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.

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.

Delivery system performance as financial risk varies.

OBJECTIVES: Banner Health, a large delivery system in Maricopa County, Arizona, entered into both Medicare and commercial insurance contracts that varied the amount of financial risk that Banner assumed. Rates of utilization and spending under these various contracts were investigated. STUDY DESIGN: Prior to 2012, Banner held Medicare Advantage (MA) contracts, and in 2012 it began as a Medicare Pioneer accountable care organization (ACO). Banner also introduced a commercial ACO contract in that year. We compared risk-adjusted healthcare utilization and spending in the MA plan, the ACO, and a local traditional Medicare (TM) comparison group. We also compared risk-adjusted utilization and spending in Banner's commercial ACO with that of a comparison group drawn from the same employment groups who were not attributed to Banner providers. METHODS: We used claims and encounter data to measure utilization and spending. We risk adjusted using CMS and HHS Hierarchical Condition Categories. RESULTS: Within Medicare, MA enrollees had lower risk-adjusted utilization and total spending than either the Pioneer ACO participants or a local TM comparison group. Participation in the Pioneer ACO program was associated with a greater reduction in hospitalization rates for ACO patients relative to local TM patients served by non-ACO providers, but the effect on total medical spending was ambiguous. Risk-adjusted differences between the commercial ACO group and the fee-for-service comparison group were generally small. CONCLUSIONS: The results are consistent with CMS' efforts to shift reimbursement away from pure fee-for-service reimbursement.

Potential life years not saved due to lack of access to anti-EGFR tyrosine kinase inhibitors for lung cancer treatment in the Brazilian public healthcare system: Budget impact and strategies to improve access. A pharmacoeconomic study

ABSTRACT BACKGROUND: Lung cancer is the fourth most common cancer in Brazil. In the 2000s, better understanding of molecular pathways led to development of epidermal growth factor receptor (EGFR)-targeted treatments that have improved outcomes. However, these treatments are unavailable in most Brazilian public healthcare services (Sistema Único de Saúde, SUS). OBJECTIVE: To assess the potential number of years of life not saved, the budget impact of the treatment and strategies to improve access. DESIGN AND SETTING: Pharmacoeconomic study assessing the potential societal and economic impact of adopting EGFR-targeted therapy within SUS. METHODS: We estimated the number of cases eligible for treatment, using epidemiological data from the National Cancer Institute. We used data from a single meta-analysis and from the Lung Cancer Mutation Consortium (LCMC) study as the basis for assessing differences in patients' survival between use of targeted therapy and use of chemotherapy. The costs of targeted treatment were based on the national reference and were compared with the amount reimbursed for chemotherapy through SUS. RESULTS: There was no life-year gain with EGFR-targeted therapy in the single meta-analysis (hazard ratio, HR, 1.01). The LCMC showed that 1,556 potential life-years were not saved annually. We estimated that the annual budget impact was 125 million Brazilian reais (BRL) with erlotinib, 48 million BRL with gefitinib and 52 million BRL with afatinib. Their incremental costs over chemotherapy per life-year saved were 80,329 BRL, 31,011 BRL and 33,225 BRL, respectively. A drug acquisition discount may decrease the budget impact by 30% (with a 20% discount). A fixed cost of 1,000 BRL may decrease the budget impact by 95%. CONCLUSION: Reducing drug acquisition costs may improve access to EGFR-targeted therapy for lung cancer.

Impacts of shifting responsibility for high-cost individuals on Health Insurance Exchange plan premiums and cost-sharing provisions.

Insurance companies can respond to increases in expected per-capita healthcare expenditures by adjusting premiums, cost-sharing requirements, and/or plan generosity. We use a Difference-in-Difference model with Plan-level Fixed Effects to estimate the impacts of increases in expected expenditures generated by closure of state-operated High Risk Pools (HRPs). For Silver plans, we find that issuers responded to HRP closures by increasing both premiums and deductibles, and by increasing the ratios of premiums to deductibles. This adjustment to the structure of plan prices is consistent with the hypothesis that issuers will be reluctant to adjust deductibles, because consumers tend to overweight changes in deductibles over changes in premiums. The increase in the ratio of premiums to deductibles indicates that the increase in expected expenditures triggered an increase in the share of total risk-pool healthcare expenditures paid by low healthcare utilizers, and a decrease in the share paid by high utilizers.

