Upload
others
View
6
Download
0
Embed Size (px)
Citation preview
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
© 2020. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries.
EFPIA Patients W.A.I.T. Indicator 2019 Survey May 2020
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
2
In this study the term ‘availability’ is used throughout. The definition of ‘availability’ is as follows and should be considered when interpreting the data:
ACCESSIBILITY ON THE PUBLIC REIMBURSEMENT LIST IN A COUNTRY
This definition allows a standardised measure to compare across countries. Where appropriate it takes into consideration things like managed entry agreements, line-of-therapy or formulary restrictions. However, it does not have a correlation to the use / uptake of the medicines. Country-specific nuances should be discussed with the local associations or EFPIA directly to ensure correct interpretation of the data.
3
• “Patients W.A.I.T.” stands for Patients Waiting to Access Innovative Therapies. The INDICATOR provides a benchmark of the rate of availability and waiting times in European countries.
• The Patients W.A.I.T. Indicator shows, for new medicines (i.e. medicines including a substance that has not been previously available in Europe) within a (rolling) 4 year cohort:
1. The rate of availability, measured by the number of medicines available to patients in European countries. For most countries this is the point at which the product gains access to the reimbursement list
2. The average time between marketing authorisation and patient access, measured by the number of days elapsing from the date of EU marketing authorisation (or Swissmedic approval in the case of Switzerland) to the day of completion of post-marketing authorisation administrative processes
• Source of information: EFPIA member associations, who either refer to information available from official sources or gather this information directly from member companies.
• Some country associations did not submit full datasets. Countries with substantially limited datasets were Bosnia (16% complete), Macedonia (26% complete), Serbia (40% complete). This is noted on each slide with an asterisk (*).
Introduction (1)
4
• The Patients W.A.I.T. Indicator gives a snapshot of the 2 parameters at a cut-off date (1st January 2020) – data from medicines cohorts dropping out of the reference period are not included.
• Waiting times reflected in the Patients W.A.I.T. Indicator includes time to access, whether attributable to companies or to competent authorities.
• Rate of availability in a country does not necessarily indicate medicine uptake. Some medicines may be available in a market with no uptake (sales or volume).
• The Patients W.A.I.T. Indicator is not a measurement of the delays as defined in the “Transparency” Directive (directive 89/105/EEC). Delays under the “Transparency” Directive reflect the number of days that national competent authorities need to make their decisions regarding price and inclusion of medicines in the positive list, where applicable. These delays do not include the time needed to prepare submissions under relevant national regulations, which may also include clock-stops for supply of additional information during the process; neither do “Transparency” Directive delays include time required to complete other formalities before a new medicine can be made available in a given country.
Introduction (2)
5
Method for product selection
1397 310 213 172
EMA list • Products with EMA authorisation year:
2014, 2015, 2016, 2017, 2018 • Status: Authorised, Withdrawn, Suspended • Non-generic; Non-biosimilar • Include combinations (both products can
have already been approved before) • Remove ATC K, V & T*
• Medicines in the 4-year rolling cohort 2015 - 2018
• List of all historic Marketing Authorisations for human and veterinary medicines (European Public Assessment Reports) accessed November 2019
• Human medicines only
• Remove products with an active substance approved pre-2014
• New combination products (those containing already approved active substances are included)
• New formulations were excluded • New indications of already approved
active substances, leading to a separate marketing authorisation only for an orphan drug are included
• For molecules with multiple names from the same company only one molecule is included
Products in scope Survey cohort (5-years) Report cohort (4-years)
6
• 172 products approved by EMA between 1st January 2015 to 31st December 2018
• The 2019 study provides an analysis of products approved between 2015-2016-2017-2018, for the following datasets: a) All 172 products: 45 in 2015, 35 in 2016, 38 in 2017, 54 in 2018 b) 43 Oncology products: 10 in 2015, 10 in 2016, 11 in 2017, 12 in 2018 c) 54 Orphan products: 12 in 2015, 9 in 2016, 12 in 2017, 21 in 2018 d) 39 Non-oncologic orphan products: 9 in 2015, 7 in 2016, 7 in 2017, 16, in 2018 e) 34 Combination products: 10 in 2015, 8 in 2016, 6 in 2017, 10 in 2018
• Definitions: - Orphan status from EMA (September 2019) - Oncology products flagged using IQVIA MIDAS Oncology market definition* - Combination products include any product with more than one molecule, including branded/generic combinations
• The date of availability cut off point was 1st January 2020 (to account for Estonia, Iceland, Czech Republic, Latvia, Slovakia which had a few products with a reimbursement decision on 1st January 2020).
• 34 countries included in the study (including split of UK into England and Scotland).
Study scope
7
• The aim of the W.A.I.T. indicator is to measure the differences in time to reimbursement across European countries
• A medicine is available on the market if patients can receive the medicine under a reimbursement scheme
• The availability date is the first date when doctors can prescribe / hospitals can administer the medicine to patients in the country, who will be able to benefit from reimbursement conditions applicable in the country (i.e. administrative procedures to be included in the positive reimbursement list have been completed, where applicable)
• IQVIA have defined a set of “rules” to determine market availability:
Definition of Availability
Reimbursement status of medicine Is the medicine available?
Reimbursed through the 'normal' reimbursement system Available
Automatically reimbursed or financed by a different budget (e.g. hospital) or managed entry Available
Reimbursed on an individual basis, and/or to a subpopulation*, and/or in some cases whilst reimbursement is pending Available (LA*)
Available only within the private market at the patients expense Only privately available
Not reimbursed, or pending reimbursement (excluding availability at the patients expense) Not available
In cases where a product has been categorised as “not available”, their dates will not be included in the delay analysis; *In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average. LA*: product available for limited availability
8
• IQVIA has differentiated between products which are reimbursed through the regular process in a country, and products with “limited availability” (LA)
• Products with LA have special reimbursement conditions, where reimbursement is only granted for certain patients, indications, or only through special programs (e.g. early access schemes)
• Restricted or optimised recommendations may be due to either the company or HTA body
• Products which have been reimbursed with the following criteria are marked as “Available”, however have been flagged in the “Rate of Availability %” charts:
Definition of products with limited availability
Reimbursement conditions for medicine
Restricted patient cohort (specific populations)
Individual reimbursement (case by case / named patient program)
Special programs (e.g. early access scheme)*
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
9
. For countries where this differs, the definition of Availability is below:
• Austria: A medicine is available if it is included in the reimbursement system (EKO) or available through the Austrian pharmacies list.
• Belgium: Medicine is available if it is listed on the official website of INAMI-RIZIV as a definitive reimbursement or as a temporary reimbursement (code T) under a Managed Entry Agreement.
• Czech Republic: A medicine is available if it is on the reimbursement list, or funded through the hospital
• England: Medicines are deemed available if NICE has issued a positive recommendation. For the remaining medicines, IQVIA sales data are analysed to determine if routinely available.
• Estonia: A pharmacy product is available if it is reimbursed (pharmacy products) or added to the hospital service list.
• Finland: A pharmacy product is available if it is reimbursed (pharmacy products). Hospital products become available straight away.
• Germany: Following marketing authorisation, prescription drugs automatically receive reimbursed status. These products are classified as available.
• Hungary: Medicines are either reimbursed through the 'normal' reimbursement system, are available through a Name Patient Program or are available but financed by the hospital budget.
• Lithuania: A medicine is available if it is on the Lithuanian market (the State Medicines Control Agency has data on the sales volume of this medicinal product)
• North Macedonia (referred to as Macedonia in the slides): The medicine is included on the positive drug list or reimbursement list. No new medicines have been included on the reimbursement list for the past 10 years.
• Norway: The medicine has received a positive reimbursement decision by NoMA (out-patient drugs), or the Decision Forum for New Technologies has recommended the introduction of the new drug into hospitals (hospital drugs).
• Scotland: Medicines are deemed available if SMC has issued a positive recommendation. For the remaining medicines, IQVIA sales data are analysed to determine if routinely available.
