Association of Medicare's Bundled Payment Reform With Changes in Use of Vitamin D Among Patients Receiving Maintenance Hemodialysis: An Interrupted Time-Series Analysis.

BACKGROUND & RATIONALE: Medicare's 2011 prospective payment system (PPS) was introduced to curb overuse of separately billable injectable drugs. After epoietin, intravenous (IV) vitamin D analogues are the biggest drug cost drivers in hemodialysis (HD) patients, but the association between PPS introduction and vitamin D therapy has been scarcely investigated. STUDY DESIGN: Interrupted time-series analyses. SETTING & PARTICIPANTS: Adult US HD patients represented in the US Renal Data System between 2008 and 2013. EXPOSURES: PPS implementation. OUTCOMES: The cumulative dose of IV vitamin D analogues (paricalcitol equivalents) per patient per calendar quarter in prevalent HD patients. The average starting dose of IV vitamin D analogues and quarterly rates of new vitamin D use (initiations/100 person-months) in incident HD patients within 90 days of beginning HD therapy. ANALYTICAL APPROACH: Segmented linear regression models of the immediate change and slope change over time of vitamin D use after PPS implementation. RESULTS: Among 359,600 prevalent HD patients, IV vitamin D analogues accounted for 99% of the total use, and this trend was unchanged over time. PPS resulted in an immediate 7% decline in the average dose of IV vitamin D analogues (average baseline dose = 186.5 µg per quarter; immediate change = -13.5 µg [P < 0.001]; slope change = 0.43 per quarter [P = 0.3]) and in the starting dose of IV vitamin D analogues in incident HD patients (average baseline starting dose = 5.22 µg; immediate change = -0.40 µg [P < 0.001]; slope change = -0.03 per quarter [P = 0.03]). The baseline rate of vitamin D therapy initiation among 99,970 incident HD patients was 44.9/100 person-months and decreased over time, even before PPS implementation (pre-PPS ß = -0.46/100 person-months [P < 0.001]; slope change = -0.19/100 person-months [P = 0.2]). PPS implementation was associated with an immediate change in initiation levels (by -4.5/100 person-months; P < 0.001). LIMITATIONS: Incident HD patients were restricted to those 65 years or older. CONCLUSION: PPS implementation was associated with a 7% reduction in the average dose and starting dose of IV vitamin D analogues and a 10% reduction in the rate of vitamin D therapy initiation.

Recombinant Parathyroid Hormone Versus Usual Care: Do the Outcomes Justify the Cost?

BACKGROUND: Hypoparathyroidism is a potential outcome of anterior neck surgery. Commonly it is managed by calcium and vitamin D supplementation in large doses, with attendant side effects. A recombinant human parathyroid hormone (rhPTH) is now available in the USA, offering a potentially more effective treatment. No cost-effectiveness model investigating this new medication versus standard care has yet been published. METHODS: We constructed a decision analytic model comparing usual care versus rhPTH treatment for postsurgical hypoparathyroidism. Threshold and sensitivity analyses on key parameters were conducted to assess robustness of the model. Costs and health outcomes were represented in US dollars and quality-adjusted life-years (QALYs). RESULTS: The rhPTH strategy was both more costly and more effective than the usual care (UC) strategy. In the base case, UC cost $37,196 and provided 7.54 QALYs. The rhPTH strategy cost $777,224 and provided 8.46 QALYs for an incremental cost-effectiveness ratio of $804,378/QALY. As this was above our willingness-to-pay of $100,000, treatment with rhPTH was not considered cost-effective. The model was robust to all other parameters. CONCLUSIONS: To our knowledge, this is the first formal cost-effectiveness analysis of rhPTH in comparison with UC. Our model suggests that although the new treatment is slightly more effective than UC, the modest gain in quality of life for patients who are reasonably well-managed by UC does not justify the cost. However, consideration must be given to rhPTH for patients who have failed UC, as the expenditure may be justified in that context.

Public health impact and economic evaluation of vitamin D-fortified dairy products for fracture prevention in France.

