assessing the benefit of medicine in italy
Post on 12-Mar-2022
3 Views
Preview:
TRANSCRIPT
International Public Affairs and Policy
2
Innovative medicines are having a significant impact on
public health in Italy
Life expectancy
in Italy is
increasing…
… and innovative
medicines have
contributed
significantly to
this increase
However, there
remains scope
for further
improvement in
public health
Continued
innovation will
bring further
benefit to
patients
Cardiovascular disease
Diabetes
Cancer
Infectious disease
Rheumatoid arthritis
Orphan disease
Schizophrenia
However, further emphasis on innovation in Italy is needed – the proportion
of GDP spent on R&D is much lower than the European average
May 2010
Modena (2001)
International Public Affairs and Policy
3
Life expectancy in Italy is increasing
May 2010
World Bank (2010), Istat (2009)
40
45
50
55
60
65
70
75
80
85
1960
1963
1966
1969
1972
1975
1978
1981
1984
1987
1990
1993
1996
1999
2002
2005
Year
Lif
e e
xp
ec
tan
cy
Life expectancy at birth
crossed the threshold of 80
years for the population as a
whole in 2000
It is estimated that a male
born in 2008 can expect to live
79 years, and a female can
expect to live 84 years.
12 years
Countr
y-level data
International Public Affairs and Policy
4
Innovative medicines have contributed to this increase in life
expectancy
40-59% of the total increase in life expectancy across 52 countries including Italy is
attributable to innovative medicine launches. Life expectancy is continuing to increase as a
result of progress in the treatment and prevention of cardiovascular disease and cancer
Lichtenberg (2005)
0.23
0.37
0.57
0.76
0.941.07
1.21
1.37
1.531.65
1.82
1.96
0.70
0.12
0.30
0.600.7
0.06
0.21
0.380.45
0.510.56
0.62 0.660.74 0.79
0
0.25
0.5
0.75
1
1.25
1.5
1.75
2
2.25
1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000
Inc
rea
se
in
lif
e e
xp
ec
tan
cy
, y
ea
rs Total increase
Increase due to new medicines
40-59% of the
increase in
life
expectancy is
due to
innovative
medicine
May 2010G
lobal-le
vel data
International Public Affairs and Policy
5
However, there remains scope for further improvement in public
health
Istat (2009)
May 2010
Even though death rates for
most categories are falling,
mortality rates due to disease
are still high. The leading
cause of death in Italy in
2009 was cardiovascular
disease (39% of all deaths),
followed by cancer (30% of
all deaths)
Unlike other disease specific
death rates, death due to
cancer has increased over
the last 30 years
13
39
61
286
373
16
58
77
190
446
0 100 200 300 400 500
Infectious and
parasitic diseases
Diseases of the
digestive system
Diseases of the
resporatory
system
Neoplasms
Cardiovascular
disease
Death rate (deaths per 100 000 persons
2006 1971
Countr
y-level data
International Public Affairs and Policy
6
Through the continued process of innovation, further benefits can
be brought to patients
• In 2008, Italy invested approximately
1% GDP in R&D activities, which is
half of the European average of 2%
and almost 4 times less then the
European leader Sweden
• The Italian pharmaceutical industry
was ranked 5th globally for sales in
1999. However, this high level of
production and distribution is not
matched by research activities
• Therefore, investment in innovation
and R&D should be an important focus
for Italy in the future in order to
improve the countries contribution to
the industry and ultimately the
contribution to reducing disease-
related morbidity and mortality
WHO (2006), Modena (2001), Eurostat (2010)
May 2010C
ountr
y-level data
International Public Affairs and Policy
7
Cardiovascular disease
CHAPTER 1: Innovation is significantly benefiting patients with…
International Public Affairs and Policy
8
Pharmaceutical innovation has reduced cardiovascular-related
mortality
Prevention of
cardiovascular
disease
Treatment of
cardiovascular
disease
Increased
survival
Reduction in risk
factors
Pharmaceutical
innovation
Prevention and
treatment of
associated
problems
Innovative therapies are
recognised as being a
major contributor to the
observed increase in
survival and reduction in
risk factors
However, cardiovascular disease remains the leading cause of death in
Italy and there remains a significant need for innovation in the treatment of
this problem
May 2010
International Public Affairs and Policy
9
Pharmaceutical innovation has resulted in significant progress in both
the prevention and the treatment of cardiovascular disease and its
associated problems 1910-1940’s
1919 Organic
mercury causes
diuresis and is
beneficial in oedema
associated with heart
failure
1949 Sulfa drug used to
treat oedema due to
heart failure. However,
long term toxicity a
problem
Identification of
Chlorthiazide –
improved reduction of
oedema and high blood
pressure with a safer
profile
1950’s
1950
Acetazolamide
identified – 300
times more potent.
