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WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES
Zlatareva
World Journal of Pharmacy and Pharmaceutical Sciences
SJIF Impact Factor 5.210
Volume 4, Issue 05, 197-204.
Research Article
ISSN 2278 – 4357
ANALYSIS OF THE PUBLIC FUNDS SPENT FOR ANTI-CANCER
DRUGS IN BULGARIA
Albena Zlatareva,*
Medical University of Varna, Faculty of Public Health.
Article Received on
06 March 2015,
Revised on 27 March 2015,
Accepted on 18 April 2015
SUMMARY
Тhe purpose of this study is to analyze the cost of anti-cancer drugs ,
paid by NHIF in Annex 2 of the PLC for the period 2013-2014 year. It
is a macroeconomic analysis of the expenditures paid by the public
funds for anti-cancer medicines. Collected are official data for 2013
*Correspondence for
and 2014 years and is analysed the cost of cancer disease by ICD code,
Author
INN, producer, as well as costs for individual diagnoses in these
Albena Zlatareva
Medical University of
groups of diseases. Spending on anti-cancer medicines in the first nine
Varna, Faculty of Public
months of 2014, compared to the first nine months of 2013 Increased
Health.
by 24.9%. The reason is due to the increased number of patients with a
diagnosis of cancer and to expand the treatment of a patient, and the
inclusion of new expensive drugs in the PDL ,paid with public funds. Lack of patient
registries and adequate at the time of treatment and payment information system, covering the
number of patients with specific diagnoses and treatment regimens also a factor influencing
the increase of costs and the lack of real agreements between pharma companies and NHIF to
reduce prices of drugs.
KEYWORDS: Public funds, costs, cancer diseases, anticancer medicines.
INTRODUCTION
A number of authors in their analyzes indicate that cancer disease are increasing in countries
with low economic status, and levels of morbidity are already struggling with high levels of
infectious diseases, including HIV / AIDS, tuberculosis (TB) and malaria.[9] So the UN,
including WHO urged Member States to develop strategies for coping with the growing
burden of noncommunicable diseases, including cancer, in developing and poorer economic
countries.
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In Europe, the majority of the costs for the treatment of cancer are covered by the
government or the public health funds. Budgets for anti-cancer drugs are regulated from
Government
in most European countries.[1,2,3,4,5.11] The main form of central control is
pricing control in form of setting reference prices.
Studies have shown, however, large differences among European countries in terms of patient
access to cancer drugs.[12,13,14,15,16,17] Explanation for these variations include differences in
research funding, the process of obtaining permission to use the drugs, the role of health
economics (Health Technology Assessment) in the process of decision-making and budgetary
matters concerning a given country as a whole.
Тhe purpose of this study is to analyze the cost of anti-cancer drugs , paid by public fund in
2013-2014 in Bulgaria.
METHODOLOGY
It is a macroeconomic analysis of the expenditures paid by the public funds for anti-cancer
medicines.
Collected are official data for 2013 and 2014 years and is analysed the cost of cancer disease
by ICD code, INN, producer, as well as costs for individual diagnoses in these groups of
diseases.[6,7,8]
There are calculated relative shares of the costs as well as the percentage change in both
observed years and based on the data is constructed statistical regression model costs. All
costs are in national currency (BGN) at the exchange rate of 1BGN=0.95 Euro.
RESULTS
Figure 1. Monthly cost for anticancer medicines paid by the public funds in 2013 and
2014.
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Spending on anti-cancer medicines in the first nine months of 2014, compared to the first
nine months of 2013 rose by 24.9% (Figure 1). In the second half of 2014 a trend of sharp
increase in costs is observed due to the previous delay into the inclusion of new oncology
medicines into the positive drug list.
For the period January-September 2013 the public payer National health insurance fund
(NHIF) paid for antiemetic medicines 462 823 BGN (231 412 Euro). Since 2014 products
for medicinal therapy of malignant diseases are determined by the positive drug list (PDL) Annex 2. Malignancies (solid tumors and hematologic diseases) are set out in Regulation
40/2004 for determining the basic package of activities paid by the NHIF4 and became the
responsibility of the fund as part of the hospital care. As a result in 2014 NHIF expenditures
on anticancer medicines reached 197 330 018 BGN (98 665 009 Euro). The regression model
built to explore the monthly trends shows that this value will continue growing (Figure 2)
Regression model (F = 18.527, p = 0.002) for the prediction of costs:
(Value paid by NHIF) = 16 047 430.491 + 315 277.009 * (month)
The estimated value for December is: 19 830 754.60 BGN
expenditures paid by the public fund
month
Figure 2. Regression model on monthly cost changes
Detailed analysis for the reasons for costs increase revealed that since January 2014 are
included 5 new International Non-proprietary Names (INN) - target costly therapy (Table 2),
with 8 expensive original medicinal products. Included are 39 generic products. Separate
original molecules are with permanently higher prices, under which NHIF cannot affect
downward by the current regulations.
