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1.
J Med Econ ; 22(8): 766-776, 2019 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-30969797

RESUMEN

Aim: The approved indication for denosumab (120 mg) was expanded in 2018 to include skeletal-related event (SRE) prevention in patients with multiple myeloma (MM). Therefore, a cost-effectiveness analysis was conducted comparing denosumab with zoledronic acid (ZA) for SRE prevention in patients with MM from the national healthcare system perspective in a representative sample of European countries: Austria, Belgium, Greece, and Italy. Methods: The XGEVA global economic model for patients with MM was used to calculate incremental cost-effectiveness ratios (ICERs) for denosumab vs ZA over a lifetime horizon. Clinical inputs were derived from the denosumab vs ZA randomized, phase 3 study ("20090482") in patients newly-diagnosed with MM, and comprised real-world adjusted SRE rates, serious adverse event (SAE) rates, treatment duration, dose intensity, progression-free survival (PFS), and overall survival (OS). Economic inputs comprised country-specific denosumab and ZA acquisition and administration costs, SRE and SAE management costs, and discount rates. Health utility decrements associated with MM disease progression, SRE and SAE occurrence, and route of administration were included. Results: Estimated ICERs (cost per quality-adjusted life-year [QALY] gained) for denosumab vs ZA in Austria, Belgium, Greece, and Italy were €26,294, €17,737, €6,982, and €27,228, respectively. Using 1-3 times gross domestic product (GDP) per capita per QALY as willingness to pay thresholds, denosumab was 69-94%, 84-96%, 79-96%, and 50-92% likely to be cost-effective vs ZA, respectively. Limitations: Economic inputs were derived from various sources, and time to event inputs were extrapolated from 20090482 study data. Conclusions: Denosumab is cost-effective vs ZA for SRE prevention in patients with MM in Austria, Belgium, Greece, and Italy, based on often-adopted World Health Organization thresholds. This conclusion is robust to changes in model parameters and assumptions. Cost-effectiveness estimates varied across the four countries, reflecting differences in healthcare costs and national economic evaluation guidelines.


Asunto(s)
Conservadores de la Densidad Ósea/uso terapéutico , Enfermedades Óseas/tratamiento farmacológico , Enfermedades Óseas/etiología , Denosumab/uso terapéutico , Mieloma Múltiple/complicaciones , Ácido Zoledrónico/uso terapéutico , Conservadores de la Densidad Ósea/efectos adversos , Conservadores de la Densidad Ósea/economía , Análisis Costo-Beneficio , Denosumab/efectos adversos , Denosumab/economía , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Europa (Continente) , Gastos en Salud , Humanos , Cadenas de Markov , Modelos Económicos , Mieloma Múltiple/mortalidad , Años de Vida Ajustados por Calidad de Vida , Análisis de Supervivencia , Ácido Zoledrónico/efectos adversos , Ácido Zoledrónico/economía
2.
J Med Econ ; 21(11): 1075-1083, 2018 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-30091652

RESUMEN

AIMS: This analysis investigated the cost-effectiveness of panitumumab plus mFOLFOX6 (oxaliplatin, 5-fluorouracil, and leucovorin) compared with bevacizumab plus mFOLFOX6 in the first-line treatment of patients with wild-type RAS metastatic colorectal cancer (mCRC). MATERIALS AND METHODS: The cost-effectiveness analysis was developed from a third-party payer perspective in the US and was implemented using a partitioned survival model with health states for first-line treatment (progression-free), disease progression with and without subsequent active treatment, and death. Survival analyses of patients with wild-type RAS mCRC from the PEAK head-to-head clinical trial of panitumumab vs bevacizumab were performed to estimate time in the model health states. Additional data from PEAK informed the amount of each drug consumed, duration of therapy, subsequent therapy use, and toxicities related to mCRC treatment. Literature and US public data sources were used to estimate unit costs associated with treatment and duration of subsequent active therapies. Utility weights were calculated from patient-level data from panitumumab trials in the first-, second-, and third-line settings. A life-time perspective was taken with future costs and outcomes discounted at 3% per annum. Scenario, one-way, and probabilistic sensitivity analyses were performed. RESULTS: Compared with bevacizumab, the use of panitumumab resulted in an incremental cost of US $60,286, and an incremental quality-adjusted life-year (QALY) of 0.445, translating into a cost per QALY gained of US $135,391 in favor of panitumumab. Results were sensitive to wastage and dose rounding assumptions modeled. LIMITATIONS: Progression-free and overall survival were extrapolated beyond the follow-up of the primary analysis using fitted parametric curves. Costs and quality of life were estimated from multiple and different data sources. CONCLUSIONS: The efficacy of panitumumab in extending progression-free and overall survival and improving quality of life makes it a cost-effective option for first-line treatment of patients with wild-type RAS mCRC compared with bevacizumab.


Asunto(s)
Inhibidores de la Angiogénesis/economía , Antineoplásicos Inmunológicos/economía , Bevacizumab/economía , Neoplasias Colorrectales/tratamiento farmacológico , Panitumumab/economía , Inhibidores de la Angiogénesis/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica , Bevacizumab/uso terapéutico , Neoplasias Colorrectales/patología , Análisis Costo-Beneficio , Supervivencia sin Enfermedad , Fluorouracilo , Humanos , Leucovorina , Modelos Econométricos , Metástasis de la Neoplasia , Compuestos Organoplatinos , Panitumumab/uso terapéutico , Calidad de Vida , Años de Vida Ajustados por Calidad de Vida , Análisis de Supervivencia , Proteínas ras/genética
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