Copyright © 2017 IQVIA. All rights reserved.
3 April 2019
EFPIA Patient W.A.I.T. Indicator 2018 survey
1
• “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) 3, or 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 effective marketing authorisation in non-EEA countries) 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
Introduction (1)
2
• The Patients W.A.I.T. Indicator gives a snapshot of the 2 parameters at a cut-off date (19th December 2018) – data from medicines cohorts dropping out of the reference period are not included.
• Waiting times reflected in the Patients W.A.I.T. Indicator include any delay, 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)
3
Method for product selection
EMA list of authorisations (September 2018)Step 1
Products in scopeStep 2• Status: Authorised, Withdrawn, Suspended• Non-generic• Non-biosimilar• Remove ATC K, V & T• Include combinations (both products can have already been approved before)• Products with EMA authorisation year 2014, 2015, 2016, 2017
Remove products with an active substance which has an EMA authorisation prior to 2014Step 3
• New combination products (even those containing already approved active substances) are included• New formulations are excluded• New indications of already approved active substances, leading to a separate marketing authorisation only for an orphan drug are included• Duplicates (products launched on the same date, but same company for same indication ) - only one is included but both product names are added on one line
Additional criteria for products with active substances with multiple MA’s between 2014-2017Step 4
4
• 121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products which were withdrawn between 2015-2017)
• The 2018 study provides an analysis of products approved between 2015-2016-2017, for the following datasets:a) All 121 products: 45 in 2015, 38 in 2016, 38 in 2017b) 38 Orphan products: 13 in 2015, 13 in 2016, 12 in 2017c) 31 Oncology products: 10 in 2015, 12 in 2016, 9 in 2017d) 24 Combination products: 10 in 2015, 8 in 2016, 6 in 2017
• Definitions:- Orphan status from EMA (September 2018)- Oncology products flagged using IQVIA MIDAS Oncology market definition*- Combination products include any product with more than one molecule
• The date of availability cut off point is 19th December 2018 (except for Estonia, Iceland, Czech Republic, Latvia, Slovakia which had a few products with a reimbursement decision on 1st January 2019)
• 30 countries included in the study
* L1&L2&V3C&Revlimid&Xgeva&Proleukin&Pomalyst
Study scope
5
• 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 accessibility 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:
Availability and accessibility date
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) Available
Reimbursed on an individual basis, in some cases whilst reimbursement is pending Available (LA*)
Not reimbursed and only available at the patients expense Not available
Pending reimbursement and only available 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
*LA: product available for limited availability
6
• 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)
• Products which have been reimbursed with the following criteria are marked as “Available”, however have been flagged in the “Rate of Availability %” charts:
*Some innovative products can be made available prior to market authorization through early access schemes in countries. As these are not taken into account in the analysis in some countries, the average delay in these countries will be higher than in reality.
Products with particular reimbursement conditions
Reimbursement conditions for medicine
Restricted patient cohort (specific populations)
Individual reimbursement (case by case / named patient program)
Special programs (e.g early access scheme)*
Conditional reimbursement
7
The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list*.
Rate of Availability
0 3 7 10 7 12 12 11 16 22 17 21 26 23 27 22 25 26 32 31 31 32 32 34 36 38 38 39 38 40 45
1 3 2 5 2 9 8 612 14 15
16 19 16 17 21 2221 19 25 25 24 30 26 29 32 34 32 35
38
01 4 5 5
2 5 69 15 12 9 10 12 23 18 20 17 23 19 18 27
25 32 29 31 29 34 3138
0
20
40
60
80
100
120
140
Macedonia
Serbia
Latvia
Lithuan
ia
Croatia
Turkey
Bulgaria
Poland
Estonia
Czech
Rep.
Hungar
y
Icelan
d
Irelan
d
Portuga
l
Slovakia
Norway
Slovenia
Belgium
Greec
e
France
FinlandSpa
in
Sweden
Switzer
land
Netherla
nds
Italy
Denmar
k
Austri
a
Germany UK
EUROPE
Rate
of A
vaila
bilit
y
2015 2016 2017 Data N/A EMA approved
Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)*See next slide for country specific definitions
8
Definition of AvailabilityFor most countries a product is available if it gains access to the national reimbursement list. 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.• Czech Republic: A medicine is available if it is on the reimbursement list, or funded through the hospital
• 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).
• 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 either gains access to the reimbursement list or is available through a named patient scheme. Delay calculated using local market authorisation dates.
• UK: Two data sources are used- IQVIA sales data and publication of NICE opinion. IQVIA sales data is taken as the main source of information for availability; NICE opinion is used if sales aren’t captured by IQVIA.
9
The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.
Rate of Availability (%)
3%9% 13% 14% 16%
19% 20%23%
36% 38% 40% 42% 43% 45%51% 53% 56% 58% 60% 62% 62%
69% 74% 78% 79% 83% 84% 86% 88%
24%
36% 23%
87%
11%
84% 81% 80% 77%64% 62% 60% 58% 57% 55%
49% 47% 44% 41% 40% 38% 38%30%
26% 22% 21% 17% 16% 14% 12%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Macedo
niaSerbi
aLa
tvia
Lithu
ania
Croatia
Turkey
Bulgaria
Poland
Estonia
Czech
Rep
.
Hunga
ry
Icelan
d
Ireland
Portuga
l
Slovak
ia
Norway
Sloven
ia
Belgium
Greece
France
Finland
Spain
Sweden
Switzerl
and
Netherla
nds Italy
Denmark
Austria
German
y UK
Rate
of A
vaila
bilit
y
Available Not Available Data N/A
Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)
10
The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list*.