Measuring financial risk protection in health benefits packages: scoping review protocol to inform allocative efficiency studies.

INTRODUCTION: To progress towards Universal Health Coverage (UHC), countries will need to define a health benefits package of services free at the point of use. Financial risk protection is a core component of UHC and should therefore be considered a key dimension of health benefits packages. Allocative efficiency modelling tools can support national analytical capacity to inform an evidence-based selection of services, but none are currently able to estimate financial risk protection. A review of existing methods used to measure financial risk protection can facilitate their inclusion in modelling tools so that the latter can become more relevant to national decision making in light of UHC. METHODS AND ANALYSIS: This protocol proposes to conduct a scoping review of existing methods used to measure financial risk protection and assess their potential to inform the selection of services in a health benefits package. The proposed review will follow the methodological framework developed by Arksey and O'Malley and the subsequent recommendations made by Levac et al. Several databases will be systematically searched including: (1) PubMed; (2) Scopus; (3) Web of Science and (4) Google Scholar. Grey literature will also be scanned, and the bibliography of all selected studies will be hand searched. Following the selection of studies according to defined inclusion and exclusion criteria, key characteristics will be collected from the studies using a data extraction tool. Key characteristics will include the type of method used, geographical region of focus and application to specific services or packages. The extracted data will then be charted, collated, reported and summarised using descriptive statistics, a thematic analysis and graphical presentations. ETHICS AND DISSEMINATION: The scoping review proposed in this protocol does not require ethical approval. The final results will be disseminated via publication in a peer-reviewed journal, conference presentations and shared with key stakeholders.

Acuerdos de Riesgo Compartido: Lecciones Para su Diseño e Implementación a la Luz de la Experiencia Internacional.

BACKGROUND: Despite the growing interest in risk-sharing agreements as appropriate payment mechanisms for high-cost treatments, few practical resources facilitate their adoption. OBJECTIVE: To identify and propose lessons for designing and implementing these models based on a review of the international experience, and to offer a concise model based on these lessons. METHODS: The steps of the Joanna Briggs Institute were adopted, which included identifying the concept and its relevant variants in scientific and gray literature. RESULTS: Forty-one references were examined in depth. The design of these payment mechanisms should be a process carried out by competent actors (payer, producer, specialists, patients, and a neutral entity); the design must be supported by a sound regulatory and contractual framework that structures its components and clarifies the functions of each actor. Finally, there are critical activities for each actor in each phase of the agreement's progress. CONCLUSIONS: The participation of all actors and the clarification of critical elements and tasks are fundamental for the optimal development of the experiences.

Potential life years not saved due to lack of access to anti-EGFR tyrosine kinase inhibitors for lung cancer treatment in the Brazilian public healthcare system: Budget impact and strategies to improve access. A pharmacoeconomic study.

BACKGROUND: Lung cancer is the fourth most common cancer in Brazil. In the 2000s, better understanding of molecular pathways led to development of epidermal growth factor receptor (EGFR)-targeted treatments that have improved outcomes. However, these treatments are unavailable in most Brazilian public healthcare services (Sistema Único de Saúde, SUS). OBJECTIVE: To assess the potential number of years of life not saved, the budget impact of the treatment and strategies to improve access. DESIGN AND SETTING: Pharmacoeconomic study assessing the potential societal and economic impact of adopting EGFR-targeted therapy within SUS. METHODS: We estimated the number of cases eligible for treatment, using epidemiological data from the National Cancer Institute. We used data from a single meta-analysis and from the Lung Cancer Mutation Consortium (LCMC) study as the basis for assessing differences in patients' survival between use of targeted therapy and use of chemotherapy. The costs of targeted treatment were based on the national reference and were compared with the amount reimbursed for chemotherapy through SUS. RESULTS: There was no life-year gain with EGFR-targeted therapy in the single meta-analysis (hazard ratio, HR, 1.01). The LCMC showed that 1,556 potential life-years were not saved annually. We estimated that the annual budget impact was 125 million Brazilian reais (BRL) with erlotinib, 48 million BRL with gefitinib and 52 million BRL with afatinib. Their incremental costs over chemotherapy per life-year saved were 80,329 BRL, 31,011 BRL and 33,225 BRL, respectively. A drug acquisition discount may decrease the budget impact by 30% (with a 20% discount). A fixed cost of 1,000 BRL may decrease the budget impact by 95%. CONCLUSION: Reducing drug acquisition costs may improve access to EGFR-targeted therapy for lung cancer.

