Corresponding author: Rumyana Simeonova ( rvitanska@gmail.com ) Academic editor: Guenka Petrova
© 2020 Lidija Chakuleska, Rumyana Simeonova, Nikolay Danchev.
This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Citation:
Chakuleska L, Simeonova R, Danchev N (2020) Pharmacotherapy costs and medicines reimbursement policies of osteoporosis in the Republic of Bulgaria and Republic of North Macedonia. Pharmacia 67(4): 199-207. https://doi.org/10.3897/pharmacia.67.e55835
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The aim of the present study was to analyze and compare the number of health insured persons suffering from osteoporosis and antiosteoporotic drugs reimbursed by the National Health Insurance Funds (NHIF) in the Republic of Bulgaria (RBG) and Republic of North Macedonia (RNM) for the period 2015–2018. The reimbursement cost paid by the NHIF for the same period in both countries was surveyed.
The results show an increase in both the number of patients with osteoporosis and the cost of the treatment. The most prescribed drug in R. Bulgaria is denosumab and it has the highest costs respectively, while in R.N. Macedonia the most prescribed and respectively the most expensive treatment is the bisphosphonate ibandronic acid, tablets of 150 mg. The trend of rising costs in both countries is likely to continue due to the increasing number of patients with osteoporosis.
The number of patients and cost of pharmacotherapy in RNM and RBG are increasing but the reimbursement policy in RNM is more restrictive in terms of reimbursed medicines. On the other side, the RNM is with a higher level of reimbursement that might positively affect the cost of pharmacotherapy.
bisphosphonate, Health Insurance Fund, reimbursement status
Osteoporosis is a progressive, metabolic disease that affects the skeletal system and is characterized by microstructural deterioration in bone tissue and a decrease in bone strength (WHO 1994;
There are no officially published recent data on the epidemiology of osteoporosis in Bulgaria. 426,000 women over the age of 50 (26.6%) have had osteoporosis of the spine or femoral neck (data 2008–2010) (Borisova et al. 2019).
One of the most serious complications is the fracture, which can occur after a minor injury. The risk of fractures increases significantly with age. The most common fractures are of the femur, spine, pelvis, proximal tibia. The consequences of severe fractures result in increased morbidity and mortality (
Fractures are associated with the appearance of acute pain, in some cases, depending on the location, to loss of function, and the need of hospitalization. The recovery process is slow and incomplete and can affect patients’ mobility and social distance (
According to various therapeutic guidelines (Nuti et al. 2017;
Prevention and basic therapy include lifestyle changes with physical activity, avoidance of alcohol consumption, smoking cessation, and consumption of healthy food with sufficient intake of calcium and vitamin D. In case of insufficient intake of these elements in the diet, the use of dietary supplements with calcium and vitamin D is recommended. A minimum daily intake of 1000 mg of calcium and 800–1000 IU of vitamin D is recommended for all patients with osteoporosis (
Pharmacotherapy includes treatment with different pharmacological groups, mainly bisphosphonates (BPs) as first-line drugs (
Other drugs used for the prevention and treatment of fractures are:
Hormone replacement therapy, in particular oestrogens, are also used in the prophylaxis and treatment of osteoporosis.
The success of pharmacological therapy is assessed by measuring bone density and at the population level by reducing complications.
Although the osteoporosis is having high economic burden on the reimbursement institutions, little is known about the cost of this disease in Bulgaria and Macedonia (
The aim of the present study was to analyze and compare the number of health insured persons suffering from osteoporosis and antiosteoporotic drugs reimbursed by the NHIF in RBG and RNM for the period 2015–2018.
The present study is a retrospective analysis of the number of patients with the respective International Classification of Diseases (ICDs) codes by years and costs of the NHIF for the pharmacotherapy of the diagnoses summarized in osteoporosis group for the period 2015–2018 in both countries.
The analysis of the expenses for the period 2015–2018 paid by the NHIF for the health insured persons includes the following ICD codes – M80.0, M80.1, M80.2, M80.3, M80.4, M80.5, M80.8, M81.0, M81.1, M81.2, M81.3, M81.4, M81.5, and M81.8 combined to diagnose osteoporosis.
