Value-based payment for high-cost treatments in Singapore: a qualitative study of stakeholders' perspectives.

OBJECTIVES: The rising costs of drugs have necessitated the exploration of innovative payment methods in healthcare systems. Risk-sharing agreements (RSAs) have been implemented in many countries as a value-based payment mechanism to manage the uncertainty associated with expensive technologies. This study aimed to investigate stakeholder perspectives on value-based payment in the Singaporean context, providing insights for future directions in health technology assessment and financing. METHODS: This descriptive qualitative inquiry involved participant interviews conducted between October 2021 and April 2022. Thematic analysis was conducted in two phases to analyze the interview transcripts. RESULTS: Seventeen respondents participated in the study, and five key themes emerged from the analysis. Stakeholders viewed RSAs as moderately positive, despite limited experience with them. They emphasized the importance of clearly defining objectives and establishing transparent criteria for implementing these schemes. The current data infrastructure was identified as both a barrier and facilitator, as RSAs impose administrative burdens. To successfully implement these payment mechanisms, capacity building, and effective stakeholder engagement that fosters mutual trust and cocreation are crucial. CONCLUSION: This study confirms previously identified barriers and facilitators to successful RSA implementation while contextualizing them within the Singaporean setting. The findings suggest that value-based payment has the potential to address uncertainty and improve access to healthcare technologies, but these barriers must be addressed for the schemes to be effective.

Financial ''risk-sharing'' or refund programs in assisted reproduction: an Ethics Committee opinion.

Financial "risk-sharing" fee structures in assisted reproduction programs charge patients a higher initial fee that includes multiple cycles but offers a partial or complete refund if treatment fails. This opinion of the American Society for Reproductive Medicine Ethics Committee analyzes the ethical issues raised by these fee structures, including patient selection criteria, conflicts of interest, success rate transparency, and patient-informed consent. This document replaces the document of the same name, last published in 2016.

Using risk-sharing agreements as a tool to promote the introduction of new, innovative medicine.

Risk-sharing agreements have been suggested as a tool to accelerate access to new innovative medicines by reducing risk for the stakeholders. Especially uncertainty in clinical effectiveness, safety and financial consequences for patients and buyers are aimed at being reduced. This article outlines the concept, a terminology and advantages and disadvantages of the agreements. We argue that all risk-sharing agreements involve both advantages and disadvantages among relevant stakeholders.

Performance-based risk-sharing arrangements for devices and procedures in cardiac electrophysiology: an innovative perspective.

There is an increasing pressure on demonstrating the value of medical interventions and medical technologies resulting in the proposal of new approaches for implementation in the daily practice of innovative treatments that might carry a substantial cost. While originally mainly adopted by pharmaceutical companies, in recent years medical technology companies have initiated novel value-based arrangements for using medical devices, in the form of 'outcomes-based contracts', 'performance-based contracts', or 'risk-sharing agreements'. These are all characterized by linking coverage, reimbursement, or payment for the innovative treatment to the attainment of pre-specified clinical outcomes. Risk-sharing agreements have been promoted also in the field of electrophysiology and offer the possibility to demonstrate the value of specific innovative technologies proposed in this rapidly advancing field, while relieving hospitals from taking on the whole financial risk themselves. Physicians deeply involved in the field of devices and technologies for arrhythmia management and invasive electrophysiology need to be prepared for involvement as stakeholders. This may imply engagement in the evaluation of risk-sharing agreements and specifically, in the process of assessment of technology performances or patient outcomes. Scientific Associations may have an important role in promoting the basis for value-based assessments, in promoting educational initiatives to help assess the determinants of the learning curve for innovative treatments, and in promoting large-scale registries for a precise assessment of patient outcomes and of specific technologies' performance.

Acordo de Compartilhamento de Risco: projeto-piloto no Sistema Único de Saúde / Risk Sharing Agreement: a pilot project in the Brazilian Unified Health System

O Acordo de Compartilhamento de Risco é definido como um acordo no qual o Estado concorda em oferecer acesso temporário a um novo medicamento, enquanto a indústria farmacêutica aceita receber pelo produto conforme o desempenho do medicamento em reais condições de uso. A partilha de risco depende, necessariamente, da coleta de evidências adicionais, que podem se referir aos benefícios terapêuticos ou ao volume de pacientes, conforme avaliação de seu uso na prática. Os autores descreveram a experiência do projeto-piloto de Acordo de Compartilhamento de Risco no Sistema Único de Saúde.