• Slovakia: Primary data source used is National Health Information Center, but where not available, consumption data recorded through IQVIA is used
• Slovenia: A medicine is available if it is reimbursed through the regular system, or automatically reimbursed (e.g. all medicines for TBC)
• Sweden: A medicine is classified as available if it is currently marketed in Sweden (listed supplied FASS), and has received either: (a) a positive TLV reimbursement decision (non hospital drug), (b) a positive NT recommendation (hospital drug), (c) lacks an NT recommendation but is assessed to have a relevant level of sales based on rough estimation number patients treated in relation to the size of the patient population (hospital drug), or (d) is indicated in the treatment of a communicable disease (i.e. reimbursement decision/NT recommendation not requirement).
• Switzerland: The medicine gained market approval by Swissmedic. Delay calculated using local market authorisation dates.
• Turkey: A medicine is available if it gains access to the reimbursement list.
For most countries a product is available if it gains access to the national reimbursement list Definition of Availability
10
For most countries a product has limited availability if a restriction is placed upon the SmPC Definition of Limited availability (LA)
For countries with specific considerations, the definition of Limited availability is below: • Austria: Products only reimbursed on an individual basis
• Croatia: Products are available for specific patient cohorts (reimbursement guidelines outline specific criteria describing patient eligibility for treatment).
• Czech Republic: Only reimbursed for limited indications (compared to what was approved at market authorisation)
• Denmark: Products which don’t automatically receive public reimbursement, however, the patient can obtain an individual reimbursement if the doctors apply on their behalf.
• England: Recommended for a restricted patient cohort relative to licensed indication, either through an optimised NICE decision (including optimised CDF decisions) or an individual funding request • Estonia: Only reimbursed for restricted patient cohort.
• France: Some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations
• Greece: Only reimbursed for restricted patient cohort, or by case by case reimbursement if the responsible committee judges its use necessary.
• Hungary: Medicine is pending reimbursement decision or has not been reimbursed, but is available through a Name Patient Program.
• Iceland: Products are available to the patients with full reimbursement, but only through individual reimbursement, which can be applied for on individual basis by the patient’s doctor. • Ireland: Only reimbursed for restricted patient cohort
• Latvia: Only available through individual reimbursement
• Lithuania: Only reimbursed for limited indications (compared to what was approved at market authorisation)
• Netherlands: Only reimbursed under certain therapeutic conditions (annex 2 on the positive reimbursement list).
• Norway: Only reimbursed for restricted patient cohort • Poland: Only reimbursed for limited indications (compared to what was approved at market authorisation)
• Portugal: Product is only available on a patient by patient basis and after an Exceptional Authorisation has been granted
• Scotland: Recommended for a restricted patient cohort relative to licensed indication through restricted SMC recommendation
• Serbia: Products are reimbursed with significant restrictions. Sometimes these restrictions are based on number of patients (e.g. for new generation HepC medicines, there is a cap on only 60 patients per year), sometimes on the number of indications, or there is some other limit.
• Slovakia: Drugs included in the Reimbursement List have some limitation (prescription limitation, indication limitation and limitation based on prior insurance company approval), or are reimbursed for individual patients
• Slovenia: Only reimbursed for restricted patient cohort
• Spain: Only reimbursed for restricted patient cohort
• Sweden: Only reimbursed for restricted patient cohort • Switzerland: For products pending reimbursement, patients have restricted reimbursement access. Such restricted access includes ‘individual reimbursement’ regulated by Art. 71a-d of KVV ordinance.
• Turkey: Products only available through a “Named Patient Scheme”. These medicines do not require TITCK (Turkish Medical Agency) approval but are reimbursed.
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
11
Comparable across markets and highlights major restrictions Visual of the limited availability definition
Price volume agreements Limited subpopulation Hospital restrictions Individual basis / Named Patient Population
Partial access during decision pending
Direct patient availability restrictions (e.g. restrictions of eligible patients upon
Summary of Product Characteristics)
Indirect restrictions (e.g. care setting, specialist usage, or
confidential managed entry agreements) Definition of Limited Availability
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
© 2020. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries.
All medicines Availability by approval year Rate of availability Channels of availability Time to availability
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
13
Total availability by approval year (2015 - 2018)
45 38 38 40 36 36 39 34 34 33 31 27 33 29 28 26 26 29 24 25 29 19 27
16 19 15 19 16 16 10 12 12 2
35 30 32 32
30 28 28 29 24 23 22 21 22
18 23 22 19 19 21 17 15 16
16
13 14 14 10 10 12 5 6 4
3 1
1
38
35 35 32 30 30 32
26 27 33 29
25 24
26 23 20 21 17 21 20 19 17
17
17 17 16 13 11 8
7 10 3 2
2
54
44 40 36 36
30 25 31 31 27
26 28 21
22 17 19 18
12 11 10 9
18 9
13 8 11 11
9 1 1
2
0
20
40
60
80
100
120
140
160
180
Italy
Sw
itzer
land
Eng
land
Fran
ce
Net
herla
nds
147
Lith
uani
a
Sw
eden
Nor
way
Cro
atia
Spa
in
124
Sco
tland
Bel
gium
Por
tuga
l
132
5
EU A
vg.
Irela
nd
Slo
veni
a
4
Cze
ch
*Mac
edon
ia
Gre
ece
Hun
gary
Icel
and
Est
onia
5
Pol
and
124
172
Rom
ania
Latv
ia
Bul
garia
Alb
ania
Turk
ey
Aus
tria
Den
mar
k
5
77
116
*Bos
nia
4
Slo
vaki
a
3
2
Ger
man
y
*Ser
bia
EMA
appr
oval
s
116
145 140
120 108
101 100
Finl
and
91 87 85 77 72 72 70 69
59 58
95
53 42 36 31 31
21 11 8 8 6
56
2015 2016 2018 2017
The total of availability by approval year is the number of medicines available to patients in European countries (for most countries this is the point at which the product gains access to the reimbursement list*) split by the year in which the EMA granted marketing authorisation.
Num
ber o
f pro
duct
s
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
14
Rate of availability (2015 – 2018)
172
0
20
40
60
80
100
120
140
160
180
EMA
appr
oval
s
Aus
tria
67%
85%
Slo
veni
a
81%
12%
Ger
man
y
Cze
ch
77% 84%
Den
mar
k
45%
Sw
itzer
land
42%
Lith
uani
a
72%
24% 34%
Finl
and
100
Fran
ce
72%
Italy
51%
70%
Eng
land
63%
EU A
vg.
67%
Gre
ece
Irela
nd
Net
herla
nds
Sw
eden
Turk
ey
59%
Nor
way
58%
Spa
in
18%
55%
41%
Sco
tland
53%
Por
tuga
l
49%
Est
onia
140
Bul
garia
45% 42% 34%
Slo
vaki
a
Cro
atia
40%
Hun
gary
Icel
and
33% 31%
Pol
and
6%
21%
Rom
ania
Latv
ia
18%
Alb
ania
5%
*Bos
nia
5%
*Ser
bia
3%
108
*Mac
edon
ia
147 145 132
124 124
70
Bel
gium
116 116 101 95 91
53
87 85 77 77 72 72
120
59 58 56 42 36 31 31
21 11 8 8 6
69
Row Labels Distinct Count of Medicine Name 2014 45 2015 45 2016 37 2017 41 2018 54
The rate of availability is the number of medicines available to patients in European countries (for most countries this is the point at which the product gains access to the reimbursement list*), inc. limited availability
Num
ber o
f pro
duct
s
Availability
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
15
Rate of availability (%, 2015 – 2018)
172
0
20
40
60
80
100
120
140
160
180
42%
84%
Nor
way
23%
3%
55%
1% 26%
27%
28%
EMA
appr
oval
s
15%
Slo
vaki
a
16%
72%
Ger
man
y
1%
42%
20%
85%
53%
Den
mar
k
Sco
tland
3% 80%
Alb
ania
1%
56%
6%
13% A
ustri
a
24%
22%
Sw
itzer
land
67% 72%
84%
Sw
eden
47%
Eng
land
1%
27%
1%
43%
Spa
in
Finl
and
72%
Italy
30% 33%
Net
herla
nds
13%
33%
Fran
ce
45%
Por
tuga
l
33%
47%
30%
13%
Irela
nd
12%
15%
2%
36%
28%
27%
Bel
gium
1%
49%
45%
1%
55%
40%
2%
49%
Cze
ch
22%
58%
31% 7%
12%
47%
Cro
atia
32%
11%
49%
13%
Gre
ece
27%
62%
Hun
gary
28%
66%
Icel
and
33%
2%
65%
22%
Bul
garia
19%
12%
64%
Est
onia
11%
13%
53%
Lith
uani
a
Pol
and
7%
20%
1%
Rom
ania
13%
77%
54%
75%
Turk
ey
15%
73% 85%
9%
2%
26%
3%
60%
*Ser
bia
1% 3%
2%
10%
*Bos
nia
22%
74%
Latv
ia
5%
Slo
veni
a
51%
6%
8% 4% 9%
8% 5% 5%
7%
5%
4% 8%
6%
8% 9%
3%
*Mac
edon
ia
The rate of availability is the number of medicines available to patients in European countries (for most countries this is the point at which the product gains access to the reimbursement list*). This includes all medicines status to provide a complete picture of the availability of the cohort of medicines studied.
