EFPIA Patients W.A.I.T . Indicator 2019 Survey · 2020. 7. 1. · IQVIA Template (V2.0.1) 9 . For countries where this differs, the definition of Availability is below: • Austria:

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IQVIA Template (V2.0.1)

© 2020. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States, the European Union, and various other countries.

EFPIA Patients W.A.I.T. Indicator 2019 Survey May 2020

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In this study the term ‘availability’ is used throughout. The definition of ‘availability’ is as follows and should be considered when interpreting the data:

ACCESSIBILITY ON THE PUBLIC REIMBURSEMENT LIST IN A COUNTRY

This definition allows a standardised measure to compare across countries. Where appropriate it takes into consideration things like managed entry agreements, line-of-therapy or formulary restrictions. However, it does not have a correlation to the use / uptake of the medicines. Country-specific nuances should be discussed with the local associations or EFPIA directly to ensure correct interpretation of the data.

3

•  “Patients W.A.I.T.” stands for Patients Waiting to Access Innovative Therapies. The INDICATOR provides a benchmark of the rate of availability and waiting times in European countries.

•  The Patients W.A.I.T. Indicator shows, for new medicines (i.e. medicines including a substance that has not been previously available in Europe) within a (rolling) 4 year cohort:

1.  The rate of availability, measured by the number of medicines available to patients in European countries. For most countries this is the point at which the product gains access to the reimbursement list

2.  The average time between marketing authorisation and patient access, measured by the number of days elapsing from the date of EU marketing authorisation (or Swissmedic approval in the case of Switzerland) to the day of completion of post-marketing authorisation administrative processes

•  Source of information: EFPIA member associations, who either refer to information available from official sources or gather this information directly from member companies.

•  Some country associations did not submit full datasets. Countries with substantially limited datasets were Bosnia (16% complete), Macedonia (26% complete), Serbia (40% complete). This is noted on each slide with an asterisk (*).

Introduction (1)

4

•  The Patients W.A.I.T. Indicator gives a snapshot of the 2 parameters at a cut-off date (1st January 2020) – data from medicines cohorts dropping out of the reference period are not included.

•  Waiting times reflected in the Patients W.A.I.T. Indicator includes time to access, whether attributable to companies or to competent authorities.

•  Rate of availability in a country does not necessarily indicate medicine uptake. Some medicines may be available in a market with no uptake (sales or volume).

•  The Patients W.A.I.T. Indicator is not a measurement of the delays as defined in the “Transparency” Directive (directive 89/105/EEC). Delays under the “Transparency” Directive reflect the number of days that national competent authorities need to make their decisions regarding price and inclusion of medicines in the positive list, where applicable. These delays do not include the time needed to prepare submissions under relevant national regulations, which may also include clock-stops for supply of additional information during the process; neither do “Transparency” Directive delays include time required to complete other formalities before a new medicine can be made available in a given country.

Introduction (2)

5

Method for product selection

1397 310 213 172

EMA list •  Products with EMA authorisation year:

2014, 2015, 2016, 2017, 2018 •  Status: Authorised, Withdrawn, Suspended •  Non-generic; Non-biosimilar •  Include combinations (both products can

have already been approved before) •  Remove ATC K, V & T*

•  Medicines in the 4-year rolling cohort 2015 - 2018

•  List of all historic Marketing Authorisations for human and veterinary medicines (European Public Assessment Reports) accessed November 2019

•  Human medicines only

•  Remove products with an active substance approved pre-2014

•  New combination products (those containing already approved active substances are included)

•  New formulations were excluded •  New indications of already approved

active substances, leading to a separate marketing authorisation only for an orphan drug are included

•  For molecules with multiple names from the same company only one molecule is included

Products in scope Survey cohort (5-years) Report cohort (4-years)

