Compared with zoledronic acid, denosumab provides a cost-effective treatment option for the prevention of SREs in patients with prostate cancer, breast cancer, and OST in the Czech Republic.
Objective To predict the real-world (RW) cost-effectiveness of carfilzomib in combination with lenalidomide and dexamethasone (KRd) versus lenalidomide and dexamethasone (Rd) in relapsed multiple myeloma (MM) patients after one to three prior therapies. Methods A partitioned survival model that included three health states (progression-free, progressed disease and death) was built. Progression-free survival (PFS), overall survival (OS) and time to discontinuation (TTD) data for the Rd arm were derived using the Registry of Monoclonal Gammopathies in the Czech Republic; the relative treatment effects of KRd versus Rd were estimated from the phase 3, randomised, ASPIRE trial, and were used to predict PFS, OS and TTD for KRd. The model was developed from the payer perspective and included drug costs, administration costs, monitoring costs, palliative care costs and adverse-event related costs collected from Czech sources. Results The base case incremental cost effectiveness ratio for KRd compared with Rd was €73,156 per quality-adjusted life year (QALY) gained. Patients on KRd incurred costs of €117,534 over their lifetime compared with €53,165 for patients on Rd. The QALYs gained were 2.63 and 1.75 for patients on KRd and Rd, respectively. Conclusions Combining the strengths of randomised controlled trials and observational databases in cost-effectiveness models can generate policy-relevant results to allow well-informed decision-making. The current model showed that KRd is likely to be cost-effective versus Rd in the RW and, therefore, the reimbursement of KRd represents an efficient allocation of resources within the healthcare system.
Východiska: Farmakoekonomická hodnocení jsou součástí rozhodovacího procesu nejen v systému stanovení úhrady, ale i v klinické praxi. Předložená farmakoekonomická analýza hodnotí panitumumab + mFOLFOX6 oproti režimu bevacizumab + mFOLFOX6 v 1. linii léčby u pa cientů s metastatickým kolorektálním karcinomem (metastatic colorectal cancer-mCRC) s expresí nemutovaného typu (wild-type) onkogenu RAS v podmínkách České republiky. Materiál a metody: Adaptovaný Markovův model vychází z perspektivy plátce zdravotního pojištění, klinická data (účinnost, utilizace zdravotní péče a výskyt nežádoucích účinků) z přímého srovnání ve studii PEAK. Pa cienti se v modelu nacházejí v jednom z následujících stavů: bez progrese s léčbou, progrese (s/ bez léčby), resekce metastáz, stav po úspěšné resekci a smrt. Aktuální výše úhrady byla použita pro odhad nákladů, literární data pro odhad délky následné léčby. Utility vychází z klinických studií s panitumumabem v 1.-3. linii léčby. Analýza uvažuje celoživotní horizont, nejistota byla limitována jednocestnou a pravděpodobnostní analýzou senzitivity. Parametr přínosu je rok zachráněného života (life-year gained-LYG) a rok života v plné kvalitě (quality-adjusted life-year-QALY). Výsledky: Panitumumab + mFOLFOX6 je účinnější a nákladnější než bevacizumab + mFOLFOX6 u pa cientů s mCRC a wild-type RAS v 1. linii léčby. Inkrementální náklady na QALY jsou 837 270 Kč, na LYG 615 022 Kč. Propočtené náklady leží pod hranicí ochoty platit v České republice. Závěr: Režim panitumumab + mFOLFOX6 je nákladově efektivní intervencí oproti režimu bevacizumab + mFOLFOX6 v 1. linii wild-type RAS mCRC. Klíčová slova nákladová efektivita-panitumumab-bevacizumab-kolorektální karcinom Prohlášení o střetu zájmů: Spoluautorka článku Jandová P. je zaměstnanec společnosti Amgen s. r. o., Praha a nepodílela se na tvorbě a validaci modelu, modelování a interpretaci výsledků. Co-author of the article Jandova P. is employed with Amgen s. r. o., Prague. She did not participate in the creation and validation of models, modeling and interpretation of results.
A483of breast cancer with BMs was derived assuming a steady state approach (with incidence equivalent to mortality of metastatic disease), and the average survival for metastatic breast cancer patients from published literature. Annual SRE rates from a European observational retrospective study and the treatment effect observed in a head-to-head clinical trial of denosumab versus zoledronic acid were used to estimate the total number of predicted SREs by treatment option. Country-specific findings from two retrospective studies were used to estimate the total number of hospitalisations, inpatient days and direct medical costs associated with the management of SREs. Results: Across all countries, the estimated prevalence of breast cancer patients with BMs was 87,592 patients:
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