The recommended intake of vitamin D-fortified dairy products can substantially decrease the burden of osteoporotic fractures and seems an economically beneficial strategy in the general French population aged over 60 years. INTRODUCTION: This study aims to assess the public health and economic impact of vitamin D-fortified dairy products in the general French population aged over 60 years. METHODS: We estimated the lifetime health impacts expressed in number of fractures prevented, life years gained, and quality-adjusted life years (QALY) gained of the recommended intake of dairy products in the general French population over 60 years for 1 year (2015). A validated microsimulation model was used to simulate three age cohorts for both women and men (60-69, 70-79, and >80 years). The incremental cost per QALY gained of vitamin D-fortified dairy products compared to the absence of appropriate intake was estimated in different populations, assuming the cost of two dairy products per day in base case. RESULTS: The total lifetime number of fractures decreased by 64,932 for the recommended intake of dairy products in the general population over 60 years, of which 46,472 and 18,460 occurred in women and men, respectively. In particular, 15,087 and 4413 hip fractures could be prevented in women and men. Vitamin D-fortified dairy products also resulted in 32,569 QALYs and 29,169 life years gained. The cost per QALY gained of appropriate dairy intake was estimated at €58,244 and fall below a threshold of €30,000 per QALY gained in women over 70 years and in men over 80 years. CONCLUSION: Vitamin D-fortified dairy products have the potential to substantially reduce the burden of osteoporotic fractures in France and seem an economically beneficial strategy, especially in the general population aged above 70 years.

Temporal and regional variability in the request of vitamin D from general practitioners in Spain.

BACKGROUND: Our main goal is to study the inter-practice regional variability and the temporal evolution in the request of 25-hydroxyvitamin D (25[OH]D) by general practitioners (GPs) in Spain. METHODS: Clinical laboratories in different autonomic communities (AACCs) were invited to report the number of 25(OH)D test requested by GPs during 2012 and 2014. The number of 25(OH)D requested per 1000 inhabitants and the index of variability were calculated, and compared between regions and time periods. We calculated the number of tests that could have been potentially saved in regions where 25(OH)D could be requested from primary care without restrictions taking into account the request in those where it is restricted, and the potential economical savings. RESULTS: Seventy-six laboratories participated in the 2012 edition, and 110 in 2014, corresponding to 17,679,195 and 27,798,262 inhabitants (59.8% Spanish population). The number of 25(OH)D requested per 1000 inhabitants increased from 1.1 in 2012 to 3.4 in 2014 (p<0.001). The variability index also increased from 51.7 to 68. There was a significantly variability among the different AACCs, ranging from 0.94 to 21.24 (p=0.002). 173,885 tests could have been not measured from primary care in regions without ordering restrictions, resulting in potential 886,813.5€ savings. CONCLUSIONS: There was a high variability in the request of 25(OH)D by GPs in Spain, which significantly increased in a 2 year period. The demand was higher in areas where the request of 25(OH)D was not restricted in primary care, with potential savings if the request would approach to regions with ordering restrictions.

Costs of vitamin D testing and prescribing among children in primary care.

Vitamin D has attracted considerable interest in recent years, with a marked increase in diagnosis of vitamin D deficiency seen among children in clinical practice in the UK. The economic implications of this change in diagnostic behaviour have not been explored. We performed a cohort study to examine longitudinal trends in healthcare expenditure arising from vitamin D testing and prescribing for children in primary care in England, using the electronic healthcare records of 722,525 children aged 0-17 years held in The Health Improvement Network database. Combined costs of vitamin D tests and prescriptions increased from £1647 per 100,000 person-years in 2008 (95% CI, £934 to £3007) to £28,913 per 100,000 person-years in 2014 (95% CI, £26,361 to £31,739). The total cost of vitamin D prescriptions and tests for children in primary care at the national level in England in 2014 was estimated to be £4.31 million (95% CI, £2.96-£6.48 million). CONCLUSION: There has been a marked increase in healthcare expenditure on vitamin D tests and prescriptions for children in primary care over the past decade. Future research should explore the drivers for this change in diagnostic behaviour and the reasons prompting investigation of vitamin D status in clinical practice. What is Known: • Vitamin D deficiency has attracted considerable interest in recent years, with a marked increase in diagnosis seen in children. • The economic implications of this change in diagnostic behaviour have not been explored. What is New: • There has been a large increase in healthcare expenditure on vitamin D tests and prescriptions for children in primary care in England over the past decade (> 15 fold between 2008 and 2013). • Screening of vitamin D status in children without specific risk factors or clinical features of deficiency may represent avoidable healthcare expenditure.

Economic evaluation of vitamin D and calcium food fortification for fracture prevention in Germany.