Official data for the number of patients and costs of osteoporosis pharmacotherapy in RNM were collected from the Health Insurance Fund (http://www.fzo.org.mk/default-mk.asp), subdivision “Consumption of drugs” from the list of drugs by generics for the period 2015–2018.
Information on the number of patients and reimbursement amount in RBG was also taken from the site of NHIF of the RBG (https://www.nhif.bg) and the registers of National Council on Prices and Reimbursement of Medicinal Products (NCPR) (https://portal.ncpr.bg/registers/pages/register/list-medicament.xhtml).
Data for the reimbursed prescriptions in the RNM were taken from the information system of NHIF, for medicines purchased from pharmacies and reimbursed by the Fund for the period from 2015 to 2018.
Reimbursed costs every year were presented in absolute value, % of the total cost, and % change in comparison with the previous year.
The prescribed medicines were analyzed by INN and pharmaceutical dosage form. It was also calculated the % of the total cost for every INN paid by both NHIF, as well as the % change in every year in comparison with the previous one.
According to the Law for Health Insurance (State Gazette 25/ March, 2000, last amended State Gazette 113/ July, 2014), the NHIF in RNM is a buyer of health services that include drugs from the list of the Health Insurance Fund. The health insured persons exercise their right to receive drugs from the Fund through the pharmacies, on the basis of a prescription form given by the chosen doctor of medicine, in accordance with the legal provisions and the contractual provisions of the Fund.
The reimbursed drugs in RNM are classified into two main groups: List A – List of medicines for primary health care (pre-hospital care) and List B – medicines for hospital care. The medicines from the List – A are paid by the NHIF in RNM and are prescribed on a prescription form sent for implementation in pharmacies that have a contract with the NHIF of RNM for outpatient care. One patient could receive one prescription per one medicine.
Reimbursable price of the drug is the maximum amount that the Fund provides for a particular drug. The reference price of the medicine is determined according to the lowest defined wholesale price of the medicines, which are put into circulation in the RNM, according to the Law on Medicines and Medical Devices, with comparative analysis of the reference prices of the funds for compulsory health insurance determined by Article 63-c of the Law for Health Insurance (Official Gazette of the R Macedonia 8/ January, 2008). The treatment of osteoporosis in RNM is paid 100% by the Health Insurance Fund.
Table
The number of prescriptions issued for the treatment of osteoporosis and paid by the NHIF in the RNM.
INN and dosage form | 2015 | % of all Rp in 2015 | 2016 | % of all Rp in 2016 | % change (2016 to 2015) | 2017 | % of all Rp in 2017 | % change (2017 to 2016) | 2018 | % of all Rp in 2018 | % change (2018 to 2017) | Total № Rp | % of all Rp for the period |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Alendronate sodium + cholecalciferol tabl. (70 mg + 5.600IE) | 18465 | 8,47 | 26678 | 11,64 | 144,48 | 27425 | 11,24 | 102,80 | 31589 | 12,32 | 115,18 | 104157 | 10,99 |
Alendronic acid tablets (70 mg) | 9920 | 4,55 | 8342 | 3,64 | 84,09 | 7449 | 3,05 | 89,30 | 6868 | 2,68 | 92,20 | 32579 | 3,44 |
Calcitriol caps. (0.25mcg) | 1053 | 0,48 | 1150 | 0,50 | 109,21 | 1135 | 0,46 | 98,70 | 1169 | 0,46 | 103,00 | 4507 | 0,48 |
Calcitriol caps. (0.50 mcg) | 1288 | 0,59 | 1421 | 0,62 | 110,33 | 1461 | 0,60 | 102,81 | 1327 | 0,52 | 90,83 | 5497 | 0,58 |
Calcium carbonate tabl. (1 g) | 20910 | 9,59 | 23168 | 10,11 | 110,80 | 24423 | 10,01 | 105,42 | 26178 | 10,21 | 107,19 | 94679 | 9,99 |
Clodronic acid caps. (400 mg) | 152 | 0,07 | 121 | 0,05 | 79,61 | 115 | 0,05 | 95,04 | 86 | 0,03 | 74,78 | 474 | 0,05 |
Cholecalciferol oral drops (20,000 IU/ ml) | 45640 | 20,94 | 47670 | 20,79 | 104,45 | 54946 | 22,51 | 115,26 | 64435 | 25,13 | 117,27 | 212691 | 22,44 |
Cholecalciferol oral drops (4.000 IU/ml) | 30151 | 13,83 | 30722 | 13,40 | 101,89 | 31946 | 13,09 | 103,98 | 29596 | 11,54 | 92,64 | 122415 | 12,92 |
Ibandronic acid tablets (150 mg) | 90136 | 41,36 | 89972 | 39,25 | 99,82 | 95199 | 39,00 | 105,81 | 95173 | 37,12 | 99,97 | 370480 | 39,09 |
Risedronic acid tablets (35 mg) | 217 | 0,10 | 0,00 | 0,00 | 0,00 | 217 | 0,02 | ||||||
Calcitonin nasal spray (200.000 IU/ ml) | 15 | 0,01 | 0,00 | 0,00 | 0,00 | 15 | 0,00 | ||||||
Total number of prescriptions | 217947 | 100,00 | 229244 | 100,00 | 105,18 | 244099 | 100,00 | 106,48 | 256421 | 100,00 | 105,05 | 947711 | 100,00 |
The costs of the NHIF for the individual drugs used for the treatment of osteoporosis in R. N. Macedonia by years are presented in Table
Costs (in euro) paid by the NHIF in RNM for antiosteoporotic medicines by year.
