Sani Pogorilic_Dostupnost i primjena inovativnih lijekova u

DOSTUPNOST I PRIMJENA INOVATIVNIH LIJEKOVA
U BOLNIČKIM ZDRAVSTVENIM USTANOVAMA
iF! je skraćenica naziva udruge „Inovativna farmaceutska inicijativa” koja okuplja inovativne proizvođače lijekova prisutne na
hrvatskom tržištu. Predstavljamo glas 24 inovativne farmaceutske kompanije koje zapošljavaju 970 djelatnika i osiguravaju 56 %
lijekova u Hrvatskoj. Udruga je član EFPIA – europskog udruženja farmaceutskih kompanija sa sjedištem u Bruxelless-u.
Sani Pogorilić
iF!
Zdravstvena zaštita
• Pokazatelji kvalitete su ishodi liječenja
Pacijenti
Sustav
ISHODI
Resursi
Strategija
Kako su u EU regulirana prava bolesnika?
Active Citizenship Network's European Charter of Patients' Rights
•
• Right to preventive measures
Every individual has the right to a proper service in order to prevent
illness.
• Right of access
Every individual has the right of access to the health services that •
his or her health needs require. The health services must guarantee
equal access to everyone, without discriminating on the basis of
•
financial resources, place of residence, kind of illness or time of
access to services.
Right to respect of patients’ time
Each individual has the right to receive necessary treatment within a
swift and predetermined period of time. This right applies at each
phase of the treatment.
Right to the observance of quality standards
Each individual has the right of access to high quality health services
on the basis of the specification and observance of precise standards.
Right to safety
Each individual has the right to be free from harm caused by the poor
functioning of health services, medical malpractice and errors, and
the right of access to health services and treatments that meet high
safety standards.
• Right to information
Every individual has the right to access to all information
regarding his or her state of health, the health services • Right to innovation
and how to use them, and all that scientific research and
Each individual has the right of access to innovative
technological innovation make available.
procedures, including diagnostic procedures, according to
• Right to consent
international standards and independently of economic or
Every individual has the right of access to all information that might
financial considerations.
enable him or her to actively participate in the decisions regarding
his or her health; this information is a prerequisite for any
procedure and treatment, including the participation in scientific
research.
• Right to free choice
Each individual has the right to freely choose from among different
treatment procedures and providers on the basis of adequate
information.
• Right to privacy and confidentiality
Every individual has the right to the confidentiality of personal
information, including information regarding his or her state of
health and potential diagnostic or therapeutic procedures, as well
as the protection of his or her privacy during the performance of
diagnostic exams, specialist visits, and medical/surgical treatments
in general.
• Right to avoid unnecessary suffering and pain
Each individual has the right to avoid as much suffering and pain as
possible, in each phase of his or her illness.
• Right to personalized treatment
Each individual has the right to diagnostic or therapeutic programmes
tailored as much as possible to his or her personal needs.
• Right to complain
Each individual has the right to complain whenever he or she has
suffered a harm and the right to receive a response or other feedback.
• Right to compensation
Each individual has the right to receive sufficient compensation within
a reasonably short time whenever he or she has suffered physical or
moral and psychological harm caused by a health service treatment.
