Real-world bone turnover marker use: impact on treatment decisions and fracture.

The use of bone turnover marker (BTM) testing for patients with osteoporosis in the USA has not been well characterized. This retrospective US-based real-world data study found BTM testing has some association with treatment decision-making and lower fracture risk in patients with presumed osteoporosis, supporting its use in clinical practice. INTRODUCTION: The purpose of this study was to characterize bone turnover marker (BTM) testing patterns and estimate their clinical utility in treatment decision-making and fragility fracture risk in patients with osteoporosis using a retrospective claims database. METHODS: Data from patients aged ≥ 50 years with newly diagnosed osteoporosis enrolled in the Truven MarketScan® Commercial Claims and Encounters and Medicare Supplemental and Co-ordination of Benefits databases from January 2008 to June 2018 were included. Osteoporosis was ascertained by explicit claims, fragility fracture events associated with osteoporosis, or prescribed anti-resorptive or anabolic therapy. BTM-tested patients were 1:1 propensity score matched to those untested following diagnosis. Generalized estimating equation models were performed to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for testing versus no testing on both treatment decision-making and fragility fracture. RESULTS: Of the 457,829 patients with osteoporosis, 6075 were identified with ≥ 1 BTM test following diagnosis; of these patients, 1345 had a unique treatment decision made ≤ 30 days from BTM testing. The percentage of patients receiving BTM tests increased significantly each year (average annual % change: + 8.1%; 95% CI: 5.6-9.0; p = 0.01). Patients tested were significantly more likely to have a treatment decision (OR: 1.14; 95% CI: 1.13-1.15), and testing was associated with lower odds of fracture versus those untested (OR: 0.87; 95% CI: 0.85-0.88). CONCLUSION: In this large, heterogeneous population of patients with presumed osteoporosis, BTM testing was associated with treatment decision-making, likely leading to fragility fracture reduction following use.

Recommendations for the conduct of economic evaluations in osteoporosis: outcomes of an experts' consensus meeting organized by the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) and the US branch of the International Osteoporosis Foundation.

Economic evaluations are increasingly used to assess the value of health interventions, but variable quality and heterogeneity limit the use of these evaluations by decision-makers. These recommendations provide guidance for the design, conduct, and reporting of economic evaluations in osteoporosis to improve their transparency, comparability, and methodologic standards. INTRODUCTION: This paper aims to provide recommendations for the conduct of economic evaluations in osteoporosis in order to improve their transparency, comparability, and methodologic standards. METHODS: A working group was convened by the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis to make recommendations for the design, conduct, and reporting of economic evaluations in osteoporosis, to define an osteoporosis-specific reference case to serve a minimum standard for all economic analyses in osteoporosis, to discuss methodologic challenges and initiate a call for research. A literature review, a face-to-face meeting in New York City (including 11 experts), and a review/approval by a larger group of experts worldwide (including 23 experts in total) were conducted. RESULTS: Recommendations on the type of economic evaluation, methods for economic evaluation, modeling aspects, base-case analysis and population, excess mortality, fracture costs and disutility, treatment characteristics, and model validation were provided. Recommendations for reporting economic evaluations in osteoporosis were also made and an osteoporosis-specific checklist was designed that includes items to report when performing an economic evaluation in osteoporosis. Further, 12 minimum criteria for economic evaluations in osteoporosis were identified and 12 methodologic challenges and need for further research were discussed. CONCLUSION: While the working group acknowledges challenges and the need for further research, these recommendations are intended to supplement general and national guidelines for economic evaluations, improve transparency, quality, and comparability of economic evaluations in osteoporosis, and maintain methodologic standards to increase their use by decision-makers.

Hip fracture trends in the United States, 2002 to 2015.