INN dosage form | 2015 | % of all cost in 2015 | 2016 | % of all cost in 2016 | % change (2016 to 2015) | 2017 | % of all cost in 2017 | % change (2017 to 2016) | 2018 | % of all cost in 2018 | % change (2018 to 2017) | Total | % of total cost |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Alendronate sodium/ cholecalciferol tabl. (70 mg/ 5.600 IU) | 161511,3 | 15,85 | 233357,14 | 21,52 | 144,48 | 239895,12 | 21,17 | 102,80 | 276491,86 | 23,56 | 115,26 | 911561,24 | 20,67 |
Alendronic acid tabl. (70 mg) | 68190,66 | 6,69 | 57345,59 | 5,29 | 84,10 | 51197,17 | 4,52 | 89,28 | 47241,56 | 4,03 | 92,27 | 224164,85 | 5,08 |
Calcitriol caps. (0.25mcg) | 4413,4 | 0,43 | 4 819,82 | 0,44 | 109,21 | 4 757,00 | 0,42 | 98,70 | 4 903,34 | 0,42 | 103,08 | 19102,763 | 0,43 |
Calcitriol caps. (0.50 mcg) | 8749,42 | 0,86 | 9653,21 | 0,89 | 110,33 | 9 924,62 | 0,88 | 102,81 | 9 015,74 | 0,77 | 90,84 | 37558,756 | 0,85 |
Calcium carbonate tabl. (1g) | 40 237,15 | 3,95 | 44 567,94 | 4,11 | 110,76 | 46 932,86 | 4,14 | 105,31 | 50 326,93 | 4,29 | 107,23 | 182293,15 | 4,13 |
Clodronic acid caps. (400 mg) | 17 614,16 | 1,73 | 14 021,74 | 1,29 | 79,60 | 13 298,48 | 1,17 | 94,84 | 9 971,89 | 0,85 | 74,99 | 55084,912 | 1,25 |
Cholecalciferol oral drops (20 000 IU)/ml | 55 364,10 | 5,43 | 57 827,04 | 5,33 | 104,45 | 66 653,25 | 5,88 | 115,26 | 78 211,72 | 6,67 | 117,34 | 258292,47 | 5,86 |
Cholecalciferol oral drops (4 000 IU)/ml | 43 430,71 | 4,26 | 44 249,65 | 4,08 | 101,89 | 46 015,33 | 4,06 | 103,99 | 42 656,21 | 3,64 | 92,70 | 176570,18 | 4,00 |
Ibandronic acid tabl. (150 mg) | 619 725,16 | 60,80 | 618 502,60 | 57,04 | 99,80 | 654 466,95 | 57,76 | 105,81 | 654 649,97 | 55,79 | 100,03 | 2547725,9 | 57,76 |
Total reimbursement value | 1 019 236,09 | 100,00 | 1 084 344,73 | 100,00 | 106,39 | 1 133140,78 | 100,00 | 104,50 | 1 173 469,00 | 100,00 | 103,56 | 4410701,5 | 100,00 |
N of osteoporotic prescriptions | 217947 | 229244 | 244099 | 256421 | 947711 | ||||||||
Average cost per osteoporotic Rp | 4,68 | 4,73 | 4,64 | 4,58 | 4,65 |
The calculated average cost per prescription is almost steady for the period around 4,5 Euro (Table
For the investigated period the NHIF of RNM has paid the largest amount (2 547 725.9 euro) for ibandronic acid tablets (150 mg) (Table
The combination of alendronate sodium/ cholecalciferol tablets (70 mg/ 5.600 IU) is on the second place with a total reimbursement value of 911,561.24 euro. For the cholecalciferol oral drops (20.000 IU/ml) the NHIF reimbursed 258,292.47 euro for the period 2015–2018 (Table
