negative and almost 13% were conditional. The highest percentage of positive reimbursement recommendations was observed in Spain (97%) and France (95%) and the highest percentage of negative reimbursement recommendations was revealed for Poland (49%). On average, 65% of the 163 analyzed orphan drugs were reimbursed from public funds. The highest number of reimbursed orphan drugs was observed in Germany (n = 148), while the lowest, in Poland (n = 41). Considering all analyzed drugs, the highest agreement between recommendations and reimbursement status was observed for Spain (value of 1), and the lowest, for Germany (κ = -0.03). Conclusions: On average, more than 60% of identified orphan drugs were reimbursed from public funds in the included countries, and the majority of reimbursement recommendations were found to be positive. The agreement between reimbursement recommendations and reimbursement status differed between the countries, but overall, it did not show any patterns, as it ranged from -0.03 to 1 (κ coefficient).

Bulgaria health system review.

In the last 20 years, demographic development in Bulgaria has been characterized by population decline, a low crude birth rate, a low fertility rate, a high mortality rate and an ageing population. A stabilizing political situation since the early 2000s and an economic upsurge since the mid-2000s were important factors in the slight increase of the birth and fertility rates and the slight decrease in standardized death rates. In general, Bulgaria lags behind European Union (EU) averages in most mortality and morbidity indicators. Life expectancy at birth reached 73.3 years in 2008 with the main three causes of death being diseases of the circulatory system, malignant neoplasms and diseases of the respiratory system. One of the most important risk factors overall is smoking, and the average standardized death rate for smoking-related causes in 2008 was twice as high as the EU15 average. The Bulgarian health system is characterized by limited statism. The Ministry of Health is responsible for national health policy and the overall organization and functioning of the health system and coordinates with all ministries with relevance to public health. The key players in the insurance system are the insured individuals, the health care providers and the third party payers, comprising the National Health Insurance Fund, the single payer in the social health insurance (SHI) system, and voluntary health insurance companies (VHICs). Health financing consists of a publicprivate mix. Health care is financed from compulsory health insurance contributions, taxes, outofpocket (OOP) payments, voluntary health insurance (VHI) premiums, corporate payments, donations, and external funding. Total health expenditure (THE) as a share of gross domestic product (GDP) increased from 5.3% in 1995 to 7.3% in 2008. At the latter date it consisted of 36.5% OOP payments, 34.8% SHI, 13.6% Ministry of Health expenditure, 9.4% municipality expenditure and 0.3% VHI. Informal payments in the health sector represent a substantial part of total OOP payments (47.1% in 2006). The health system is economically unstable and health care establishments, most notably hospitals, are suffering from underfunding. Planning of outpatient health care is based on a territorial principle. Investment for state and municipal health establishments is financed from the state or municipal share in the establishments capital. In the first quarter of 2009, health workers accounted for 4.9% of the total workforce. Compared to other countries, the relative number of physicians and dentists is particularly high but the relative number of nurses remains well below the EU15, EU12 and EU27 averages. Bulgaria is faced with increased professional mobility, which is becoming particularly challenging. There is an oversupply of acute care beds and an undersupply of longterm care and rehabilitation services. Health care reforms after 1989 focused predominantly on ambulatory care and the restructuring of the hospital sector is still pending on the government agenda. Citizens as well as medical professionals are dissatisfied with the health care system and equity is a challenge not only because of differences in health needs, but also because of socioeconomic disparities and territorial imbalances. The need for further reform is pronounced, particularly in view of the low health status of the population. Structural reforms and increased competitiveness in the system as well as an overall support of reform concepts and measures are prerequisites for successful progress.

Hungary health system review.

Hungary has achieved a successful transition from an overly centralized, integrated Semashko-style health care system to a purchaser provider split model with output-based payment methods. Although there have been substantial increases in life expectancy in recent years among both men and women, many health outcomes remain poor, placing Hungary among the countries with the worst health status and highest rate of avoidable mortality in the EU (life expectancy at birth trailed the EU27 average by 5.1 years in 2009). Lifestyle factors especially the traditionally unhealthy Hungarian diet, alcohol consumption and smoking play a very important role in shaping the overall health of the population.In the single-payer system, the recurrent expenditure on health services is funded primarily through compulsory, non-risk-related contributions made by eligible individuals or from the state budget. The central government has almost exclusive power to formulate strategic direction and to issue and enforce regulations regarding health care. In 2009 Hungary spent 7.4% of its gross domestic product (GDP) on health, with public expenditure accounting for 69.7% of total health spending, and with health expenditure per capita ranking slightly above the average for the new EU Member States, but considerably below the average for the EU27 in 2008. Health spending has been unstable over the years, with several waves of increases followed by longer periods of cost-containment and budget cuts. The share of total health expenditure attributable to private sources has been increasing, most of it accounted for by out-of-pocket (OOP) expenses. A substantial share of the latter can be attributed to informal payments, which are a deeply rooted characteristic of the Hungarian health system and a source of inefficiency and inequity. Voluntary health insurance, on the other hand, amounted to only 7.4% of private and 2.7% of total health expenditure in 2009. Revenue sources for health have been diversified over the past 15 years, but the current mix has yet to be tested for sustainability. The fit between existing capacities and the health care needs of the population remains less than ideal, but improvements have been made over the past 15 years. In general, the average length of stay and hospital admission rates have decreased since 1990, as have bed occupancy rates. However, capacity for long-term nursing care in both the inpatient and outpatient setting is still considered insufficient. Hungary is currently also facing a health workforce crisis, explained by the fact that it is a net donor country with regard to health care worker migration, and health care professionals on the whole are ageing. Although the overall technical efficiency of the system has increased considerably, mainly due to the introduction of output-based payment systems, allocative efficiency remains a problem. Considerable variations exist in service delivery both geographically and by specialization, and equity of access is far from being realized, a fact which is mirrored in differing health outcomes for different population groups. A key problem is the continuing lack of an overarching, evidence-based strategy for mobilizing resources for health, which leaves the health system vulnerable to broader economic policy objectives and makes good governance hard to achieve. On the other hand, Hungary is a target country for cross-border health care, mainly for dental care but also for rehabilitative services, such as medical spa treatment. The health industry can thus be a potential strategic area for economic development and growth.