An analysis of United States (US) Medicare claims data from 2002 to 2015 for women aged ≥ 65 years found that age-adjusted hip fracture rates for 2013, 2014, and 2015 were higher than projected, resulting in an estimated increase of more than 11,000 hip fractures. INTRODUCTION: Hip fractures are a major public health concern due to high morbidity, mortality, and healthcare expenses. Previous studies have reported a decrease in the annual incidence of hip fractures in the US beginning in 1995, coincident with the introduction of modern diagnostic tools and therapeutic agents for osteoporosis. In recent years, there has been less bone density testing and fewer prescriptions for osteoporosis treatments. The large osteoporosis treatment gap raises concern of possible adverse effects on hip fracture rates. METHODS: We assessed hip fracture incidence in the US to determine if the previous decline in hip fracture incidence continued. Using 2002 to 2015 Medicare Part A and Part B claims for women ≥ 65 years old, we calculated age-adjusted hip fracture rates, weighting to the 2014 population. RESULTS: We found that hip fracture rates declined each year from 2002 to 2012 and then plateaued at levels higher than projected for years 2013, 2014, and 2015. CONCLUSIONS: The plateau in age-adjusted hip fracture incidence rate resulted in more than 11,000 additional estimated hip fractures over the time periods 2013, 2014, and 2015. We recommend further study to assess all factors contributing to this remarkable change in hip fracture rate and to develop strategies to reduce the osteoporosis treatment gap.

The cost of a patient activation intervention for achieving successful outcomes: results from the PAADRN randomized controlled trial.

In a large, pragmatic clinical trial, we calculated the costs of achieving four successful patient-centered outcomes using a tailored patient activation DXA result letter accompanied by a bone health brochure. The cost to achieve one successful outcome (e.g., a 0.5 standard deviation improvement in care satisfaction) ranged from $127.41 to $222.75. INTRODUCTION: Pragmatic randomized controlled trials (RCTs) should focus on patient-centered outcomes and report the costs for achieving those outcomes. We calculated per person incremental intervention costs, the number-needed-to-treat (NNT), and incremental per patient costs (cost per NNT) for four patient-centered outcomes in a direct-to-patient bone healthcare intervention. METHODS: The Patient Activation after DXA Result Notification (PAADRN) pragmatic RCT enrolled 7749 patients presenting for DXA at three health centers between February 2012 and August 2014. Interviews occurred at baseline and 52 weeks post-DXA. Intervention subjects received an individually tailored DXA result letter accompanied by an educational bone health brochure 4 weeks post-DXA, while the usual care subjects did not. Outcomes focused on patients (a) correctly identifying their results, (b) contacting their providers, (c) discussing their results with their providers, and (d) satisfaction with their bone healthcare. NNTs were determined using intention-to-treat linear probability models, per person incremental intervention costs were calculated, and costs per NNT were computed. RESULTS: Mean age was 66.6 years old, 83.8% were women, and 75.3% were non-Hispanic whites. The incremental per patient cost (costs per NNT) to increase the ability of a patient to (a) correctly identify their DXA result was $171.07; (b) contact their provider about their DXA result was $222.75; (c) discuss their DXA result with their provider was $193.55; and (d) achieve a 0.5 SD improvement in satisfaction with their bone healthcare was $127.41. CONCLUSION: An individually tailored DXA result letter accompanied by an educational brochure can improve four patient-centered outcomes at a modest cost. TRIAL REGISTRATION: clinicaltrials.gov identifier NCT01507662.

Association between osteoporosis treatment change and adherence, incident fracture, and total healthcare costs in a Medicare Advantage Prescription Drug plan.

UNLABELLED: We examined the association between osteoporosis treatment change and adherence, incident fractures, and healthcare costs among Medicare Advantage Prescription Drug (MAPD) plan members. Treatment change was associated with a small but significant increase in adherence, but was not associated with incident fracture or total healthcare costs. Overall adherence remained low. INTRODUCTION: We examined the association between osteoporosis treatment change and adherence, incident fractures, and healthcare costs among MAPD plan members in a large US health plan. METHODS: We conducted a retrospective cohort study of MAPD plan members aged≥50 years newly initiated on an osteoporosis medication between 1 January 2006 and 31 December 2008. Members were identified as having or not having an osteoporosis treatment change within 12 months after initiating osteoporosis medication. Logistic regression analyses and difference-in-difference (DID) generalized linear models were used to investigate the association between osteoporosis treatment change and (1) adherence to treatment, (2) incident fracture, and (3) healthcare costs at 12 and 24 months follow-up. RESULTS: Of the 33,823 members newly initiated on osteoporosis treatment, 3,573 (10.6%) changed osteoporosis treatment within 12 months. After controlling for covariates, osteoporosis treatment change was associated with significantly higher odds of being adherent (medication possession ratio [MPR]≥0.8) at 12 months (odds ratio [OR]=1.18) and 24 months (OR=1.13) follow-up. However, overall adherence remained low (MPR=0.59 and 0.51 for the change cohort and MPR=0.51 and 0.44 for the no-change cohort at 12 and 24 months, respectively). Osteoporosis treatment change was not significantly associated with incident fracture (OR=1.00 at 12 months and OR=0.98 at 24 months) or total direct healthcare costs (p>0.4) in the DID analysis, but was associated with higher pharmacy costs (p<0.004). CONCLUSIONS: Osteoporosis treatment change was associated with a small but significant increase in adherence, but was not associated with incident fracture or total healthcare costs in the MAPD plan population. Overall adherence to therapy remained low.