The bisphosphonate alendronic acid (tablets 70 mg) is on the 4th place with a total reimbursement value of 224,164.85 euro (Table
Calcium carbonate 1g is prescribed alone or in combination with other drugs, as additional therapy for the prevention and treatment of osteoporosis. For Calcium carbonate 1g 182,293 euros were reimbursed (Table
For clodronic acid 400 mg NHIF reimbursed 55,084.912 euros for the period from 2015 to 2018 (Table
Calcitriol 0.25 mcg and calcitriol 0.50 mcg were also prescribed for the treatment of osteoporosis and a total of 19,102.76 and 37,558.76 euros respectively were spent for them, for the period 2015–2018 (Table
Table
2015 | 2016 | 2017 | 2018 | |
Total reimbursement value for all drugs (in €) | 39,472,098 | 42,734,219 | 45,337,420 | 45,559,918 |
Reimbursement amount paid for antiosteoporotic drugs (in €) | 1,019,236 | 1,084,344 | 1,133,141 | 1,173,469 |
% of the amount reimbursed for antiosteoporotic drugs | 2,58% | 2,54% | 2,5% | 2,56% |
Similar to RNM in RBG the NHIF is a buyer of health services that include medicines from the list of the NCPR (https://portal.ncpr.bg/registers/pages/register/list-medicament.xhtml). The health insured persons receive prescriptions from their family physician for one or 3 months for their ambulatory therapy (National People Assembly. Law for health insurance, State Gazette 70/ 19 June, 1998, last amended State Gazette 54/ 16 June 2020).
The reimbursed medicines in RBG are classified into three main groups: Annex 1 – List of medicines for outpatients paid by the NHIF, Annex 2 medicines for hospital care paid by the hospital budgets or by the NHIF, and Annex 3 – list of medicines for infectious diseases and vaccines covered by the Governmental budget. One patient could receive one prescription per three medicines for the therapy of one ICD code of the disease (Ministry Council, Decree on conditions, rules, and order of regulation and registration of prices of medicinal products. State Gazette 40/30 April 2013; last amended State Gazette 19/ 6 March 2020).
Reimbursable price of the medicines is settled as the lowest price per define daily dose (DDD), out of all trade names and dosage forms belonging to the same INN. The treatment of osteoporosis in Bulgaria is reimbursed 50% by the Health Insurance Fund.
As can be seen in Table
Number of health insured persons (HIP) for the period 2015–2018 for the sections with ICD codes M80 and M81 in the RBG.
