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Pregled bibliografske jedinice broj: 1223202

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


Malinowski, Krzysztof Piotr 1*; Kawalec, Paweł 1; Trabka, Wojciech 2; Sowada, Christoph 1; Petrova, Guenka 3; Manova, Manoela 3, 4; Savova, Alexandra 3, 4; Draganić, Pero 5, 6; Slaby, Juraj 7; Männik, Agnes 8 et al.
Health technology assessment and reimbursement policy for oncology orphan drugs in Central and Eastern Europe // Orphanet journal of rare diseases, 15 (2020), 1; 10.1186, 13 doi:.org/10.1186/s13023-020-01556-9 (međunarodna recenzija, članak, znanstveni)


CROSBI ID: 1223202 Za ispravke kontaktirajte CROSBI podršku putem web obrasca

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

Autori
Malinowski, Krzysztof Piotr 1* ; Kawalec, Paweł 1 ; Trabka, Wojciech 2 ; Sowada, Christoph 1 ; Petrova, Guenka 3 ; Manova, Manoela 3, 4 ; Savova, Alexandra 3, 4 ; Draganić, Pero 5, 6 ; Slaby, Juraj 7 ; Männik, Agnes 8 ; Márky, Kristof 9 ; Rugaja, Zinta 10 ; Gulbinovic, Jolanta 11 ; Tesar, Tomas 12 ; Paveliu, S. Marian 13.

Izvornik
Orphanet journal of rare diseases (1750-1172) 15 (2020), 1; 10.1186, 13

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
Orphan drugs, Oncology, Reimbursement, Health technology assessment, Policy, Central and Eastern Europe

Sažetak
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.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti, Biotehnologija u biomedicini (prirodno područje, biomedicina i zdravstvo, biotehničko područje)



POVEZANOST RADA


Profili:

Avatar Url Pero Draganić (autor)

Poveznice na cjeloviti tekst rada:

doi

Citiraj ovu publikaciju:

Malinowski, Krzysztof Piotr 1*; Kawalec, Paweł 1; Trabka, Wojciech 2; Sowada, Christoph 1; Petrova, Guenka 3; Manova, Manoela 3, 4; Savova, Alexandra 3, 4; Draganić, Pero 5, 6; Slaby, Juraj 7; Männik, Agnes 8 et al.
Health technology assessment and reimbursement policy for oncology orphan drugs in Central and Eastern Europe // Orphanet journal of rare diseases, 15 (2020), 1; 10.1186, 13 doi:.org/10.1186/s13023-020-01556-9 (međunarodna recenzija, članak, znanstveni)
Malinowski, K., Kawalec, P., Trabka, W., Sowada, C., Petrova, G., Manova, Manoela 3, 4, Savova, Alexandra 3, 4, Draganić, Pero 5, 6, Slaby, J. & Männik, A. (2020) Health technology assessment and reimbursement policy for oncology orphan drugs in Central and Eastern Europe. Orphanet journal of rare diseases, 15 (1), 10.1186, 13 doi:.org/10.1186/s13023-020-01556-9.
@article{article, author = {Malinowski, Krzysztof Piotr 1\ast and Kawalec, Pawe\l 1 and Trabka, Wojciech 2 and Sowada, Christoph 1 and Petrova, Guenka 3 and Slaby, Juraj 7 and M\"{a}nnik, Agnes 8 and M\'{a}rky, Kristof 9 and Rugaja, Zinta 10 and Gulbinovic, Jolanta 11 and Tesar, Tomas 12 and Paveliu, S. Marian 13.}, year = {2020}, pages = {13}, DOI = {doi.org/10.1186/s13023-020-01556-9}, chapter = {10.1186}, keywords = {Orphan drugs, Oncology, Reimbursement, Health technology assessment, Policy, Central and Eastern Europe}, journal = {Orphanet journal of rare diseases}, doi = {doi.org/10.1186/s13023-020-01556-9}, volume = {15}, number = {1}, issn = {1750-1172}, title = {Health technology assessment and reimbursement policy for oncology orphan drugs in Central and Eastern Europe}, keyword = {Orphan drugs, Oncology, Reimbursement, Health technology assessment, Policy, Central and Eastern Europe}, chapternumber = {10.1186} }
@article{article, author = {Malinowski, Krzysztof Piotr 1\ast and Kawalec, Pawe\l 1 and Trabka, Wojciech 2 and Sowada, Christoph 1 and Petrova, Guenka 3 and Slaby, Juraj 7 and M\"{a}nnik, Agnes 8 and M\'{a}rky, Kristof 9 and Rugaja, Zinta 10 and Gulbinovic, Jolanta 11 and Tesar, Tomas 12 and Paveliu, S. Marian 13.}, year = {2020}, pages = {13}, DOI = {doi.org/10.1186/s13023-020-01556-9}, chapter = {10.1186}, keywords = {Orphan drugs, Oncology, Reimbursement, Health technology assessment, Policy, Central and Eastern Europe}, journal = {Orphanet journal of rare diseases}, doi = {doi.org/10.1186/s13023-020-01556-9}, volume = {15}, number = {1}, issn = {1750-1172}, title = {Health technology assessment and reimbursement policy for oncology orphan drugs in Central and Eastern Europe}, keyword = {Orphan drugs, Oncology, Reimbursement, Health technology assessment, Policy, Central and Eastern Europe}, chapternumber = {10.1186} }

Časopis indeksira:


  • Web of Science Core Collection (WoSCC)
    • Science Citation Index Expanded (SCI-EXP)
    • SCI-EXP, SSCI i/ili A&HCI
  • Scopus
  • MEDLINE


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