Fixed Combination Calcipotriene and Betamethasone Dipropionate (Cal/BD) Foam for Beyond-Mild Psoriasis: A Possible Alternative to Systemic Medication.

Calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) aerosol foam is a topical agent indicated for the treatment of plaque psoriasis. While topical treatments are typically reserved for milder disease, in clinical trials with Cal/BD foam, the vast majority of patients had beyond-mild psoriasis at baseline, and multiple studies (including subgroup analyses from randomized controlled trials and other small-scale studies) have demonstrated favorable outcomes with the use of Cal/BD foam in this population. The objective of this article is to review existing data on the efficacy, safety, and cost-effectiveness of Cal/BD foam used in patients with beyond-mild psoriasis, either alone as topical monotherapy or as adjunctive therapy. Practical recommendations for managing beyond-mild psoriasis with Cal/BD foam are also provided. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5300.

Effectiveness comparison and incremental cost-per-responder analysis of calcipotriene 0.005%/betamethasone dipropionate 0.064% foam vs. halobetasol 0.01%/tazarotene 0.045% lotion for plaque psoriasis: a matching-adjusted indirect comparative analysis.

Background: The fixed-dose combination foam formulation of calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) has demonstrated efficacy and a favorable safety profile for the treatment of plaque psoriasis. Recently, a topical lotion of the combination of halobetasol 0.01% plus tazarotene 0.045% (HP/TAZ) was approved for treating adult plaque psoriasis. Currently, no head-to-head studies have compared Cal/BD foam with HP/TAZ lotion.Objective: Compare the effectiveness and drug incremental cost per responder (ICPR) of Cal/BD foam vs. HP/TAZ lotion in moderate-to-severe plaque psoriasis.Methods: An anchor-based, matching-adjusted indirect comparison was conducted for PGA treatment success (Physician's Global Assessment of "clear" or "almost clear," [PGA 0/1] with at least a 2-point improvement) using individual patient data from 3 randomized clinical studies of Cal/BD foam and published data from 2 randomized, Phase 3 clinical studies of HP/TAZ lotion. The number needed to treat and ICPR were also calculated.Results: After reweighting of patients in the Cal/BD foam studies to match summary baseline characteristics of the HP/TAZ lotion study patients and anchoring to vehicle effect, 4 weeks of Cal/BD foam produced a significantly greater rate of treatment success than 8 weeks of HP/TAZ lotion treatment (51.4 vs. 30.7%; treatment difference = 20.7%, p < .001). The number needed to treat with Cal/BD foam was also less than HP/TAZ lotion (1.9 vs. 3.3). Using US wholesale acquisition costs and equal weekly consumption rates, the incremental cost per PGA 0/1 responder relative to vehicle for Cal/BD foam was $3,988 and was 37% lower compared with HP/TAZ lotion ($6,294).Conclusions: The indirect comparison analyses showed that Cal/BD foam was associated with a greater rate of treatment success, lower ICPR, and quicker treatment response than HP/TAZ lotion in adult patients with moderate-to-severe plaque psoriasis.

A comparative cost-utility analysis of postoperative calcium supplementation strategies used in the current management of hypocalcemia.

BACKGROUND: Symptomatic hypocalcemia is a common complication of total thyroidectomy. Management strategies include responsive treatment initiation for symptoms or prevention by routine or parathyroid hormone-directed calcium supplementation. The comparative cost-effectiveness of even the most often utilized strategies is unclear. METHODS: A Markov cohort model was created to compare routine supplementation with calcium alone (RS), postoperative parathyroid hormone-based selective supplementation with calcium and calcitriol (SS), and no supplementation (NS) in asymptomatic patients. Patients could remain asymptomatic or develop symptomatic hypocalcemia, managed with outpatient oral supplementation or intravenous calcium infusion and administered either inpatient or outpatient. Effectiveness was measured in quality-adjusted life years. Sensitivity analyses were performed to test model parameter assumptions. RESULTS: RS was the preferred strategy, costing $329/patient and resulting in 0.497 quality-adjusted life years, which was only marginally better compared to SS ($373 for 0.495 quality-adjusted life years). NS was most costly at $4,955 for 0.491 quality-adjusted life years. Preference for RS over SS was sensitive to the probability of developing symptoms and the probability of symptom treatment with intravenous supplementation. On probabilistic sensitivity analysis, RS was preferred in 75.4% of scenarios. CONCLUSION: After total thyroidectomy, a preventative calcium supplementation strategy should be strongly considered. In this data-driven theoretical model, RS was the least costly option and resulted in an incremental gain in quality-adjusted life years.