6

•  172 products approved by EMA between 1st January 2015 to 31st December 2018

•  The 2019 study provides an analysis of products approved between 2015-2016-2017-2018, for the following datasets: a)  All 172 products: 45 in 2015, 35 in 2016, 38 in 2017, 54 in 2018 b)   43 Oncology products: 10 in 2015, 10 in 2016, 11 in 2017, 12 in 2018 c)  54 Orphan products: 12 in 2015, 9 in 2016, 12 in 2017, 21 in 2018 d)   39 Non-oncologic orphan products: 9 in 2015, 7 in 2016, 7 in 2017, 16, in 2018 e)  34 Combination products: 10 in 2015, 8 in 2016, 6 in 2017, 10 in 2018

•  Definitions: -  Orphan status from EMA (September 2019) -  Oncology products flagged using IQVIA MIDAS Oncology market definition* -  Combination products include any product with more than one molecule, including branded/generic combinations

•  The date of availability cut off point was 1st January 2020 (to account for Estonia, Iceland, Czech Republic, Latvia, Slovakia which had a few products with a reimbursement decision on 1st January 2020).

•  34 countries included in the study (including split of UK into England and Scotland).

Study scope

7

•  The aim of the W.A.I.T. indicator is to measure the differences in time to reimbursement across European countries

•  A medicine is available on the market if patients can receive the medicine under a reimbursement scheme

•  The availability date is the first date when doctors can prescribe / hospitals can administer the medicine to patients in the country, who will be able to benefit from reimbursement conditions applicable in the country (i.e. administrative procedures to be included in the positive reimbursement list have been completed, where applicable)

•  IQVIA have defined a set of “rules” to determine market availability:

Definition of Availability

Reimbursement status of medicine Is the medicine available?

Reimbursed through the 'normal' reimbursement system Available

Automatically reimbursed or financed by a different budget (e.g. hospital) or managed entry Available

Reimbursed on an individual basis, and/or to a subpopulation*, and/or in some cases whilst reimbursement is pending Available (LA*)

Available only within the private market at the patients expense Only privately available

Not reimbursed, or pending reimbursement (excluding availability at the patients expense) Not available

In cases where a product has been categorised as “not available”, their dates will not be included in the delay analysis; *In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average. LA*: product available for limited availability

8

•  IQVIA has differentiated between products which are reimbursed through the regular process in a country, and products with “limited availability” (LA)

•  Products with LA have special reimbursement conditions, where reimbursement is only granted for certain patients, indications, or only through special programs (e.g. early access schemes)

•  Restricted or optimised recommendations may be due to either the company or HTA body

•  Products which have been reimbursed with the following criteria are marked as “Available”, however have been flagged in the “Rate of Availability %” charts:

Definition of products with limited availability

Reimbursement conditions for medicine

Restricted patient cohort (specific populations)

Individual reimbursement (case by case / named patient program)

Special programs (e.g. early access scheme)*

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. For countries where this differs, the definition of Availability is below:

•  Austria: A medicine is available if it is included in the reimbursement system (EKO) or available through the Austrian pharmacies list.

•  Belgium: Medicine is available if it is listed on the official website of INAMI-RIZIV as a definitive reimbursement or as a temporary reimbursement (code T) under a Managed Entry Agreement.

•  Czech Republic: A medicine is available if it is on the reimbursement list, or funded through the hospital

•  England: Medicines are deemed available if NICE has issued a positive recommendation. For the remaining medicines, IQVIA sales data are analysed to determine if routinely available.

•  Estonia: A pharmacy product is available if it is reimbursed (pharmacy products) or added to the hospital service list.

•  Finland: A pharmacy product is available if it is reimbursed (pharmacy products). Hospital products become available straight away.

•  Germany: Following marketing authorisation, prescription drugs automatically receive reimbursed status. These products are classified as available.

•  Hungary: Medicines are either reimbursed through the 'normal' reimbursement system, are available through a Name Patient Program or are available but financed by the hospital budget.

•  Lithuania: A medicine is available if it is on the Lithuanian market (the State Medicines Control Agency has data on the sales volume of this medicinal product)

•  North Macedonia (referred to as Macedonia in the slides): The medicine is included on the positive drug list or reimbursement list. No new medicines have been included on the reimbursement list for the past 10 years.

