Transcript 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
 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

1.
2.
3.
4.
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.
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 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

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
A1-N
A1-G
A3
CN
A1-R
CN-R
Changes
30. 9. 2007
30. 9. 2007
31. 10. 2007
31. 10. 2007
30. 11. 2007
30. 11. 2007
30. 9. 2007
# of days
180
180
150
150
120
120
180
Working groups

1.
2.
Working groups directly involved in the
proces
Reimbursement commitee (RC)
23 other working groups
Reimbursement commitee
Health care insurance companies
poisťovne
doctors
MoH
odborníci
ministerstvo
Reimbursement commitee 23 subgroups
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
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
A02BC01
98710
98708
98709
57408
53974
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
Product
Omeprazol
Omeprazol Sandoz 10 mg
Omeprazol Sandoz 10 mg
Omeprazol Sandoz 10 mg
HELICID 10
HELICID 10
DDD/
CRP
p.o. do 10 mg
20
cps 56x10 mg SAN
cps 14x10 mg SAN
cps 28x10 mg SAN
cps 28x10 mg LEX
cps 14x10 mg LEX
Presentation
State
mg
A
A
A
CZ
CZ
Pharmacy Reimburs
CoCo-paym.
p.
ement
paym.%
522,8
134,0
268,1
278,4
139,3
490,0
122,5
245,0
245,0
122,5
32,8
11,5
23,1
33,4
16,8
6,27%
8,58%
8,62%
12,00%
12,06%
PL
GIT, PED, HEP
GIT, PED, HEP
GIT, PED, HEP
GIT, PED, HEP
GIT, PED, HEP
Reimb. DDD
/ IL
17,5
ind.obm.
ind.obm.
ind.obm.
ind.obm.
ind.obm.
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%
 6,6 % price cut
 Degressive margin

10%)
Payment of health care insurance companies
ÚZP
ÚZP bez zásahov
40
38,09
33,57
35
32,47
30,349
change of
VAT
30
27,104
25
mld SKK
6,6%
price cut
20
15
new
goverment
10
5
0
2004
2005
2006
Year
2007
Degressive margin
Maximum 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% 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
Thank you for your attention