EFPIA Patients W.A.I.T.
Indicator 2023 Survey
Published June 2024

Max Newton, Engagement Manager, GS&AR
Kelsey Stoddart, Consultant, GS&AR
Marco Travaglio, Consultant, GS&AR
Per Troein, VP, Strategic Partners© 2024. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries.

This year’s Patients W.A.I.T. indicator covers 36 countries andincludes the full EU27 countries
Indicators measure availability, limited availability and time to local authorisation dates
Foreword from the IQVIA project team:
The Patients W.A.I.T. (Waiting to Access Innovative Therapies) Indicator has
been running in evolving formats since 2004, and is the largest European study
into innovative medicines availability and the time to patient access.
It shows a set of Key Performance Indicators (KPIs) on the European accessenvironment for innovative medicines across 5 cohorts of medicines (allmedicines, oncology, orphan medicines, non-oncology orphan medicines, andcombination therapies) to show how different segments of the market areprioritised and how the market access landscape varies.
The charts in the following report includes data on 36 countries (27 EU, and 9
non-EU), giving a full European picture of availability. Information on the 167innovative medicines with central-marketing authorisation between 2019 and2022 are included, with the study running on a one year delay to permit
countries to include these medicines on their public reimbursement list,
meaning that the data on availability is accurate as of January 5th 2024. This
period is therefore inclusive of the COVID-19 pandemic. Although no significant
impact is noted in the indicator, the continued impact on launch has beenshown through other studies.
Local pharmaceutical industry associations provide the information directly to
IQVIA and EFPIA, and their methods are included within the appendix toensure full transparency to the study.

Notable exclusions:×
Ukraine×
Belarus×
Moldova×
Russia×
Kazakhstan
×Albania36

167

Europeancountries

innovative
medicines

Data available

4
year cohort(‘19-’22)

Data not available / included12023 WAIT indicator:
7 KPIs for 5 cohorts of medicines

Data coverage
Full data coverage for 31 out of the 36
countries included

Study composition~43%
EU average rate ofavailability in 2023 vs
45% in the previous
study

531
Average time for a new
medicine to be available inEuropean market is 14 days
longer than the previous study

Includes a fewer combination products
than the previous study

Limited availability
40% of available medicines are granted
limited availability

Access disparities
Access gap between the highest andlowest country is 84% in the 4-year

cohort, and 80% for longer timelines

persist between Northern/Western andSouthern/Eastern European countries

Oncology medicines
take the longest time to reimburse across allstudied segments

Source: EFPIA Patients WAIT indicator (2022 and 2023)

2

Contents
Click on hyperlinks for navigation to specific indicators+ Study summary+ The Patients W.A.I.T. indicators
1. Overview (all products)
2. Oncology medicines
3. Orphan medicines
4. Non-oncology orphan medicines
5. Combination therapies
6. Historic comparisons and extended period+ Appendix & detailed methodology

3Patients W.A.I.T. survey has evolved, and is entering its 20th year
The indicator long-running, and one of the largest datasets on medicines availability in Europe

2024

2023

2022

2021

2020

2019

2018

2017

2016

2015

2014

2013

2012

2011

2010

2009

2008

2007

2006

2005

Patients W.A.I.T. stands for:

2004

EFPIA had requested that IMS Healthprepare a database that can be used toanalyse delays in market access for
medicines in Europe. This database is issued
on a 6-monthly basis, providing a benchmark
analysis of time needed for pricing /reimbursement processes after MA.

Waiting to
AccessInnovative
Therapies
Sources include: https://www.efpia.eu/media/412416/market-access-delays-2017-final-140318.pdf; https://studylib.net/doc/7634123/patients--w.a.i.t.-indicator---report-201;
https://www.efpia.eu/publications/downloads/efpia/efpia-patients-wait-indicator-2019-survey/; https://www.efpia.eu/media/602652/efpia-patient-wait-indicator-final-250521.pdf;
https://www.efpia.eu/media/s4qf1eqo/efpia_patient_wait_indicator_final_report.pdf

EFPIA/ CRA reporton root causes
4

The study is based on the core concept of “availability”
Definition of availability

Inclusion of a centrallyapproved medicine on the public
reimbursement list in a country
In this study the term‘availability’ is usedthroughout to permit
standardised measurement
across 36 healthcare
systems

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 interpretationof the data, please see the appendix for further details.

5Study composition
By year of marketing authorisation
100%

167

90%
80%

53

48
14

63

24

47

20

13
1

50%

45

2022
2021
2020
2019

15

15

10

40%
30%

Products with central marketing
authorisation, sourced from EMA
EPARs (last accessed November 2023)•

Orphan status from EMA on orphan
medical products (OMP) status•

Oncology products flagged using IQVIA
MIDAS Oncology market definition: L1& L2 & V3C & Revlimid & Xgeva &Proleukin & Pomalyst•

Combination products include any
product with more than one molecule,including branded / generic
combinations in fixed doses.

7
43

11

20%
10%

•

4

70%
60%

Definitions:26

8

All products

Onco

0%

Note: figures are subject to change versus previous year’s due to product withdrawals

19

14

5

3

1

OrphanNon-onco
OrphanCombotherapies6

Study summary
Full methodology and definitions by country are available in the appendix of the report
Core metrics
The Patients W.A.I.T. Indicator shows 2
main metrics for new medicines (i.e.
medicines including a substance notpreviously available in Europe) within a
4 year rolling cohort:1.) Rate of availability, measured by the
number of medicines available to patients in
European countries. For most countries thisis the point at which the product gains
access to the reimbursement list (this does
not necessarily indicate uptake / usage).
2.) The time to availability*, measuring
the average time between marketing
authorisation and availability, using days
from the date of marketing authorisation to
the day of completion of post-marketing
authorisation administrative processes(whether it is attributable to companies orcompetent authorities).

Availability definition
Description

StatusFull reimbursement through a national
reimbursement system
Available

Full automatic reimbursement by ahospital budget (e.g. Nordic system)
Limited reimbursement to specificsubpopulations of approved indication
Limited reimbursement on a national
named patient basis (individual patient)
Limited reimbursement while decision
is pending (where system permits)

Available(marked LA^)

Availability through a special program(e.g. managed entry agreements)
Available only within the private
market at the patients expense

Only privately
available

Not reimbursed, or not reimbursed
while awaiting decision

Not available

Notes and caveats
Source of information: EFPIA member associations,who either refer to information available from official
sources, gather the information directly from member
companies or in some cases use IQVIA sales data.

Local marketing exceptions: Countries where local
marketing authorisation dates are used to calculate thetime to availability are: Bosnia and Herzegovina, England,
North Macedonia, Scotland, Serbia, Switzerland andTurkey.
Completeness: Some country associations did not submit
full datasets. Countries with substantially limited data sets
are: Bosnia (53% complete), Croatia (63% complete),
Cyprus (77% complete), and North Macedonia (66%complete). This is noted on slides with an asterisk (*). One
country (Italy) submitted 98% dataset, which is notconsidered substantially limited.
Average calculations: The EU averages noted
throughout are averages for the 27 countries in theEuropean Union. This is the third year that Cyprus, Malta,
and Luxembourg have participated in the study.

* 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 competentauthorities 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. ^ LA =Limited Availability7

1. Overview (all products)
Indicators:
1.1. Total availability by approval year
1.2. Rate of availability
1.3. Rate of full availability
1.4. Breakdown of availability
1.5. Time from central approval to availability
1.6. Time to availability
1.7. Median time to availability

All products

Oncology

Orphans

Non-onc orphans

Combination

Total availability by approval year (2019-2022)
The total availability by approval year is the number of medicines available to patients in European
countries as of 5th January 2024 (for most countries this is the point at which the product gains access to thereimbursement list†), split by the year the product received marketing authorisation in Europe.
167

21

20

16

20

19

19

17

17

15

17

15

12

2020

25
17

21

2019

20

16

18

16

2021

21
16

7
12

5
12

40

17

17

13

6
8

11

15

11

14

13

13

31 31 29 29
9
11
8

3 7
6
10
8

8
9

4
16

12

9

14 14 12 1 11 1
3
1

2
6 1
3 6
2
4
5 8 1 4 3
465
5 1 2 1

2022

European Union average: 72 products available (43%) †In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, LU, NO, SE where some hospital products are not covered by the general reimbursement scheme.
Country-specific nuances are listed in the appendix. *Countries with asterisks did not complete a full dataset and therefore availability may be unrepresentative. **In Spain, the WAIT analysis does not identify those medicinal products being accessible earlier inconformity with Spain's Royal Decree 1015/2009 relating to Medicines in Special Situations

Malta

27

14

Turkey25

11*North Macedonia

25

18

52 50
47

*Bosnia25

Bulgaria

28

Belgium

29

19

6

19

Greece30

14Lithuania

20

23
29

20

Serbia22

61 60

Romania21

8

Slovakia

23

13

Estonia

24

Portugal

34

14

17

Latvia12*Croatia

27

Ireland25

Sweden19

26

29

Luxemburg

20

25

84 83
79 76
72 71 70 69
18 20
16

Scotland

20

35

17

Netherlands

28

17

England

30

31

16

**Spain

23

30

30

France24

32

Austria

23

41

Italy

0

26

Germany

20

37

31

19

Czech

34

93 91 90 89

Hungary

38

43

19

35

60
40

22

29

*Cyprus

80

42

28

Norway45

104 103

Iceland33

109 106

Poland33

Slovenia

117
29

Finland120
100

129 126
45

Denmark

140

147
53

EU approvals

Number of products

160

Switzerland

180

9All products

Oncology

Orphans

Non-onc orphans

Combination

Rate of availability (2019-2022)
The rate of availability, measured by the number of medicines available to patients in European countries asof 5th January 2024. For most countries this is the point at which the product gains access to thereimbursement list†, including products with limited availability.
167
147

140

129 126

46% 43% 43% 43% 42%

41%

37% 36%

NorwayIceland

PolandSlovenia

FinlandEU average

Bulgaria

Belgium

GreecePortugal

SwedenLuxemburg

Scotland

Netherlands

England**Spain

Czech

FranceDenmark

Switzerland

Austria

Italy

Germany0

EU approvals

20

40
31 31 29 29

31% 30% 28%

24%

19% 19% 17% 17%

14 14 12 11
8%

8% 7%

7%

Availability
European Union average: 72 products available (43%) †In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, LU, NO, SE where some hospital products are not covered by the general reimbursement scheme.
*Countries with asterisks did not complete a full dataset and therefore availability may be unrepresentative. **In Spain, the WAIT analysis does not identify those medicinal products being accessible earlier in conformity with Spain's Royal Decree 1015/2009
relating to Medicines in Special Situations

6
4%

6
Malta

50% 50% 47%

Turkey56% 54% 54% 53%

52 50
47

*North Macedonia

40

61 60

*Bosnia

65% 63% 62% 62%

Lithuania

70%

Serbia

77% 75%60

Romania

88%

84 83
79 76
72 72 71 70 69

Slovakia

80

Estonia

93 91 90 89

Latvia100

104 103*Croatia

109 106

Ireland117

120

Hungary

Number of products

160*Cyprus

180

4%

10

All products

Oncology

Orphans

Non-onc orphans

Combination

Rate of full availability (%, 2019-2022)

167

1%

20%
35%

32%
35%

Limited availability

European Union average: 72 products available (43%), Limited Availability (40% of available products) Netherlands did not submit complete information on restrictions to available medicines meaning LA* is not captured in these countries. †In mostcountries' availability equates to granting of access to the reimbursement list, except in DK, FI, LU, NO, SE where some hospital products are not covered by the general reimbursement scheme. *Countries with asterisks did not complete a full dataset andtherefore availability may be unrepresentative. **In Spain, the WAIT analysis does not identify those medicinal products being accessible earlier in conformity with Spain's Royal Decree 1015/2009 relating to Medicines in Special Situations

Malta

Turkey69% 86% 43%
100% 82%83%
17%83%
17%
14% 57%18%*North Macedonia

39% 52% 21%

31%*Bosnia

79%

Lithuania

61% 48%Serbia73%

4%

NorwaySlovenia

Finland

Bulgaria

Belgium

GreecePortugal

SwedenLuxemburg

Scotland

Netherlands

England**Spain

Czech

FranceDenmark

Switzerland

Austria

83%
46%

17% 30%

Full public availability

28%

Romania

48%

17%

Italy

88% 96%17%

Slovakia

44% 41% 52%

80%

54%

Estonia82%

58%

48% 51%

Iceland45%

83% 70%100%

Latvia

100%

65%

12%

*Croatia

100%

20%
52%

Ireland80%
65% 68%18%

56% 59% 48%

Hungary

42%

49%

83%

*Cyprus52%

Poland55%

99%

Germany

180
160
140
120
100
80
60
40
20
0

EU approvals

Number of products

The rate of full availability shows the proportion of medicines available to patients in European countries as of
5th January 2024 (for most countries this is the point at which the product gains access to the reimbursement
list†) without any restrictions to the patient population, or through named patient basis schemes which haveincreased significantly in recent years and were not always captured in survey submissions.