•  Norway: The medicine has received a positive reimbursement decision by NoMA (out-patient drugs), or the Decision Forum for New Technologies has recommended the introduction of the new drug into hospitals (hospital drugs).

•  Scotland: Medicines are deemed available if SMC has issued a positive recommendation. For the remaining medicines, IQVIA sales data are analysed to determine if routinely available.

•  Slovakia: Primary data source used is National Health Information Center, but where not available, consumption data recorded through IQVIA is used

•  Slovenia: A medicine is available if it is reimbursed through the regular system, or automatically reimbursed (e.g. all medicines for TBC)

•  Sweden: A medicine is classified as available if it is currently marketed in Sweden (listed supplied FASS), and has received either: (a) a positive TLV reimbursement decision (non hospital drug), (b) a positive NT recommendation (hospital drug), (c) lacks an NT recommendation but is assessed to have a relevant level of sales based on rough estimation number patients treated in relation to the size of the patient population (hospital drug), or (d) is indicated in the treatment of a communicable disease (i.e. reimbursement decision/NT recommendation not requirement).

•  Switzerland: The medicine gained market approval by Swissmedic. Delay calculated using local market authorisation dates.

•  Turkey: A medicine is available if it gains access to the reimbursement list.

For most countries a product is available if it gains access to the national reimbursement list Definition of Availability

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For most countries a product has limited availability if a restriction is placed upon the SmPC Definition of Limited availability (LA)

For countries with specific considerations, the definition of Limited availability is below: •  Austria: Products only reimbursed on an individual basis

•  Croatia: Products are available for specific patient cohorts (reimbursement guidelines outline specific criteria describing patient eligibility for treatment).

•  Czech Republic: Only reimbursed for limited indications (compared to what was approved at market authorisation)

•  Denmark: Products which don’t automatically receive public reimbursement, however, the patient can obtain an individual reimbursement if the doctors apply on their behalf.

•  England: Recommended for a restricted patient cohort relative to licensed indication, either through an optimised NICE decision (including optimised CDF decisions) or an individual funding request •  Estonia: Only reimbursed for restricted patient cohort.

•  France: Some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations

•  Greece: Only reimbursed for restricted patient cohort, or by case by case reimbursement if the responsible committee judges its use necessary.

•  Hungary: Medicine is pending reimbursement decision or has not been reimbursed, but is available through a Name Patient Program.

•  Iceland: Products are available to the patients with full reimbursement, but only through individual reimbursement, which can be applied for on individual basis by the patient’s doctor. •  Ireland: Only reimbursed for restricted patient cohort

•  Latvia: Only available through individual reimbursement

•  Lithuania: Only reimbursed for limited indications (compared to what was approved at market authorisation)

•  Netherlands: Only reimbursed under certain therapeutic conditions (annex 2 on the positive reimbursement list).

•  Norway: Only reimbursed for restricted patient cohort •  Poland: Only reimbursed for limited indications (compared to what was approved at market authorisation)

•  Portugal: Product is only available on a patient by patient basis and after an Exceptional Authorisation has been granted

•  Scotland: Recommended for a restricted patient cohort relative to licensed indication through restricted SMC recommendation

•  Serbia: Products are reimbursed with significant restrictions. Sometimes these restrictions are based on number of patients (e.g. for new generation HepC medicines, there is a cap on only 60 patients per year), sometimes on the number of indications, or there is some other limit.

•  Slovakia: Drugs included in the Reimbursement List have some limitation (prescription limitation, indication limitation and limitation based on prior insurance company approval), or are reimbursed for individual patients

•  Slovenia: Only reimbursed for restricted patient cohort

•  Spain: Only reimbursed for restricted patient cohort

•  Sweden: Only reimbursed for restricted patient cohort •  Switzerland: For products pending reimbursement, patients have restricted reimbursement access. Such restricted access includes ‘individual reimbursement’ regulated by Art. 71a-d of KVV ordinance.