Not available Full public availability Not submitted by association Limited Availability Only available privately
Avai
labi
lity
brea
kdow
n (%
)
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
16
Time to availability (2015 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).
298 398
517 521 522 584 596 634 660 682 711 752 797 806 812 823
0
200
400
600
800
1,000
1,200
1,400
1,600
1,800
*Ser
bia
Net
herla
nds
252 127
Bul
garia
Sw
itzer
land
Den
mar
k
445
Pol
and
Ger
man
y
414
154 158 269
Sw
eden
Finl
and
307
Cro
atia
Aus
tria
349 **
* E
ngla
nd
Turk
ey
Spa
in
Icel
and
425
***S
cotla
nd
512 436
Italy
Slo
veni
a
*Mac
edon
ia
**Fr
ance
436
Latv
ia
Gre
ece
Irela
nd
439
Bel
gium
452
Nor
way
566
Alb
ania
Hun
gary
Slo
vaki
a
687
Est
onia
Cze
ch
Por
tuga
l
*Bos
nia
Lith
uani
a
812
Rom
ania
Tim
e (d
ays)
Available medicines / 172 Dates submitted / 172
147 145 132 116 108 124 140 120 31 100 95 124 69 91 77 58 70 31 77 101 116 11 59 72 53 72 56 87 8 21 6 8 36 42
147 145 89 116 108 120 140 120 27 100 95 124 59 91 77 54 46 8 75 92 93 10 47 71 49 69 56 74 8 21 6 8 34 40
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
17
Median time to availability (2015 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).
Tim
e (d
ays)
53 75 81
194 195 212 273 293
330 348 352 356 358 389 398 414 423 436 438 467 490 496 515 533 560
611 612 681 681 684 706
749 775
877
***E
ngla
nd
Net
herla
nds
Cze
ch
Sw
eden
Ger
man
y
Sw
itzer
land
Finl
and
Spa
in
Den
mar
k
Bul
garia
Turk
ey
Aus
tria
Bel
gium
Latv
ia
***S
cotla
nd
Italy
Icel
and
Pol
and
Gre
ece
Cro
atia
Nor
way
Alb
ania
Hun
gary
Irela
nd
**Fr
ance
Est
onia
Slo
vaki
a
*Mac
edon
ia
*Bos
nia
Por
tuga
l
*Ser
bia
Rom
ania
Lith
uani
a
Slo
veni
a
Median
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
© 2020. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries.
All medicines study comparison Rate of availability 2018 vs 2019 W.A.I.T study Time to availability 2018 vs 2019 W.A.I.T study
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
19
Comparison of availability (2018 study vs 2019 study)
86 83 84
74
62
79
60
78
69
51
62 56
43 42
53
36
45
14
58
38 40
19 23
20
9
16 13
3
85 84 81
77 72 72
67 67 63
59 58 53 51
45 45 42 42 41 40
34 34 33 31
24
18 18 12
5
0 10 20 30 40 50 60 70 80 90
100
Net
herla
nds
Ger
man
y
Den
mar
k
Aus
tria
Sw
itzer
land
Fran
ce
Italy
Finl
and
Por
tuga
l
Sw
eden
Gre
ece
Bel
gium
Nor
way
Spa
in
Irela
nd
Lith
uani
a
Cze
ch
Slo
vaki
a
Cro
atia
Hun
gary
Icel
and
Bul
garia
Est
onia
Pol
and
Latv
ia
Turk
ey
Ser
bia
Slo
veni
a
2019 study (2015 - 2018) 2018 study (2014 – 2017)
% a
vaila
bilit
y
Delta in % availability* (2018 / 2019)
The rate of availability, measured by the number of medicines available to patients in European countries as of 2019, compared to the rate of availability in the 2018 W.A.I.T. indicator study
-1% 1% -3% 3% 10% -7% 7% -11% -6% 8% -4% -3% 8% 3% -8% 6% -3% 27% -18% -4% -6% 14% 8% 4% 9% 2% -1% 2%
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
20
Comparison of time to availability (2018 study vs 2019 study)
119 146
171 220
269 291 288 292
385 402 428
395 417 401 445
492 486
333
498 449
539 603 618
547
634
726
925
612
127 154 158
252 269 298 307
398 414 436 436 439 445 452
512 517 521 522 566
596 634 660 682 687 711
797 812 823
0 100 200 300 400 500 600 700 800 900
1,000
Sw
eden
Finl
and
Aus
tria
Ger
man
y
Den
mar
k
Sw
itzer
land
Turk
ey
Cro
atia
Net
herla
nds
Fran
ce
Spa
in
Hun
gary
Italy
Gre
ece
Bel
gium
Icel
and
Latv
ia
Irela
nd
Slo
vaki
a
Nor
way
Est
onia
Cze
ch
Bul
garia
Por
tuga
l
Lith
uani
a
Ser
bia
Pol
and
Slo
veni
a 2018 study (2014 – 2017) 2019 study (2015 - 2018)
Tim
e to
ava
ilabi
lity
Delta in days* (2018 / 2019)
The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients compared to the rate of availability in the 2018 W.A.I.T. indicator study
8 8 -13 32 0 7 19 106 29 34 8 44 28 51 67 25 35 189 68 147 95 57 64 140 77 71 -113 211
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
21
All medicines
• Patient access to new medicines is highly varied across Europe, with the greatest rate of availability in Northern and Western European countries and lowest in Southern and Eastern European countries.
• In some countries, up to 30% of products are available and reimbursed but with specific conditions.
• The average delay between market authorisation and patient access can vary by a factor greater than x 6 across Europe, with patients in Northern /Western Europe accessing new products 100 - 350 days after market authorisation and patients mainly in Southern/ Eastern Europe between 600-850 days.
• Even within a country there is a large variation in the speed of patient access to different products. Often the level of variation within a country is greater than between countries e.g. shortest versus longest delays in Scotland (159 vs. 1789 days), Austria (24 vs. 1689 days) and Estonia (52 vs. 1657 days).
• Comparison to 2018 W.A.I.T. indicator study: of the countries overlapping both analyses, 54% countries have a higher rate of availability, although 93% countries have a longer delay in the 2019 study.
Key observations
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
© 2020. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries.
Oncology medicines Availability by approval year Rate of availability Channels of availability Time to availability
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
23
Oncology availability by approval year (2015 - 2018)
10 10 9 8 8 9 9 10 7 8 8 7 7 7 5 7 7 7 7 5
8 6 4 7 7
4 6 6 5 5 4 2 2 1 1 1
10 10 10 9 8 8 9 8
10 8 8 6 6 4 6
8 6 6 5
6
7
5 6
4 6
5 5 5
3 4 2
1 2
11 11 10
10 9 8
10 8 10 10 7
9 9
7 8
6 7 8
7 7
5
5 5 5 5
6 5 4
4 1 2
2 1 1
12 11
8 9 11 10
7 8 6 7
6 7 6
8 7 4 4 2 3 3
3 3 2 2
2
0
5
10
15
20
25
30
35
40
45
Fran
ce
Finl
and
Aus
tria
Ger
man
y
36
23
35
Den
mar
k
Net
herla
nds
Irela
nd
Eng
land
Sw
itzer
land
Italy
35
Rom
ania
Bel
gium
Spa
in
*Ser
bia
Nor
way
Sco
tland
Slo
veni
a
Turk
ey
EU A
vg.
