In an observational cohort of patients treated with biphosphonates (BP), we observed that poor adherence to these drugs causes important expenditures in terms of avoidable fractures. Of particular interest are the amounts of money wasted by patients who did not take their BPs long enough to obtain a clinical benefit.
A large proportion of patients initiated with oral weekly BP therapy stop their treatment within the first year. The objective of this study was to estimate the impact of the poor adherence to BPs in terms of drug wasted and avoidable fractures.
The study was done on primary and secondary prevention cohorts from the Régie de l'assurance maladie du Québec (Québec). The concept of the "point of visual divergence" was used to determine the amount of wasted drug. The risk of fracture was estimated using Cox regression models. The hazard ratios of compliant patients (+80%) versus non compliant patients were used to estimate the number of fractures saved.
The cost of wasted drugs was $25.87 per patient initiated in the primary prevention cohort and $30.52 in the secondary prevention cohort. If all patients had been compliant, 110 fractures would have been avoided in the primary prevention cohort and 19 fractures in the secondary prevention cohort. The cost of these avoidable fractures per patient initiated on BP therapy was $62.95 in primary prevention cohort and $330.84 in secondary prevention cohort.
This study confirms that poor adherence to oral BPs leads to a significant waste of money and avoidable fractures.
INTRODUCTION: Strontium ranelate is a new therapy for the treatment and prevention of osteoporosis that has been shown in two phase III clinical trials (the Spinal Osteoporosis Therapeutic Intervention [SOTI] and the Treatment Of Peripheral OSteoporosis Study [TROPOS] trials) to reduce the risk of osteoporotic fractures at the vertebral, non-vertebral and hip level in postmenopausal women. The aim of this study was to estimate the potential cost-effectiveness of strontium ranelate in the treatment of osteoporosis in postmenopausal Swedish patients. METHODS: A Markov cohort model was adapted to fit patients corresponding to the patients in the SOTI and TROPOS clinical trials. The model was populated with Swedish cost and epidemiological data. In the base case, the cost-effectiveness was estimated for 69-year old women with low bone mineral density (BMD) and prevalent vertebral fractures (SOTI) and for 77-year old women with low BMD (TROPOS). The cost-effectiveness analysis had a societal perspective. RESULTS: In the base case analysis, the cost per quality-adjusted life years (QALY) gained of strontium ranelate patients compared to no treatment patients was estimated at SEK 472,586 and SEK 259,643, including costs in added life years, based on the SOTI and the TROPOS trials, respectively. Excluding cost in added life years, the cost per QALY gained was estimated at SEK 336,420 (SOTI) and SEK 165,680 (TROPOS). In subgroup analyses, in patients 74 years and older with a T-score lower than -2.4 and patients older than 80 years of age, strontium ranelate was found to be cost saving compared to no treatment. CONCLUSIONS: The results in the base case analyses and the sensitivity analyses of this study indicate that, compared to no treatment, strontium ranelate is cost-effective in the treatment of postmenopausal women with low BMD.
To update the 1993 burden of illness of osteoporosis in Canada, administrative and community data were used to calculate the 2010 costs of osteoporosis at $2.3 billion in Canada or 1.3% of Canada's healthcare expenditures. Prevention of fractures in high-risk individuals is key to decrease the financial burden of osteoporosis.
Since the 1996 publication of the burden of osteoporosis in 1993 in Canada, the population has aged and the management of osteoporosis has changed. The study purpose was to estimate the current burden of illness due to osteoporosis in Canadians aged 50 and over.
Analyses were conducted using five national administrative databases from the Canadian Institute for Health Information for the fiscal-year ending March 31 2008 (FY 2007/2008). Gaps in national data were supplemented by provincial and community data extrapolated to national levels. Osteoporosis-related fractures were identified using a combination of most responsible diagnosis at discharge and intervention codes. Fractures associated with severe trauma codes were excluded. Costs, expressed in 2010 dollars, were calculated for osteoporosis-related hospitalizations, emergency care, same day surgeries, rehabilitation, continuing care, homecare, long-term care, prescription drugs, physician visits, and productivity losses. Sensitivity analyses were conducted to measure the impact on the results of key assumptions.