•  Turkey: Products only available through a “Named Patient Scheme”. These medicines do not require TITCK (Turkish Medical Agency) approval but are reimbursed.

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Comparable across markets and highlights major restrictions Visual of the limited availability definition

Price volume agreements Limited subpopulation Hospital restrictions Individual basis / Named Patient Population

Partial access during decision pending

Direct patient availability restrictions (e.g. restrictions of eligible patients upon

Summary of Product Characteristics)

Indirect restrictions (e.g. care setting, specialist usage, or

confidential managed entry agreements) Definition of Limited Availability

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All medicines Availability by approval year Rate of availability Channels of availability Time to availability

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Total availability by approval year (2015 - 2018)

45 38 38 40 36 36 39 34 34 33 31 27 33 29 28 26 26 29 24 25 29 19 27

16 19 15 19 16 16 10 12 12 2

35 30 32 32

30 28 28 29 24 23 22 21 22

18 23 22 19 19 21 17 15 16

16

13 14 14 10 10 12 5 6 4

3 1

1

38

35 35 32 30 30 32

26 27 33 29

25 24

26 23 20 21 17 21 20 19 17

17

17 17 16 13 11 8

7 10 3 2

2

54

44 40 36 36

30 25 31 31 27

26 28 21

22 17 19 18

12 11 10 9

18 9

13 8 11 11

9 1 1

2

0

20

40

60

80

100

120

140

160

180

Italy

Sw

itzer

land

Eng

land

Fran

ce

Net

herla

nds

147

Lith

uani

a

Sw

eden

Nor

way

Cro

atia

Spa

in

124

Sco

tland

Bel

gium

Por

tuga

l

132

5

EU A

vg.

Irela

nd

Slo

veni

a

4

Cze

ch

*Mac

edon

ia

Gre

ece

Hun

gary

Icel

and

Est

onia

5

Pol

and

124

172

Rom

ania

Latv

ia

Bul

garia

Alb

ania

Turk

ey

Aus

tria

Den

mar

k

5

77

116

*Bos

nia

4

Slo

vaki

a

3

2

Ger

man

y

*Ser

bia

EMA

appr

oval

s

116

145 140

120 108

101 100

Finl

and

91 87 85 77 72 72 70 69

59 58

95

53 42 36 31 31

21 11 8 8 6

56

2015 2016 2018 2017

The total of availability by approval year is the number of medicines available to patients in European countries (for most countries this is the point at which the product gains access to the reimbursement list*) split by the year in which the EMA granted marketing authorisation.

Num

ber o

f pro

duct

s

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Rate of availability (2015 – 2018)

172

0

20

40

60

80

100

120

140

160

180

EMA

appr

oval

s

Aus

tria

67%

85%

Slo

veni

a

81%

12%

Ger

man

y

Cze

ch

77% 84%

Den

mar

k

45%

Sw

itzer

land

42%

Lith

uani

a

72%

24% 34%

Finl

and

100

Fran

ce

72%

Italy

51%

70%

Eng

land

63%

EU A

vg.

67%

Gre

ece

Irela

nd

Net

herla

nds

Sw

eden

Turk

ey

59%

Nor

way

58%

Spa

in

18%

55%

41%

Sco

tland

53%

Por

tuga

l

49%

Est

onia

140

Bul

garia

45% 42% 34%

Slo

vaki

a

Cro

atia

40%

Hun

gary

Icel

and

33% 31%

Pol

and

6%

21%

Rom

ania

Latv

ia

18%

Alb

ania

5%

*Bos

nia

5%

*Ser

bia

3%

108

*Mac

edon

ia

147 145 132

124 124

70

Bel

gium

116 116 101 95 91

53

87 85 77 77 72 72

120

59 58 56 42 36 31 31

21 11 8 8 6

69

Row Labels Distinct Count of Medicine Name 2014 45 2015 45 2016 37 2017 41 2018 54

