dr joanna lis president-elect polish society of pfarmacoeconomics
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How to provide the proper access for innovative treatment to the patients in Poland ? Let’s discuss about new trends and planned changes …. Dr Joanna Lis President-Elect Polish Society of Pfarmacoeconomics. Expentitures on health care in Poland are not to high as…. - PowerPoint PPT PresentationTRANSCRIPT
How to provide the proper access for innovative treatment
to the patients in Poland?Let’s discuss about new trends and planned
changes…
Dr Joanna LisPresident-Elect Polish Society of Pfarmacoeconomics
Expentitures on health care in Poland are not to high
as…
Public expenditure on health [Exch. rate, million US$]
Slova
k Rep
ublic
Hungary
Czech Rep
ublic
Finlan
dIre
land
Greece
Poland
Denmark
Austria
Swed
enSp
ain Italy
France
German
y0
50,000
100,000
150,000
200,000
250,000
300,000
3,8877,236
10,03015,038
15,95218,099
19,33025,593
28,73633,601
87,353
141,304
225,546
266,179
Source: OECD Health Data 2009: data from 2007 year
Poland
Slova
k Rep
ublic
Hungary
Czech Rep
ublic
Greece
Finlan
dIre
land
Spain Ita
ly
Swed
en
Austria
German
y
Denmark
France
-3.0%
0.0%
3.0%
6.0%
9.0%
12.0%
15.0%
4.6% 5.
2%
5.2% 5.
8%
5.8% 6.
1%
6.1%
6.1% 6.
7% 7.4% 7.
7% 8.0% 8.2% 8.
7%
Expenditure [Exch. rate, million US$]
Expenditure as % GDP
PUBLIC EXPENDITURE ON PHARMACEUTICALS AND OTHER MEDICAL NON-DURABLES* [Exch. rate, million US$]
0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
40,000
* expenditure on pharmaceuticals and other medical non-durables comprises pharmaceuticals such as medicinal preparations, branded and generic medicines, drugs, patent medicines, serums and vaccines, vitamins and minerals and oral contraceptives.
Source: OECD Health Data 2009, data from 2007 year
Denmark
Finlan
dPolan
d
Swed
en Italy
Austria
Czech Rep
ublicFra
nce
German
ySp
ain
Hungary
Slova
k Rep
ublic
Greece
0.0%
0.2%
0.4%
0.6%
0.8%
1.0%
1.2%
1.4%
1.6%
1.8%
2.0%
0.5% 0.
6%
0.6%
0.7%
0.8% 0.
9%
1.0%
1.2%
1.2%
1.3%
1.4% 1.
5%
1.9%
Expenditure [Exch. rate, million US$]
Expenditure as % GDP
State expenditures on therapeutics groups – 2007
Antineoplastic and immunomodulating agents;
6,27%Systemic hormonal
preparations, excluding sex hormones and insulins;
1,23%
Genito-urinary system and sex hormones ;
3,98%
Alimentary tract and metabolism ;
15,52%
n/a ; 7,92%
Respiratory system; 1,42%
Antiparasitic products, insecticides and repellents;
0,08%
Antiinfectives for systemic use;
7,35%
Dermatologicals ; 0,71%
Cardiovascular system; 14,68%
Blood and blood forming organs; 5,02%
Respiratory system 14,28%
Nervous system; 16,02%
Musculo-skeletal system; 3,99%
VARIA; 1,55%
Source: National Health Found, Report 2008
Level of health care expenditure vs quality of diabetic health care
◦ corelation between level of health care expenditure vs quality of diabetics health care
◦ 0,74 (p<0,05)
Wydatki na ochronę zdrowia 2006 r. (USD, ppp) a ocena systemu opieki nad pacjentami z cukrzycą
AUS
BEL
BŁG
CYP
CZE
DAN
EST
FIN
FRA
GRE
HISZ
HOL
IRL
LIT LUXŁOT
MAL
NIE
NOR
POL
PORRUM
SK
SLO
SZWCSZWE
WĘG
UK
WŁO
0 500 1000 1500 2000 2500 3000 3500 4000 4500
wydatki na ochronę zdrowia per capita 2006 (USD, ppp)
450
500
550
600
650
700
750
800
850
900
RA
NK
ING
SY
STE
MÓ
W O
PIE
KI N
AD
PA
CJE
NTA
MI Z
CU
KR
ZYC
Ą
Wydatki na ochronę zdrowia (OECD Health Data, 12.2008)
Level of health care expenditure vs quality of health care in cardiovacular
Strong corelation between level of health care expenditure vs quality of health care in cardiology
0,84 (p<0,05)Wydatki na ochronę zdrowia per capita w 2006 r. (USD, ppp) a ocena systemu opieki nad pacjentami z chorobami serca
AUS
BEL
CYP
CZE
DAN
EST
FIN
FRA
GRE
HISZ
HOL
IRL
LIT
LUX
ŁOT
MALNIE
POL
POR
SK
SLO SZW
WĘG
UKWŁO
0 500 1000 1500 2000 2500 3000 3500 4000 4500
WYDATKI NA OCHRONĘ ZDROWIA PER CAPITA 2006 (USD, PPP)
450
500
550
600
650
700
750
800
850
900
RA
NK
ING
SY
STE
MÓ
W O
PIE
KI N
AD
PA
CJE
NTA
MI Z
CH
OR
OB
AM
I SE