Osteoporosis-related fractures were responsible for 57,413 acute care admissions and 832,594 hospitalized days in FY 2007/2008. Acute care costs were estimated at $1.2 billion. When outpatient care, prescription drugs, and indirect costs were added, the overall yearly cost of osteoporosis was over $2.3 billion for the base case analysis and as much as $3.9 billion if a proportion of Canadians were assumed to be living in long-term care facilities due to osteoporosis.
Osteoporosis is a chronic disease that affects a large segment of the adult population and results in a substantial economic burden to the Canadian society.
During the years following menopause, estrogen levels decline leading to accelerated bone loss and an increased risk of osteoporosis and osteoporosis-related fractures.
Using a Markov model and decision analytic techniques, the long-term costs and outcomes of five treatment and secondary prevention strategies for osteoporosis were compared: 'no intervention', alendronate, etidronate, risedronate, and raloxifene. The base case analysis examined postmenopausal (65 year old) osteoporotic women without prior fracture. Probabilistic sensitivity analysis (PSA) was used to incorporate the impact of parameter uncertainty, and deterministic sensitivity analysis (DSA) was used to compare alternative patient populations and modeling assumptions. Life years and Quality Adjusted Life Years (QALYs) were used as measures of effectiveness.
In the base case analysis, risedronate was dominated by etidronate and alendronate. Alendronate and etidronate were projected to have similar costs and QALYs, and the efficiency frontier was represented by 'no intervention', etidronate, alendronate, and raloxifene (Can$32 571, Can$38 623 and Can$114 070 per QALY respectively). Alternative assumptions of raloxifene's impact on CHD and breast cancer, alternative discount rates and alternative patient risk factors (e.g., starting age of therapy, CHD risk, and prior fracture risk) had significant impacts on the overall cost-effectiveness results for both the bisphosphonates and raloxifene.
Using conventionally quoted benchmarks and compared to no therapy, alendronate, etidronate, and raloxifene would all be considered cost-effective alternatives for treating women with osteoporosis. Potential limitations of this study include the usual caveats and cautions associated with long-term projection models and the fact that not all inputs into the model are Canadian data sources.
Denosumab is a novel biologic agent approved in Canada for treatment of post-menopausal osteoporosis (PMO) in women at high risk for fracture or who have failed or are intolerant to other osteoporosis therapies. This study estimated cost-effectiveness of denosumab vs usual care from the perspective of the Ontario public payer.
A previously published PMO Markov cohort model was adapted for Canada to estimate cost-effectiveness of denosumab. The primary analysis included women with demographic characteristics similar to those from the pivotal phase III denosumab PMO trial (FREEDOM; age 72 years, femoral neck BMD T-score -2.16 SD, vertebral fracture prevalence 23.6%). Three additional scenario sub-groups were examined including women: (1) at high fracture risk, defined in FREEDOM as having at least two of three risk factors (age 70+; T-score = -3.0 SD at lumbar spine, total hip, or femoral neck; prevalent vertebral fracture); (2) age 75+; and (3) intolerant or contraindicated to oral bisphosphonates (BPs). Analyses were conducted over a lifetime horizon comparing denosumab to usual care ('no therapy', alendronate, risedronate, or raloxifene [sub-group 3 only]). The analysis considered treatment-specific persistence and post-discontinuation residual efficacy, as well as treatment-specific adverse events. Both deterministic and probabilistic sensitivity analyses were conducted.
The multi-therapy comparisons resulted in incremental cost-effectiveness ratios for denosumab vs alendronate of $60,266 (2010 CDN$) (primary analysis) and $27,287 per quality-adjusted life year gained for scenario sub-group 1. Denosumab dominated all therapies in the remaining scenarios.
Key limitations include a lack of long-term, real-world, Canadian data on persistence with denosumab as well as an absence of head-to-head clinical data, leaving one to rely on meta-analyses based on trials comparing treatment to placebo.