ICD codes | ICD code name | 2015 | % of all patients in 2015 | 2016 | % of all patients in 2016 | % change (2016 to 2015) | 2017 | % of all patients in 2017 | % change (2017 to 2016) | 2018 | % of all patients in 2017 | % change (2018 to 2017) |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Total | 17691 | 100 | 19200 | 100 | 108,53 | 21307 | 100 | 110,97 | 23621 | 100 | 110,86 | |
M80.0 | OP with pathological fracture after menopause | 3188 | 18,02 | 3271 | 17,04 | 102,60 | 3489 | 16,37 | 106,66 | 3772 | 15,97 | 108,11 |
M80.1 | OP with pathological fracture after ovariectomy | 255 | 1,44 | 248 | 1,29 | 97,25 | 273 | 1,28 | 110,08 | 276 | 1,17 | 101,10 |
M80.2 | Immobilization OP with pathological fracture | 0,00 | 0,00 | 1 | 0,00 | 2 | 0,01 | 200,00 | ||||
M80.4 | Drug-induced osteoporosis with pathological fracture | 1 | 0,01 | 13 | 0,07 | 1300,00 | 14 | 0,07 | 107,69 | 6 | 0,03 | 42,86 |
M80.5 | Idiopathic osteoporosis with pathological fracture | 3 | 0,02 | 2 | 0,01 | 66,67 | 2 | 0,01 | 100,00 | 1 | 0,00 | 50,00 |
M80.8 | Another osteoporosis with a pathological fracture | 104 | 0,59 | 100 | 0,52 | 96,15 | 142 | 0,67 | 142,00 | 179 | 0,76 | 126,06 |
M81.0 | OP after menopause | 13443 | 75,99 | 14866 | 77,43 | 110,59 | 16631 | 78,05 | 111,87 | 18523 | 78,42 | 111,38 |
M81.1 | OP after ovariectomy | 334 | 1,89 | 346 | 1,80 | 103,59 | 339 | 1,59 | 97,98 | 349 | 1,48 | 102,95 |
M81.2 | Immobilization OP | 5 | 0,03 | 0,00 | 0,00 | 0,00 | 1 | 0,00 | ||||
M81.4 | Drug-induced osteoporosis | 0,00 | 0,00 | 1 | 0,00 | 0,00 | 0,00 | |||||
M81.5 | Idiopathic osteoporosis | 11 | 0,06 | 0,00 | 0,00 | 0,00 | 0,00 | |||||
M81.8 | Other osteoporosis | 347 | 1,96 | 354 | 1,84 | 102,02 | 415 | 1,95 | 117,23 | 512 | 2,17 | 123,37 |
In 2015, the total number of patients with OP after menopause (ICD M81.0) was 13443 (Table
Costs for the period 2015–2018 for the sections with ICD codes M80 and M81 in the RBG.
ICD codes | 2015 | % of all cost in 2015 | 2016 | % of all cost in 2016 | % change (2016 to 2015) | 2017 | % of all cost in 2017 | % change (2017 to 2016) | 2018 | % of all cost in 2018 | % change (2018 to 2017) |
---|---|---|---|---|---|---|---|---|---|---|---|
M80.0 | 291149,28 | 16,50 | 376993,66 | 17,86 | 129,48 | 482512,46 | 18,85 | 127,99 | 501686,09 | 16,75 | 103,97 |
M80.1 | 16643,18 | 0,94 | 19649,40 | 0,93 | 118,06 | 24777,17 | 0,97 | 126,10 | 62227,02 | 2,08 | 251,15 |
M80.2 | 0,00 | 0,00 | 1672,84 | 0,07 | #DIV/0! | 2452,86 | 0,08 | 146,63 | |||
M80.4 | 446,67 | 0,03 | 11577,18 | 0,55 | 2591,89 | 16313,41 | 0,64 | 140,91 | 4182,87 | 0,14 | 25,64 |
M80.5 | 2,55 | 0,00 | 1760,14 | 0,08 | 69025,10 | 2661,64 | 0,10 | 151,22 | 352,23 | 0,01 | 13,23 |
M80.8 | 15349,63 | 0,87 | 16892,30 | 0,80 | 110,05 | 25694,51 | 1,00 | 152,11 | 35187,91 | 1,18 | 136,95 |
M81.0 | 1363802,00 | 77,30 | 1592256,00 | 75,45 | 116,75 | 1901723,00 | 74,31 | 119,44 | 2265654,30 | 75,66 | 119,14 |
M81.1 | 22622,44 | 1,28 | 28041,18 | 1,33 | 123,95 | 29069,29 | 1,14 | 103,67 | 32399,15 | 1,08 | 111,45 |
M81.2 | 7,15 | 0,00 | 0,00 | 0,00 | 0,00 | 703,95 | 0,02 | ||||
M81.4 | 0,00 | 0,00 | 1056,18 | 0,04 | 0,00 | 0,00 | |||||
M81.5 | 16,34 | 0,00 | 0,00 | 0,00 | 0,00 | 0,00 | |||||
M81.8 | 54288,03 | 3,08 | 63246,96 | 3,00 | 116,50 | 73707,72 | 2,88 | 116,54 | 89716,88 | 3,00 | 121,72 |
Total | 1764327,27 | 100,00 | 2110416,82 | 100,00 | 2559188,22 | 100,00 | 2994563,26 | 100,00 |
The total number of patients with osteoporosis in 2015 was 17691 people and increased to 23621 persons in 2018 (Table
The most commonly used medicines in Bulgaria for the treatment of osteoporosis and included in Annex 1 of the Positive Drug List – Medicinal products intended for the treatment of diseases, which are paid for under the Health Insurance Act are presented in Table
Cost (in euro) paid by the NHIF of RBG by year for antidsteoporotic drugs.