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Table 2. The most resource consuming INNs for the period 01-09.2014
ATCode
B02BX05
L01BC53
L01XC11
L01XE15
L01XX41
Total:
INN
Eltrombopag
Tegafur/Gimeracil/Oteracil
Ipilimumab
Vemurafenib
Eribulin
Costs for period 01-09.2014
212 453
20 843
197 220
1 539 725
294 346
2 264 587
Since the beginning of 2014 and at the end of September 2014 have been deleted 43
medicines mainly to marketing authorization holder request. These are generic drugs, often
bearing referent. The number of treated patients also increased from 26 125 in 2013 to 28 123
in 2014, showing an increase of 10%. The latter could also contribute to cost increase.
In Table 3 are listed the top 10 products for which NHIF spent most large resources. The
amounts range from around 4 million BGN to 20 million BGN. For the year 2013 spending
for those 10 leading medicines were 107 170 800 BGN, for 2014 spending for those 10
medicines is 130 149 279 BGN, which represents 50.5% of total spending in the observed
period.
Table 3. Top 10 medicinal products for cancer diseases in 2013 and 2014year
№ INN
Trastuzumab , powd. for concentrate for sol.
1 for inf. 150mg x 1
Bevacizumab ,concentrate for sol. for inf.
2 400mg x 1
3 Imatinib, film-coated tabl. 100mg x 120
Zoledronic acid, powd. and solv. for sol. for
4 inj. 4mg x 1
5 Nilotinib,caps. hard 200mg x 28
Rituximab ,concentrate for sol. for inf.
6 500mg/50 ml x 1
7 Bortezomib ,powder for sol. for inj. 3.5mg x 1
8 Sunitinib ,caps. hard 50mg x 30
9
Capecitabine,film-coated tabl. 500mg x 120
10 Pazopanib,film-coated tabl. 400mg x 60
11 Pemetrexed,powd. for conc. for inf. 500mg x 1
amount paid by
NHIF in 2013
(in BGN)
amount paid by
NHIF in 2014
(in BGN)
19 436 160
19 803 003
12 871 407
8 719 124
19 170 008
6 115 573
5 842 498
5 261 383
5 474 913
4 909 602
4 606 831
4 196 012
4 124 302
4 057 782
5 506 920
5 023 121
4 382 681
5 611 034
4 416 727
Table 3 show that the first three places in the funds paid by the NHIF, are occupied by
products of two marketing authorization holders.
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Analysis of the expenditures paid by the hospitals revealed that the procedures under the
Public Procurement Act (PPA) by each hospital account for different prices for the same
product. In practice NHIF pays for the same product different prices as shown for leading
products -Table 4. The range in values due to the PPA are different, because of huge
differences between the
negotiated prices by medical institutions with the Marketing
Authorisation Holders or wholesalers of medicines.
Table 4. Differences among hospital tender prices of top products in hospitals
INN
Dosage form and package
Epoetin alfa
Rituximab
Rituximab
Trastuzumab
Sunitinib
Everolimus
sol.inj. in pre-filled syr. 10000 IU/1ml x 6
concentrate for sol. for inf. 100mg/10ml x 2
concentrate for sol. for inf. 500mg/50ml x 1
powd. for concen. for sol. for inf. 150mg x 1
hard caps. 50mg x 30
tabl. 10mg x 30
Price per pack
approved into the
positive drug list
(BGN)
527.90
1 011.45
2 528.62
1 170.70
9 725.21
7 149.41
Price per pack of
individual hospitals
paid by NHIF / from to / (BGN)
189.43 -260.86
982.15 -1011.40
2458.08 - 2528.60
1103.70 - 1145.00
9318.60 - 9567.24
5625.27 - 7122.00
The cost on ICD rubrics that have the largest share of total expenditure for 2013 and 2014 is
shown on figure 3. Major proportion and reason takes ICD C50.
Figure 3. Dynamics of the cost of the top 10 diagnoses on ICD rubrics
Statistically significant increase is on C50, C34, C18, S92, C90, C56 and C61. (p <0.05)
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DISCUSSION
Тhanks to the development of medicine and advances in diagnostics has increased the
number of patients with a specific genetic status clarified, аs well as the number of patients
treated for long periods with innovative expensive medicines9. The application of new
expensive medicines should lead to a better quality of life and increased survival. This
increases in the number of patients with cancer is influencing the rose in expenditures. A
continuous accumulation and increase in the financial resources is also expected in the future.
At the same time the lack of centrally negotiated prices, and real agreements between the
NHIF and representatives of companies permits the use of high priced medicines that leads to
uncontrolled growth of expenses in different hospitals.
The growth of paid trade names play a role in the short term inclusion of innovative
medicines in PLD. According to recommendations of the EU Directive 89/105, this period
may be increased to 180 days. This will help the Government to perform in-depth analysis of
the documentation and the use of additional expertise from outside medical specialists.
10,11
A number of authors studied the possibility for reducing the cost of medicines for cancer
treatment and prescription drugs generally offer the following measures absolutely applicable
to our country- health education of patients, shortening the path of the drug to the patient,
patient registries and uniform information system between different Government institutions
and medical institutions.
Lack of patient registries and adequate at the time of treatment and payment information
system, covering the number of patients with specific diagnoses and treatment regimens also
a factor influencing the increase of costs and the lack of real agreements between pharma
companies and NHIF to reduce prices of drugs.
CONCLUSION
The oncology medicines play a crucial role in the permanently increasing public health
expenditures for medicines. The future tendency shows an increase too. Thus the need for
patients educations and prescribing control is necessary.
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