Denosumab may be cost-effective compared to oral PMO treatments for women at high risk of fractures and those who are intolerant and/or contraindicated to oral BPs.
In the US, 26 % of women aged =65 years, and over 50 % of women aged =85 years are affected with postmenopausal osteoporosis (PMO). Each year, the total direct health care costs are estimated to be $US12-18 billion.
The cost effectiveness of denosumab versus oral bisphosphonates in postmenopausal osteoporotic women from a US third-party payer perspective was evaluated.
A lifetime cohort Markov model was developed with seven health states: 'well', hip fracture, vertebral fracture, 'other' osteoporotic fracture, post-hip fracture, post-vertebral fracture, and dead. During each cycle, patients could have a fracture, remain healthy, remain in a post-fracture state or die. Relative fracture risk reductions, background fracture risks, mortality rates, treatment-specific persistence rate, utilities, and medical and drug costs were derived using published sources. Expected costs and quality-adjusted life years (QALYs) were estimated for generic alendronate, denosumab, branded risedronate, and branded ibandronate in the overall PMO population and high-risk subgroups: (a) =2 of the following risks: >70 years of age, bone mineral density (BMD) T score less than or equal to -3.0, and prevalent vertebral fracture; and (b) =75 years of age. Costs and QALYs were discounted at 3 % annually, and all costs were inflated to 2012 US dollars. Sensitivity analyses were conducted by varying parameters e.g., efficacies of interventions, costs, utilities, and the medication persistence ratio.
In the overall PMO population, total lifetime costs for alendronate, denosumab, risedronate, and ibandronate were $US64,400, $US67,400, $US67,600 and $US69,200, respectively. Total QALYs were 8.2804, 8.3155, 8.2735 and 8.2691, respectively. The incremental cost-effectiveness ratio (ICER) for denosumab versus generic alendronate was $US85,100/QALY. Risedronate and ibandronate were dominated by denosumab. In the high-risk subgroup (a), total costs for alendronate, denosumab, risedronate and ibandronate were $US70,400, $US70,800, $US74,000 and $US76,900, respectively. Total QALYs were 7.2006, 7.2497, 7.1969 and 7.1841, respectively. Denosumab had an ICER of $US7,900/QALY versus generic alendronate and dominated all other strategies. Denosumab dominated all strategies in women aged =75 years. Base-case results between denosumab and generic alendronate were most sensitive to the relative risk of hip fracture for both drugs and the cost of denosumab.
In each PMO population examined, denosumab represented good value for money compared with branded bisphosphonates. Furthermore, denosumab was either cost effective or dominant compared with generic alendronate in the high-risk subgroups.
Strontium ranelate has been introduced recently for the prevention and treatment of osteoporosis in Europe and in many countries worldwide. This article reviews the published cost-effectiveness literature pertaining to strontium ranelate. Six studies were identified: two in the UK, two in Belgium and two in Sweden. The findings were consistent across the literature, suggesting that strontium ranelate is a cost-saving drug for women with osteoporosis aged over 80 years, and it is a cost-effective treatment compared with no treatment for osteoporotic women aged over 70 years and for younger women with clinical risk factors for fragility fracture. Strontium ranelate was also shown to be cost effective compared with branded risedronate in osteoporotic women aged over 75 years. Further analyses are required to assess the effectiveness and adherence to strontium ranelate in real-life settings, as well as to evaluate the cost-effectiveness of strontium ranelate in other countries and in populations of men.
This paper presents the model and results to evaluate the use of teriparatide as a first-line treatment of severe postmenopausal osteoporosis (PMO) and glucocorticoid-induced osteoporosis (GIOP). The study's objective was to determine if teriparatide is cost effective against oral bisphosphonates for two large and high risk cohorts.