The rate of availability is the number of medicines available to patients in European countries (for most countries this is the point at which the product gains access to the reimbursement list*), inc. limited availability

Num

ber o

f pro

duct

s

Availability

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Rate of availability (%, 2015 – 2018)

172

0

20

40

60

80

100

120

140

160

180

42%

84%

Nor

way

23%

3%

55%

1% 26%

27%

28%

EMA

appr

oval

s

15%

Slo

vaki

a

16%

72%

Ger

man

y

1%

42%

20%

85%

53%

Den

mar

k

Sco

tland

3% 80%

Alb

ania

1%

56%

6%

13% A

ustri

a

24%

22%

Sw

itzer

land

67% 72%

84%

Sw

eden

47%

Eng

land

1%

27%

1%

43%

Spa

in

Finl

and

72%

Italy

30% 33%

Net

herla

nds

13%

33%

Fran

ce

45%

Por

tuga

l

33%

47%

30%

13%

Irela

nd

12%

15%

2%

36%

28%

27%

Bel

gium

1%

49%

45%

1%

55%

40%

2%

49%

Cze

ch

22%

58%

31% 7%

12%

47%

Cro

atia

32%

11%

49%

13%

Gre

ece

27%

62%

Hun

gary

28%

66%

Icel

and

33%

2%

65%

22%

Bul

garia

19%

12%

64%

Est

onia

11%

13%

53%

Lith

uani

a

Pol

and

7%

20%

1%

Rom

ania

13%

77%

54%

75%

Turk

ey

15%

73% 85%

9%

2%

26%

3%

60%

*Ser

bia

1% 3%

2%

10%

*Bos

nia

22%

74%

Latv

ia

5%

Slo

veni

a

51%

6%

8% 4% 9%

8% 5% 5%

7%

5%

4% 8%

6%

8% 9%

3%

*Mac

edon

ia

The rate of availability is the number of medicines available to patients in European countries (for most countries this is the point at which the product gains access to the reimbursement list*). This includes all medicines status to provide a complete picture of the availability of the cohort of medicines studied.

Not available Full public availability Not submitted by association Limited Availability Only available privately

Avai

labi

lity

brea

kdow

n (%

)

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16

Time to availability (2015 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).

298 398

517 521 522 584 596 634 660 682 711 752 797 806 812 823

0

200

400

600

800

1,000

1,200

1,400

1,600

1,800

*Ser

bia

Net

herla

nds

252 127

Bul

garia

Sw

itzer

land

Den

mar

k

445

Pol

and

Ger

man

y

414

154 158 269

Sw

eden

Finl

and

307

Cro

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Aus

tria

349 **

* E

ngla

nd

Turk

ey

Spa

in

Icel

and

425

***S

cotla

nd

512 436

Italy

Slo

veni

a

*Mac

edon

ia

**Fr

ance

436

Latv

ia

Gre

ece

Irela

nd

439

Bel

gium

452

Nor

way

566

Alb

ania

Hun

gary

Slo

vaki

a

687

Est

onia

Cze

ch

Por

tuga

l

*Bos

nia

Lith

uani

a

812

Rom

ania

Tim

e (d

ays)

Available medicines / 172 Dates submitted / 172

147 145 132 116 108 124 140 120 31 100 95 124 69 91 77 58 70 31 77 101 116 11 59 72 53 72 56 87 8 21 6 8 36 42

147 145 89 116 108 120 140 120 27 100 95 124 59 91 77 54 46 8 75 92 93 10 47 71 49 69 56 74 8 21 6 8 34 40

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Median time to availability (2015 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).

