Cost-Effectiveness of Denosumab for the Treatment of Postmenopausal Osteoporosis in South Korea.

BACKGROUND: Osteoporosis is a progressive skeletal disease associated with an increased risk of bone fracture. This study aimed to estimate the cost-effectiveness of denosumab for osteoporotic fracture prevention compared to bisphosphonates (alendronate, ibandronate, risedronate, and zoledronate) and selective estrogen receptor modulators (raloxifene) in a cohort of postmenopausal women with osteoporosis. METHODS: A Markov model was used to evaluate the cost and effectiveness of denosumab versus comparators. The model had a cycle length of 6 months and was run from the age of 68 years to individual patients' lifetime or the age of 100 years. The health states considered in the model were well, hip fracture, vertebral fracture, wrist fracture, other osteoporotic fracture, post-hip fracture, post-vertebral fracture, and death. Recent local data were used as inputs for the model parameters. A discount rate of 4.5% was applied to both costs and outcomes. RESULTS: From the perspective of the healthcare system, denosumab was cost-effective or cost-saving compared to all comparators, considering one unit of Korea's gross domestic product per capita, USA dollar (USD) 34,870. Denosumab was cost-saving compared to ibandronate (oral) and raloxifene. Compared to alendronate, denosumab was cost-effective with an incremental cost-effectiveness ratio (ICER) of USD 767.10 per quality-adjusted life year (QALY). The ICER of denosumab vs. ibandronate IV, risedronate, and zoledronate was USD 685.63, USD 1,469.71, USD 4,668.53 per QALY, respectively. CONCLUSIONS: The findings of this analysis suggest that denosumab is a cost-effective therapeutic option for preventing fractures in postmenopausal women with osteoporosis in South Korea.

Cost-effectiveness of romosozumab for the treatment of postmenopausal women at very high risk of fracture in Canada.

This study evaluated the cost-effectiveness of 1 year of romosozumab followed by alendronate versus oral bisphosphonates alone in women with postmenopausal osteoporosis at very high risk for fracture in Canada. Results showed that romosozumab sequenced to alendronate is a cost-effective treatment option, dominating both alendronate and risedronate alone. PURPOSE: To demonstrate the value of romosozumab sequenced to alendronate compared to alendronate or risedronate alone, for the treatment of osteoporosis in postmenopausal women with a history of osteoporotic fracture and who are at very high risk for future fracture in Canada. METHODS: A Markov model followed a hypothetical cohort of postmenopausal osteoporotic women at very high risk for future fractures, to estimate the cost-effectiveness of romosozumab and alendronate compared to oral bisphosphonates alone. A total treatment period of 5 years was assumed. Quality-adjusted life years and costs were estimated for each comparator across health states defined by different types of fragility fractures. RESULTS: Romosozumab/alendronate was associated with a lifetime gain of 0.103 and 0.127 QALYs and a cost reduction of $343 and $3805, relative to alendronate and risedronate, respectively. These results were driven by a reduction of the number of fractures (2561 per 1000 patients, versus 2700 for alendronate and 2724 for risedronate over lifetime). Romosozumab/alendronate had the highest probability of being cost-effective, relative to alendronate and risedronate, at any willingness to pay threshold value. CONCLUSION: Romosozumab/alendronate was associated with reduced costs and greater benefit relative to other comparators. Probabilistic, deterministic, and scenario analyses indicate that romosozumab/alendronate represents the best value for money; the uncertainty analyses are robust, and therefore romosozumab should be considered for reimbursement by public drug plans in Canada .

Real-world cost-effectiveness of denosumab for the treatment of postmenopausal osteoporosis in Taiwan.

This study assessed the cost-effectiveness of continued denosumab treatment, compared with discontinuation of denosumab after one dose, for the treatment of postmenopausal osteoporosis in Taiwan, using real-world fracture reduction effectiveness and cost data. Outcomes indicate that continued denosumab treatment produces an incremental cost-effectiveness ratio of USD $16,743 per QALY. PURPOSE: To evaluate the cost-effectiveness of continued denosumab use versus discontinuation after one dose, for the treatment of postmenopausal osteoporosis in Taiwan, using real-world fracture reduction effectiveness and cost data. METHODS: A Markov cohort model was used to evaluate the lifetime costs and QALYs associated with continued denosumab treatment versus discontinuation of treatment after one dose. The evaluation was conducted from the perspective of Taiwan's healthcare system and used a discount rate of 3% per annum. The patient population consisted of postmenopausal women with osteoporosis with a mean age of 77 years who initiated denosumab treatment. Fracture reduction effectiveness data, baseline fracture rates, mortality data, and costs of fracture were informed by Taiwan's National Health Insurance Research Database. RESULTS: Model outcomes showed that continued treatment with denosumab produced an expected gain of 0.042 QALYs and an incremental cost of USD $704, compared with discontinuation of denosumab after one dose. This corresponds to an incremental cost-effectiveness ratio of USD $16,743 per QALY gained. Probabilistic and scenario analysis showed that results are stable to variations in model assumptions and parameters. CONCLUSION: In a real-world setting, at a cost per QALY threshold equivalent to gross domestic product per capita in 2020 in Taiwan (USD $30,038), continued treatment with denosumab in postmenopausal women with osteoporosis is cost-effective compared with treatment discontinuation.