Rate of Availability (%)
0% 3% 2%11%
7…5% 0… 1%
3%1%
16%
30%
1%
22% 36%
1% 1% 0%
9%31%
0%2%
31%
15%4% 0%
14%
29%
0%
26%
7%2% 7% 11%
19% 19% 20%35%
22%
10%
41%
21%
9%
50% 52% 56%49%
30%
62% 60%
37%59%
74% 79%
69%
55%
86%
61%
24%
36% 23%
87%
11%
84% 81% 80% 77%64% 62% 60% 58% 57% 55%
49% 47% 44% 41% 40% 38% 38% 30%26% 22% 21% 17% 16% 14% 12%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Macedo
niaSerbi
aLa
tvia
Lithu
ania
Croatia
Turkey
Bulgaria
Poland
Estonia
Czech
Rep
.
Hunga
ry
Icelan
d
Ireland
Portuga
l
Slovak
ia
Norway
Sloven
ia
Belgium
Greece
France
Finland
Spain
Sweden
Switzerl
and
Netherla
nds Italy
Denmark
Austria
German
y UK
Rate
of A
vaila
bilit
y
Available (LA) Available Not Available Data N/A
Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)*Available (LA) - products which have been reimbursed or are pending reimbursement, with specific conditions - see next slide for country specific definitions
11
Definition of Available with special reimbursement conditions
• 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. • 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• 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.• UK: England, Scotland and Wales do not limit reimbursement for medicines for specific groups of patients relative to license. But following a health technology appraisal by the national appraisal body (National Institute
of health and Clinical Evidence, Scottish Medicines Committee, All Wales Medicines Strategy Group) recommended usage of medicines may be restricted to a subgroup of patients relative to the scope of the license under consideration.
12
The rate of availability, measured by the number of medicines available to patients in European countries as of 2018, compared to the rate of availability in the 2017 W.A.I.T. indicator study
Rate of Availability (%)
Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)Note: there are differences in country scope and methodology for product selection between the 2017 and 2018 studies (26 countries included in 2017 study; 30 countries in 2018 study)
14% 20% 21% 23% 28%31% 37% 39% 40% 41% 47% 49% 51% 53% 53% 55% 59% 68% 69% 71% 73% 77% 79% 82% 85%
33%
86% 80% 79% 77% 72%
3%
60% 61%34%
59% 53% 51% 49% 47%28% 34%
38%32% 31% 29% 27% 23% 21% 18% 15%
0%
20%
40%
60%
80%
100%
Serbia
Latvi
a
Lithu
ania
Estonia
Bulgaria
Croatia
Poland
Hunga
ry
Ireland
Portuga
l
Slovak
ia
Belgium
Sloven
ia
France
Czech
Rep
.
Norway
Sweden
Spain
Finland
Switzer
land
Netherla
nds Italy
Austria
Denmark UK
German
yRate
of A
vaila
bilit
y
2017
stu
dy
(201
4-20
16)
3% 9% 13% 14% 16%19% 20% 23%
36% 38% 40% 42% 43% 45% 51% 53% 56% 58% 60% 62% 62% 69% 74% 78% 79% 83% 84% 86% 88%
24%36% 23%
87%
11%
84% 81% 80% 77%64% 62% 60% 58% 57% 55% 49% 47% 44% 41% 40% 38% 38% 30% 26% 22% 21% 17% 16% 14% 12%
0%
20%
40%
60%
80%
100%
Macedo
nia
Serbia
Latvi
a
Lithu
ania
Croatia
Turkey
Bulgaria
Poland
Estonia
Czech
Rep
.
Hunga
ry
Icelan
d
Ireland
Portuga
l
Slovak
ia
Norway
Sloven
ia
Belgium
Greec
e
France
Finland
Spain
Sweden
Switzer
land
Netherla
nds Italy
Denmark
Austria
German
y UK
Rate
of A
vaila
bilit
y
Available Not Available Data N/A
2018
stu
dy
(201
5-20
17)
13
The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes
Length of market access delays (average)
925
726
634 618 612 603547 539
498 492 486449 445 428 426 417 402 401 395 385
333292 291 288 269
220 209171 146 119
0100200300400500600700800900
1000
Serbia
Lithu
ania
Portug
al
Czech
Rep.
Poland
Estonia
Bulgari
a
Slovak
ia
Franc
eLa
tviaIre
land
Hunga
ry
Croatia
Greece
EU29 av
erage
Sloven
iaIta
ly
Icelan
d
Belgium Spa
in
Norway
Turke
y
Finlan
d
Austria
Sweden
Netherl
ands UK
Switzerla
nd
Denmark
German
y
Aver
age
dela
y (da
ys)
In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.
• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.
• Average of 29 European countries in the analysis (excludes Macedonia)
14
The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes
Length of market access delays (average)
925
726
634 618 612 603547 539
498 492 486449 445 428 417 402 401 395 385
333292 291 288 269
220 209171 146 119
0
10000
20000
30000
40000
50000
60000
70000
80000
0100200300400500600700800900
1000
Serbia
Lithu
ania
Portug
al
Czech
Rep.