Republika Hrvatska smatra zdravlje važnim segmentom društvenog interesa:
- razina učešća za zdravstvo u državnom proračunu (18%)
- udio javnog financiranja zdravstvene potrošnje (85%)
95
90
Luxembourg
United Kingdom
85
Croatia
Denmark
Czech
Ireland
Sweden
Public Expenditure as % of Total Health Expenditure (2008,%)
80
Romania
Estonia
Italy
Malta
75
France
Germany
Finland
Hungary
70
Lithuania
Poland
Spain
Slovenia
Belgium
Austria
Netherlands
Portugal
65
Slovakia
60
Greece
Latvia
Bulgaria
55
50
Bubble size represents the total
pharmaceutical market size (2010, LC$) ~
38 million
Cyprus
45
0
0.0
10.0
10.5
11.0
11.5
12.0
12.5
13.0
Public Health Expenditure as % of Total Gov’t Expenditure
Source: WHO; IMS Market Prognosis
13.5
14.0
14.5
15.0
15.5
16.0
16.5
17.0
17.5
18.0
18.5
19.0
Porast ukupne potrošnje u zdravstvu je 8%,
dok udio lijekova u potrošnji od 2002. stagnira ili opada
4
24
CAGR (2003 – 2010)
• HZZO expenditure: 8.2%
• Drug expenditure (Rx+V-exp): 3.9%
23
22
+8.2%
20
18
18
HZZO expenditure (Kuna, Billions)
14
10
16
16
20%
19%
17%
19%
22
15%
13%
2%
2%
21
15%
14%
3%
2%
2%
28
26
20
18
16
21%
20%
82%
80%
6
80%
30
22
2%
12
10
32
24
1%
8
4
16%
17
16
12
21
81%
81%
83%
85%
83%
83%
81%
14
12
10
8
79%
6
4
2
2
0
0
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
% drug expenditure - prescription drugs + V-exp.
very expensive drugs (kuna)
prescrption drugs (kuna)
other expenditure (excl. prescription drugs or V-exp.)
Source: Table 1 of the annual reports from 2001 to 2012; HZZO website; IMS Management Consulting
CARPC Second Interim Meeting July 2013
resursi
Percent of total HZZO expenditure (%)
22
34
…kada se usporedimo s drugima…
Peer
Aspiration
Country
Life
expectancy
Cancer
Incidence
Physicians
(latest available)
(per 100000)
Hospital
Beds
(per 100000)
(per 100000)
In-patient
admissions
(per 100000)
Croatia
76
490
540
259
17
Austria
80
523
770
475
28
France
82
496
690
350
19
Netherlands
81
395
470
392
11
Czech
78
431
710
367
20
Hungary
75
536
710
310
21
Slovakia
76
495
650
300
19
Source: 2005-2012 WHO data, population (US Census Bureau), CIA World Factbook
CARPC Second Interim Meeting July 2013
Other
Peer
Aspiration
Republika Hrvatska izdvaja usporediv udio svog BDP-a za zdravstvo,
međutim potrošnja na lijekove po stanovniku u apsolutnom iznosu je mala
GDP
GDP/Capita
($)
Total Health Exp.
as % of GDP
Total Rx Pharma
Exp. Per capita
(LC €)
Country
Population
(million)
(billion $)
Croatia
4.4
84
18800
7.8
128
Austria
8.3
334
41300
10.1
332
France
62.1
2180
34000
11.1
395
Netherlands
16.4
696
41800
9.1
185
Czech
10.4
268
26200
6.8
169
Hungary
10.1
201
20100
7.4
183
Slovakia
5.4
122
22400
7.8
187
Germany
82.2
2998
36400
10.4
268
Sources: 2005-2008 WHO data, population (US Census Bureau),
CIA World Factbook
IMS Consulting Group
Cijene bolničkih lijekova i lijekova na recept niske su u
usporedbi s drugim zemljama
Hospital price evolution
vs. comparator countries
Price per SU (LC€, absolute)
Total Rx price evolution
vs. comparator countries
Retail price evolution vs.
comparator countries
0,6
2,5
0,6
0,5
2,0
0,5
0,4
0,4
1,5
0,3
0,3
1,0
0,2
0,2
0,1
0,5
0,1
0,0
0,0
0,0
2010 2007
2010 2007
2007
Croatia
Austria
Netherlands
Hungary
Croatia (A-M)
France
Czech
Slovakia
In all countries market defined as ‘total Rx excluding TAs not of interest’;
Croatia (A-M): Total Croatia Analysis Market (i.e. with non-HZZO covered products also excluded)
No retail/hospital split for the Netherlands
IMS Consulting Group
Source: IMS Consulting Analysis
2010
Razina cijena lijekova u Hrvatskoj je na 73% prosječne
razine cijena lijekova u EU zemljama
MK
PL
TR
LT
RO
SK
CZ
BG
HR
EL
HU
ES
LV
EE
SI
FR
UK
PT
SE
CY
LU
BE
MT
AT
NL
FI
IT
IE
NO
DK
DE
IS
CH
58
68
69
70
70
71
71
72
73
73
74
77
79
79
86
91
93
94
95
100
102
103
106
106
107
109
111
118
119
120
121
128
160
187
0
20
40
60
80
100
120
140
160
180
200
Source: Economy and Finance, Statistics in focus,
Pharmaceutical products – comparative price levels in 33 European countries in 2005; 45/2007
Potrošnja na lijekove u Hrvatskoj niža je u odnosu na
zemlje sličnog ekonomskog razvoja
Total RX value per capita across countries, 2010
0
Total RX volume per capita across countries, 2010
LCEuro (absolute) per capita
Standard Units (absolute) per capita
50 100 150 200 250 300 350 400
0
Croatia
100 200 300 400 500 600 700 800
Croatia
ASP.
