Cost of fremanezumab, erenumab, galcanezumab and onabotulinumtoxinA associated adverse events, for migraine prophylaxis in Spain.

Objective: To compare the cost of adverse events (AEs) associated with preventive treatment of migraine with fremanezumab, versus erenumab, galcanezumab, and onabotulinumtoxinA.Methods: A probabilistic modeling analysis was performed, using second-order Monte Carlo simulations, with 1,000 simulations, in patients with at least 4 days of migraine per month, from the perspective of the National Health System and a time horizon of 12 weeks. The frequency of AEs described in the clinical trials was analyzed with 12 weeks of treatment. Unit costs (€) of management of AEs were obtained from public health prices, expert panels, and published Spanish studies.Results: Fremanezumab would generate average savings of -€469 (95% CI -€303; -€674) versus erenumab, -€268 (95% CI -€171; -€391) versus galcanezumab, -€1,100 (95% CI -€704; -€1,608) or -€1,295 (95% CI -€835; -€1,893) versus onabotulinumtoxinA using real-life or clinical trial data, respectively.Conclusions: The different safety profile of treatment with fremanezumab, compared to erenumab, galcanezumab, and onabotulinumtoxinA, would generate savings in health-care resources in all the scenarios considered.

Identification of factors involved in medication compliance: incorrect inhaler technique of asthma treatment leads to poor compliance.

OBJECTIVE: To identify the impact of delivery device of inhaled corticosteroids and long-acting ß2-agonist (ICS/LABA) on asthma medication compliance, and investigate other factors associated with compliance. MATERIALS AND METHODS: We conducted a retrospective and multicenter study based on a review of medical registries of asthmatic patients treated with ICS/LABA combinations (n=2,213) whose medical devices were either dry powder inhalers (DPIs, such as Accuhaler(®), Turbuhaler(®), and NEXThaler(®)) or pressurized metered-dose inhalers (pMDI). Medication compliance included persistence outcomes through 18 months and medication possession ratios. Data on potential confounders of treatment compliance such as asthma exacerbations, comorbidities, demographic characteristics, and health care resource utilization were also explored. RESULTS: The probability of asthma medication compliance in case of DPIs was lower compared to pMDIs, which suggests that inhaler devices influence inhalation therapies. There were additional confounding factors that were considered as explanatory variables of compliance. A worse measure of airflow obstruction (forced expiration volume in 1 second), comorbidities and general practitioner (GP) consultations more than once per month decreased the probability of compliance. Within comorbidities, alcoholism was positively associated with compliance. Patients of 29-39, 40-50, and 51-61 age groups or suffering from more than two exacerbations during the study period were more likely to comply with their medication regime. The effects of DPIs toward compliance varied with the different DPIs. For instance, Accuhaler(®) had a greater negative effect on compliance compared to Turbuhaler(®) and Nexthaler(®) in cases of patients who suffered exacerbations. We found that GP consultations reduced the probability of medication compliance for patients treated with formoterol/budesonide combination. For retired patients, visiting the GP increased the probability of medication compliance. CONCLUSION: We concluded that inhaler devices influence patients' compliance for long-term asthma medication. The impact of Accuhaler(®), Turbuhaler(®), and NEXThaler(®) on medication compliance was negative. We also identified some confounders of medication compliance such as patient's age, severity of asthma, comorbidities, and health care costs.

Cost analysis of glatiramer acetate versus interferon-ß for relapsing-remitting multiple sclerosis in patients with spasticity: the Escala study.

OBJECTIVE: The Escala Study evidenced that the administration of glatiramer acetate for relapsing-remitting multiple sclerosis improved the spasticity of patients previously treated with interferon-ß. However, whether such an improvement was translated into cost savings remained unclear. We therefore conducted a cost analysis of glatiramer acetate versus interferon-ß in these patients with multiple sclerosis and spasticity. METHODS: This cost analysis encompassed data from the observational Escala Study, which included patients with relapsing-remitting multiple sclerosis and spasticity whose treatment had been switched from interferon-ß to glatiramer acetate. Costs prior to starting glatiramer acetate (interferon-ß period) were compared to the subsequent six months on glatiramer acetate (glatiramer acetate period). The analysis was carried out following the recommendations for conducting pharmacoeconomic studies and from the Spanish National Health System perspective. Costs associated with multiple sclerosis treatment, spasticity treatment and relapse management were expressed in 2014 euros (€); a 7.5 % discount was applied-when needed-as stipulated in Spanish law. RESULTS: The management of relapsing-remitting multiple sclerosis, spasticity and relapses accounted for a 6-month cost per patient of 7,078.02€ when using interferon-ß and 4,671.31€ when using glatiramer acetate. Switching from interferon-ß to glatiramer acetate therefore represented a cost saving of 2,406.72€ per patient in favour of glatiramer acetate, which resulted from savings in treatment costs, relapse management and spasticity treatment of 1,890.02€, 430.48€ and 86.21€, respectively. The ratio of the costs during interferon-ß was 1.5 times the costs during glatiramer acetate; thus, a fixed budget of 5,000,000€ would enable 1,070 patients to be treated with glatiramer acetate and only 706 patients with interferon-ß. CONCLUSIONS: The treatment of relapsing-remitting multiple sclerosis with glatiramer acetate entailed cost savings when compared to interferon-ß in patients with spasticity, which not only resulted from its lower costs of therapy and relapse management but also from its favourable effect on reducing spasticity. Thus, glatiramer acetate may be regarded as a more efficient alternative than interferon-ß from the perspective of the Spanish National Health System.