Risk Sharing Agreement is defined as an agreement in which the State agrees to offer temporary access to a new drug, while the pharmaceutical industry accepts to receive the product according to the performance of the drug in real conditions of use. Risk sharing necessarily depends on the collection of additional evidence that may refer to the therapeutic benefits or the volume of patients, according to the assessment of its use in practice. The authors described the experience of the pilot project of a Risk Sharing Agreement in the Unified Health System.

Performance-based risk-sharing arrangements for devices and diagnostics in the United States: a systematic review.

BACKGROUND: Performance-based risksharing arrangements (PBRSAs) have continued to emerge and evolve over the last 2 decades. To date, most of the attention and available literature have focused on pharmaceuticals. OBJECTIVE: To assess the current status and trends regarding the use of PBRSAs for diagnostics and devices in the United States. METHODS: We reviewed publicly available PBRSAs for diagnostics and devices using the University of Washington Performance Based Risk Sharing Database. We augmented the review using PubMed, Google, and payer and industry websites. Key words and phrases such as outcomes-based, value-based, coverage with evidence development, performance-based, and risk-sharing were used in combination with device or diagnostic. To characterize arrangements in terms of product and market attributes, we extracted data for each product, including arrangement descriptions, arrangement type, year, therapeutic area, product manufacturer, payer, and product type. Arrangements were analyzed using descriptive statistics. RESULTS: Fifty-two arrangements were identified between the years 2001 and 2019, with 30 (57.7%) for devices and 22 (42.3%) for diagnostic tests. Among these, 23 (44.2%) were coverage with evidence development (CED), only in research; 17 (32.7%) were performance-linked reimbursement (PLR); and 12 (23.1%) were CED, only with research. The majority of arrangements for devices were developed in cardiology (12, 40%), endocrinology (4, 13.3%), and radiology (3, 10%). Most of arrangements for identified diagnostic tests were in oncology (17, 77.3%). Over time, there has been a trend towards increasing adoption of PLR and CED, only with research, especially since 2014. CONCLUSIONS: This is the first study to comprehensively review PBRSA arrangements for diagnostics and devices in the United States. Our findings demonstrated that there is substantial PBRSA activity for devices and diagnostics, and the pace of PBRSA adoption appears to be increasing in terms of frequency and variety. These arrangements have implications for managed care into the future as the health care system shifts towards value-based care and value-based pricing to contain cost for payers and ensure value in the patient populations. DISCLOSURES: No funding supported this study. The authors have nothing to disclose.

Linha de cuidados no tratamento da asma: informações úteis para o gestor / Comprehensive care in asthma treatment: useful information for the health-care manager

Realizou-se, no dia 29 de agosto de 2020, um encontro virtual com gestores, representantes de associações de pacientes e médicos prescritores envolvidos no tratamento da asma, com o objetivo de discutir a necessidade e a viabilidade da incorporação de novas tecnologias para o tratamento dessa patologia. A asma é uma enfermidade caracterizada pela inflamação crônica das vias aéreas. É a principal causa de absenteísmo escolar e laboral e estima-se que seja responsável por até cinco mortes diárias em nosso país. Em pesquisa efetuada em operadora de autogestão, com vidas espalhadas por todo o país, observou-se que essa patologia (associada à doença pulmonar obstrutiva crônica ­ DPOC) acomete quase 7% dos seus segurados e que a utilização do plano foi, nesse grupo, 1,9x maior para consultas, 1,6x maior para exames, 2,5x maior para terapias e 2,9x maior para internações, resultando em um aumento de 25,5% nos gastos assistenciais. Observou-se que é de elevada importância que o gestor tenha um profundo conhecimento de sua carteira e que priorize toda a linha de cuidado do paciente. Dessa maneira, atuando diretamente no controle da severidade da patologia, terão os melhores resultados de qualidade de vida e restringirão os doentes que necessitarão de medicações mais modernas e, também, mais caras, com resultado óbvio no controle de custos. A asma ainda não tem, em geral, para os gestores de operadoras de saúde privadas, no Brasil, uma importância tão grande na sinistralidade das suas carteiras. Os novos imunobiológicos são úteis e efetivos e alguma contrapartida por parte do fabricante, como, por exemplo, o compartilhamento de riscos, pode ser necessária para uma incorporação desse arsenal no Rol de produtos que serão disponibilizados para os pacientes que deles necessitarem

