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Author(s): Fonarow, Gregg C; Kosiborod, Mikhail N; Rane, Pallavi B; Nunna, Sasikiran; Villa, Guillermo; Habib, Mohdhar; Arellano, Jorge; Mues, Katherine E; Sun, Kainan; Wade, Rolin L | Abstract: BackgroundThe risk for subsequent major cardiovascular (CV) events among patients with very high-risk (VHR) atherosclerotic CV disease (ASCVD) remains to be fully elucidated.HypothesisWe assessed the characteristics and major CV event rates of patients with VHR versus non-VHR ASCVD in a real-world setting in the United States (US), hypothesizing that patients with VHR ASCVD would have higher CV event rates.MethodsThis was a retrospective cohort study conducted from January 01, 2011, to June 30, 2018, in the US using the Prognos LDL-C database linked to the IQVIA PharMetrics Plus® database supplemented with the IQVIA prescription claims (Dx/LRx) databases. Patients were ≥18 years old and had ≥2 non-ancillary medical claims in the linked databases at least 30 days apart. The study was conducted in 2 stages: (1) identification of patients with ASCVD who met the definition of VHR ASCVD and a matched cohort of non-VHR ASCVD patients using the incidence density sampling (IDS) approach; (2) estimation of the occurrence of major CV events.ResultsAmong patients with ≥1 major ASCVD event (N=147,679), most qualified as VHR ASCVD (79.5%). There were 115,460 patients each in IDS-matched VHR and non-VHR ASCVD cohorts. The composite myocardial infarction/ischemic stroke event rates in the VHR and non-VHR ASCVD cohorts were 8.04 (95% confidence interval [95% CI]: 7.87-8.22) and 0.82 (95% CI: 0.77-0.88) events per 100 patient-years, respectively, during the 1-year post-index period.ConclusionsMost patients with ≥1 previous major ASCVD event treated in real-world US clinical practice qualified as VHR ASCVD. Patients with VHR ASCVD had much higher rates of major CV events versus non-VHR ASCVD patients.

Objective: Osteoporosis is under-diagnosed and under-treated worldwide. Information on the burden of osteoporosis in Latin American countries is limited. This study aimed to estimate the economic burden of osteoporosis in adults aged 50–89 years in Brazil, Mexico, Colombia, and Argentina. Methods: Analyses were conducted using a burden of illness model. Where possible, country-specific model inputs were informed by a systematic review and expert opinion. Osteoporosis-related fracture costs were calculated for hospitalizations, testing, surgeries, prescription drugs, and patient productivity losses. Costs were expressed in 2018 USD for the annual burden, annual burden per 1,000 at risk, and projected 5-year burden. No discounting was applied. Results: Over 840,000 osteoporosis-related fractures were predicted to occur in 2018, amounting to a total annual cost of ∼1.17 billion USD. The total projected 5-year cost was ∼6.25 billion USD. Annual costs were highest in Mexico (411 million USD), followed by Argentina (360 million USD), Brazil (310 million USD), and Colombia (94 million USD). The average burden per 1,000 at risk was greatest in Argentina (32,583 USD), followed by Mexico (16,671 USD), Colombia (8,240 USD), and Brazil (6,130 USD). Conclusions: Over the next 5 years, ∼4,485,352 fractures are anticipated to occur in Brazil, Mexico, Colombia, and Argentina. To control and prevent these fractures, stakeholders must work together to close the care gap. Efforts to identify individuals at high fracture risk, initiate treatment, and improve long-term treatment persistence will be essential in minimizing the financial and patient burden of osteoporosis in Latin America.