Revenue-sharing clubs provide economic insurance and incentives for sustainability in common-pool resource systems.

Harvesting behaviors of natural resource users, such as farmers, fishermen and aquaculturists, are shaped by season-to-season and day-to-day variability, or in other words risk. Here, we explore how risk-mitigation strategies can lead to sustainable use and improved management of common-pool natural resources. Over-exploitation of unmanaged natural resources, which lowers their long-term productivity, is a central challenge facing societies. While effective top-down management is a possible solution, it is not available if the resource is outside the jurisdictional bounds of any management entity, or if existing institutions cannot effectively impose sustainable-use rules. Under these conditions, alternative approaches to natural resource governance are required. Here, we study revenue-sharing clubs as a mechanism by which resource users can mitigate their income volatility and importantly, as a co-benefit, are also incentivized to reduce their effort, leading to reduced over-exploitation and improved resource governance. We use game theoretic analyses and agent-based modeling to determine the conditions in which revenue-sharing can be beneficial for resource management as well as resource users. We find that revenue-sharing agreements can emerge and lead to improvements in resource management when there is large variability in production/revenue and when this variability is uncorrelated across members of the revenue-sharing club. Further, we show that if members of the revenue-sharing collective can sell their product at a price premium, then the range of ecological and economic conditions under which revenue-sharing can be a tool for management greatly expands. These results have implications for the design of bottom-up management, where resource users themselves are incentivized to operate in ecologically sustainable and economically advantageous ways.

Spending Carveouts Substantially Improve the Accuracy of Performance Measurement in Shared Savings Arrangements: Findings From Simulation Analysis of Medicaid ACOs.

Accuracy of spending-based provider performance metrics is limited by random variation and components of spending that are uncontrollable by providers. Such components vary according to the care management focus and operational maturity of each provider group. This study uses data from New Jersey Medicaid accountable care organizations (ACOs) to examine how carving out uncontrollable components of spending affects the accuracy of performance measures in shared savings arrangements. Spending on injury care, custodial care in facilities (CCF), and amounts above $100 000 per patient are used as examples of potentially uncontrollable spending. Data from 7 applicant Medicaid ACOs are used to conduct Monte Carlo simulations examining the effects of carving out each type of uncontrollable spending under the assumption that controllable spending is reduced by 5%. The simulations show that failure to carve out uncontrollable injury care spending adds -3 to +1 percentage points of bias to the measurement of the true average savings rate (ASR) of 5% and can increase mean squared error (MSE) by a factor of up to 3. Failure to carve out uncontrollable CCF spending generates bias ranging from -4 to +9 percentage points and increases MSE by factors of 8 or more. Failure to carve out uncontrollable spending above $100 000 per person generates bias ranging from -5 to +5 percentage points and increases MSE by factors of 13 or more. Compared with the main modeling reported above, sensitivity analyses find even greater distortions in measured performance when uncontrollable spending is not carved out of the ASR calculation.

Progress Toward Universal Health Coverage: A Comparative Analysis in 5 South Asian Countries.