On August 29 (2020), a virtual meeting was held with managers, representatives of patient associations and physicians involved in the treatment of asthma, in order to discuss the need and the feasibility of incorporating new technologies for the treatment of this disease. Asthma is a condition characterized by chronic inflammation of the airways. It is the main cause of school and work absenteeism and it is estimated that it is the cause of up to 5 daily deaths in our country, annually. In a survey carried out at a Health Care Plan, with patients spread across the country, it was observed that this pathology (associated with COPD) affects almost 7% of its insured persons and that the use of the plan was, in this group, 1.9x higher for consultations, 1.6x higher for exams, 2.5x higher for therapies and 2.9x higher for hospitalizations, resulting in a 25.5% increase in the global health care expenses. It was observed that it is highly important that managers have a deep knowledge of his portfolio and that they prioritize the entire process of patient care. In this way, acting directly in the control of the severity of the pathology, they will have the best quality of life results and will restrict the number of patients who will need more modern and also more expensive medications, with obvious impact on costs. Asthma still does not have, for the manager of a Private Health Operator, in Brazil, such importance in the expenses of his portfolio. The new immunobiologicals are useful, effective and some counterpart on the part of the manufacturer, such as, for example, the risk-share agreements, may be necessary for the incorporation of this into the arsenal of products that will be made available to patients that need them

How do insurance firms respond to financial risk sharing regulations? Evidence from the Affordable Care Act.

Many insurance markets have reinstated premium stabilization programs to ensure financial protection from market volatility. In this paper, we focus on one such regulation-risk corridors (RCs)-in the context of the Health Insurance Marketplaces established under the Affordable Care Act. We develop a model to show how the program provided incentives for some insurers to lower their premiums. The RCs program was defunded unexpectedly for coverage year 2016, before its legislated end in 2016. Consistent with the model, we find that making a RCs claim before the program ended is associated with higher premium growth after the program's demise. The model and empirical evidence are consistent with the view that the end of the RCs program contributed to premium growth in the Marketplaces.

Informal risk-sharing between smallholders may be threatened by formal insurance: Lessons from a stylized agent-based model.

Microinsurance is promoted as a valuable instrument for low-income households to buffer financial losses due to health or climate-related risks. However, apart from direct positive effects, such formal insurance schemes can have unintended side effects when insured households lower their contribution to traditional informal arrangements where risk is shared through private monetary support. Using a stylized agent-based model, we assess impacts of microinsurance on the resilience of those smallholders in a social network who cannot afford this financial instrument. We explicitly include the decision behavior regarding informal transfers. We find that the introduction of formal insurance can have negative side effects even if insured households are willing to contribute to informal risk arrangements. However, when many households are simultaneously affected by a shock, e.g. by droughts or floods, formal insurance is a valuable addition to informal risk-sharing. By explicitly taking into account long-term effects of short-term transfer decisions, our study allows to complement existing empirical research. The model results underline that new insurance programs have to be developed in close alignment with established risk-coping instruments. Only then can they be effective without weakening functioning aspects of informal risk management, which could lead to increased poverty.

Performance-based risk-sharing agreements in renal care: current experience and future prospects.

INTRODUCTION: Performance-based risk-sharing agreements (PBRSAs), between payers, health care providers, and technology manufacturers can be useful when there is uncertainty about the (cost-) effectiveness of a new technology or service. However, they can be challenging to design and implement. AREAS COVERED: A total of 18 performance-based agreements were identified through a literature review. All but two of the agreements identified were pay-for-performance schemes, agreed between providers and payers at the national level. No examples were found of agreements between health care providers and manufacturers at the local level. The potential for these local agreements was illustrated by hypothetical case studies of water quality management and an integrated chronic kidney disease program. EXPERT OPINION: Performance-based risk-sharing agreements can work to the advantage of patients, health care providers, payers, and technology manufacturers, particularly if they facilitate the introduction of technologies or systems of care that might not have been introduced otherwise. However, the design, conduct, and implementation of PBRSAs in renal care pose a number of challenges. Efforts should be made to overcome these challenges so that more renal care patients can benefit from technological advances and new models of care.

