Heavy clinical and economic burden of osteoporotic fracture among elderly female Medicare beneficiaries.

We comprehensively described elderly Medicare women with an outpatient visit in 2011 and fracture within 2 years before. These women were at very high risk for subsequent fracture and high healthcare utilization and cost, especially those with vertebral or multiple fractures. However, rates of fracture prevention treatments were low. INTRODUCTION: Postmenopausal women with osteoporosis are stratified to high and very-high fracture risk categories, and this categorization drives algorithms for osteoporosis management in osteoporosis treatment guidelines. This study comprehensively describes a very-high-risk cohort. METHODS: This retrospective cohort study used the Medicare 20% database; elderly women with an outpatient visit in 2011 and fracture within 2 years before the visit were included. Outcomes included fracture risk, all-cause and fracture-related healthcare resource utilization and cost, and osteoporosis medication use in the 5 years after the visit. RESULTS: Overall, 43,193 patients were included. The 5-year probability was 0.36 for major fracture and 0.11 and 0.17 for hip fracture and vertebral fracture, respectively, much higher than the guidelines' 10-year probability thresholds for very-high-risk (0.3 for major fracture, 0.045 for hip fracture). Rates of hospitalizations, emergency department visits or observation stays, and skilled nursing facility stays in year 1 were 53.7, 57.0, and 18.8 per 100 patient-years, respectively, decreasing slightly in subsequent years. Mean healthcare cost was $23,700 in year 1, decreasing to $18,500 in year 5. About 29.1% of patients received osteoporosis medications in year 1, decreasing to 16.9% by year 5. Rates for all outcomes, especially fractures, were much higher among vertebral and multiple fracture cohorts. CONCLUSION: Elderly women with a fracture within last 2 years were at very-high-risk for subsequent fracture and high healthcare utilization and cost, especially those with vertebral or multiple fractures. However, rates of fracture prevention treatments were low. More effort is needed to identify and treat patients at very-high-risk for fracture.

Treatment patterns and long-term persistence with osteoporosis therapies in women with Medicare fee-for-service (FFS) coverage.

Osteoporosis, a chronic disease, requires long-term therapy. In Medicare-insured women, denosumab persistence was higher than oral bisphosphonate persistence over up to 3 years of follow-up. Longer-term persistence was higher among women who persisted in the first year of therapy. INTRODUCTION: Osteoporosis, a chronic, progressive disease, requires long-term therapy; this study assessed long-term persistence with anti-resorptive therapies in postmenopausal women. METHODS: This retrospective cohort study used administrative claims for women with data in the 100% Medicare osteoporosis sample who initiated (index date) denosumab, oral/intravenous (IV) bisphosphonate, or raloxifene between 2011 and 2014 and who had ≥ 1 year (zoledronic acid: 14 months) of pre-initiation medical/pharmacy coverage (baseline). Persistence was assessed from index date through end of continuous coverage, post-index evidence of censoring events (e.g., incident cancer), death, or end of study (December 31, 2015). RESULTS: The study included 318,419 oral bisphosphonate users (78% alendronate), 145,056 denosumab users, 48,066 IV bisphosphonate users, and 31,400 raloxifene users; mean age ranged from 75.5 years (raloxifene) to 78.5 years (denosumab). In women with at least 36 months of follow-up (denosumab N = 25,107; oral bisphosphonates N = 79,710), more denosumab than oral bisphosphonate initiators were persistent at 1 year (73% vs. 39%), 2 years (50% vs. 25%), and 3 years (38% vs. 17%). Persistence decreased over time for all treatment groups, with denosumab users having the highest persistence in every follow-up time interval at or after 18 months. Women using denosumab, oral bisphosphonates, or raloxifene who persisted in a given year were more likely to remain persistent through the subsequent year. CONCLUSIONS: Denosumab users persisted longer with therapy than women using other anti-resorptive medications, including oral bisphosphonates. Early persistence may predict long-term persistence. Overall persistence with osteoporosis medications is suboptimal and may impact fracture risk. Efforts to improve first year persistence are needed.

Cost effectiveness of romosozumab versus teriparatide for severe postmenopausal osteoporosis in Japan.