A Cost-utility Analysis of Calcipotriol/Betamethasone Dipropionate Aerosol Foam versus Ointment for the Topical Treatment of Psoriasis Vulgaris in Sweden.

Psoriasis is a chronic inflammatory disorder that imposes a substantial economic burden. We conducted a cost-utility analysis from a Swedish healthcare payers perspective using a decision-tree model with a 12-week time horizon. Patients with psoriasis vulgaris could have two 4-week cycles of topical treatment with calcipotriol 50 µg/g and betamethasone 0.5 mg/g as dipropionate (Cal/BD) foam or Cal/BD ointment before progressing to phototherapy/methotrexate. In the base-case analysis, Cal/BD foam dominated over Cal/BD ointment. The increased efficacy of Cal/BD foam resulted in fewer consultations and a decreased risk of progressing to phototherapy/methotrexate. Although Cal/BD foam costs more than Cal/BD ointment, this was offset by lower costs for phototherapy/methotrexate or consultation visits. Sensitivity analyses revealed that the base-case net monetary benefit was robust to plausible variations in key parameters. In conclusion, Cal/BD foam was predicted to be more cost-effective than Cal/BD ointment in the treatment of psoriasis vulgaris.

Efficacy, safety, and cost-effectiveness of all-trans retinoic acid/Clobetasol Propionate Compound Ointment in the treatment of mild to moderate psoriasis vulgaris: A randomized, single-blind, multicenter clinical trial.

To assess the efficacy, safety, and cost-effectiveness of all-trans retinoic acid/Clobetasol Propionate Compound Ointment and calcipotriol/betamethasone dipropionate ointment in the treatment of mild-to-moderate patients with psoriasis vulgaris. This was a randomized, single-blind, multicenter clinical trial. A total of 240 patients were randomized to receive twice-daily all-trans retinoic acid/Clobetasol Propionate Compound Ointment (treatment group) or once-daily calcipotriol/betamethasone dipropionate ointment (control group) for 4 weeks. The efficacy, safety, and cost-effectiveness were assessed at Weeks 2 and 4. After 4 weeks, both groups showed a significant clinical improvement compared to baseline (88.33% vs. 89.83%, respectively, p = .7112). But PASI 75 response in the treatment group was superior to the control group (44.12% vs. 28.57%, respectively, p = .0200), at Week 4. SSRI improvement rate in the treatment group was also superior to control group (67.11% vs. 59.43%, respectively, p = .0119) at Week 4. All-trans retinoic acid/Clobetasol Propionate Compound Ointment showed a significant clinical improvement in erythema, infiltration, and scales of skin lesions and PASI score compared to baseline. 1.67% of patients (treatment group) reported adverse reactions compared to 2.50% (control group) with no statistical significance. In addition, the cost-effectiveness assessment showed a higher cost-effectiveness of the treatment group compared to the control group in 4 weeks (199.25 vs. 801.51). All-trans retinoic acid/Clobetasol Propionate Compound Ointment was effective and safe in the treatment of psoriasis vulgaris with similar efficacy as calcipotriol/betamethasone dipropionate ointment and lower treatment costs.

A cost-effectiveness analysis of calcipotriol plus betamethasone dipropionate aerosol foam versus gel for the topical treatment of plaque psoriasis.

BACKGROUND: Calcipotriol 50 µg/g and betamethasone 0.5 mg/g dipropionate (Cal/BD) aerosol foam formulation provides greater effectiveness and improved patient preference compared with traditional Cal/BD formulations for the topical treatment of plaque psoriasis. OBJECTIVE: To determine the cost-effectiveness of Cal/BD foam compared with Cal/BD gel from the Australian perspective. METHODS: A Markov model was developed to evaluate the cost-effectiveness of topical Cal/BD foam and gel for the treatment of people with plaque psoriasis. Treatment effectiveness, safety, and utilities were based on a randomized control trial, resource use was informed by expert opinion, and unit costs were obtained from public sources. Outcomes were reported in terms of 1-year costs, quality-adjusted life years, and incremental cost-effectiveness ratios. All costs were reported in 2017 Australian Dollars. RESULTS: The model showed that patients using Cal/BD foam had more QALYs and higher costs over 1 year compared with patients using Cal/BD gel, resulting in a cost of $13,609 per QALY gained at 4-weeks. When 4 weeks of Cal/BD foam was compared with 8 weeks of Cal/BD gel treatment, Cal/BD foam was $8 less expensive and resulted in 0.006 more QALYs gained. Sensitivity analyses showed that, compared with Cal/BD ointment, Cal/BD foam was associated with an incremental cost of $15,091 per QALY gained. CONCLUSION: Cal/BD foam is the most cost-effective Cal/BD formulation for the topical treatment of patients with plaque psoriasis.