Drug (INN) | 2015 | % of all cost in 2015 | 2016 | % of all cost in 2016 | % change (2016 to 2015) | 2017 | % of all cost in 2017 | % change (2017 to 2016) | 2018 | % of all cost in 2018 | % change (2018 to 2017) |
---|---|---|---|---|---|---|---|---|---|---|---|
Teriparatide | 1935,32 | 0,12 | 83446,02 | 4,37 | 4311,74 | 153385,5 | 6,51 | 183,81 | 130485,42 | 4,72 | 85,07 |
Ibandronic acid | 214645,75 | 13,77 | 160117,32 | 8,39 | 74,60 | 139315,9 | 5,91 | 166,95 | 131229,99 | 4,74 | 94,20 |
Calcitonin | 279 | 0,02 | 115 | 0,01 | 41,22 | – | – | ||||
Alendronic acid | 2983 | 0,19 | 8564,43 | 0,45 | 287,11 | 8411,95 | 0,36 | 10,08 | 4328,27 | 0,16 | 51,45 |
Strontium ranelate | 127123,61 | 8,15 | 87811,9 | 4,60 | 69,08 | 65813,01 | 2,79 | 78,87 | 4790,64 | 0,17 | 7,28 |
Denosumab | 1055097,2 | 67,66 | 1388346,9 | 72,74 | 131,58 | 1799047 | 76,33 | 2155,94 | 2291197,7 | 82,84 | 127,36 |
Alendronate sodium/ colecalciferol | 157050,22 | 10,07 | 180205,77 | 9,44 | 114,74 | 191065,2 | 8,11 | 228,97 | 203729,32 | 7,37 | 106,63 |
Raloxifene | 187,37 | 0,01 | 15,36 | 0,00 | 8,20 | 15,36 | 0,00 | 0,02 | – | ||
Total | 1559301,47 | 100,00 | 1908622,73 | 100,00 | 2357054 | 100,00 | 2765761,31 | 100,00 |
It was found that the highest costs were spent on the monoclonal antibody denosumab, for which NHIF has paid 6,533,689.10 euro over a period of 4 years. The analysis of the value for denosumab for each year separately (Table
From the analysis of the drug use for osteoporosis in Bulgaria (Table
For the drug teriparatide, the Bulgarian NHIF reimbursed a total of 238,766.8 euro for the period of 4 years (Fig.
In the Republic of Bulgaria for the treatment of osteoporosis, raloxifene and calcitonin were the least commonly used drugs, for which the NHIF has reimbursed 218.09 and 394.12 euro, respectively. Some restrictions for calcitonin, due to the increased risk of malignancies, are also known. In view of the new safety concerns in relation to the risk of cancer in long-term use and the limited efficacy of calcitonin in the treatment of osteoporosis, EMA is of the opinion that the benefit-risk balance of the intranasal formulations of calcitonin-containing medicinal products is not positive under normal conditions of use. Therefore the Committee recommended the suspension of the Marketing Authorisations for the intranasal formulation of calcitonin. EMA recommends do not use it in osteoporosis (EMA/109665/2013), which affects its consumption in Bulgaria. Since 2016, the sale of calcitonin (salmon synthetic) in RBG has been suspended. EMA therefore considered the benefit-risk balance of injectable calcitonin-containing products for the treatment of Paget’s disease, for the prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures, and for the treatment of hypercalcaemia of malignancy for the shortest possible time using the minimum effective dose (EMA/109665/2013).