Does distance to a cystic fibrosis center impact health outcomes?

INTRODUCTION: This paper considers the impact of geographic distance from cystic fibrosis centers on lung function in children, young adults, and adults with cystic fibrosis. METHODS: Clinical patient-level data on 20 351 patients from 1986 to 2011 were evaluated from the Cystic Fibrosis Foundation National Patient Registry. We measure distance using a patient's zip code centroid to the center where they received care. A heteroscedastic mixed effects model was used to capture the association of distance with longitudinal variation in patients' lung function. RESULTS: Children, young adults, and adults in lower socioeconomic categories had a %FEV1 between 3 and 10 percentage-points lower than those living in higher income areas and those privately insured. For patients who changed distance categories, high distance was associated with lower lung function in young adults (P-value <0.001). For older patients we observed the reverse, suggesting that the choice to move farther away is associated with better health (P-value <0.001). For patients who did not change distance categories, only medium distance in children was significant (P-value = 0.01). Known confounding factors including age and CFTR mutation class were statistically significantly associated to health outcomes (P-value <0.001). CONCLUSIONS: This study shows distance is not found to be associated with health lung function among patients whose distance category remained unchanged during the analysis. For patients who move, the association of health with distance depends on the age of the patient; adult patients further from their care center are healthier. Overall, we find that socioeconomic and genetic factors appear to impact health outcomes to a greater extent.

The cost-effectiveness of three interventions for providing preventive services to low-income children.

OBJECTIVE: We evaluated the impact of loan repayment programmes, revising Medicaid fee-for-service rates, and changing dental hygienist supervision requirements on access to preventive dental care for children in Georgia. METHODS: We estimated cost savings from the three interventions of preventive care for young children after netting out the intervention cost. We used a regression model to evaluate the impact of changing the Medicaid reimbursement rates. The impact of supervision was evaluated by comparing general and direct supervision in school-based dental sealant programmes. RESULTS: Federal loan repayments to dentists and school-based sealant programmes (SBSPs) had lower intervention costs (with higher potential cost savings) than raising the Medicaid reimbursement rate. General supervision had costs 56% lower than direct supervision of dental hygienists for implementing a SBSP. Raising the Medicaid reimbursement rate by 10 percentage points would improve utilization by <1% and cost over $38 million. Given one parameter set, SBSPs could serve over 27 000 children with an intervention cost between $500 000 and $1.3 million with a potential cost saving of $1.1 million. Loan repayment could serve almost 13 000 children for a cost of $400 000 and a potential cost saving of $176 000. CONCLUSIONS: The three interventions all improved met need for preventive dental care. Raising the reimbursement rate alone would marginally affect utilization of Medicaid services but would not substantially increase acceptance of Medicaid by providers. Both loan repayment programmes and amending supervision requirements are potentially cost-saving interventions. Loan repayment programmes provide complete care to targeted areas, while amending supervision requirements of dental hygienists could provide preventive care across the state.

Estimating Demand for and Supply of Pediatric Preventive Dental Care for Children and Identifying Dental Care Shortage Areas, Georgia, 2015.

OBJECTIVES: Demand for dental care is expected to outpace supply through 2025. The objectives of this study were to determine the extent of pediatric dental care shortages in Georgia and to develop a general method for estimation that can be applied to other states. METHODS: We estimated supply and demand for pediatric preventive dental care for the 159 counties in Georgia in 2015. We compared pediatric preventive dental care shortage areas (where demand exceeded twice the supply) designated by our methods with dental health professional shortage areas designated by the Health Resources & Services Administration. We estimated caries risk from a multivariate analysis of National Health and Nutrition Examination Survey data and national census data. We estimated county-level demand based on the time needed to perform preventive dental care services and the proportion of time that dentists spend on pediatric preventive dental care services from the Medical Expenditure Panel Survey. RESULTS: Pediatric preventive dental care supply exceeded demand in Georgia in 75 counties: the average annual county-level pediatric preventive dental care demand was 16 866 hours, and the supply was 32 969 hours. We identified 41 counties as pediatric dental care shortage areas, 14 of which had not been designated by the Health Resources & Services Administration. CONCLUSIONS: Age- and service-specific information on dental care shortage areas could result in more efficient provider staffing and geographic targeting.

