TY  - JOUR
AU  - Kamusheva, Maria
AU  - Manova, Manoela
AU  - Savova, Alexandra
AU  - Petrova, Guenka
AU  - Mitov, Konstantin
AU  - Harsanyi, Andras
AU  - Kalo, Zoltan
AU  - Marky, Kristof
AU  - Kawalec, Pawel
AU  - Angelovska, Bistra
AU  - Lakić, Dragana
AU  - Tesar, Tomas
AU  - Draganić, Pero
AU  - Geitona, Mary
AU  - Hatziko, Magdalini
AU  - Paveliu, Marian S.
AU  - Mannik, Agnes
PY  - 2018
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3195
AB  - Objectives: The aim of the study was to compare the access of patients with rare diseases (RDs) to biotechnological drugs in several Central and Eastern European countries (CEECs). We focused on the legislative pricing and reimbursement requirements, availability of biotechnological orphan medicinal products (BOMPs) for RDs, and reimbursement expenditures. Methods: A questionnaire-based survey was conducted among experts from 10 CEECs: Bulgaria, Croatia, Estonia, Greece, Hungary, Poland, Romania, Slovakia, Serbia, and Macedonia. The legal requirements for reimbursement and pricing of BOMPs were collected. All BOMPs and medicines without prior orphan designations were extracted from the European list of orphan medicinal products, 2017. The reimbursement status of these medicinal products in 2017 in the public coverage of the included CEECs as well as the share of their costs in relation to the total public pharmaceutical spending for the period from 2014 to 2016 were defined. Results: Our survey revealed that some differences in the legal requirements for pricing and reimbursement of BOMPs amongst the countries included in the study. All European Union countries have developed and implemented pharmacoeconomic guidelines with or without some specific reimbursement requirements for orphan medicinal products. Cost-effectiveness analysis, cost-utility analysis, Markov models, meta-analysis, and discount levels of costs and results were required only in Bulgaria, Poland and Hungary. The number of reimbursed BOMPs and biotechnological medicinal products for RDs without prior orphan designation was the highest in Hungary (17 and 40, respectively). Patient-based reimbursement schemes were available only in Hungary for 11 out of 17 BOMPs. Poland and Greece have the highest pharmaceutical expenditure of reimbursed BOMPs with are similar to 214 million and 180 million EUR, respectively in the observed period from 2014 to 2016. High proportion of the pharmaceutical expenditure on the reimbursed biotechnological medicinal products for RDs for the observed period 2014-2016 is presented in Bulgaria and Slovakia. Conclusions: The non-European Union CEECs face a significant delay in the legal implementation of pharmacoeconomic guideline for assessment of BOMPs. The access to BOMPs is similar among the observed CEECs and the countries with the best access are Hungary and Greece. The influence of BOMP expenditures on the budget in the individual countries is significant.
PB  - Frontiers Media Sa, Lausanne
T2  - Frontiers in Pharmacology
T1  - Comparative Analysis of Legislative Requirements About Patients' Access to Biotechnological Drugs for Rare Diseases in Central and Eastern European Countries
VL  - 9
DO  - 10.3389/fphar.2018.00795
ER  - 