OBJECTIVE: The study evaluates the economic benefit of population-wide vitamin D and Ca food fortification in Germany. DESIGN: Based on a spreadsheet model, we compared the cost of a population-wide vitamin D and Ca food-fortification programme with the potential cost savings from prevented fractures in the German female population aged 65 years and older. SETTING: The annual burden of disease and the intervention cost were assessed for two scenarios: (i) no food fortification; and (ii) voluntary food fortification with 20 µg (800 IU) of cholecalciferol (vitamin D3) and 200 mg of Ca. The analysis considered six types of fractures: hip, clinical vertebral, humerus, wrist, other femur and pelvis. SUBJECTS: Subgroups of the German population defined by age and sex. RESULTS: The implementation of a vitamin D and Ca food-fortification programme in Germany would lead to annual net cost savings of €315 million and prevention of 36 705 fractures in the target population. CONCLUSIONS: Vitamin D and Ca food fortification is an economically beneficial preventive health strategy that has the potential to reduce the future health burden of osteoporotic fractures in Germany. The implementation of a vitamin D and Ca food-fortification programme should be a high priority for German health policy makers because it offers substantial cost-saving potential for the German health and social care systems.

Preventing vitamin D deficiency (VDD): a systematic review of economic evaluations.

Background: Vitamin D deficiency (VDD) is a public health concern worldwide. If untreated, it can lead to reduced quality of life and escalated costs brought about by ill-health. Preventive programmes to improve population vitamin D status exist but little is known about their cost-effectiveness. This information is vital so that decision-makers adopt efficient strategies and optimise use of public resources. Aims: Systematically review and critically appraise economic evaluations of population strategies to prevent VDD. Methods: The databases reviewed were MEDLINE, EMBASE, Econlit, NHS EED, CEA, and RepEc. All full economic evaluations of VDD prevention strategies were included. Interventions considered were food fortification, supplementation and public health campaigns. Data extracted included type of evaluation, population, setting, measure of benefit and main results. Results: Of the 2492 records screened, 14 studies were included. The majority of studies focused on supplementation within at-risk groups with the primary objective of either preventing fractures or falls in older adults. There was insufficient economic evidence to draw conclusions about the cost-effectiveness of population strategies. No study was identified that offered a direct comparison of the two main alternative population strategies: food fortification vs. supplementation. Conclusions: Whilst there is a growing body of evidence on the cost-effectiveness of micro nutrient programmes, there is a paucity of data on vitamin D fortification and how fortification programmes compare to population supplementation programmes. We highlight research gaps, and offer suggestions of what is required to undertake population-based cost-effectiveness analysis.

Cost-effectiveness of vitamin D supplementation and exercise in preventing injurious falls among older home-dwelling women: findings from an RCT.

UNLABELLED: This study assessed the cost-effectiveness of vitamin D supplementation and exercise, separately and combined, in preventing medically attended injurious falls among older home-dwelling Finnish women. Given a willingness to pay of €3,000 per injurious fall prevented, the exercise intervention had an 86 % probability of being cost-effective in this population. INTRODUCTION: The costs of falling in older persons are high, both to the individual and to society. Both vitamin D and exercise have been suggested to reduce the risk of falls. This study assessed the cost-effectiveness of vitamin D supplementation and exercise, separately and combined, in preventing medically attended injurious falls among older Finnish women. METHODS: Economic evaluation was based on the results of a previously published 2-year randomized controlled trial (RCT) where 409 community-dwelling women aged 70 to 80 years were recruited into four groups: (1) no exercise + placebo (D-Ex-), (2) no exercise + vitamin D 800 IU/day (D+Ex-), (3) exercise + placebo (D-Ex+), and (4) exercise + vitamin D 800 IU/day (D+Ex+). The outcomes were medically attended injurious falls and fall-related health care utilization costs over the intervention period, the latter evaluated from a societal perspective based on 2011 unit costs. Incremental cost-effectiveness ratios (ICER) were calculated for the number of injurious falls per person-year prevented and uncertainty estimated using bootstrapping. RESULTS: Incidence rate ratios (95 % CI) for medically attended injurious falls were lower in both Ex+ groups compared with D-Ex-: 0.46 (0.22 to 0.95) for D-Ex+, 0.38 (0.17 to 0.81) for D+Ex+. Step-wise calculation of ICERs resulted in exclusion of D+Ex- as more expensive and less effective. Recalculated ICERs were €221 for D-Ex-, €708 for D-Ex+, and €3,820 for D+Ex+; bootstrapping indicated 93 % probability that each injurious fall avoided by D-Ex+ per person year costs €708. At a willingness to pay €3,000 per injurious fall prevented, there was an 85.6 % chance of the exercise intervention being cost-effective in this population. CONCLUSIONS: Exercise was effective in reducing fall-related injuries among community-dwelling older women at a moderate cost. Vitamin D supplementation had marginal additional benefit. The results provide a firm basis for initiating feasible and cost-effective exercise interventions in this population.