Poland
Estonia
Bulgari
a
Slovak
ia
Franc
eLa
tviaIre
land
Hunga
ry
Croatia
Greece
Sloven
iaIta
ly
Icelan
d
Belgium Spa
in
Norway
Turke
y
Finlan
d
Austria
Sweden
Netherl
ands UK
Switzerla
nd
Denmark
German
y GDP
per c
apita
, PPP
(cur
rent
inte
rnat
iona
l $),
2017
Aver
age
dela
y (da
ys)
Average delay (days) GDP per capita, PPP (current international $)
Source: GDP per capita, PPP (current international $), 2017 - World Development Indicators, World Bank
15
The average time between marketing authorisation and patient access - compared to the average delay in the 2017 W.A.I.T. indicator study
Length of market access delays (average)
Note: there are differences in methodology for product selection between the 2017 and 2018 studies; chart only shows countries overlapping both studies
979
563
637
356
632
436
535
419
500467
408 391
479 494
383411
374
291250
329281
228
111 123155
106
925
726
634 618 612 603547 539
498 492 486449 445
417 402 395 385333
291 288 269220 209
171 146 119
0
200
400
600
800
1000
1200
Serbia
Lithu
ania
Portug
al
Czech
Rep.
Poland
Estonia
Bulgari
a
Slovak
ia
Franc
eLa
tviaIre
land
Hunga
ry
Croatia
Sloven
iaIta
ly
Belgium Spa
in
Norway
Finlan
d
Austria
Sweden
Netherl
ands UK
Switzerla
nd
Denmark
German
y
Aver
age
dela
y (da
ys)
2017 study: 2014-2016 2018 study: 2015-2017
16
The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes
Length of market access delays (average, maximum, minimum)
925
726634 618 612 603
547 539 498 492 486 449 445 428 417 402 401 395 385333 292 291 288 269
220 209 171 146 119
0
200
400
600
800
1000
1200
1400
1600
0
20
40
60
80
100
120
Serbia
Lithu
ania
Portug
al
Czech
Rep
.
Poland
Estonia
Bulgari
a
Slovak
ia
France
Latvi
a
Irelan
d
Hunga
ry
Croatia
Greece
Sloven
iaIta
ly
Icelan
d
Belgium Spa
in
Norway
Turkey
Finlan
d
Austria
Sweden
Netherl
ands UK
Switzerl
and
Denmark
German
y
Del
ay (d
ays)
No. o
f pro
duct
s in
sam
ple
# of Products with accessibility date Maximum delay Minimum delay Average
• In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.
• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.
17
The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes
Length of market access delays (median)
969
677
585 577 547 534493 492 457
418 411 407 398 382 369 352 351 344 340 320 303 272 259196 167 138 128
75 67 47
0
200
400
600
800
1000
1200
Serbia
Lithu
ania
Poland
Portug
al
Czech
Rep.
Bulgari
a
Slovak
ia
Estonia
Franc
e
Croatia
Hunga
ry
Sloven
ia
Greece
Irelan
d
EU29 Ave
rage
Icelan
dLa
tvia
Belgium Ita
lySpa
inTu
rkey
Norway
Austria
Sweden
Finlan
d
Netherl
ands UK
Switzerla
nd
Denmark
German
y
Med
ian
dela
y (da
ys)
In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.
• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.
• Average of 29 European countries in the analysis (excludes Macedonia)
18
The average time between marketing authorisation and patient access - compared to the average delay in the 2017 W.A.I.T. indicator study
Length of market access delays (median)
1,021
525
638601
316
534
374 383
460429
387454
282
419378
343 347
235288
216
0
163
44 56 73 51
969
677
585 577547 534
493 492457
418 411 407 382351 344 340 320
272 259196
167138 128
75 67 47
0
200
400
600
800
1000
1200
Serbia
Lithu
ania
Poland
Portug
al
Czech
Rep.
Bulgari
a
Slovak
ia
Estonia
Franc
e
Croatia
Hunga
ry
Sloven
iaIre
land
Latvia
Belgium Ita
lySpa
in
Norway
Austria
Sweden
Finlan
d
Netherl
ands UK
Switzerla
nd
Denmark
German
y
Aver
age
dela
y (da
ys)
2017 study (2014-2016) 2018 study (2015-2017)
Note: there are differences in methodology for product selection between the 2017 and 2018 studies; chart only shows countries overlapping both studies
19
• 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, over 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 7 across Europe, with patients in Northern /Western Europe accessing new products 100-200 days after market authorisation and patients mainly in Southern/ Eastern Europe between 600-1000 days.
• Countries with more products available tend to have faster access to medicines.
• 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 Estonia (21 vs. 1443 days), Ireland (0 vs. 1321 days) and Austria (33 vs. 1383 days).
• Comparison to 2017 W.A.I.T. indicator study: of the countries overlapping both analyses, 65% countries have a higher rate of availability, and 58% countries have a longer delay in the 2018 study.
Key observations
20
Orphans
21
The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.
Rate of Availability
0 0 0 1 2 1 2 3 5 6 5 6 4 6 5 5 6 8 7 10 8 8 11 9 10 11 12 12 12 13 13
0 00 1 0
3 1 1 4 54
5 7 46
6 87
6 98
8 810 10 10 13 12 13
0 0 1 0 3 31 1
2 42 2 5
5 3 4 2 6
8 7 10 98 8 9
10 11 12
0
5
10
15
20
25
30
35
40
Macedonia
Serbia
Croatia
Latvia
Lithuan
ia
Poland
Turkey
Bulgaria
Czech
Rep.
Estonia
Icelan
d
Irelan
d
Hungary
Portuga
l
Slovenia
Norway
Slovakia
Spain
Belgium
Finland
Sweden
Switzerl
and
Greece
France
Netherla
nds
Italy
Austria
Denmark UK
Germany
EUROPE
Rate
of A
vaila
bilit
y
2015 2016 2017 Data N/A EMA approved
Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)Orphan status from EMA (September 2018)
Orphans
22
The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.