Background Low‐density lipoprotein cholesterol (LDL‐C) is a risk factor for atherosclerotic cardiovascular disease (ASCVD). There are limited real‐world data on LDL‐C lowering with evolocumab in United States clinical practice. Hypothesis We assessed LDL‐C lowering during 1 year of evolocumab therapy. Methods This retrospective cohort study used linked laboratory (Prognos) and medical claims (IQVIA Dx/LRx and PharMetrics Plus®) data. Patients with a first fill for evolocumab between 7/1/2015 and 10/31/2019 (index event) and LDL‐C ≥ 70 mg/dL were included (overall cohort; N = 5897). Additionally, a patient subgroup with a recent myocardial infarction (MI) within 12 months (median 130 days) before the first evolocumab fill was identified (N = 152). Reduction from baseline LDL‐C was calculated based on the lowest LDL‐C value recorded during a 12‐month follow‐up period. Results The mean (SD) age was 65 (10) years; 61.9% of patients had ASCVD diagnoses and 70.7% of patients were in receipt of lipid‐lowering therapy. Following evolocumab treatment, changes in LDL‐C from baseline were −60% in the overall cohort (median [interquartile range (IQR)] 146 [115–180] mg/dL to 58 [36–84] mg/dL) and −65% in the recent MI subgroup (median [IQR] 137 [109–165] mg/dL to 48 [30–78] mg/dL). In the overall cohort and recent MI subgroup, 62.1% and 69.7% of patients achieved LDL‐C

Objective We assessed national- and state-level geographic variations among patients with a history of ≥1 major atherosclerotic cardiovascular disease (ASCVD) event in: (1) the proportion of patients with retrospectively identified 2018 American College of Cardiology/American Heart Association guideline very high-risk (VHR) ASCVD criteria; (2) utilization of guideline-directed lipid-lowering therapy (LLT); and (3) the proportion of patients with persistent low-density lipoprotein cholesterol (LDL-C) elevations despite statin and/or ezetimibe use. Methods A retrospective cohort study using the Prognos LDL-C database linked to IQVIA longitudinal medical and prescription claims databases. The study period was from January 01, 2011, to November 30, 2019 and the index period was from January 01, 2016, to November 30, 2019; the index date was defined as the most recent LDL-C test during the index period. The study included patients aged ≥18 years at index who had a measured LDL-C level during the index period and had ≥1 inpatient/outpatient claim for ASCVD during the 5-year pre-index period. Results Of patients with any ASCVD (N=4652,468), 1537,514 (33.1%) patients had ≥1 major ASCVD event. Among patients with ≥1 major ASCVD event, the VHR ASCVD criteria were retrospectively identified in 1139,018 (74.1%) patients; Hawaii had the highest (81.7%) and Colorado the lowest (65.0%) proportion of these patients. Nationally, 48.8% and 50.2% of patients with ≥1 major ASCVD event and retrospectively identified VHR ASCVD criteria, respectively, had current LLT use; Massachusetts and Colorado had the highest and lowest proportions, respectively. After standardizing for age and sex, 57.3% and 58.8% of patients with ≥1 major ASCVD event and retrospectively identified VHR ASCVD criteria, respectively, had LDL-C ≥70 mg/dL (≥1.8 mmol/L) despite statin and/or ezetimibe use, with substantial state-level variations observed. Conclusions The study highlights high rates of elevated LDL-C and pervasive underuse of LLT in health-insured patients with a history of major ASCVD events treated in the United States, with state-level geographic variations observed.

Objective Our study aimed to estimate the impact of addressing modifiable risk factors on the future burden of cardiovascular diseases (CVD) in the general population and in two high-risk populations (heterozygous familial hypercholesterolemia and secondary prevention) for Turkey. Methods One model investigated the impact of reaching the World Health Organization (WHO) voluntary targets for tobacco use, hypertension, type 2 diabetes, obesity and physical inactivity in the general population. Another model estimated the impact of reducing LDL-cholesterol in two high-risk populations through increased access to effective treatment. Inputs for the models include disease and risk factor prevalence rates, a population forecast, baseline CVD event rates, and treatment effectiveness, primarily derived from the published literature. Direct costs to the public health care system and indirect costs from lost production are included, although the cost of programs and pharmacological interventions to reduce risk factors were not considered. Results The value of reaching WHO risk factor reduction targets is estimated at US$9.3 billion over the next 20 years, while the value of reducing LDL-cholesterol is estimated at up to US$8.1 billion for high-risk secondary prevention patients and US$691 million for heterozygous familial hypercholesterolemia patients. Conclusion Efforts to achieve WHO risk factor targets and further lower LDL-cholesterol through increased access to treatment for high-risk patients are projected to greatly reduce the growing clinical and economic burden of CVD in Turkey.

