• Je něco špatně v tomto záznamu ?

Health technology assessment and reimbursement policy for oncology orphan drugs in Central and Eastern Europe

KP. Malinowski, P. Kawalec, W. Trąbka, C. Sowada, G. Petrova, M. Manova, A. Savova, P. Draganić, J. Slabý, A. Männik, K. Márky, Z. Rugaja, J. Gulbinovic, T. Tesar, MS. Paveliu

. 2020 ; 15 (1) : 277. [pub] 20201008

Jazyk angličtina Země Velká Británie

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc21019997

BACKGROUND: The reimbursement of orphan drugs (OD) is an increasingly important for country policymakers, and still insufficiently understood, especially in Central and Eastern Europe. The aim of this research was to provide a comprehensive description of country-specific health technology assessment (HTA) policies as well as evaluate the percentage of HTA recommendations and reimbursement decisions for oncology OD. In addition, the study was designed to elucidate the impact of reimbursement of these drugs on the public budget and the agreement between HTA recommendations and reimbursement decisions in the analysed countries. A questionnaire survey was used to collect data on the reimbursement status, HTA recommendation, marketing authorisation, and public expenses on reimbursement in 2014, 2015, and 2016 for all oncology drugs with an orphan designation by the European Medicine Agency in 2017 in Bulgaria, Croatia, Czechia, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, and Slovakia. The agreement between the HTA recommendation and reimbursement status was assessed using the kappa coefficient. The Pearson's correlation was used to analyse the relationship between gross domestic product (GDP) and GDP per capita and reimbursement expenses. RESULTS: A total of 36 drugs were analysed (25% conditionally approved; 5.56% approved under exceptional circumstances). The share of reimbursed drugs ranged from 11.11% in Latvia to 41.67% in Poland. The highest share of positive recommendations was observed for Bulgaria and Estonia (36.11%), and the lowest, for Latvia (11.11%). The agreement varied from 0.4 for Poland to 1 for Latvia, Hungary, and Slovakia. Expenses were correlated with GDP (0.95 [0.81-0.99]), and not with GDP per capita (0.54 [- 0.136 to 0.873]). Expenses per capita were not correlated with GDP per capita (0.52 [- 0.15 to 0.87]). CONCLUSIONS: In Hungary, Latvia, and Slovakia, a positive recommendation was associated with a reimbursement, and a negative one, with the lack of reimbursement. The reimbursement of oncology OD is associated with a growing burden for public budget, and the expenses are correlated with the total GDP. The highest share of drugs with any recommendation was observed in Poland, and the lowest, in Latvia and Romania. The share of reimbursed drugs was the lowest in Latvia and the highest in Poland.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc21019997
003      
CZ-PrNML
005      
20210830101608.0
007      
ta
008      
210728s2020 xxk f 000 0|eng||
009      
AR
024    7_
$a 10.1186/s13023-020-01556-9 $2 doi
035    __
$a (PubMed)33032634
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxk
100    1_
$a Malinowski, Krzysztof Piotr $u Institute of Public Health, Faculty of Health Sciences, Jagiellonian University Medical College, ul. Grzegórzecka 20, 31-531, Kraków, Poland. krzysztof.malinowski@doctoral.uj.edu.pl
245    10
$a Health technology assessment and reimbursement policy for oncology orphan drugs in Central and Eastern Europe / $c KP. Malinowski, P. Kawalec, W. Trąbka, C. Sowada, G. Petrova, M. Manova, A. Savova, P. Draganić, J. Slabý, A. Männik, K. Márky, Z. Rugaja, J. Gulbinovic, T. Tesar, MS. Paveliu
520    9_
$a BACKGROUND: The reimbursement of orphan drugs (OD) is an increasingly important for country policymakers, and still insufficiently understood, especially in Central and Eastern Europe. The aim of this research was to provide a comprehensive description of country-specific health technology assessment (HTA) policies as well as evaluate the percentage of HTA recommendations and reimbursement decisions for oncology OD. In addition, the study was designed to elucidate the impact of reimbursement of these drugs on the public budget and the agreement between HTA recommendations and reimbursement decisions in the analysed countries. A questionnaire survey was used to collect data on the reimbursement status, HTA recommendation, marketing authorisation, and public expenses on reimbursement in 2014, 2015, and 2016 for all oncology drugs with an orphan