@article{
author = "Kamusheva, Maria and Manova, Manoela and Savova, Alexandra and Petrova, Guenka and Mitov, Konstantin and Harsanyi, Andras and Kalo, Zoltan and Marky, Kristof and Kawalec, Pawel and Angelovska, Bistra and Lakić, Dragana and Tesar, Tomas and Draganić, Pero and Geitona, Mary and Hatziko, Magdalini and Paveliu, Marian S. and Mannik, Agnes",
year = "2018",
abstract = "Objectives: The aim of the study was to compare the access of patients with rare diseases (RDs) to biotechnological drugs in several Central and Eastern European countries (CEECs). We focused on the legislative pricing and reimbursement requirements, availability of biotechnological orphan medicinal products (BOMPs) for RDs, and reimbursement expenditures. Methods: A questionnaire-based survey was conducted among experts from 10 CEECs: Bulgaria, Croatia, Estonia, Greece, Hungary, Poland, Romania, Slovakia, Serbia, and Macedonia. The legal requirements for reimbursement and pricing of BOMPs were collected. All BOMPs and medicines without prior orphan designations were extracted from the European list of orphan medicinal products, 2017. The reimbursement status of these medicinal products in 2017 in the public coverage of the included CEECs as well as the share of their costs in relation to the total public pharmaceutical spending for the period from 2014 to 2016 were defined. Results: Our survey revealed that some differences in the legal requirements for pricing and reimbursement of BOMPs amongst the countries included in the study. All European Union countries have developed and implemented pharmacoeconomic guidelines with or without some specific reimbursement requirements for orphan medicinal products. Cost-effectiveness analysis, cost-utility analysis, Markov models, meta-analysis, and discount levels of costs and results were required only in Bulgaria, Poland and Hungary. The number of reimbursed BOMPs and biotechnological medicinal products for RDs without prior orphan designation was the highest in Hungary (17 and 40, respectively). Patient-based reimbursement schemes were available only in Hungary for 11 out of 17 BOMPs. Poland and Greece have the highest pharmaceutical expenditure of reimbursed BOMPs with are similar to 214 million and 180 million EUR, respectively in the observed period from 2014 to 2016. High proportion of the pharmaceutical expenditure on the reimbursed biotechnological medicinal products for RDs for the observed period 2014-2016 is presented in Bulgaria and Slovakia. Conclusions: The non-European Union CEECs face a significant delay in the legal implementation of pharmacoeconomic guideline for assessment of BOMPs. The access to BOMPs is similar among the observed CEECs and the countries with the best access are Hungary and Greece. The influence of BOMP expenditures on the budget in the individual countries is significant.",
publisher = "Frontiers Media Sa, Lausanne",
journal = "Frontiers in Pharmacology",
title = "Comparative Analysis of Legislative Requirements About Patients' Access to Biotechnological Drugs for Rare Diseases in Central and Eastern European Countries",
volume = "9",
doi = "10.3389/fphar.2018.00795"
}

Kamusheva, M., Manova, M., Savova, A., Petrova, G., Mitov, K., Harsanyi, A., Kalo, Z., Marky, K., Kawalec, P., Angelovska, B., Lakić, D., Tesar, T., Draganić, P., Geitona, M., Hatziko, M., Paveliu, M. S.,& Mannik, A.. (2018). Comparative Analysis of Legislative Requirements About Patients' Access to Biotechnological Drugs for Rare Diseases in Central and Eastern European Countries. in Frontiers in Pharmacology
Frontiers Media Sa, Lausanne., 9.
https://doi.org/10.3389/fphar.2018.00795

Kamusheva M, Manova M, Savova A, Petrova G, Mitov K, Harsanyi A, Kalo Z, Marky K, Kawalec P, Angelovska B, Lakić D, Tesar T, Draganić P, Geitona M, Hatziko M, Paveliu MS, Mannik A. Comparative Analysis of Legislative Requirements About Patients' Access to Biotechnological Drugs for Rare Diseases in Central and Eastern European Countries. in Frontiers in Pharmacology. 2018;9.
doi:10.3389/fphar.2018.00795 .

Kamusheva, Maria, Manova, Manoela, Savova, Alexandra, Petrova, Guenka, Mitov, Konstantin, Harsanyi, Andras, Kalo, Zoltan, Marky, Kristof, Kawalec, Pawel, Angelovska, Bistra, Lakić, Dragana, Tesar, Tomas, Draganić, Pero, Geitona, Mary, Hatziko, Magdalini, Paveliu, Marian S., Mannik, Agnes, "Comparative Analysis of Legislative Requirements About Patients' Access to Biotechnological Drugs for Rare Diseases in Central and Eastern European Countries" in Frontiers in Pharmacology, 9 (2018),
https://doi.org/10.3389/fphar.2018.00795 . .