RC
A
Wydatki na ochronę zdrowia (OECD Health Data, 12.2008)
Payer perspective: Necessity to control of the
HC expenditures …
PRICE CONTROL x VOLUMEN CONTROL = SPENDING CONTROL
SUPPLY
PRICE REGULATIONSj, (freezing, lowering, …) CUT TING COSTS FOR
MARKETING RSS
NATIONAL REFERENCE PRICING
International Price Comparisons
PRODUCT VOLUME CAPS REVENUE CONTROL
"Cost-effectiveness pricing" PROFIT CONTROL
REBATES PRODUCT RENEVUE CAPS
VBP
DEMAND
PATIENT’S COPAYMENT FOLUMULARIES PATIENT/DISEASE BUDGET
REGISTRATION & MARKET AUTHORISATION RULES POSITIVE/NEGATIVE
REIMBURSEMENT LISTS PHYSICIAN RX BUDGET
INSURANCE SYSTEM CONTROL PRESCRIPTION PHUSICIAN HEALTH CARE
BUDGET
GENERIC SUBSTITIUTION TRATMENT GUIDELINES
TAXES PARALLEL TRADE
10
MoH Legislative road map in PolandName Merits Advance
Pharma Law
Amendment implementing EU DirImportant: introduction of 8+2+1 RDP regime
Consulted in 2009
Clinical trials
Assumptions of new Law ( single act) Important: - New (obligatory) insurance for each participant- 1 trials at a time by one investigator
Consulted in Jan’10
Registra-tion
New law on Regulatory Office Important: MA issued by President of Reg. Office (not MoH)
Consulted in 2009
Reimbur-sement
New reimbursement law : expected important changes: Individual decisions Fixed margins and prices Risk-sharing agreements Tax on pharma activities (Garattini tax)
Not Consulted yet
Doctors Draft law on New types of specializations Consulted Jan 2010
Clinical hospitals
New regime of clinical hospitals (erected by Medical Universities)
n/a
11
MoH Legislative Assumptions in Poland: Risk Sharing Agreements
CompanyMoH
risk- sharing
agreem.
conditionalreimbursement
Healthoutcome
Financialoutcom
population based
individualpatient based
pay forperformance
Coverage with clinical evidence development
Payment for treatment continuation only
Payment for treatment outcome
Upfront payment refunded in case of no treatment outcome
Defined market share and overspendings’ pay-back
Defined volume and overspendings’ pay-back
Limited no of treatment
Natural rebate
DRAFT!
Tools for new planned solutions in health care
system in Poland are needed…
A complete assessment of health technology comprises the following analyses:
1) Analysis of decision problem 2) Clinical effectiveness analysis
3) Economic analysis
4) Analysis of impact on health care system
Guidelines for conducting Health Technology Assessment (HTA)
Analysis of impact on health care system
covers ◦ the budget impact analysis and
◦ the assessment of organizational consequences for the heath care system, and possibly the assessment of possible ethical and social implications
Guidelines for conducting Health Technology Assessment (HTA) - BIA
◦ Lantus utilization after reimbursement decision
Future expenditures on Lantus after its reimbursement are calculated based on predicted use of Lantus given in international units (IU).
Share of estimated consumption of Lantus within basal insulin market was estimated on the basis of data from European countries where Lantus is reimbursed. ◦ Lantus utilization without reimbursement decision
Values for this forecast was obtained based on the dynamics of the consumption of Lantus in Poland (IMS Health data)
◦ Insulin dosage Calculator gives the opportunity to use input data on insulin dosage
from RCTs, observational studies or market research studies
EXAMPLE: DESCRIPTION OF THE MODEL* in diabetes for LAA
* HTA Consulting, 2010
EXAMPLE: DESCRIPTION OF THE MODEL* in diabetes
DAILY INSULIN DOSES (IU)
Insulin RCT Observational studies Market research study
Lantus 39 23,1 27,9
NPH 37 23,1 28,3
Premixed insulin 46,5 35 41,2
Proportions of use between Lantus and other insulin
Insulin RCT Observational studies Market research study
NPH 0,94 1,00 1,01
Premixed insulin 1,19 1,59 1,48
HTA Consulting, 2010
Utilization of insulin glycaemic test strips
Comparison of use of test strips in addition to insulin therapy indicates differences between patients on Lantus, NPH and premixes.