Por
tuga
l
Alb
ania
Bul
garia
Gre
ece
Cro
atia
Cze
ch
28
Icel
and
Hun
gary
Pol
and
14
33
Sw
eden
43
1
Lith
uani
a
1
*Bos
nia
*Mac
edon
ia
1
Est
onia
26
Slo
vaki
a
29
18
Latv
ia
42
37 36 34
EMA
appr
oval
s
19
29 26 25 24
22 21 20 18
33
17 16 15
11 8
5 4 3 3
18
2018 2015 2017 2016
The total of availability by approval year is the number of medicines available to patients in European countries (for most countries this is the point at which the product gains access to the reimbursement list*) split by the year in which the EMA granted marketing authorisation.
Num
ber o
f pro
duct
s
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
24
The rate of availability, measured by the number of medicines available to patients in European countries as of 2019: for most countries this is the point at which the product gains access to the reimbursement list, inc. limited availability
Oncology rate of Availability (2015 - 2018)
43
0
5
10
15
20
25
30
35
40
45
Ger
man
y
98%
53%
33
84%
EMA
appr
oval
s
Den
mar
k
23 24
Por
tuga
l
86%
Aus
tria
Rom
ania
18 84%
Sw
eden
Eng
land
Bul
garia
81%
Fran
ce
EU A
vg.
81% Fi
nlan
d
Sw
itzer
land
Net
herla
nds
77% 79% 77%
Icel
and
Italy
67%
*Bos
nia
12%
Bel
gium
67%
Gre
ece
2%
65% 60%
Nor
way
60%
Cro
atia
33% 42%
Sco
tland
56% 51%
Irela
nd
49% 47% 44%
Slo
vaki
a
42%
Lith
uani
a
Cze
ch
42%
28
58%
37%
Slo
veni
a
40%
Hun
gary
Pol
and
35%
Est
onia
26%
Turk
ey
19% 9%
3
*Mac
edon
ia
7%
Alb
ania
7%
Latv
ia
Spa
in
*Ser
bia
42
37 35 36 35 34 33
29 29
14
26 26
20 22 21
36
18 18
25
17 16 15
11 8
5 4 3 1
19
Num
ber o
f pro
duct
s
Availability
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
25
Oncology rate of availability (%, 2015 – 2018)
7% 7% 7% 7%
7%
7%
9% 7% 5%
5%
5%
9%
9% 7%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90%
100% 12%
2%
Ger
man
y
2%
86%
100%
EMA
appr
oval
s
98%
2%
Aus
tria
84%
16%
Latv
ia
16% 19% D
enm
ark
19%
40%
44%
40%
12%
Finl
and
Italy
16%
77%
Eng
land
67% 63%
19%
33%
Fran
ce
81%
Net
herla
nds
67%
47% 12%
37%
21%
Spa
in
Sw
itzer
land
77%
23%
2%
Bel
gium
21%
42%
26%
33%
12%
21%
5%
Sw
eden
58%
2%
58%
2%
23%
Nor
way
40%
40%
Sco
tland
53%
Slo
veni
a
47%
26%
47%
Por
tuga
l
51%
12%
49%
Irela
nd
49%
51%
Bul
garia
44%
Gre
ece
*Ser
bia
30%
14%
56%
Slo
vaki
a
35%
12%
44%
2%
Cro
atia
16% 37%
Cze
ch
42%
58%
Icel
and
14%
60%
Hun
gary
16%
21%
23%
37%
2%
21%
33%
Lith
uani
a
2%
56%
Rom
ania
19%
14%
60%
Est
onia
21%
12%
63%
Turk
ey
12%
21%
Pol
and
84%
*Bos
nia
2% 2%
14% 19%
74%
*Mac
edon
ia
74%
Alb
ania
77%
23%
30%
44%
43
60%
The rate of availability is the number of medicines available to patients in European countries (for most countries this is the point at which the product gains access to the reimbursement list*). This includes all medicines status to provide a complete picture of the availability of the cohort of medicines studied.
Avai
labi
lity
brea
kdow
n (%
)
Full public availability Not submitted by association Not available Limited Availability Only available privately
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
26
Oncology time to availability (2015 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).
Tim
e (d
ays)
Available medicines / 43 Dates submitted / 43
134
280 375
468 519 560 584 624 626 698 708 722
871 878 879 886 890 891 896 981
0
200
400
600
800
1,000
1,200
1,400
1,600
1,800
Lith
uani
a
Aus
tria
*Mac
edon
ia
Net
herla
nds
790
Den
mar
k
449
86
*Ser
bia
Sw
eden
234
371
Ger
man
y
211
Cro
atia
Icel
and
Sw
itzer
land
Gre
ece
Slo
veni
a
374 **
*Eng
land
Finl
and
397
***S
cotla
nd
441
Italy
Bel
gium
Latv
ia
450
Spa
in
Turk
ey
Rom
ania
Bul
garia
551
Nor
way
279
579
**Fr
ance
Hun
gary
Alb
ania
Slo
vaki
a
Irela
nd
Cze
ch
Pol
and
*Bos
nia
Est
onia
493
Por
tuga
l
36 42 37 35 29 34 20 36 33 26 33 29 28 11 25 1 26 22 35 18 18 17 3 21 19 23 18 8 5 15 14 16 4 336 42 37 35 29 25 17 36 32 26 33 29 28 9 25 1 23 22 27 18 16 12 2 21 19 20 16 8 5 14 13 16 4 1
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
27
Oncology median time to availability (2015 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).
Tim
e (d
ays)
35 59 61
177 186 203
332 350 352 353 358 361 368 373 423 452 483 511 519 533 557 583
685 698 706 781 808 809 836
895 898 924 947 981
Spa
in
Bel
gium
Ger
man
y
Irela
nd
**Fr
ance
Aus
tria
Den
mar
k
Sw
itzer
land
Net
herla
nds
Gre
ece
Sw
eden
***E
ngla
nd
***S
cotla
nd
Finl
and
Turk
ey
Italy
Rom
ania
Hun
gary
Icel
and
Nor
way
*Ser
bia
Lith
uani
a
Cro
atia
Bul
garia
Alb
ania
Slo
vaki
a
Pol
and
*Mac
edon
ia
Por
tuga
l
Cze
ch
*Bos
nia
Est
onia
Latv
ia
Slo
veni
a Median
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
28
Oncology medicines
• Patient access to new Oncology medicines is highly varied across Europe, with the greatest rate of availability in Northern and Western European countries.
• In 88% of the countries, the rate of availability is higher for Oncology products compared to all products approved between 2015-2018
• In Germany, France, England, Netherlands, Belgium, Bulgaria, and Romania, the availability of oncology medicines in more than 10% above the rate of all medicines approvals.
• Limited availability is prevalent within the oncology medicines with over 20% of oncology medicines having a restriction placed upon them after SmPC in England (40%), Sweden (26%), Scotland, (21%), and Poland (21%)
• The average delay between market authorisation and patient access for Oncology products varies 2.5 months to over 2.5 years
Key observations
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
© 2020. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries.
Orphans medicines Availability by approval year Rate of availability Channels of availability Time to availability
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
30
Orphan availability by approval year (2015 - 2018)
12 12 11 9 11 9 10 8 9 9 9 9 8 6 7 7 7 7 6 6 5 5 7 4 6 4 4 6
3 4 2
9 8 7
6 7
8 7 7 5 3
7 5 6 5 3 3 4 4
3 4 6 3
3 4
3 2 2
2 1
12 12 10
10 9
8 10 8 9
7
6 7 5
6 7 7 5 6 5 4 3
3 3
4 3 4 4 2
3 2
21 19
15 16 13
13 9
10 8 11 7 8
5 7 6 5 5 2 5 3
3
2
0 5
10 15 20 25 30 35 40 45 50 55
Icel
and
Finl
and
EMA
appr
oval
s
Italy
22
Ger
man
y
23
1 0
Fran
ce
30
Den
mar
k
Sw
itzer
land
29
Eng
land
Alb
ania
Hun
gary
14
Net
herla
nds
40
Sco
tland
14
12
Nor
way
Bel
gium
Por
tuga
l
Sw
eden
Spa
in
Slo
vaki
a
Gre
ece
EU A
vg.