Psoriasis treatment and management - a systematic review of full economic evaluations.

BACKGROUND: Psoriasis frequently requires lifetime control and current therapies vary significantly in price. High-quality economic evaluations are necessary to determine if higher-cost treatments are value for money. OBJECTIVES: This review aims to identify the cost-effectiveness of psoriasis care (whether more expensive interventions are associated with savings in health care and psoriasis management and/or improve patients' health); assess the level of uncertainty and transferability of this evidence to policy and practice; and, identify future research needs. METHODS: Searches of electronic databases Embase, MEDLINE and NHS EED for full economic evaluations were conducted in January 2012 (updated April 2014). Included articles were screened, selected and critically appraised using predefined inclusion criteria and data extraction forms: 1355 articles were identified; 37 papers reporting 71 comparisons met the inclusion criteria. Treatments evaluated were systemic (n = 45), topical (n = 22), phototherapies (n = 14) and combination (n = 4). RESULTS: Despite a significant number of recent economic evaluations, the cost-effectiveness of all therapies remains unclear. This uncertainty arises from a diversity in settings, perspective and design. Economic evaluations were constrained by limited availability of high-quality short- and long-term head-to-head comparisons of the effectiveness, safety and adherence of different interventions. CONCLUSIONS: The economic evidence is dominated by comparisons of interventions to placebo, with implicit comparisons of different therapies. There is a lack of evaluations of service model innovations to deliver complex packages of care for psoriasis. Primary and secondary integrated clinical and economic research is needed to address the limitations and to identify patient preferences and barriers/facilitators to treatment.

Cost-effectiveness of vitamin D and calcium supplementation in the treatment of elderly women and men with osteoporosis.

BACKGROUND: The supplementation with vitamin D and calcium has been recommended for elderly, specifically those with increased risk of fractures older than 65 years. This study aims to assess the cost-effectiveness of vitamin D and calcium supplementation in elderly women and men with osteoporosis and therefore to assess if this recommendation is justified in terms of cost-effectiveness. METHODS: A validated model for economic evaluations in osteoporosis was used to estimate the cost per quality-adjusted life-year (QALY) gained of vitamin D/calcium supplementation compared with no treatment. The model was populated with cost and epidemiological data from a Belgian health-care perspective. Analyses were conducted in women and men with a diagnosis of osteoporosis (i.e. bone mineral density T-score ≤-2.5). A literature search was conducted to describe the efficacy of vitamin D and calcium in terms of fracture risk reduction. RESULTS: The cost per QALY gained of vitamin D/calcium supplementation was estimated at €40 578 and €23 477 in women and men aged 60 years, respectively. These values decreased to €7912 and €10 250 at the age of 70 years and vitamin D and calcium supplementation was cost-saving at the age of 80 years, meaning that treatment cost was less than the costs of treating osteoporotic fractures of the no-treatment group. CONCLUSION: This study suggests that vitamin D and calcium supplementation is cost-effective for women and men with osteoporosis aged over 60 years. From an economic perspective, vitamin D and calcium should therefore be administrated in these populations including those also taking other osteoporotic treatments.

Utilization and costs of medications associated with CKD mineral and bone disorder in dialysis patients enrolled in Medicare Part D.