Budget impact model in moderate-to-severe psoriasis vulgaris assessing effects of calcipotriene and betamethasone dipropionate foam on per-patient standard of care costs.

AIMS: To develop a budget impact model (BIM) for estimating the financial impact of formulary adoption and uptake of calcipotriene and betamethasone dipropionate (C/BD) foam (0.005%/0.064%) on the costs of biologics for treating moderate-to-severe psoriasis vulgaris in a hypothetical US healthcare plan with 1 million members. METHODS: This BIM incorporated epidemiologic data, market uptake assumptions, and drug utilization costs, simulating the treatment mix for patients who are candidates for biologics before (Scenario #1) and after (Scenario #2) the introduction of C/BD foam. Predicted outcomes were expressed in terms of the annual cost of treatment (COT) and the COT per member per month (PMPM). RESULTS: At year 1, C/BD foam had the lowest per-patient cost ($9,913) necessary to achieve a Psoriasis Area and Severity Index (PASI)-75 response compared with etanercept ($73,773), adalimumab ($92,871), infliximab ($34,048), ustekinumab ($83,975), secukinumab ($113,858), apremilast ($47,960), and ixekizumab ($62,707). Following addition of C/BD foam to the formulary, the annual COT for moderate-to-severe psoriasis would decrease by $36,112,572 (17.91%, from $201,621,219 to $165,508,647). The COT PMPM is expected to decrease by $3.00 (17.86%, from $16.80 to $13.80). LIMITATIONS: Drug costs were based on Medi-Span reference pricing (January 21, 2016); differences in treatment costs for drug administration, laboratory monitoring, or adverse events were not accounted for. Potentially confounding were the definition of "moderate-to-severe" and the heterogeneous efficacy data. The per-patient cost for PASI-75 response at year 1 was estimated from short-term efficacy data for C/BD foam and apremilast only. CONCLUSIONS: The introduction of C/BD foam is expected to decrease the annual COT for moderate-to-severe psoriasis treatable with biologics by $36,112,572 for a hypothetical US healthcare plan with 1 million plan members, and to lower the COT PMPM by $3.00.

Economic burden of psoriatic patients in Japan: Analysis from a single outpatient clinic.

Topical and systemic agents have dramatically improved the treatment efficacy of psoriasis. Few reports, however, exist describing the economic burden in Japanese psoriatic patients. The aim of the study was to evaluate the total costs as well as cost versus efficacy of topical and systemic treatments of psoriatic patients under the Japanese health insurance system. The retrospective study was performed from the database of our clinic, which is located in Hokkaido Prefecture. Cost and effectiveness of psoriatic patients were evaluated during the 12-month period from April 2015 to March 2016. Data were collected and calculated for the total cost per year, treatment efficacy and cost versus efficacy. The mean total cost of topical corticosteroid treatment was ¥18 184/year and was lowest among the treatments. The systemic treatment with biologics was most expensive and the costs were over ¥400 000/year. Among the topical treatments, calcipotriol/betamethasone dipropionate was most expensive (¥34 693/year). However, cost versus efficacy was not significantly different from that of topical corticosteroid treatments. The cost of secukinumab was highest among all the treatments (¥631 600/year). However, treatment day per cost was lowest of all the psoriasis treatments. Biologics showed the highest cost than topical or systemic treatments. However, they showed most marked efficacy in terms of improving the psoriatic skin lesions.

First-Line Fixed-Combination Psoriasis Treatment Is Associated With Lower Healthcare Costs.

Treatment of psoriasis is associated with significant healthcare-related costs. A retrospective, observational study was conducted to investigate whether first-line treatment with calcipotriene/betamethasone dipropionate (CBD) fixed-combination topical products would lower the cost impact of psoriasis compared with using the fixed-combination product later in the course of treatment. Patients were classified as being initially treated with CBD combination products (cohort A, n=7307) or other topical psoriasis medications (cohort B, n=9670). We included only patients who, at some point after diagnosis, were prescribed a CBD fixed-combination product. During the 1-year followup, the mean±standard deviation values and number of total office visits and psoriasis-related office visits were significantly lower in cohort A (13.36±14.39; 2.79±7.60) than in cohort B (16.08±16.68; 4.25±10.23) (both P<.0001). Mean total healthcare costs were also significantly lower for cohort A ($7785.80±$15,255.60; median, $3411.30) than for cohort B ($11,757.20±$19,747.60; median, $5595.80) (P<.0001). Compared with other topical psoriasis medications, first-line treatment with CBD fixed-combination topical products was associated with fewer office visits and lower total healthcare costs.

Cost-effectiveness analysis of paricalcitol versus calcitriol for the treatment of SHPT in dialytic patients from the SUS perspective.