The prehospital burden of disease due to trauma in KwaZulu-Natal: the need for Afrocentric trauma systems.

BACKGROUND: Trauma is one of the leading prehospital disease profiles in South Africa in general and in KwaZulu-Natal (KZN) in particular. The present study was designed to review the prehospital burden of injury in KZN, identify trauma burden to ambulance ratios, analyze system deficiencies, and propose a prehospital trauma system that is Afrocentric in nature. METHODS: Approval from the relevant ethics authorities was obtained. Using a convenience data set all Emergency Medical Service (EMS) call data for the months of March and September 2010 were reviewed for the three main EMS providers in KZN. Data were extrapolated to annual data and placed in the context of population, ambulance service, and facility. The data were then mapped for area distribution and prehospital workload relative to the entire province. Questionnaire-based assessments of knowledge and deficiencies of the current system were completed by senior officers of the provincial system as part of the analysis of the current system. RESULTS: The total annual call burden for trauma ranges between 94,840 and 101,420, or around 11.6 trauma calls per thousand of the population per year. Almost 70 % of calls were either for interpersonal intentional violence or vehicular collisions. Only 0.25 % of calls involved aeromedical resources. Some 80 % of patients were considered to be moderately to seriously injured, yet only 41 % of the patients were transported to a suitable level of care immediately, with many going to inappropriate lower level care facilities. Many rural calls are not attended within the time norms accepted nationally. Deficiencies noted by the questionnaire survey are the general lack of a bypass mechanism and the feeling among staff that most EMS bases do not have a bypass option or feel part of a system of care, despite large numbers of staff having been recently trained in triage and major trauma care. CONCLUSIONS: The prehospital trauma burden in KZN is significant and consumes vital resources and gridlocks facilities. A prehospital trauma system that is financially sustainable and meets the needs of the trauma burden is proposed to enable Afrocentric emergency care planning for low and middle income regions.

Reducing high pressure oxygen system risk.

A risk management approach to the selection of non-metallic materials used in high pressure medical oxygen systems is discussed by Ben Johnson, product manager at BeaconMedaes.

Stepped-care approach to treating MS: a managed care treatment algorithm.

OBJECTIVE: To introduce a model treatment algorithm for use in the managed care setting as a strategy to provide ongoing disease management and long-term care for patients with multiple sclerosis (MS), with the goal of delaying disease progression and the associated disability and cognitive dysfunction. SUMMARY: MS is a chronic inflammatory disorder of the central nervous system that is associated with progressive disability and cognitive dysfunction. Currently, management of MS involves planning an effective long-term treatment strategy that can delay the progression of the disease. This article reviews a typical stepped-care approach to treating MS that is based on the concept of a platform drug, which is an agent that provides baseline immunomodulatory action throughout the course of the disease. Considerations for selecting a platform therapy include the effect on the full spectrum of MS (disability, relapses, lesion load, and atrophy as well as patient compliance and the potential impact of neutralizing antibodies [NAbs]). Currently, 4 first-line therapies are approved for relapsing MS: the 3 interferon beta (IFNbeta) products and glatiramer acetate. Of these, the IFNbetas are generally recommended as platform therapy because all have shown significant effects on relapses, magnetic resonance imaging parameters of the disease, and because intramuscular (i.m.) IFNbeta-1a (Avonex) and subcutaneous (s.c.) IFNbeta-1a (Rebif) have been shown to slow the progression of sustained disability. Patients being treated with IFNbetas can develop NAbs to the drug, which can lead to a loss of efficacy and subsequent occurrence of breakthrough disease. The 3 different formulations of IFNbeta are associated with a varying incidence of NAbs (i.m. IFNbeta-1a, 5%; s.c. IFNbeta-1a, 24%; IFNbeta-1b [Betaseron], 45%). Antibodies also form against glatiramer acetate, although their clinical significance needs to be elucidated. As the disease progresses or has periods of aggressive activity, the stepped-care approach is to add other agents onto the platform therapy to improve control of the disease. CONCLUSION: Stepped care, as outlined in this model treatment algorithm for the managed care setting, is an effective method to achieve the fundamental goal of MS treatment, that is, to delay disease progression and the associated disability and cognitive impairment.