scholarly journals How Risky Is That Risk Sharing Agreement? Mean-Variance Tradeoffs and Unintended Consequences of Six Common Risk Sharing Agreements

2021 ◽  
Vol 6 (1) ◽  
pp. 238146832199040
Author(s):  
Gregory S. Zaric

Background. Pharmaceutical risk sharing agreements (RSAs) are commonly used to manage uncertainties in costs and/or clinical benefits when new drugs are added to a formulary. However, existing mathematical models of RSAs ignore the impact of RSAs on clinical and financial risk. Methods. We develop a model in which the number of patients, total drug consumption per patient, and incremental health benefits per patient are uncertain at the time of the introduction of a new drug. We use the model to evaluate the impact of six common RSAs on total drug costs and total net monetary benefit (NMB). Results. We show that, relative to not having an RSA in place, each RSA reduces expected total drug costs and increases expected total NMB. Each RSA also improves two measures of risk by reducing the probability that total drug costs exceed any threshold and reducing the probability of obtaining negative NMB. However, the effects on variance in both NMB and total drug costs are mixed. In some cases, relative to not having an RSA in place, implementing an RSA can increase variability in total drug costs or total NMB. We also show that, for some RSAs, when their parameters are adjusted so that they have the same impact on expected total drug cost, they can be rank-ordered in terms of their impact on variance in drug costs. Conclusions. Although all RSAs reduce expected total drug costs and increase expected total NMB, some RSAs may actually have the undesirable effect of increasing risk. Payers and formulary managers should be aware of these mean-variance tradeoffs and the potentially unintended results of RSAs when designing and negotiating RSAs.

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 5017-5017
Author(s):  
Dave Smart ◽  
Wendy Moore ◽  
Karina Hjort ◽  
Karen Keating ◽  
Bob Holt ◽  
...  

Abstract Introduction Measures taken to mitigate infection spread during the 2020 COVID-19 pandemic are considered to have caused significant unintended consequences on other diseases. Large decreases in the numbers of symptomatic and asymptomatic people presenting for diagnosis of heart disease, diabetes and cancer have been observed. A recent analysis of solid tumors showed up to 70% reduction in the number of patients presenting for diagnosis. The potential exists for significantly increased morbidity and mortality for these missed or delayed presenting patients. Further, it is important to determine whether infection spread mitigation measures affected the diagnostic testing and treatment decisions for these patients. This study aimed to determine whether pandemic control measures affected presentation, testing and treatment of patients across eight different hematologic cancers. Methods CMS claims data were analyzed for the presence of diagnostic (DX) ICD 10 codes indicative of hematologic cancer. Patients with a DX code first appearing in 2019 or in 2020 were selected to provide newly diagnosed pre-COVID-19 and during COVID-19 cohorts for comparison, with unique patient counts being calculated for each month. A "COVID-19 dip" i.e. a decrease in the number of patients was calculated as the change in number of patients diagnosed in a given month relative to the number for JAN2020. Dip duration was calculated only when the decrease was >10% of the JAN2020 figure. Patients who received treatment via a "J" code Healthcare Common Procedure Coding System (HCPCS) code were extracted from the cohorts and the time taken from initial diagnosis to first treatment calculated. Results Eight hematologic cancers: AML, CLL, CML, HEME (a group of different hematologic cancers), Hodgkins (HOG), Myelodysplasia (MDS), Non-Follicular Lymphomas (NFL), and Non-Hodgkins Lymphoma (NHL) showed a decrease in the number of patients being diagnosed during the early part of 2020 (Fig.1) Fig.1. Change in new patient diagnoses for selected hematologic cancers as a proportion of their JAN2020 value There was some variation in the depth and duration of the COVID-19 dip (Table 1) with MDS having both the longest and deepest dip. Median depth and duration of the dip was 33% and 3.5 months, respectively, with all dips starting either in FEB or MAR2020. Table 1. Duration and depth of COVID-19 dips for selected hematological cancers The proportions of patients receiving therapy via J HCPCS code (JRX) are shown in Table 2 Table 2. Proportions of patients receiving J code therapy Conclusions The decline in new patient diagnoses for heme cancers during the period when COVID-19 control measures were implemented is similar to that seen with solid tumors, although the depth of the COVID-19 dip was generally larger in the latter. There is no evidence of "catch up" diagnosis occurring i.e. patients missing from Q2 2020 are not reappearing en masse in subsequent quarters. The decline for MDS patients has, except for SEP to OCT2020, remained. Collectively, (depending on the calculation method), the COVID-19 dip for these eight heme cancers represents 16,584-33,671 patients who will likely have significantly increased rates of morbidity and mortality due to delayed diagnosis. Analysis of J code treatments show little difference between the proportions of patients receiving these treatments in 2020 compared to 2019 suggesting that at least some aspects of treatment e.g. infused chemotherapy, IO drugs for these patients was relatively unchanged by pandemic control measures. It also suggests that the main cause for decreased patient numbers treated is due to decreased testing for diagnosis, rather than not being treated once diagnosed. This aligns with findings from studies in the US and UK. The results of this study indicate that there may be a "backlog" of tens of thousands of people with cancer whose diagnosis has been significantly delayed and who urgently need to be identified in order to get on proper treatment to lessen the impact of that delay. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.