Introduction: Secondary hyperparathyroidism (SHPT) is a consequence of chronic kidney disease. The treatment at the Brazilian Unified Heath System (SUS) is performed with calcitriol, a drug which favors hypercalcemia and/or hyperphosphatemia, hindering the control of SHPT. Another option is paricalcitol, which causes parathormone (PTH) suppression faster than calcitriol, with minor changes in calcium-phosphorus product and calcium and phosphorus serum levels. Objective: This study aims to develop a cost-effectiveness analysis of paricalcitol versus calcitriol for patients in dialytic treatment with SHPT, from the SUS perspective. Methods: A Markov decision model was developed for patients ≥ 50 years old with end stage renal disease in dialytic treatment and SHPT. Quarterly cycles and a lifetime time horizon were considered. Life years (LY) gained were assessed as clinical outcome. Clinical and economic inputs were obtained from systematic literature review and official databases. Costs are presented in Brazilian real (BRL), for the year 2014. Results: In the base case: paricalcitol generated a clinical benefit of 16.28 LY gained versus 14.11 LY gained with calcitriol, total costs of BRL 131,064 and BRL 114,262, respectively, determining an incremental cost-effectiveness ratio of BRL 7,740 per LY gained. The data robustness was confirmed by the sensitivity analysis. Conclusions: According to cost-effectiveness threshold recommended by the World Health Organization for 2013, the treatment of SHPT in patients on dialysis with paricalcitol is cost-effective when compared to calcitriol, from the public healthcare system perspective, in Brazil.

Introdução: O hiperparatireoidismo secundário (HPTS) é uma consequência da doença renal crônica. O tratamento no SUS é realizado com calcitriol, que favorece a hipercalcemia e/ou hiperfosfatemia, dificultando o controle do HPTS. Uma opção clinicamente relevante é o paricalcitol, que ocasiona a supressão do paratormônio (PTH) de forma mais rápida que o calcitriol e com menores alterações nas taxas séricas de cálcio, fósforo e do produto cálcio-fósforo. Objetivo: Este trabalho tem como objetivo desenvolver uma análise de custo-efetividade de paricalcitol versus calcitriol para pacientes em diálise com HPTS, perspectiva do SUS. Métodos: Foi desenvolvido um modelo de decisão de Markov para a população ≥ 50 anos, com DRC em diálise e HPTS. Foram considerados ciclos trimestrais e um horizonte temporal lifetime. O desfecho clínico avaliado foram os anos de vida ganhos. Dados foram obtidos a partir de revisão sistemática da literatura e bases de dados oficiais. Custos em reais (R$), ano de 2014. Resultados: No caso base: paricalcitol gerou benefício clínico de 16,28 anos de vida ganhos versus 14,11 anos de vida ganhos com calcitriol, custos totais de R$ 131.064 e R$ 114.262, respectivamente. A razão de custo-efetividade incremental de R$ 7.740 por ano de vida salvo. Dados robustos confirmados pela análise de sensibilidade. Conclusão: De acordo com o limiar de custo-efetividade recomendado pela Organização Mundial de Saúde para o ano de 2013, o tratamento de pacientes com HPTS em diálise com paricalcitol é custo-efetivo, comparado ao calcitriol, perspectiva SUS.

Cost-effectiveness analysis of paricalcitol versus calcitriol for the treatment of SHPT in dialytic patients from the SUS perspective / Análise de custo-efetividade de paricalcitol versus calcitriol no tratamento do HPTS em pacientes do SUS dialíticos, da perspectiva

Abstract Introduction: Secondary hyperparathyroidism (SHPT) is a consequence of chronic kidney disease. The treatment at the Brazilian Unified Heath System (SUS) is performed with calcitriol, a drug which favors hypercalcemia and/or hyperphosphatemia, hindering the control of SHPT. Another option is paricalcitol, which causes parathormone (PTH) suppression faster than calcitriol, with minor changes in calcium-phosphorus product and calcium and phosphorus serum levels. Objective: This study aims to develop a cost-effectiveness analysis of paricalcitol versus calcitriol for patients in dialytic treatment with SHPT, from the SUS perspective. Methods: A Markov decision model was developed for patients ≥ 50 years old with end stage renal disease in dialytic treatment and SHPT. Quarterly cycles and a lifetime time horizon were considered. Life years (LY) gained were assessed as clinical outcome. Clinical and economic inputs were obtained from systematic literature review and official databases. Costs are presented in Brazilian real (BRL), for the year 2014. Results: In the base case: paricalcitol generated a clinical benefit of 16.28 LY gained versus 14.11 LY gained with calcitriol, total costs of BRL 131,064 and BRL 114,262, respectively, determining an incremental cost-effectiveness ratio of BRL 7,740 per LY gained. The data robustness was confirmed by the sensitivity analysis. Conclusions: According to cost-effectiveness threshold recommended by the World Health Organization for 2013, the treatment of SHPT in patients on dialysis with paricalcitol is cost-effective when compared to calcitriol, from the public healthcare system perspective, in Brazil.