11All products

Oncology

Orphans

Non-onc orphans

Combination

Breakdown of availability (%, 2019-2022)

167

2%
12%
23%
37%

63%

20%
4%

51%

28% 29% 23%

36%

5%

8%

8%
4%

22%

62%
54%
31%

29% 28%22% 20% 25%

34%

23%
14%

Full public availability

Limited Availability

Slovenia

Finland

Bulgaria

Belgium

GreecePortugal

SwedenLuxemburg

Scotland

Netherlands

England

7% 11%**Spain

Czech

FranceDenmark

16%

20%

11%

Switzerland

5%

4% 11%
6%
7%

32% 30%

Iceland

29%

35%

44%

2%

34% 26%

46%

41%

Poland

49% 48%

53%

54%

8%

Only available privately

11% 9%
17%1%

Not available

25%

5% 11%
14%

5% 10%
5% 1% 1%
1% 3% 3%

12% 7%
7% 10% 4%
1%

4%
5%

2%
7%

*Bosnia*NorthMacedonia
Turkey

2%

23%

28%

86%

92%

30%

Lithuania

32%

1%

71%
83% 83% 80%

Serbia36%

75%

Estonia

1%

71%

72%

38%

16%

Latvia22%

87%Austria

68%

1%

22%

Italy

53%

Malta

58%

Hungary26%

54% 53%47%

Romania

49% 50%

16%

34%

37%

*Croatia

44% 46% 46% 46%

34%

Slovakia

34%

Ireland

35% 37% 38% 37%*Cyprus30%

Norway1% 20% 25%

Germany

100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%

EU approvals

Availability breakdown (%)

The breakdown of availability is the composition of medicines available to patients in European countries as of
5th January 2024 (for most countries this is the point at which the product gains access to the reimbursement
list†). This includes all medicine’s status to provide a complete picture of the availability of the cohort studied.

Not submitted by association

European Union average: 72 products available (43%), Limited Availability (16% of all products) Netherlands did not submit complete information on restrictions to available medicines meaning LA* is not captured in these countries. †In most countries
availability equates to granting of access to the reimbursement list, except in DK, FI, LU, NO, SE where some hospital products are not covered by the general reimbursement scheme. *Countries with asterisks did not complete a full dataset and therefore
availability may be unrepresentative. **In Spain, the WAIT analysis does not identify those medicinal products being accessible earlier in conformity with Spain's Royal Decree 1015/2009 relating to Medicines in Special Situations

12All products

Oncology

Orphans

Non-onc orphans

Combination

Time from central approval to availability (2019-2022)

983
657

577

470 494 498

416
283

299

404

539
525 527

555

556

563

587

565
577

661

943
804
728
778
710 723

650

990

588

418 424

347 371***Scotland

Netherlands

Finland

Luxemburg

Italy

Switzerland

NorwayCzech

Ireland**France

Iceland*Croatia*NorthMacedonia
Slovenia

Belgium*Cyprus

Slovakia

GreeceEstonia

Hungary

LatviaSpain

Portugal

Lithuania

Bulgaria

Romania

PolandSerbia*Bosnia

TurkeyMalta

147 109 126

84

93

90

91

71

89

129 117

60

104

47

106

61

40

11

70

76

52

29

79

31

50

31

103

83

14

72

29

69

14

12

6

6

Dates submitted / 167

147 109 126

84

93

90

91

69

75

129

55

101

47

79

61

36

6

70

76

16

29

54

30

46

31

103

36

13

72

29

69

11

4

5

0

Denmark

Available medicines / 167

Germany***England

126 169

Sweden

2,000
1,800
1,600
1,400
1,200
1,000
800
600
400
200
0
-200

Austria

Time (days)

The time from central approval to availability is the days between marketing authorisation and the date ofavailability to patients in European countries (for most this is the point at which products gain access to thereimbursement list†). The marketing authorisation date is the date of central EU authorisation throughout.

80

European Union average: 531 days (mean %) (Note: Malta is not included in EU27 average as no dates were submitted in total) †In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, NO, SE where some
hospital products are not covered by the general reimbursement scheme. *Countries with asterisks did not complete a full dataset and therefore availability may be unrepresentative **For France, the time to availability (527 days, n=79 dates submitted) includes
products under the Accès précoce system (n=18 dates submitted) for which the price negotiation process is usually longer. If one considers that products under the Accès précoce system are directly available (time to availability = 0), the average time toavailability is 424 days. ***In the UK, MHRA’s Early Access to Medicines Scheme provides access prior to marketing authorisation but is not included within this analysis, and would reduce the overall days for a small subset of medicines.

13All products

Oncology

Orphans

Non-onc orphans

Combination

Time to availability (2019-2022)
The time to availability is the days between 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†). The
marketing authorisation date is the date of central EU authorisation in most countries, except for countries
shown in italics where local authorisation dates have been used. Data is correct to 5th January 2024.
2,000Time (days)

1,500

1,000
344 356283

500

284 299

243

416
404
368

494

418

498

565

525

539 555 563
527

587

577

577

615 650657

710

723 728

778

804

661

588

565

424

126 169

Sweden***England*Bosnia***Scotland

Netherlands

Finland

Luxemburg

Italy

NorwayCzech

Ireland**France

Iceland*Croatia

Slovenia

Belgium

Turkey*Cyprus

Slovakia

GreeceEstonia

SerbiaHungary

LatviaSpain

Portugal

Lithuania

Bulgaria

Romania

PolandMalta

147 10911

126 117

84

93

12

90

91

71

89

129

60

104

47

106

61

40

70

76

6

52

29

79

31

14

50

31

103

83

14

72

29

69

6

Dates submitted / 167

147 109

6

126

84

93

4

90

91

69

75

129

55

101

47

79

61

36

70

76

5

16

29

54

30

9

46

31

103

36

13

72

29

69

0

Denmark*NorthMacedonia
Austria

Available medicines / 167

Germany

Switzerland

080

European Union average: 531 days (mean %) (Note: Malta is not included in EU27 average as no dates were submitted in total) †In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, NO, SE where some
hospital products are not covered by the general reimbursement scheme. *Countries with asterisks did not complete a full dataset and therefore availability may be unrepresentative **For France, the time to availability (527 days, n=79 dates submitted) includes
products under the Accès précoce system (n=18 dates submitted) for which the price negotiation process is usually longer. If one considers that products under the Accès précoce system are directly available (time to availability = 0), the average time toavailability is 424 days. ***In the UK, MHRA’s Early Access to Medicines Scheme provides access prior to marketing authorisation but is not included within this analysis, and would reduce the overall days for a small subset of medicines. In this analyses, MHRA
dates have been used for 2021-2022 products and EMA dates used for 2019-2020 products

14All products

Oncology

Orphans

Non-onc orphans

Combination

Median time to availability (2019-2022)
The median time to availability is the days between marketing authorisation and the date of availability topatients in European countries (for most this is the point at which products gain access to the reimbursement
list†). The marketing authorisation date is the date of central EU authorisation in most countries, except for
countries shown in italics where local authorisation dates have been used. Data is correct to 5th January 2024.
770 775

800

150

613
600
500

461

400
299 313 317 321

300
200

166

340 358

375 384

487 493 494 494

514 516 532 534 535

547 561 563 569
100

418

50

201 203 223

109
100

Germany

Denmark*NorthMacedonia
Austria

Switzerland

Sweden***England***Scotland*CyprusNetherlands*Bosnia

Italy

Finland

Luxemburg

Czech**France

Slovenia

Ireland

Iceland

Norway*Croatia

Belgium

SerbiaEstonia

Slovakia

TurkeyGreeceLatviaHungary

SpainPortugal

Bulgaria

PolandRomania

Lithuania

Dates submitted
/ 167

Malta

0

47

0

147

109

80

84

93

90

16

91

4

129

69

75

101

79

70

47

61

55

36

76

9

30

29

5

54

31

46

103

36

72

69

29

13

6

126

Median time to availability

Number of products
available

681 698

700

Time (days)

794

0

Number of medicines available

European Union average: 474 days (median) (Note: Malta is not included in EU27 average as no dates were submitted in total) †In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, NO, SE where some hospital
products are not covered by the general reimbursement scheme. *Countries with asterisks did not complete a full dataset and therefore availability may be unrepresentative **For France, the median time to availability (461 days, n=79 dates submitted) includes
products under the Accès précoce system (n=18 dates submitted) for which the price negotiation process is usually longer. If one considers that products under the Accès précoce system are directly available (time to availability = 0), the median time to availability is
383 days. ***In the UK, MHRA’s Early Access to Medicines Scheme provides access prior to marketing authorisation but is not included within this analysis, and would reduce the overall days for a small subset of medicines. In this analyses, MHRA dates have beenused for 2021-2022 products and EMA dates used for 2019-2020 products

15

Key observations
Executive summary (EU27 averages)
Oncology

OrphanNon-oncologic
orphanCombination
therapy

MeasureAll products

Average rateof availability

43%

52%

35%

32%

54%

(45% in 2022)(50% in 2022)(39% in 2022)(39% in 2022)(50% in 2022)

Average timeto availability

531
Days

559
Days

542
Days

530
Days

433
Days

(517 days in 2022)(526 days in 2022)(625 days in 2022)(626 days in 2022)(426 days in 2022)

Key Insights
Rate of availability• Patient access to innovative products in Europe is highly variable, with >80% variance between
Northern/Western countries and Southern/Eastern European countries• Europe’s average rate of availability has marginally deteriorated versus last year

Time to availability• The average delay from marketing authorisation to patient access can vary by a factor greater than
7x in Europe, from as little as 4 months to 31 months (~2.5 years)• 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

Metrics key:
Text colour indicates relative
position versus the current (2023) EUaverage (significantly worse thancurrent EU average / significantly
better than current EU average)
Arrow colour indicates significant
changes versus the previous (2021)
EU average (significant improvement
versus previous year
/ significant
deterioration versus prior year)
Average calculations:
Only a difference of +/- 5% (~30days) is considered a significant
change and therefore highlighted
Malta is not included in EU27
average for time to availability as nodates were submitted in total• Many countries with low data availability appear high in the indicator, but it is important to take into
account the small number of available medicines that the figure represents16

2. Oncology medicines
Indicators:
2.1. Total availability by approval year
2.2. Rate of availability
2.3. Rate of full availability
2.4. Breakdown of availability
2.5. Time to availability
2.6. Median time to availability

All products

Oncology

Orphans

Non-onc orphans

Combination

Oncology availability by approval year (2019-2022)

44
41 40

13

12

30 29
6

5

13
10

10

11

27 27 26 26 26 26
25 24 24
4
5
7

10

10

9

8

7

7
6

11

10

10

10

11

8

11

8

9

7

9

9

7

6

8
7

5
8

4
8

8

5

4
7

8

8

7

5
5
6

3

21 21 21
1

8

7

3

6

4

16

7

4

4

7

7

2019

2020

2021

2022

2

5

5

6

1

10
1

4

5

5

5

*Croatia

6

Ireland7

3
1

Hungary

7

Netherlands

6

Norway8

Scotland6

Slovenia

6

Poland6

Belgium

7

Bulgaria

6*Cyprus8

Finland8

England7

Sweden6**Spain

7

Luxemburg

7

France8

Greece6

Portugal

8

Czech

7

Italy

8

Austria8

Switzerland

8

Germany

82

Iceland

6

14 14

3

9

9

1
3

1
4

8
2
4

5

4

2

7
1

6
1

3
2

2
3

1 4

European Union average: 25 products available (52%) †In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, LU, NO, SE where some hospital products are not covered by the general reimbursement scheme.
*Countries with asterisks did not complete a full dataset and therefore availability may be unrepresentative. **In Spain, the WAIT analysis does not identify those medicinal products being accessible earlier in conformity with Spain's Royal Decree 1015/2009
relating to Medicines in Special Situations

3
2 1

2
Malta

8

Turkey

32
8

15

10
5
0

8

Lithuania

15

9*Bosnia

1020
15

36 36 35
34

Serbia9Denmark

30
25

11*North Macedonia

1335

Estonia13

Romania

40

14

46

Slovakia

48

Latvia50
45

EU approvals

Number of products

The total availability by approval year is the number of medicines available to patients in European
countries as of 5th January 2024 (for most countries this is the point at which the product gains access to thereimbursement list†), split by the year the product received marketing authorisation in Europe.