Subject Options for euro-area reform. Significance As negotiations advance towards the formation of a new German government, talks between Paris and Berlin about a reform of the euro-area’s governance and functioning are also under way. Whatever the new German executive looks like, it will face important choices about the future institutional architecture of the European single currency. Impacts A euro-area budget could buffer future shocks and dampen the impact of economic crises. The prospect of more financial risk-sharing through a deposit insurance scheme may trigger resistance in richer states such as Germany. Deepening the euro-area could intensify reluctance of Eastern member states not in the euro to join.


2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 41-41 ◽  
Author(s):  
Henry Jacob Conter

41 Background: New cancer treatments have become increasingly costly. Although new drugs may be sufficiently cost-efficiency for a primary indication (i1) to receive funding, subsequent indications (ia) may not prove cost-effective. A financial risk-sharing agreement to increase access is proposed. A potential 2012 real-world implementation in Canada for pazopanib use in metastatic renal cell carcinoma (mRCC) as i1, and soft-tissue sarcoma (STS) as ia is presented. Methods: The market value of an indication can be approximated by its net-present-value (NPV) of expected cash flows. If the incremental cost-effectiveness ratio (ICER) for ia is expected to be greater than willingness-to-pay (WTP), the payer then has an incentive to enter into a risk-sharing agreement. A binomial option pricing model is employed to compute the price of the call option to contract such an agreement. The probability of being eligible for ia is extracted from the pan-Canadian Oncology Drug Review (pCODR), a national drug funding advisory body. Correspondence with industry was performed to identify additional ia. Cost, effectiveness, the ICER, discount rates, and drug revenues are calculated using inputs from pCODR, the Bank of Canada, Statistics Canada, and pazopanib’s relevant clinical data at the time of its submission for i1. Results: Of the 47 drugs eligible for i1, 46% are eligible for an ia(Wilson interval 33%-60%). For pazopanib in mRCC, at a mean price of $164/day and an ICER of $0-$57,309, the expected NPV was computed to be $338M. In STS, based on its clinical data at the time, at the same price, the ICER was expected to be > $100,000, with an NPV of $37M. The price of the call option is $17M. Alternatively, the price of pazopanib could be adjusted to $172/day in mRCC, keeping its ICER below WTP, with an agreement that if efficacious, the drug would be provided by the company gratis for STS patients. Conclusions: In a reality where high drug costs are limiting access for vulnerable patients, risk sharing agreements using financial instruments offer an opportunity to re-deploy health technology assessment to expand drug access. For a price increase of $8 per day in i1, Canadian STS patients could have had access to an effective treatment instead of nothing.


