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List of Reimbursed Drugs in the Czech Republic. Tomas Sechser Daniela Rrahmaniova Ministry of Health Czech Republic. [citace ]. CR PPR 29.10.2007 [email protected]. Healthcare system in the CR. till now health care reform 1.1.2008 -. [MoH CR 2007 ]. CR PPR 29.10.2007 [email protected]. - PowerPoint PPT Presentation
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Drug Policy Experience of Visegrad Group countries, Warszava Oct 29-30, 2007
List of Reimbursed DrugsList of Reimbursed Drugs in the Czech Republic in the Czech Republic
Tomas Sechser Daniela Rrahmaniova
Ministry of Health Czech Republic
Healthcare system in the CR till now health care reform 1.1.2008 -
CR PPR 29.10.2007 [email protected]
[citace]
STABILISATION AND HEALTH CARE REFORMin the Czech Republic
Target
Steps
Horizone Phase of stabilisation 2006 - 2007
Reform measure I2007 - 2009
Reformn measure II- 2010 …
Return to standard relationships and commucation
Reform of Institutions – increase of effectiveness of the current system
Drug reimbursement according to their benefits
Reform of financing
CR PPR 29.10.2007 [email protected]
[MoH CR 2007]
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 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 Expenditurein 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 Expenditurein 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 marketNumber of products
02 0004 0006 0008 000
10 00012 00014 00016 000
registered OTC marketed
CR PPR 29.10.2007 [email protected]
[Svihovec, Suchopar, 2002]
Svihovec, Suchopar, 2002
Relative drug prices in EU and CR (1998) Italy = 1,0
0 0,5 1 1,5 2 2,5
CZ I
ESP GR
F UK
IRL
PG B
D NL
CR PPR 29.10.2007 [email protected]
[citace]
Reimbursement – managing utilisation of a limited resource
Access to Healthcare
Achieving access to high quality care across the populationPriorities/ targetsAchieving clinical improvementsHealth outcomes relevant to patient’s prioritiesEquity / Fairness
Managing available budget
Scarce resource vs demands on budgetNew pharmaceuticals taking up all available new moneyBudget difficult to manage because uptake not predictableNeed to focus available resource where it will deliver most benefit
Agenda
a) Type of reimbursementb) Criteria for price setting, criteria for
reimbursementc) Updating reimbursement listsd) Rules for including/excluding drugs in/from
the liste) 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
CR PPR 29.10.2007 [email protected]
[Amendment of Public health insurance Act 2007 ]
Drug Policy Experience of Visegrad Group countries, Warszava Oct 29-30, 2007
Reference pricing system
State Institutefor DrugControl(SÚKL)
InsuranceFunds(VZP)
Pharmacetical industry
Pricing&
Reimbursment
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.
CR PPR 29.10.2007 [email protected]
[Kanavos 2003]
group of medical products essentially therapeutically interchangeable with a similar efficacy and safety and with a similar clinical use
CR PPR 29.10.2007 [email protected]
[Amendment of Public health insurance Act 2007 ]
Reference group § 39c
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
CR PPR 29.10.2007 [email protected]
[Amendment of Public health insurance Act 2007 ]
Criteria for reimbursementbasic reimbursement
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%
•
CR PPR 29.10.2007 [email protected]
[Amendment of Public health insurance Act 2007 ]
Criteria for reimbursementcurrent reimbursement
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
CR PPR 29.10.2007 [email protected]
[Amendment of Public health insurance Act 2007 ]
Updating reimbursement lists
regular evaluation of the agreement between reimbursement (both quantitative and qualitative aspects)
at least once a year 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
CR PPR 29.10.2007 [email protected]
[citace]
Rules for including/excluding drugs in/from the list
- not lincensed - price not setted - lack of evidence of clinical and cost-
effectiveness
CR PPR 29.10.2007 [email protected]
[citace]
Limitations used regarding single diseases
Prescription limits orphan drugs
CR PPR 29.10.2007 [email protected]
[Amendment of Public health insurance Act 2007
Determination of limits for reimbursement
for certain medical specialisations for certain health conditions of the patientdetermination of the method of
reimbursement - on medical prescription - on requisition - by a lump-sum payment
• 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)
CR PPR 29.10.2007 [email protected]
[Amendment of Public health insurance Act 2007 ]
What is the method/system for drug reimbursement?
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•
State Institutefor Drug Control
(SÚKL)
InsuranceFunds
PharmaceuticalIndustry
• Submisions
Evidenceevaluation
Reimbursementdetermination
• Decision making process
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
Drug Policy Experience of Visegrad Group countries, Warszava Oct 29-30, 2007
Current Reimbursement
Phar
mac
olog
ical
Eva
luat
ion
Ther
apeu
tical
eval
uatio
n
Hea
lthEc
onom
ical
eval
uatio
n
Pricing&
Reimbursment
CR PPR 29.10.2007 [email protected]
[Waechter 2007]
Assessment of products for reimbursement decision making
• Information requirement is becoming:-
Clinical benefitCost effectivenessBudget 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 post-launch 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
CR PPR 29.10.2007 [email protected]
[citace]
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
CR PPR 29.10.2007 [email protected]
[Waechter 2007]
Conclusion
Reference price system Objective criteria for price setting, criteria for
reimbursement are given Decision making process?
CR PPR 29.10.2007 [email protected]