Transcript Document

3rd Baltic Conference on Medicines
Economic Evaluation, Reimbursement and Rational Use of
Pharmaceuticals
Pricing and Reimbursement of Pharmaceuticals in
Baltic Countries
Daiga Behmane
Medicines Pricing and Reimbursement Agency, Latvia
June 17, 2004, Tallinn, Estonia
Health care system reforms
in 1990s in Baltic countries
Introduction of market economy principles in health care
Changes in status and structure of health care providers
Introduction of new insurance schemes
Increased availability of new technologies,
pharmaceuticals
Increased quality of health care services and providers
Rapid increase in health care costs
Health policies in Baltic countries
European social model: equity and solidarity in access to
health services
Insurance schemes: compulsory and private insurance
Balance between primary and secondary health care
Reimbursement systems of pharmaceuticals
A lot of debate around the health care systems
What is the result of the reform? Do we measure it?
Is the health system good and fair?
Is it performing as good as it could?
Does only health care system performance determins the status of
population health ? Socio-economic factors? Lifestyles? Physical
environment?
How to dicrease the gap between patient expectations and real access
to health care services?
What is the role of pharmaceutical policy to meet better health
outcomes?
Pharmaceutical policies in Baltic countries,
common features
Equitable access for patients to effective, safe and good
quality medicines - 1990s
Enhancing rational use of medicines for better outcomes in
health care (treatment guidelines, therapeutic committees
in hospitals e.t.c.)
Ensuring value for money
access and affordability
Baltic cooperation on medicines
Baltic cooperation on medicines has started already in the
beginning of 1990s
1993 –
an Agreement on mutual recognition of marketing
authorizations of pharmaceutical products manufactured in
Lithuania, Latvia and Estonia
1995 –
the Cooperation agreement in the field of Medicine, Health
Care and Health Insurance was signed
the Baltic Coordinating Committee on Pharmaceuticals
was established
Common problems
Public funds for healthcare do not cover all public needs
Growing expenditure for pharmaceuticals (volume and
costs), justified or unreasonable?
Consumption of pharmaceuticals per capita is 4 to 5 times
less than EU average
GDP per capita is 6-7 times less than EU average
Newly introduced medicines are marketed at EU prices,
There is a growing disparity between availability of
products on the market and possibility to pay
Affordability is a burning question
Pharmaceutical market, Baltic countries,
pharmacy prices, 2002-2003
2002
Estonia
Latvia
Lithuania
2003
Pharmaceutical Pharmaceutical
Pharmaceutical Pharmaceutical
Population, consumption, mln consumption per Population, consumption, mln consumption per
mln
EUR
capita, EUR
mln
EUR
capita, EUR
1,36
104
76
1,36
125 (120%)
92
2,35
123
52
2,33
143 (116%)
61
3,47
290
84
3,46
348 (120%)
101
total: 517 mln
total: 616 mln
total: 7.18
EUR
aver: 72 EUR total: 7.15 EUR (119%)
aver: 86 EUR
Data source: Health care authorities, Baltic countries
Cooperation in the field of pricing and
reimbursement of pharmaceuticals
EU legislation has less influence on price regulations and
the design of reimbursement systems on the national level
Implementation of the requirements of the Transparency
directive (89/105/EEC)
Pricing and reimbursement decisions are strongly based on
demand side measures and health budget impact – national
decisions
1990s – disparities in pharmaceutical prices, small markets
Cooperation and information exchange between national
authorities
Reimbursement systems of pharmaceuticals in
Baltic countries
Similar features
Reimbursement based on the severity and chronic nature of
the disease
Price control for reimbursed pharmaceuticals
Regulated maximum wholesale and retail margins
Positive lists
Reference pricing mechanisms
Special reimbursement conditions for most expensive
pharmaceuticals
Increased role of therapeutic and economic evaluation
of pharmaceuticals
Reimbursement systems of pharmaceuticals in
Baltic countries
Similar criteria for reimbursement
•
•
•
•
burden of disease (100%, 75%, 50%)
therapeutic value of a drug
cost-effectiveness data
impact on healthcare budget
Economic evaluation of pharmaceuticals
Baltic Guideline for Economic Evaluation of Pharmaceuticals
Adopted as a common methodology for economic evaluation of
pharmaceuticals in the Baltic countries during Ministers’ meeting in
Riga on the 6th September 2002
Each country has adopted it’s own legislative act enforcing the use of
the Guideline on the national level
In force since the second half of 2002 or the 1st January 2003
Use of economic evaluation of pharmaceuticals in
decision making in Baltic countries
 For budget allocation in health care
 For selection of drugs for reimbursement or other state funding
 For setting a reasonable price for pharmaceuticals
 For rational pharmacotherapy guidelines
 For promoting rational prescribing
Why economic evaluation?
