Evaluation of a Pharmacy-Driven Calcitonin Protocol for Treating Hypercalcemia in Hospitalized Patients: A Multisite Study.

BACKGROUND: The dramatic increase in the acquisition cost of injectable calcitonin led to creating a pharmacy-driven calcitonin protocol to improve the appropriate use of calcitonin and other treatment modalities for hypercalcemia. OBJECTIVE: This study aimed to characterize the use of calcitonin before and after implementation of a pharmacy-driven calcitonin protocol. METHODS: This was a multi-center, retrospective study of the use of injectable calcitonin in adult hospitalized patients with hypercalcemia. The study included patients treated with calcitonin from October 2014 to September 2016 and from October 2017 to September 2019. The primary outcomes were percentage of patients with a complete response, partial response, and non-responders. The secondary outcomes were time to relapse, duration of partial response, number of doses, and associated costs of calcitonin. RESULTS: Of the 131 patients included in this study, 93 were included in a pre-protocol group and 38 were included in a post-protocol group. The primary outcome of complete response by 3 days was met in 28% of patients in the pre-protocol group and 53% of patients in the post-protocol group (P = 0.007). Calcitonin spending in dollars in the pre-protocol group was $818,956 compared to $224,320 in the post-protocol group; a difference of $594,636. CONCLUSION: Implementation of a pharmacy-driven calcitonin protocol effectively improved calcium levels, reduced inappropriate calcitonin use, and reduced calcitonin spending during a period of 2 fiscal years.

Calcitonin Stewardship Strategies.

Despite being approved by the Food and Drug Administration for over 30 years, calcitonin salmon has seen a dramatic increase in acquisition cost over the last few years. Being commonly used for the treatment of hypercalcemia of malignancy, health systems must implement stewardship strategies in order to curtail usage. This review is intended to provide a background on calcitonin usage for hypercalcemia of malignancy and associated strategies to ensure appropriateness of utilization within health systems.

Saving antibiotics prescribed in pharyngitis and lower respiratory tract infections in Primary Care: Author's reply / Ahorro de antibióticos prescritos en faringitis e infecciones del tracto respiratorio inferior en Atención Primaria: Respuesta de los autores

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Clinical and Cost-Effectiveness of Procalcitonin Test for Prodromal Meningococcal Disease-A Meta-Analysis.

BACKGROUND: Despite vaccines and improved medical intensive care, clinicians must continue to be vigilant of possible Meningococcal Disease in children. The objective was to establish if the procalcitonin test was a cost-effective adjunct for prodromal Meningococcal Disease in children presenting at emergency department with fever without source. METHODS AND FINDINGS: Data to evaluate procalcitonin, C-reactive protein and white cell count tests as indicators of Meningococcal Disease were collected from six independent studies identified through a systematic literature search, applying PRISMA guidelines. The data included 881 children with fever without source in developed countries.The optimal cut-off value for the procalcitonin, C-reactive protein and white cell count tests, each as an indicator of Meningococcal Disease, was determined. Summary Receiver Operator Curve analysis determined the overall diagnostic performance of each test with 95% confidence intervals. A decision analytic model was designed to reflect realistic clinical pathways for a child presenting with fever without source by comparing two diagnostic strategies: standard testing using combined C-reactive protein and white cell count tests compared to standard testing plus procalcitonin test. The costs of each of the four diagnosis groups (true positive, false negative, true negative and false positive) were assessed from a National Health Service payer perspective. The procalcitonin test was more accurate (sensitivity=0.89, 95%CI=0.76-0.96; specificity=0.74, 95%CI=0.4-0.92) for early Meningococcal Disease compared to standard testing alone (sensitivity=0.47, 95%CI=0.32-0.62; specificity=0.8, 95% CI=0.64-0.9). Decision analytic model outcomes indicated that the incremental cost effectiveness ratio for the base case was £-8,137.25 (US $ -13,371.94) per correctly treated patient. CONCLUSIONS: Procalcitonin plus standard recommended tests, improved the discriminatory ability for fatal Meningococcal Disease and was more cost-effective; it was also a superior biomarker in infants. Further research is recommended for point-of-care procalcitonin testing and Markov modelling to incorporate cost per QALY with a life-time model.