TY  - JOUR
AU  - Petrova, Guenka
AU  - Benbassat, Boriana
AU  - Lakić, Dragana
AU  - Dimitrova, Maria
AU  - Mitov, Konstantin
AU  - Dimitrov, Josif
PY  - 2016
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2551
AB  - The aim of this study was to explore the cost-effectiveness of short protocols including different types of gonadotropins for controlled ovarian hyperstimulation (COH) for in vitro fertilization (IVF). A retrospective, observational study of the real-life practice in a specialized IVF gynaecology clinic in 2009-2013 was carried out. All women on short COH protocols were recruited into three groups: COH including recombinant follicle stimulating hormone (rFSH) and urinary-FSH (urFSH) (n = 173); including urFSH alone (n = 289); and including rFSH alone (n = 212). The cost-effectiveness of the COH protocols was explored in two different case scenarios for possible outcomes. The first case scenario took into consideration a successful live birth, and the second one, the women to achieve pregnancy with live birth. Decision modelling was done using the TreeAge 2014 Software. According to the results in the first case scenario, the rFSH plus urFSH COH approach showed the highest weighted probability (p = 0.38) of live birth, but the urFSH alternative was cost-effective. The results in the second case scenario demonstrated that the urFSH protocol was again the cost-effective alternative. These results suggest that the strategy with urFSH should be preferred in both cases, but rFSH could also be considered as a cost-effective alternative for successful live birth and achieving pregnancy and delivery, since the incremental cost-effectiveness ratio in comparison with the urFSH protocol is below the gross domestic product per capita. The combined approach of rFSH and urFSH was shown not to be cost-effective in both explored scenarios.
PB  - Taylor & Francis Ltd, Abingdon
T2  - Biotechnology & Biotechnological Equipment
T1  - Cost-effectiveness of short COH protocols with GnRH antagonists using different types of gonadotropins for in vitro fertilization
VL  - 30
IS  - 3
SP  - 614
EP  - 621
DO  - 10.1080/13102818.2016.1160796
ER  - 

@article{
author = "Petrova, Guenka and Benbassat, Boriana and Lakić, Dragana and Dimitrova, Maria and Mitov, Konstantin and Dimitrov, Josif",
year = "2016",
abstract = "The aim of this study was to explore the cost-effectiveness of short protocols including different types of gonadotropins for controlled ovarian hyperstimulation (COH) for in vitro fertilization (IVF). A retrospective, observational study of the real-life practice in a specialized IVF gynaecology clinic in 2009-2013 was carried out. All women on short COH protocols were recruited into three groups: COH including recombinant follicle stimulating hormone (rFSH) and urinary-FSH (urFSH) (n = 173); including urFSH alone (n = 289); and including rFSH alone (n = 212). The cost-effectiveness of the COH protocols was explored in two different case scenarios for possible outcomes. The first case scenario took into consideration a successful live birth, and the second one, the women to achieve pregnancy with live birth. Decision modelling was done using the TreeAge 2014 Software. According to the results in the first case scenario, the rFSH plus urFSH COH approach showed the highest weighted probability (p = 0.38) of live birth, but the urFSH alternative was cost-effective. The results in the second case scenario demonstrated that the urFSH protocol was again the cost-effective alternative. These results suggest that the strategy with urFSH should be preferred in both cases, but rFSH could also be considered as a cost-effective alternative for successful live birth and achieving pregnancy and delivery, since the incremental cost-effectiveness ratio in comparison with the urFSH protocol is below the gross domestic product per capita. The combined approach of rFSH and urFSH was shown not to be cost-effective in both explored scenarios.",
publisher = "Taylor & Francis Ltd, Abingdon",
journal = "Biotechnology & Biotechnological Equipment",
title = "Cost-effectiveness of short COH protocols with GnRH antagonists using different types of gonadotropins for in vitro fertilization",
volume = "30",
number = "3",
pages = "614-621",
doi = "10.1080/13102818.2016.1160796"
}

Petrova, G., Benbassat, B., Lakić, D., Dimitrova, M., Mitov, K.,& Dimitrov, J.. (2016). Cost-effectiveness of short COH protocols with GnRH antagonists using different types of gonadotropins for in vitro fertilization. in Biotechnology & Biotechnological Equipment
Taylor & Francis Ltd, Abingdon., 30(3), 614-621.
https://doi.org/10.1080/13102818.2016.1160796

Petrova G, Benbassat B, Lakić D, Dimitrova M, Mitov K, Dimitrov J. Cost-effectiveness of short COH protocols with GnRH antagonists using different types of gonadotropins for in vitro fertilization. in Biotechnology & Biotechnological Equipment. 2016;30(3):614-621.
doi:10.1080/13102818.2016.1160796 .