The state of osteoporosis care in Latin America is not well known. The results of our scorecard indicate an urgent need to improve policy frameworks, service provision, and service uptake for osteoporosis in Brazil, Mexico, Colombia, and Argentina. The scorecard serves as an important marker to measure future progress. We developed a scorecard to summarize key indicators of the burden of osteoporosis and its management in Brazil, Mexico, Colombia, and Argentina. The goal of the scorecard is to reduce the risk of osteoporotic fractures by promoting healthcare policies that will improve patient access to timely diagnosis and treatment. We conducted a systematic review of osteoporosis. We also interviewed several key opinion leaders to gather information on government policy, access to fracture risk assessments, and access to medications. We then leveraged a peer-reviewed template, initially applied to 27 European countries, to synthesize the information into a scorecard for Latin America. We presented information according to four main categories: burden of disease, policy framework, service provision, and service uptake and used a traffic light color coding system to indicate high, intermediate, and low risk. The systematic review included 108 references, of which 49 were specific to Brazil. The number of osteoporotic fractures in Brazil, Mexico, Colombia, and Argentina was forecasted to increase substantially (34% to 76% in each country) from 2015 to 2030. In general, policy frameworks, service provision, and service uptake were not structured to support current patients with osteoporosis and did not account for the future increases in fracture burden. Across all four countries, there was inadequate access to programs for secondary fracture prevention and only a small minority of patients received treatment for osteoporosis. Osteoporosis management, including the rate of post-fracture care, is very poor in Brazil, Mexico, Colombia, and Argentina and needs to be strengthened. Improvements in the rates of care are necessary to curb the debilitating impact of osteoporotic fractures on patients and health systems.

Physician prescription patterns for lipid lowering therapy, particularly high-intensity statins (HIS), and risk of cardiovascular events (CVE) is not well documented in the real-world clinical setting among patients hospitalized with acute myocardial infarction (AMI). We aim to examine the

We describe patient characteristics, lipid lowering therapy (LLT) use, and risks of subsequent cardiovascular events (CVE) in the 12-months following a coronary revascularization (CR). We identified patients undergoing CR between 01/2014-05/2019 (index period) in the linked IQVIA PharMetrics+/

Lipid lowering therapy, particularly use of high-intensity statins (HIS) is vital for secondary prevention of cardiovascular events, after acute myocardial infarction (AMI). However, physician prescription patterns for HIS are not well documented in the real-world setting in post-AMI patients. We

Proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) antibodies significantly reduce low-density lipoprotein cholesterol (LDL-C) in patients uncontrolled with statins and/or ezetimibe. Here we characterize the baseline cardiovascular risk profile in a subset of patients with recent

Introduction This study aims to estimate the current and future burden of cardiovascular diseases (CVD) in Saudi Arabia, and quantify the impact of reducing modifiable risk factors. Methodology A burden of disease model was used to forecast the burden of CVD in Saudi Arabia, and estimate the impact of reducing modifiable risk factors (tobacco use, hypertension, type 2 diabetes, obesity and physical inactivity) in the Saudi Nationals population, in accordance with World Health Organization (WHO) targets. Another model estimated the impact of reducing LDL-cholesterol through increased access to effective treatment for two high risk populations: heterozygous familial hypercholesterolemia (HeFH) and secondary prevention (SP), with a focus on patients with LDL-cholesterol >100 mg/dL. Inputs for the models included disease and risk factor prevalence, population forecast, CVD event rates, and treatment effectiveness, primarily derived from published literature. Direct costs to the public health care system and indirect costs from lost productivity due to premature mortality, hospitalizations, and early retirement were included, although the cost of programs and pharmacological interventions to reduce risk factors was not considered. Results The prevalence of CVD is projected to increase to 479,500 Nationals by 2035, while the economic burden, including both direct and indirect costs, would increase threefold to US$9.8 billion. The value of reducing modifiable risk factors (except LDL-cholesterol) is estimated at US$3.7 billion over the forecast period. Reducing the prevalence of uncontrolled LDL-cholesterol through increased access to evolocumab could lead to savings of up to US$532 million for HeFH patients and up to US$9 billion for high-risk SP patients over the forecast period. Conclusion The burden of CVD is significant and growing. Efforts to achieve WHO risk factor targets and further lower LDL-cholesterol through increased access to effective treatment for high-risk patients are projected to greatly reduce the clinical, economic, and humanistic burden of cardiovascular disease in Saudi Arabia.