Clinical and demographic factors associated with fractures among older Americans.

UNLABELLED: Medicare claims data were used to investigate associations between history of previous fractures, chronic conditions, and demographic characteristics and occurrence of fractures at six anatomic sites. The study confirmed previously established associations for hip and spine fractures and identified several new associations of interest for nonhip, nonspine fractures. INTRODUCTION: This study investigates the associations of a history of fracture, comorbid chronic conditions, and demographic characteristics with incident fractures among Medicare beneficiaries. The majority of fracture incidence studies have focused on the hip and on white females. This study examines a greater variety of fracture sites and more population subgroups than prior studies. METHODS: We used Medicare claims data to examine the incidence of fracture at six anatomic sites in a random 5% sample of Medicare beneficiaries during the time period 2000 through 2005. RESULTS: For each type of incident fracture, women had a higher rate than men, and there was a positive association with age and an inverse association with income. Whites had a higher rate than nonwhites. Rates were lowest among African-Americans for all sites except ankle and tibia/fibula, which were lowest among Asian-Americans. Rates of hip and spine fracture were highest in the South, and fractures of other sites were highest in the Northeast. Fall-related conditions and depressive illnesses were associated with each type of incident fracture, conditions treated with glucocorticoids with hip and spine fractures and diabetes with ankle and humerus fractures. Histories of hip and spine fractures were associated positively with each site of incident fracture except ankle; histories of nonhip, nonspine fractures were associated with most types of incident fracture. CONCLUSIONS: This study confirmed previously established associations for hip and spine fractures and identified several new associations of interest for nonhip, nonspine fractures.

Cost-effectiveness of multifaceted evidence implementation programs for the prevention of glucocorticoid-induced osteoporosis.

SUMMARY: Using a computer simulation model, we determined that an intervention aimed at improving the management of glucocorticoid-induced osteoporosis is likely to be cost-effective to third-party health insurers only if it focuses on individuals with very high fracture risk and the proportion of prescriptions for generic bisphosphonates increases substantially. INTRODUCTION: The purpose of this study is to determine whether an evidence implementation program (intervention) focused on increasing appropriate management of glucocorticoid-induced osteoporosis (GIOP) might be cost-effective compared with current practice (no intervention) from the perspective of a third-party health insurer. METHODS: We developed a Markov microsimulation model to determine the cost-effectiveness of the intervention. The hypothetical patient cohort was of current chronic glucocorticoid users 50-65 years old and 70% female. Model parameters were derived from published literature, and sensitivity analyses were performed. RESULTS: The intervention resulted in incremental cost-effectiveness ratios (ICERs) of $298,000 per quality adjusted life year (QALY) and $206,000 per hip fracture averted. If the cohort's baseline risk of fracture was increased by 50% (10-year cumulative incidence of hip fracture of 14%), the ICERs improved significantly: $105,000 per QALY and $137,000 per hip fracture averted. The ICERs improved significantly if the proportion of prescriptions for generic bisphosphonates was increased to 75%, with $113,000 per QALY and $77,900 per hip fracture averted. CONCLUSIONS: Evidence implementation programs for the management of GIOP are likely to be cost-effective to third-party health insurers only if they are targeted at individuals with a very high risk of fracture and the proportion of prescriptions for less expensive generic bisphosphonates increases substantially.

"Pathologic" fractures: should these be included in epidemiologic studies of osteoporotic fractures?

