List of Reimbursed Drugs in the Czech Republic

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


[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


[]

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


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


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%


Czech drug marketNumber of products

02 0004 0006 0008 000

10 00012 00014 00016 000

registered OTC marketed


[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


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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


Type of reimbursement

• Reference pricing• Evidence based reimbursement direct price regulation reimbursement regulation


[Amendment of Public health insurance Act 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.


[Kanavos 2003]

group of medical products essentially therapeutically interchangeable with a similar efficacy and safety and with a similar clinical use



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



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%

•



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



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


[citace]

Rules for including/excluding drugs in/from the list

- not lincensed - price not setted - lack of evidence of clinical and cost-

effectiveness


[citace]

Limitations used regarding single diseases

Prescription limits orphan drugs


[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)



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


Current Reimbursement

Phar

mac

olog

ical

Eva

luat

ion

Ther

apeu

tical

eval

uatio

n

Hea

lthEc

onom

ical

eval

uatio

n

Pricing&

Reimbursment


[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


[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


[Waechter 2007]

Conclusion

Reference price system Objective criteria for price setting, criteria for

reimbursement are given Decision making process?


List of Reimbursed Drugs in the Czech Republic

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