Resumo Introdução: O hiperparatireoidismo secundário (HPTS) é uma consequência da doença renal crônica. O tratamento no SUS é realizado com calcitriol, que favorece a hipercalcemia e/ou hiperfosfatemia, dificultando o controle do HPTS. Uma opção clinicamente relevante é o paricalcitol, que ocasiona a supressão do paratormônio (PTH) de forma mais rápida que o calcitriol e com menores alterações nas taxas séricas de cálcio, fósforo e do produto cálcio-fósforo. Objetivo: Este trabalho tem como objetivo desenvolver uma análise de custo-efetividade de paricalcitol versus calcitriol para pacientes em diálise com HPTS, perspectiva do SUS. Métodos: Foi desenvolvido um modelo de decisão de Markov para a população ≥ 50 anos, com DRC em diálise e HPTS. Foram considerados ciclos trimestrais e um horizonte temporal lifetime. O desfecho clínico avaliado foram os anos de vida ganhos. Dados foram obtidos a partir de revisão sistemática da literatura e bases de dados oficiais. Custos em reais (R$), ano de 2014. Resultados: No caso base: paricalcitol gerou benefício clínico de 16,28 anos de vida ganhos versus 14,11 anos de vida ganhos com calcitriol, custos totais de R$ 131.064 e R$ 114.262, respectivamente. A razão de custo-efetividade incremental de R$ 7.740 por ano de vida salvo. Dados robustos confirmados pela análise de sensibilidade. Conclusão: De acordo com o limiar de custo-efetividade recomendado pela Organização Mundial de Saúde para o ano de 2013, o tratamento de pacientes com HPTS em diálise com paricalcitol é custo-efetivo, comparado ao calcitriol, perspectiva SUS.

Budget impact of secondary hyperparathyroidism treatment in chronic kidney disease in an Ecuadorian social security hospital.

BACKGROUND: Chronic kidney disease (CKD) is a disorder with high morbidity and mortality worldwide whose complications generate multiple costs. In Ecuador, only a few healthcare institutions have implemented management protocols aimed to reduce costs and to improve the quality of life of patients. The aim of this study is to evaluate the short-term (1-year) and long-term (5-year) costs and savings in the management of secondary hyperparathyroidism (SHPT) of hemodialyzed CKD patients by comparing calcitriol and paricalcitol in a large social security hospital in Quito, Ecuador. METHODS: The estimation model assessed the resources used in the management of SHPT by comparing prospectively the cost savings within 1-year and 5-year time horizon with calcitriol and paricalcitol. Hospitalization, erythropoietin (EPO), treatment doses, intravenous iron consumption, and medical supplies were estimated according international references, based on the initial parathormone level (iPTH) of patients. The Ecuadorian National Reference costs (2014-2015) and institutional costs were used to calculate treatment costs. A statistical sensitivity analysis was also performed. RESULTS: The study was based on data from 354 patients of whom 147 (41.4 %) had a value of iPTH in the range 300-600 pg/ml, 45 (12.8 %) in the range 601-800 pg/ml, and 162 (45.7 %) over 800 pg/ml. The 1-year estimated costs per patient for calcitriol and paricalcitol, respectively, were: medication, 63.88 USD and 1,123.44 USD; EPO, 19,522.95 USD and 16,478 USD; intravenous iron 143.21 USD and 187.76 USD. Yearly hospitalization costs per patient were 11,647.99 USD with calcitriol and 8,019.41 USD with paricalcitol. Total yearly costs per patient amounted to 31,378.02 USD with calcitriol and 25,809.50 USD with paricalcitol. Total savings using paricalcitol were 5,568.52 USD per patient compared with calcitriol. The 5-year cumulative medication costs were 319 USD for calcitriol and 2,403 USD for paricalcitol; EPO with calcitriol was 97,615 USD and with paricalcitol 82,394 USD; intravenous iron with calcitriol was 716 USD and paricalcitol 939 USD. Hospitalization costs for patients with calcitriol and paricalcitol were 43,095 USD and 62,595 USD, respectively. Total savings using paricalcitol amounted 32,414 USD per patient compared with calcitriol. CONCLUSIONS: Paricalcitol use generated more cost savings than calcitriol after 1 and 5 years.