24
Cze
ch
*Mac
edon
ia
1
Slo
veni
a
Cro
atia
1 1
Pol
and
Bul
garia
Irela
nd
Rom
ania
51
1
33
Est
onia
38
Turk
ey
Lith
uani
a
*Bos
nia
29
Latv
ia
31
*Ser
bia
41
54
Aus
tria
36
19
24 21
19 17 15
12
43
11 10 9 7
0 0 0 0
11
2017 2015 2016 2018
The total of availability by approval year is the number of medicines available to patients in European countries (for most countries this is the point at which the product gains access to the reimbursement list*) split by the year in which the EMA granted marketing authorisation.
Num
ber o
f pro
duct
s
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
31
The rate of availability, measured by the number of medicines available to patients in European countries as of 2019: for most countries this is the point at which the product gains access to the reimbursement list, inc. limited availability
Orphan rate of availability (2015 - 2018)
Data N/A- data is not provided by associations (companies have not sent data or are not members of the association) Oncology products flagged using IQVIA MIDAS Oncology market definition*
54
0 5
10 15 20 25 30 35 40 45 50 55
EMA
appr
oval
s
94%
22%
74%
Italy
Ger
man
y
26%
12
76%
Alb
ania
Bul
garia
Spa
in
Den
mar
k
Fran
ce
Cze
ch
26%
Aus
tria
70%
20%
Eng
land
13% 0
24
67% 61%
28%
Icel
and
Sw
itzer
land
Rom
ania
Por
tuga
l
57%
19 N
ethe
rland
s
22% 31%
56%
Pol
and
Sco
tland
41%
54%
Sw
eden
Finl
and
54%
0 N
orw
ay
Turk
ey
44%
Est
onia
Bel
gium
44% 43%
Gre
ece
39%
4%
EU A
vg.
35%
*Bos
nia
Slo
vaki
a
35%
Cro
atia
Irela
nd
Slo
veni
a
20%
Hun
gary
19% 17%
Lith
uani
a
Latv
ia
33
*Mac
edon
ia
*Ser
bia
51
43 41 40
38
80%
31 30 29 29
24 23 22 21
15 19
17
36
14 12 11 11 10 9
7
2 0 0 0
14
Num
ber o
f pro
duct
s
Availability
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
32
Orphan rate of availability (%, 2015 – 2018)
9% 9% 7% 7% 4% 7% 6% 6% 9%
6%
9%
7%
6% 7%
4%
9% 9% 6%
7%
7% 9%
9%
6% 6%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90%
100%
41%
Den
mar
k
20%
EMA
appr
oval
s
15%
94%
24%
43%
Ger
man
y
80%
Eng
land
35%
2%
Fran
ce
30% 28%
74%
59%
17%
Aus
tria
20%
48%
57%
*Mac
edon
ia
46%
22%
54%
30%
67%
33%
33%
Italy
39% 44%
44%
Sw
itzer
land
Slo
vaki
a
Latv
ia
19%
57%
26%
Net
herla
nds
Alb
ania
30%
Finl
and
46%
39%
26%
65%
Nor
way
37%
24%
19%
22% S
cotla
nd
56%
*Ser
bia
Bel
gium
56%
26%
Por
tuga
l
33%
Sw
eden
11%
15%
44%
Gre
ece
20%
85%
Spa
in
Cze
ch
26%
2%
63%
Slo
veni
a
22%
52%
Cro
atia
74%
Irela
nd
94%
19%
78%
24%
22%
2%
76%
Rom
ania
20%
80%
Bul
garia
11%
78%
Hun
gary
76%
Est
onia
78%
Icel
and
19%
69%
Pol
and
15%
81%
Lith
uani
a
93%
*Bos
nia
94%
15%
15%
76%
54
Turk
ey
The rate of availability is the number of medicines available to patients in European countries (for most countries this is the point at which the product gains access to the reimbursement list*). This includes all medicines status to provide a complete picture of the availability of the cohort of medicines studied.
Full public availability Not available Limited Availability Only available privately Not submitted by association
Avai
labi
lity
brea
kdow
n (%
)
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
33
Orphan time to availability (2015 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).
246
404 413 430 439 458 563
696 739 748 784 815 831 881 887 902 914
0 100 200 300 400 500 600 700 800 900
1,000 1,100 1,200 1,300 1,400 1,500
280
Ger
man
y
403
Sw
itzer
land
345
Est
onia
Aus
tria
194
Den
mar
k
483
Net
herla
nds
Gre
ece
1,138
Turk
ey
678
Sw
eden
***E
ngla
nd
Finl
and
440
**Fr
ance
***S
cotla
nd
Slo
vaki
a
Italy
Icel
and
618
485
Spa
in
Bel
gium
Latv
ia
Lith
uani
a
Cro
atia
Nor
way
Bul
garia
Irela
nd
Hun
gary
111
Rom
ania
Cze
ch
Pol
and
Alb
ania
Por
tuga
l
*Mac
edon
ia
*Ser
bia
Slo
veni
a
535
*Bos
nia
Tim
e (d
ays)
Available medicines / 54 Dates submitted / 54
51 43 33 40 31 22 9 23 29 38 30 36 12 19 15 24 41 2 14 19 29 11 14 11 10 24 12 17 7 0 0 0 0 051 43 12 40 31 18 7 23 28 38 30 36 11 19 15 24 22 2 8 19 27 11 13 6 8 14 12 14 6 0 0 0 0 0
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
34
Orphan median time to availability (2015 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).
Tim
e (d
ays)
39 108
158 192 278 305 315 356 361 385 395 415 435 444
519 540 573 648 668 682 687
770 850 869 891 898 925 952
1,236
Finl
and
Net
herla
nds
Pol
and
Ger
man
y
Aus
tria
Est
onia
Turk
ey
Bul
garia
Den
mar
k
Sw
itzer
land
*Bos
nia
Hun
gary
Cze
ch
Italy
***S
cotla
nd
Slo
vaki
a
Gre
ece
***E
ngla
nd
Sw
eden
Por
tuga
l
Bel
gium
Spa
in
Rom
ania
Icel
and
Slo
veni
a
**Fr
ance
Nor
way
Cro
atia
Lith
uani
a
Irela
nd
*Ser
bia
Alb
ania
*Mac
edon
ia
Latv
ia
Median
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
35
Orphan drugs
• Patient access to new Orphan medicines is highly varied across Europe, with the greatest rate of availability in Northern and Western European countries.
• In over 80% of the countries, the rate of availability is lower for Orphan drugs compared to all products approved between 2015-2018
• Only in Germany, England, Switzerland, Greece, and France is the rate of orphan medicines availability higher than all products approved 2015 - 2018
• Almost 80% of the countries have a longer average delay to EMA authorisation for Orphan drugs compared to all products approved 2015-2017
• The average delay between market authorisation and patient access for Orphan drugs is between 3.7 months to 3.2 years
• 15% of all countries studied do not have access to any of the orphan medicines approved between 2015 and 2018
Key observations
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
© 2020. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries.
Non-oncology orphans medicines Availability by approval year Rate of availability Channels of availability Time to availability
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
37
Non-oncology orphan availability by approval year (2015 - 2018)
9 9 8 8 6 6 8 7 5 7 7 6 4 4 5 5 6
4 5 4 4 5 2 2 3 4 2 2 2
16
6 5 5 7
4
6 5
5 3 5
3 4 2
4 3
3 2 2 2 3 2
4 2
2
7
7
5 4 4 5
5 4
4 3 2
4 2 4
2 2
3
3 2
1 3 1 1
7
15
11 11 9 11 5
5 7 7 5 6 7 5 3 4 4
2 2 1 1
0
5
10
15
20
25
30
35
40 A
ustri
a
1
EMA
appr
oval
s
26
Ger
man
y
Nor
way
Pol
and
Italy
*Ser
bia
21
Sco
tland
Den
mar
k
Fran
ce
Lith
uani
a
Gre
ece
Eng
land
Sw
itzer
land
Net
herla
nds
1
Por
tuga
l
Bel
gium
EU A
vg.