Tim

e (d

ays)

53 75 81

194 195 212 273 293

330 348 352 356 358 389 398 414 423 436 438 467 490 496 515 533 560

611 612 681 681 684 706

749 775

877

***E

ngla

nd

Net

herla

nds

Cze

ch

Sw

eden

Ger

man

y

Sw

itzer

land

Finl

and

Spa

in

Den

mar

k

Bul

garia

Turk

ey

Aus

tria

Bel

gium

Latv

ia

***S

cotla

nd

Italy

Icel

and

Pol

and

Gre

ece

Cro

atia

Nor

way

Alb

ania

Hun

gary

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nd

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ance

Est

onia

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a

*Mac

edon

ia

*Bos

nia

Por

tuga

l

*Ser

bia

Rom

ania

Lith

uani

a

Slo

veni

a

Median

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All medicines study comparison Rate of availability 2018 vs 2019 W.A.I.T study Time to availability 2018 vs 2019 W.A.I.T study

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19

Comparison of availability (2018 study vs 2019 study)

86 83 84

74

62

79

60

78

69

51

62 56

43 42

53

36

45

14

58

38 40

19 23

20

9

16 13

3

85 84 81

77 72 72

67 67 63

59 58 53 51

45 45 42 42 41 40

34 34 33 31

24

18 18 12

5

0 10 20 30 40 50 60 70 80 90

100

Net

herla

nds

Ger

man

y

Den

mar

k

Aus

tria

Sw

itzer

land

Fran

ce

Italy

Finl

and

Por

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l

Sw

eden

Gre

ece

Bel

gium

Nor

way

Spa

in

Irela

nd

Lith

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a

Cze

ch

Slo

vaki

a

Cro

atia

Hun

gary

Icel

and

Bul

garia

Est

onia

Pol

and

Latv

ia

Turk

ey

Ser

bia

Slo

veni

a

2019 study (2015 - 2018) 2018 study (2014 – 2017)

% a

vaila

bilit

y

Delta in % availability* (2018 / 2019)

The rate of availability, measured by the number of medicines available to patients in European countries as of 2019, compared to the rate of availability in the 2018 W.A.I.T. indicator study

-1% 1% -3% 3% 10% -7% 7% -11% -6% 8% -4% -3% 8% 3% -8% 6% -3% 27% -18% -4% -6% 14% 8% 4% 9% 2% -1% 2%

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20

Comparison of time to availability (2018 study vs 2019 study)

119 146

171 220

269 291 288 292

385 402 428

395 417 401 445

492 486

333

498 449

539 603 618

547

634

726

925

612

127 154 158

252 269 298 307

398 414 436 436 439 445 452

512 517 521 522 566

596 634 660 682 687 711

797 812 823

0 100 200 300 400 500 600 700 800 900

1,000

Sw

eden

Finl

and

Aus

tria

Ger

man

y

Den

mar

k

Sw

itzer

land

Turk

ey

Cro

atia

Net

herla

nds

Fran

ce

Spa

in

Hun

gary

Italy

Gre

ece

Bel

gium

Icel

and

Latv

ia

Irela

nd

Slo

vaki

a

Nor

way

Est

onia

Cze

ch

Bul

garia

Por

tuga

l

Lith

uani

a

Ser

bia

Pol

and

Slo

veni

a 2018 study (2014 – 2017) 2019 study (2015 - 2018)

Tim

e to

ava

ilabi

lity

Delta in days* (2018 / 2019)

The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients compared to the rate of availability in the 2018 W.A.I.T. indicator study

8 8 -13 32 0 7 19 106 29 34 8 44 28 51 67 25 35 189 68 147 95 57 64 140 77 71 -113 211

100% 50% 75% 25%

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21

All medicines

•  Patient access to new medicines is highly varied across Europe, with the greatest rate of availability in Northern and Western European countries and lowest in Southern and Eastern European countries.

•  In some countries, up to 30% of products are available and reimbursed but with specific conditions.

•  The average delay between market authorisation and patient access can vary by a factor greater than x 6 across Europe, with patients in Northern /Western Europe accessing new products 100 - 350 days after market authorisation and patients mainly in Southern/ Eastern Europe between 600-850 days.

•  Even within a country there is a large variation in the speed of patient access to different products. Often the level of variation within a country is greater than between countries e.g. shortest versus longest delays in Scotland (159 vs. 1789 days), Austria (24 vs. 1689 days) and Estonia (52 vs. 1657 days).