18

All products

Oncology

Orphans

Non-onc orphans

Combination

Oncology rate of availability (2019-2022)

48

46

44
41 40
36 36 3534

30 29

27 27 26 26 26 26
25 25 24 24
21 21 2185% 83%

52% 52% 50% 50%

14 14
10

44% 44% 44%

33%

9

9

Romania

Slovakia

Latvia*Croatia

Ireland

Hungary

IcelandNetherlands

NorwayScotlandSlovenia

EU average

PolandBelgium

Bulgaria*CyprusFinlandEnglandSweden**Spain

Luxemburg

FranceGreecePortugal

Czech

Denmark

Italy

Austria

Switzerland

21% 19% 19%

Available

8

29% 29%7

17% 15%

6
13%

European Union average: 25 products available (52%) †In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, LU, NO, SE where some hospital products are not covered by the general reimbursement scheme.
*Countries with asterisks did not complete a full dataset and therefore availability may be unrepresentative. **In Spain, the WAIT analysis does not identify those medicinal products being accessible earlier in conformity with Spain's Royal Decree 1015/2009
relating to Medicines in Special Situations

4

3

8%

6%

2
4%

Malta

56% 56% 54% 54% 54% 54%

Turkey16
63% 60%Lithuania

67%*Bosnia

71%

Serbia

75% 75% 73%*North Macedonia

92%

32

Estonia96%

Germany

50
45
40
35
30
25
20
15
10
5
0

EU approvals

Number of products

The rate of availability, measured by the number of medicines available to patients in European countries asof 5th January 2024. For most countries this is the point at which the product gains access to thereimbursement list†, including products with limited availability.

19All products

Oncology

Orphans

Non-onc orphans

Combination

Oncology rate of full availability (%, 2019-2022)

48

30%
29% 23%

4%
8%

48% 56% 50%

69%
33%

European Union average: 25 products available (52%), Limited availability (40% of available products). Netherlands did not submit complete information on restrictions to available medicines meaning LA* is not captured in these countries. †In mostcountries availability equates to granting of access to the reimbursement list, except in DK, FI, LU, NO, SE where some hospital products are not covered by the general reimbursement scheme. *Countries with asterisks did not complete a full dataset andtherefore availability may be unrepresentative. **In Spain, the WAIT analysis does not identify those medicinal products being accessible earlier in conformity with Spain's Royal Decree 1015/2009 relating to Medicines in Special Situations

Malta

TurkeyLithuania*Bosnia

IcelandNetherlands

NorwayScotland

Limited availability

Serbia50%
33%
67% 50% 86% 100%100%
33%
50%
67% 50%14%

31%

Slovenia

PolandBelgium

Bulgaria*CyprusFinlandEnglandSweden**Spain

Luxemburg

FranceGreeceFull public availability

86% 86% 60% 67%*North Macedonia

43%8%Portugal

Czech

Denmark

Italy

Austria

79% 100%100%

52% 44% 50%

8%

Switzerland

14% 14%92%

Estonia69%

50% 56%

57%

Romania

43%

36%

100% 96% 100% 92%

Slovakia

100%

Latvia

70% 71% 78%

21%*Croatia

92%

Ireland31%

Hungary

57% 50% 44%

64%

100%

Germany

50
45
40
35
30
25
20
15
10
5
0

EU approvals

Number of products

The rate of full availability shows the proportion of medicines available to patients in European countries as of
5th January 2024 (for most countries this is the point at which the product gains access to the reimbursement
list†) without any restrictions to the patient population, or through named patient basis schemes which haveincreased significantly in recent years and were not always captured in survey submissions.

20All products

Oncology

Orphans

Non-onc orphans

Combination

Oncology breakdown of availability (%, 2019-2022)

48
2%
10%

65%

54% 52% 54% 48%
42%
29%

46%

40%

44% 44%

Limited Availability

25% 25%
10%

ScotlandSlovenia

Belgium

Bulgaria

Only available privately

44%

4%
4% 15%

23%
19%*CyprusFinlandEnglandSweden**Spain

Luxemburg

FranceGreeceFull public availability

2%
4%

4%

Portugal

Czech

Denmark

Italy

Austria25%

25% 27%

6%

Switzerland

50%

Not available

13%

13%

8%

6%

6%
13%

4%
8%

2%
13%

8%

46%

15%

2%

19%
2%
13%
8%

2%
2%
4% 2%

Malta

31%

27%

10%

Turkey63%
35% 38%94%

Estonia*NorthMacedonia
Serbia

65%

77%

35%

31% 27%

Poland60%

73%

81% 81% 79%

2%
4%

27%

69%
65%

2%

19%

71%

Romania

42% 35% 29%

65%

31%

10%
48%

54%

56% 56%

25%

15%

96%

46%

50% 50%Lithuania

2%

33%*Bosnia

25% 46% 46% 46%

31%

Slovakia

25% 19%44%

Latvia

27%

25%

29%

38% 40%*Croatia

33%

Ireland

25% 25% 27% 27%

21%

Hungary

15%

Iceland15%

Netherlands

8%

Norway4%Germany

100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%

EU approvals

Availability breakdown (%)

The breakdown of availability is the composition of medicines available to patients in European countries as of
5th January 2024 (for most countries this is the point at which the product gains access to the reimbursement
list†). This includes all medicine’s status to provide a complete picture of the availability of the cohort studied.

Not submitted by association

European Union average: 25 products available (52%), Limited availability (19% of all oncology products). Netherlands did not submit complete information on restrictions to available medicines meaning LA* is not captured in these countries. †In mostcountries availability equates to granting of access to the reimbursement list, except in DK, FI, LU, NO, SE where some hospital products are not covered by the general reimbursement scheme. *Countries with asterisks did not complete a full dataset andtherefore availability may be unrepresentative. **In Spain, the WAIT analysis does not identify those medicinal products being accessible earlier in conformity with Spain's Royal Decree 1015/2009 relating to Medicines in Special Situations

21

All products

Oncology

Orphans

Non-onc orphans

Combination

Oncology time to availability (2019-2022)
The time to availability is the days between 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†). The
marketing authorisation date is the date of central EU authorisation in most countries, except for countries
shown in italics where local authorisation dates have been used. Data is correct to 5th January 2024.
2,000Time (days)

1,500
705

568

1,000

589
459
350
235

500
93

274

320

344

547

548

594
573

567

642
610

779 794

827

828

858

926

664

420

387

Denmark***England

Austria*Bosnia

Netherlands

Switzerland*NorthMacedonia
FinlandSweden***Scotland

Italy

Luxemburg

Czech

Slovenia

Turkey**France

Hungary

NorwayGreece*Cyprus

Ireland

Belgium

Iceland

Serbia*Croatia

Estonia

Slovakia

Spain

Bulgaria

Portugal

PolandRomania

LatviaLithuania

Malta

134

Germany

0

247

417

369 370

556

541

725

594

Available medicines / 48

46

36

27

41

4

21

44

7

26

27

24

40

30

36

24

2

32

16

21

34

26

14

26

21

6

14

8

9

29

26

35

25

9

10

3

0

Dates submitted / 48

46

36

27

41

3

21

31

4

26

27

24

40

23

36

24

1

20

16

19

22

7

14

26

21

4

12

7

9

29

26

15

25

9

10

3

0

European Union average: 559 days (mean) (Note: Malta is not included in EU27 average as no dates were submitted in total) †In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, NO, SE where some hospital
products are not covered by the general reimbursement scheme. *Countries with asterisks did not complete a full dataset and therefore availability may be unrepresentative. unrepresentative **For France, the time to availability (548 days, n=20 dates submitted)
includes products under the Accès précoce system (n=5 dates submitted) for which the price negotiation process is usually longer. If one considers that products under the Accès précoce system are directly available (time to availability = 0), the average time toavailability is 438 days. ***In the UK, MHRA’s Early Access to Medicines Scheme provides access prior to marketing authorisation but is not included within this analysis, and would reduce the overall days for a small subset of medicines. In this analyses, MHRA
dates have been used for 2021-2022 products and EMA dates used for 2019-2020 products22All products

Oncology

Orphans

Non-onc orphans

Combination

Oncology median time to availability (2019-2022)
The median time to availability is the days between marketing authorisation and the date of availability topatients in European countries (for most this is the point at which products gain access to the reimbursement
list†). The marketing authorisation date is the date of central EU authorisation in most countries, except for
countries shown in italics where local authorisation dates have been used. Data is correct to 5th January 2024.
1,000

924

Time (days)

815

800
701

700
600
500
400

300
200

155

100

40

740

35

641

30
25
20

15
10

84

Denmark

Austria*Cyprus***England*Bosnia*NorthMacedonia
Netherlands***Scotland

SwedenSwitzerland

Italy

FinlandCzech

Luxemburg

GreeceHungary

Slovenia*Croatia

Iceland**France

TurkeyBelgium

Slovakia

NorwaySerbiaEstonia

Ireland

Spain

Bulgaria

Portugal

PolandRomania

LatviaLithuania

5

Germany

Dates submitted
/ 48

262

340

465

547

45

Malta

0

38

198 210307 323274 296358 375

414 422 432

493 509 513 523

590 597 603
554 578857 863 867

0

46

36

41

7

27

3

24

27

31

40

26

36

23

22

16

24

12

21

20

1

26

9

19

4

7

14

29

26

15

25

9

10

3

4

21

Median time to availability

Number of products
available

900

50

0

Number of medicines available

European Union average: 509 days (median) †In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, NO, SE where some hospital products are not covered by the general reimbursement scheme. *Countries
with asterisks did not complete a full dataset and therefore availability may be unrepresentative **For France, the median time to availability (523 days, n=20 dates submitted) includes products under the Accès précoce system (n=5 dates submitted) for which theprice negotiation process is usually longer. If one considers that products under the Accès précoce system are directly available (time to availability = 0), the median time to availability is 443 days. ***In the UK, MHRA’s Early Access to Medicines Scheme
provides access prior to marketing authorisation but is not included within this analysis, and would reduce the overall days for a small subset of medicines. In this analyses, MHRA dates have been used for 2021-2022 products and EMA dates used for 2019-2020
products

23Key observations
Executive summary (EU27 averages)
Oncology

OrphanNon-oncologic
orphanCombination
therapy

MeasureAll products

Average rateof availability

43%

52%

35%

32%

54%

(45% in 2022)(50% in 2022)(39% in 2022)(39% in 2022)(50% in 2022)

Average timeto availability

531
Days

559
Days

542
Days

530
Days

433
Days

(517 days in 2022)(526 days in 2022)(625 days in 2022)(626 days in 2022)(426 days in 2022)

Key Insights
Rate of availability• The EU’s rate of availability for oncology medicines was 9% higher than the average rate ofavailability for all products in 2023
• Four countries (DE, CH, AT, IT) have a rate of availability for oncology medicines higher than 80%
in 2023

Time to availability• The average delay from marketing authorisation to patient access for oncology products varies from
3 to 31 months (>2.5 years) between all countries included in the 2023 WAIT survey• The average time to availability for oncology products is 33 days slower than comparable data
published in the 2022 report

Metrics key:
Text colour indicates relative
position versus the current (2023) EUaverage (significantly worse thancurrent EU average / significantly
better than current EU average)
Arrow colour indicates significant
changes versus the previous (2021)
EU average (significant improvement
versus previous year
/ significant
deterioration versus prior year)
Average calculations:
Only a difference of +/- 5% (~30days) is considered a significant
change and therefore highlighted
Malta is not included in EU27
average for time to availability as nodates were submitted in total

24

3. Orphan medicines
Indicators:
3.1. Total availability by approval year
3.2. Rate of availability
3.3. Rate of full availability
3.4. Breakdown of availability
3.5. Time to availability
3.6. Median time to availability

All products

Oncology

Orphans

Non-onc orphans

Combination

Orphan availability by approval year (2019-2022)
The total availability by approval year is the number of medicines available to patients in European
countries as of 5th January 2024 (for most countries this is the point at which the product gains access to thereimbursement list†), split by the year the product received marketing authorisation in Europe.
70
60
24

43 42

8

7

18

5

5

4

5

3

3

4

3

4

4

2

3

4

3

3

3

1

2

2

4
2

England

Bulgaria

GreeceScotland

Luxemburg

Netherlands

Slovenia

Belgium

PolandSwedenIcelandFinland6

3
4

Denmark

5

5

7

0

3

3
4
3

10

9

4
2

Portugal10

15 15 15 14**Spain

11

6

Switzerland

11

5

1
7

Czech

12

5

Austria

11

7

6France

16

7

Italy

13

8

5

Germany

13

8

2019

9

10

8

10

10

2020

7

2021

12 12 12

6
1

2022

3

2

8

2
5

1

3

5
2

4

1 9

9
2 2

7

7

1
2
2
3 1
2 3 1 4 1 4 1 4 1 33
4 1 3 21 2 1 2 1 2 1 2 1 2 1
1 1
1

European Union average: 22 products available (35%) †In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, LU, NO, SE where some hospital products are not covered by the general reimbursement scheme.
*Countries with asterisks did not complete a full dataset and therefore availability may be unrepresentative. **In Spain, the WAIT analysis does not identify those medicinal products being accessible earlier in conformity with Spain's Royal Decree 1015/2009
relating to Medicines in Special Situations