Clinical relevance of procalcitonin and C-reactive protein as infection markers in renal impairment: a cross-sectional study.

INTRODUCTION: Although the clinical application of procalcitonin (PCT) as an infection marker in patients with impaired renal function (estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m(2)) has been increasing recently, it is unclear whether PCT is more accurate than C-reactive protein (CRP). We investigated the clinical value of CRP and PCT based on renal function. METHODS: From November 2008 to July 2011, a total of 493 patients who simultaneously underwent CRP and PCT tests were enrolled. The area under the receiver operating characteristic (ROC) curve and characteristics of both markers were analyzed according to infection severity and renal function. RESULTS: In patients with impaired renal function, the area under the ROC curve was 0.876 for CRP and 0.876 for PCT. In patients with infection, CRP levels differed depending on whether the infection was localized, septic, or severely septic, whereas PCT levels were higher in patients with severe sepsis or septic shock. In patients without infection, CRP did not correlate with eGFR, while PCT was negatively correlated with eGFR. CONCLUSION: This study demonstrates that CRP is accurate for predicting infection in patients with impaired renal function. The study suggests that in spite of its higher cost, PCT is not superior to CRP as an infection marker in terms of diagnostic value.

Cost-effectiveness of procalcitonin-guided antibiotic therapy for outpatient management of acute respiratory tract infections in adults.

BACKGROUND: Two clinical trials suggest that procalcitonin-guided antibiotic therapy can safely reduce antibiotic prescribing in outpatient management of acute respiratory tract infections (ARTIs) in adults. Yet, it remains unclear whether procalcitonin testing is cost-effective in this setting. OBJECTIVE: To evaluate the cost-effectiveness of procalcitonin-guided antibiotic therapy in outpatient management of ARTIs in adults. DESIGN: Cost-effectiveness model based on results from two published European clinical trials, with all parameters varied widely in sensitivity analyses. PATIENTS: Two hypothetical cohorts were modeled in separate trial-based analyses: adults with ARTIs judged by their physicians to require antibiotics and all adults with ARTIs. INTERVENTIONS: Procalcitonin-guided antibiotic therapy protocols versus usual care. MAIN MEASURES: Costs and cost per antibiotic prescription safely avoided. KEY RESULTS: We estimated the health care system willingness-to-pay threshold as $43 (range $0­$333) per antibiotic safely avoided, reflecting the estimated cost of antibiotic resistance per outpatient antibiotic prescribed. In the cohort including all adult ARTIs judged to require antibiotics by their physicians, procalcitonin cost $31 per antibiotic prescription safely avoided and the likelihood of procalcitonin use being favored compared to usual care was 58.4 % in a probabilistic sensitivity analysis. In the analysis that included all adult ARTIs, procalcitonin cost $149 per antibiotic prescription safely avoided and the likelihood of procalcitonin use being favored was 2.8 %. CONCLUSIONS: Procalcitonin-guided antibiotic therapy for outpatient management of ARTIs in adults would be cost-effective when the costs of antibiotic resistance are considered and procalcitonin testing is limited to adults with ARTIs judged by their physicians to require antibiotics.

Evidence to inform decision makers in Thailand: a cost-effectiveness analysis of screening and treatment strategies for postmenopausal osteoporosis.

OBJECTIVES: To assess value for money of providing systematic screening for osteoporosis among postmenopausal women and medical treatments for those diagnosed with osteoporosis as evidence-based decision making for the revision of the National List of Essential Medicines. METHODS: Decision analytic models were constructed, using a societal perspective, to assess the cost per quality-adjusted life-years (QALYs) gained from systematic screening using the Osteoporosis Self-Assessment Tool and dual-energy X-ray absorptiometry or dual-energy X-ray absorptiometry alone compared with no screening. Alendronate, risedronate, raloxifene, and nasal calcitonin were economically evaluated to determine a treatment of choice for the prevention of osteoporosis-related fractures. Most input parameters were obtained from literature reviews, and systematic reviews and meta-analyses, if available. The service costs and related household expenses were based on the Thai setting. Probabilistic and one-way sensitivity analyses were used to incorporate the impact of parameter uncertainty. RESULTS: The Osteoporosis Self-Assessment Tool and sequential dual-energy X-ray absorptiometry provided better value for money for osteoporosis screening among young age groups (<60 years old). Although there was no significant difference in cost per QALY for older age groups, alendronate provided the lowest incremental cost-effectiveness ratio while nasal calcitonin presented the highest incremental cost-effectiveness ratio. It was shown that providing medication for a secondary prevention yielded a much higher cost per QALY gained compared with providing medication for a primary prevention. CONCLUSIONS: Given the benchmark set at 100,000 Thai baht per QALY gained, providing systematic screening and treatment for osteoporosis was cost-ineffective in the Thai setting.