Rate of Availability (%)
3% 3% 5%13%
13%18%
18% 18%29% 29% 32% 34% 37% 37%
45% 45% 50% 50% 53%66% 68% 71% 71% 76% 79% 82%
92% 95%
18%26%
13%
26%
95%87% 87% 82% 82% 82%
71% 71% 68% 66% 63% 63%55% 55% 50% 50% 45%
34% 32% 29% 29% 24% 21% 18%8% 5%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Macedo
niaSerbi
a
Croatia
Latvia
Lithu
ania
Poland
Turkey
Bulgaria
Czech
Rep
.
Estonia
Icelan
d
Ireland
Hunga
ry
Portuga
l
Sloven
ia
Norway
Slovak
iaSpain
Belgium
Finland
Sweden
Switzerl
and
Greece
France
Netherla
nds Italy
Austria
Denmark UK
German
y
Rate
of A
vaila
bilit
y
Available Not Available Data N/A
Rate of availability for Orphans is at least 10% lower than all products approved 2015-2017
Rate of availability for Orphans is at least 10% higher than all products approved 2015-2017
Orphans
Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)Orphan status from EMA (September 2018)
23
The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes
Length of market access delays (average)
1,141
940
802 775736
693 690 677
551 537 512 493 493 477 469 464 435 428 399 373 368 351272 262 248 239 207
156113
0
200
400
600
800
1000
1200
Poland
Estonia
Czech
Rep.
Irelan
d
Portug
al
Bulgari
a
Slovak
ia
Lithu
ania
Franc
e
Icelan
dSpa
in
EU28 Ave
rage
Croatia
Finlan
d
Sloven
ia
Belgium
Greece Ita
ly
Hunga
ry
Norway
Sweden
Latvia
Turke
y
Austria UK
Netherl
ands
Switzerla
nd
Denmark
German
y
Aver
age
dela
y (da
ys)
In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in
the analysis, the average for France is higher than in reality.• Average of 28 European countries in the analysis (excludes Macedonia, Serbia)• Orphan status from EMA (September 2018)
Average delay for Orphans is at least 100 days longer than all products approved 2015-2017
Average delay for Orphans is at least 100 days shorter than all products approved 2015-2017
Orphans
24
The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes
Length of market access delays (median)
1,141
1,038
769 740 713 685 677 651597
554 519 493 466 459 444 420 396 385 376 351 329 323272
206140 132 126
7434
0
200
400
600
800
1000
1200
Poland
Estonia
Portug
al
Irelan
d
Czech
Rep.
Bulgari
a
Lithu
ania
Slovak
ia
Finlan
d
Franc
e
Icelan
d
Croatia
EU28 av
erage
Sloven
iaSpa
in
Hunga
ry
Greece
Belgium
Norway
Latvia Ita
ly
Sweden
Turke
y
Netherl
ands UK
Switzerla
nd
Austria
Denmark
German
y
Med
ian
dela
y (da
ys)
In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.
• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.
• Average of 28 European countries in the analysis (excludes Macedonia, Serbia)• Orphan status from EMA (September 2018)
Orphans
25
Oncology
26
The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.
Rate of Availability
0 1 1 25 4 4 5 4 6 5 7 6 6 7 6 7 8 7 7 9 8 7 8 10 9 9 10 9 10
1 03 2
1 1 2 2 46
55 5
8 7 9 9 8 10 88 10 10
1110 12 12 12 12 12
0 0
1 2 1 1 1 1
1 6 4 63 4 4 4 5 4 7
6 5 87 7
8 8 8 9 9
0
5
10
15
20
25
30
35
Macedonia
Latvia
Serbia
Poland
Croatia
Estonia
Lithuan
ia
Turkey
Czech
Rep.
Bulgaria
Irelan
d
Hungary
Icelan
d
Norway
Slovakia
Portuga
lSpa
in
Slovenia
Belgium
Finland
Sweden
France
Greece
Italy
Denmark
Switzerl
and
Austria
Netherla
nds
Germany UK
EUROPE
Rate
of A
vaila
bilit
y
2015 2016 2017 Data N/A EMA approved
Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)Oncology market definition: L1&L2&V3C&Revlimid&Xgeva&Proleukin&Pomalyst
Oncology
27
The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.
Rate of Availability (%)
3%16%
19% 19%19% 23%
26% 29%42%
52% 52% 55% 55% 58% 61% 65% 68% 68% 71% 74% 74%81% 84% 87%
94% 94% 97% 97%
19%
45%55%
84%
26%
81% 81% 77% 74% 71%58%
48% 48% 45% 45% 42% 39% 35% 32% 32% 29% 26% 26%19% 16% 13%
6% 6% 3% 3%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Macedo
niaLa
tviaSerbi
a
Poland
Croatia
Estonia
Lithu
ania
Turkey
Czech
Rep
.
Bulgaria
Ireland
Hunga
ry
Icelan
d
Norway
Slovak
ia
Portuga
lSpain
Sloven
ia
Belgium
Finland
Sweden
France
Greece Ita
ly
Denmark
Switzerl
and
Austria
Netherla
nds
German
y UK
Rate
of A
vaila
bilit
y
Available Not Available Data N/A
Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)Oncology market definition: L1&L2&V3C&Revlimid&Xgeva&Proleukin&Pomalyst
Rate of availability for Oncologics is at least 10% lower than all products approved 2015-2017
Rate of availability for Oncologics is at least 10% higher than all products approved 2015-2017
Oncology
28
The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes
Length of market access delays (average)
988 981902
761 755665
586 573536 519 496
445 428 425 418 413 395 389 368318 309 295 281 253 232 198 163
12482 67
0
200
400
600
800
1000
1200
Estonia
Latvia
Lithu
ania
Czech
Rep.