BACKGROUND: Information is limited regarding utilization patterns and costs for chronic kidney disease-mineral and bone disorder (CKD-MBD) medications in Medicare Part D-enrolled dialysis patients. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Annual cohorts of dialysis patients, 2007-2010. PREDICTORS: Cohort year, low-income subsidy status, and dialysis provider. OUTCOMES: Utilization and costs of prescription phosphate binders, oral and intravenous vitamin D analogues, and cinacalcet. MEASUREMENTS: Using logistic regression, we calculated adjusted odds of medication use for low-income subsidy versus non-low-income subsidy patients and for patients from various dialysis organizations, and we report per-member-per-month and average out-of-pocket costs. RESULTS: Phosphate binders (∼83%) and intravenous vitamin D (77.5%-79.3%) were the most commonly used CKD-MBD medications in 2007 through 2010. The adjusted odds of prescription phosphate-binder, intravenous vitamin D, and cinacalcet use were significantly higher for low-income subsidy than for non-low-income subsidy patients. Total Part D versus CKD-MBD Part D medication costs increased 22% versus 36% from 2007 to 2010. For Part D-enrolled dialysis patients, CKD-MBD medications represented ∼50% of overall net Part D costs in 2010. LIMITATIONS: Inability to describe utilization and costs of calcium carbonate, an over-the-counter agent not covered under Medicare Part D; inability to reliably identify prescriptions filled through a non-Part D reimbursement or payment mechanism; findings may not apply to dialysis patients without Medicare Part D benefits or with Medicare Advantage plans, or to pediatric dialysis patients; could identify only prescription drugs dispensed in the outpatient setting; inability to adjust for MBD laboratory values. CONCLUSIONS: Part D net costs for CKD-MBD medications increased at a faster rate than costs for all Part D medications in dialysis patients despite relatively stable use within medication classes. In a bundled environment, there may be incentives to shift to generic phosphate binders and reduce cinacalcet use.

Cost-effectiveness analysis of hip fracture prevention with vitamin D supplementation: a Markov micro-simulation model applied to the French population over 65 years old without previous hip fracture.

UNLABELLED: We performed a cost-effectiveness analysis of four vitamin D supplementation strategies for primary prevention of hip fracture among the elderly population and found that the most cost-effective strategy was screening for vitamin D insufficiency followed by adequate treatment to attain a minimum 25(OH) serum level. INTRODUCTION: Vitamin D supplementation has a demonstrated ability to reduce the incidence of hip fractures. The efficiency of lifetime supplementation has not yet been assessed in the population over 65 years without previous hip fracture. The objective was to analyze the efficiency of various vitamin D supplementation strategies for that population. METHODS: A Markov micro-simulation model was built with data extracted from published studies and from the French reimbursement schedule. Four vitamin D supplementation strategies were evaluated on our study population: (1) no treatment, (2) supplementation without any serum level check; (3) supplementation with a serum level check 3 months after initiation and subsequent treatment adaptation; (4) population screening for vitamin D insufficiency followed by treatment based on the vitamin D serum level. RESULTS: "Treat, then check" and "screen and treat" were two cost-effective strategies and dominated "treat without check" with incremental cost-effectiveness ratios of €5,219/quality-adjusted life-years (QALY) and €9,104/QALY, respectively. The acceptability curves showed that over €6,000/QALY, the "screen and treat" strategy had the greatest probability of being cost-effective, and the "no treatment" strategy would never be cost-effective if society were willing to spend over €8,000/QALY. The sensitivity analysis showed that among all parameters varying within realistic ranges, the cost of vitamin D treatment had the greatest effect and yet remained below the WHO cost-effectiveness thresholds. CONCLUSIONS: Population screening for vitamin D insufficiency followed by treatment based on the vitamin D serum level is the most cost-effective strategy for preventing hip fracture occurrence in the population over 65 years old.

Cost-minimization study comparing annual infusion of zoledronic acid or weekly oral alendronate in women with low bone mineral density.

Cost-minimization study to assess the annual direct costs of 2 antiresorptive strategies in postmenopausal women with low bone mineral densities (BMDs). Patients were randomly assigned to receive 70 mg of oral weekly alendronate or a 1-time 5mg of intravenous zoledronic acid. All medical and nonmedical direct costs were recorded for 1 yr. Student's t-test or the Chi-squared test was used. A total of 101 postmenopausal women were enrolled with a mean age of 58.3 ± 7.6 yr and a postmenopausal period of 13.5 ± 8.3 yr. A total of 50 patients completed 1 yr of alendronate and 51 patients received zoledronic acid. At baseline, no differences were seen between the 2 groups in anthropometric measures, comorbidities, and bone mineral density. The costs for medical attention for low bone mass were $81,532 (US Dollars) for the alendronate group and $69,251 for the zoledronic acid group; the cost per patient was $1631 in the alendronate group vs $1358 in the zoledronic acid group (p<0.0001). Therefore, zoledronic acid treatment provided an annual savings of 15% of the direct costs compared with oral alendronate treatment. Moreover, there was a significant increase in lumbar spine T-scores in the zoledronic acid group when compared with the alendronate group. Annual zoledronic acid infusion as an antiresorptive treatment in women with low BMD provides significant monetary savings when compared with weekly alendronate therapy for 1 yr. Zoledronic acid infusion is also linked to higher increase in BMD and compliance.