UNLABELLED: Pathologic fractures are often excluded in epidemiologic studies of osteoporosis. Using Medicare administrative data, we identified persons with vertebral and hip fractures. Among these, 48% (vertebral) and 3% (hip) of the fractures were coded as pathologic. Only 25% and 66% of persons with these pathologic fractures had evidence for malignancy. INTRODUCTION: Analyses of osteoporosis-related fractures that use administrative data often exclude pathologic fractures (ICD-9 733.1x) due to concern that these are caused by cancer. We examined "pathologic" fractures of the vertebrae and hip to evaluate their contribution to fracture incidence and assessed the evidence for a malignancy. METHODS: We studied US Medicare beneficiaries age > or =65 with new fractures identified using ICD-9 diagnosis codes 733.13 (pathologic vert), 805.0, 805.2, 805.4, 805.8 (nonpathologic vert); and 733.14 (pathologic hip), 820.0, 820.2, 820.8 (nonpathologic hip). We further examined the proportion of cases with a diagnosis of a malignancy proximate to the fracture. RESULTS: We identified 44,120 individuals with a vertebral fracture and 60,354 with a hip fracture. Approximately 48% of vertebral fractures and 3% of hip fractures were coded as pathologic. For only approximately 25% of persons with a "pathologic" vertebral fracture ICD-9 code, but 66% of persons with a "pathologic" hip fracture, there was evidence of a possible cancer diagnosis. CONCLUSION: Among US Medicare beneficiaries, one fourth of pathologic vertebral fracture and two thirds of pathologic hip fracture cases had evidence for a malignancy. Particularly for vertebral fractures, excluding persons with pathologic fractures in epidemiologic analyses that utilize administrative claims data substantially underestimates the burden of fractures due to osteoporosis.

Estimated prevalence and patterns of presumed osteoporosis among older Americans based on Medicare data.

INTRODUCTION: Estimates of osteoporosis (OP) prevalence based on bone mineral density testing and fracture occurrence may be imprecise for small demographic groups. Medicare data are a useful supplemental source of information on OP. METHODS: We studied people ages > or = 65 years covered by Medicare 2005. Cases of presumed OP were beneficiaries with physician services or inpatient claims for OP or for an associated fracture (hip, distal forearm, spine) in 1999-2005. RESULTS: Among 911,327 beneficiaries with 6 or 7 years of Medicare coverage, the overall prevalence of OP and associated fractures was 29.7%. Prevalence was four times higher for women than men, increased with age, and was two times higher for whites, Hispanic Americans, and Asian Americans than African Americans. Among people with OP-associated fracture claims, the proportion with an OP diagnosis was 49.7% overall (women, 57.1%; men, 21.9%) and was lower for men than women and for African Americans than other ethnic groups. CONCLUSIONS: The low proportion of beneficiaries who had an OP-associated fracture and also had an OP diagnosis, particularly among men and African American women, suggests suboptimal recognition and management of OP. Study limitations included lack of validation of our definition of OP and potential misclassification of race/ethnicity.

The geographic availability and associated utilization of dual-energy X-ray absorptiometry (DXA) testing among older persons in the United States.

UNLABELLED: Using national Medicare data from 1999-2006, we evaluated the relationship between travel distance and receipt of dual-energy X-ray absorptiometry (DXA). After adjusting for potentially confounding factors, travel distance was strongly associated with DXA testing. Rural residents were most strongly dependent on the availability of DXAs performed in physician offices. INTRODUCTION: Medicare reimbursement for DXAs performed in non-facility settings (e.g., physician offices) decreased in 2007. With declining reimbursement, some DXA providers may cease providing this service, which would increase travel distance for some people. The impact of travel distance on access to DXA is unclear. METHODS: Using national Medicare data, we identified claims for DXA to evaluate trends in the number and locations of DXAs performed. Travel distance was the distance from beneficiaries' residence and the nearest DXA provider. Binomial regression evaluated the relationship between travel distance and receipt of DXA. RESULTS: In 2006, 2.9 million DXAs were performed, a 103% increase since 1999. In 2005-2006, 8.0% of persons were tested at non-facility sites versus 4.2% at facility sites. The remainder (88%) had no DXA. Persons traveling 5-9, 10-24, 25-39, and 40-54, and > or = 55 miles were less likely to receive DXA (adjusted risk ratios = 0.92, 0.79, 0.43, 0.32, and 0.26, respectively, < 5 miles referent). Rural residents were more dependent than urban residents on the availability of DXA from non-facility providers. CONCLUSION: Approximately two-thirds of DXAs in 2005-2006 were performed in non-facility settings (e.g., physician offices). Rural residents would have preferentially reduced access to DXA if there were fewer non-facility sites.