This study assessed the cost effectiveness of romosozumab versus teriparatide, both sequenced to alendronate, for the treatment of severe postmenopausal osteoporosis in Japan, using bone mineral density (BMD) efficacy data. Results show that romosozumab/alendronate produces greater health benefits at a lower cost than teriparatide/alendronate. INTRODUCTION: This study aims to assess the cost effectiveness of romosozumab versus teriparatide, both sequenced to alendronate, for the treatment of severe postmenopausal osteoporosis in Japanese women previously treated with bisphosphonates. METHODS: A Markov model was used to assess the relative cost effectiveness of 1 year of romosozumab versus 2 years of teriparatide, both sequenced to alendronate for a total treatment duration of 5 years. Outcomes for a cohort of women with a mean age of 78 years, a T-score ≤-2.5 and a previous fragility fracture were simulated over a lifetime horizon. The analysis was conducted from the perspective of the Japanese healthcare system and used a discount rate of 2% per annum. To inform relative fracture incidence, the bone mineral density (BMD) advantage of romosozumab over teriparatide was translated into relative risks of fracture, using relationships provided by a meta-regression of osteoporosis therapy trials. Outcomes were assessed in terms of lifetime costs (2020 US dollars) and quality-adjusted life years (QALYs). RESULTS: Base case results showed that, compared with teriparatide/alendronate, romosozumab/alendronate reduced costs by $5134 per patient and yielded 0.045 additional QALYs. Scenario analyses and probabilistic sensitivity analysis confirmed that results are robust to uncertainty in model assumptions and inputs. CONCLUSION: Results show that romosozumab/alendronate produces greater health benefits at a lower total cost than teriparatide/alendronate.

Lipid-lowering treatment patterns in patients with new cardiovascular events - estimates from population-based register data in Sweden.

OBJECTIVES: The aim of this study was to assess treatment patterns of lipid-lowering therapy (LLT) in patients with hyperlipidaemia or prior cardiovascular (CV) events who experience new CV events. METHODS: A retrospective population-based cohort study was conducted using Swedish medical records and registers. Patients were included in the study based on a prescription of LLT or CV event history and followed up for up to 7 years for identification of new CV events and assessment of LLT treatment patterns. Patients were stratified into three cohorts based on CV risk level. All outcomes were assessed during the year following index (the date of first new CV event). Adherence was defined as medication possession ratio (MPR) > 0.80. Persistence was defined as no gaps > 60 days in supply of drug used at index. RESULTS: Of patients with major cardiovascular disease (CVD) history (n = 6881), 49% were not on LLT at index. Corresponding data for CV risk equivalent and low/unknown CV risk patients were 37% (n = 3226) and 38% (n = 2497) respectively. MPR for patients on LLT at index was similar across cohorts (0.74-0.75). The proportions of adherent (60-63%) and persistent patients (56-57%) were also similar across cohorts. Dose escalation from dose at index was seen within all cohorts and 2-3% of patients switched to a different LLT after index while 5-6% of patients augmented treatment by adding another LLT. CONCLUSIONS: Almost 50% of patients with major CVD history were not on any LLT, indicating a potential therapeutic gap. Medication adherence and persistence among patients on LLT were suboptimal.

Work productivity loss and indirect costs associated with new cardiovascular events in high-risk patients with hyperlipidemia: estimates from population-based register data in Sweden.