A computer simulation model was created to model treatment, osteoporosis related fractures, and the remaining life of PMO and GIOP patients. Natural mortality and additional mortality from osteoporosis related fractures were included in the model. Costs for treatment with both teriparatide and oral bisphosphonates were included. Drug efficacy was modeled as a reduction to the relative fracture risk for subsequent osteoporosis related fractures. Patient health utilities associated with age, gender, and osteoporosis related fractures were included in the model. Patient costs and utilities were summarized and incremental cost-effectiveness ratios (ICERs) for teriparatide versus oral bisphosphonates and teriparatide versus no treatment were estimated.For each of the PMO and GIOP populations, two cohorts differentiated by fracture history were simulated. The first contained patients with both a historical vertebral fracture and an incident vertebral fracture. The second contained patients with only an incident vertebral fracture. The PMO cohorts simulated had an initial Bone Mineral Density (BMD) T-Score of -3.0. The GIOP cohorts simulated had an initial BMD T-Score of -2.5.
The ICERs for teriparatide versus bisphosphonate use for the one and two fracture PMO cohorts were €36,995 per QALY and €19,371 per QALY. The ICERs for teriparatide versus bisphosphonate use for the one and two fracture GIOP cohorts were €20,826 per QALY and €15,155 per QALY, respectively.
The selection of teriparatide versus oral bisphosphonates as a first-line treatment for the high risk PMO and GIOP cohorts evaluated is justified at a cost per QALY threshold of €50,000.
Socioeconomic factors have been suggested to influence the prescribing of newer and more expensive drugs. In the present study, individual and health care provider factors were studied in relation to the prevalence of differently priced drugs.
Register data for dispensed drugs were retrieved for 18?486 individuals in a county council in Sweden. The prevalence of dispensed drugs was combined with data for the individual's gender, age, education, income, foreign background, and type of caregiver. For each of the diagnostic groups (chronic obstructive pulmonary disease [COPD], depression, diabetes, and osteoporosis), selected drugs were dichotomized into cost categories, lower and higher price levels. Univariate and multivariate logistic regressions were performed using cost category as the dependent variable and the individual and provider factors as independent variables.
In all four diagnostic groups, differences were observed in the prescription of drugs of lower and higher price levels with regard to the different factors studied. Age and gender affected the prescription of drugs of lower and higher price levels more generally, except for gender in the osteoporosis group. Income, education, foreign background, and type of caregiver affected prescribing patterns but in different ways for the different diagnostic groups.
Certain individual and provider factors appear to influence the prescribing of drugs of different price levels. Because the average price for the cheaper drugs versus more costly drugs in each diagnostic group was between 19% and 69%, there is a risk that factors other than medical needs are influencing the choice of drug.
The RisedronatE and ALendronate (REAL) study provided a unique opportunity to conduct cost-effectiveness analyses based on effectiveness data from real-world clinical practice. Using a published osteoporosis model, the researchers found risedronate to be cost-effective compared to generic or brand alendronate for the treatment of Canadian postmenopausal osteoporosis in patients aged 65 years or older.
The REAL study provides robust data on the real-world performance of risedronate and alendronate. The study used these data to assess the cost-effectiveness of brand risedronate versus generic or brand alendronate for treatment of Canadian postmenopausal osteoporosis patients aged 65 years or older.
A previously published osteoporosis model was populated with Canadian cost and epidemiological data, and the estimated fracture risk was validated. Effectiveness data were derived from REAL and utility data from published sources. The incremental cost per quality-adjusted life-year (QALY) gained was estimated from a Canadian public payer perspective, and comprehensive sensitivity analyses were conducted.
The base case analysis found fewer fractures and more QALYs in the risedronate cohort, providing an incremental cost per QALY gained of $3,877 for risedronate compared to generic alendronate. The results were most sensitive to treatment duration and effectiveness.
The REAL study provided a unique opportunity to conduct cost-effectiveness analyses based on effectiveness data taken from real-world clinical practice. The analysis supports the cost-effectiveness of risedronate compared to generic or brand alendronate and the use of risedronate for the treatment of osteoporotic Canadian women aged 65 years or older with a BMD T-score