•  Comparison to 2018 W.A.I.T. indicator study: of the countries overlapping both analyses, 54% countries have a higher rate of availability, although 93% countries have a longer delay in the 2019 study.

Key observations

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Oncology medicines Availability by approval year Rate of availability Channels of availability Time to availability

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Oncology availability by approval year (2015 - 2018)

10 10 9 8 8 9 9 10 7 8 8 7 7 7 5 7 7 7 7 5

8 6 4 7 7

4 6 6 5 5 4 2 2 1 1 1

10 10 10 9 8 8 9 8

10 8 8 6 6 4 6

8 6 6 5

6

7

5 6

4 6

5 5 5

3 4 2

1 2

11 11 10

10 9 8

10 8 10 10 7

9 9

7 8

6 7 8

7 7

5

5 5 5 5

6 5 4

4 1 2

2 1 1

12 11

8 9 11 10

7 8 6 7

6 7 6

8 7 4 4 2 3 3

3 3 2 2

2

0

5

10

15

20

25

30

35

40

45

Fran

ce

Finl

and

Aus

tria

Ger

man

y

36

23

35

Den

mar

k

Net

herla

nds

Irela

nd

Eng

land

Sw

itzer

land

Italy

35

Rom

ania

Bel

gium

Spa

in

*Ser

bia

Nor

way

Sco

tland

Slo

veni

a

Turk

ey

EU A

vg.

Por

tuga

l

Alb

ania

Bul

garia

Gre

ece

Cro

atia

Cze

ch

28

Icel

and

Hun

gary

Pol

and

14

33

Sw

eden

43

1

Lith

uani

a

1

*Bos

nia

*Mac

edon

ia

1

Est

onia

26

Slo

vaki

a

29

18

Latv

ia

42

37 36 34

EMA

appr

oval

s

19

29 26 25 24

22 21 20 18

33

17 16 15

11 8

5 4 3 3

18

2018 2015 2017 2016


Num

ber o

f pro

duct

s

100% 50% 75% 25%

5% Charcoal


24

The rate of availability, measured by the number of medicines available to patients in European countries as of 2019: for most countries this is the point at which the product gains access to the reimbursement list, inc. limited availability

Oncology rate of Availability (2015 - 2018)

43

0

5

10

15

20

25

30

35

40

45

Ger

man

y

98%

53%

33

84%

EMA

appr

oval

s

Den

mar

k

23 24

Por

tuga

l

86%

Aus

tria

Rom

ania

18 84%

Sw

eden

Eng

land

Bul

garia

81%

Fran

ce

EU A

vg.

81% Fi

nlan

d

Sw

itzer

land

Net

herla

nds

77% 79% 77%

Icel

and

Italy

67%

*Bos

nia

12%

Bel

gium

67%

Gre

ece

2%

65% 60%

Nor

way

60%

Cro

atia

33% 42%

Sco

tland

56% 51%

Irela

nd

49% 47% 44%

Slo

vaki

a

42%

Lith

uani

a

Cze

ch

42%

28

58%

37%

Slo

veni

a

40%

Hun

gary

Pol

and

35%

Est

onia

26%

Turk

ey

19% 9%

3

*Mac

edon

ia

7%

Alb

ania

7%

Latv

ia

Spa

in

*Ser

bia

42

37 35 36 35 34 33

29 29

14

26 26

20 22 21

36

18 18

25

17 16 15

11 8

5 4 3 1

19

Num

ber o

f pro

duct

s

Availability

100% 50% 75% 25%

5% Charcoal


25

Oncology rate of availability (%, 2015 – 2018)