Performance-Based Risk-Sharing Arrangements (PBRSA): Is it a Solution to Increase Bang for the Buck for Pharmaceutical Reimbursement Strategy for Our Nation and Around the World?

Due to the risks involved in not achieving desired health outcomes for the dollar spent on drugs, healthcare decision makers, including payers, providers, drug manufacturers, and patients, need a mechanism to share this financial risk among the involved parties. Performance-based risk-sharing arrangements (PBRSAs) are agreements that can potentially reduce the 'drug lag' in which patients wait for an unknown amount of time until a particular drug is covered under their health plan. In addition, PBRSAs can mitigate the risk of investing heavily in drugs that are ineffective or do not deliver good value or "bang for the buck". This review describes and evaluates PBRSAs for drugs in the USA and juxtaposes to other developed nations (i.e. Germany) that adopted PBRSAs in their healthcare model. There are different types of outcomes-based health schemes, namely conditional coverage, which can be further broken down into coverage with evidence development (CED), conditional treatment continuation (CTC), and performance-linked reimbursement, which includes outcomes guarantees. Both CED and CTC are 'conditional' on the collected evidence of the new drug's effectiveness, offering discount only if the drug delivers desirable results. The outcomes guarantee scheme offers discount or even a full refund if the outcome is less than expected, forcing the drug to meet the expected effectiveness. The USA can follow the German reference pricing model in which the assessment of new drugs is centralized and done collectively by representatives from a group of healthcare decision makers. In any shape or form, PBRSA is a clever mechanism to cope with uncertainty if drug price is scaled appropriately based on value.

International experience with performance-based risk-sharing arrangements: implications for the Chinese innovative pharmaceutical market.

OBJECTIVES: Various forms of outcomes-based or risk-sharing agreements have been implemented since early 2000s as a way of access to innovative medicinal products. This study aims to summarize the international experience of performance-based risk-sharing arrangements (PBRSAs) and identify the preconditions for a successful implementation of such schemes. Their implications for the Chinese healthcare market are discussed. METHODS: A systematic literature review (in PubMed) was conducted to review the evidence on the nature and performance of PBRSAs in the past 10 years. Grey literature was searched for reports in government websites of the countries in scope. RESULTS: The search identifies 463 records from PubMed and 3 additional records from other sources. Thirty-one publications are included in the final review. The following preconditions were identified to support a successful implementation of PBRSAs: (1) Identify meaningful and feasible outcome measurements; (2) Establish an effective and efficient data collection infrastructure; (3) Control of the implementation costs; (4) Develop governance and administrative infrastructure to allow delisting and rebate/refund; (5) Clarify personal data protection issues. CONCLUSIONS: The implementation of PBRSAs has proven to be challenging. Although the Chinese healthcare system is not yet well equipped to implement such schemes, some recent changes may pave the way to successful PBRSAs for particular innovative products.

When are Pharmaceuticals Priced Fairly? An Alternative Risk-Sharing Model for Pharmaceutical Pricing.

The most common solutions to the problem of high pharmaceutical prices have taken the form of regulations, price negotiations, or changes in drug coverage by insurers. These measures for the most part transfer the burden of drug expenditures between pharmaceutical companies and payers or between payers. The aim of this study is to propose an alternative model for the relationship between the main stakeholders (the pharmaceutical companies, third party payers, and the public) involved in the price setting and purchasing of pharmaceuticals, one that encourages a more cooperative approach. We draw from principles of ethics and health economics and apply them to the context of the pharmaceutical industry. The model prioritises two objectives, (1) to make drugs financially accessible to the patients who need them, and (2) to keep pharmaceutical companies viable and profitable. It is centered around the sharing of financial risk between the main stakeholders, which we describe as 'enlightened risk sharing'. After establishing the foundations of this model, we expand on the type of policies that can follow these principles with current day examples.