Topical therapies for the treatment of localized plaque psoriasis in primary care: a cost-effectiveness analysis.

BACKGROUND: Topical therapies are a mainstay of psoriasis treatment, but they vary substantially in terms of cost. OBJECTIVES: To determine the cost-effectiveness and optimal treatment sequence for psoriasis of the trunk, limbs and scalp. METHODS: Probabilities of response from a network meta-analysis were used to determine the short-term efficacy of topical therapies. Longer-term outcomes, including relapse, were informed by published evidence and clinical opinion. Benefits of treatment were measured as quality-adjusted life years (QALYs). Direct costs included topical agents, primary and secondary care visits and second-line therapies for treatment failures. RESULTS: For the trunk and limbs, initial treatment with a two-compound formulation (TCF) product containing vitamin D and potent corticosteroid provided the most QALYs, followed by separate morning and evening application of vitamin D and potent corticosteroid [two-compound application, TCA (am/pm)], and then twice-daily potent corticosteroids. The use of twice-daily potent corticosteroids was the most cost-effective first-line strategy (incremental cost-effectiveness ratio £ 20,000 per QALY), followed by TCA (am/pm) (£ 22,658 per QALY) and TCF product (£ 179,439 per QALY). For scalp psoriasis, initial treatment with very potent corticosteroids generated the most QALYs, followed by TCF product and then potent corticosteroids. Very potent corticosteroids were the most cost-effective treatment but, if too aggressive, potent corticosteroids were optimal followed by TCF product (£ 219,846 per QALY). The cost-effectiveness of second- and third-line topical agents varied with the assumptions made. CONCLUSIONS: Potent corticosteroids, used alone or in combination with vitamin D, are the most cost-effective treatment for patients with psoriasis of the trunk and limbs. Potent or very potent corticosteroids are the most cost-effective treatment for patients with scalp psoriasis.

[Kidney and bone update : the 5-year history and future of CKD-MBD. Pharmacoeconomics in the field of CKD-MBD].

Pharmacoeconomics (PE) , which contributes to the decisions on the population rather than the patient level such as policy making, provides us with the cost and value of a given drug. Recent Japanese PE studies in the field of CKD-MBD are reviewed in this manuscript. Lanthnum carbonate is not cost effective as a first-line phosphate binder, while cost effective as a second-line drug added on conventional treatments for those with serum phosphate >6.0 mg/dL, as shown in incremental cost-effectiveness ratio (ICER) of $34,896. Cinacalcet hydrochloride was found to be cost effective only for those who cannot undergo parathyroidectomy. Taking these findings into account, when cinacalcet have to be used, we should give priority to calcium containing phosphate binders rather than expensive sevelamer or lanthanum from the viewpoint of the medical cost. Moreover, the doses of cinacalcet should be minimized by administering inexpensive vitamin D concomitantly.

Potential of Vitamin D Food Fortification in Prevention of Cancer Deaths-A Modeling Study.

Meta-analyses of randomized controlled trials (RCTs) have estimated a 13% reduction of cancer mortality by vitamin D supplementation among older adults. We evaluated if and to what extent similar effects might be expected from vitamin D fortification of foods. We reviewed the literature on RCTs assessing the impact of vitamin D supplementation on cancer mortality, on increases of vitamin D levels by either supplementation or food fortification, and on costs of supplementation or fortification. Then, we derived expected effects on total cancer mortality and related costs and savings from potential implementation of vitamin D food fortification in Germany and compared the results to those for supplementation. In RCTs with vitamin D supplementation in average doses of 820-2000 IU per day, serum concentrations of 25-hydroxy-vitamin D increased by 15-30 nmol/L, respectively. Studies on food fortification found increases by 10-42 nmol/L, thus largely in the range of increases previously demonstrated by supplementation. Fortification is estimated to be considerably less expensive than supplementation. It might be similarly effective as supplementation in reducing cancer mortality and might even achieve such reduction at substantially larger net savings. Although vitamin D overdoses are unlikely in food fortification programs, implementation should be accompanied by a study monitoring the frequency of potentially occurring adverse effects by overdoses, such as hypercalcemia. Future studies on effectiveness of vitamin D supplementation and fortification are warranted.