1970’s 1960’s 1980’s 1990’s 2000 and
beyond
Early 1960s
Loop diuretics
discovered (new
mechanism of
action) followed
shortly by the
potassium
sparing diuretics
Spironolactone
and Amiloride
1913 Adrenaline
found to be able to
relax and constrict
vessels – alpha and
beta receptors
identified
1958 First Beta-
blocker identified,
but initial compound
has low potency
Propanalol
identified soon after
– revolutionary as
it offers for the
first time
preventative
therapy for
asymptomatic
patients
1980s Angiotensin
converting enzymes
investigated for heart
disease. ACE
inhibitors used to
control high blood
pressure – the active
compound Captopril
discovered with
further developments
with pro-drugs such
as Quinapril
As a result further
research leads to the
discovery of the
angiotensin II receptor
with medicines
developed to block it
such as Losartan
ABPI (2004), OsMed (2009)
1950’s-60’s Medicines to treat high cholesterol first
identified but there were many unwanted side effects
1971 Start of
research into
Statin therapy by
inhibiting the
enzyme associated
with synthesis of
cholesterol
Mevastatin
identified followed
by the isolation of
the more effective
inhibitor
Lovastatin
Today – Six
statins are
available in Italy:
Atorvastatin,
Fluvastatin,
Lovastatin,
Pravastatin,
Rosuvastatin
and Simvastatin.
“The fundamental mechanisms of disease are being explored for future novel
innovative treatments to offer further patient benefits”
STATINSBETA-BLOCKERS, ACE INHIBITORS,
ANGIOTENSIN II ANTAGONISTSDIURETICS
May 2010G
lobal-
and C
ountr
y-leve
l data
International Public Affairs and Policy
10
Cancer
CHAPTER 3: Innovation is significantly benefiting patients with…
International Public Affairs and Policy
11
Pharmaceutical innovation has increased the likelihood of survival for
patients with cancer
Incremental
innovation
Increased
survival
Pharmaceutical
innovation
Mortality is
decreasing across a
range of cancers
despite the
increasing incidence
of disease
However, cancer remains one of the leading causes of death in Italy and
survival is varied across different cancer sites; there remains a significant
need for innovation in the treatment of this disease
Tyrosine kinase inhibitors
Monoclonal antibodies
Taxoids
Aromatase inhibitors
Novel therapies
New therapeutic
targets
e.g. colorectal cancer
e.g. prevention of cell
division
May 2010
The earlier detection
and diagnosis of
cancer has also
contributed to
increased survival in
patients with cancer
International Public Affairs and Policy
12
Cancer mortality in Italy has stabilised despite a 25% increase in the
incidence of cancer
Capocaccia (2007), Istat (2009)
May 2010
0
100
200
300
400
500
600
700
1970 1975 1980 1985 1990 1995 2000 2005Year
ca
se
s/d
ea
ths
pe
r 1
00
00
0 p
op
ula
tio
n
Incidence (male) Incidence (female) Cancer mortality
• Over the past 30
years, the mortality
rates for all malignant
neoplasms have
increased by 50%
• However, over the last
decade mortality rates
have been constant
despite rising
incidence rates
27% increase in
incidence of cancer
in males
23% increase in
incidence of cancer
in females
Constant mortality rates
Countr
y-level data
International Public Affairs and Policy
13
And increasing survival rates can be seen across a wide range of
cancers in Italy
EUROCARE (2009)
May 2010
