AIMS: This study assessed the cost-effectiveness of the subcutaneous RANKL inhibitor, denosumab, vs the intravenous bisphosphonate, zoledronic acid, for the prevention of skeletal-related events (SREs) in patients with prostate cancer, breast cancer, and other solid tumors (OST) in the Czech Republic. MATERIALS AND METHODS: A lifetime Markov model was developed to compare the effects of denosumab and zoledronic acid on costs (including drug costs and administration, patient management, SREs, and adverse events), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios from a national payer perspective. Different discount rates, time horizons, SRE rates, distributions, and nature (asymptomatic vs all SREs), and the inclusion of treatment discontinuation were considered in scenario analyses. The robustness of the model was tested using deterministic and probabilistic sensitivity analyses. RESULTS: Across tumor types, denosumab was associated with fewer SREs, improved QALYs, and higher total costs over a lifetime. The incremental cost per QALY gained for denosumab vs zoledronic acid was 382,673 CZK for prostate cancer, 408,450 CZK for breast cancer, and 608,133 CZK for OST. Incremental costs per SRE avoided for the same tumor type were 54,007 CZK, 51,765 CZK, and 94,426 CZK, respectively. In scenario analyses, the results remained similar to baseline, when different discount rates and time horizons were considered. At a non-official willingness-to-pay threshold of 1.2 million CZK, the probabilities of denosumab being cost-effective vs zoledronic acid were 0.64, 0.67, and 0.49 for prostate cancer, breast cancer, and OST, respectively. LIMITATIONS: The SRE rates used were obtained from clinical trials; studies suggest rates may be higher in clinical practice. Additional evidence on real-world SRE rates could further improve the accuracy of the modeling. CONCLUSIONS: 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.
- MeSH
- analýza nákladů a výnosů MeSH
- bisfosfonáty aplikace a dávkování ekonomika MeSH
- denosumab aplikace a dávkování ekonomika MeSH
- dvojitá slepá metoda MeSH
- ekonometrické modely MeSH
- imidazoly aplikace a dávkování ekonomika MeSH
- inhibitory kostní resorpce aplikace a dávkování ekonomika MeSH
- kvalita života MeSH
- kvalitativně upravené roky života MeSH
- lidé MeSH
- Markovovy řetězce MeSH
- nádory prostaty komplikace MeSH
- nádory prsu komplikace MeSH
- nádory komplikace MeSH
- nemoci kostí etiologie prevence a kontrola MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- randomizované kontrolované studie MeSH
- Geografické názvy
- Česká republika MeSH
- MeSH
- absorpční fotometrie metody MeSH
- bisfosfonáty terapeutické užití MeSH
- časové faktory MeSH
- cholekalciferol aplikace a dávkování MeSH
- dospělí MeSH
- estrogeny nedostatek škodlivé účinky MeSH
- inhibitory aromatasy * farmakologie škodlivé účinky terapeutické užití MeSH
- inhibitory kostní resorpce ekonomika farmakologie terapeutické užití MeSH
- kostní denzita účinky léků MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory prsu * patologie terapie MeSH
- osteoporotické fraktury chemicky indukované prevence a kontrola MeSH
- ovarektomie MeSH
- raloxifen hydrochlorid škodlivé účinky MeSH
- selektivní modulátory estrogenních receptorů farmakologie škodlivé účinky terapeutické užití MeSH
- senioři MeSH
- věkové faktory MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- ženské pohlaví MeSH
- MeSH
- analýza nákladů a výnosů MeSH
- bisfosfonáty terapeutické užití MeSH
- financování organizované MeSH
- hodnotící studie jako téma MeSH
- hormonální substituční terapie ekonomika metody MeSH
- inhibitory kostní resorpce ekonomika terapeutické užití MeSH
- konsensus MeSH
- lidé MeSH
- naftaleny ekonomika terapeutické užití MeSH
- nemoci kostí etiologie prevence a kontrola MeSH
- parathormon krev MeSH
- primární hyperparatyreóza farmakoterapie komplikace krev MeSH
- vápník krev MeSH
- výběr pacientů MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- souhrny MeSH
- MeSH
- bisfosfonáty ekonomika terapeutické užití MeSH
- inhibitory kostní resorpce ekonomika škodlivé účinky terapeutické užití MeSH
- lidé MeSH
- ligand RANK škodlivé účinky terapeutické užití MeSH
- monoklonální protilátky škodlivé účinky terapeutické užití MeSH
- osteoporóza ekonomika farmakoterapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- úvodní články MeSH
OBJECTIVE: Alendronate and calcitonin are antiresorptive drugs that were used for the treatment of postmenopausal osteoporosis and were shown to increase bone mineral density (BMD). However, the effect of both drugs in daily clinical practice may differ from that observed in clinical trials. METHOD: About 50 postmenopausal osteoporotic women were observed during their first year of treatment. Among them, 32 patients used alendronate and 18 used calcitonin. Lumbar spine and femoral neck BMD were measured by dual energy X-ray absorptiometry (DXA) at baseline and after 1 year of therapy. Biochemical markers (B-ALP--bone-specific alkaline phosphatase, OTC--osteocalcin and DPD/UCr--deoxypyridinoline/creatinine ratio) of bone metabolism were measured at baseline and 6 months later. Patient compliance was assumed by tablet counting and verified at interview. Each patient was further questioned about her attitude towards the treatment, as well as her dairy product intake, physical activity, use of other medications, smoking and social status.Main outcome measure: (1) Annual percent change in BMD in lumbar spine and femoral neck after the one-year treatment with either alendronate or calcitonin. (2) The change in biochemical markers of bone turnover. RESULTS: The lumbar spine BMD significantly increased by 7.0% (P < 0.001), the femoral neck BMD by 4.3% (P < 0.01). OTC, B-ALP and DPD/UCr decreased significantly during the therapy with alendronate. Compliance with therapy was 79% (95% CI 68-90%). In the calcitonin-treated group, the lumbar spine BMD significantly increased by 3.1 % (P < 0.05), while the femoral neck BMD remained unchanged. OTC, B-ALP and DPD/UCr did not change significantly during the treatment with calcitonin. Compliance with calcitonin therapy was 87% (95% CI 63-110%). The annual change of BMD in both treatment groups was independent on all questioned factors. CONCLUSION: In daily practice, alendronate enhanced significantly BMD both in lumbar spine and femoral neck. Calcitonin showed increase only in the lumbar spine BMD.
- MeSH
- adherence pacienta MeSH
- alendronát ekonomika terapeutické užití MeSH
- financování organizované MeSH
- inhibitory kostní resorpce ekonomika terapeutické užití MeSH
- kalcitonin ekonomika terapeutické užití MeSH
- kostní denzita účinky léků MeSH
- krček femuru patologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- náklady a analýza nákladů MeSH
- osteoporóza ekonomika farmakoterapie patologie MeSH
- páteř patologie MeSH
- retrospektivní studie MeSH
- senioři MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- senioři MeSH
- ženské pohlaví MeSH