37
26
1
Sw
eden
Slo
vaki
a
1
Spa
in
29
1
Cro
atia
1
28
1
Bul
garia
Cze
ch
1
Latv
ia
Irela
nd 1
Hun
gary
Turk
ey
1
Slo
veni
a
14
*Mac
edon
ia
1
Icel
and
Alb
ania
1
Rom
ania
1
Est
onia
1
1
9 Fi
nlan
d
*Bos
nia
39
24 21 20 19 19
17 15
13 13 13 10
0
9 9 7 6 6 5 5 5 4 4
1 0 0 0 0
2015 2017 2018 2016
The total of availability by approval year is the number of medicines available to patients in European countries (for most countries this is the point at which the product gains access to the reimbursement list*) split by the year in which the EMA granted marketing authorisation.
Num
ber o
f pro
duct
s
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
38
The rate of availability, measured by the number of medicines available to patients in European countries as of 2019: for most countries this is the point at which the product gains access to the reimbursement list, inc. limited availability.
Non-oncology orphan rate of availability (2015 - 2018)
Data N/A- data is not provided by associations (companies have not sent data or are not members of the association) Oncology products flagged using IQVIA MIDAS Oncology market definition*
39
0
5
10
15
20
25
30
35
40
33%
Ger
man
y
54%
72%
Cze
ch
Bul
garia
EMA
appr
oval
s
Spa
in
95%
Net
herla
nds
Den
mar
k
51% 62%
74%
Lith
uani
a
67%
Eng
land
23% 26%
67%
Fran
ce
Italy
Nor
way
54%
Sw
itzer
land
Sco
tland
Alb
ania
49% Fi
nlan
d 49% 44%
Pol
and
Por
tuga
l 13%
38%
Gre
ece
36%
13%
Bel
gium
33%
EU A
vg.
33%
Slo
vaki
a
10%
Sw
eden
Est
onia
23%
19
Cro
atia
Icel
and
23%
Irela
nd
Slo
veni
a
4 15% 15%
Rom
ania
18%
*Bos
nia
13%
Hun
gary
Turk
ey
10% 3%
Latv
ia
5
*Mac
edon
ia
*Ser
bia
21
37
29 28 26 26
24 21
Aus
tria
19 17
15 14 13 13 13 10 9 9
1
20
6 6 7 5 5 4
0 0 0 0 0
9
Num
ber o
f pro
duct
s
Non-oncology orphans represent 72% of the total orphan medicines group
Availability
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
39
Non-oncology orphan rate of availability (%, 2015 – 2018)
8% 5% 5% 8% 5%
5%
5%
5% 5%
5% 5% 8%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90%
100%
95%
10%
39
100%
74%
Ger
man
y
28% 15%
EMA
appr
oval
s
3%
26%
Alb
ania
36%
Den
mar
k
62%
85%
72%
13%
Slo
vaki
a
67%
100%
15%
46%
Aus
tria
Est
onia
49%
18%
49%
44% E
ngla
nd
23% 33%
33%
26%
33%
Fran
ce
3% 26% 36%
38%
Italy
44%
10% N
orw
ay
15%
18%
46%
Sw
itzer
land
13%
49%
Sco
tland
49%
Finl
and
51% 51%
Net
herla
nds
Pol
and
21%
56%
Por
tuga
l
Gre
ece
36%
64%
23%
Bel
gium
38%
18%
15%
23%
Sw
eden
10%
64% 54%
Spa
in
23%
23%
90%
Cro
atia
18%
10%
67%
Cze
ch
77%
Irela
nd
18%
10%
72%
Slo
veni
a
10%
85%
Icel
and
33%
3%
Rom
ania
3%
85%
3%
10%
85%
Turk
ey
10% 10%
90%
Bul
garia
3%
85%
15%
13%
3%
77%
3%
87%
Lith
uani
a
97%
Latv
ia
10%
*Mac
edon
ia
92%
*Bos
nia
87%
*Ser
bia
Hun
gary
The rate of availability is the number of medicines available to patients in European countries (for most countries this is the point at which the product gains access to the reimbursement list*). This includes all medicines status to provide a complete picture of the availability of the cohort of medicines studied.
Full public availability Only available privately Limited Availability Not available Not submitted by association
Avai
labi
lity
brea
kdow
n (%
)
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
40
Non-oncology orphan time to availability (2015 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).
329 388
438 440 446 450 451 470 509 518 524
767 794 863 870
927 954 976
0 100 200 300 400 500 600 700 800 900
1,000 1,100 1,200 1,300 1,400 1,500
Net
herla
nds
Den
mar
k
645
Icel
and
106
Ger
man
y
Nor
way
234
Sw
itzer
land
*Bos
nia
118
606
Aus
tria
Latv
ia
399
Gre
ece
Sw
eden
Finl
and
Cze
ch
***E
ngla
nd
***S
cotla
nd
Italy
479
Spa
in
Cro
atia
Por
tuga
l
802
Lith
uani
a
Pol
and
Bel
gium
**Fr
ance
Slo
vaki
a
Hun
gary
*Ser
bia
Turk
ey
Irela
nd
Est
onia
Bul
garia
Rom
ania
821
Alb
ania
*Mac
edon
ia
Slo
veni
a
568
1,017
Tim
e (d
ays)
Available medicines / 39 Dates submitted / 39
37 21 29 28 5 15 19 13 19 26 24 6 20 9 1 10 7 14 26 13 21 5 9 5 17 4 6 9 4 0 0 0 0 0 37 6 29 28 4 12 19 13 18 26 24 5 20 3 1 10 7 14 13 13 20 2 8 4 9 4 6 8 3 0 0 0 0 0
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
41
Non-oncologic orphan median time to availability (2015 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).
Tim
e (d
ays)
60 109 143
227 305 308 340 352 395 397 405 405 427 460 486 518 519 540
636 703
770 802 828 841 842 915 933
976
1,207
Cro
atia
Gre
ece
Italy
Sw
eden
Aus
tria
Den
mar
k
Ger
man
y
Slo
vaki
a
**Fr
ance
Sw
itzer
land
Turk
ey
Cze
ch
Por
tuga
l
Finl
and
***E
ngla
nd
Net
herla
nds
***S
cotla
nd
Bel
gium
Spa
in
Alb
ania
Lith
uani
a
Icel
and
Nor
way
Hun
gary
Est
onia
Bul
garia
Pol
and
Irela
nd
Rom
ania
*Ser
bia
*Mac
edon
ia
*Bos
nia
Latv
ia
Slo
veni
a
Median
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
42
Non-oncology orphan drugs
• Patient access to new Orphan medicines is generally low across Europe versus other segments, with the greatest rate of availability in Northern and Western European countries.
• In 95% of the countries, the rate of availability is lower for non-oncology orphan drugs compared to all orphan medicinal products approved between 2015-2018
• Only in Germany, and Norway is the rate of non-oncology orphan medicines availability equivalent to all orphan medicinal products approved 2015 - 2018
• The average delay between market authorisation and patient access for Orphan drugs is between 3.7 months to 2.8 years
• 15% of all countries studied do not have access to any of the non-oncology orphan medicines approved between 2015 and 2018
Key observations
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
© 2020. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries.
Combination therapies Availability by approval year Rate of availability Channels of availability Time to availability
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
44
Combination therapies availability by approval year (2015 - 2018)
10 9 9 8 8 8 8 7 7 6 8 7 7 6 5
7 6 5 6 5 6 6 5 4 6 5
3 3 4 2 2 2
2 1
8 8 8
8 8 8 8 7 7
6
7 7 7
7 7
8 6
6 6
5 6 5
3 6 4 5
5 5 2 3 2 3
6 6 6
6 5 6 5 5 5
6
5 4 4 5
5 3
5 6 4 4
5 6
5 4 4 4
4 4
3 3
10 8
6 7 7 6
6 8 7
6 4
5 5 4 4 3
4 3 4 5
2
4 2 2 3
0
5
10
15
20
25
30
35
EMA
appr
oval
s
Irela
nd
Sw
itzer
land
22
Den
mar
k
9
Icel
and
Italy
EU A
vg.
