Reimbursement system in Slovakia

Michaela GajdošováGabriela Kliešková

Ministry of Health Slovakia

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

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

Types of applications for reimbursement Clear and transparent rules of

submission1. A1N – for new molecules2. A1G – for generic drugs3. A1R – for generic drugs entering via fast

track4. A3 – withdrawal from the R.L.

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

Price proposals

Online price proposals Always published on web site

www.health.gov.sk

Risperidon example

Normal and fast track of price proposals Normal track150 days before reimbursementFirst price proposal - entrance ticketIn the following days second price proposal

submition Fast track120 days before reimbursementWill be encluded only if the price for DDD is at

least 10% lower then the cheapest competitor´s price per DDD

Time lines

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

Type of application Day of submision # of days

A1-N 30. 9. 2007 180A1-G 30. 9. 2007 180

A3 31. 10. 2007 150CN 31. 10. 2007 150

A1-R 30. 11. 2007 120CN-R 30. 11. 2007 120

Changes 30. 9. 2007 180

Working groups

Working groups directly involved in the proces

1. Reimbursement commitee (RC)

2. 23 other working groups

Reimbursement commitee

poisťovne

odborníci

ministerstvo

Health care insurance companies

MoH

doctors

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 groupsF EK a KV – working group for farmacoeconomics and clinical

outcomes

Procedure of the reimbursement

Applications Farmacoeconomic working group (A1N) Heads of ATC working groups Reimbursement commitee

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

Criteria for price setting

Prices in 9 reference countries +10% of average of 3 lowest prices –

maximum accepted COMPARED ARE EXFACTORY

(manufacturer) PRICES

Reimbursement list

ATC/ Code

Product PresentationDDD/ CRP

StatePharmacy

p.Reimburs

ementCo-paym.

Co-paym.%

PLReimb. DDD

/ ILA02BC01 Omeprazol p.o. do 10 mg 20 mg 17,5

98710 Omeprazol Sandoz 10 mg cps 56x10 mg SAN A 522,8 490,0 32,8 6,27% GIT, PED, HEP ind.obm.98708 Omeprazol Sandoz 10 mg cps 14x10 mg SAN A 134,0 122,5 11,5 8,58% GIT, PED, HEP ind.obm.98709 Omeprazol Sandoz 10 mg cps 28x10 mg SAN A 268,1 245,0 23,1 8,62% GIT, PED, HEP ind.obm.57408 HELICID 10 cps 28x10 mg LEX CZ 278,4 245,0 33,4 12,00% GIT, PED, HEP ind.obm.53974 HELICID 10 cps 14x10 mg LEX CZ 139,3 122,5 16,8 12,06% GIT, PED, HEP ind.obm.

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

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

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

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%

3 main tools in 2007

Change of VAT (19% 10%) 6,6 % price cut Degressive margin

Payment of health care insurance companies

27,104

30,349

32,47

38,09

33,57

0

5

10

15

20

25

30

35

40

2004 2005 2006 2007

Year

mld

SK

K

ÚZP ÚZP bez zásahov

new goverment

6,6% price cut

change of VAT

Degressive marginMaximum exfactory price maximum margin

  Wholesaler Pharmacy

od 0,00 do 80,00 0,00 Sk 14,10% 0,00 Sk 32,90%

od 80,01 do 160,00 11,28 Sk + 11,100% základu presahujúceho 80,00 Sk 26,32 Sk+ 25,900% základu presahujúceho

80,00 Sk

od 160,01 do 240,00 20,16 Sk + 8,100% základu presahujúceho 160,00 Sk 47,04 Sk+ 18,900% základu presahujúceho

160,00 Sk

od 240,01 do 400,00 26,64 Sk + 5,100% základu presahujúceho 240,00 Sk 62,16 Sk+ 11,900% základu presahujúceho

240,00 Sk

od 400,01 do 700,00 34,80 Sk + 3,300% základu presahujúceho 400,00 Sk 81,20 Sk+ 7,700% základu presahujúceho

400,00 Sk

od 700,01 do 1 200,00 44,70 Sk + 2,700% základu presahujúceho 700,00 Sk 104,30 Sk + 6,300% základu presahujúceho

700,00 Sk

od 1 200,01 do 2 200,00 58,20 Sk + 2,400% základu presahujúceho 1 200,00 Sk 135,80 Sk+ 5,600% základu presahujúceho

1 200,00 Sk

od 2 200,01 do 5 000,00 82,20 Sk + 2,250% základu presahujúceho 2 200,00 Sk 191,80 Sk+ 5,250% základu presahujúceho

2 200,00 Sk

od 5 000,01 do 10 000,00 145,20 Sk + 2,100% základu presahujúceho 5 000,00 Sk 338,80 Sk+ 4,900% základu presahujúceho

5 000,00 Sk

od 10 000,01 do 20 000,00 250,20 Sk + 1,950% základu presahujúceho 10 000,00 Sk 583,80 Sk

+ 4,550% základu presahujúceho 10 000,00 Sk

Viac ako 20 000,01 445,20 Sk + 1,800% základu presahujúceho 20 000,00 Sk 1 038,80 Sk+ 4,200% % základu presahujúceho

20 000,00 Sk

Changes since 1.1.2008

For new molecules at the entry: Reference prices – all EU countries No +10% ruleFor 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

Thank you for your attention