Experience of a Performance-Based Risk-Sharing Arrangement for the Treatment of Rheumatoid Arthritis With Certolizumab Pegol.

OBJECTIVES: To describe the process and results of the implementation of a performance-based risk-sharing arrangement for the use of certolizumab pegol (Cimzia) in patients with rheumatoid arthritis (RA), based on rational pharmacotherapy. METHODS: In 2014, the area of Management of Drugs and Supplies of the health maintenance organization of the Hospital Italiano de Buenos Aires signed a performance-based risk-sharing arrangement with Montpellier Laboratory for the use of certolizumab pegol in patients with RA. The laboratory would reimburse the hospital the cost of the first 10 doses of the drug if an optimal clinical response was not achieved (difference greater than or equal to 1.2 in the Disease Activity Score 28 with erythrocyte sedimentation [Δ DAS28 ESR] measured at the beginning and at the end), or if the patient presented with an adverse drug reaction, during the first 12 weeks of treatment. RESULTS: Forty patients with RA were included between September 2014 and January 2018. Thirty-six patients completed 12 weeks of treatment, of which 25 (69.4 %) had an optimal clinical response (Δ DAS28 ESR ≥ 1.2). The laboratory reimbursed the hospital 116 doses of certolizumab pegol, corresponding to 12 patients (12 of 40, 30%). Eleven of them did not reach the optimal clinical response, and 1 presented with an adverse drug reaction. CONCLUSIONS: The performance-based risk-sharing arrangement proved to be a useful tool to optimize the resources of the healthcare payer and contributed to the collection of scientific evidence in real-life patients.

Implementation and results of a risk-sharing scheme for enzyme replacement therapy in lysosomal storage diseases.

OBJECTIVE: To describe a risk-sharing program's implementation and  results on enzyme replacement therapy for lysosomal diseases. METHOD: The program was designed and implemented in a referral hospital for congenital metabolic diseases. The conclusion of  agreements required the following phases: 1) To define and agree on  response variables and criteria to treatment; 2) to assign discount  percentage to each stage of effectiveness; 3) to prepare and sign the  agreement by all parties; 4) to implement the agreement; 5) to  individualize purchases management; 6) to evaluate clinical results, and  7) to issue an annual report. RESULTS: Eight patients were included in the program (four with Hurler's disease, two with Pompe and two with Gaucher), five of them  were women and three were men. After analyzing the defined variables  and response criteria, all patients presented full effectiveness after two  or three years of follow-up except one of them that could not be  evaluated. Given the effectiveness achieved, the hospital made full  payment of all administered therapies. CONCLUSIONS: The implanted risk-sharing program is Spain's first  published event of paying for clinical results using orphan drugs.  Economic impact has been limited, and program implementation has  gone through a complex process of formulation and management.  However, the greatest achievement has been to reduce the knowledge  gap between efficacy and effectiveness, stating that the therapies  administered have shown the optimal benefits for which the funder is  willing to pay.

Objetivo: Describir la implantación y los resultados de un programa de riesgo compartido para el tratamiento enzimático sustitutivo de  enfermedades lisosomales.Método: Se diseñó y aplicó el programa en un hospital de referencia para enfermedades congénitas del metabolismo. La  consecución de los acuerdos requirió las siguientes fases: 1) Definir y  consensuar las variables y criterios de respuesta al tratamiento; 2)  asignar el porcentaje de descuento a cada escalón de efectividad; 3)  elaborar y firmar el acuerdo por todas las partes; 4) implantar el  acuerdo; 5) individualizar la gestión de compras; 6) evaluar los  resultados clínicos, y 7) emitir un informe anual.Resultados: Se incluyeron ocho pacientes en el programa (cuatro con enfermedad de Hurler, dos con enfermedad de Pompe y dos con  enfermedad de Gaucher), siendo cinco de ellos mujeres y tres varones.  Tras analizar las variables y criterios de respuesta definidos, todos los  pacientes presentaron efectividad plena tras dos o tres años de  seguimiento, excepto uno de ellos que no se pudo evaluar. Dada la  efectividad alcanzada, el hospital realizó el pago íntegro de todos los  tratamientos administrados.Conclusiones: El programa de riesgo compartido implantado es la primera experiencia publicada de pago por resultados clínicos en  medicamentos huérfanos en España. El impacto económico ha sido  limitado y la implantación del programa no ha estado exenta de  complejidad de formulación y de gestión. Sin embargo, el mayor logro  ha sido reducir la brecha de conocimiento entre eficacia y efectividad,  constatando que las terapias administradas han mostrado los beneficios  óptimos por los que está dispuesto a pagar el financiador.