5 7 18 20 26 32 38 40 41 42 4562 64
82
10 12 19 3044 43 54 53
7958 63 70 77 89
020406080
100
OesophagusLung
Brain
Stom
ach
Leukaemia
Multiple m
yeloma
NHL
Rectum
Prosta
teColon
Kidney
Larynx
Bladder
Testis
Ag
e s
tan
dard
ised
5 y
ear
su
rviv
al, %
1983-1985
1995-1999
MA
LE
SF
EM
AL
ES
9 1223 24 26 26
39 40 41 44 4557 64 68 72
16
4435
6556 59
76
2015
584436
8378
65
0
2040
6080
100
OesophagusLung
Brain
Leukaemia
StomachOvary
Multiple m
yeloma
Kidney
RectumColon
NHL
Cervix
Bladder
Corpus uteri
Breast
Ag
e s
tan
dard
ised
5 y
ear
su
rviv
al, %
Countr
y-level data
International Public Affairs and Policy
14
Infectious Disease
CHAPTER 4: Innovation is significantly benefiting patients with…
International Public Affairs and Policy
15
However, severe infectious disease remains a significant problem,
requiring innovation in both the development of effective
treatments and preventative vaccines
Pharmaceutical innovation has enhanced the prevention
and treatment of infectious disease
Prevention of
infection through
vaccination
Treatment of
infection
Reduction or
elimination of
previously
common
infections
Pharmaceutical
innovation Enhanced
survival
e.g. polio
e.g. invasive aspergillosis
Enhanced
patient
outcomes
e.g. hepatitis B
Reversal of viral
infection
damage
e.g. hepatitis C
May 2010
International Public Affairs and Policy
16 Adapted from NHS (2008)
Pharmaceutical innovation has enabled the development of
many vaccines
May 2010
1700 1800 1900 1910 1920 1930 1940 1950 1960 1970 1980 1990 2000
1796
Development of the
first smallpox vaccine
1870
First live
attenuated
bacterial vaccine
1885
First live attenuated viral
vaccine
1896
Typhoid
1900s
Cholera
1950
Pertussis
BCG
1956
Inactivated
polio
1960
Influenza
1961
Tetanus
1962
Live oral polio
1942
Diphtheria
1970
Rubella
Meningococcal
A&C
polysaccharide
1976
Measles
1982
Hepatitis B
1988
MMR
1992
Hib conjugate
Hepatitis A
1999
Meningococcal
C conjugate
2001
Pneumonococcal
conjugate
2006
Combined
Hib/MenC
2008
Human
papillomavirusGlo
bal-le
vel data
International Public Affairs and Policy
17
And vaccination has reduced the incidence of many previously
common infectious diseases
Measles
Pertussis
(Whooping cough)
Salmaso (2001), Istat (1999,2001, 2002, 2005), Sorvelianza Pediatri Sentinella (2010), Rota (2005), WHO (2010), Manfredi (2005), MdS (2008)
May 2010
0
50
100
150
200
1960
1963
1966
1969
1972
1975
1978
1981
1984
1987
1990
1993
1996
1999
2002
2005
2008
Year
Incid
en
ce (
cases p
er
100,0
00 p
op
ula
tio
n)
0
20
40
60
80
100
Vaccin
e c
overa
ge (
%)
Incidence Vaccine coverage
0
10
20
30
40
50
60
1955
1958
1961
1964
1967
1970
1973
1976
1979
1982
1985
1988
1991
1994
1997
2000
2003
2006
Year
Incid
en
ce (
cases p
er
100,0
00 p
op
ula
tio
n)
0
20
40
60
80
100
Vaccin
e c
overa
ge (
%)
Incidence Vaccine coverage
Vaccine introduced in 1976
Vaccine introduced in 1960’s
“Although childhood
vaccination coverage has
increased in recent years,
reaching the national average
of 88% in 2006, it is still below
the target of 95%, and
outbreaks continue to occur.”
“Since the introduction of the
pertussis vaccine in 1962, epidemic
peaks have regularly occurred every
3–4 years… [with] decreasing
incidence and decreasing peak
height… Since 1998 no further
epidemics have been observed
although a slight increase in
incidence was reported in 2002.”
