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.

Amgen GmbH Zug Switzerland

b Pilsen Faculty Hospital Clinic of Oncology and Radiotherapy Pilsen Czech Republic

c Amgen s r o Prague Czech Republic

e Amgen Inc Thousand Oaks CA USA

Oaks Consulting Prague Czech Republic

000      

00000naa a2200000 a 4500

001      

bmc18025039

003      

CZ-PrNML

005      

20180717093127.0

007      

ta

008      

180709s2017 enk f 000 0|eng||

009      

AR

024    7_

$a 10.1080/13696998.2017.1328423 $2 doi

035    __

$a (PubMed)28485692

040    __

$a ABA008 $b cze $d ABA008 $e AACR2

041    0_

$a eng

044    __

$a enk

100    1_

$a Cristino, Joaquim $u a Amgen (Europe) GmbH , Zug , Switzerland.

245    10

$a Cost-effectiveness of denosumab versus zoledronic acid for preventing skeletal-related events in the Czech Republic / $c J. Cristino, J. Finek, P. Jandova, M. Kolek, B. Pásztor, C. Giannopoulou, Y. Qian, T. Brezina, M. Lothgren,

520    9_

$a 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.

650    _2

$a inhibitory kostní resorpce $x aplikace a dávkování $x ekonomika $7 D050071

650    _2

$a nemoci kostí $x etiologie $x prevence a kontrola $7 D001847

650    _2

$a nádory prsu $x komplikace $7 D001943

650    _2

$a analýza nákladů a výnosů $7 D003362

650    _2

$a Česká republika $7 D018153

650    _2

$a denosumab $x aplikace a dávkování $x ekonomika $7 D000069448

650    _2

$a bisfosfonáty $x aplikace a dávkování $x ekonomika $7 D004164

650    _2

$a dvojitá slepá metoda $7 D004311

650    _2

$a ženské pohlaví $7 D005260

650    _2

$a lidé $7 D006801

650    _2

$a imidazoly $x aplikace a dávkování $x ekonomika $7 D007093

650    _2

$a mužské pohlaví $7 D008297

650    _2

$a Markovovy řetězce $7 D008390

650    _2

$a ekonometrické modely $7 D017059

650    _2

$a nádory $x komplikace $7 D009369

650    _2

$a nádory prostaty $x komplikace $7 D011471

650    _2

$a kvalita života $7 D011788

650    _2

$a kvalitativně upravené roky života $7 D019057

655    _2

$a klinické zkoušky, fáze III $7 D017428

655    _2

$a časopisecké články $7 D016428

655    _2

$a randomizované kontrolované studie $7 D016449

700    1_

$a Finek, Jíndřich $u b Pilsen Faculty Hospital, Clinic of Oncology and Radiotherapy (FN v Plzni) , Pilsen , Czech Republic.

700    1_

$a Jandova, Petra $u c Amgen s.r.o. , Prague , Czech Republic.

700    1_

$a Kolek, Martin $u d Oaks Consulting , Prague , Czech Republic.

700    1_

$a Pásztor, Bálint $u d Oaks Consulting , Prague , Czech Republic.

700    1_

$a Giannopoulou, Christina $u a Amgen (Europe) GmbH , Zug , Switzerland.

700    1_

$a Qian, Yi $u e Amgen Inc. , Thousand Oaks , CA , USA.

700    1_

$a Brezina, Tomas $u c Amgen s.r.o. , Prague , Czech Republic.

700    1_

$a Lothgren, Mickael $u a Amgen (Europe) GmbH , Zug , Switzerland.

773    0_

$w MED00193522 $t Journal of medical economics $x 1941-837X $g Roč. 20, č. 8 (2017), s. 799-812

856    41

$u https://pubmed.ncbi.nlm.nih.gov/28485692 $y Pubmed

910    __

$a ABA008 $b sig $c sign $y a $z 0

990    __

$a 20180709 $b ABA008

991    __

$a 20180717093427 $b ABA008

999    __

$a ok $b bmc $g 1317170 $s 1021960

BAS    __

$a 3

BAS    __

$a PreBMC

BMC    __

$a 2017 $b 20 $c 8 $d 799-812 $e 20170607 $i 1941-837X $m Journal of medical economics $n J Med Econ $x MED00193522

LZP    __

$a Pubmed-20180709