Petrova, Guenka, Benbassat, Boriana, Lakić, Dragana, Dimitrova, Maria, Mitov, Konstantin, Dimitrov, Josif, "Cost-effectiveness of short COH protocols with GnRH antagonists using different types of gonadotropins for in vitro fertilization" in Biotechnology & Biotechnological Equipment, 30, no. 3 (2016):614-621,
https://doi.org/10.1080/13102818.2016.1160796 . .

TY  - JOUR
AU  - Kamusheva, Maria
AU  - Georgieva, Svetla
AU  - Lakić, Dragana
AU  - Mitov, Konstantin
AU  - Savova, Alexandra
AU  - Stoimenova, Assena
AU  - Petrova, Guenka
PY  - 2013
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1965
AB  - The aim of the present study was to analyze the cost of pharmacotherapy and quality of life of patients with cystic fibrosis (CF), Gaucher disease (GD) and chronic myeloid leukemia (CML) in Bulgaria. Data for the pharmacotherapy cost were compiled retrospectively. The second part of the study included a prospective quality-of-life survey (conducted at the Medical University Hospital "Alexandrovska" in 2010 and 2011). We estimated the average monthly pharmacotherapy costs according to data from the hospital registries. The quality-of-life survey was done through interviews based on the short form of SF-36, which measures 9 health domains. The total number of patients was 18, of which 10 were with CML, 5 with cystic fibrosis and 3 with Gaucher disease. The average age of the male and female patients with CML was 49.1 years and 48.3 years, respectively; 25 and 24 years in the group with GD, respectively; and 29.5 and 35.3 years in CF group, respectively. No statistical difference between the average monthly pharmacotherapy costs for the observed period was revealed In all patients the quality of life was below the maximum possible value, which is equal to 100 points. The lowest values for the different indicators of quality of life were observed in the CF patients, most likely due to the chronic progression of this particular rare disease. The average range of quality of life for this group was 53.75. We found a statistical correlation between the pharmacotherapy costs and the quality of life. The Spearman correlation analysis revealed a correlation between the drug therapy costs and some quality-of-life indicators only in the patients with CIVIL. The correlation between the pharmacotherapy costs and physiological functions in patients with CIVIL was positive, i.e. higher costs improved this indicator The pharmacotherapy costs were high, the average values for the three groups of patients being: BGN 9221.61 for 2010 and BGN 8254.64 for January March 2011 for patients with CF, BGN 32954.08 for those with GD, and BGN 6389.38 for 2010 and BGN 6591.19 for the second period for the CML patients. The quality of life was significantly reduced for the observed patients: the average value for quality of life were 53.75, 65.03 and 67, respectively, from a maximum of 100.
PB  - Diagnosis Press Ltd, Sofia
T2  - Biotechnology & Biotechnological Equipment
T1  - A health-related quality of life and pharmacotherapy costs study for patients with cystic fybrosis, gaucher disease and chronic myeloid leukemia in Bulgaria
VL  - 27
IS  - 3
SP  - 3896
EP  - 3900
DO  - 10.5504/BBEQ.2013.0029
ER  - 