Economic analysis of cinacalcet in combination with low-dose vitamin D versus flexible-dose vitamin D in treating secondary hyperparathyroidism in hemodialysis patients.

BACKGROUND: The ACHIEVE (Optimizing the Treatment of Secondary Hyperparathyroidism: A Comparison of Sensipar and Low Dose Vitamin D vs Escalating Doses of Vitamin D Alone) trial evaluated the efficacy of treatment with cinacalcet plus low-dose activated vitamin D analogues (Cinacalcet-D) compared with vitamin D analogues alone (Flex-D) in attaining KDOQI (Kidney Disease Outcomes Quality Initiative) targets for secondary hyperparathyroidism (SHPT). The economic implications of these treatment regimens have not been explored. STUDY DESIGN: Economic analysis of SHPT treatment in hemodialysis patients. SETTING & POPULATION: This analysis used data from the ACHIEVE trial, in which patients received either Cinacalcet-D or Flex-D. MODEL, PERSPECTIVE, & TIME FRAME: We assessed the relative cost-effectiveness of these regimens in treating SHPT during the 27-week ACHIEVE trial, using a US payer perspective, with medication costs valued in 2006 US dollars. INTERVENTION & OUTCOMES: Relative cost-effectiveness was assessed using cost-minimization analysis or incremental cost-effectiveness ratios. Effectiveness was measured using biochemical markers. RESULTS: Mean medication costs per patient were $5,852 and $4,332 for the Cinacalcet-D and Flex-D treatment arms, respectively. There were no significant differences for the primary end point (parathyroid hormone level of 150-300 pg/mL and calcium-phosphorus product < 55 mg²/dL²) and several of the secondary end points, rendering Cinacalcet-D more costly than Flex-D. For secondary end points, for which Cinacalcet-D was more effective, incremental cost-effectiveness ratios ranged from $2,957 (calcium < 9.5 mg/dL) to $22,028 (all KDOQI targets) per patient reaching target. Switching to generic calcitriol would have increased the cost difference between treatment arms ($2,079), whereas switching sevelamer to lanthanum decreased the difference ($1,426). LIMITATIONS: Costs and outcomes were derived from a short-term randomized controlled trial and were protocol driven. Clinical outcomes, such as mortality, were not available. Long-term economic conclusions cannot be drawn from these data. CONCLUSIONS: Cinacalcet combined with vitamin D analogues was no more effective than vitamin D analogues in achieving the primary ACHIEVE end point and incurred greater costs. This conclusion was not tempered substantially by the cost of vitamin D analogues or oral phosphate binders. Whether the additional costs of cinacalcet are warranted will require longer term models to determine whether changes in serum levels of mineral metabolic markers translate into lower morbidity, mortality, and downstream costs.

Cost-Effectiveness and Estimated Health Benefits of Treating Patients with Vitamin D in Pre-Dialysis.

Background The optimal timing of treatment with vitamin D therapy for patients with chronic kidney disease (CKD), vitamin D insufficiency, and secondary hyperparathyroidism (SHPT) is a pressing question in nephrology with economic and patient outcome implications. Objective The objective of this study was to estimate the cost-effectiveness of earlier vitamin D treatment in CKD patients not on dialysis with vitamin D insufficiency and SHPT. Design A cost-effectiveness analysis based on a Markov model of CKD progression was developed from the Medicare perspective. The model follows a hypothetical cohort of 1000 Stage 3 or 4 CKD patients over a 5-year time horizon. The intervention was vitamin D therapy initiated in CKD stages 3 or 4 through CKD stage 5/end-stage renal disease (ESRD) versus initiation in CKD stage 5/ESRD only. The outcomes of interest were cardiovascular (CV) events averted, fractures averted, time in CKD stage 5/ESRD, mortality, quality-adjusted life years (QALYs), and costs associated with clinical events and CKD stage. Results Vitamin D treatment in CKD stages 3 and 4 was a dominant strategy when compared to waiting to treat until CKD stage 5/ESRD. Total cost savings associated with treatment during CKD stages 3 and 4, compared to waiting until CKD stage 5/ESRD, was estimated to be $19.9 million. The model estimated that early treatment results in 159 averted CV events, 5 averted fractures, 269 fewer patient-years in CKD stage 5, 41 fewer deaths, and 191 additional QALYs. Conclusions Initiating vitamin D therapy in CKD stages 3 or 4 appears to be cost-effective, largely driven by the annual costs of care by CKD stage, CV event costs, and risks of hypercalcemia. Further research demonstrating causal relationships between vitamin D therapy and patient outcomes is needed to inform decision making regarding vitamin D therapy timing.