Importance: Achieving universal health coverage is one of the key targets in the newly adopted Sustainable Development Goals of the United Nations. Objective: To investigate progress toward universal health coverage in 5 South Asian countries and assess inequalities in health services and financial risk protection indicators. Design and Settings: In a population-based study, nationally representative household (335 373 households) survey data from Afghanistan (2014 and 2015), Bangladesh (2010 and 2014), India (2012 and 2014), Nepal (2014 and 2015), and Pakistan (2014) were used to calculate relative indices of health coverage, financial risk protection, and inequality in coverage among wealth quintiles. The study was conducted from June 2012 to February 2016. Main Outcomes and Measures: Three dimensions of universal health coverage were assessed: access to basic services, financial risk protection, and equity. Composite and indicator-specific coverage rates, stratified by wealth quintiles, were then estimated. Slope and relative index of inequality were used to assess inequalities in service and financial indicators. Results: Access to basic care varied substantially across all South Asian countries, with mean rates of overall prevention coverage and treatment coverage of 53.0% (95% CI, 42.2%-63.6%) and 51.2% (95% CI, 45.2%-57.1%) in Afghanistan, 76.5% (95% CI, 61.0%-89.0%) and 44.8% (95% CI, 37.1%-52.5%) in Bangladesh, 74.2% (95% CI, 57.0%-88.1%) and 83.5% (95% CI, 54.4%-99.1%) in India, 76.8% (95% CI, 66.5%-85.7%) and 57.8% (95% CI, 50.1%-65.4%) in Nepal, and 69.8% (95% CI, 58.3%-80.2%) and 50.4% (95% CI, 37.1%-63.6%) in Pakistan. Financial risk protection was generally low, with 15.3% (95% CI, 14.7%-16.0%) of respondents in Afghanistan, 15.8% (95% CI, 14.9%-16.8%) in Bangladesh, 17.9% (95% CI, 17.7%-18.2%) in India, 11.8% (95% CI, 11.8%-11.9%) in Nepal, and 4.4% (95% CI, 4.0%-4.9%) in Pakistan reporting incurred catastrophic payments due to health care costs. Access to at least 4 antenatal care visits, institutional delivery, and presence of skilled attendant during delivery were at least 3 times higher among the wealthiest mothers in Afghanistan, Bangladesh, Nepal, and Pakistan compared with the rates among poor mothers. Access to institutional delivery was 60 to 65 percentage points higher among wealthy than poor mothers in Afghanistan, Bangladesh, Nepal, and Pakistan compared with 21 percentage points higher in India. Coverage was least equitable among the countries for adequate sanitation, institutional delivery, and the presence of skilled birth attendants. Conclusions and Relevance: Health coverage and financial risk protection was low, and inequality in access to health care remains a serious issue for these South Asian countries. Greater progress is needed to improve treatment and preventive services and financial security.

Sensitivity of measuring the progress in financial risk protection to survey design and its socioeconomic and demographic determinants: A case study in Rwanda.

Reliable and comparable information on households with catastrophic health expenditure (HCHE) is crucial for monitoring and evaluating our progress towards achieving universal financial risk protection. This study aims to investigate the sensitivity of measuring the progress in financial risk protection to survey design and its socioeconomic and demographic determinants. Using the Rwanda Integrated Living Conditions Survey in 2005 and 2010/2011, we derived the level and trend of the percentage of the HCHE using out-of-pocket health spending data derived from (1) a health module with a two-week recall period and six (2005)/seven (2010/2011) survey questions (Method 1) and (2) a consumption module with a four-week/ten-/12-month recall period and 11(2005)/24 (2010/2011) questions (Method 2). Using multilevel logistic regression analysis, we investigated the household socioeconomic and demographic characteristics that affected the sensitivity of estimating the HCHE to survey design. We found that Method 1 generated a significantly higher HCHE estimate (9.2%, 95% confidence interval 8.4%-10.0%) than Method2 (7.4%, 6.6%-8.1%) in 2005 and lower estimate (5.6%, 5.2%-6.1%) than Method 2 (8.2%, 7.6%-8.7%) in 2010/2011. The estimated trends of the HCHE using the two methods were not consistent between the two years. A household's size, its income quintile, having no under-five children, and educational level of its head were positively associated with the consistency of its HCHE status when using the two survey methods. Estimates of the progress in financial risk protection, especially among the most vulnerable households, are sensitive to survey design. These results are robust to various thresholds of catastrophic health spending. Future work must focus on mitigating survey effects through the development of statistical tools.