Portug
al
Slovak
ia
Bulgari
a
Irelan
dFra
nce
Serbia
Sloven
ia
EU29 av
erage
Greece
Croatia
Icelan
d
Belgium Spa
in
Norway Ita
ly
Poland
Switzerla
nd
Hunga
ry
Sweden
Turke
y
Finlan
d
Austria
Netherl
ands UK
German
y
Denmark
Aver
age
dela
y (da
ys)
In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in
the analysis, the average for France is higher than in reality.• Average of 29 European countries in the analysis (excludes Macedonia)• Oncology market definition: L1&L2&V3C&Revlimid&Xgeva&Proleukin&Pomalyst
Average delay for Oncologics is at least 100 days longer than all products approved 2015-2017
Average delay for Oncologics is at least 100 days shorter than all products approved 2015-2017
Oncology
29
The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes
Length of market access delays (median)
997 987 981
855771
706623
559 538 519443 436 420 418 388 381 348 348 343 318
264 251211 187
10058 58 52 33 0
0
200
400
600
800
1000
1200
Estonia
Lithu
ania
Latvia
Portug
al
Czech
Rep.
Slovak
iaIre
land
Bulgari
a
Franc
eSerb
ia
Croatia
Sloven
ia
EU29 av
erage
Norway
Icelan
d
Greece
Belgium Spa
inIta
ly
Poland
Turke
y
Hunga
ry
Sweden
Switzerla
nd
Netherl
ands
Austria UK
Denmark
German
y
Finlan
d
Med
ian
dela
y (da
ys)
In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.
• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.
• Average of 29 European countries in the analysis (excludes Macedonia)• Oncology market definition: L1&L2&V3C&Revlimid&Xgeva&Proleukin&Pomalyst
Oncology
30
• Patient access to new Orphan and Oncology medicines is highly varied across Europe, with the greatest rate of availability in Northern and Western European countries.
• Orphan drugs- In over 80% of the countries, the rate of availability is lower for Orphan drugs compared to all products approved
between 2015-2017
- 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 4 months to 3 years
• Oncology drugs- In 73% of the countries, the rate of availability is higher for Oncology products compared to all products approved
between 2015-2017
- The average delay between market authorisation and patient access for Oncology products is between 2 months to over 2.5 years
Key observations: Orphan and Oncology drugs
31
Combination products
32
The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.
Rate of Availability
0 1 2 2 3 2 3 3 3 4 4 5 7 6 7 5 6 7 6 7 6 7 7 6 7 8 9 9 8 9 10
13 3 3 3 2 4 3
6 6 4 56
6 6 6 6 6 8 7 7 7 68 7 7 8 8 8
0
1 1 33 4
3 2 3 43 6 5 4 5 5 4 4 4 6 6
5 5 6 6 6 6
0
5
10
15
20
25
30
Macedonia
Serbia
Turkey
Croatia
Bulgaria
Poland
Latvia
Lithuan
ia
Estonia
Hungary
Icelan
d
Portuga
l
Slovakia
France
Greece
Belgium
Germany
Irelan
d
Slovenia
Czech
Rep.
FinlandSpa
in
Switzerl
and
Norway
Netherla
nds
Austria UK
Italy
Sweden
Denmark
EUROPE
Rate
of A
vaila
bilit
y
2015 2016 2017 Data N/A EMA approved
Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)
Combinations
33
The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.
Rate of Availability (%)
8%21%
25% 25%29% 33% 42% 46%
54% 54% 58% 63% 67% 71% 71% 71% 71% 75% 75% 75% 75% 79% 79%88% 88% 92% 92% 96%
29%
46%
92%
8%
75% 75%
13%
67%58% 54%
46% 46% 42%38% 33% 29% 29% 29% 29% 25% 25% 25% 25% 21% 21%
13% 13% 8% 8% 4%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Macedo
niaSerbi
aTurk
ey
Croatia
Bulgaria
Poland
Latvia
Lithu
ania
Estonia
Hunga
ry
Icelan
d
Portuga
l
Slovak
ia
France
Greece
Belgium
German
y
Ireland
Sloven
ia
Czech
Rep
.
Finland
Spain
Switzerl
and
Norway
Netherla
nds
Austria UK
Italy
Sweden
Denmark
Rate
of A
vaila
bilit
y
Available Not Available Data N/A
Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)
Rate of availability for Combinations is at least 10% lower than all products approved 2015-2017
Rate of availability for Combinations is at least 10% higher than all products approved 2015-2017
Combinations
34
The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes
Length of market access delays (average)
969
640
509 501446 444 430 423 410 407 404 402 388 386 369 355 336 332 324 319
273 271 266220
181 157 153 130 12172
0
200
400
600
800
1000
1200
Serbia
Lithu
ania
Latvia
Portug
al
Hunga
ryTu
rkey
Croatia
Greece
Bulgari
a
Franc
e
Czech
Rep.
