1. Drug Policy Experience of Visegrad Group countries, Warszava Oct 29-30, 2007 List of Reimbursed Drugs in the Czech Republic Tomas Sechser Daniela Rrahmaniova Ministry of Health Czech Republic

2. Healthcare system in the CR  till now  health care reform  1.1.2008 - CR PPR 29.10.2007 tosc@volny.cz [citace]

3. STABILISATION AND HEALTH CARE REFORM in the Czech Republic Target Steps Horizone Phase of stabilisation 2006 - 2007 Reform measure I 2007 - 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 tosc@volny.cz [MoH CR 2007]

4. 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 tosc@volny.cz [][]

5. 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 tosc@volny.cz

6. 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 tosc@volny.cz

7. 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 tosc@volny.cz

8. [ Svihovec, Suchopar, 2002 ]

9. Svihovec, Suchopar, 2002 Relative drug prices in EU and CR (1998) Italy = 1,0 00,511,522,5 CZ I ESP GR F UK IRL PG B D NL CR PPR 29.10.2007 tosc@volny.cz [citace]

10. 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

11. 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 tosc@volny.cz

12. Type of reimbursement Reference pricing Evidence based reimbursement  direct price regulation  reimbursement regulation CR PPR 29.10.2007 tosc@volny.cz [ Amendment of Public health insurance Act 2007 ]

13. Drug Policy Experience of Visegrad Group countries, Warszava Oct 29-30, 2007 Reference pricing system State Institute for Drug Control (SÚKL) Insurance Funds (VZP) Pharmacetical industry Pricing & Reimbursment

14. 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 tosc@volny.cz [Kanavos 2003]

15.  group of medical products essentially therapeutically interchangeable with a similar efficacy and safety and with a similar clinical use CR PPR 29.10.2007 tosc@volny.cz [ Amendment of Public health insurance Act 2007 ] Reference group § 39c

16. 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 tosc@volny.cz [Amendment of Public health insurance Act 2007 ]

17. Criteria for reimbursement basic 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 tosc@volny.cz [Amendment of Public health insurance Act 2007 ]

18. Criteria for reimbursement current 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 tosc@volny.cz [Amendment of Public health insurance Act 2007 ]

19. 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 reimbursementevaluation 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 tosc@volny.cz [citace]

20. 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 tosc@volny.cz [citace]

21. Limitations used regarding single diseases  Prescription limits  orphan drugs CR PPR 29.10.2007 tosc@volny.cz [ Amendment of Public health insurance Act 2007

22. 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

23. 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 tosc@volny.cz [ Amendment of Public health insurance Act 2007 ] What is the method/system for drug reimbursement?

24. 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

25. State Institute for Drug Control (SÚKL) Insurance Funds Pharmaceutical Industry Submisions Evidence evaluation Reimbursement determination Decision making process

26. New technologies and pharmaceutical innovations Major trends: omore intensive use of hospital facilities; patients stay in hospital for much shorter periods and receive more tests and tretment whilst in hospital oMore procedures are caried out in hospital outpatient departments or in surgeries and clinics ogreater emphasis on treatment in the community rather than institutions omore patients with chronic conditions, many of whom are on maintenance medication

27. Drug Policy Experience of Visegrad Group countries, Warszava Oct 29-30, 2007 Current Reimbursement Pharmacological Evaluation Therapeutical evaluation Health Economical evaluation Pricing & Reimbursment

28. CR PPR 29.10.2007 tosc@volny.cz [Waechter 2007]

29. Assessment of products for reimbursement decision making 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 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?

30. 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 tosc@volny.cz [citace]

31. 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

32. CR PPR 29.10.2007 tosc@volny.cz [Waechter 2007]

33. Reimbursement and Pricing have Historically been Closely Linked Room for national level freedom of pricing within the EU is reducing In most EU markets price is controlled and has to be agreed before reimbursement was granted - so price and listing go hand in hand EU free movement of goods has the effect of leveling prices so significantly different national price levels are unlikely in the future Many EU markets now use cross-referencing prices in other EU markets as a main mechanism of price setting Control of national budgets for reimbursement of pharmaceuticals will increasingly have to be at the level of controls on overall reimbursement status and on when the product is allowed to be reimbursed

34. Conclusion Reference price system Objective criteria for price setting, criteria for reimbursement are given Decision making process? CR PPR 29.10.2007 tosc@volny.cz