Eggs Are Cost-Efficient in Delivering Several Shortfall Nutrients in the American Diet: A Cost-Analysis in Children and Adults.

The purpose of the current study was to examine the cost of eggs in relation to nutrient delivery in children and adults. The present analysis used dietary intake data from the National Health and Nutrition Examination Survey 2013-2016 (egg consumers: 2-18 years-old, N = 956; 19+ years-old, N = 2424). Inflation adjusted food cost and the cost of nutrients were obtained from the Center for Nutrition Promotion and Policy food cost database. Cost and nutrient profiles for What We Eat in America food categories were compared to whole eggs. Of the 15 main food groups examined, whole eggs ranked third for lowest cost per 100 g (excluding beverages), such that eggs cost 0.35 USD per 100 g, with dairy and grains representing the first and second most cost-efficient foods, at 0.23 USD and 0.27 USD per 100 g, respectively. In children and adults, eggs represented a cost-efficient food for protein delivery, such that eggs provided nearly 2.7% and 3.7% of all protein in the diet, respectively, at a cost of about 0.03 USD per g of protein. Eggs contributed 3.8% and 6.0% of all vitamin A in the diet of children and adults, at a cost of approximately 0.002 USD and 0.003 USD per RAE mcg of vitamin A, respectively. In children 2-18 years-old, nearly 12% of all choline in the diet is delivered from eggs, at a cost of approximately 0.002 USD per mg of choline. Similarly, in adults 19-years-old+, eggs provide nearly 15% of all dietary choline in the diet, at a cost of approximately 0.002 USD per mg of choline. Eggs provide nearly 5% and 9.5% of all vitamin D in the diet of children and adults, at a cost of approximately 0.21 USD and 0.22 USD per mcg of vitamin D, respectively. Overall, eggs ranked as the most cost-efficient food for delivering protein, choline, and vitamin A, second for vitamin E, and third for vitamin D in children. In adults, eggs ranked as the most cost-efficient food for delivering protein and choline, second for vitamin A, and third for vitamin D and vitamin E. In summary, eggs represent an economical food choice for the delivery of protein and several shortfall nutrients (choline, vitamin A, and vitamin D) in the American diet.

The economic case for prevention of population vitamin D deficiency: a modelling study using data from England and Wales.

BACKGROUND: Vitamin D deficiency (VDD) affects the health and wellbeing of millions worldwide. In high latitude countries such as the United Kingdom (UK), severe complications disproportionally affect ethnic minority groups. OBJECTIVE: To develop a decision-analytic model to estimate the cost effectiveness of population strategies to prevent VDD. METHODS: An individual-level simulation model was used to compare: (I) wheat flour fortification; (II) supplementation of at-risk groups; and (III) combined flour fortification and supplementation; with (IV) a 'no additional intervention' scenario, reflecting the current Vitamin D policy in the UK. We simulated the whole population over 90 years. Data from national nutrition surveys were used to estimate the risk of deficiency under the alternative scenarios. Costs incurred by the health care sector, the government, local authorities, and the general public were considered. Results were expressed as total cost and effect of each strategy, and as the cost per 'prevented case of VDD' and the 'cost per Quality Adjusted Life Year (QALY)'. RESULTS: Wheat flour fortification was cost saving as its costs were more than offset by the cost savings from preventing VDD. The combination of supplementation and fortification was cost effective (£9.5 per QALY gained). The model estimated that wheat flour fortification alone would result in 25% fewer cases of VDD, while the combined strategy would reduce the number of cases by a further 8%. CONCLUSION: There is a strong economic case for fortifying wheat flour with Vitamin D, alone or in combination with targeted vitamin D3 supplementation.