Slovak
ia
Poland
Estonia Ita
ly
EU29 av
erage
Belgium
Sloven
ia
Norway
Irelan
d
Austria
Spain
Icelan
d
Netherl
ands
Finlan
d
Sweden
Denmark UK
German
y
Switzerla
nd
Aver
age
dela
y (da
ys)
In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in
the analysis, the average for France is higher than in reality.• Average of 29 European countries in the analysis (excludes Macedonia)
Average delay for Combinations is at least 100 days longer than all products approved 2015-2017
Average delay for Combinations is at least 100 days shorter than all products approved 2015-2017
Combinations
35
The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes
Length of market access delays (median)
969
501 471 444 424 409370 363 351 346 338 337 329 327 319 299 295 279 259 259 231 225 212
15897 84 54 48 43
00
200
400
600
800
1000
1200
Serbia
Portug
al
Lithu
ania
Turke
y
Greec
e
Bulgari
a
Hunga
ry
Czech
Rep
.
Latvi
a
Estonia
Croatia
Sloven
ia
Poland
Slovak
iaIta
ly
Fran
ce
EU29 av
erag
e
Austria
Belgium
Irelan
dSpa
in
Icelan
d
Norway
Nether
lands UK
Sweden
Denmark
Switzerl
and
German
y
Finlan
d
Med
ian
dela
y (da
ys)
In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.
• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.
• Average of 29 European countries in the analysis (excludes Macedonia)
Combinations
36
• Patient access to new combination medicines is highly varied across Europe
• Over 40% of these combinations are for HIV or Hep C. One product is an Oncology combination.
• In 87% of the countries, the rate of availability is higher for combination products compared to all products approved between 2015-2017
• Over 80% of the countries have a shorter average delay to EMA authorisation for combination drugs compared to all products approved 2015-2017
• The average delay between market authorisation and patient access for combination products is between 2.4 months to over 2.5 years
Key observations: Combination drugs
37
- Products approved between 2014-2015-2016-2017 (165 products)
- Products approved between 2014-2015-2016 (127 products)
Appendix
38
The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.
Rate of Availability
0 7 13 8 13 14 20 19 20 20 28 28 31 31 33 30 32 31 32 28 31 34 36 36 41 42 40 40 38 41 443
7 7 10 12 12 11 16 2122 17
26 23 27 22 25 26 32 31 31 32 32 34 36 38 38 39 38 40 45
01
3 5 2 29 8 6
1512 14
16 19 1617 21 22 21 25 19 25 24 30 26 29 32 34 32 35
38
0
1 5 4 52 5 6
12 9 159 10 12 23 18 20 17 19 23
18 27 25 32 29 31 29 34 3138
0
20
40
60
80
100
120
140
160
180
Macedonia
Serbia
Latvia
Croatia
Lithuan
ia
Turkey
Bulgaria
Poland
Estonia
Icelan
d
Czech
Rep.
Hungar
y
Irelan
d
Portuga
l
Slovakia
Norway
Slovenia
Belgium
Greec
e
Finland
France
Spain
Sweden
Switzer
land
Netherla
nds
Italy
Denmar
k
Austri
a
Germany UK
EUROPE
Rate
of A
vaila
bilit
y
2014 2015 2016 2017 Data N/A EMA approved
Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)
2014-2017
39
The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.
Rate of Availability (%)
15% 15%18% 20%
26% 26%29%
41% 43% 45%50% 50% 53% 56% 58% 60% 62% 62% 63% 66%
72% 76%82% 84% 85% 86% 86% 89%
29%
36% 24%
12%
82% 80%74% 74% 71%
59% 57% 55%50% 50% 47% 44% 42% 40% 38% 38% 37% 34%
27%24%
18% 16% 15% 14% 14% 11%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Macedo
nia
Serbia
Latvi
a
Croatia
Lithu
ania
Turkey
Bulgaria
Poland
Estonia
Icelan
d
Czech
Rep
.
Hunga
ry
Ireland
Portuga
l
Slovak
ia
Norway
Sloven
ia
Belgium
Greec
e
Finland
France
Spain
Sweden
Switzer
land
Netherla
nds Italy
Denmark
Austria
German
yUK
Rate
of A
vaila
bilit
y
Available Not Available Data N/A
Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)
2014-2017
40
The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.
Rate of Availability (%)
0% 4% 1% 7% 1… 6% 0… 1%2%
30%
1%
15%
1%
22%
45%
2% 1% 0%
8%
0%
30%
1%
33%
12% 7%0%
14%
29%
0%
24%13%
8%5% 14%
26% 25% 27%
12%
42%
30%49%
28%
8%
53% 58% 60%54%
62%
33%
65%
39%
64% 75% 84%
72%
57%
86%
65%
29%
36% 24%12%
82% 80%74% 74% 71%
59% 57% 55% 50% 50% 47% 44%42% 40% 38% 38% 37% 34% 27% 24%
18% 16% 15% 14% 14% 11%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Macedo
niaSerbi
aLa
tvia
Croatia
Lithu
ania
Turkey
Bulgaria
Poland
Estonia
Icelan
d
Czech
Rep
.
Hunga
ry
Ireland
Portuga
l
Slovak
ia
Norway
Sloven
ia
Belgium
Greece
Finland
France
Spain
Sweden
Switzerl
and
Netherla
nds Italy
Denmark
Austria
German
y UK
Rate
of A
vaila
bilit
y
Available (LA) Available Not Available Data N/A
Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)Available (LA) - products which have been reimbursed or are pending reimbursement, with specific conditions
2014-2017
41
The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes
Length of market access delays (average)
1,099
838757
682 681 674 658 650
527 519 505 490 484 481 473 451 447 437 437 405 394345 313 308 272
230 229150 148 116
0
200
400
600
800
1000
1200
Serbia
Lithu
ania
Poland
Bulgari
a
Portug
al
Czech
Rep.