PEER
+47%
+26%
Czech
Czech
Hungary
Hungary
Slovakia
+166%
Slovakia
Austria
Austria
France
France
Netherlands
Netherlands
In all countries market defined as ‘total Rx excluding TAs not of interest’;
• In 2010 Croatia spent approx. 50% less on Rx medicines per capita than peer countries and
approx. 3x less than aspirational countries
Source: IMS MIDAS, IMS Consulting Analysis, US Census Bureau
+20%
Kasni dostupnost inovativnih lijekova
u odnosu na uspoređivane zemlje EU Inovativni
lijekovi su u RH dostupni nakon dvije do šest
godina.
Launch Lag of Croatia 2010 Launches vs. Comparator Countries
2000
Average
Launch
Sequence
2005
2010
Sample
size
28
Originator
Launch
Sequence
25
Gx Launch
Sequence
Source: IMS Consulting Analysis
3
Zdravstvena administracija odgađanjem i onemogućivanjem dostupnosti novih,
inovativnih lijekova direktno utječe na zdravstvene ishode i očekivano trajanje
kvalitetnog života
Inovativni lijek donosi dodatnu vrijednost za bolesnika (bolji
zdravstveni ishodi, bolja kvaliteta života, jednostavnija primjena) i
društvo (uštede u cjelokupnom liječenju bolesti, inkrementni
terapijski napredak).
Lichtenberg FR. Contribution of pharmaceutical innovation to longevity growth in Germany
and France, 2001-7. Pharmacoeconomics. 2012 Mar;30(3):197-211. doi:
10.2165/11587150-000000000-00000.
Abstract
This paper investigates the contribution of pharmaceutical innovation to recent longevity
growth in Germany and France. The effect of the vintage of prescription drugs (and other
variables) on the life expectancy and age-adjusted mortality rates of residents of Germany
is examined, using longitudinal, annual, state-level data during the period 2001-7. The
estimates imply that about one-third of the 1.4-year increase in German life expectancy
during the period 2001-7 was due to the replacement of older drugs by newer drugs. The
effect of the vintage of chemotherapy treatments on age-adjusted cancer mortality rates
of residents of France is also investigated, using longitudinal, annual, cancer-site-level data
during the period 2002-6. The estimates imply that chemotherapy innovation accounted
for at least one-sixth of the decline in French cancer mortality rates, and may have
accounted for as much as half of the decline.
Identificirano je pet područja strateških problema u
hrvatskom zdravstvu (Strategija zdravstva 2012-2020)
12
1) Slaba povezanost i manjkav kontinuitet u zdravstvu
2) Neujednačena ili nepoznata kvaliteta zdravstvene zaštite
3) Nedovoljna učinkovitost i djelotvornost u zdravstvenom sustavu
Izdatci za lijekove su neproporcionalno visoki i često neopravdani, među
ostalim jer ne postoji funkcionalni proces procjene zdravstvenih
tehnologija niti dovoljan broj kvalitetnih kliničkih smjernica.