Aus
tria
27 S
wed
en
Ger
man
y
20
2
Nor
way
23
Slo
veni
a
Finl
and
Net
herla
nds
34
Turk
ey
Spa
in
Pol
and
Eng
land
31
Sco
tland
Cro
atia
9
Por
tuga
l
Bel
gium
15
Fran
ce
Latv
ia
Lith
uani
a
1
29
Cze
ch
Hun
gary
1
Est
onia
Slo
vaki
a
Gre
ece
1
20
Bul
garia
23
1
19
Alb
ania
Rom
ania
1
24
*Bos
nia
19
29
21
1
*Ser
bia
*Mac
edon
ia
28 28 27 26
20
24 21
18 17 16 16 15 13
9
5 5
2016 2015 2018 2017
The total of availability by approval year is the number of medicines available to patients in European countries (for most countries this is the point at which the product gains access to the reimbursement list*) split by the year in which the EMA granted marketing authorisation.
Num
ber o
f pro
duct
s
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
45
The rate of availability, measured by the number of medicines available to patients in European countries as of 2019: for most countries this is the point at which the product gains access to the reimbursement list, inc. limited availability.
Combination therapies rate of availability (2015 - 2018)
Data N/A- data is not provided by associations (companies have not sent data or are not members of the association) Oncology products flagged using IQVIA MIDAS Oncology market definition*
34
0
5
10
15
20
25
30
35
Nor
way
85%
Pol
and
50%
6%
Sw
itzer
land
15%
EMA
appr
oval
s
Italy
Den
mar
k
Cro
atia
71%
91% 82% 85%
Rom
ania
Aus
tria
Net
herla
nds
82%
15%
Sw
eden
Slo
veni
a
79%
Finl
and
79%
Irela
nd
EU A
vg.
62%
76% G
erm
any
Slo
vaki
a
71%
56% S
pain
Eng
land
68%
47%
68%
Est
onia
65%
Sco
tland
Por
tuga
l
62% 59% 59%
Bel
gium
38%
59%
Fran
ce
56%
Gre
ece
Latv
ia
53%
20
Cze
ch
Hun
gary
47% 44%
Bul
garia
44%
Icel
and
26%
Lith
uani
a
26% 26%
Alb
ania
Turk
ey
6%
*Bos
nia
*Ser
bia
*Mac
edon
ia
31 29 29
28 28 27
2
26 24 24
23 23 22
21 21 20 20
19 18
27
19
16 16 15 15
13
9 9 9
5 5
2
17
Total
Num
ber o
f pro
duct
s
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
46
Combination therapies rate of availability (%, 2015 – 2018)
6% 6%
9%
6%
6% 6%
9%
6%
6%
9%
6% 9% 9%
6%
6%
9%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90%
100%
76%
12%
56%
Nor
way
Finl
and
44%
100%
15%
53%
EMA
appr
oval
s
59%
Sw
eden
Eng
land
62%
Italy
3%
91%
3% 79%
Den
mar
k
85%
53%
21%
*Ser
bia
15%
24%
Sw
itzer
land
12%
76%
Aus
tria
41%
53%
47%
29%
12%
32%
12%
12%
79%
26% 3%
24%
Ger
man
y
Fran
ce
Por
tuga
l
71%
3%
29%
Spa
in
Net
herla
nds
71%
3%
26%
56%
35%
12%
68%
18%
29%
Irela
nd
41%
24%
*Mac
edon
ia
Sco
tland
35%
Cro
atia
3%
Cze
ch
59%
35% 41%
Bel
gium
44%
3%
41%
Latv
ia
34
38%
53%
38%
47%
3%
Turk
ey
12%
50%
Hun
gary
32%
15%
50%
Est
onia
18%
29%
32%
53%
76%
Slo
vaki
a
44%
15%
41%
Gre
ece
Icel
and
38%
56%
Bul
garia
15%
68%
Lith
uani
a
15%
29%
44%
Pol
and
26%
12%
62%
Rom
ania
15%
Alb
ania
15%
12%
74%
3%
15%
*Bos
nia
35%
65%
Slo
veni
a
50%
38%
The rate of availability is the number of medicines available to patients in European countries (for most countries this is the point at which the product gains access to the reimbursement list*). This includes all medicines status to provide a complete picture of the availability of the cohort of medicines studied.
Full public availability Limited Availability Not submitted by association Only available privately Not available
Avai
labi
lity
brea
kdow
n (%
)
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
47
Combination therapies time to availability (2015 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).
158 195
381 471 500 513 552 563 577
631 671 686 714 821
0 100 200 300 400 500 600 700 800 900
1,000 1,100 1,200 1,300 1,400 1,500 1,600
Bul
garia
242 136
Rom
ania
781
138
Sw
eden
151 70
320
***E
ngla
nd
Den
mar
k
350
Sw
itzer
land
Ger
man
y
479
Finl
and
183
Por
tuga
l
***S
cotla
nd
Turk
ey
Icel
and
244 N
ethe
rland
s 307
Est
onia
Aus
tria
Bel
gium
315
Irela
nd
324 338
Slo
veni
a
Spa
in
Nor
way
393
Italy
*Mac
edon
ia
414 411 451
Cze
ch
Alb
ania
Cro
atia
**Fr
ance
Gre
ece
Slo
vaki
a
Latv
ia
Pol
and
Hun
gary
*Bos
nia
Lith
uani
a
*Ser
bia
Tim
e (d
ays)
Available medicines / 34 Dates submitted / 34
29 31 26 28 27 23 5 15 24 28 22 23 20 19 24 27 29 18 21 20 5 15 16 16 19 9 17 2 13 21 9 2 9 020 31 26 28 27 23 5 14 24 28 22 22 20 19 24 24 29 18 11 18 5 15 15 15 6 9 16 2 13 20 9 2 8 0
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
48
Combination therapy median time to availability (2015 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).
Tim
e (d
ays)
1 41 53 56
86
169 191 191 201 211 232 253 259 279 284 299 335 337
372 391 396 441 458 463 467 471 490
524 588 595
631
772 781
Italy
*Bos
nia
Finl
and
Pol
and
Ger
man
y
Icel
and
Net
herla
nds
Den
mar
k
Nor
way
Sw
itzer
land
***E
ngla
nd
Sw
eden
Turk
ey
Irela
nd
Gre
ece
***S
cotla
nd
Bel
gium
Spa
in
Aus
tria
**Fr
ance
Cze
ch
Slo
veni
a
Cro
atia
Hun
gary
Est
onia
Slo
vaki
a
Lith
uani
a
Latv
ia
Alb
ania
Por
tuga
l
Bul
garia
Rom
ania
*Ser
bia
*Mac
edon
ia
Median
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
49
Combination therapies
• Patient access to new combination medicines is highly varied across Europe
• Over 40% of these combinations are for HIV or Hep-C, two products are Oncology combinations
• In 82% of the countries, the rate of availability is higher for combination products compared to all products approved between 2015-2018
• Over 75% of the countries have a shorter average delay to EMA authorisation for combination drugs compared to all products approved 2015-2018
• The average delay between market authorisation and patient access for combination therapies is between 4.7 months to 2.2 years
Key observations
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
50
Appendix 5-year rolling cohort: 2014-2018
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
51
• 213 products approved by EMA between 1st January 2014 to 31st December 2018
• The 2019 study provides an analysis of products approved between 2014-2015-2016-2017-2018, for the following dataset: a) All 213 products: 41 in 2014, 45 in 2015, 35 in 2016, 38 in 2017, 54 in 2018 b) 52 Oncology products: 9 in 2014,10 in 2015, 10 in 2016, 11 in 2017, 12 in 2018 c) 66 Orphan products: 12 in 2014, 12 in 2015, 9 in 2016, 12 in 2017, 21 in 2018 d) 44 Combination products: 10 in 2014, 10 in 2015, 8 in 2016, 6 in 2017, 10 in 2018
• Definitions:
- Orphan status from EMA (September 2019) - Oncology products flagged using IQVIA MIDAS Oncology market definition* - Combination products include any product with more than one molecule, including branded/generic combinations
• The date of availability cut off point was 1st January 2020 (to account for Estonia, Iceland, Czech Republic, Latvia, Slovakia which had a few products with a reimbursement decision on 1st January 2020).