Estonia
Latvia
Franc
e
Slovak
ia
Sloven
iaIre
land
Croatia
Greece
EU29 av
erage Ita
ly
Hunga
ry
Belgium
Icelan
dSpa
in
Norway
Turke
y
Finlan
d
Austria
Sweden
Netherl
ands UK
Denmark
Switzerla
nd
German
y
Aver
age
dela
y (da
ys)
In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.
• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.
• Average of 29 European countries in the analysis (excludes Macedonia)
2014-2017
42
The average time between marketing authorisation and patient access - the number of days elapsing
from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the
day of completion of post-marketing authorisation administrative processes
Length of market access delays (average, maximum, minimum)
1099
838757
682 681 674 658 650
527 519 505 490 484 481 451 447 437 437 405 394345 313 308
272230 229
150 148 116
0
200
400
600
800
1000
1200
1400
1600
1800
2000
0
20
40
60
80
100
120
140
160
Ser
bia
Lith
uania
Pol
and
Bul
garia
Por
tuga
l
Cze
ch R
ep.
Est
onia
Latv
ia
Fra
nce
Slo
vakia
Slo
veni
a
Irelan
d
Cro
atia
Gre
ece
Italy
Hun
gary
Bel
gium
Icelan
d
Spa
in
Nor
way
Tur
key
Finla
nd
Aus
tria
Swed
en
Net
herla
nds
UK
Den
mar
k
Switz
erland
Ger
man
y
Del
ay (d
ays)
No. o
f pro
duct
s in
sam
ple
# of Products with accessibility date Maximum delay Minimum delay Average
• In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.
• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.
2014-2017
43
The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes
Length of market access delays (median)
1,212
811 774
630 613558 532
487 484 452 446 425 424 410 409 407 376 365 364 348 320 314259
204 199143 118
74 68 50
0
200
400
600
800
1000
1200
1400
Serbia
Lithu
ania
Poland
Portug
al
Bulgari
a
Czech
Rep.
Estonia
Latvia
Franc
e
Greece
Sloven
ia
Croatia
Slovak
ia
Hunga
ry
EU29 av
erage
Icelan
d
Belgium
Irelan
dIta
lySpa
inTu
rkey
Norway
Austria
Sweden
Finlan
d
Netherl
ands UK
Switzerla
nd
Denmark
German
y
Med
ian
dela
y (da
ys)
In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.
• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.
• Average of 29 European countries in the analysis (excludes Macedonia)
2014-2017
44
- Products approved between 2014-2015-2016-2017 (165 products)
- Products approved between 2014-2015-2016 (127 products)
Appendix
45
The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.
Rate of Availability
0 7 8 13 13 14 19 20 20 20 28 28 30 31 31 33 32 31 31 28 32 34 36 36 41 38 42 40 40 41 443 7 7 10 12 11 12 16 21
17 22 22 26 23 27 25 26 31 31 32 32 32 3436 38 38 38 39 40
45
01
5 3 2 28 9 6
15 14 12 17 16 19 16 21 22 19 25 21 25 24 30 26 32 29 32 34 3538
0
20
40
60
80
100
120
140
Macedonia
Serbia
Croatia
Latvia
Lithuan
ia
Turkey
Poland
Bulgaria
Estonia
Icelan
d
Hungary
Czech
Rep.
Norway
Irelan
d
Portuga
l
Slovakia
Slovenia
Belgium
France
Finland
Greece
Spain
Sweden
Switzerl
and
Netherla
nds
Germany Ita
ly
Denmark
Austria UK
EUROPE
Rate
of A
vaila
bilit
y
2014 2015 2016 Data N/A EMA approved
Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)The date of availability cut-off point is December 2018 for this study
2014-2016
46
The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.
Rate of Availability (%)
16% 18% 20% 22%
30% 32%33%
44% 46% 49% 54% 57% 57% 60% 61% 62% 64% 66% 67% 72% 72%79% 81% 85% 86% 87% 89% 91%
28%
33%12%
20%
80% 78%70% 68% 67%
56% 54% 51% 46% 43% 43% 40% 39% 38% 36% 34% 33% 28% 27%21% 19% 15% 14% 13% 11% 9%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Macedo
niaSerbi
a
Croatia
Latvia
Lithu
ania
Turkey
Poland
Bulgaria
Estonia
Icelan
d
Hunga
ry
Czech
Rep
.
Norway
Ireland
Portuga
l
Slovak
ia
Sloven
ia
Belgium
France
Finland
Greece
Spain
Sweden
Switzerl
and
Netherla
nds
German
yIta
ly
Denmark
Austria UK
Rate
of A
vaila
bilit
y
Available Not Available Data N/A
Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)The date of availability cut-off point is December 2018 for this study
2014-2016
47
The rate of availability, measured by the number of medicines available to patients in European countries as of 2018, compared to the rate of availability in the 2017 W.A.I.T. indicator study
Rate of Availability (%)
Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)Note: there are differences in country scope and methodology for product selection between the 2017 and 2018 studies (26 countries included in 2017 study; 30 countries in 2018 study); For the 2018 study, the date of availability cut-off point is December 2018
14% 20% 21% 23% 28%31% 37% 39% 40% 41% 47% 49% 51% 53% 53% 55% 59% 68% 69% 71% 73% 77% 79% 82% 85%
33%
86% 80% 79% 77% 72%
3%
60% 61%34%
59% 53% 51% 49% 47%28% 34%
38%32% 31% 29% 27% 23% 21% 18% 15%
0%
20%
40%
60%
80%
100%
Serbia
Latvi
a
Lithu
ania
Estonia
Bulgaria
Croatia
Poland
Hunga
ry
Ireland
Portuga
l
Slovak
ia
Belgium
Sloven
ia
France
Czech
Rep
.