Countr
y-level data
International Public Affairs and Policy
18
But prevention through vaccination is still needed for many
serious infections
Meningitis
• Around 900 people in Italy are affected by bacterial Meningitis each year,
associated with a 14% mortality rate
• In survivors, one in seven people will be left with a permanent disability
• In the past 20 years vaccines have been developed against Haemophilus
influenzae type B (Hib) (1992), Meningitis C (1999), and Pneumococcal Meningitis
(2006), but there is no vaccine for Meningitis B – the strain accounting for
66% of all cases in Italy
HIV/AIDs
• Around 150 000 people in Italy are estimated to be living
with HIV, up from 140 000 in 2001
• The annual number of deaths due to HIV has fallen
dramatically since the introduction of HAART in 1996
• In September 2009 the discovery of a breakthrough
new vaccine was reported which may reduce the risk
of HIV by a third, however, no cure or vaccine is
currently available to treat HIV/AIDS
Istituto Superiore di Sanità (2007), WHO (2008), EU-IBIS Network (2007)
May 2010C
ountr
y-level data
International Public Affairs and Policy
19
Orphan Diseases
CHAPTER 6: Innovation is significantly benefiting patients with…
International Public Affairs and Policy
20
Pharmaceutical innovation has led to significant benefits
for patients with rare diseases
Challenges in
treating rare
diseases has led
to substantial
unmet need
Improved control
of symptoms
Pharmaceutical
innovation
New therapeutic
options
However, there remains a significant unmet need for innovation in the
development of therapies for orphan diseases with limited therapy options
in order to improve symptom control and survival
May 2010
Significant
number of
patients with rare
diseases
The development of
innovative
treatments for
orphan diseases is
increasing
The number of
diseases given
orphan status is
increasing
Limited therapeutic
options or no
treatments available Enhanced
survival
International Public Affairs and Policy
21
The number of diseases given orphan status is expanding, but
the number of treatments available is also increasing
May 2010
• The definition of an orphan or
rare disease in Europe is a
disease that affects 5 in
10 000 people
• Rare diseases are often
severe, chronic, progressive,
and life-threatening
• The number of rare diseases
around the world with no
treatment currently available
is estimated to be between
4000 to 5000 and still
increasing
• 27 to 36 million people are
estimated to be affected by
rare diseases in the EU
37
12
1822
30
43
49
55
0
10
20
30
40
50
60
2001 2002 2003 2004 2005 2006 2007 2008 2009
Year
To
tal o
rph
an
dru
gs
re
ce
ivin
g
ma
rke
t a
uth
ori
sa
tio
n
Orphanet (2009), EMEA (2007), EURORDIS (2005)
The development of innovative orphan drugs
to treat rare diseases has increased, offering
patients new options or treatments that were
previously unavailable
EU
-le
vel data
International Public Affairs and Policy
22
With regional strategies in place to prioritise the diagnosis
and treatment of rare disease in Italy• Rare diseases have been a priority topic in Italy since
1998
• Since 2001, rare diseases have been a priority in all
Italian National Health Plans (2003-2005, 2006-2008)
• Although there is not a single overarching national
plan, there are a series of regional plans designed to
emphasise the diagnosis and treatment of rare
diseases
• A national registry of rare diseases has been
established and there is a national research
programme
• Italy is one of only four countries (Denmark, France,
Sweden) that has dedicated centres of expertise for
rare diseases
• 36 of the 46 authorized orphan drugs are now
available for patients in Italy:
“Funding research programmes will lead to
discovery of new drugs”
May 2010
Taruscio (2008), EUROPLAN (2008), ECRD (2007)
The Ministry of Health published a
decree in 2001 that aimed at
improving the prevention,
diagnosis, and treatment of rare
diseases
The Italian National Centre for Rare
Diseases (Istituto Superiore di
Sanità) is the leading organization
in EUROPLAN, an EU-wide
initiative to develop national
strategic plans for rare diseases
Orphan drugs are a research
priority for the Italian National
Medicines Agency (AIFA), with 20
independent research proposals
funded in 2005, and 24 funded in
2006
Countr
y-level data
International Public Affairs and Policy
23
Pharmaceutical innovation provides many patient benefits
and are having a significant impact on public health in Italy
Pharmaceutical
innovation
Prevention of illness
Inhibition and reversal of
disease-related damage
Reduced disease
progression and
disease-related events
Increased survival
Improved public
health and
increased life
expectancy
Social benefits and
improved quality of life
Reduced adverse events
Increased therapeutic
options
Continued pharmaceutical innovation is vital for the continued
improvement of public health
May 2010
top related