Cost-effectiveness strategies to treat osteoporosis in elderly women.

BACKGROUND: Comparing the cost-effectiveness of various antiosteoporotic drugs has not been defined. METHODS: We determined the cost-effectiveness of calcitonin, raloxifene, bisphosphates and PTH in a base-case cohort of women aged 65 or older with osteoporosis. After bone densitometry, women were stratified into groups of treatment or no treatment. Our outcome goal was a value of dollars 100,000 or less per quality-adjusted life years (QALY). A sensitivity analysis varied nonvertebral fracture reduction and compliance between the two most effective strategies to test various cost per QALY thresholds. RESULTS: Bisphosphonates displayed the most favorable incremental cost saving and prevented more fractures in our base-case analysis. In a sensitivity analysis, virtually all values of bisphosphonates were under dollars 100,000 per QALY and parathyroid hormone (PTH) was between dollars 100,000 and dollars 200,000 per QALY. CONCLUSIONS: Only bisphosphonates are cost-effective for fracture prevention in osteoporotic women aged 65 or older and this economic advantage is also maintained in subsets who have a lower relative risk of future fracture.

[Osteoporosis treatment in Portugal: trends and geographical variation]. / Tratamento da osteoporose em Portugal: tendência e variação geográfica.

INTRODUCTION: The drugs available in the Portuguese market, for the treatment of osteoporosis, have different mechanisms of action, efficacy, indications, safety profile, and cost, which may influence prescription and acquisition by patients. OBJECTIVES: To describe the use of drugs for osteoporosis treatment (estimated by sales), between 1998 and 2004, and the geographical variation in the drug utilization, in 2004. METHODS: Data was obtained from IMS Health for the sales of drugs used in the ambulatory treatment of osteoporosis, in the whole country, from 1998 to 2004, and by region, in 2004. For each group (bisphosphonates, raloxifene, calcitonins, Hormone replacement therapy (HRT) and calcium and vitamin D), we computed the sum of the amount of packages and the value of the sales in each year, regardless of the strength or the package size. For bisphosphonates, raloxifene and calcitonins, we computed the DDD (Defined Daily Dose) sold in Portugal. All consumption data are presented by women aged 45 to 74 years. National data was used to describe the trends in sales, from 1998 to 2004, and regional data was used to map the 2004 consumptions. RESULTS: The expenses with drugs used in osteoporosis increased 60% from 1998 to 2004. The bisphosphonates sales increased more than five times, and in 2004 this group was responsible for 60% of the national market of drugs for osteoporosis treatment. Raloxifene represented approximately 10% of the sales in 2004. The consumption of calcitonins decreased nearly 70% in the observation period. The use of HRT increased 30% to 40% until 2001/2002, and decreased just about the same from there on. Geographical differences were observed in the sales of osteoporosis drugs in 2004, the amplitude of variation ranging from two (bisphosphonates, calcium and vitamin D, HRT) to three times (raloxifene, calcitonins) across regions. The lowest consumptions were observed in Beja and Bragança, and the highest in Aveiro. Raloxifene is used mainly in the Northwest of the country, and HRT in the sea side regions. CONCLUSIONS: In Portugal, the trends in the consumption of drugs used for osteoporosis treatment, as well as the relative weight of each pharmacological group, follow a similar pattern to the observed in other countries. The differences in consumption across the years and regions may reflect a variation in the frequency of disease or in the proportion of subjects being treated, but the magnitude of the variation suggests that there are unmet needs in diagnosis and treatment of osteoporosis in our country, and that social and economic factors may contribute to the regional differences observed.

