Transcript Slajd 1 - Agencja Oceny Technologii Medycznej

IMPLEMENTATION OF
TRANSPARENT PROCESS OF
DRUG REIMBURSEMENT
DECISIONS IN POLAND
Aleksandra Zagorska, Iga Lipska, Zbigniew Krol
Agency for Health Technology Assessment in Poland
Artur Falek - Ministry of Health, Poland
Phillippe Sauvage, Alexandre Barna
Ministry of Health, France
Thijs van Ormondt – law expert, Holland
Poland in EU
from 2004
Polish reimbursement decisionmaking process -2006
Failure of full implementation of „Transparency
Directive” (89/105/EEC):
• Unclear and long decision making process:
– Criteria
– Deadlines
– Information
– Lack of appeal proceedings against a
decision
Lack of experienced staff in newly created HTA
Agency
EU founded project
• EU twinning project signed between Poland and
France (from October 2006 to April 2008)
– 2 components (institutional and trainings)
• During almost 2 years – 68 experts from all over
EU came to help establish transparent and clear
decision making process
– Missions
– Workshops
– Study visits, trainings, internships
Experts missions
• Analysis of law regulations, institutions
involved, problems
• Recommendations in missions’ reports
But…
no progress
Workshops with decision makers!
Workshops
•
•
Participants: experts, decision makers,
industry, stakeholders
1st was awareness workshop !
– Ministers confirmed the new bill will be
prepared!
•
Continuation after project in Ministry of
Health
Workshops
3 groups:
1.Reimbursement and pricing criteria
2.Division of responsibilities between
institutions involved
3.Role of stakeholders ( doctors, pharmacists,
patients, other institutions)
Reimbursement criteria
1. Impact on public health (health priorities)
2. Consequences of the disease (severity)
3. Proven clinical efficacy compared to gold
standard;
4. Proven safety profile compared to gold
standard;
5. Beneficial ratio of health effects vs. costs;
6. Justification, proven by HTA Agency
(AHTAPol) recommendation
7. Proven accessibility on the market and/or
guarantee of supply;
6. Impact of drug on direct costs of treatment;
7. Number of patient's population to whom
the pharmacotherapy may refer;
8. Criterion of categorization of patients for
therapy;
9. Known annual cost of reimbursement and
its potential follow-up in respective years;
10. Financial feasibility of subject obliged to
finance health services from public means
Levels of reimbursement
reimbursement levels
Free or lump sum
Saving lives drugs
First choice drugs
Long lasting diseases
Important to society
50%
70%
New drugs <1 year
Planned to be withdrawn
Very expensive
Pricing criteria
• Reimbursement limits:
– Therapeutic group
– Generic group (the same active substance)
• The limit is the price of DDD of the cheapest
drug in the group
Setting reimbursement system
1. Reimbursement application sent to Ministry
of Health
2. New molecules – assessment in AHTAPol
3. Recommendation of Consultative Council
(8 types)
4. Price negotiations - Negotiation
Committee
5. Final decision - Minister + Reimbursement
Committee
Results
•
Law from August 2007 has fully implemented
provisions of Transparency Directive related to
deadlines of application examination (90 and
180 days).
•
The bill about reimbursement from October
2008 implements workshops results.
Results - AHTAPol
Changes in regulations concerning Agency:
• The bill gives stable legal framework for
Agency (20 Oct 2008)
– Stronger and independent position of
AHTAPol
• New ordinance signed at 10 September
2008:
– Regulates tasks of Agency and it’s
Consultative Council
What to do next?
• Act of law concerning Agency has been
prepared and will be implemented in
January 2009
• New template of reimbursement
application still not prepared
• Knowledge about HTA and EBM still has
to be disseminated
Lesson learned:
• Good cooperation and dialogue between
policy makers and industry is important
• Policy makers are aware of importance of
transparent and understandable process
• Help from experienced countries is
indispensible (the same problems, the
same solutions)