Norway
Sweden
Spain
Finland
Switzer
land
Netherla
nds Italy
Austria
Denmark UK
German
yRate
of A
vaila
bilit
y
2017
stu
dy
(201
4-20
16)
9% 16% 18% 20% 22%30% 32%
33%44% 46% 49% 54% 57% 57% 60% 61% 62% 64% 66% 67% 72% 72% 79% 81% 85% 86% 87% 89% 91%
28%33% 12%
20%
80% 78% 70% 68% 67%56% 54% 51% 46% 43% 43% 40% 39% 38% 36% 34% 33% 28% 27% 21% 19% 15% 14% 13% 11% 9%
0%
20%
40%
60%
80%
100%
Macedo
nia
Serbia
Croatia
Latvi
a
Lithu
ania
Turkey
Poland
Bulgaria
Estonia
Icelan
d
Hunga
ry
Czech
Rep
.
Norway
Ireland
Portuga
l
Slovak
ia
Sloven
ia
Belgium
France
Finland
Greec
eSpain
Sweden
Switzer
land
Netherla
nds
German
yIta
ly
Denmark
Austria UK
Rate
of A
vaila
bilit
y
Available Not Available Data N/A
2018
stu
dy
(201
4-20
16)
2014-2016
48
The average time between marketing authorisation and patient access - the number of days elapsing
from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the
day of completion of post-marketing authorisation administrative processes
Length of market access delays (average)
1,099
910
770
709 707 693 692663
561 547 533 528 519 513 500 490 481 470 464 453429
365335 326
297250 250
160 157123
0
200
400
600
800
1000
1200
Ser
bia
Lith
uania
Polan
d
Cze
ch R
ep.
Por
tuga
l
Eston
ia
Bulga
ria
Latvia
Fran
ce
Slove
nia
Slova
kia
Cro
atia
Ireland
Gre
ece
EU29
ave
rage
Italy
Hun
gary
Belgium
Nor
way
Icelan
d
Spa
in
Turk
ey
Finlan
d
Aus
tria
Swed
en UK
Nethe
rland
s
Switz
erla
nd
Den
mar
k
Ger
man
y
Aver
age
dela
y (da
ys)
In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.
• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.
• Average of 29 European countries in the analysis (excludes Macedonia)• The date of availability cut-off point is December 2018 for this study
2014-2016
49
The average time between marketing authorisation and patient access - compared to the average delay in the 2017 W.A.I.T. indicator study
Length of market access delays (average)
Note: there are differences in methodology for product selection between the 2017 and 2018 studies; chart only shows countries overlapping both studiesFor the 2018 study, the date of availability cut-off point is December 2018
979
563
632
356
637
436
535
467500 494
419479
408 383 391 411
291
374
250
329281
111
228
123155
106
1099
910
770709 707 693 692
663
561 547 533 528 519490 481 470 464
429
335 326297
250 250
160 157123
0
200
400
600
800
1000
1200
Serbia
Lithu
ania
Poland
Czech
Rep.
Portug
al
Estonia
Bulgari
aLa
tvia
Franc
e
Sloven
ia
Slovak
ia
Croatia
Irelan
dIta
ly
Hunga
ry
Belgium
Norway
Spain
Finlan
d
Austria
Sweden UK
Netherl
ands
Switzerla
nd
Denmark
German
y
Aver
age
dela
y (da
ys)
2017 study (2014-2016) 2018 study (2014-2016)
2014-2016
50
The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes
Length of market access delays (average, maximum, minimum)
1099
910770
709 707 693 692 663561 547 533 528 519 513 490 481 470 464 453 429
365 335 326 297 250 250160 157 123
0
200
400
600
800
1000
1200
1400
1600
1800
2000
0
20
40
60
80
100
120
140
Serbia
Lithu
ania
Poland
Czech
Rep.
Portug
al
Estonia
Bulgari
aLa
tvia
Franc
e
Sloven
ia
Slovak
ia
Croatia
Irelan
d
Greece Ita
ly
Hunga
ry
Belgium
Norway
Icelan
dSpa
inTu
rkey
Finlan
d
Austria
Sweden UK
Netherl
ands
Switzerla
nd
Denmark
German
y
Del
ay (d
ays)
No. o
f pro
duct
s in
sam
ple
# of Products with accessibility date Maximum delay Minimum delay Average
• In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.
• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.
• The date of availability cut-off point is December 2018 for this study
2014-2016
51
The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes
Length of market access delays (median)
1,212
919
785692 656
587 553 528 506 478 473 458 443 436 434 407 406 403 386 376 354 347259 217 206 183
109 73 70 54
0
200
400
600
800
1000
1200
1400
Serbia
Lithu
ania
Poland
Portug
al
Bulgari
a
Czech
Rep.
Estonia
Franc
eLa
tvia
Greece
Sloven
ia
Croatia
Hunga
ry
Slovak
ia
EU29 av
erage
Icelan
dIre
land
Italy
Belgium
Norway
SpainTu
rkey
Austria
Sweden
Finlan
d
Netherl
ands UK
Switzerla
nd
Denmark
German
y
Med
ian
dela
y (da
ys)
In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.
• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.
• Average of 29 European countries in the analysis (excludes Macedonia)• The date of availability cut-off point is December 2018 for this study
2014-2016