1
Lithuania

928 27
26 25 25
24 23
7
22 20
5
10
6
7
5

Turkey

10

16

8

9

10
19

9

*Bosnia

20

12

10

Malta

12

7

*North Macedonia

1011

Serbia14

32 32 32

Slovakia

15

Estonia

34

8

Latvia36*Croatia

30

12

Ireland14

Hungary

11

Norway40

45

Romania

21*Cyprus50

56

EU approvals

Number of products

6326All products

Oncology

Orphans

Non-onc orphans

Combination

Orphan rate of availability (2019-2022)
The rate of availability, measured by the number of medicines available to patients in European countries asof 5th January 2024. For most countries this is the point at which the product gains access to thereimbursement list†, including products with limited availability.
70
60

56

43 42
32 32 32

Available

97

7

14% 14% 11% 11%

4

4

6% 6%

4

3

3

6% 5%

5%

European Union average: 22 products available (35%) †In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, LU, NO, SE where some hospital products are not covered by the general reimbursement scheme.
*Countries with asterisks did not complete a full dataset and therefore availability may be unrepresentative. **In Spain, the WAIT analysis does not identify those medicinal products being accessible earlier in conformity with Spain's Royal Decree 1015/2009
relating to Medicines in Special Situations

1
2%

1
Lithuania

19% 19% 19%9Turkey*CyprusFinland

IcelandSwedenPolandEU average

Belgium

Slovenia

Netherlands

Luxemburg

Scotland

GreeceBulgaria

EnglandDenmark

Portugal**Spain

Switzerland

Czech

Austria

FranceItaly

12 12 12

35% 35% 32%*Bosnia

40% 40% 38% 37%

24% 24% 24% 22%

Germany0

15 15 15 14

Malta

10

44% 43% 41%*North Macedonia

51% 51% 51%

20

Serbia

57% 54%

Slovakia

67%

Estonia

71% 68%20

Latvia28 27
26 25 25
24 23
22 22

89%

*Croatia

30

34

Ireland36

Hungary

40

Norway45

Romania50

EU approvals

Number of products

6327All products

Oncology

Orphans

Non-onc orphans

Combination

Orphan rate of full availability (%, 2019-2022)
The rate of full availability shows the proportion of medicines available to patients in European countries as of
5th January 2024 (for most countries this is the point at which the product gains access to the reimbursement
list†) without any restrictions to the patient population, or through named patient basis schemes which haveincreased significantly in recent years and were not always captured in survey submissions.
63

60

50
9%

28%

17%

Limited availability

European Union average: 22 products available (35%), Limited availability (42% of available products). Netherlands did not submit complete information on restrictions to available medicines meaning LA* is not captured in these countries. †In mostcountries availability equates to granting of access to the reimbursement list, except in DK, FI, LU, NO, SE where some hospital products are not covered by the general reimbursement scheme. *Countries with asterisks did not complete a full dataset andtherefore availability may be unrepresentative. **In Spain, the WAIT analysis does not identify those medicinal products being accessible earlier in conformity with Spain's Royal Decree 1015/2009 relating to Medicines in Special Situations

100%

Lithuania

Turkey*Bosnia

Malta

SerbiaSlovakia

Estonia

Latvia

13%

22%
29%
75% 22%
50%75%
57%
78% 78%100%
25%
43% 71% 50% 100% 25% 100%100%*Croatia

67%

92%

Ireland53%

8%

Hungary

Poland

40%

33%
100%

*North Macedonia

Full public availability

Belgium

Netherlands

Scotland

GreeceBulgaria**Spain

5%

47%
87%

Norway100% 95% 60%

Romania

83%*Cyprus72%

25%

Switzerland

Czech

47% 57% 59% 54%

Finland

100%100%
53% 56%Austria

Italy

Germany

46%

64%

14%

EU approvals

43% 41%England

53%

10

53%
75%

Iceland86%

Luxemburg

91%

Sweden47% 44%

Slovenia

100%

20

0

36%

Denmark

47%

30

Portugal

40

FranceNumber of products

7028All products

Oncology

Orphans

Non-onc orphans

Combination

Orphan rate of availability (%, 2019-2022)

63
6%
29%

22% 32% 33%

37%
49% 49% 49%

6%

56% 54% 59%

60% 60% 62% 63%

56%

51%

57%

51%

65% 68%
76%

79%

81%

24%

73%

86% 84%

86%

43%

89%
49%

94%

27%
38%

19% 17%

19%

11%

21%

6%

40%

30%

19%

56%
44%

Limited Availability

Only privately available

Not available

Serbia*NorthMacedonia
Malta

Slovakia

Estonia

Latvia*Croatia

Ireland

13%
3%

2%

Hungary

22%

2%

22%
2%
14% 3% 3% 3% 5%
3%
17%
6%
3% 2%
13%
11% 11%
3%
5% 5% 5% 5%
5%
5% 8% 3% 6% 2%
2% 2%
6%

Romania

SwedenPolandBelgium

Slovenia

Netherlands

Luxemburg

Scotland

GreeceBulgaria

EnglandDenmark

Portugal**Spain

Full public availability

11%
21%

*Cyprus10%
2%

Switzerland

Czech

Austria

France35% 30% 14%

13%

8%

Italy

24% 25% 25% 22%

30%

29%

Finland

40% 38%29% 29%Iceland

43%

Norway

6%
37%

98%

3%

25% 22%
65%

94% 90%Lithuania

32%

44%

Turkey43% 46%*Bosnia

11%

Germany

100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%

EU approvals

Availability breakdown (%)

The breakdown of availability is the composition of medicines available to patients in European countries as of
5th January 2024 (for most countries this is the point at which the product gains access to the reimbursement
list†). This includes all medicine’s status to provide a complete picture of the availability of the cohort studied.

Not submitted by association

European Union average: 22 products available (35%), Limited availability (13% of all orphan products). Netherlands did not submit complete information on restrictions to available medicines meaning LA* is not captured in these countries. †In mostcountries availability equates to granting of access to the reimbursement list, except in DK, FI, LU, NO, SE where some hospital products are not covered by the general reimbursement scheme. *Countries with asterisks did not complete a full dataset andtherefore availability may be unrepresentative. **In Spain, the WAIT analysis does not identify those medicinal products being accessible earlier in conformity with Spain's Royal Decree 1015/2009 relating to Medicines in Special Situations

29

All products

Oncology

Orphans

Non-onc orphans

Combination

Orphan time to availability (2019-2022)
The time to availability is the days between 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†). The
marketing authorisation date is the date of central EU authorisation in most countries, except for countries
shown in italics where local authorisation dates have been used. Data is correct to 5th January 2024.
2,000Time (days)

1,500

1,000
329

500

194
192

533 558578

597 597
601

613

622

671 700

615

958

744

431 476*Cyprus*NorthMacedonia
Denmark

Austria

Switzerland

FinlandSweden***England***Scotland*Bosnia

Italy

Slovakia

Luxemburg

Iceland

GreeceNetherlands

Hungary

Slovenia**France

Ireland

NorwayBelgium

Czech

Estonia*Croatia

LatviaSpain

Bulgaria

Romania

PolandPortugal

Lithuania

Malta

Turkey202 206

Germany96

417

492 530

750 798

Serbia0

95

365

366 394401

491

704 716

Available medicines / 63

4

56

14

4

32

42

34

15

15

28

25

3

45

4

25

15

26

24

12

23

43

9

12

22

36

7

9

7

32

27

12

20

32

1

3

1

Dates submitted / 63

1

56

4

3

32

42

18

15

15

28

25

1

45

4

18

15

19

24

12

23

27

9

10

22

35

7

7

7

32

27

12

20

9

1

0

0

European Union average: 542 days (mean) (Note: Malta is not included in EU27 average as no dates were submitted in total) †In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, NO, SE where some hospital products
are not covered by the general reimbursement scheme. *Countries with asterisks did not complete a full dataset and therefore availability may be unrepresentative.; **For France, the time to availability (597 days, n=27 dates submitted) includes products under the Accès
précoce system (n=11 dates submitted) for which the price negotiation process is usually longer. If one considers that products under the Accès précoce system are directly available (time to availability = 0), the average time to availability is 420 days. ***In the UK,
MHRA’s Early Access to Medicines Scheme provides access prior to marketing authorisation but is not included within this analysis, and would reduce the overall days for a small subset of medicines. In this analyses, MHRA dates have been used for 2021-2022 products
and EMA dates used for 2019-2020 products30All products

Oncology

Orphans

Non-onc orphans

Combination

Orphan median time to availability (2019-2022)
The median time to availability is the days between marketing authorisation and the date of availability topatients in European countries (for most this is the point at which products gain access to the reimbursement
list†). The marketing authorisation date is the date of central EU authorisation in most countries, except for
countries shown in italics where local authorisation dates have been used. Data is correct to 5th January 2024.
1,000

958
859

Time (days)

800
700
600
500

332

400

478 503513 525721

586 630400 402 417

179 232 232

200

158

100
TurkeyGermany

SerbiaAustria

Denmark*Cyprus

Switzerland*NorthMacedonia
Sweden***England***Scotland

Slovakia

Finland

Luxemburg

GreeceItaly

Estonia*Bosnia

Hungary

Netherlands

Iceland

Belgium

Slovenia**France

NorwayLatvia*Croatia

Czech

Spain

Ireland

PolandBulgaria

Romania

Portugal

Lithuania

44

95 98

Malta

Dates submitted/ 63

358 374

307 317300

0378 398580
541 549 556 563

685 704 706

0

0

56

1

42

32

4

18

28

25

4

15

18

19

45

7

1

12

24

15

22

23

27

10

7

7

35

32

9

20

27

12

9

1

3

15

Median time to availability

Number of products
available

900

60
55
50
45
40
35
30
25
20
15
10
5
0

Number of medicines available

European Union average: 488 days (median) †In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, NO, SE where some hospital products are not covered by the general reimbursement scheme. *Countries
with asterisks did not complete a full dataset and therefore availability may be **For France, the median time to availability (549 days, n=27 dates submitted) includes products under the Accès précoce system (n=11 dates submitted) for which the pricenegotiation process is usually longer. If one considers that products under the Accès précoce system are directly available (time to availability = 0), the median time to availability is 445 days. ***In the UK, MHRA’s Early Access to Medicines Scheme provides
access prior to marketing authorisation but is not included within this analysis, and would reduce the overall days for a small subset of medicines. In this analyses, MHRA dates have been used for 2021-2022 products and EMA dates used for 2019-2020 products

31Key observations
Executive summary (EU27 averages)
Oncology

OrphanNon-oncologic
orphanCombination
therapy

MeasureAll products

Average rateof availability

43%

52%

35%

32%

54%

(45% in 2022)(50% in 2022)(39% in 2022)(39% in 2022)(50% in 2022)

Average timeto availability

531
Days

559
Days

542
Days

530
Days

433
Days

(517 days in 2022)(526 days in 2022)(625 days in 2022)(626 days in 2022)(426 days in 2022)

Key Insights
Rate of availability• Average rate of availability for orphan medicines is 8% lower than the average for all products• The rate of availability for orphan medicines in 2023 is 35%, which represents a 4% decline sincelast year’s survey

Time to availability• The average time to availability for orphan products is significantly faster than last year’s study,
which reflects a change in product composition• The average delay between market authorisation and patient availability for orphan drugs can be as
short as 3 months in some countries or as long as 2.5 years for others

Metrics key:
Text colour indicates relative
position versus the current (2023) EUaverage (significantly worse thancurrent EU average / significantly
better than current EU average)
Arrow colour indicates significant
changes versus the previous (2021)
EU average (significant improvement
versus previous year
/ significant
deterioration versus prior year)
Average calculations:
Only a difference of +/- 5% (~30days) is considered a significant
change and therefore highlighted
Malta is not included in EU27
average for time to availability as nodates were submitted in total

32

4. Non-oncology orphan
medicines
Indicators:
4.1. Total availability by approval year
4.2. Rate of availability
4.3. Rate of full availability
4.4. Breakdown of availability
4.5. Time to availability
4.6. Median time to availability

All products

Oncology

Orphans

Non-onc orphans

Combination

Non-oncology orphan availability by approval year (2019-2022)

47
40
20

2019

2020

2021

3
1

4
1

9
1
4

7

4

2
3
1

7
1

2
3
1

1 5

5

4

3 3 3 2
1
2
2
1 2
1
1
1 2 1 2
1
1
1
1

2

3

2022

European Union average: 15 products available (32%) †In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, LU, NO, SE where some hospital products are not covered by the general reimbursement scheme.
*Countries with asterisks did not complete a full dataset and therefore availability may be unrepresentative. **In Spain, the WAIT analysis does not identify those medicinal products being accessible earlier in conformity with Spain's Royal Decree 1015/2009
relating to Medicines in Special Situations

1

1

1
Turkey

1

5

6

4

3
2
3
1

Lithuania

2

79*Bosnia

1

2

5

2

7

9

*North Macedonia

6

3

Malta

1

7

4

9

Serbia1

2

7

2

Slovakia

2

7

7

3
2

Estonia

1

2

8

8

10 10

4

*Croatia

83

Latvia6

Ireland**Spain5

NorwayAustria5

14 14*Cyprus2

5

3

Finland3

4

Hungary

3

4

Romania2

9England311

4

17 17 17

6

Denmark

3

Italy

9

5

8

6
4

9

6

Iceland6

6

Sweden6

4

Belgium

7

13
10

20 20 19 19 19

Poland7

6

Greece7

France1186Luxemburg

8

5

Switzerland

9

14

6

7

Slovenia

10

24 24 23
22

Bulgaria

9

Scotland

8

Netherlands

12

29

Portugal

32 31

Czech

17

Germany

50
45
40
35
30
25
20
15
10
5
0

EU approvals

Number of products

The total availability by approval year is the number of medicines available to patients in European
countries as of 5th January 2024 (for most countries this is the point at which the product gains access to thereimbursement list†), split by the year the product received marketing authorisation in Europe.