@article{
author = "Kamusheva, Maria and Georgieva, Svetla and Lakić, Dragana and Mitov, Konstantin and Savova, Alexandra and Stoimenova, Assena and Petrova, Guenka",
year = "2013",
abstract = "The aim of the present study was to analyze the cost of pharmacotherapy and quality of life of patients with cystic fibrosis (CF), Gaucher disease (GD) and chronic myeloid leukemia (CML) in Bulgaria. Data for the pharmacotherapy cost were compiled retrospectively. The second part of the study included a prospective quality-of-life survey (conducted at the Medical University Hospital "Alexandrovska" in 2010 and 2011). We estimated the average monthly pharmacotherapy costs according to data from the hospital registries. The quality-of-life survey was done through interviews based on the short form of SF-36, which measures 9 health domains. The total number of patients was 18, of which 10 were with CML, 5 with cystic fibrosis and 3 with Gaucher disease. The average age of the male and female patients with CML was 49.1 years and 48.3 years, respectively; 25 and 24 years in the group with GD, respectively; and 29.5 and 35.3 years in CF group, respectively. No statistical difference between the average monthly pharmacotherapy costs for the observed period was revealed In all patients the quality of life was below the maximum possible value, which is equal to 100 points. The lowest values for the different indicators of quality of life were observed in the CF patients, most likely due to the chronic progression of this particular rare disease. The average range of quality of life for this group was 53.75. We found a statistical correlation between the pharmacotherapy costs and the quality of life. The Spearman correlation analysis revealed a correlation between the drug therapy costs and some quality-of-life indicators only in the patients with CIVIL. The correlation between the pharmacotherapy costs and physiological functions in patients with CIVIL was positive, i.e. higher costs improved this indicator The pharmacotherapy costs were high, the average values for the three groups of patients being: BGN 9221.61 for 2010 and BGN 8254.64 for January March 2011 for patients with CF, BGN 32954.08 for those with GD, and BGN 6389.38 for 2010 and BGN 6591.19 for the second period for the CML patients. The quality of life was significantly reduced for the observed patients: the average value for quality of life were 53.75, 65.03 and 67, respectively, from a maximum of 100.",
publisher = "Diagnosis Press Ltd, Sofia",
journal = "Biotechnology & Biotechnological Equipment",
title = "A health-related quality of life and pharmacotherapy costs study for patients with cystic fybrosis, gaucher disease and chronic myeloid leukemia in Bulgaria",
volume = "27",
number = "3",
pages = "3896-3900",
doi = "10.5504/BBEQ.2013.0029"
}

Kamusheva, M., Georgieva, S., Lakić, D., Mitov, K., Savova, A., Stoimenova, A.,& Petrova, G.. (2013). A health-related quality of life and pharmacotherapy costs study for patients with cystic fybrosis, gaucher disease and chronic myeloid leukemia in Bulgaria. in Biotechnology & Biotechnological Equipment
Diagnosis Press Ltd, Sofia., 27(3), 3896-3900.
https://doi.org/10.5504/BBEQ.2013.0029

Kamusheva M, Georgieva S, Lakić D, Mitov K, Savova A, Stoimenova A, Petrova G. A health-related quality of life and pharmacotherapy costs study for patients with cystic fybrosis, gaucher disease and chronic myeloid leukemia in Bulgaria. in Biotechnology & Biotechnological Equipment. 2013;27(3):3896-3900.
doi:10.5504/BBEQ.2013.0029 .

Kamusheva, Maria, Georgieva, Svetla, Lakić, Dragana, Mitov, Konstantin, Savova, Alexandra, Stoimenova, Assena, Petrova, Guenka, "A health-related quality of life and pharmacotherapy costs study for patients with cystic fybrosis, gaucher disease and chronic myeloid leukemia in Bulgaria" in Biotechnology & Biotechnological Equipment, 27, no. 3 (2013):3896-3900,
https://doi.org/10.5504/BBEQ.2013.0029 . .

