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Reimbursement system in Slovakia

Reimbursement system in Slovakia. Michaela Gajdošová Gabriela Kliešková Ministry of Health Slovakia. History before May 2005. Reimbursement once yearly Price decrease could eliminate patients´s copayment Reimbursement based on DDD

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Reimbursement system in Slovakia

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  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 • A1N – for new molecules • A1G – for generic drugs • A1R – for generic drugs entering via fast track • 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 • Reimbursement commitee (RC) • 23 other working groups

  11. 5 poisťovne 3 3 ministerstvo odborníci Reimbursement commitee Health care insurance companies doctors MoH

  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. 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 Reimbursement list

  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

  21. Degressive margin

  22. 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

  23. Thank you for your attention

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