34All products

Oncology

Orphans

Non-onc orphans

Combination

Non-oncology orphan rate of availability (2019-2022)

47
40

29

9

9

*CyprusFinland

Hungary

Romania

IcelandSwedenBelgium

PolandEU average

GreeceLuxemburg

Slovenia

Bulgaria

Scotland

Switzerland

Netherlands

Portugal

EnglandDenmark

Czech**Spain

Austria

Italy

France21% 21% 19% 19% 19% 19%

77

15% 15%554

11% 11% 9%

3

3

3

6% 6%

6%

2

2

4%

4%

1
2%

Turkey9Lithuania

932% 30% 30%*Bosnia

10 10
36% 36% 36%*North Macedonia

43% 43% 40% 40% 40%

Malta

47%

Serbia

51% 51% 49%

15 14 14

Slovakia

62%

Estonia

17 17 17

*Croatia

68% 66%20 20 19 19 19

Latvia85%

Ireland

24 24 23
22

Norway32 31

Germany

50
45
40
35
30
25
20
15
10
5
0

EU approvals

Number of products

The rate of availability, measured by the number of medicines available to patients in European countries asof 5th January 2024. For most countries this is the point at which the product gains access to thereimbursement list†, including products with limited availability.

Availability
European Union average: 15 products available (32%) †In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, LU, NO, SE where some hospital products are not covered by the general reimbursement scheme.
*Countries with asterisks did not complete a full dataset and therefore availability may be unrepresentative. **In Spain, the WAIT analysis does not identify those medicinal products being accessible earlier in conformity with Spain's Royal Decree 1015/2009
relating to Medicines in Special Situations

35

All products

Oncology

Orphans

Non-onc orphans

Combination

Non-oncology orphan rate of full availability (%, 2019-2022)

47

6%
47%

38%

100%
52% 41%

Limited availability

European Union average: 15 products available (32%). Limited availability (46% of available products) Netherlands did not submit complete information on restrictions to available medicines meaning LA* is not captured in these countries. †In mostcountries availability equates to granting of access to the reimbursement list, except in DK, FI, LU, NO, SE where some hospital products are not covered by the general reimbursement scheme. *Countries with asterisks did not complete a full dataset andtherefore availability may be unrepresentative. **In Spain, the WAIT analysis does not identify those medicinal products being accessible earlier in conformity with Spain's Royal Decree 1015/2009 relating to Medicines in Special Situations

TurkeyLithuania*Bosnia

Malta

SerbiaSlovakia

Estonia*Croatia

LatviaIreland

11% 33%

14% 29% 40% 20% 25%
86% 71% 60% 80%
67%100%100% 50%100%
75% 33%50%
100%

Norway56%
10%*Cyprus89% 67% 100%

Finland

Belgium

44%*North Macedonia

Full public availability

PolandGreeceSlovenia

Bulgaria

Scotland

Switzerland

Netherlands

Portugal

England

40%

7%

90%

Hungary

93% 100% 60%
53%

Romania47%

Sweden

53%

76%

20%

Denmark

Czech**Spain

100%

79%

48% 59%13%

Austria47%

Iceland

100%
46%

Italy

53% 24%

80%

62%

53%

France

21%
47%

88%

Luxemburg

54%
94%

Germany

50
45
40
35
30
25
20
15
10
5
0

EU approvals

Availability breakdown (%)

The rate of full availability shows the proportion of medicines available to patients in European countries as of
5th January 2024 (for most countries this is the point at which the product gains access to the reimbursement
list†) without any restrictions to the patient population, or through named patient basis schemes which haveincreased significantly in recent years and were not always captured in survey submissions.

36All products

Oncology

Orphans

Non-onc orphans

Combination

Non-oncology orphan breakdown of availability (%, 2019-2022)

47
6%
15%
32%

28% 38%
64% 64% 64%

4%

64%

70% 70%79% 81% 79%

85%

23%
4%
9%

Full public availability

Only available privately

13% 11% 6%
4%

2% 6%
2%
2%
9% 6%

Not available

15%
2%
4% 6%
2%

6%

2%
2%
2% 4%

2%

4%

Turkey6%

4%*Croatia

2%
19%

Latvia13%

Ireland2%

49%

Norway

11%

2%

57%

4%

Finland

Belgium

Slovenia

Bulgaria

Scotland

Switzerland

Limited Availability

17%

Hungary

9%

19%

9%

Romania

19%

2%

Netherlands

Portugal

EnglandDenmark

Czech**Spain

28%
19%

9%

6%

Austria21%

Iceland28%

28% 30% 13%

Poland23%

98% 96%

30%

17%
2%

36%

32%

94% 91%

45%

21%
17%

43%
23%

Italy

9%

34%

38%

36%

21%

Sweden19%

45%

Greece62%26% 19%Luxemburg

28%

79%

45%

Estonia85%

France85%

89%

Lithuania

32%

47%

55%

57%

Malta
*NorthMacedonia*Bosnia

57% 57% 60% 60% 55%

Serbia53%

Slovakia

49% 49% 51%

36%

43%

*Cyprus32%

Germany

100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%

EU approvals

Availability breakdown (%)

The breakdown of availability is the composition of medicines available to patients in European countries as of
5th January 2024 (for most countries this is the point at which the product gains access to the reimbursement
list†). This includes all medicine’s status to provide a complete picture of the availability of the cohort studied.

Not submitted by association

European Union average: 15 products available (32%), Limited availability (13% of all non-onc orphan products). Netherlands did not submit complete information on restrictions to available medicines meaning LA* is not captured in these countries. †In
most countries availability equates to granting of access to the reimbursement list, except in DK, FI, LU, NO, SE where some hospital products are not covered by the general reimbursement scheme. *Countries with asterisks did not complete a full dataset andtherefore availability may be unrepresentative. **In Spain, the WAIT analysis does not identify those medicinal products being accessible earlier in conformity with Spain's Royal Decree 1015/2009 relating to Medicines in Special Situations

37

All products

Oncology

Orphans

Non-onc orphans

Combination

Non-oncology orphan time to availability (2019-2022)
The time to availability is the days between 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†). The
marketing authorisation date is the date of central EU authorisation in most countries, except for countries
shown in italics where local authorisation dates have been used. Data is correct to 5th January 2024.
2,000

1,000
367
296 326500

382 421500 505426

558

585 601

608

627

750

958

735 741644 654610

551

433 440 475

641

207 229
95

107

35

*CyprusAustria

Denmark

Switzerland

Slovakia***Scotland

SwedenFinland

Iceland***England

Italy

Luxemburg*Croatia

Hungary

GreeceNetherlands

Belgium

Slovenia

Ireland**France

Estonia

NorwaySpain

Bulgaria

Czech

Romania

Portugal

LatviaPolandLithuania

Malta*Bosnia

Turkey190

Germany

0

734

633

*NorthMacedonia
SerbiaTime (days)

1,500

Available medicines / 47

2

3

40

9

29

23

19

3

19

10

9

10

22

31

17

5

9

17

20

14

17

7

32

4

7

24

19

24

9

20

5

14

1

3

2

0

Dates submitted / 47

1

1

40

3

29

23

10

3

19

10

9

10

22

31

13

4

9

13

20

14

17

7

20

4

6

24

19

23

9

5

5

14

1

0

0

0

European Union average: 530 days (mean) (Note: Malta is not included in EU27 average as no dates were submitted in total) †In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, NO, SE where some hospital products are not covered by
the general reimbursement scheme. *Countries with asterisks did not complete a full dataset and therefore availability may be unrepresentative, **For France, the time to availability (610 days, n=20 dates submitted) includes products under the Accès précoce system (n=10 dates submitted)
for which the price negotiation process is usually longer. If one considers that products under the Accès précoce system are directly available (time to availability = 0), the average time to availability is 401 day. ***In the UK, MHRA’s Early Access to Medicines Scheme provides access prior
to marketing authorisation but is not included within this analysis, and would reduce the overall days for a small subset of medicines. In this analyses, MHRA dates have been used for 2021-2022 products and EMA dates used for 2019-2020 products38All products

Oncology

Orphans

Non-onc orphans

Combination

Non-oncology orphan median time to availability (2019-2022)
The median time to availability is the days between marketing authorisation and the date of availability topatients in European countries (for most this is the point at which products gain access to the reimbursement
list†). The marketing authorisation date is the date of central EU authorisation in most countries, except for
countries shown in italics where local authorisation dates have been used. Data is correct to 5th January 2024.
1,000

958

35

Time (days)

800
700

578

600
500

355

400

300

252 258

200
35 45

25
20
15
10

160
93 95

Austria

Serbia*CyprusDenmark

Switzerland

SwedenSlovakia***Scotland

Luxemburg***England

Hungary

IcelandFinland

Italy

Estonia

Belgium

Netherlands*Croatia**France

Slovenia

LatviaSpain

GreeceNorwayPortugal

Romania

Bulgaria

Ireland

PolandCzech

Lithuania

5

Turkey*NorthMacedonia
Germany

Dates submitted/ 47

587 587*Bosnia0

340 354475 480563

30

687 692 704 705

Malta

100

310

375 379415 418 425

514 526 535 541

655 680

0

0

0

29

1

3

23

10

10

3

19

13

22

9

10

9

31

4

14

20

4

20

17

5

24

13

6

5

9

19

7

14

23

1

1

40

Median time to availability

Number of products
available

900

40

0

Number of medicines available

European Union average: 487 days (median) †In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, NO, SE where some hospital products are not covered by the general reimbursement scheme. *Countries with asterisks
did not complete a full dataset and therefore availability may be unrepresentative **For France, the median time to availability (535 days, n=20 dates submitted) includes products under the Accès précoce system (n=10 dates submitted) for which the price negotiation
process is usually longer. If one considers that products under the Accès précoce system are directly available (time to availability = 0), the median time to availability is 382 day. ***In the UK, MHRA’s Early Access to Medicines Scheme provides access prior to marketing
authorisation but is not included within this analysis, and would reduce the overall days for a small subset of medicines. In this analyses, MHRA dates have been used for 2021-2022 products and EMA dates used for 2019-2020 products

39Key observations
Executive summary (EU27 averages)
Oncology

OrphanNon-oncologic
orphanCombination
therapy

MeasureAll products

Average rateof availability

43%

52%

35%

32%

54%

(45% in 2022)(50% in 2022)(39% in 2022)(39% in 2022)(50% in 2022)

Average timeto availability

531
Days

559
Days

542
Days

530
Days

433
Days

(517 days in 2022)(526 days in 2022)(625 days in 2022)(626 days in 2022)(426 days in 2022)

Key Insights
Rate of availability• Average rate of availability for non-oncology orphan medicines is 11% lower than the average forall products• The rate of availability for non-oncology orphan medicines in 2023 is 32%, which represents a 7%
decline since last year’s survey

Time to availability• The average time to availability for non-oncology orphan products is in line with the average for all
products, making it one of the segments with the fastest time to availability• Europe’s time to availability for non-oncology orphan drugs can vary from less than 3 months toover 31 months