Lifting the burden: State Medicaid expansion reduces financial risk for the injured.

BACKGROUND: Injuries are unanticipated and can be expensive to treat. Patients without sufficient health insurance are at risk for financial strain because of high out-of-pocket (OOP) health care costs relative to their income. We hypothesized that the 2014 Medicaid expansion (ME) in Washington (WA) state, which extended coverage to more than 600,000 WA residents, was associated with a reduction in financial risk among trauma patients. METHODS: We analyzed all trauma patients aged 18 to 64 years admitted to the sole level 1 trauma center in WA from 2012 to 2017. We defined 2012 to 2013 as the prepolicy period and 2014 to 2017 as the postpolicy period. We used a multivariable linear regression model to evaluate for changes in length of stay, inpatient mortality, and discharge disposition. To evaluate for financial strain, we used WA state and US census data to estimate postsubsistence income and OOP expenses for our sample and then applied these two estimates to determine catastrophic health expenditure (CHE) risk as defined by the World Health Organization (OOP health expenses ≥40% of estimated household postsubsistence income). RESULTS: A total of 16,801 trauma patients were included. After ME, the Medicaid coverage rate increased from 20.4% to 41.0%, and the uninsured rate decreased from 19.2% to 3.7% (p < 0.001 for both). There was no significant change in private insurance coverage. Medicaid expansion was not associated with significant changes in clinical outcomes or discharge disposition. Estimated CHE risk by payer was 81.4% for the uninsured, 25.9% for private insurance, and less than 0.1% for Medicaid. After ME, the risk of CHE for the policy-eligible sample fell from 26.4% to 14.0% (p < 0.01). CONCLUSION: State ME led to an 80% reduction in the uninsured rate among patients admitted for injury, with an associated large reduction in the risk of CHE. However, privately insured patients were not fully protected from CHE. Additional research is needed to evaluate the impact of these policies on the financial viability of trauma centers. LEVEL OF EVIDENCE: Economic analysis, level II.

Strategy and risk sharing in hospital-postacute care integration.

ISSUE/TREND: Postacute care has been identified as a primary area for cost containment. The continued shift of payment structures from volume to value has often put hospitals at the forefront of addressing postacute care cost containment. However, hospitals continue to struggle with models to manage patients in postacute care institutions, such as skilled nursing facilities or in home health agencies. Recent research has identified postacute care network development as one mechanism to improve outcomes for patients sent to postacute care providers. Many hospitals, though, have not utilized this strategy for fear of not adhering to Centers for Medicare & Medicaid Services requirements that patients are given choice when discharged to postacute care. MANAGERIAL APPROACH: A hospital's approach to postacute care integration will be dictated by environmental uncertainty and the level of embeddedness hospitals have with potential postacute care partners. Hospitals, though, must also consider how and when to extend shared savings to postacute care partners, which will be based on the complexity of the risk-sharing calculation, the ability to maintain network flexibility, and the potential benefits of preserving competition and innovation among the network members. For hospital leaders, postacute care network development should include a robust and transparent data management process, start with an embedded network that maintains network design flexibility, and include a care management approach that includes patient-level coordination. CONCLUSION: The design of care management models could benefit from elevating the role of postacute care providers in the current array of risk-based payment models, and these providers should consider developing deeper relationships with select postacute care providers to achieve cost containment.

Utilization of Predictive Modeling to Determine Episode of Care Costs and to Accurately Identify Catastrophic Cost Nonwarranty Outlier Patients in Adult Spinal Deformity Surgery: A Step Toward Bundled Payments and Risk Sharing.