OBJECTIVES: To estimate productivity loss and associated indirect costs in high-risk patients treated for hyperlipidemia who experience cardiovascular (CV) events. METHODS: Retrospective population-based cohort study conducted using Swedish medical records linked to national registers. Patients were included based on prescriptions of lipid-lowering therapy between 1 January 2006 and 31 December 2011 and followed until 31 December 2012 for identification of CV events and estimation of work productivity loss (sick leave and disability pension) and indirect costs. Patients were stratified into two cohorts based on CV risk level: history of major cardiovascular disease (CVD) and coronary heart disease (CHD) risk equivalent. Propensity score matching was applied to compare patients with new events (cases) to patients without new events (controls). The incremental effect of CV events was estimated using a difference-in-differences design, comparing productivity loss among cases and controls during the year before and the year after the cases' event. RESULTS: The incremental effect on indirect costs was largest in the CHD risk equivalent cohort (n = 2946) at €3119 (P value <0.01). The corresponding figure in the major CVD history cohort (n = 4508) was €2210 (P value <0.01). There was substantial variation in productivity loss depending on the type of event. Transient ischemic attack and revascularization had no significant effect on indirect costs. Myocardial infarction (€3465), unstable angina (€2733) and, most notably, ischemic stroke (€6784) yielded substantial incremental cost estimates (P values <0.01). CONCLUSIONS: Indirect costs related to work productivity losses of CV events are substantial in Swedish high-risk patients treated for hyperlipidemia and vary considerably by type of event.

Healthcare costs associated with cardiovascular events in patients with hyperlipidemia or prior cardiovascular events: estimates from Swedish population-based register data.

OBJECTIVES: To estimate healthcare costs of new cardiovascular (CV) events (myocardial infarction, unstable angina, revascularization, ischemic stroke, transient ischemic attack, heart failure) in patients with hyperlipidemia or prior CV events. METHODS: A retrospective population-based cohort study was conducted using Swedish national registers and electronic medical records. Patients with hyperlipidemia or prior CV events were stratified into three cohorts based on CV risk level: history of major cardiovascular disease (CVD), coronary heart disease (CHD) risk-equivalent, and low/unknown risk. Propensity score matching was applied to compare patients with new events to patients without new events for estimation of incremental costs of any event and by event type. RESULTS: A CV event resulted in increased costs over 3 years of follow-up, with the majority of costs occurring in the 1st year following the event. The mean incremental cost of patients with a history of major CVD (n = 6881) was €8588 during the 1st year following the event. This was similar to that of CHD risk-equivalent patients (n = 3226; €6663) and patients at low/unknown risk (n = 2497; €8346). Ischemic stroke resulted in the highest 1st-year cost for patients with a history of major CVD and CHD risk-equivalent patients (€10,194 and €9823, respectively); transient ischemic attack in the lowest (€3917 and €4140). Incremental costs remained elevated in all cohorts during all three follow-up years, with costs being highest in the major CVD history cohort. CONCLUSIONS: Healthcare costs of CV events are substantial and vary considerably by event type. Incremental costs remain elevated for several years after an event.

Impact on health-related quality of life in kidney transplant recipients with late posttransplant anemia administered darbepoetin alfa: results from the STRATA study.

Posttransplant anemia (PTA) is a common, multifactorial condition that has a substantial negative impact on patients' health-related quality of life (HRQOL). Erythropoietin-stimulating agents are an effective treatment for PTA, but there is little research on HRQOL in posttransplant patients. This multicenter, prospective study enrolled adults with PTA (hemoglobin [Hb] < 11.0 g/dL). Subjects (n = 66) received subcutaneous darbepoetin alfa every 2 weeks for 24 weeks. Hb and patient-reported outcomes using the Short Form (SF)-36 questionnaire were assessed. Mean (standard deviation) Hb concentration increased from 9.9 (1.2) g/dL at baseline to 11.7 (1.3) g/dL during the evaluation period (14 to 24 weeks). At baseline, SF-36 scores in all the eight domains were lower (worse) compared with the general population and patients with other chronic conditions. In subjects with baseline Hb < 10 g/dL, SF-36 subscales and component summary scores were lower than in subjects with Hb ≥ 10 g/dL. Following treatment with darbepoetin alfa, statistically significant improvements were observed for all subjects in physical component summary (0.5 points, P < .001), physical functioning (11.8 points, P = .001), limitations due to physical health (26.5 points, P < .001), bodily pain (7.7 points, P = .01), limitations due to emotional health (15.7 points, P = .01), and vitality (12.8 points, P < .001) from baseline to week 24. Clinically significant improvements (>5 points) were observed in six subscales: physical functioning, limitations due to physical health, limitations due to emotional health, bodily pain, social functioning, and vitality. Darbepoetin alfa in kidney transplant recipients with PTA significantly increased Hb concentrations and improved HRQOL scores.