TY  - JOUR
AU  - Georgieva, Svetla
AU  - Kamusheva, Maria
AU  - Lakić, Dragana
AU  - Mitov, Konstantin
AU  - Savova, Alexandra
AU  - Petrova, Guenka
PY  - 2012
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1729
AB  - The aim of the present study was to analyze the pharmacotherapy cost and quality of life of patents after kidney transplantation compared to those with chronic kidney disease in Bulgaria. This retrospective pharmacotherapy cost study and prospective health related quality of life (QoL) study was performed during 2010 - 2011 at the biggest Sofia hospital serving all transplant patients. The cost of pharmacotherapy was analyzed after reviewing patients' records. The health related quality of life was evaluated with the multi-attributable questionnaire SF-36, which measures 9 health domains. Forty-two percent of the patients with chronic kidney disease, and 26% of those with kidney transplant were female. The average age of the transplanted patients was 39.7 for male patients and 42.2 for female ones, while in the group suffering from chronic kidney disease the average male age was 48.3 and that of female patients, 51.2. No statistically significant difference was observed among the mean monthly cost of therapy per patient during the two-year period. The QoL was with lower values in the role limitations domain for patients with chronic kidney diseases and this difference was statistically significant. We found a correlation among the mean cost of pharmacotherapy and mean QoL in both groups of patients. In the group of patients with kidney transplantation the place of living and general health state were positively correlated. The cost of pharmacotherapy and the health state in comparison with the previous year were also positively correlated. This is the first Bulgarian study of the quality of life of kidney transplant patients. It shows that the SF-36 could be successfully used in this group of patients as well as for comparison with the QoL of patients with chronic kidney disease.
PB  - Diagnosis Press Ltd, Sofia
T2  - Biotechnology & Biotechnological Equipment
T1  - The health related quality of life for kidney transplant patients in Bulgaria - A pilot study
VL  - 26
IS  - 3
SP  - 3062
EP  - 3065
DO  - 10.5504/BBEQ.2012.0005
ER  - 

@article{
author = "Georgieva, Svetla and Kamusheva, Maria and Lakić, Dragana and Mitov, Konstantin and Savova, Alexandra and Petrova, Guenka",
year = "2012",
abstract = "The aim of the present study was to analyze the pharmacotherapy cost and quality of life of patents after kidney transplantation compared to those with chronic kidney disease in Bulgaria. This retrospective pharmacotherapy cost study and prospective health related quality of life (QoL) study was performed during 2010 - 2011 at the biggest Sofia hospital serving all transplant patients. The cost of pharmacotherapy was analyzed after reviewing patients' records. The health related quality of life was evaluated with the multi-attributable questionnaire SF-36, which measures 9 health domains. Forty-two percent of the patients with chronic kidney disease, and 26% of those with kidney transplant were female. The average age of the transplanted patients was 39.7 for male patients and 42.2 for female ones, while in the group suffering from chronic kidney disease the average male age was 48.3 and that of female patients, 51.2. No statistically significant difference was observed among the mean monthly cost of therapy per patient during the two-year period. The QoL was with lower values in the role limitations domain for patients with chronic kidney diseases and this difference was statistically significant. We found a correlation among the mean cost of pharmacotherapy and mean QoL in both groups of patients. In the group of patients with kidney transplantation the place of living and general health state were positively correlated. The cost of pharmacotherapy and the health state in comparison with the previous year were also positively correlated. This is the first Bulgarian study of the quality of life of kidney transplant patients. It shows that the SF-36 could be successfully used in this group of patients as well as for comparison with the QoL of patients with chronic kidney disease.",
publisher = "Diagnosis Press Ltd, Sofia",
journal = "Biotechnology & Biotechnological Equipment",
title = "The health related quality of life for kidney transplant patients in Bulgaria - A pilot study",
volume = "26",
number = "3",
pages = "3062-3065",
doi = "10.5504/BBEQ.2012.0005"
}

Georgieva, S., Kamusheva, M., Lakić, D., Mitov, K., Savova, A.,& Petrova, G.. (2012). The health related quality of life for kidney transplant patients in Bulgaria - A pilot study. in Biotechnology & Biotechnological Equipment
Diagnosis Press Ltd, Sofia., 26(3), 3062-3065.
https://doi.org/10.5504/BBEQ.2012.0005

Georgieva S, Kamusheva M, Lakić D, Mitov K, Savova A, Petrova G. The health related quality of life for kidney transplant patients in Bulgaria - A pilot study. in Biotechnology & Biotechnological Equipment. 2012;26(3):3062-3065.
doi:10.5504/BBEQ.2012.0005 .

Georgieva, Svetla, Kamusheva, Maria, Lakić, Dragana, Mitov, Konstantin, Savova, Alexandra, Petrova, Guenka, "The health related quality of life for kidney transplant patients in Bulgaria - A pilot study" in Biotechnology & Biotechnological Equipment, 26, no. 3 (2012):3062-3065,
https://doi.org/10.5504/BBEQ.2012.0005 . .