Effects of alendronate and calcitonin on bone mineral density in postmenopausal osteoporotic women. An observational study.

OBJECTIVE: Alendronate and calcitonin are antiresorptive drugs that were used for the treatment of postmenopausal osteoporosis and were shown to increase bone mineral density (BMD). However, the effect of both drugs in daily clinical practice may differ from that observed in clinical trials. METHOD: About 50 postmenopausal osteoporotic women were observed during their first year of treatment. Among them, 32 patients used alendronate and 18 used calcitonin. Lumbar spine and femoral neck BMD were measured by dual energy X-ray absorptiometry (DXA) at baseline and after 1 year of therapy. Biochemical markers (B-ALP--bone-specific alkaline phosphatase, OTC--osteocalcin and DPD/UCr--deoxypyridinoline/creatinine ratio) of bone metabolism were measured at baseline and 6 months later. Patient compliance was assumed by tablet counting and verified at interview. Each patient was further questioned about her attitude towards the treatment, as well as her dairy product intake, physical activity, use of other medications, smoking and social status. MAIN OUTCOME MEASURE: (1) Annual percent change in BMD in lumbar spine and femoral neck after the one-year treatment with either alendronate or calcitonin. (2) The change in biochemical markers of bone turnover. RESULTS: The lumbar spine BMD significantly increased by 7.0% (P < 0.001), the femoral neck BMD by 4.3% (P < 0.01). OTC, B-ALP and DPD/UCr decreased significantly during the therapy with alendronate. Compliance with therapy was 79% (95% CI 68-90%). In the calcitonin-treated group, the lumbar spine BMD significantly increased by 3.1 % (P < 0.05), while the femoral neck BMD remained unchanged. OTC, B-ALP and DPD/UCr did not change significantly during the treatment with calcitonin. Compliance with calcitonin therapy was 87% (95% CI 63-110%). The annual change of BMD in both treatment groups was independent on all questioned factors. CONCLUSION: In daily practice, alendronate enhanced significantly BMD both in lumbar spine and femoral neck. Calcitonin showed increase only in the lumbar spine BMD.

Cost effectiveness of nasal calcitonin in postmenopausal women: use of Cochrane Collaboration methods for meta-analysis within economic evaluation.

OBJECTIVE: To assess the cost effectiveness of nasal calcitonin (Miacalcin) compared with no therapy, alendronate or etidronate in the treatment of postmenopausal women with previous osteoporotic fracture. DESIGN AND SETTING: Meta-analysis followed by economic analysis. PERSPECTIVE: A Canadian provincial Ministry of Health. METHODS: The meta-analysis of randomised controlled clinical trials was based on the recommendations of the Cochrane Collaboration. Economic analysis was conducted within a Markov model using probabilities and costs derived from Canadian sources. RESULTS: The meta-analysis found evidence of the positive effect of both nasal calcitonin and alendronate in reducing the risks of hip, wrist and vertebral fractures in postmenopausal women. However, there was a lack of evidence of the effect of etidronate on hip and wrist fractures. For a 65-year-old woman, with 5 years' therapy, the incremental cost per quality-adjusted life-year (QALY) gained for nasal calcitonin was 46,500 Canadian dollars ($Can) compared with no therapy and $Can32,600 compared with etidronate (1998 values). Comparison with alendronate was highly sensitive to the inclusion of one specific trial. CONCLUSIONS: Given the results of the analysis, based on current evidence, nasal calcitonin can be considered at the margins of being cost effective when compared with no therapy. Compared with active therapy, nasal calcitonin can be considered more cost effective than etidronate, but its cost effectiveness versus alendronate is inconclusive.

[Evaluation of the cost of non-hormonal treatment of osteoporosis]. / Evaluation du coût du traitement non hormonal de l'ostéoporose.

Osteoporosis is a disease affecting a large population of postmenopausal women. The treatment is given for a period of 5, 10, 20 years.... The cost of the treatment plays an important role in the field of health economy. A commercial form of calcium and vitamin D for 10 years represent for the patient a cost of 50,000 BF. The other treatments, alternative to hormonal substitution, have variable prices, for biphosphonates, 50,000 to 500,000 for the insurance and from 1,000 to 5,000 BF for the patient having a regular insurance. A comprehensive choice in long term treatment should take into account efficacy and cost of the treatment.