Metrics key:
Text colour indicates relative
position versus the current (2023) EUaverage (significantly worse thancurrent EU average / significantly
better than current EU average)
Arrow colour indicates significant
changes versus the previous (2021)
EU average (significant improvement
versus previous year
/ significant
deterioration versus prior year)
Average calculations:
Only a difference of +/- 5% (~30days) is considered a significant
change and therefore highlighted
Malta is not included in EU27
average for time to availability as nodates were submitted in total

40

5. Combination therapies
Indicators:
5.1. Total availability by approval year
5.2. Rate of availability
5.3. Rate of full availability
5.4. Breakdown of availability
5.5. Time to availability
5.6. Median time to availability

Combination therapies availability by approval year (2019-2022)
The total availability by approval year is the number of fixed dose combination medicines available topatients in European countries as of 5th January 2024 (for most countries this is the point at which the productgains access to the reimbursement list†), split by the year the product received marketing authorisation in
Europe.
11 11 1110 10 10 10
1
2
3

8

3

3

2

3

9

9

9

9

9

2

2

2

2

2

9

9
1

3

8
1

2

6

7

7

7

7

1

1

1

1

7
2

7
1

6

6

6

6

1

1

2
6

7

6

6

7

6

6

6

6

6

6

6

6
5

5

5

5

5

5

5

5
1

5

4

4

1

4

4
3

2

3

5

3

2

3

2

2

2

2
1

1

1

1

1

1

1

1

1

Austria

Netherlands

Italy

Finland

Czech

Sweden**Spain

ScotlandNorwayLuxemburg

IcelandDenmark

FranceSlovakia

Portugal

IrelandEngland

2019

2020

1

1

1

2021

1

1

1

1

1

1

1

*Bosnia

1*Cyprus1

Lithuania

1

Serbia1*Croatia

1

Greece1

Hungary1

Romania

1

Slovenia

1

Belgium1

Bulgaria

1

Germany

1
1

Switzerland

0

5

1

Estonia

4

7

Malta

3

Turkey1*North Macedonia

1

4

Latvia10

1Poland12

13

EU approvals

Number of products

14

2022

European Union average: 7 products available (54%) Combination products can include innovative branded / generic combinations. †In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, LU, NO, SE wheresome hospital products are not covered by the general reimbursement scheme. *Countries with asterisks did not complete a full dataset and therefore availability may be unrepresentative. **In Spain, the WAIT analysis does not identify those medicinal products
being accessible earlier in conformity with Spain's Royal Decree 1015/2009 relating to Medicines in Special Situations

42

All products

Oncology

Orphans

Non-onc orphans

Combination

Combination therapies rate of availability (2019-2022)
The rate of availability, measured by the number of fixed dose combination medicines available to patients in
European countries as of 5th January 2024. For most countries this is the point at which the product gains
access to the reimbursement list†, including products with limited availability.
13

12

11

11

11
10

10

10

10

10
9

9

9

9

9

9

9
8
7

7

7

7

7

7

7

6

6

6

6

85% 85% 85%
77% 77% 77% 77%

4

5

5

69% 69% 69% 69% 69% 69% 69%
62%

4

4

54% 54% 54% 54% 54% 54% 54%
46% 46% 46% 46%2

38% 38%
31% 31%

2

2

2

2

Available*Bosnia*Cyprus

Lithuania

Serbia*Croatia

Estonia

LatviaPolandGreeceHungary

Romania

Slovenia

EU average

Belgium

Bulgaria

England

Ireland

Portugal

Slovakia

FranceDenmark

Iceland

Luxemburg

NorwayScotland**Spain

SwedenCzech

Finland

Italy

Netherlands

Austria

Germany

Switzerland0

EU approvals

15% 15% 15% 15%

1
8%

Malta

6

Turkey8*North Macedonia

Number of products

14

European Union average: 7 products available (54%) Combination products can include innovative branded / generic combinations; †In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, LU, NO, SE wheresome hospital products are not covered by the general reimbursement scheme. *Countries with asterisks did not complete a full dataset and therefore availability may be unrepresentative. **In Spain, the WAIT analysis does not identify those medicinal products
being accessible earlier in conformity with Spain's Royal Decree 1015/2009 relating to Medicines in Special Situations

43

All products

Oncology

Orphans

Non-onc orphans

Combination

Combination therapies rate of full availability (%, 2019-2022)
The rate of full availability shows the proportion of fixed dose combination medicines available to patients in
European countries as of 5th January 2024 (for most countries this is the point at which the product gains accessto the reimbursement list†) without any restrictions to the patient population, or through named patient basis
schemes which have increased significantly in recent years and were not always captured in survey submissions.
13

12
18%
20%

10%

8

50% 33%

17% 17%

56%

67%

88%

67%

100%100%

86% 86%

100%
100%100%

44%

40% 40%83% 83%
60% 60%

Full public availability

GreeceHungary

Romania

Slovenia

Belgium

Bulgaria

England

Ireland

Portugal

Slovakia

FranceDenmark

Iceland

Luxemburg

NorwayScotland**Spain

SwedenCzech

Finland

Italy

Netherlands

Austria

Germany

Switzerland

EU approvals

29%

0

50%
50%

25%
75% 50%
50%

100%

50%
50%

100%
100%

Limited availability

European Union average: 7 products available (54%), Limited availability (22% of available products). Combination products can include innovative branded / generic combinations; Netherlands did not submit complete information on restrictions toavailable medicines meaning LA* is not captured in these countries.†In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, LU, NO, SE where some hospital products are not covered by the general reimbursement
scheme. *Countries with asterisks did not complete a full dataset and therefore availability may be unrepresentative. **In Spain, the WAIT analysis does not identify those medicinal products being accessible earlier in conformity with Spain's Royal Decree
1015/2009 relating to Medicines in Special Situations

Malta

50%

2

67%

71%

Turkey100%100%*North Macedonia

80%

90%

*Bosnia100%

64%

14% 14%*Cyprus

4

13%
56%

Lithuania

82%

33%

Serbia100%

33%*Croatia

6

44%

Estonia36%

Latvia10

PolandNumber of products

1444All products

Oncology

Orphans

Non-onc orphans

Combination

Combination therapies breakdown of availability (%, 2019-2022)

13
8%

8%

15% 15% 15%15%23% 23%

23%

23%

15%

31%

31% 31% 31%
23%

15%

38%

15%
8%

31%

38%
46%

38%
46% 46%

38%
46%

8%

46% 46%
54% 54% 54%

46%
54% 54%

46%
54%

15%

62%

38% 23%

23%

23%

8%

8%

8%

85%

31%

92%
38%

8%

8%

8%

15%
85%

8%

8%

8%

77%

23%

38%

15%

69%

69%

69% 69%38%

62%

15% 15%

54%

54%
46%
38%

46%

54% 54%

46%

31%

54%
46% 46%46%8%
46% 46%

38%

23%

15%
38% 38%8%

31%
23% 8%

8%

Full public availability

Limited Availability

Only available privately

Not available

Lithuania

Serbia*Croatia

Estonia

LatviaPolandGreeceHungary

Romania

Slovenia

Belgium

Bulgaria

England

Ireland

Portugal

Slovakia

FranceDenmark

Iceland

Luxemburg

NorwayScotland**Spain

SwedenCzech

Finland

Italy

Netherlands

Austria

Germany

8%

15%
8%

8%

8%

Malta

15%

*Bosnia*NorthMacedonia
Turkey15%*Cyprus23% 23%
15%

Switzerland

100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%

EU approvals

Availability breakdown (%)

The breakdown of availability is the composition of fixed dose combination medicines available to patients in
European countries as of 5th January 2024 (for most countries this is the point at which the product gains accessto the reimbursement list†). This includes all medicine’s status to provide a complete picture of the availability of
the cohort studied.

Not submitted by association

European Union average: 7 products available (54%), Limited availability (11% of all products). Combination products can include innovative branded / generic combinations; Netherlands did not submit complete information on restrictions to available
medicines meaning LA* is not captured in these countries.†In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, LU, NO, SE where some hospital products are not covered by the general reimbursement scheme.
*Countries with asterisks did not complete a full dataset and therefore availability may be unrepresentative. **In Spain, the WAIT analysis does not identify those medicinal products being accessible earlier in conformity with Spain's Royal Decree 1015/2009
relating to Medicines in Special Situations

45

All products

Oncology

Orphans

Non-onc orphans

Combination

Combination therapies time to availability (2019-2022)
The time to availability is the days between marketing authorisation and the date of availability of fixed dosecombination medicines to patients in European countries (for most this is the point at which products gain
access to the reimbursement list†). The marketing authorisation date is the date of central EU authorisation inmost countries, except for countries shown in italics where local authorisation dates have been used. Data iscorrect to 5th January 2024.
2,000Time (days)

1,500

1,000
201

347

282
271

255

500

315
304

289

258 262 264
99

387

414
395 408

324

439

666
702

755

588
515 564
462 497***Scotland*Bosnia

SerbiaSlovenia

Estonia

Sweden**France

IrelandNetherlands

Lithuania

Luxemburg*Croatia

NorwayAustria

Italy

Belgium

Czech

Slovakia

Finland

Iceland

Latvia*CyprusRomania

GreecePortugal

Hungary

Spain

Bulgaria

PolandMalta

TurkeyAvailable medicines / 13

1

9

11

11

7

9

2

2

6

4

9

8

7

10

2

9

4

9

11

10

7

10

7

10

9

5

2

6

6

7

6

9

7

5

0

0

Dates submitted / 13

1

9

11

7

7

9

1

2

6

4

9

7

7

10

2

8

4

9

11

10

7

10

7

10

9

5

2

6

5

7

6

9

7

5

0

0

*NorthMacedonia
Denmark***England

159

Switzerland

133

359

316 321

648

Germany

0

643

624

European Union average: 433 days (mean) (Note: Malta is not included in EU27 average as no dates were submitted in total) Combination products can include innovative branded / generic combinations; †In most countries availability equates to granting of accessto the reimbursement list, except in DK, FI, NO, SE where some hospital products are not covered by the general reimbursement scheme. *Countries with asterisks did not complete a full dataset and therefore availability may be unrepresentative. **For France, no
combination therapy was approved via the Accès précoce system. ***In the UK, MHRA’s Early Access to Medicines Scheme provides access prior to marketing authorisation but is not included within this analysis, and would reduce the overall days for a small subsetof medicines. In this analyses, MHRA dates have been used for 2021-2022 products and EMA dates used for 2019-2020 products46All products

Oncology

Orphans

Non-onc orphans

Combination

Combination median time to availability (2019-2022)
The median time to availability is the days between marketing authorisation and the date of availability topatients in European countries (for most this is the point at which products gain access to the reimbursement
list†). The marketing authorisation date is the date of central EU authorisation in most countries, except for
countries shown in italics where local authorisation dates have been used. Data is correct to 5th January 2024.
864

11
10

800

Time (days)

663

8

496 5507
6
4

255 262 264

3
2
43

600
500

405

400
300

198

200

Germany

Denmark*NorthMacedonia
Estonia

Switzerland

SwedenNetherlands

Ireland***England

Slovenia*Bosnia

Serbia**France***Scotland

Austria

Lithuania

Italy

Luxemburg*Croatia

NorwayLatviaBelgium

Czech

Finland

Iceland

Portugal

Slovakia

Bulgaria

Spain*CyprusRomania

Hungary

PolandGreece100

TurkeyDates submitted/ 13

141 154 155

350 362326 330 331 334

581

Malta

1

113
86 99 107298 308 314 321

700

457 464349

5

550 564

701

0

0

11

9

7

9

10

7

7

6

1

2

7

9

11

2

10

8

4

9

5

7

10

10

9

7

7

7

9

2

6

6

5

5

1

4

Median time to availability

0

Number of products
available

9

0

900

Number of medicines available

European Union average: 375 days (median) †In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, NO, SE where some hospital products are not covered by the general reimbursement scheme. *Countries
with asterisks did not complete a full dataset and therefore availability may be unrepresentative **For France, no combination therapy was approved via the Accès précoce system. ***In the UK, MHRA’s Early Access to Medicines Scheme provides access prior tomarketing authorisation but is not included within this analysis, and would reduce the overall days for a small subset of medicines. In this analyses, MHRA dates have been used for 2021-2022 products and EMA dates used for 2019-2020 products

47

Key observations
Executive summary (EU27 averages)
Oncology

OrphanNon-oncologic
orphanCombination
therapy

MeasureAll products

Average rateof availability

43%

52%

35%

32%

54%

(45% in 2022)(50% in 2022)(39% in 2022)(39% in 2022)(50% in 2022)

Average timeto availability

531
Days

559
Days

542
Days

530
Days

433
Days

(517 days in 2022)(526 days in 2022)(625 days in 2022)(626 days in 2022)(426 days in 2022)

Key Insights
Rate of availability• Average rate of availability for combination therapies is 11% higher than the average for all
products• The rate of availability for combination therapies is 4% higher than the previous study, despite thelower number of central approvals in this year’s survey