Cost-effectiveness analysis of HLA-B*5701 typing in the prevention of hypersensitivity to abacavir in HIV+ patients in Spain

Introduction Approximately 4% to 8% of patients with HIV-1 treated with abacavir present a hypersensitivity reaction (HSR). Various studies have shown a direct association between human leukocyte antigen (HLA)-B*5701 and HSR to abacavir. The objective of this study was to analyze whether systematic HLA-B*5701 testing to prevent HSR in patients treated with abacavir is a cost-effective option for the Spanish National Health System .Methods An analytical decision-making model was constructed as a decision tree model for a simulated cohort of 1000 HIV patients to evaluate whether HLA-B*5701 testing to prevent HSR to abacavir was cost effective compared with not performing the test. The parameters included in the model and the use of healthcare resources should the patient develop HSR were taken from the PREDICT-1 study and the opinion of clinical experts. The principal result obtained was the incremental cost per HSR avoided. The time horizon of the analysis was 6 months. All costs were expressed in 2008 Euros. Results The analysis showed that the total direct healthcare costs per patient were €1344 and €1322 with and without HLA-B*5701 testing respectively, and that 36 cases of HSR were prevented per 1000 screened patients. These results yielded a cost per HSR avoided of €630. The sensitivity analysis showed that the results were sensitive to the cost of the test, with an economic saving of €102 or a cost-effectiveness ratio of €4234. Conclusions The model predicts that generalized use of the HLA-B*5701 test before prescribing abacavir in HIV+ patients could represent an economic saving or a limited additional cost for the National Health System which may be counterbalanced by the benefits in terms of a lower incidence of HSR (AU)

Introducción Aproximadamente el 4–8% de los pacientes con VIH-1 tratados con abacavir presentan una reacción de hipersensibilidad (RHS). Diversos estudios han mostrado que existe una asociación directa entre el antígeno leucocitario humano (HLA)-B*5701 y la RHS a abacavir. El objetivo del presente estudio ha sido analizar si la realización sistemática del test HLA-B*5701 para prevenir la RHS en los pacientes tratados con abacavir es una opción coste-efectiva para el Sistema Nacional de Salud (SNS) español. Métodos Se realizó un modelo analítico de decisiones mediante un modelo de árbol de decisión para simular una cohorte de 1.000 pacientes con VIH en el que se comparó si la realización del test HLA-B*5701 para prevenir la RHS al tratamiento con abacavir era una opción coste-efectiva versus no realizar el test. Los parámetros introducidos en el modelo así como el uso de recursos sanitarios en caso de que el paciente desarrollase una RHS provenían del estudio PREDICT-1 y de la opinión de expertos clínicos. El resultado principal del studio fue el coste incremental por RHS evitada. El horizonte temporal del análisis fue de 6 meses. Todos los costes se expresaron en euros del año 2008.Resultados El análisis demostró que los costes sanitarios directos totales por paciente fueron 1.344 € y 1.322 € al realizar o no el test HLA-B*5701, respectivamente, evitando unos 36 casos de RHS por cada 1.000 pacientes cribados. Estos resultados dieron lugar a una razón de coste por RHS evitada de 630 €. El análisis de sensibilidad mostró que los resultados fueron sensibles al coste del test produciendo desde un ahorro económico de 102 € hasta una razón coste-efectividad de 4.234 €. Conclusiones (..) (AU)

Cost-effectiveness analysis of HLA-B*5701 typing in the prevention of hypersensitivity to abacavir in HIV+ patients in Spain.

INTRODUCTION: Approximately 4% to 8% of patients with HIV-1 treated with abacavir present a hypersensitivity reaction (HSR). Various studies have shown a direct association between human leukocyte antigen (HLA)-B*5701 and HSR to abacavir. The objective of this study was to analyze whether systematic HLA-B*5701 testing to prevent HSR in patients treated with abacavir is a cost-effective option for the Spanish National Health System. METHODS: An analytical decision-making model was constructed as a decision tree model for a simulated cohort of 1000 HIV patients to evaluate whether HLA-B*5701 testing to prevent HSR to abacavir was cost effective compared with not performing the test. The parameters included in the model and the use of healthcare resources should the patient develop HSR were taken from the PREDICT-1 study and the opinion of clinical experts. The principal result obtained was the incremental cost per HSR avoided. The time horizon of the analysis was to 2 months [corrected] . All costs were expressed in 2008 Euros. RESULTS: The analysis showed that the total direct healthcare costs per patient were €1344 and €1322 with and without HLA-B*5701 testing respectively, and that 36 cases of HSR were prevented per 1000 screened patients. These results yielded a cost per HSR avoided of €630. The sensitivity analysis showed that the results were sensitive to the cost of the test, with an economic saving of €102 or a cost-effectiveness ratio of €4234. CONCLUSIONS: The model predicts that generalized use of the HLA-B*5701 test before prescribing abacavir in HIV+ patients could represent an economic saving or a limited additional cost for the National Health System which may be counterbalanced by the benefits in terms of a lower incidence of HSR.