Concerning the use of bisphosphonates in the RBG for the period 2015–2018, it was established that the use of alendronic acid (tablets of 70 mg) throughout the period was very low. During the same period, the use of the other two drugs alendronate sodium/ cholecalciferol tablets (70 mg/ 5.600 IE) and ibandronic acid (tablets 150 mg and solution for injection, 3 mg/ 3 ml) was higher. The use and the reimbursement value of the drug alendronate sodium/ cholecalciferol, increased over the years from 157,050.22 euro in 2015 to 203,729.32 euro in 2018. With ibandronic acid, a different situation was observed. Its use, respectively reimbursement value decreased over the years. In 2015 214,645.75 euros were reimbursed and by 2018 the value was decreased to 131,229.99 euro (Table
Comparative analysis of the reimbursement policy and financing the anti-osteoporotic medicines between RBG and RNM revealed some similarities as well as differences.
On the first place in both countries the access to anti-osteoporotic medicines is granted via the reimbursement system although the level of reimbursement is higher in RNM (100%) and lower in RBG (50%).
It was found that in Bulgaria, as well as in Macedonia, the number of people suffering from osteoporosis is progressively increasing during the years of the study period, which leads to an increase in the cost of treatment of this disease, paid by the health insurance fund.
Comparing to RBG, the NHIF of RNM has reimbursed a higher value for bisphosphonates for the period 2015–2018 (Fig.
Bisphosphonates alendronic acid, alendronate sodium/ cholecalciferol and ibandronic acid tablets of 150 mg were dispensed under the NHIF in both countries. In Bulgaria, the NHIF provides also ibandronic acid solution for injection, 3 mg/ 3 ml.
The NHIF of RBG reimbursed a total of EUR 1,401,646.71 for that three BP for the period 2015–2018. During the same period, the NHIF of RNM reimbursed a total of EUR 3,682,575.11 for these medicines. We might suppose that the prices of medicines are also higher but this needs further evaluation. The use of bisphosphonates in the RNM has been constantly increasing over the years, while in Bulgaria the use of bisphosphonates has slightly decreased or remained relatively constant for the last two years of the analysis.
The lower costs of the NHIF in Bulgaria for bisphosphonates, compared to RNM, are most likely due to the huge costs for denosumab, as well as due to the lower rate of reimbursement by the NHIF for ICD-osteoporosis – 50% compared to 100% in Macedonia.
Denosumab has not been registered in Macedonia, but it was approved for placing on the market in certain cases аccording to article 31 (Chapter III.I Marketing authorization) of the Law on Medicines and Medical Devices (Official Gazette of RM 106/ September 2007), in exceptional cases and justified reasons related to the health of patients (rare diseases, ethical aspects, vital hazardous diseases), if appropriate medication is not available, it may issue a conditional marketing authorization containing obligations for the holder of the approval, and for the longest period of one year.
Unlike Macedonia, vitamin D derivatives and calcium products, widely used in our western neighboring country, are not reimbursed in Bulgaria for the treatment of osteoporosis whereas strontium ranelate, teriparatide and raloxifene are not reimbursed in RNM.
Similarly, to other studies, we found that the cost of osteoporosis pharmacotherapy is constantly rising (
It is also evident that despite the 3 times higher population (around 7 mln Bulgarians in 2018/ just over 2 million North Macedonians) the total cost of pharmacotherapy in RBG is twice bigger than the cost in RNM. This could be explained with the reimbursement policy and high percent of reimbursement of medicines in RNM. Probably the prices are also higher in RNM because less reimbursed medicines account for high value but this factor was not explored in our study. The reason is the difference in the formation of the prices and in the reimbursement.
Regarding the reimbursed medicines we might say that the policy of RNM is more restrictive and fewer INNs are reimbursed. Bulgarian therapeutic practice includes teriparatide, denosumab, strontium ranelate that later was excluded, and other molecules while the practice in the RNM is more bisphosphonates oriented.
The new moments that this study adds are two. The first one is the comparison of reimbursement policy and cost between two neighboring countries with lots of similarities in the reimbursement policy (
The other limitation of our study is the fact that we could not compare the number of patients by ICD codes due to the different reporting of the number of patients in RBG and RNM. The same concerns also and the prescriptions reporting that is missing in Bulgaria.
The number of patients and cost of pharmacotherapy in RNM and RBG are increasing but the reimbursement policy in RNM is more restrictive in terms of the number of reimbursed medicines. On the other side, the RNM is with a higher level of reimbursement that might positively affect the cost of pharmacotherapy.