Monte Carlo Analysis of Payer and Provider Risks in Shared Savings Arrangements.

This article provides a thorough empirical analysis of random variation in shared savings arrangements. It uses claims data from seven provider coalitions that applied for certification to become Medicaid accountable care organizations (ACOs) in New Jersey to conduct Monte Carlo simulations under varying assumptions about true ACO savings. Among all the ACOs examined, the observed savings rate can be several percentage points higher or lower than the assumed true savings rate, leading to large probabilities of Type I and Type II error in determining the existence of savings. Although the effects of random variation are smaller for larger ACOs, the ACO-level coefficient of variation in health care spending also stands out as a highly relevant parameter. The risks of overpayment and underpayment can be minimized through modified specification of the savings measurement methodology. These findings have implications for the terms of shared savings arrangements negotiated between payers and providers.

Mapping Systemic Risk: Critical Degree and Failures Distribution in Financial Networks.

The financial crisis illustrated the need for a functional understanding of systemic risk in strongly interconnected financial structures. Dynamic processes on complex networks being intrinsically difficult to model analytically, most recent studies of this problem have relied on numerical simulations. Here we report analytical results in a network model of interbank lending based on directly relevant financial parameters, such as interest rates and leverage ratios. We obtain a closed-form formula for the "critical degree" (the number of creditors per bank below which an individual shock can propagate throughout the network), and relate failures distributions to network topologies, in particular scalefree ones. Our criterion for the onset of contagion turns out to be isomorphic to the condition for cooperation to evolve on graphs and social networks, as recently formulated in evolutionary game theory. This remarkable connection supports recent calls for a methodological rapprochement between finance and ecology.

Current status and trends in performance-based risk-sharing arrangements between healthcare payers and medical product manufacturers.

Our objective was to identify and characterize publicly available cases and related trends for performance-based risk-sharing arrangements (PBRSAs). We performed a review of PBRSAs over the past 20 years (1993-2013) using available databases and reports from colleagues and healthcare experts. These were categorized according to a previously published taxonomy of scheme types and assessed in terms of the underlying product and market attributes for each scheme. Macro-level trends were identified related to the timing of scheme adoption, countries involved, types of arrangements, and product and market factors. Our search yielded 148 arrangements. From this set, 65 arrangements included a coverage with an evidence development component, 20 included a conditional treatment continuation component, 54 included a performance-linked reimbursement component, and 42 included a financial utilization component. Each type of scheme addresses fundamental uncertainties that exist when products enter the market. The pace of adoption appears to be slowing, but new countries continue to implement PBRSAs. Over this 20-year period, there has been a consistent movement toward arrangements that minimize administrative burden. In conclusion, the pace of PBRSA adoption appears to be slowing but still has traction in many health systems. These remain a viable coverage and reimbursement mechanism for a wide range of medical products. The long-term viability and growth of these arrangements will rest in the ability of the parties to develop mutually beneficial arrangements that entail minimal administrative burden in their development and implementation.

The power of reinsurance in health insurance exchanges to improve the fit of the payment system and reduce incentives for adverse selection.

Risk adjustment and reinsurance protect plans against risk of losses and contend with adverse selection in the new health insurance Exchanges. This article assesses the power of reinsurance in the context of other plan payment features, including prospective and concurrent risk adjustment. Using data from the Medicare Expenditure Panel Survey (MEPS) to draw an "Exchange population," we simulate the contribution of reinsurance to improving the fit of the payment system to plan costs and to mitigating incentives for adverse selection for groups of enrollees with selected chronic illnesses. Modest reductions in attachment points equate the payment-system fit of retrospective to concurrent risk adjustment. Reinsurance is very powerful in fitting payments to costs and moderately effective in dealing with selection incentives.