Achieving Lower LDL-C Levels After a Recent Myocardial Infarction Might Be Associated with Lower Healthcare Resource Use and Costs in Spain.

INTRODUCTION: There is little evidence on the relationship between achieved low-density lipoprotein cholesterol (LDL-C) levels and costs in patients on lipid-lowering therapy (LLT). We described healthcare resource use and costs (direct and indirect) by achieved LDL-C in patients receiving LLT after a recent myocardial infarction (MI) in Spain. METHODS: This was a retrospective observational study of anonymized electronic medical records from seven regions in Spain (BIG-PAC® database; n = 1.9 million). Eligible patients were adults (≥ 18 years) hospitalized for an MI between January 2015 and December 2017, treated with a statin and/or ezetimibe, and having recorded LDL-C values at baseline and during follow-up. Healthcare resource use and direct and indirect costs (in 2018, €) were described by achieved LDL-C levels during a follow-up of 18 months. RESULTS: Of 6025 patients (mean age, 69.7 years; 77% male), only 11% achieved LDL-C goals as defined in the 2016 ESC/EAS guidelines (< 70 mg/dL), and just 1% reached the lower target (< 55 mg/dL) in the current 2019 guidelines. Achieving lower LDL-C levels translated to lower healthcare resource use and costs. Mean total (direct and indirect) costs ranged from €5044 for patients with LDL-C < 55 mg/dL to €7567 for patients with LDL-C ≥ 130 mg/dL. CONCLUSION: Very few patients achieved recommended LDL-C goals despite using LLT. Achieving lower LDL-C levels after an MI might be associated with lower healthcare resource use and costs. Use of more intensive LLT, leading to greater reductions in LDL-C, could therefore be beneficial both from a clinical and an economic perspective.

Real-world treatment patterns of PCSK9 inhibitors among patients with dyslipidemia in Germany, Spain, and the United Kingdom.

OBJECTIVE: Proprotein convertase subtilisin/kexin type 9 antibody inhibitors (PCSK9i) are approved as adjuncts to maximal tolerated statin therapy to lower low-density lipoprotein cholesterol (LDL-C). This study describes real-world use, characteristics of PCSK9i users and non-users, and factors influencing treatment choice. METHODS: A physician and patient survey was conducted in Germany, Spain, and the UK from December 2016 to April 2017 through the Adelphi Dyslipidemia Disease Specific Program. Physicians reported patients' lipid-lowering therapy (LLT) history and characteristics. PCSK9i users were systematically over-sampled. Results were summarized using frequencies and proportions. RESULTS: The study included 110, 123, and 117 physicians from Germany, Spain, and the UK, respectively, providing data on 3,073 patients (mean age = 62 years; 60% male). Most patients (63-73%) had prior statin and/or ezetimibe use. Compared to patients receiving other LLT (n = 2686), PCSK9i users (222 in Germany, 97 in Spain, 68 in the UK) were, on average, 5-7.5 years younger and had LDL-C at diagnosis averaging 23-53 mg/dl higher. Familial hypercholesterolemia (FH), coronary heart/artery disease, myocardial infarction, and acute coronary syndrome were more common among PCSK9i users than non-users. PCSK9i users were also more likely to use high-intensity statins in their current LLT regimen (64-89% vs 28-50%). Physicians commonly reported PCSK9i benefits on LDL-C and total cholesterol as reasons for initiating these agents, and PCSK9i users reported good knowledge of cardiovascular disease and treatment options. CONCLUSIONS: Results indicate that physicians are prescribing PCSK9i to patients with high cardiovascular risk in accordance with European guidelines and reimbursement requirements.

Coste por paciente con respuesta a romiplostim y rituximab en el tratamiento de la trombocitopenia inmune primaria en España / Cost-per-responder analysis comparing romiplostim to rituximab in the treatment of adult primary immune thrombocytopenia in Spain