Objective This study aims to estimate the current and future burden of cardiovascular diseases (CVD) in Turkey. Methods A burden-of-disease model was developed that included inputs on population growth, prevalence, and incidence of ischemic disease (IHD) and cerebrovascular disease (CeVD), prevalence of modifiable risk factors, mortality rates, and relationship between risk factors and IHD/CeVD. Direct costs to the public health-care system and indirect costs from lost production due to premature mortality, hospitalizations, disability, and absenteeism were considered. Results We estimated that in 2016, 3.4 million Turkish adults were living with CVD, including 2.5 million affected by IHD, and 0.9 million by CeVD. This prevalence is projected to increase to 5.4 million by 2035. The economic burden of CVD was estimated at US$10.2 billion in 2016, projected to increase twofold to US$19.4 billion by 2035. Conclusion Our study confirms that the current burden of CVD is significant, and that it is projected to increase at a steep rate over the next two decades. This growing burden of disease will likely create significant pressure on the public health-care system in the form of direct health-care costs, as well as on society in the form of lost productivity.

Introduction: Metastasis of prostate cancer (PC) to bone (metastatic bone disease, MBD) increases morbidity, but Canadian data are lacking on the associated healthcare resource utilization (HCRU) and costs. We quantified MBD-related HCRU and associated costs in this population, and assessed skeletal-related events (SREs), such as pathologic fracture, spinal cord compression, bone radiotherapy, and bone surgery. Methods: We conducted a retrospective, population-based cohort study using the Quebec health insurance agency database. Prescription drug and medical services data were retrieved for patients with ≥1 healthcare claim in 2001 with a PC diagnosis (International Classification of Diseases, 9th Revision, Clinical Modification [ICD-9-CM] code of 185.xx). Patients with ≥2 MBDrelated claims or an SRE were compared with a matched-control group of PC patients without MBD. Patients were followed until death, loss to follow-up, or the end of available data (August 31, 2010). Costs (in 2012 Canadian dollars) were adjusted for age, year of MBD diagnosis, general health status, and baseline resource utilization. Results: Compared with controls (n = 1671), MBD patients (n = 626) had significantly higher HCRU. Adjusted mean (95% confidence interval) all-cause healthcare costs were $11 820 (7248–16 058) higher, and MBD-related costs were $3 091 (1267–4861) higher in MBD patients than in controls. Nearly 50% of MBD patients received radiotherapy within 2.5 years of their MBD diagnosis, but most exited the study without experiencing other SREs. Conclusion: MBD imposes a heavy HCRU and cost burden among patients with PC in Canada. Effective therapy is needed to reduce the clinical and economic impact of MBD in this population.

To estimate, using a time and motion method, the time and labor costs associated with the administration of zoledronic acid and pamidronate in cancer patients with metastatic bone diseases.During clinic visits for participating patients receiving intravenous zoledronic acid or pamidronate, all times and activities associated with the administration of bisphosphonates were recorded by a trained observer using a stopwatch and data recording forms. The total time associated with the administration of bisphosphonates was estimated and converted to labor costs by applying corresponding health care professional hourly wage rates plus the fringe-benefit rate. The costs were presented in 2011 Canadian dollars.A convenience sample of 37 patients from 2 hospital outpatient oncology clinics in Ontario and Quebec participated in the study. Nineteen patients were diagnosed with breast cancer and 18 with prostate cancer. The average patient age was 66 years, and patients had been diagnosed with cancer and metastatic bone disease for 8 years and 3 years, respectively. The times and costs associated with the administration of bisphosphonates for the 28 patients who did not receive concurrent chemotherapy during the scheduled clinic visits are also reported. The mean infusion time for patients receiving zoledronic acid was 20.6 minutes. With the use of ambulatory infusion devices, the mean infusion time of pamidronate was 23 minutes (limited to observations of patients who were seated during administration). In contrast, the mean infusion time using regular infusion devices was 162 minutes. The mean labor cost for administering zoledronic acid was $20. The mean labor cost for administering pamidronate was $10 using ambulatory infusion devices and $68 using regular infusion devices.The time burden to cancer patients with metastatic bone disease who receive intravenous bisphosphonates and the costs to the health care system are substantial, especially when regular infusion devices are used.