Economic evaluation:
application of analytical methods
to define cost and consequences of drug treatment to support decision
making in resource allocation in health care
COSTS
OUTCOMES
Objective of the Guideline – to provide methodology
for pharmacoeconomic analysis performed as a part of an
application for a new drug to be reimbursed in Baltic
countries
Principles of the economic evaluation
Desk-top” economic analysis are carried out for the
purposes of the application
Analysis should be distinguished from a “field” analysis,
where where a specially designed economic study is
carried out
If economic analysis are performed abroad, it can be
applied to the local situation
Economic analysis can be performed only on the basis of
published clinical trial data or clinical trial data performed
as a part of drug licensing process
Perspective of the economic evaluation
All analysis are to be conducted from a health care
perspective (including only direct costs and benefits for
health care)
Analysis from a societal perspective (including all costs
and benefits outside the health care system) may only be
presented in addition, if considered relevant by the
applicant
Gains from common methodology
Possibility to exchange information on the assessment of
the cost-effectiveness of new drugs submitted for
reimbursement
Results of pharmacoeconomic analysis are comparable
between countries
More effective work of state institutions involved in
evaluations
Possibility of harmonization of prices of pharmaceuticals
Simplified application process for the industry
What is different in the reimbursement
systems?
Differences
Budgets for reimbursement
Share of reimbursement of total health care expenditures
Estonia 20%, Latvia 7,5%
Number of active substances reimbursed
Latvia
Lithuania
Estonia
600
1500
1580 (100% ;75%)
Reimbursement of pharmaceuticals,
market share, 2002-2003
Market share of reimbursable pharmaceuticals in 2003, mln EUR
350
300
250
200
150
34%
30%
100
50
0
45%
35%
22%
18%
Estonia
Lithuania
Latvia
2002 Pharm.consumption, mln EUR
104
290
123
2002 Reimb.for amb.care, mln EUR
46,73
97,9
26,8
2003 Pharm.consumption, mln EUR
125
348
143
2003 Reimb.for amb.care, mln EUR
43,77
105,7
26,2
Reimbursement of pharmaceuticals in Baltic
countries, EUR per capita, 2001-2003
45
40
35
30
25
20
15
10
5
0
2001
2002
2003
2004
Estonia
31
37
34
41
Lithuania
26
34
28
31
Latvia
7
11
11
12
Reimbursement of pharmaceuticals in Baltic
countries (including centralized purchases), EUR per capita,
2001-2003
50
45
40
35
30
25
20
15
10
5
0
2001
2002
2003
2004
Estonia
33
39
36
44
Lithuania
31
36
29
32
Latvia
12
16
16
18
Latvia
Estonia
Lithuania
Infe ctious
dise ase s
Dige stive
syste m
Mscle s,
ske le ton
and
conne ctive
tissue s
Uroge nital
syste m
Ne oplasms
O cular
dise ase s
Re spiratory
syste m
Ne rvous
syste m
Me ntal and
be havioural
disorde r
C irculatory
syste m
Endocrine
dise ase s
Comparison of reimbursement of pharmaceuticals
by disease groups
in Baltic countries, 2002, EUR per capita
14
12
10
8
6
4
2
0
Total expenditure on reimbursement and drugs for
cardiovascular diseases in Baltic states per capita EUR, 2002
35
30
25
20
15
10
5
0
Estonia
Latvia
Lithuania
Total
34
12
28
Cardiovascular diseases
15
2
6
Price dicrease due to economic evaluation of
pharmaceuticals by disease groups,
number of evaluations, Latvia, 2002, annual savings ~ 400 000 LVL
120
Number of drugs
WIT H price
decrease
100
80
60
Number of drugs
WIT HOUT
price decrease
40
20
0
C
o
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Conclusions
The growth of pharmaceutical markets and pharmaceutical
consumption in Baltic countries are mainly affected by affordability
aspects and the limited funding
Although social and economic conditions are similar, financing and
reimbursement levels of pharmaceuticals differ in Baltic countries
Health economics should be applied not only to reimbursement
decisions, but also in other health care sectors enabling cost effective
pharmaceuticals to be reimbursed
Further analysis should be developed to analyze the implications of
different reimbursement conditions on health outcomes