4) Slaba ili neujednačena dostupnost zdravstvene zaštite
5) Razmjerno slabi pokazatelji zdravlja
ZAKLJUČAK
•
•
Inovacija kasni do 6 godina, odnosno još i dodatno više ako uzmemo u obzir i period
dostupnosti inovativnog lijeka pacijentima kroz klinička ispitivanja. Na primjeru 3
onkološka lijeka izračunali smo da je kašnjenje dovelo do 648 izgubljenih mjeseci
(preživljenje bez progresije bolesti) ljudskih života u RH.
Primjena inovativnih lijekova nije sustavno integrirana i ne temelji se na
internacionalno prihvaćenim kliničkim smjernicama. Administrativno uvedene HZZO
smjernice predstavljaju ponekad nepremostive prepreke. Posljedično, ishodi takve
vrste liječenja ne dostižu ciljne vrijednosti, a resursi se ipak troše.
Na kraju…
• lijekovi
– Nisu generatori rasta troškova u zdravstvu
– Niska je potrošnja lijekova
– Inovativni lijekovi značajno kasne u dostupnosti , a
imaju značajan utjecaj na ishode
• omogućiti liječenje u bolnicama u skladu s
algoritmima liječenja koje donose stručna
društva, prema “medicini temeljenoj na
dokazima”
14
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www.ifi.hr
ORGANIZATOR:
PARTNERI KONFERENCIJE:
ZLATNI SPONZORI:
Case study
Oncology
Croatia has seen an increase in sales value of oncologics since 2010
Total Croatia RX Market Breakdown By Analysis Category
35
34
2%
Value (€ Millions)
30
32
1%
37
2%
38
1%
25
20
15
98%
99%
98%
99%
10
5
0
2009
2010
2011
Value (€ Millions)
40
Croatia ‘Analysis Market’ Breakdown by Retail/Hospital
Sales
50
45
40
35
30
25
20
15
10
5
0
2012
Plus HZZO ’Not covered’
’Analysis Market’
• There has been a decrease in the retail share of oncologic sales since 2010
• The defined ‘analysis market’ still accounts for the vast majority of Rx sales
Source: IMS MIDAS Pharmaceutical sales valued at ex-mnf price before rebates and discounts, IMS Consulting Analysis
+4%
3%
2%
97%
98%
2009
2010
Retail
Hospital
1%
1%
99%
99%
2011
2012
Case study
Oncology
Croatia’s use of oncology products remains the lowest in terms of
value sales per capita
Evolution of TA sales and volume per capita vs. comparator countries
35
30
Volume (SU) per capita
Value (LC€) per capita
25
20
15
10
5
0
2009
2010
2011
0,50
0,45
0,40
0,35
0,30
0,25
0,20
0,15
0,10
0,05
0,00
2012
2009
Croatia
France
Czech
Austria
Netherlands
Hungary
In all countries market defined as ‘total Rx excluding TAs not of interest’
Source: IMS MIDAS Pharmaceutical sales valued at ex-mnf price before rebates and discounts, IMS Consulting Analysis
2010
Slovakia
2011
2012
Case study
Oncology
Croatia remains the country with the lowest oncologic sales as %GDP
despite the small recent increase
Evolution of TA value as % GDP vs. comparator countries
0,10%
0,09%
Value sales (LC€) as % GDP
0,08%
0,07%
0,06%
0,05%
0,04%
0,03%
0,02%
0,01%
0,00%
2009
2010
2011
In all countries market defined as ‘total Rx excluding TAs not of interest’;
Croatia (A-M): Total Croatia Analysis Market (i.e. with non-HZZO covered products also excluded)
Croatia
France
Czech
Austria
Netherlands
Hungary
Source: IMS MIDAS Pharmaceutical sales valued at ex-mnf price before rebates and discounts, IMS Consulting Analysis
Slovakia
2012
Case study
Oncology
Prices of targeted oncologics continue to remain the lowest in Croatia
vs. comparator countries
Total TA price evolution vs. comparator countries
Price per SU (LC€, absolute)
150
100
50
0
2009
Price analysis does not
adjust for product mix
2010
2011
Croatia
France
Czech
Austria
Netherlands
Hungary
2012
Slovakia
Total Rx market defined as: ‘total Rx excluding TAs not of interest’