Fracture Reduction Affects Medicare Economics (FRAME): impact of increased osteoporosis diagnosis and treatment.

Osteoporosis is a common, debilitating disease affecting US Medicare beneficiaries, yet diagnosis and treatment lag behind medical advances. We estimated the cost of fractures to the Medicare program and the impact of increasing osteoporosis diagnosis and treatment. A Markov model was used to predict fracture incidence and costs in postmenopausal women aged 65 years and older, over 3 years (2001-2003). Only 1.80 million women were estimated to receive a Medicare-reimbursed bone mineral density (BMD) test in 2001. We evaluated the budget impact of testing an additional 1 million women from Medicare and patient perspectives. These women were stratified into high-risk (osteoporotic with prevalent vertebral fracture) and moderate-risk (without prevalent vertebral fracture) groups. During 2001-2003, an estimated 2.39 million fractures occurred among the 5.11 million women aged 65+ with osteoporosis, at a cost to Medicare of 12.96 billion dollars. We projected that BMD testing of an additional 1 million women in 2001 would result in treatment of 440,000 new patients with a bone-specific medication, preventing over 35,000 fractures over the 3 years. The decrease in fractures would produce a net discounted savings to the Medicare budget of 77.86 million dollars. Medicare's hospital inpatient cost would decrease by 115.41 million dollars and long-term care cost by 43.51 million dollars, more than offsetting incremental outpatient cost of 81.07 million dollars. Patients would benefit from fracture avoidance, but their out-of-pocket medical costs would increase by 63.49 million dollars during 2001-2003, or 1,771 dollars per fracture avoided. Sensitivity analyses showed that savings to the Medicare program varied in proportion to the unit cost of fractures, fracture risk of the populations tested, treatment rate, and adherence to therapy. Increased osteoporosis diagnosis may produce savings for the Medicare program if interventions are targeted to women at elevated risk for fracture and may be budget neutral if all older women are screened.

The cost of glucocorticoid-associated adverse events in rheumatoid arthritis.

OBJECTIVE: To estimate the costs of glucocorticoid associated adverse events (GAEs) in patients with rheumatoid arthritis (RA). METHODS: We conducted a literature review of studies reporting GAEs in RA patients, and developed a Markov model with the following GAEs: fractures (vertebral, hip, pelvic), hypertension, diabetes, gastrointestinal complications, pneumonia, urinary tract infection, cataract and, in an extended model, myocardial infarction (MI) and stroke. Two-year total costs were calculated using direct medical costs (2001 US dollars [USD]) and by running 10,000 Monte Carlo simulations with probability values randomly selected from the GAE literature. RESULTS: On average, glucocorticoid users spent USD 445 more than non-users, or USD 0.46 for each dollar spent on purchasing the drug. When adding MI and stroke, users spent on average USD 430 more than non-users, or USD 0.44 for each dollar spent on purchasing the drug; this incremental cost ranged from USD 193 to USD 682 if MI and stroke were excluded, respectively. In 70% of the simulations there were more deaths among users than among non-users, in both the model with and without MI and stroke. CONCLUSIONS: Although results varied depending on attributed GAEs, in general glucocorticoid users spent more than non-users on GAE treatment, and had higher mortality. Patients, providers and policy makers should consider these potential costs of GAEs when making treatment decisions.

Variations in glucocorticoid induced osteoporosis prevention in a managed care cohort.