designation by the European Medicine Agency in 2017 in Bulgaria, Croatia, Czechia, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, and Slovakia. The agreement between the HTA recommendation and reimbursement status was assessed using the kappa coefficient. The Pearson's correlation was used to analyse the relationship between gross domestic product (GDP) and GDP per capita and reimbursement expenses. RESULTS: A total of 36 drugs were analysed (25% conditionally approved; 5.56% approved under exceptional circumstances). The share of reimbursed drugs ranged from 11.11% in Latvia to 41.67% in Poland. The highest share of positive recommendations was observed for Bulgaria and Estonia (36.11%), and the lowest, for Latvia (11.11%). The agreement varied from 0.4 for Poland to 1 for Latvia, Hungary, and Slovakia. Expenses were correlated with GDP (0.95 [0.81-0.99]), and not with GDP per capita (0.54 [- 0.136 to 0.873]). Expenses per capita were not correlated with GDP per capita (0.52 [- 0.15 to 0.87]). CONCLUSIONS: In Hungary, Latvia, and Slovakia, a positive recommendation was associated with a reimbursement, and a negative one, with the lack of reimbursement. The reimbursement of oncology OD is associated with a growing burden for public budget, and the expenses are correlated with the total GDP. The highest share of drugs with any recommendation was observed in Poland, and the lowest, in Latvia and Romania. The share of reimbursed drugs was the lowest in Latvia and the highest in Poland.
650    _2
$a zdravotní politika $7 D006291
650    _2
$a lidé $7 D006801
650    _2
$a výroba orphan drugs $7 D009965
650    12
$a léčivé přípravky $7 D004364
650    _2
$a postup $7 D057766
650    12
$a hodnocení biomedicínských technologií $7 D013673
651    _2
$a Česká republika $7 D018153
651    _2
$a Evropa $7 D005060
651    _2
$a Lotyšsko $7 D007844
651    _2
$a Polsko $7 D011044
655    _2
$a časopisecké články $7 D016428
700    1_
$a Kawalec, Paweł $u Institute of Public Health, Faculty of Health Sciences, Jagiellonian University Medical College, ul. Grzegórzecka 20, 31-531, Kraków, Poland
700    1_
$a Trąbka, Wojciech $u Bioinformatics and Public Health Department, Faculty of Medicine and Health Sciences, Andrzej Frycz Modrzewski Krakow University, Kraków, Poland
700    1_
$a Sowada, Christoph $u Institute of Public Health, Faculty of Health Sciences, Jagiellonian University Medical College, ul. Grzegórzecka 20, 31-531, Kraków, Poland
700    1_
$a Petrova, Guenka $u Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria
700    1_
$a Manova, Manoela $u Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria $u National Council On Prices and Reimbursement of Medicinal Products, Sofia, Bulgaria
700    1_
$a Savova, Alexandra $u Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria $u National Council On Prices and Reimbursement of Medicinal Products, Sofia, Bulgaria
700    1_
$a Draganić, Pero $u Agency for Medicinal Products and Medical Devices of Croatia, Zagreb, Croatia $u Department of Biotechnology, University of Rijeka, Rijeka, Croatia
700    1_
$a Slabý, Juraj $u Section of Pricing and Reimbursement Regulation, State Institute for Drug Control, Prague, Czechia
700    1_
$a Männik, Agnes $u Institute of Family Medicine and Public Health, University of Tartu, Tartu, Estonia
700    1_
$a Márky, Kristóf $u National Institute of Health Insurance Fund Management, Budapest, Hungary
700    1_
$a Rugaja, Zinta $u The National Health Service, Riga, Latvia
700    1_
$a Gulbinovic, Jolanta $u Department of Pathology, Forensic Medicine and Pharmacology, Faculty of Medicine, Institute of Biomedical Sciences, Vilnius University, Vilnius, Lithuania
700    1_
$a Tesar, Tomas $u Department of Organisation and Management in Pharmacy, Faculty of Pharmacy, Comenius University in Bratislava, Bratislava, Slovakia
700    1_
$a Paveliu, Marian Sorin $u Titu Maiorescu University, Bucharest, Romania
773    0_
$w MED00165365 $t Orphanet journal of rare diseases $x 1750-1172 $g Roč. 15, č. 1 (2020), s. 277
856    41
$u https://pubmed.ncbi.nlm.nih.gov/33032634 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y p $z 0
990    __
$a 20210728 $b ABA008
991    __
$a 20210830101608 $b ABA008
999    __
$a ok $b bmc $g 1690731 $s 1140443
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2020 $b 15 $c 1 $d 277 $e 20201008 $i 1750-1172 $m Orphanet journal of rare diseases $n Orphanet J Rare Dis $x MED00165365
LZP    __
$a Pubmed-20210728

Najít záznam

Citační ukazatele

Možnosti archivace