Health economic evaluation of paricalcitol(®) versus cinacalcet + calcitriol (oral) in Italy. [corrected].

BACKGROUND AND OBJECTIVE: Chronic kidney disease (CKD) is a highly morbid disorder. The most severe form of CKD is end-stage renal disease (ESRD), in which the patient requires some form of renal replacement therapy to survive. The increasing incidence, prevalence, and costs of ESRD are major national healthcare concerns. The objective of this study was to determine the cost effectiveness of two innovative therapies, paricalcitol versus cinacalcet + calcitriol (oral) in patients with CKD stage 5 (CKD 5) in the healthcare setting in Italy in 2013. METHODS: A Markov process model was developed employing data sources from the published literature, paricalcitol clinical trials, official Italian price/tariff lists, and national population statistics. The analysis is based on a comparison of treatment with paricalcitol versus cinacalcet + calcitriol (oral) in CKD 5. The perspective of the study was that of the payer [Italian National Health Service (INHS)]. The primary efficacy outcomes in the paricalcitol and cinacalcet + calcitriol (oral) clinical trials (reduction of secondary hyperparathyroidism, complications, and mortality) were extrapolated to effectiveness outcomes: number of life-years gained (LYG) and number of quality-adjusted life-years (QALYs). Clinical and economic outcomes were discounted at 3 %. RESULTS: The base-case analysis is based on a 5-year time horizon. From the INHS perspective, the use of paricalcitol leads to a cost saving of €1,853 and an increase in LYG (0.136) and a gain in QALYs (0.089). Consequently, the use of paricalcitol is dominant over the use of combination cinacalcet + calcitriol (oral paricalcitol leads to cost savings and a higher effectiveness). Sensitivity analyses confirmed the robustness of the model. CONCLUSION: The results showed that the favorable clinical benefit of paricalcitol results in positive health economic benefits. This study suggests that the use of paricalcitol in patients with ESRD may be cost effective from the perspective of the INHS.

Using a single product (calcipotriene/betamethasone topical suspension) vs multiple products to manage body and scalp psoriasis: comparisons in resource utilization and costs.

OBJECTIVES: To compare resource utilization and costs among patients who used calcipotriene/betamethasone dipropionate topical suspension (Taclonex Scalp Topical Suspension, Leo Pharma A/S) vs those who used multiple body and scalp formulations for psoriasis. RESEARCH DESIGN AND METHODS: A retrospective study using Truven Health MarketScan Commercial Database from 2006-2011 was performed to identify patients with psoriasis (ICD code 696.1x). Two study cohorts analyzed were cohort A (used body-only formulations for psoriasis and switched on the index date to using calcipotriene/betamethasone dipropionate topical suspension alone) and cohort B (used multiple body and scalp formulations for psoriasis). Patients were required to be continuously enrolled during 180-days pre- and post-index periods. Multiple regression analyses adjusting for baseline demographic and clinical covariates were performed. MAIN OUTCOMES MEASURES: Number of psoriasis-related outpatient visits, total healthcare costs, psoriasis-related costs, and use of systemic agents during post-index period. RESULTS: A total of 1923 patients were identified with at least one prescription for calcipotriene/betamethasone dipropionate scalp topical suspension (cohort A = 367, cohort B = 1556). Patients using multiple medications (cohort B) were associated with 48% higher number of outpatient visits as compared with those who used a single formulation (cohort A) after controlling for baseline covariates (p < 0.001). A generalized linear model adjusting for baseline covariates showed significantly higher post-index total and psoriasis-related healthcare costs for cohort B as compared with cohort A (both p < 0.001). Patients in Cohort B also had twice the odds of using systemic agents as compared to patients in Cohort A (p < 0.001). CONCLUSIONS: Patients with body and scalp psoriasis using a single product had significantly lower overall and psoriasis-related healthcare costs, needed fewer psoriasis-related outpatient visits, and used less systemic agents during the post-index period. A lack of robust clinical measures to define the disease severity may have limited the interpretations from this study.

Pharmacological control of secondary hyperparathyroidism in hemodialysis subjects: a cost consequences analysis of data from the FARO study.