OBJECTIVE: To characterize glucocorticoid use and patterns of osteoporosis prevention therapies among a large US national cohort. METHODS: Health maintenance organization (HMO) members who were receiving chronic glucocorticoid therapy (> 90 day supply) within a 3 year observation period were identified along with their prescribing physicians. Receipt of anti-osteoporotic prescription therapies and bone mass measurement was determined. Multivariable analyses were used to define significant predictors of these preventive interventions. RESULTS: We identified 2378 HMO members who filled prescriptions for at least a 90 day supply of glucocorticoids, but had not filled a glucocorticoid prescription in the prior 90 days. In women over age 50, use of anti-osteoporotic therapies and bone mass measurement was 41% and 16%, respectively. Glucocorticoid-prescribing physicians were identified for 878 (37%) of these glucocorticoid users, and internal medicine specialists (39%) and rheumatologists (20%) wrote the majority of the prescriptions for glucocorticoids. Women age 50 and over were most likely to receive a prescription anti-osteoporotic preventive therapy (OR 4.0; 95% CI 1.5-10.8). Patients with a rheumatologist prescribing their glucocorticoids were more likely than those of internists to have a bone mass measurement (OR 2.2; 95% CI 1.3-3.6) and receive bisphosphonates (OR 1.9; 95% CI 1.1-3.1), but were not more likely to receive preventive treatment overall. CONCLUSION: Although better than in several prior studies, we identified low levels of selected preventive care measures for chronic glucocorticoid users in a large population based cohort. Significant demographic and practice pattern variation suggests opportunities for targeted preventive interventions.

Variation in tertiary prevention and health service utilization among the elderly: the role of urban-rural residence and supplemental insurance.

OBJECTIVES: Tertiary prevention seeks to reduce chronic disease progression and illness-related dysfunction. Using the Aday-Andersen model, we evaluated the impact of predisposing, need, and enabling factors on tertiary prevention, hypothesizing that urban-rural geographic differences in delivery would be detected. METHODS: A population-based telephone survey was conducted evaluating six common chronic indicator conditions: arthritis (n = 488), hypertension (n = 414), cardiac disease (n = 185), diabetes mellitus (n = 125), peptic ulcer disease (n = 125), and chronic obstructive pulmonary disease (n = 103). Subjects were 787 (70% women) home-dwelling elderly (age > 65 years) who had one or more of the indicator conditions and who resided in Iowa's 12 most rural and 10 most urban counties. Tertiary prevention measures included counseling for and/or treatment with: influenza and pneumococcal vaccination, smoking cessation, dietary modifications, exercise, drug side effects, chronic disease rehabilitation, aspirin/estrogen for cardiac disease, and foot/eye care for diabetes. Tertiary prevention scores were calculated to compare preventive services across disease categories and to examine relations, in particular, with enabling factors. RESULTS: Education beyond high school, alcohol use, cigarette smoking, and medical specialist use were all significantly greater among urban residents, whereas home services use was greater among rural residents. Respondents with either health maintenance organization or fee-for-service supplemental coverage had higher tertiary prevention scores than respondents without supplemental coverage. After adjustment for the significant effects of the number of diseases, higher income, and place of residence, rural respondents having health maintenance organization supplemental coverage had higher (better) tertiary prevention scores than other respondents. CONCLUSIONS: In this community-based study of elderly, enrollment in an health maintenance organization plan, as opposed to a fee-for-service supplement to Medicare, increased tertiary prevention quality for rural but not for urban residents. This study emphasizes that additional research is needed to evaluate the importance of specific types of insurance coverage for preventive services among the elderly.

Health services research.

Advances in rheumatologic arthritis health services research continue to be of interest to clinical rheumatologists and arthritis researchers interested in healthcare delivery and policy. Recent studies have shown that a higher incidence of osteoarthritis and functional disability among rural inhabitants influences delivery of arthritis care to rural areas and urban-rural variations in specialist distribution. In the United States, managed care organizations are increasingly dictating who delivers and who receives health care for arthritis. Provision of arthritis care by rheumatologists has become more discretionary and is strongly influenced by a patient's health insurance coverage. Coinciding with this trend, a higher percentage of arthritis care is being shifted to primary care providers. Based on prominent practice pattern variations, generalists have divergent knowledge and beliefs about the value of various arthritis treatments. New therapeutic programs have been proposed to better coordinate efforts between generalists and specialists. Many arthritis patients also seek alterative therapies. Of these, chiropractic care is one of the most common nontraditional therapies. Chiropractic management appears to be as cost-effective as traditional back care in certain settings.