Time to availability• The time to availability for combination therapies is the fastest across all segments, with an averageof ~14 months in Europe vs ~18 months for all products• For over half of the countries included in this year’s WAIT survey, the time to availability of
combination therapies is less than 13 months

Metrics key:
Text colour indicates relative
position versus the current (2023) EUaverage (significantly worse thancurrent EU average / significantly
better than current EU average)
Arrow colour indicates significant
changes versus the previous (2021)
EU average (significant improvement
versus previous year
/ significant
deterioration versus prior year)
Average calculations:
Only a difference of +/- 5% (~30days) is considered a significant
change and therefore highlighted
Malta is not included in EU27
average for time to availability as nodates were submitted in total

48

6. Historic comparisons andextended period
Indicators:
6.1. Comparison of availability versus prior studies (2021 – 2023)
6.2. Comparison of time to availability versus prior studies (2021 – 2023)
6.3. Extended period total availability by approval year (2014 – 2022)

Comparison of rate of availability (2021 study – 2023 study)
The comparison of rate of availability†, measured by the number of medicines available to patients in European
countries as of 5th January 2024, compared to the rate of availability in previous (comparable) studies. Figures are
based on the historic statistics published in the indicators, and major changes are often due to improved reporting.
-4%

0%

0%

1%

-2%

Serbia*Bosnia*North Macedonia

TurkeyNorway2%

Lithuania

Iceland-13%

Slovakia

Poland0%

Romania

Slovenia

2022 Availability cohort (2018-2021)

0%

Estonia-11% -4% -11% -3%*Croatia

6%

Ireland6%

Hungary

10% -11% -1%

Finland-5%

Latvia2021 Availability study (2017-2020 cohort)-7%

Bulgaria**Spain6%

Belgium

Czech

-9%

GreeceSwitzerland-9%

Portugal

Austria-10% -7%

Sweden3%

Scotland3%

Netherlands-3% -11% -3%

England-3%

France-3%Denmark

1%

Italy

100
90
80
70
60
50
40
30
20
10
0

Germany% Availability

Delta in % availability (2022 study vs. 2023 study)

2023 Availability cohort (2019-2022)

Increases of <=5% are not considered to be statistically significant and are therefore highlighted in grey. Note: Netherlands has retrospectively corrected 2020 data; †In most countries availability equates to granting of access to the reimbursement list, except in
DK, FI, LU, NO, SE some hospital products are not covered by the general reimbursement scheme. *Countries with asterisks did not complete a full dataset and therefore availability may be unrepresentative. **In Spain, the WAIT analysis does not identify those
medicinal products being accessible earlier in conformity with Spain's Royal Decree 1015/2009 relating to Medicines in Special Situations

50

Comparison of time to availability (2021 study – 2023 study)
The comparison of time to availability (previously know as length of delay) is the days between marketing
authorisation and the date of availability to patients compared to previous comparable studies. Figures are basedon the historic statistics published in the indicators, and major changes are often due to improved reporting.

2021 study (2017-2020)2022 study (2018-2021)

19

185

-13

-74

70

274

102

79

33

8

170

23

-141

-23

Hungary

LatviaSpain

Portugal

Lithuania

Bulgaria

Romania

Poland3

Serbia56

Estonia-43

Greece19

Slovakia-42

Turkey-10

Belgium

51

Slovenia***England-12*Croatia

Sweden17

Iceland

Switzerland

77**France

Austria-39

Ireland*North Macedonia

-41

Czech

15

Norway

-25

Italy

35

Finland-18

Netherlands

17***Scotland-22*Bosnia-2

Denmark

1,000
900
800
700
600
500
400
300
200
100
0

Germany

Time to availability

Delta in days (2022 study vs. 2023 study)

2023 study (2019-2022)

Changes of <=30 days are not considered to be statistically significant and are therefore highlighted in grey. *Countries with asterisks did not complete a full dataset and therefore availability may be unrepresentative. **For France, the time to availability (527days, n=79 dates submitted) includes products under the Accès précoce system (n=18 dates submitted) for which the price negotiation process is usually longer. If one considers that products under the Accès précoce system are directly available (time toavailability = 0), the average time to availability is 424 days. ***In the UK, MHRA’s Early Access to Medicines Scheme provides access prior to marketing authorisation but is not included within this analysis, and would reduce the overall days for a small subset of
medicines. In this analyses, MHRA dates have been used for 2021-2022 products and EMA dates used for 2019-2020 products51

Extended period total availability by approval year (2014-2022)
The extended period total of availability by approval year is the number of medicines available to patientsin European countries (for most countries this is the point at which the product gains access to thereimbursement list†), split by the year the product received marketing authorization. It shows the additional
data available within the Patients W.A.I.T. dataset that is not included within the standard 4-year rolling cohort.
372
319 309290 289

70

71

76

60

72

150
100

205

183 190 183 181 172 177
159 156 156 164 160 154 154

155
138 142 149 145 140

Historic approvals (2014-2018)

NorwayBelgium

Finland

Slovenia

Portugal

Scotland

GreeceSwedenLuxemburg

EnglandCzech

France**Spain

Netherlands

Switzerland

Denmark

Austria

Italy

Germany

EU approvals

50
0

191 184119

179 177

47
69

137

161 15550
61

29

150 14729
52

133 126

121

40

31

31

89
14

110

127

100

126 121

95

93

95

90

75

76
6
70

Current cohort approvals (2019-2022)

European Union average: 207 products available (56%) †In most countries availability equates to granting of access to the reimbursement list, except in DK, FI, LU, NO, SE some hospital products are not covered by the general reimbursement scheme.
*Countries with asterisks did not complete a full dataset and therefore availability may be unrepresentative.
Note: National Associations perform checks on historic products on a best efforts basis, although it has been noted that status changes do not often occur.

67
14

47 44 39
12

53

35

6
38

11
28

*North Macedonia

83

Malta

90

*Bosnia

79

Serbia84

Turkey89

Lithuania

93

Latvia103 106 104

Estonia200

225 219 216 216 215*Croatia

91

238 233 228*Cyprus109 117257 249

Romania

126

Slovakia

147 129

250

Iceland268 262 262 260

Hungary

167

Poland300

330

IrelandNumber of products

350

Bulgaria

400

52

Appendix and detailed
methodology

Method and data availability
Process for product selection

1758

489

EMA list

Products in scope

•

•

•

List of all historic Marketing Authorisations
for human and veterinary medicines(European Public Assessment Reports)
accessed November 2023
Human medicines only

•
•
•
•
•

Products with authorisation year: 2014,2015, 2016, 2017, 2018, 2019, 2020,
2021, 2022
Status: Authorised
Non-generic; Non-biosimilar; no vaccines
Include combinations (both products canhave already been approved before)
Remove ATC K & T*
Exclude specific ATC V products**

167

372
Survey cohort (9-years)
•
•
•
•

•

Remove products with an active
substance approved pre-2014
New combination products (thosecontaining 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

Report cohort (4-years)••

Medicines in the 4-year rolling cohort
2019 – 2022^
Exclude products that are recently
withdrawn prior to analysis (3)^ Note: Products included in the WAIT indicator are aligned with products included in EFPIA Access Hurdles Portal (except biosimilar products, which are included in the Portal and excluded in WAIT indicator)* Removal ATC class exclusions: K = Hospital Solutions; V = Various, T = Diagnostics; Oncology definition used throughout = L1&L2&V3C&Revlimid&Xgeva&Proleukin&Pomalyst** In previous years, all products within ATC-V class have been excluded from the WAIT indicator; However, the criteria has been adapted to exclude ATC-V products that are allergens, diagnostic agents, general nutrients, contrast media,
diagnostic radiopharmaceuticals, surgical dressings, and all other non-therapeutic products; Other new innovative therapeutics that are classified within ATC-V should be considered for inclusion.

54

Products included in the study: 2019-2022 approvals (n=167)
AbecmaAdtralza
Ajovy
AmvuttraArikayce liposomal
Artesunate Amivas
AspaveliAtectura Breezhaler / BemristBreezhaler
Ayvakyt
BaqsimiBeovu
BesremiBimzelx
Blenrep
Breyanzi
Brukinsa
ByfavoBylvayCalquence
Carvykti
Cibinqo
CopiktraDaurismo
Doptelet
DovatoDovprela (previously
Pretomanid FGK)
Drovelis/Lydisilka
Ebvallo

EladynosElzonris
Enerzair Breezhaler / Zimbus
Breezhaler
Enhertu
Enjaymo
Enspryng
Epidyolex

Kesimpta
Kimmtrak

OpdualagOrgovyx

Rukobia
Rybelsus

TukysaUltomiris

Kinpeygo
Klisyri
Koselugo
LeqvioLibmeldy

OrladeyoOxbrytaOxlumoPadcev
Palynziq

Rybrevant
Ryeqo
Saphnelo
Sarclisa
Scemblix

Uplizna
Upstaza
VabysmoVazkepa
Verquvo

ErleadaEvenity
Evkeeza
Evrenzo
EvrysdiFetcroja
Filsuvez
Fintepla
GavretoGiapreza
Givlaari
Hepcludex
Idefirix
Imcivree
Inrebic
Isturisa
Jemperli
Jyseleca

LibtayoLivmarli
Livtencity
Lorviqua
Lumykras
Lunsumio
LupkynisMayzent
Minjuvi
Mounjaro
Mulpleo
Mycapssa
Nexpovio
Nexviadyme
NgenlaNilemdoNubeqaNulibry

Pemazyre
PhesgoPiqrayPluvicto
PolivyPonvory
Pyrukynd
Qinlock
Quofenix
Quviviq
Rayvow
Reblozyl
Recarbrio
Rekambys
Retsevmo
Rhokiinsa
RinvoqRizmoic

Sibnayal
Skyrizi
Skytrofa
SogroyaSpevigoSpravato
Sunlenca
SunosiTabrecta
Talzenna
Tavlesse
Tavneos
Tecartus
Tecovirimat SIGA
Tecvayli
Tepmetko
Tezspire
Trecondi

Vitrakvi
Vizimpro
Vocabria
Voraxaze
VoxzogoVumerity
VyduraVyepti
VyvgartWaylivra
WegovyXenleta
Xenpozyme
Xofluza
Xospata
YseltyZeposia
Zokinvy

Kaftrio
Kapruvia
Kerendia

Nustendi
Obiltoxaximab SFL
Ontozry

Roclanda
RoctavianRozlytrek

Trepulmix
Trixeo Aerosphere
Trodelvy

Zolgensma
Zynlonta* Drovelis and Lydisilka were treated as one product for the purpose of this analysis as there are multiple authorisations for the same active substance combination on the same date55

Products included in the study by segment: 2019-2022 approvals
Oncologics (n=48)
Zynlonta
Pluvicto
Opdualag
Scemblix
Tecvayli
Tabrecta
Lunsumio
Carvykti
Orgovyx
Padcev
Breyanzi
Kimmtrak
Tepmetko
Lumykras
RybrevantBrukinsa
Trodelvy
Gavreto
Qinlock
Minjuvi
AbecmaCopiktraJemperli
Nexpovio

Pemazyre
Retsevmo
TukysaEnhertuElzonris
PhesgoTecartus
Calquence
Ayvakyt
Blenrep
Rozlytrek
PiqrayDaurismo
Sarclisa
Nubeqa
PolivyXospata
Vitrakvi
LibtayoTalzenna
Trecondi
LorviquaVizimpro
ErleadaNotes: Segments are not mutually exclusive; *Trelegy Ellipta andElebrato Ellipta are considered as one product as there are multiple
authorisations for the same active substance combination on the samedateOrphans (n=63)
EbvalloLivmarli
Mycapssa
Enjaymo
Livtencity
Pyrukynd
Nulibry
AmvuttraScemblix
Roctavian
Vyvgart
Zokinvy
Upstaza
Kinpeygo
Xenpozyme
Filsuvez
Lunsumio
Carvykti
Kimmtrak
OxbrytaNgenlaTavneos
Skytrofa
VoraxazeAspaveli
Artesunate Amivas
Qinlock
Minjuvi
VoxzogoAbecmaBylvayImcivree

Enspryng
Koselugo
Sogroya
EvrysdiPemazyre
Inrebic
Elzonris
Fintepla
Libmeldy
Tecartus
OxlumoObiltoxaximab SFL
Arikayce liposomal
Ayvakyt
Blenrep
Idefirix
Kaftrio
DovprelaHepcludex
Daurismo
Reblozyl
Zolgensma
Trepulmix
Givlaari
PolivyIsturisa
Xospata
Epidyolex
Trecondi
Palynziq
Waylivra

Non-oncologic orphans (n=47)

Combination therapies (n=13)