BACKGROUND AND OBJECTIVES: Secondary hyperparathyroidism (SHPT) is a frequent complication of CKD with incidence, prevalence, and costs increasing worldwide. The objective of this analysis was to estimate therapy cost of SHPT in a sub-population of the FARO study. MATERIALS AND METHODS: In the FARO study, an observational survey aimed to evaluate patterns of treatment in patients with SHPT who had undergone hemodialysis, pharmacological treatments and biochemical parameters evolution data were collected in four surveys. Patients maintaining the same treatment in all sessions were grouped by type of treatment and evaluated for costs from the Italian National Health Service perspective. RESULTS: Four cohorts were identified: patients treated with oral (PO) calcitriol (n=182), intravenous (IV) calcitriol (n=34), IV paricalcitol (n=62), and IV paricalcitol+cinacalcet therapy (n=20); the cinacalcet monotherapy group was not analysed due to low number of patients (n=9). Parathyroid hormone (PTH) level at baseline and effectiveness of treatments in suppressing PTH level were assessed to test comparability among cohorts: calcitriol PO patients were significantly less severe than others (PTH level at baseline lower than 300 pg/ml; p<0.0001); calcitriol IV patients did not reach significant reduction in PTH level. Paricalcitol and paricalcitol+cinacalcet treatment groups results were comparable, while only the IV paricalcitol cohort's PTH level, weekly dosage, and cost decreased significantly from the first to the fourth survey (p=0.020, p=0.012, and p=0.0124, respectively). Total costs per week of treatment (including calcium-based phosphate binder and sevelamer) were significantly lower in the paricalcitol vs paricalcitol+cinacalcet cohort (p<0.001). Major limitations of this study are related to the survey design: not controlled and lack of comparability between cohorts; however, reflective of true practice patterns. CONCLUSIONS: The IV Paricalcitol cohort had significantly lower treatment costs compared with patients treated with paricalcitol+calcimemtics (p<0.001), without a significant difference in terms of baseline severity and PTH control.

Cost-effectiveness analysis regarding postoperative administration of vitamin-D and calcium after thyroidectomy to prevent hypocalcaemia / Análisis de costo-efectividad de la administración postoperatoria de Vitamina D y calcio después de tiroidectomía para la prevención de la hipo calcemia

Objective Hypocalcaemia is a frequently arising complication following total thyroidectomy. Routine postoperative prophylactic administration of vitamin D or metabolites and calcium reduce the incidence of symptomatic hypocalcaemia; this article reports evaluating its cost-effectiveness in Colombia. Methods Meta-analysis was used for comparing the administration of vitamin D or metabolites to oral calcium or no treatment at all in patients following total thyroidectomy and a cost-effectiveness analysis was designed based on a decision-tree model with local costs. Results The OR value for the comparison between calcitriol and calcium compared to no treatment and to exclusive calcium treatment groups was 0.32 (0.13-0.79 95 %CI) and 0.31 (0.14-0.70 95 %CI), respectively. The most cost-effective strategy was vitamin D or metabolites and calcium administration, having a US $0.05 incremental cost-effectiveness ratio. Conclusion Prophylactic treatment of hypocalcaemia with vitamin D or metabolites + calcium or calcium alone is a cost-effective strategy.

Objetivos La hipo calcemia es la complicación más frecuente después de tiroidectomía. La administración profiláctica de vitamina D o metabolitos y calcio reduce la incidencia de hipocalcémia sintomática. Se evalúa su costo-efectividad en Colombia. Materiales y métodos Utilizamos la información de un meta-análisis que comparó la administración de vitamina D o metabolitos contra calcio no tratamiento en pacientes llevados a tiroidectomía total y diseñamos un análisis de costo-efectividad basados en un modelos de decisiones con costos locales. Resultados El valor del OR para la comparación entre calcitriol y calcio comparado con no tratamiento o calcio exclusivo fue de 0.32 (95 % IC, 0.13- 0.79) y 0.31 (95 % IC, 0.14-0.70), respectivamente. La estrategia más costo-efectiva fue la administración de vitamina D o metabolitos y calcio, con una relación de costo-efectividad incremental de US $0.05. Conclusiones El tratamiento profiláctico de la hipo calcemia con vitamina D o metabolitos y calcio o calcio exclusivo después de tiroidectomía total es una estrategia costo-efectiva.

Cost effectiveness of the two-compound formulation calcipotriol and betamethasone dipropionate gel in the treatment of scalp psoriasis in Scotland.