We describe the types of major institution health care resources consumed as a result of skeletal-related events (SREs) [ie, pathological fracture, bone surgery, radiation to bone, spinal cord compression].A retrospective multicenter chart review of cancer patients with bone metastases who experienced SREs was conducted. Patients with multiple SREs occurring during the same hospitalization within 21 days of each other were grouped into SRE clusters.We reviewed 156 patient charts from 4 Canadian institutions, accounting for 358 SREs and 259 SRE clusters. Of the total patients, 63% experienced 1 SRE; 19%, 2 SREs; 10%, 3 SREs; and 8%, ≥ 4 events. Health care resource utilization was captured for ≥ 90 days following each SRE: 54% of all SRE events resulted in an inpatient stay; 34% in an emergency visit; 85% of SREs required the use of diagnostic procedures (including radiography, magnetic resonance imaging, Computerized Axial Tomography scans, and radio scans); 57% required radiation treatment; 34% required a surgical procedure; 35% received outpatient treatment visits (ie, physiotherapy or occupational therapy). Bone surgery and spinal cord compression were more often associated with hospitalization than were other SRE types. Spinal cord compression was associated with the greatest number of inpatients stays (1.09 per SRE), longest duration of hospital stay (mean 26.18 days per SRE), and more outpatient visits, relative to other SRE types.Results of our Canadian retrospective study clearly demonstrate that SREs occur in cancer patients and each SRE is associated with considerable institutional consumption of health care resources.

Background: Skeletal-related events (SREs) occur in 80% of patients with advanced breast cancer (BC) and bone metastases. SREs are costly and can be painful and debilitating, impacting patients’ quality of life and morbidity. While intravenous bisphosphonates such as pamidronate (PAM) and zoledronic acid (ZA) have demonstrated clinical benefit in reducing SREs, skeletal metastases remain a problem as treatments that are more efficacious, well tolerated, more convenient and less costly to administer are needed. Denosumab (XGEVA™) is a novel subcutaneous human monoclonal antibody therapy that significantly reduces the risk of developing SREs in patients with bone metastases from BC. Objective: The objective of this project is to estimate the incremental cost-effectiveness of denosumab relative to ZA and PAM in the treatment of advanced BC patients with bone metastases. Methods: A lifetime Markov model with four-week cycle lengths was developed with three health states: on treatment; off treatment; and death. The model included the risk of an SRE for patients on and off treatment and adverse events during treatment. Efficacy was measured as reduction in SREs. Head-to-head efficacy data, transition probabilities, and risk of adverse events were obtained from the clinical trial of denosumab versus ZA. (Stopeck AT et al JCO 2010) Efficacy data compared to PAM was determined from a published network meta-analysis. (Ford JA et al Eur J Cancer 2012) The baseline SRE risk was derived from clinical trial data due to the absence of real-world Canadian data. Analyses were conducted from the Canadian healthcare system perspective and reported in 2011 $CAD. Resource use was determined from a Canadian retrospective chart review of oncology patients with SREs. Costs were based on the published literature, the Ontario Case Costing Initiative, and input from a physician panel. Utility inputs were based on a time trade-off study. (Matza LS et al. Eur J Health Econ 2013) Bisphosphonate administration costs were derived from a published time and motion study. (Dranitsaris G et al. J Oncol Pharm Pract 2001) Outcomes were measured as both SREs avoided and quality-adjusted life years (QALYs) gained. Dominance was assessed or incremental cost-effectiveness ratios calculated per SRE avoided and per QALY gained, for denosumab compared to ZA and PAM. Future costs and QALYs were discounted at 5% per annum. Sensitivity analyses were conducted to test the robustness of the results. Results: Denosumab was dominant and resulted in $5,733 in cost savings compared to ZA and $2,566 in cost savings compared to PAM based on a probabilistic analysis. Cost savings was driven by differences in drug administration costs and reduction in SREs. SREs avoided were 0.27 and 0.57 compared to ZA and PAM respectively. Denosumab resulted in 0.012 QALYs gained and 0.025 QALYs gained per patient compared to ZA and PAM, respectively. Sensitivity analyses showed the results were robust but most sensitive to drug administration costs and the relative risk of SREs. Conclusion: Compared to both ZA and PAM, denosumab is more efficacious and offers better value for money (i.e. dominant) in Canada for managing SREs in patients with advanced BC and bone metastases. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P6-07-02.