• 34 countries included in the study (including split of UK into England and Scotland).
Study scope
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
52
Total availability by approval year (2014 - 2018)
41 39 35 39 34 41 35 33 33 30 35 34 32 32 28 32 29 31 31 29 28 29 26 25 26 18 22 22 19 18 15 16 10 3 3 2
45 38 38 40 36
39 36 34 33 34 31 27 33 29 28 26 26 29 24 29 25 27
19 16 15 19 19 16 16 10 12 12
4 2
35 32 30
32 30
28 28 29 23 24 22 21 22
18 23 22 19 19 21 15 17 16 18
13 14 14 10 10 12 5 4
1 3 1
2
38 35
35 32
30 32
30 26 33 27 29 25 24
26 23 20 21 17 21 19 20 17 17
17 16 17 13 11 8
7 10 2 3 2
54
40 44 36 36 25
30 31 27 31 26
28 21 22 17 19 18 12 11 9 10 9 16
13 11 8 11
9 3 1 1
0 20 40 60 80
100 120 140 160 180 200 220
EMA
appr
oval
s
Ger
man
y
Sw
itzer
land
Eng
land
Italy
Net
herla
nds
4
Gre
ece
Fran
ce
Nor
way
Sco
tland
Bel
gium
EU A
vg.
Por
tuga
l
Slo
veni
a
Irela
nd
64
Slo
vaki
a
Cze
ch
Cro
atia
Hun
gary
5
Icel
and
Est
onia
5
Pol
and
Rom
ania
5 6
Lith
uani
a
Alb
ania
Bul
garia
Finl
and
Latv
ia
*Ser
bia
Aus
tria
Turk
ey
Spa
in
*Bos
nia
Den
mar
k
166 184
2
182
*Mac
edon
ia
213
179 165 159 153 149 146 143
Sw
eden
132 127 119 119 114 108 108 101 100 98 96
135
82 76 75
55 49 46 37
18 14 11 8
84
2014 2017 2018 2016 2015
The total of availability by approval year is the number of medicines available to patients in European countries (for most countries this is the point at which the product gains access to the reimbursement list*) split by the year in which the EMA granted marketing authorisation.
Num
ber o
f pro
duct
s
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
53
Rate of availability (2014 – 2018)
213
0 20 40 60 80
100 120 140 160 180 200 220
85%
Ger
man
y
Bel
gium
78%
Sw
itzer
land
Den
mar
k
Gre
ece
Sco
tland
EMA
appr
oval
s
86% 84%
8%
Aus
tria
Por
tuga
l
77%
Italy
75%
Irela
nd
Spa
in
47%
Finl
and
72%
51%
Eng
land
70%
108
Hun
gary
179
Net
herla
nds
69%
45%
14
Fran
ce
67%
Sw
eden
159
63%
Latv
ia
23% N
orw
ay
47%
62%
100
Alb
ania
60%
17%
4%
Slo
vaki
a
114
56%
Cze
ch
EU A
vg.
56% 51% 54%
Slo
veni
a
46%
Cro
atia
39% 38%
Bul
garia
Est
onia
36%
Icel
and
35% 30%
Pol
and
26%
Rom
ania
22%
Lith
uani
a
*Ser
bia
7% 5%
*Bos
nia
*Mac
edon
ia
184 182 166
Turk
ey
153 149 146
55
143 135
84
132 119
127 119
108
165
98 96 82 76 75
64 49 46
37 18 11 8
101
Row Labels Distinct Count of Medicine Name 2014 45 2015 45 2016 37 2017 41 2018 54
The rate of availability is the number of medicines available to patients in European countries (for most countries this is the point at which the product gains access to the reimbursement list*), inc. limited availability
Num
ber o
f pro
duct
s
Availability
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
54
Rate of availability (%, 2014 – 2018)
8% 5% 7%
8%
3% 8%
9% 5%
4% 6%
6%
9%
5%
6% 5% 8%
9% 8%
0% 10% 20% 30% 40% 50% 60% 70% 80% 90%
100%
85% 86%
14%
33%
EMA
appr
oval
s
Sw
eden
2%
Den
mar
k
51% 57%
Finl
and
Ger
man
y
15%
1%
82%
60%
Eng
land
*Mac
edon
ia
10%
70%
Aus
tria
23%
58%
20%
22%
40%
2%
64%
Sw
itzer
land
77%
23%
37%
Italy
3% 75%
24%
46%
31%
25%
28%
43%
26%
30%
Net
herla
nds
12%
Irela
nd
14%
30%
11%
Fran
ce
21%
12%
48%
1%
Nor
way
5%
Spa
in
16%
33%
Sco
tland
56%
44%
48%
4%
Rom
ania
1%
Por
tuga
l
51%
17%
30%
0%
52%
Slo
vaki
a
44%
44%
Cze
ch
Cro
atia
38%
11%
43%
Gre
ece
34%
11%
13%
42%
30% 25%
2%
58%
Hun
gary
38%
59%
Bul
garia
31%
Icel
and
10%
60%
Est
onia
12%
18%
Bel
gium
48%
Pol
and
25%
68%
19%
72%
Latv
ia
70%
Turk
ey
10%
16%
66%
Lith
uani
a
25%
58%
*Ser
bia
22%
83%
Alb
ania
1% 4%
1%
85%
*Bos
nia
3% 1%
23%
72%
213
48%
2%
45%
Slo
veni
a
10%
The rate of availability is the number of medicines available to patients in European countries (for most countries this is the point at which the product gains access to the reimbursement list*). This includes all medicines status to provide a complete picture of the availability of the cohort of medicines studied.
Full public availability Not submitted by association Limited Availability Only available privately Not available
Avai
labi
lity
brea
kdow
n (%
)
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
55
Time to availability (2014 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).
485 543 582 597 692 695 726
817 910 930 932 940
0
200
400
600
800
1,000
1,200
1,400
1,600
1,800
2,000
2,200
915
***E
ngla
nd
Net
herla
nds
Cze
ch
Ger
man
y
123 145
Sw
itzer
land
434
Den
mar
k
Aus
tria
165 266 284
Sw
eden
*Bos
nia
305
Bel
gium
Finl
and
322
Lith
uani
a
Por
tuga
l
***S
cotla
nd
372
Cro
atia
466 435
Bul
garia
Nor
way
Spa
in
463 491
Icel
and
485
Pol
and
Slo
veni
a
743
Hun
gary
**Fr
ance
Turk
ey
490
*Mac
edon
ia
665
Italy
Gre
ece
584 540
Irela
nd
Alb
ania
620
Slo
vaki
a
Est
onia
Latv
ia
Rom
ania
1,119
*Ser
bia
Tim
e (d
ays)
Available medicines / 213 Dates submitted / 213
182 166 184 149 143 159 179 153 127 132 76 119 108 46 165 98 135 108 146 96 14 84 101 75 49 100 119 82 64 55 37 8 11 18182 117 184 149 143 152 179 153 127 132 71 119 108 42 165 84 125 106 122 67 13 68 100 71 16 97 103 82 60 53 37 7 11 18
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
56
Median time to availability (2014 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).
Tim
e (d
ays)
54 75 82
204 206 212 279 312
354 358 379 383 389 408 410 427 446 452 453 454 472 519 547 551 560
596
696 700 701 786 814
918 924
1,021 D
enm
ark
Hun
gary
Aus
tria
Ger
man
y
Sw
itzer
land
***E
ngla
nd
Pol
and
Net
herla
nds
Finl
and
***S
cotla
nd
Rom
ania
Spa
in
Lith
uani
a
Bel
gium
Turk
ey
Italy
Sw
eden
Icel
and
Alb
ania
Slo
veni
a
Irela
nd
Gre
ece
Cro
atia
**Fr
ance
Slo
vaki
a
Latv
ia
*Mac
edon
ia
Est
onia
Cze
ch
Bul
garia
Por
tuga
l
*Bos
nia
*Ser
bia
Nor
way
Median
100% 50% 75% 25%
5% Charcoal
IQVIA Template (V2.0.1)
© 2020. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries.
Contact details: General queries: Francois Bouvy, EFPIA [email protected] Additional analyses: Per Troein, IQVIA [email protected] Country-specific insights: Local Associations