Compared to NPH/Premixes Lantus requires less strips. ◦ The difference is 20 less strips a month for new patients starting therapy and ◦ 13 strips a month for patients using insulin for before
Insulin prices
Perspective of the analysis: The analysis was conducted from public payer (NHF) and patient perspective.
Time horizon The analysis was conducted in 5 years perspective.
EXAMPLE: DESCRIPTION OF THE MODEL* in diabetes
HTA Consulting, 2010
Replacement (switching) of insulin (NPH and premixes) by Lantus
Based on the insulin utilization from European countries (analysis of the structure of insulin market relating to replacement of NPH and premixes after Lantus reimbursement)
User can choose: ◦ Selected country (choice between different European
countries can be made) ◦ European mean calculated as arithmetic mean◦ European mean calculated as mean weighted by
population size ◦ European mean calculated as mean weighted by insulin
utilization ◦ User prognosis – user can choose the degree of share
between NPH and Premixes which are replaced by Lantus Data on consumption of different types of insulin,
together with the characteristics that describe the dynamics of the consumption trends (for the sample country (Greece))
EXAMPLE: DESCRIPTION OF THE MODEL* in diabetes
HTA Consulting, 2010
Insulin utilization and trends used in the prognosis in Greece
2010 2011 2012 2013 2014-20,000,000
-15,000,000
-10,000,000
-5,000,000
0
5,000,000
10,000,000
15,000,000
20,000,000
Reimbursement by payer – scenario with OADs
LantusNPHMieszankiMetforminaGlimepirydPaski glikemiczne
YEAR
Refu
ndac
ja N
FZ [m
ln P
LN]
HTA Consulting, 2010
2010 2011 2012 2013 2014-200,000,000
-150,000,000
-100,000,000
-50,000,000
0
50,000,000
100,000,000
150,000,000
200,000,000
250,000,000
Insulins usage
Lantus NPH
Mix
Rok
Zuży
cie in
sulin
[mln
IU]
HTA Consulting, 2010
2010 2011 2012 2013 2014-25,000,000-20,000,000-15,000,000-10,000,000
-5,000,0000
5,000,00010,000,00015,000,00020,000,000
Reimbursement by payer – scenario without OADs
LantusNPHMieszankiMetforminaGlimepirydPaski glikemiczne
Rok
Refu
ndac
ja N
FZ [m
ln P
LN]
Analysis of impact on health care system
ECONOMIC
SOCIAL
NEGOTIATIONin
RSS
ORGANIZATION
ETHICS
New Changes to Reimbursement Law in Poland is planned soon … Individual decisions: changes to administrative procedures leading to full
implementation of EU Transparency Directive No 105. Decisions are to be taken in the individual form Drugs reimbursement lists will be often updated and published in form of internal MoH
order/ not as legal Act published in Official Journal. New bodies will be introduced: Transparency Council and Economic Committee which
will conduct negotiations with pharmaceutical companies Fixe margins and prices
Rebates will be forbidden as well as all kinds of commercial practices concerning decreasing of ex-factory official price.
Pharmacy margins will be accounted from reimbursement limit/ not from the price. Risk-sharing agreements
Arrangements between a payer and a pharmaceutical, device, or diagnostic manufacturer
Tax on pharma activities („Garattini tax”) 3% of reimbursed drugs sales paid by Pharmaceutical Companies to the state budget. This money are going to be spent on independent clinical trials and registers (CER)
Others: Limits will be based on the cheapest drug with 15% market share level in therapeutic
group. Constant cost-reevaluation under reference price system
In case of lack of head to head trials comparing directly an assessed and an alternative technology, it is recommended to conduct an indirect comparison.
Indirect comparisons can be performed and presented independently of direct comparisons. In the case of mixed comparisons involving both direct and indirect comparisons, the results of direct comparisons alone should be presented separately and independently from the results of the mixed comparison.
Guidelines for conducting Health Technology Assessment (HTA) in Poland – Relative Effectiveness
Health Technology Assessment
Evidence Based Medicine
EFFICACy
Does
it W
ork?
For w
hom
?
ComparativeCost
EFFECTIVENESS
Health Technology Assessment
Evidence Based Medicine
EFFICACy
Does
it W
ork?
For w
hom
?
Comparative
Cost
EFFECTIVENESS
The structure remain but the setting changes !
Comparative Effectiveness is the conduct and synthesis of research comparing the benefits and harms of different interventions in a „real world” settings. The purpose of this research is to improve health
outcomes by developing and disseminating evidence – based information to patients, clinicians and other decision makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances”
Additional taxes for financing CER
CER in Poland
How to provide the proper access for innovative
treatment to the patients in Poland?
CHANGES IN HEALTH CARE SYSTEM WHICH ALLOW TO GET BETTER ACCESS
WITHIN LIMITED RESOURCES
Let’s do together!