[Calcitonin prescriptions: an estimate of the expenditure due to inadequate prescription]. / Estudio de las prescripciones de calcitonina: estimación del gasto por prescripción inadecuada.

BACKGROUND: The use of calcitonin is very common in patients diagnosed with osteoporosis. The objective of this study was to determine the percentage of adequate prescriptions of calcitonin for patients with osteoporosis and to estimate the costs due to inadequate prescription. PATIENTS AND METHODS: Observational study. Four pharmacies in Osona County (Barcelona) were randomly selected. During two time periods, July-September and November-December of 1994, all women filling prescriptions for calcitonin in any of the eight pharmacies were invited to participate in the study. Adequate and inadequate prescription of calcitonin was determined based on the patient's clinical record. Justifiable and non-justifiable prescriptions were then determined after implementing a protocol and reviewing X-rays of the spine. RESULTS: Forty-eight women agreed to participate (participation rate: 68%). In the first analysis, 58.3% (95% CI: 43-72) of prescriptions were determined to be inadequate whereas in the second analysis 29.2% (95% CI: 17-44) were considered non-justifiable. Chronic back pain was associated with non-justifiable prescription of calcitonin (odds ratio: 5.2; 95% CI: 1.3-33.4). In the best of situations, the excess in annual spending due to inadequate prescription was estimated at 13 million pesetas for Osona County, 1,300 million for Catalonia, and 4,300 million for Spain. CONCLUSIONS: Between one-third and one-half of patients prescribed calcitonin in the study area apparently do not need it. Many cases of chronic back pain are being treated as osteoporosis without being properly studied. The costs derived from this incorrect practice are important. This study highlights the need for better practices in the diagnosis of osteoporosis.

Estimating the cost per avoided hip fracture by osteoporosis treatment in Italy.

OBJECTIVES: A cost-effectiveness analysis on osteoporosis treatment has been carried out as the basis for an estimate of the cost per avoided hip fracture (CPAHF) in Italy. METHODS: We have assumed as correct, reported data on the efficacy of calcitonin in preventing hip fractures in European women over 50 (Mediterranean Osteoporosis Study). Health-care costs were calculated using Weinstein and Stason's equation. RESULTS: Given the incidence of such fractures in Italy and their cost to the health service, we calculate that in order to prevent one hip fracture 1285 women need to be treated with calcitonin at a cost of over two million dollars. The introduction of an element of screening (bone mass measurement to select a high risk subpopulation) would reduce the CPAHF by 65%. Choice of a more effective treatment (as the hormone replacement therapy) would be cost-neutral. CONCLUSIONS: Drug-related costs, selection of high risk subpopulations and drug efficacy have important implications in the estimation of optimal CPAHF.

Using economics to prioritize research: a case study of randomized trials for the prevention of hip fractures due to osteoporosis.

OBJECTIVES: To assess the role of economics, in combination with clinical judgement, for setting research priorities, using osteoporosis prevention (and, as a result, hip fracture prevention) as an example. METHODS: Modelling the cost and effectiveness of each of six potential interventions to prevent hip fractures over the 5-year length of a randomized trial (vitamin D injection; thiazide diuretics; hormone replacement therapy; oral calcium and vitamin D; calcium alone; calcitonin). Drug costs were derived from the Monthly Index of Medical Specialties (MIMS); averted fracture costs and estimates of effectiveness were derived from published sources. RESULTS: Vitamin D injection proved to be the most potentially cost-effective treatment with a cost-effectiveness ratio of 584 Pounds. If averted costs are included, this leads to a saving of 9,176,496 Pounds per 100,000 women treated. By contrast, the most expensive therapy was calcitonin (marginal cost-effectiveness ratio of 433,548 Pounds). This suggests that priority should be given to trials assessing the effectiveness of vitamin D injections. CONCLUSIONS: Relatively simple economic modelling exercises can inform research priorities and could help optimize the use of scarce research resources.