2020 ◽  
Vol 91 (8) ◽  
pp. 651-661
Author(s):  
Joshua T. Davis ◽  
Hilary A. Uyhelji

INTRODUCTION: Although the impact of microorganisms on their hosts has been investigated for decades, recent technological advances have permitted high-throughput studies of the collective microbial genomes colonizing a host or habitat, also known as the microbiome. This literature review presents an overview of microbiome research, with an emphasis on topics that have the potential for future applications to aviation safety. In humans, research is beginning to suggest relationships of the microbiome with physical disorders, including type 1 and type 2 diabetes mellitus, cardiovascular disease, and respiratory disease. The microbiome also has been associated with psychological health, including depression, anxiety, and the social complications that arise in autism spectrum disorders. Pharmaceuticals can alter microbiome diversity, and may lead to unintended consequences both short and long-term. As research strengthens understanding of the connections between the microbiota and human health, several potential applications for aerospace medicine and aviation safety emerge. For example, information derived from tests of the microbiota has potential future relevance for medical certification of pilots, accident investigation, and evaluation of fitness for duty in aerospace operations. Moreover, air travel may impact the microbiome of passengers and crew, including potential impacts on the spread of disease nationally and internationally. Construction, maintenance, and cleaning regimens that consider the potential for microbial colonization in airports and cabin environments may promote the health of travelers. Altogether, the mounting knowledge of microbiome effects on health presents several opportunities for future research into how and whether microbiome-based insights could be used to improve aviation safety.Davis JT, Uyhelji HA. Aviation and the microbiome. Aerosp Med Hum Perform. 2020; 91(8):651–661.


2020 ◽  
Vol 22 (1) ◽  
pp. 6-12
Author(s):  
Nelia Volkova ◽  
◽  
Alina Mukhina ◽  

Abstract. Introduction. The issue of financial risk management of commercial banks is quite relevant today, because the activity of banks is the most risky of all. The presence of risks in banking can lead to unexpected losses, namely the loss of own resources. That’s why for the stable operation of the bank without loss the priority is to assess the financial risks, which is the basis for their further neutralization. Purpose. The purpose of the article is to develop conceptual provisions for assessment financial risks and justifying the need to neutralize them. Results. The article analyzes the impact of risks on the financial stability of a banking institution. The main methods of bank risk assessment are considered. All these include the statistical method, the analytical method, the expert method, the analogue method and the combined method. The necessity of neutralization of financial risks in order to avoid negative consequences is substantiated. Also the methods of bank risks neutralization are considered. It should be noted that these methods of neutralization can not only be used, but also supplement the list with new methods must be done, which in the future will protect the bank from the influence of undesirable factors. A conceptual approach to the assessment and neutralization of financial risks is proposed. This conceptual approach aims to ensure effective assessment of the level of risk with their subsequent neutralization Conclusions. Use of a conceptual approach will allow an effective risk assessment and decision-making to avoid or accept risk. Thanks to using this approach, the banking institution will be able to react swiftly to the presence of financial risks and to prevent the occurrence of negative consequences, which may lead to a violation of the financial stability of the bank.


2020 ◽  
pp. 1-6
Author(s):  
Paul Park ◽  
Victor Chang ◽  
Hsueh-Han Yeh ◽  
Jason M. Schwalb ◽  
David R. Nerenz ◽  
...  

