Transcript Pricing and Reimbursement in the Czech republic

List of Reimbursed Drugs
in the Czech Republic
Tomas Sechser
Daniela Rrahmaniova
Ministry of Health Czech Republic
Drug Policy Experience of Visegrad Group
countries, Warszava Oct 29-30, 2007
Healthcare system in the CR
 till now
 health care reform
 1.1.2008 -
[citace]
CR PPR 29.10.2007 [email protected]
STABILISATION AND HEALTH CARE REFORM
in the Czech Republic
Reformn measure II
- 2010 …
Reform measure I
2007 - 2009
Horizone
Phase of stabilisation
2006 - 2007
Target
Return to standard
relationships and
commucation
Steps
Reform of Institutions
– increase of effectiveness
of the current system
Reform of financing
Drug reimbursement
according to their benefits

[MoH CR 2007]
CR PPR 29.10.2007 [email protected]
Legislation
Stabilisation of public budgets Act No 261/2007 Coll. 85
Amendment of Public health insurance Act 2007
– part 44
New Drug Law
[]
CR PPR 29.10.2007 [email protected]
Healthcare system in the CR
 there is a distinction between the primary and
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secondary care sectors in terms of budgeting, funding
and mechanisms for constraining expenditure
increases
system is funded on the principle of social solidarity
funding: general taxation
access is determined on the basis of medical need
rather than an ability to pay
state pays for a large proportion of healthcare
expenditure
treatment has been provided free at the point of
delivery
CR PPR 29.10.2007 [email protected]
Health Care Expenditure
in the CR
 total health care expenditure 7,1% GDP
 Drug expenditure – 23% of total
 All citizens are covered by health care
insurance
 General health insurance system build on
solidarity, equity and availability of health
CR PPR 29.10.2007 [email protected]
Health Care Expenditure
in the CR
 Public expenditure for healthcare
 EU average 77%, CZ 94-96%
 Drugs expenditure as % of total healthcare
expenditures:
 Old EU 7-23%, CZ 23%
CR PPR 29.10.2007 [email protected]
Czech drug market
Number of products
16 000
14 000
12 000
10 000
8 000
6 000
4 000
2 000
registered
OTC
00
20
99
19
98
19
97
19
96
19
95
19
94
19
93
19
92
19
91
19
90
19
19
89
0
marketed
[Svihovec, Suchopar, 2002]
CR PPR 29.10.2007 [email protected]
Relative drug prices in EU and CR (1998)
Italy = 1,0
NL
D
B
PG
IRL
UK
F
GR
ESP
I
CZ
0
0,5
1
1,5
2
2,5
[citace]
CR PPR 29.10.2007 [email protected]
Svihovec, Suchopar, 2002
Reimbursement – managing utilisation
of a limited resource
Access to
Healthcare
Achieving access to
high quality care across
the population
Priorities/ targets
Achieving clinical
improvements
Health outcomes
relevant to patient’s
priorities
Equity / Fairness
Managing available
budget
Scarce resource vs
demands on budget
New pharmaceuticals
taking up all available
new money
Budget difficult to
manage because uptake
not predictable
Need to focus available
resource where it will
deliver most benefit
Agenda
a) Type of reimbursement
b) Criteria for price setting, criteria for
reimbursement
c) Updating reimbursement lists
d) Rules for including/excluding drugs in/from
the list
e) Limitations used regarding single diseases
CR PPR 29.10.2007 [email protected]
Type of reimbursement
• Reference pricing
• Evidence based reimbursement
 direct price regulation
 reimbursement regulation
[Amendment of Public health insurance Act 2007 ]
CR PPR 29.10.2007 [email protected]
Pricing
&
Reimbursment
State
Institute
for Drug
Control
(SÚKL)
Insurance
Funds
(VZP)
Pharmacetical
industry
Reference pricing system
Drug Policy Experience of Visegrad Group
countries, Warszava Oct 29-30, 2007
Breadth of references groups
Three possibilities:
 (1) products with the same active chemical
ingredients,
 (2) products with chemically related active
ingredients that are pharmacologically
equivalent, and
 (3) products that may be neither chemically
identical nor pharmacologically equivalent but
have comparable therapeutic effects.