OBJECTIVES: To compare the cost effectiveness of the two-compound formulation (TCF) calcipotriol plus betamethasone dipropionate gel used first-, second- or third-line to standard topical treatments for moderately severe scalp psoriasis from a Scottish NHS perspective. RESEARCH DESIGN AND METHODS: Treatment pathways for scalp psoriasis patients in primary care were defined by Scottish prescribing statistics, an interview programme and published sources. The extensive 1-year Markov model included 12 different topical treatment pathways, each simulating three lines of therapy. Seven pathways contained the TCF gel in first-, second- or third-line. The remaining five pathways were included as comparators, reflecting the heterogeneity across clinical practice. The cost effectiveness of TCF gel was compared to the average of five non-TCF gel pathways. The clinical effectiveness measure was the ability of topical treatments to control disease at 4 weeks. Response rates were derived from indirect comparisons of ten randomised controlled trials. Utilities were elicited from SF-36 (v2) scores in one TCF gel trial. The main outcome was the incremental cost per quality-adjusted life-year (QALY). Extensive sensitivity analyses were performed to assess the robustness of the results. RESULTS: TCF gel used first-, second- or third-line was projected to increase QALYs (around 0.0025) with cost savings per patient (£20-30) over 1 year. The study analysis acknowledged a number of limitations including lack of quality comparator data, the need to make assumptions in the absence of evidence and lack of model validation. However the results showed that TCF gel was the dominant treatment strategy across a broad range of credible scenarios. CONCLUSIONS: Scalp psoriasis is difficult to treat. Many different topical preparations can be used but several factors such as greasiness, irritation, time needed to apply, and lack of efficacy often result in reduced adherence to treatment regimens. Where cosmetic properties are important for patient acceptability and compliance is a major issue contributing to treatment failure, the once-daily TCF gel offers patients with scalp psoriasis an attractive, cost-saving treatment option.

The two-compound formulation of calcipotriol and betamethasone dipropionate for treatment of moderately severe body and scalp psoriasis - an introduction.

Psoriasis is a common chronic inflammatory skin disease and many patients require lifelong treatment. Characteristic scaly, itchy, unsightly psoriatic lesions affect many body areas and most patients commonly experience scalp involvement. The cosmetic embarrassment of visible body lesions, inaccessibility of scalp skin to application of therapies and proximity of sensitive facial skin add to the challenges of most patients managing their psoriasis long term. Psoriasis can severely impact patients' quality of life. This can impact significantly on the patient. In economic terms patients may incur increased out-of-pocket expenditure or extended time away from work as a direct consequence of psoriasis, particularly in severe cases; In many countries, specialist review of patients provides pressures on hard-pressed services and the costs of psoriasis care are substantial, particularly in patients with severe recalcitrant psoriasis which may require lengthy inpatient admission. Around 80% of patients with psoriasis have mild to moderately severe disease and the majority are treated with topical medicines by their physician in primary care. Despite the availability of a wide range of treatment options, regimens have been unsatisfactory, associated with patient dissatisfaction, poor compliance and often safety concerns with long-term use. Evidence-based clinical guidelines aim to improve healthcare of patients and while there are such guidelines for psoriasis, to date the challenges of (and recommendations for) managing scalp psoriasis are often limited or missing from these treatment guidelines. In the following in-journal supplement, a connected suite of five papers focus on the use of topical therapies for the treatment of the person afflicted with psoriasis. This work harnesses robust evidence from randomised clinical trials (RCTs) of topical therapies commonly used in psoriasis patients and translates this into recommendations for the most appropriate treatment of patients with body or scalp psoriasis, from an efficacy, safety and cost-effectiveness perspective. Based upon systematic review and harnessing 'state of the art' evidence assessment methodologies, the modelling work suggests that the use of a two-compound formulation (TCF) product of calcipotriol and betamethasone dipropionate is the most appropriate treatment option for both body and scalp psoriasis. This Editorial acknowledges the results of any modelling exercise have limitations; indeed such limitations are acknowledged in each modelling contribution in this issue. With these caveats in mind, this introductory paper considers the implications of this research and distillation of the evidence. This work should guide cost-effective treatment choices for body and scalp psoriasis, assist in recommendations for management of scalp psoriasis in future iterations of psoriasis clinical guidelines and help primary care physicians striving to attain best outcomes in the care of the person with psoriasis.

Cost-effectiveness analysis regarding postoperative administration of vitamin-D and calcium after thyroidectomy to prevent hypocalcaemia.

OBJECTIVE: Hypocalcaemia is a frequently arising complication following total thyroidectomy. Routine postoperative prophylactic administration of vitamin D or metabolites and calcium reduce the incidence of symptomatic hypocalcaemia; this article reports evaluating its cost-effectiveness in Colombia. METHODS: Meta-analysis was used for comparing the administration of vitamin D or metabolites to oral calcium or no treatment at all in patients following total thyroidectomy and a cost-effectiveness analysis was designed based on a decision-tree model with local costs. RESULTS: The OR value for the comparison between calcitriol and calcium compared to no treatment and to exclusive calcium treatment groups was 0.32 (0.13-0.79 95 %CI) and 0.31 (0.14-0.70 95 %CI), respectively. The most cost-effective strategy was vitamin D or metabolites and calcium administration, having a US $0.05 incremental cost-effectiveness ratio. CONCLUSION: Prophylactic treatment of hypocalcaemia with vitamin D or metabolites + calcium or calcium alone is a cost-effective strategy.