Transcript The Authorities and the Economic Assessment Field of

Economic Evaluation Applied to Decision Making
Portugal
Isaura Vieira
INFARMED, I.P. – National Authority for Medicines and Health Products
I Pan-American Seminar on Economic Regulation of Pharmaceuticals
Brasília, 18th March 2009
PORTUGAL
10 Millions inhabitants
National Health Service that is
universal, comprehensive and free
of charge
covers 7 Millions inhabitants
Other Health Systems (Civil
Servants, and other) responsible
for 3 millions
All the inhabitants have the right
to health to be delivered through
NHS
Total health expenditure - % gross domestic product
12
10
8
%
6
4
2
0
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Source OECD HEALTH DATA 2008, Dez. 08
2006
Total pharmaceutical expenditure - % of total health
2006
D ina m a rc a
Á us t ria
S ué c ia
F inlâ ndia
A le m a nha
F ra nç a
B é lgic a
G ré c ia
It á lia
P o rt uga l
E s pa nha
R e p. C he c a
P o ló nia
E s lo v á quia
H ungria
0
5
Source: OECD HEALTH DATA 2008, Dez. 08
10
15
20
%
25
30
35
The Reimbursement System
For being on the market medicines need an authorisation
from Infarmed
• Hospitals
NHS or third payer is responsible for all the
expenses with in-patient consumed medicines
• Pharmacies
NHS or third payer is responsible for all or part of
the expenses with consumed medicines
on the purchasing act the consumer does not pay or pay
only a part of medicine’s price
The Reimbursement System
Medicines subject to reimbursement
Prescription only medicines
The level of co-payment depends on
medicines therapeutic classification
For example:
Insulins - 100%
Antiepileptics – 95%
Anti-hypertensives and Antibiotics - 69%
Corticosteroids and Analgesics - 37%
Level of co-payment or
co-payment rate
% of retail price paid by state/third payer
General
Low
Retiring
Pensions
100 –
only for insulin, imunomodulators, and pituitary
and hypothalamic hormones and analogues
95
+5
69
+ 15
37
15 -
Transitory level - no more than 2 years
Additional data required after
reimbursement is granted
Transitoriness of reimbursement status can be used
independently of the level of co-payment
M edicines Grow t h Rat e
1997-2007
30%
25%
20%
Taxa
15%
10%
5%
0%
-5%
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Main Challenges
• Limited economic growth
• Increasing costs of R&D
• Innovation increasing costs
• Ageing society
• Society expectations
• Changes on the disease patterns - more
chronic diseases
Policies Developed
• Price control /price negotiations
• Tendering procedures
• Co-payments
• Reference pricing
• Generics promotion
• Development of information instruments to support doctors decision
• Educational campaigns on rational use of medicines
• Industry payback associated to a level of NHS growth
• Agreements on budgets and prices with companies for drug
reimbursement
• Relative effectiveness and cost-effectiveness evaluation for
reimbursement decision – ambulatory and hospital
Generic Medicines Market Share
2001
0,34%
2008
19,16%
Reference Price System
•
For medicines with generics marketed the retail price still
exist but the user is responsible for the difference
between retail price and reference price
• Reimbursement reference price system based on higher
generic price marketed
Agreements on budgets and prices with
companies for drug reimbursement
• Medicines with recognized therapeutic added valued but
with some doubts or need to make some restrictions, like a
specific indication or group of patients
Conditions:
•
limited on time (2 years with possibility for renewal)
•
presentation of extra information on relative effectiveness or
cost- effectiveness
•
reduction on reimbursement or prices of other medicines already
reimbursed
•
•
reduction on NHS price for the drug under evaluation
definition of a maximum budget for the drug under evaluation,
once sales exceeded the budget, the MaH should return the extra
value.
Relative effectiveness and cost-effectiveness
evaluation for reimbursement decision –
ambulatory and hospital
• Instrument to better identify and value the real innovative
medicines
• Since 1998 for ambulatory care reimbursement decisions
• Since 2007 for hospital medicines funding decisions
•High level of growth rate
•Decisions made by each hospital – need for harmonization
•Iincrease of new medicines approved for hospital use – need for
increase of rational use
Relative effectiveness and cost-effectiveness
evaluation for reimbursement decision –
ambulatory and hospital
Need to:

promote the development of new tools to provide
suport on decision making process - Economic
Evaluation Studies on Medicines

creat guidelines to implement good practices on the
execution and evaluation od Economic Evaluation
Studies of Medicines - Guidelines
15
Relative effectiveness and cost-effectiveness evaluation for
reimbursement decision – ambulatory and hospital
Relative effectiveness
/added therapeutic value
Economic Evaluation
Evidence based report to
suport the decision
The Authorities and the Economic Assessment
Field of Application
Mandatory for:
Always:
• New Chemical Entities (NCE) for a well defined
therapeutical need.
If required:
• New medicines
related to other
indications
with added therapeutic value,
medicines used for the same
The Authorities and the Economic Assessment
Field of Application
Time for Study submission:
• Before Reimbursement Approval
• Submission as part of reimbursement dossier
(very common)
• When INFARMED ask for it (in this situations
firms take no less then 6 months to have it done in the meantime the process stops)
• After Reimbursement Approval
•In some well defined situations MA holder can
celebrate an agreament with Infarmed in order to
get fast access to reimbursement market, and has
12 to 24 months to submit additional information
(health economic study; new clinical trials ,
epidemiological data etc)
The Authorities and the Economic Assessment
Field of Application
Main problems
•Population under study
•Dificult to have good evidence to suport added
therapeutical value
•Cost identification and measuring and valuing costs
•Evaluation of medicines for rare deaseases
•Lack of cost-effectiveness evidence for sub-groups of
population or for restricted indications
•Budget Impact – data on prevalence and incidence and
need to imclude all the alternatives used for the same
indication
The Authorities and the Economic Assessment
Field of Application
Results
The utilisation of HTA techniques as an integrated
instrument to support the assessment of the reimbursement
processes, led to:
- acceptance of reimbursement conditions for some new
medicines;
- decrease in the price of some new medicines;
- refusal of reimbursement of some medicines.
The submitted Economic Drug Assessment studies allowed
the reimbursement of cost-effective medicines, on the
basis of a better knowledge of the medicines’ properties and
its effect in the population that is supposed to use them.
The Authorities and the Economic Assessment
Field of Application
Results
• Time taken to assess the studies led, in some products to
delays in the market assess;
• At the present MA holders seek to prove on scientific basis
the add value of new products;
• The costs involved in the production/adaptation of
economic evaluation studies keep opportunistic products
out of the premium price market;
Thank you for your attention
[email protected]