• Croatia has the lowest average prices compared to other countries, with the gap slowly widening
Source: IMS MIDAS Pharmaceutical sales valued at ex-mnf price before rebates and discounts, IMS Consulting Analysis
Case study
Oncology
Oncologics are increasingly listed on the VE drug list, now accounting for
over 50% of the value and 25% of volume
TA – Evolution of reimbursement list sales and volume
70
60
59
57
60
1.6
52
30
0%
47%
50%
0%
10
0
0%
0%
20
47%
46%
49%
52%
54%
Volume (SU) Millions
Value (LC€) Millions
40
2
2
2
2
66%
67%
65%
65%
0%
17%
0%
19%
0%
0%
24%
25%
17%
15%
11%
10%
2009
2010
2011
2012
1.4
50
52%
0%
1.8
+2%
1.2
1.0
0.8
0.6
0.4
0.2
1%
1%
1%
1%
2009
2010
2011
2012
List A
List B
0.0
Very Expensive
Not covered
NB: Both lists A and B have been backtracked from the latest 2013 reimbursement list. Certain products exist on different lists with different indications; this
analysis has not split out sales by indication, hence these products are double counted in the total of all lists; Figures shown do not include “TAs excluded”
Source: IMS MIDAS Pharmaceutical sales valued at ex-mnf price before rebates and discounts , IMS Consulting Analysis
Case study
Oncology
Croatia’s use of generics in this TA remains the highest in both value
and volume among comparators
TA - Evolution of generic sales and volume per capita vs. comparator countries
0,08
0,20
0,07
0,15
Volume (SU) per capita
Value (LC€) per capita
0,06
0,05
0,04
0,03
0,02
0,01
0,00
2009
0,10
0,05
0,00
2010
2011
2012
2009
Croatia
France
Czech
Austria
Netherlands
Hungary
In all countries market defined as ‘total Rx excluding TAs not of interest’;
Nb - 2007 and 2008 sales in Netherlands are all unclassified
Source: IMS MIDAS Pharmaceutical sales valued at ex-mnf price before rebates and discounts, IMS Consulting Analysis
2010
Slovakia
2011
2012
Case study
Oncology
Croatia still has the lowest use of originator products in this TA
compared to other countries
TA - Evolution of originator sales and volume per capita vs. comparator countries
35
30
Volume (SU) per capita
Value (LC€) per capita
25
20
15
10
5
0
2009
2010
2011
0,50
0,45
0,40
0,35
0,30
0,25
0,20
0,15
0,10
0,05
0,00
2012
2009
Croatia
France
Czech
Austria
Netherlands
Hungary
In all countries market defined as ‘total Rx excluding TAs not of interest’
Source: IMS MIDAS Pharmaceutical sales valued at ex-mnf price before rebates and discounts, IMS Consulting Analysis
2010
Slovakia
2011
2012
Three oncology products with significant delay in market access
could have contributed to 648 months of progression free
survival for patients during the launch lag period
Projected sales volume during launch lag
Croatia launch
1.500
1.000
500
Projected
volume during
1.4 year launch
lag* = 6750 units
(47 patients**)
Sales Volume (SUs)
800
700
600
500
400
300
Actual sales
200
Projected sales
0
2009
Average per capita sales volume
900
Gains
reimbursement in
Slovakia
100
2010
2011
2012
2013
0
0
Total patient PFS during 1.4 year launch lag =
215 months
1
2
Years post launch
Avg aspirational
Avg peer
3
4
Peer
Aspiration
Očekivana životna dob u Hrvatskoj
je ispod prosjeka EU 27
2005-2008 WHO data, population (US Census Bureau),
CIA World Factbook
Country
Life
expectancy
Croatia
76
Austria
80
France
81
Netherlands
80
Czech
77
Hungary
74
Slovakia
75
EUROSTAT, 2010.
Croatia (average)
Norht West region
Central East region
Adriatic region
Life expectancy at birth (y)
M
73,5
73,3
71,8
75,3
F
79,9
80,0
78,6
81,2
Life expectancy at age 65 (y)
M
14,6
14,6
13,4
15,7
F
18,2
18,3
16,9
19,3

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