STUDY DESIGN: Retrospective review of prospectively-collected, multicenter adult spinal deformity (ASD) database. OBJECTIVE: The aim of this study was to evaluate the rate of patients who accrue catastrophic cost (CC) with ASD surgery utilizing direct, actual costs, and determine the feasibility of predicting these outliers. SUMMARY OF BACKGROUND DATA: Cost outliers or surgeries resulting in CC are a major concern for ASD surgery as some question the sustainability of these surgical treatments. METHODS: Generalized linear regression models were used to explain the determinants of direct costs. Regression tree and random forest models were used to predict which patients would have CC (>$100,000). RESULTS: A total of 210 ASD patients were included (mean age of 59.3 years, 83% women). The mean index episode of care direct cost was $70,766 (SD = $24,422). By 90 days and 2 years following surgery, mean direct costs increased to $74,073 and $77,765, respectively. Within 90 days of the index surgery, 11 (5.2%) patients underwent 13 revisions procedures, and by 2 years, 26 (12.4%) patients had undergone 36 revision procedures. The CC threshold at the index surgery and 90-day and 2-year follow-up time points was exceeded by 11.9%, 14.8%, and 19.1% of patients, respectively. Top predictors of cost included number of levels fused, surgeon, surgical approach, interbody fusion (IBF), and length of hospital stay (LOS). At 90 days and 2 years, a total of 80.6% and 64.0% of variance in direct cost, respectively, was explained in the generalized linear regression models. Predictors of CC were number of fused levels, surgical approach, surgeon, IBF, and LOS. CONCLUSION: The present study demonstrates that direct cost in ASD surgery can be accurately predicted. Collectively, these findings may not only prove useful for bundled care initiatives, but also may provide insight into means to reduce and better predict cost of ASD surgery outside of bundled payment plans. LEVEL OF EVIDENCE: 3.

How to solve financing gap to ensure patient access to patented pharmaceuticals in CEE countries? - the good, the bad, and the ugly ways.

Introduction: There is significant difference in utilization of patented medicines in the EU, as pharmaceuticals at Western European price levels are usually not cost-effective in Central and Eastern European (CEE) countries. The article reviews options to solve the 'financing gap' posed by the challenge of covering patented medicines from more restricted resources in countries with greater unmet medical need.Areas covered: Hidden volume restrictions to patented pharmaceuticals implemented by payers to facilitate financial sustainability may increase European inequity in patient access. Confidential price discounts and financial risk-sharing agreements improve cost-effectiveness of pharmaceuticals with limited impact on the European floor price. Narrowing the eligible group of patients on the positive drug list can help to target the medicines to patients with potentially greater health benefit whilst reducing the budget impact. Pay-for-performance schemes can improve cost-effectiveness of pharmaceuticals with significant uncertainty or heterogeneity in the magnitude of added therapeutic value. Increased utilization of off-patent pharmaceuticals can increase patient access through re-investing the savings from generic or biosimilar price erosion.Expert opinion: Transparent and sustainable pharmaceutical policies aiming to improve the allocative efficiency of scarce resources should be implemented in CEE to reduce financing gap and improve patient access to high-cost medicines.

Risk sharing or risk shifting? On the development of patient access schemes in the process of updating the national list of health services in Israel.

Background: Agreements between payers and pharmaceutical/medical device companies are widely implemented to address financial and clinical uncertainties. We analyzed the main characteristics of these agreements in Israel from 2011-2018.Research design and methods: We reviewed all agreements implemented during the study period. Information regarding the type of agreement, therapeutic indications, its time frame and the total budget involved are presented.Results: A total of 56 agreements were signed since 2011, of which 53 (95%) were financial-based and 50 (89%) referred to pharmaceuticals. The annual number of agreements increased from one in 2011 to 21 in 2018. The main therapeutic areas covered were: oncology (41%), hepatitis C (16%), neurology (11%), respiratory (9%), and cardiovascular (7%). The proportion of the annual budget allocated subject to these agreements increased accordingly from 3% in 2011 to 73% in 2018. The majority (63%) of the agreements were signed for 5 years, 9% were shorter-term and 20% have no time-limit. In 14 (44%) of the financial-based agreements implemented through 2017, the actual utilization exceeded the pre-specified threshold and the companies reimbursed the health-plans accordingly.Conclusions: The number of agreements and the allocated budget subject to these agreements increased substantially in recent years. Most agreements are financial-based that, in many cases, shifted the short-term financial risk from health-plans to the industry.