EbvalloLivmarli
Mycapssa
Enjaymo
Livtencity
Pyrukynd
Nulibry
AmvuttraRoctavian
Vyvgart
Zokinvy
Upstaza
Kinpeygo
Xenpozyme
Filsuvez
OxbrytaNgenlaTavneos
Skytrofa
VoraxazeAspaveli
Artesunate Amivas
VoxzogoBylvayOpdualag
Ryeqo
Drovelis/Lydisilka
Sibnayal
Roclanda
PhesgoTrixeo Aerosphere
Kaftrio
Enerzair Breezhaler / Zimbus Breezhaler
Atectura Breezhaler / Bemrist Breezhaler
Nustendi
Recarbrio
DovatoImcivree
Enspryng
Koselugo
Sogroya
EvrysdiInrebic
Fintepla
Libmeldy
OxlumoObiltoxaximab SFL
Arikayce liposomal
Idefirix
Kaftrio
DovprelaHepcludex
Reblozyl
Zolgensma
Trepulmix
Givlaari
Isturisa
Epidyolex
Palynziq
Waylivra

56

Country specific definitions of products with availability
Country
Austria
Belgium
BosniaBulgaria
Croatia
Cyprus
Czech
Denmark
England
Estonia
FinlandFranceGermany
GreeceHungary
Iceland
IrelandItaly
LatviaLithuania
Luxembourg
North Macedonia
Malta
Netherlands
NorwayPolandPortugal
Romania
ScotlandSerbiaSlovakia
Slovenia
Spain
SwedenSwitzerland
TurkeyDefinition of availability
A medicine is available if it is included in the reimbursement system (EKO) or available through the Austrian pharmacies list
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
Accessibility on the public reimbursement list
Accessibility on the public reimbursement list
Accessibility on the public reimbursement list
Accessibility on the public reimbursement list
Product present on the market either (a) reimbursed or (b) not reimbursed but covered by patient or by individual patient approval by insurance funds
Products that are accessible in Denmark and available for public reimbursement
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.
A pharmacy product is available if it is reimbursed (pharmacy products) or added to the hospital service list.
A pharmacy product is available if it is on a national reimbursement list. Hospital products need an appraisal for COHERE (Council of Choices in Healthcare in Finland) or from the National Assessment Network coordinated by FinCCHTA(Finnish Coordinating Center for HTA).
Accessibility on the public reimbursement list
Following marketing authorisation, prescription drugs automatically receive reimbursed status
Accessibility on the public reimbursement list
Medicines are either reimbursed through the indication linked reimbursement system, or available by special finance system (item based) or financed by hospital budget
Accessibility on the public reimbursement list
Accessibility on the public reimbursement list, through a hospital setting or other public scheme
A product is available if it has received reimbursement status
Accessibility on the public reimbursement list
Accessibility on the public reimbursement list
Accessibility on the public reimbursement list (retail drugs); or product D and H commercialized medicines (hospital drugs)
Product is available via specially allocated budget for all eligible patients
Accessibility on the public reimbursement list
Accessibility on the public reimbursement list
The medicines has received a positive reimbursement decision by NoMA (out-patient drugs), or the Decision Forum (hospital products)
In most cases a medicine is available if it gains access to the reimbursement list; some medicines are financed via state budget and the date of accessibility would be the date of tender results published by governmental payers.
Accessibility on the public reimbursement list
For 98% of reimbursed medicines, accessibility is considered to be at therapeutic protocol publication (as the HCP cannot prescribe the product until the therapeutic protocols are published). For the remaining 2% of reimbursed medicinesthat don't need therapeutic protocols, accessibility is after publication in the reimbursement list.
Medicines are deemed available if SMC has issued a positive HTA recommendation. For the remaining medicines, IQVIA sales data are analysed to determine if routinely available.
Accessibility on the public reimbursement list
Availability according to the National Health Information Center. For remaining medicines, IQVIA sales data is used.
A medicine is available if it is reimbursed through the regular system, or automatically reimbursed
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.
A medicine is classified as available (nationally reimbursed) if it was marketed in Sweden as of December 21st 2023 (listed as supplied in FASS), and: Is indicated for a disease included in the communicable disease program, or Had
received a positive TLV decision (prescribed drugs), or - Had received a positive recommendation from the New Therapies (NT) Council (hospital drugs), or - Had not received an NT-recommendation and is not part of national managed
introduction (hospital drugs)
The medicine gained market approval by Swissmedic. Delay calculated using local market authorisation dates.
A medicine is available if it gains access to the reimbursement list.
57

Country specific definitions of products with limited availability
Country
Austria
Belgium
BosniaBulgaria
Croatia
Cyprus
Czech
Denmark
England
Estonia
FinlandFranceGermany
GreeceHungary
Iceland
IrelandItaly
LatviaLithuania
Luxembourg
North Macedonia
Malta
Netherlands
NorwayPolandPortugal
Romania
ScotlandSerbiaSlovakia
Slovenia
Spain
SwedenSwitzerland
TurkeyDefinition of limited availability
Products outside reimbursement system (EKO), but reimbursed on individual pre-approval (No Box)
No products are reported to have limited availability
There are no restrictions on availability meaning medicines are reimbursable in all approved patient populations
Reimbursement is only granted for specific subpopulations of the approved indications, for individual patients on a named patient basis or there is limited reimbursement while a decision is pending.
Products are available for specific patient cohorts (reimbursement guidelines outline specific criteria describing patient eligibility for treatment).
Reimbursment is only granted, on an indivitual name patient basis or for specifi subpopulations of the approved indications.
Reimbursed only if: (a) prescribed by specific speciality of physician; (b) specific setting (e.g. Centers of excellence) (c) hospital product only
Products that have received a partial recommendation or are not recommended by the Danish Medicines Council as well as products that have received conditional reimbursement or individual reimbursement by The Reimbursement
Committee.
Recommended for a restricted patient cohort relative to licensed indication, either: (a) through an optimised NICE decision (including optmised CDF decisions) or an individual funding request. (b) where at least one indication isrecommended for use but either optmised, not recommended, or no decision reached to date for another indication.
Only reimbursed for restricted patient cohort.
Reimbursement is only granted for specific subpopulations of the approved indications, for individual patients on a named patient basis or there is limited reimbursement while a decision is pending.
Some innovative products without competitors can be made available prior to market authorisation under the Early Access program.
There are no restrictions on availability meaning drugs are reimbursable in all patient populations.
Only reimbursed for restricted patient cohorts, or case by case reimbursement if the responsible committee judges its use necessary.
Medicine is available through a Name Patient Program (access depends on application for individual use)
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.
Subject to Managed Access Protocol
A product has limited availability if it has not received the reimbursement status (decision is pending) but it is dispensed, generally, via hospital for a specific subpopulation, subject to medical advice. It is not at patient's expense
Limited reimbursement to specific subpopulations of the approved indications; individual reimbursement (limited reimbursement on the named patient basis)
Only reimbursed for limited indications (compared to what was approved at market authorisation)
There are no restrictions on availability
Product is available via specially allocated budget for limited number of patients
Limited availability means on a named patient basis or similar or at times approved on a named patient basis for subpopulations.
Only reimbursed under certain therapeutic conditions (annex 2 on the positive reimbursement list).
The Association has only information on limited availability for specific subpopulation of the approved indication. We have no access to public information on limited availability to individual patients (named patient basis), or a group ofpatients while decision is pending
Only reimbursed for limited indications (compared to what was approved at market authorisation)
Product is only available on a patient by patient basis and after an Exceptional Authorisation has been granted, usually while public financing decision is pending (i.e., during the assessment process)
Reimbursement is only granted for specific subpopulations of the approved indications, for individual patients on a named patient basis or there is limited reimbursement while a decision is pending. Limited availability refers also to MEA.
Recommended for a restricted patient cohort relative to licenced indication by SMC using their HTA process (through submission or resubmission)
Products are reimbursed with significant restrictions on the number of patients (e.g. for new generation HepC medicines, there is a cap on only 60 patients per year) or number of indications
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
Only reimbursed for restricted patient cohort
Recommended for a resticted patient cohort relative to licensed indication by SMC using their HTA process (through submission or resubmission).
Only reimbursed for restricted patient cohort
For products pending reimbursement, patients have restricted reimbursement access. Such restricted access includes ‘individual reimbursement’ regulated by Art. 71a-b of KVV ordinance.
Products only available through a “Named Patient Scheme”. These medicines do not require TITCK (Turkish Medical Agency) approval but are reimbursed.
58

Country specific definitions of the availability date
Country
Austria
Belgium
BosniaBulgaria
Croatia
Cyprus
Czech
Denmark
England
Estonia
FinlandFranceGermany
GreeceHungary
Iceland
IrelandItaly
LatviaLithuania
Luxembourg
North Macedonia
Malta
Netherlands
NorwayPolandPortugal
Romania
ScotlandSerbiaSlovakia
Slovenia
Spain

SwedenSwitzerland

Definition of the availability date
The first date of availability on the public reimbursement list or Austrian Pharmacies list
The first date of availability on the public reimbursement list available on the website of the payer INAMI-RIZIV : https://ondpanon.riziv.fgov.be/SSPWebApplicationPublic/fr/Public/ProductSearch
The first date of availability on the public reimbursement list
In general, new innovative products are eligible for reimbursement as of 1st January following the year they have been included in PDL, however there are nuances and exceptions.
The first date of availability on the public reimbursement list
The first date of availability on the public reimbursement list
The first date of availability on the public reimbursement list
Products are available when they have been marketed on the Danish pharmaceutical market and a price has been listed on Medicinpriser.dk.
For medicines with a positive NICE recommendation, the accessibility date is the date of publication of the Final Draft Guidance produced by NICE (oncology medicines), or date of published guidance + 90 days (non-oncology
medicines). Oncology medicines benefit from earlier funding. For the remaining medicines, IQVIA sales data is analysed to determine month of routine availability.
Availability date of reimbursement list and date of inclusion to the health service list or state project tender decision time.
Availability for reimbursed products is the date of Pharmaceutical Pricing Board approval. For hospital products, the date of availability is the COHERE appraisal date OR the National Assessment Network appraisal date.
The first date of availability on the public reimbursement list
Date of market entry listed in the LauerTaxe
The first date of availability on the public reimbursement list
The date when the therapy is available for the first patient. This is the earliest date that the therapy is available on the public reimbursement list or the date the first patient received the therapy in Named Patient Program.
The first date of availability on the public reimbursement list
The first date of availability on the public reimbursement list
The first date of availability on the public reimbursement list
The first date of availability on the public reimbursement list
The first date of availability on the public reimbursement list
The date of the decision to include the medicine into the public reimbursement list
The Positive Drug List has not been revised for more than 10 years. Therefore, availability dates are provided on a case by case basis.
The first date of availability on the public reimbursement list
The first date of availability on the public reimbursement list; or for hospital products, the date of the positive decision in Decision ForumThe first date of availability on the public reimbursement list, except for HIV / haemophilia drugs (financed by state budget) where availability date is date of publication of tender results or date of first order received from companies.
The first date of availability on the public reimbursement list
Date of publication of government decision (for medicines that don't need therapeutic protocols elaboration or update) or therapeutic protocols (for the majority of medicines) in the Official Journal.
For medicines with a positive SMC recommendation, the accessibility date is the date of published guidance. For remaining medicines, IQVIA sales data is analysed to determine month of routine availability.
The first date of availability on the public reimbursement list
The first date of availability on the public reimbursement list (published on monthly basis)
The first date of availability on the public reimbursement list
For medicines with a positive SMC recommendation, the accessibility date is the date of published guidance. For the remaining medicines, the IQVIA sale data is analysed to determine month of routine availability.
For medicines indicated For diseases included in the communicable disease program: date of marketing in Sweden (supplied in FASS); For nationally reimbursed prescription medicines with a TLV decision: date of TLV decision; For
nationally reimbursed hospital drugs with an NT-recommendation: date of NT recommendation; For nationally reimbursed hospital medicines lacking an NT-recommendation and not part of national managed introduction: date ofmarketing in Sweden (supplied in FASS)
For medicines indicated For diseases included in the communicable disease program: date of marketing in Sweden (supplied in FASS); For nationally reimbursed prescription medicines with a TLV decision: date of TLV decision; For
nationally reimbursed hospital drugs with an NT-recommendation: date of NT recommendation; For nationally reimbursed hospital medicines lacking an NT-recommendation and not part of national managed introduction: date ofmarketing in Sweden (supplied in FASS)
The date of full availability is the first date of availability on the public reimbursement list; the date of limited availability is the first date of availability on the list of products reimbursed through “Named Patient Scheme”
59Contact details
General queries:
Francois Bouvy, EFPIA francois.bouvy@efpia.eu

Additional analysis:
Max Newton, IQVIA
maximilian.newton@iqvia.com

Country-specific insights:
Local pharma industry associations