OBJECTIVEIn 2017, Michigan passed new legislation designed to reduce opioid abuse. This study evaluated the impact of these new restrictive laws on preoperative narcotic use, short-term outcomes, and readmission rates after spinal surgery.METHODSPatient data from 1 year before and 1 year after initiation of the new opioid laws (beginning July 1, 2018) were queried from the Michigan Spine Surgery Improvement Collaborative database. Before and after implementation of the major elements of the new laws, 12,325 and 11,988 patients, respectively, were treated.RESULTSPatients before and after passage of the opioid laws had generally similar demographic and surgical characteristics. Notably, after passage of the opioid laws, the number of patients taking daily narcotics preoperatively decreased from 3783 (48.7%) to 2698 (39.7%; p < 0.0001). Three months postoperatively, there were no differences in minimum clinically important difference (56.0% vs 58.0%, p = 0.1068), numeric rating scale (NRS) score of back pain (3.5 vs 3.4, p = 0.1156), NRS score of leg pain (2.7 vs 2.7, p = 0.3595), satisfaction (84.4% vs 84.7%, p = 0.6852), or 90-day readmission rate (5.8% vs 6.2%, p = 0.3202) between groups. Although there was no difference in readmission rates, pain as a reason for readmission was marginally more common (0.86% vs 1.22%, p = 0.0323).CONCLUSIONSThere was a meaningful decrease in preoperative narcotic use, but notably there was no apparent negative impact on postoperative recovery, patient satisfaction, or short-term outcomes after spinal surgery despite more restrictive opioid prescribing. Although the readmission rate did not significantly increase, pain as a reason for readmission was marginally more frequently observed.


2000 ◽  
Vol 35 (2) ◽  
pp. 169-175 ◽  
Author(s):  
Robert A. Quercia ◽  
Ronald Abrahams ◽  
C. Michael White ◽  
John D'Avella ◽  
Mary Campbell

A pharmacy-managed anemia program included distribution and clinical components, with the goal of making epoetin alpha therapy for hemodialysis patients more cost-effective. The Pharmacy Department prepared epoetin alpha doses for patients in unit-dose syringes, utilizing and documenting vial overfill. Pharmacists dosed epoetin alpha and iron (oral and intravenous) per protocol for new and established patients. Baseline data were obtained in 1994, one year prior to implementation of the program, and were re-evaluated in 1995 and 1998. Cost avoidance from utilization of epoetin alpha vial overfill in 1995 and 1998 was $83,560 and $91,148 respectively. In 1995 and 1998, cost avoidance from pharmacy management of anemia was $191,159 and $203,985 respectively. The total cost avoidance from 1995 through 1998 was estimated at $1,018,638. The number of patients with hematocrits under 31% decreased from 32% in 1994 to 21% and 14% in 1995 and 1998 respectively. We conclude that a pharmacy-managed anemia program for hemodialysis patients results in significant cost savings and better achievement of target hematocrits.


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Antonio Leon-Justel ◽  
Jose I. Morgado Garcia-Polavieja ◽  
Ana Isabel Alvarez-Rios ◽  
Francisco Jose Caro Fernandez ◽  
Pedro Agustin Pajaro Merino ◽  
...  

Abstract Background Heart failure (HF) is a major and growing medical and economic problem, with high prevalence and incidence rates worldwide. Cardiac Biomarker is emerging as a novel tool for improving management of patients with HF with a reduced left ventricular ejection fraction (HFrEF). Methods This is a before and after interventional study, that assesses the impact of a personalized follow-up procedure for HF on patient’s outcomes and care associated cost, based on a clinical model of risk stratification and personalized management according to that risk. A total of 192 patients were enrolled and studied before the intervention and again after the intervention. The primary objective was the rate of readmissions, due to a HF. Secondary outcome compared the rate of ED visits and quality of life improvement assessed by the number of patients who had reduced NYHA score. A cost-analysis was also performed on these data. Results Admission rates significantly decreased by 19.8% after the intervention (from 30.2 to 10.4), the total hospital admissions were reduced by 32 (from 78 to 46) and the total length of stay was reduced by 7 days (from 15 to 9 days). The rate of ED visits was reduced by 44% (from 64 to 20). Thirty-one percent of patients had an improved functional class score after the intervention, whereas only 7.8% got worse. The overall cost saving associated with the intervention was € 72,769 per patient (from € 201,189 to € 128,420) and €139,717.65 for the whole group over 1 year. Conclusions A personalized follow-up of HF patients led to important outcome benefits and resulted in cost savings, mainly due to the reduction of patient hospitalization readmissions and a significant reduction of care-associated costs, suggesting that greater attention should be given to this high-risk cohort to minimize the risk of hospitalization readmissions.


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