Fundamento y objetivo: Romiplostim, agonista del receptor de la trombopoyetina, está aprobado para el tratamiento de segunda línea en pacientes con trombocitopenia inmune primaria (PTI). El tratamiento con rituximab no es infrecuente, aunque esta indicación no esté recogida en la ficha técnica. Este análisis compara el coste por paciente respondedor a romiplostim frente a rituximab en España. Materiales y método: Se ha diseñado un modelo para estimar el coste de 6 meses de tratamiento por paciente que responde (recuento plaquetario ≥ 50 × 109/l). Este modelo toma las referencias conforme a los datos publicados más sólidos. Los pacientes tratados con romiplostim recibieron inyecciones semanales; los pacientes tratados con rituximab recibieron 4 infusiones intravenosas semanales. Los precios se obtuvieron de las listas de reembolso españolas. Los pacientes sin respuesta incurrieron en gastos por el tratamiento de episodios relacionados con sangrado (ERS), tal como se notificó en los ensayos clínicos. La utilización de recursos médicos y la práctica clínica se basaron en las guías de tratamiento españolas y fueron validadas por expertos locales. Resultados: Las tasas de respuesta para romiplostim y rituximab fueron del 83 y 62,5%, y el coste medio por paciente fue de 16.289 Euros y 13.459 Euros, respectivamente. Con rituximab el coste por paciente respondedor fue un 10% superior (21.535 Euros) comparado con romiplostim (19.625 Euros). Romiplostim redujo el coste de administración de fármacos, el uso de inmunoglobulina intravenosa y los costes relacionados con ERS comparado con rituximab. Conclusiones: Romiplostim representaría una opción terapéutica eficiente en comparación con rituximab para el tratamiento de pacientes adultos con PTI crónica en el Sistema Nacional de Salud español (AU)

Background and objective: Romiplostim, a thrombopoietin-receptor agonist, is approved for second-line use in idiopathic thrombocytopenic purpura (ITP) patients where surgery is contraindicated. Anti-CD20 rituximab, an immunosuppressant, is currently used off-label. This analysis compared the cost per responder for romiplostim versus rituximab in Spain. Materials and method: A decision analytic model was constructed to estimate the 6-month cost per responding patient (achieving a platelet count ≥ 50 × 109/l) according to the most robust published data. A systematic literature review was performed to extract response rates from phase 3 randomized controlled trials. Romiplostim patients received weekly injections; rituximab patients received 4 weekly intravenous infusions. Medical resource costs were obtained from Spanish reimbursement lists. Treatment non-responders incurred bleeding-related event (BRE) management costs as reported in clinical trials. Medical resource utilization and clinical practice were based on Spanish treatment guidelines and validated by local clinical experts. Results: The literature review identified phase 3 romiplostim trials with a response rate of 83%. Due to a lack of phase 3 controlled rituximab trials, a systematic review of studies was selected as the best source, reporting a response rate of 62.5%. The mean cost per patient for romiplostim was 16,289 Euros and 13,459 Euros for rituximab. Rituximab resulted in a 10% higher cost per responder (21,535 Euros versus 19,625 Euros for romiplostim). Romiplostim use reduced drug administration, intravenous immunoglobulin, and bleeding-related costs compared to rituximab. Conclusions: Due to its high level of efficacy leading to lower BRE costs, romiplostim represents an efficient use of resources for adult ITP patients in the Spanish Healthcare System (AU)

[Cost-per-responder analysis comparing romiplostim to rituximab in the treatment of adult primary immune thrombocytopenia in Spain]. / Coste por paciente con respuesta a romiplostim y rituximab en el tratamiento de la trombocitopenia inmune primaria en España.

BACKGROUND AND OBJECTIVE: Romiplostim, a thrombopoietin-receptor agonist, is approved for second-line use in idiopathic thrombocytopenic purpura (ITP) patients where surgery is contraindicated. Anti-CD20 rituximab, an immunosuppressant, is currently used off-label. This analysis compared the cost per responder for romiplostim versus rituximab in Spain. MATERIALS AND METHOD: A decision analytic model was constructed to estimate the 6-month cost per responding patient (achieving a platelet count≥50×10(9)/l) according to the most robust published data. A systematic literature review was performed to extract response rates from phase 3 randomized controlled trials. Romiplostim patients received weekly injections; rituximab patients received 4 weekly intravenous infusions. Medical resource costs were obtained from Spanish reimbursement lists. Treatment non-responders incurred bleeding-related event (BRE) management costs as reported in clinical trials. Medical resource utilization and clinical practice were based on Spanish treatment guidelines and validated by local clinical experts. RESULTS: The literature review identified phase 3 romiplostim trials with a response rate of 83%. Due to a lack of phase 3 controlled rituximab trials, a systematic review of studies was selected as the best source, reporting a response rate of 62.5%. The mean cost per patient for romiplostim was €16,289 and €13,459 for rituximab. Rituximab resulted in a 10% higher cost per responder (€21,535 versus €19,625 for romiplostim). Romiplostim use reduced drug administration, intravenous immunoglobulin, and bleeding-related costs compared to rituximab. CONCLUSIONS: Due to its high level of efficacy leading to lower BRE costs, romiplostim represents an efficient use of resources for adult ITP patients in the Spanish Healthcare System.