1. Reimbursement system in Slovakia Michaela Gajdošová Gabriela Kliešková Ministry of Health Slovakia

2. History before May 2005 Reimbursement once yearly Price decrease could eliminate patients´s copayment Reimbursement based on DDD Maximum price had to be submitted 5 months before reimbursement to the MoF

3. Reimbursement today Quaterly basis Based on DDD Level of reimbursement is set by a reimbursement commitee Maximum prices can be submitted at the same time as reimbursement apllication Fixed % patient´s copayment

4. Types of applications for reimbursement Clear and transparent rules of submission 1. A1N – for new molecules 2. A1G – for generic drugs 3. A1R – for generic drugs entering via fast track 4. A3 – withdrawal from the R.L.

5. Types of price proposals Running whole year based on monthly period CN1 – first price proposal-normal track CN2 – second price proposal – normal track CNR1- first price proposal - fast track CN2R – second price proposal - fast track

6. Price proposals Online price proposals Always published on web site www.health.gov.sk

7. Risperidon example

8. Normal and fast track of price proposals Normal track 150 days before reimbursement First price proposal - entrance ticket In the following days second price proposal submition Fast track 120 days before reimbursement Will be encluded only if the price for DDD is at least 10% lower then the cheapest competitor´s price per DDD

9. Time lines According to the transparency directive 89/105/EHS Ex. Applications to reimbursement since 1st of April 2008

10. Working groups Working groups directly involved in the proces 1. Reimbursement commitee (RC) 2. 23 other working groups

11. Reimbursement commitee poisťovne odborníci ministerstvo Health care insurance companies MoH doctors

12. Reimbursement commitee 23 sub- groups Profesional working groups (ATC groups) A – Odborná pracovná skupina pre tráviaci systém a metabolizmus (A okrem A01 a A10) A01 – Odborná pracovná skupina pre stomatologické prípravky (A01) A10 – Odborná pracovná skupina pre antidiabetiká (A10) B – Odborná pracovná skupina pre krv a krvotvorné orgány (B okrem B05) C – Odborná pracovná skupina pre kardiovaskulárny systém (C) D – Odborná pracovná skupina pre dermatologiká (D) G – Odborná pracovná skupina pre urogenitálny trakt - gynekologiká a sexuálne hormóny (G okrem G04)........................... Other working groups F EK a KV – working group for farmacoeconomics and clinical outcomes

13. Procedure of the reimbursement Applications Farmacoeconomic working group (A1N) Heads of ATC working groups Reimbursement commitee

14. Procedure of the reimbursement Farmacoeconomic working group – written statment about the farmacoenomic part and if the data are relavant to RC Heads of ATC working groups are active members of the RC (1 nonstable member) Decision based on the voting of the RC

15. Criteria for price setting Prices in 9 reference countries +10% of average of 3 lowest prices – maximum accepted COMPARED ARE EXFACTORY (manufacturer) PRICES

16. Reimbursement list Since 1.1.2008 4581 reimbursed drugs According to law 577/2004 at least 114 drugs have to be without patient´s copayment In reimbursement list valid since 1.1.2008 app. 1600 drugs are without co-payment

17. Criteria for reimbursement (law 577/2004) Based on clinical trials Life-saving drug Recovers from desease Avoids complications Avoids progress to chronic stage Efficient profylaxy

18. Criteria for reimbursement of fixed combination Sum of reimbursement of DDD 10% bonus for compliance

19. Excluding drugs from the positive list OTC drug 3 or more months not available on the market (800 drugs excluded since 1.1.2008) The treatment is too expensive compared to the existing Price of new drug is higer than average of 3 lowest reference prices +10%

20. 3 main tools in 2007 Change of VAT (19% 10%) 6,6 % price cut Degressive margin

22. Maximum exfactory pricemaximum margin WholesalerPharmacy od 0,00 do 80,000,00 Sk14,10%0,00 Sk32,90% od 80,01 do 160,0011,28 Sk+ 11,100% základu presahujúceho 80,00 Sk26,32 Sk + 25,900% základu presahujúceho 80,00 Sk od 160,01 do 240,0020,16 Sk+ 8,100% základu presahujúceho 160,00 Sk47,04 Sk + 18,900% základu presahujúceho 160,00 Sk od 240,01 do 400,0026,64 Sk+ 5,100% základu presahujúceho 240,00 Sk62,16 Sk + 11,900% základu presahujúceho 240,00 Sk od 400,01 do 700,0034,80 Sk+ 3,300% základu presahujúceho 400,00 Sk81,20 Sk + 7,700% základu presahujúceho 400,00 Sk od 700,01 do 1 200,0044,70 Sk+ 2,700% základu presahujúceho 700,00 Sk104,30 Sk + 6,300% základu presahujúceho 700,00 Sk od 1 200,01 do 2 200,0058,20 Sk+ 2,400% základu presahujúceho 1 200,00 Sk135,80 Sk + 5,600% základu presahujúceho 1 200,00 Sk od 2 200,01 do 5 000,0082,20 Sk+ 2,250% základu presahujúceho 2 200,00 Sk191,80 Sk + 5,250% základu presahujúceho 2 200,00 Sk od 5 000,01 do 10 000,00145,20 Sk+ 2,100% základu presahujúceho 5 000,00 Sk338,80 Sk + 4,900% základu presahujúceho 5 000,00 Sk od 10 000,01 do 20 000,00250,20 Sk+ 1,950% základu presahujúceho 10 000,00 Sk583,80 Sk + 4,550% základu presahujúceho 10 000,00 Sk Viac ako 20 000,01445,20 Sk+ 1,800% základu presahujúceho 20 000,00 Sk1 038,80 Sk + 4,200% % základu presahujúceho 20 000,00 Sk

23. Changes since 1.1.2008 For new molecules at the entry: Reference prices – all EU countries No +10% rule For existing molecules on Q basis: Reference prices – all EU countries No +10% rule Database from Ph.companies and other MoH of other countries Reimbursement list since Jan 2008 exfactory price Generic substitution – negative list

24. Thank you for your attention