[Kanavos 2003]
CR PPR 29.10.2007 [email protected]
Reference group
§ 39c
 group of medical products essentially
therapeutically interchangeable with a similar
efficacy and safety and with a similar clinical
use
[Amendment of Public health insurance Act 2007 ]
CR PPR 29.10.2007 [email protected]
Criteria for price setting
 list of the „reference basket“ i.e. cross
reference pricing
 reference group – fully reimbursed and
partially reimbursed (not efficient)
 maximum price stipulated by (State
Institute for Drug Control) =SÚKL
(till now by Ministry of Finance)
 maximum price of the 1st generics- 20%
 innovative drugs
[Amendment of Public health insurance Act 2007
CR PPR 29.10.2007 [email protected]
]
Criteria for reimbursement
basic reimbursement
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basic reimbursement of the reference group
essentially similar – ATC clasification, the same
efficacy, the same therapeutic use
ex-factory prices
basic reimbursement in partially reimbursed
reference groups (lower efficiency) – maximum
60%
products not included in reference group –
maximum 70%
•
[Amendment of Public health insurance Act 2007
CR PPR 29.10.2007 [email protected]
]
Criteria for reimbursement
current reimbursement
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set of rules
→ therapeutic effectiveness and safety
→ severity of the treated disease
→ cost effectiveness and cost vs outcomes (benefits)
→ public interest
→ way of administration, dosage form, strength and sice of the package
→ usual therapeutic dosing
→ necessary time of the treatment
→ compliance, persistence, adherence
→ interchangebility of other reimbursed product
budget impact of
guidelines and standard procedures – from the perspective of cost
effectiveness and budget impact
[Amendment of Public health insurance Act 2007
CR PPR 29.10.2007 [email protected]
]
Updating reimbursement lists
 regular evaluation of the agreement between reimbursement
(both quantitative and qualitative aspects)
 at least once a year
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Namely,
- the achievement of the expected outcomes and reasons for
pharmacotherapy
- usefullness of the list of reference groups
- the size and conditions both of the basic and current
reimbursement
evaluation of clinical and cost
effectiveness of interventions and their
comparison with original aims of pharmatherapy
- revision report with proposals for changes in reference
groups
[citace]
CR PPR 29.10.2007 [email protected]
Rules for including/excluding drugs
in/from the list
- not lincensed
- price not setted
- lack of evidence of clinical and costeffectiveness
[citace]
CR PPR 29.10.2007 [email protected]
Limitations used
regarding single diseases
 Prescription limits
 orphan drugs
[Amendment of Public health insurance Act 2007
CR PPR 29.10.2007 [email protected]
Determination of limits for
reimbursement
 for certain medical specialisations
 for certain health conditions of the patient
determination of the method of
reimbursement
- on medical prescription
- on requisition
- by a lump-sum payment
•
What is the method/system for drug
reimbursement?
reference reimbursement system
•  the reimbursement is based on the content
(amount) of an active substance in the given
pharmacotherapeutic group
•  the same reimbursement for the same amount
•  the amount was expressed as DDD or in other
units
•  the same, reference reimbursement for the drug
with the same effectiveness (efficacy)
[Amendment of Public health insurance Act 2007 ]
CR PPR 29.10.2007 [email protected]
Transparency Directive (89/105/EEC)
• does not alter the rights of government to manage
pricing and reimbursement of pharmaceuticals, but
stipule that:
• the system must not discriminate against imports
• decision should be based on objective criteria
• pricing and reimbursement decision should be taken
with specified time limits
• a reason must be given for any refusal of a price or
price increase
• a right of appeal is provided in cases of national
dispute
•
Insurance
Funds
• Submisions
Pharmaceutical
Industry
State Institute
for Drug Control
(SÚKL)
Evidence
evaluation
• Decision making process
Reimbursement
determination
New technologies and pharmaceutical innovations
Major trends:
o more intensive use of hospital facilities; patients stay
in hospital for much shorter periods and receive more
tests and tretment whilst in hospital
o More procedures are caried out in hospital outpatient
departments or in surgeries and clinics
o greater emphasis on treatment in the community
rather than institutions
o more patients with chronic conditions, many of whom
are on maintenance medication
Health
Economical
evaluation
Therapeutical
evaluation
Pharmacological
Evaluation
Pricing
&
Reimbursment
Current Reimbursement
Drug Policy Experience of Visegrad Group
countries, Warszava Oct 29-30, 2007
[Waechter 2007]
CR PPR 29.10.2007 [email protected]
Assessment of products
for reimbursement decision making
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Information requirement is becoming:-
Clinical benefit
Cost effectiveness
Budget Impact
Providing information to cover effectiveness and cost effectiveness in different
target patient groups and against different alternatives at the time of launch is
challenging for pharmaceutical companies and could lead to delays in making
products available and add to costs
Need to consider benefits lost through delaying access against risks of a false
assumption – the information may be better obtained by more effective postlaunch tracking
This may involve risk sharing agreements with the manufacturers – already
some authorities are asking for rebates against volume and budget impact
assumptions that prove erroneous
Reimbursement conditions could be re-assessed after 1 or 2 years – but would
authorities be willing to take the political risk that they might need to reverse a
funding decision?
Health economic evaluations
• a reimbursement price is negotiated on the
basis of a variety of factors
• the therapeutic benefit of a product vis-à-vis
those of its competitors
• if a product is unquestionably superior in
therapeutic terms, it wiill be reimbursed
irrespective of the outcome of any health
economic evaluation
[citace]
CR PPR 29.10.2007 [email protected]
Assessment of products
for reimbursement decision making
Where basis for decision making is firstly should a product be
reimbursed followed by when should it be reimbursed the
information required is broader:
• Requires information on performance relative to
relevant alternatives for specific usage situations
• Information on how treatment costs may change as a
result of introducing the product for specific usage
situations
• Decision makers are broadening the cost horizon from
comparative product costs to treatment costs
• Also require an understanding of potential budget
impact for different patient target groups
[Waechter 2007]
CR PPR 29.10.2007 [email protected]
Conclusion
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Reference price system
Objective criteria for price setting, criteria for
reimbursement are given
Decision making process?
CR PPR 29.10.2007 [email protected]