7% 7% 7% 7%

7%

7%

9% 7% 5%

5%

5%

9%

9% 7%

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

100% 12%

2%

Ger

man

y

2%

86%

100%

EMA

appr

oval

s

98%

2%

Aus

tria

84%

16%

Latv

ia

16% 19% D

enm

ark

19%

40%

44%

40%

12%

Finl

and

Italy

16%

77%

Eng

land

67% 63%

19%

33%

Fran

ce

81%

Net

herla

nds

67%

47% 12%

37%

21%

Spa

in

Sw

itzer

land

77%

23%

2%

Bel

gium

21%

42%

26%

33%

12%

21%

5%

Sw

eden

58%

2%

58%

2%

23%

Nor

way

40%

40%

Sco

tland

53%

Slo

veni

a

47%

26%

47%

Por

tuga

l

51%

12%

49%

Irela

nd

49%

51%

Bul

garia

44%

Gre

ece

*Ser

bia

30%

14%

56%

Slo

vaki

a

35%

12%

44%

2%

Cro

atia

16% 37%

Cze

ch

42%

58%

Icel

and

14%

60%

Hun

gary

16%

21%

23%

37%

2%

21%

33%

Lith

uani

a

2%

56%

Rom

ania

19%

14%

60%

Est

onia

21%

12%

63%

Turk

ey

12%

21%

Pol

and

84%

*Bos

nia

2% 2%

14% 19%

74%

*Mac

edon

ia

74%

Alb

ania

77%

23%

30%

44%

43

60%


Avai

labi

lity

brea

kdow

n (%

)

Full public availability Not submitted by association Not available Limited Availability Only available privately

100% 50% 75% 25%

5% Charcoal


26

Oncology time to availability (2015 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).

Tim

e (d

ays)


134

280 375

468 519 560 584 624 626 698 708 722

871 878 879 886 890 891 896 981

0

200

400

600

800

1,000

1,200

1,400

1,600

1,800

Lith

uani

a

Aus

tria

*Mac

edon

ia

Net

herla

nds

790

Den

mar

k

449

86

*Ser

bia

Sw

eden

234

371

Ger

man

y

211

Cro

atia

Icel

and

Sw

itzer

land

Gre

ece

Slo

veni

a

374 **

*Eng

land

Finl

and

397

***S

cotla

nd

441

Italy

Bel

gium

Latv

ia

450

Spa

in

Turk

ey

Rom

ania

Bul

garia

551

Nor

way

279

579

**Fr

ance

Hun

gary

Alb

ania

Slo

vaki

a

Irela

nd

Cze

ch

Pol

and

*Bos

nia

Est

onia

493

Por

tuga

l

36 42 37 35 29 34 20 36 33 26 33 29 28 11 25 1 26 22 35 18 18 17 3 21 19 23 18 8 5 15 14 16 4 336 42 37 35 29 25 17 36 32 26 33 29 28 9 25 1 23 22 27 18 16 12 2 21 19 20 16 8 5 14 13 16 4 1

100% 50% 75% 25%

5% Charcoal


27

Oncology median time to availability (2015 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).

Tim

e (d

ays)

35 59 61

177 186 203

332 350 352 353 358 361 368 373 423 452 483 511 519 533 557 583

685 698 706 781 808 809 836

895 898 924 947 981

Spa

in

Bel

gium

Ger

man

y

Irela

nd

**Fr

ance

Aus

tria

Den

mar

k

Sw

itzer

land

Net

herla

nds

Gre

ece

Sw

eden

***E

ngla

nd

***S

cotla

nd

Finl

and

Turk

ey

Italy

Rom

ania

Hun

gary

Icel

and

Nor

way

*Ser

bia

Lith

uani

a

Cro

atia

Bul

garia

Alb

ania

Slo

vaki

a

Pol

and

*Mac

edon

ia

Por

tuga

l

Cze

ch

*Bos

nia

Est

onia

Latv

ia

Slo

veni

a Median

100% 50% 75% 25%

5% Charcoal


28

Oncology medicines

•  Patient access to new Oncology medicines is highly varied across Europe, with the greatest rate of availability in Northern and Western European countries.

•  In 88% of the countries, the rate of availability is higher for Oncology products compared to all products approved between 2015-2018

•  In Germany, France, England, Netherlands, Belgium, Bulgaria, and Romania, the availability of oncology medicines in more than 10% above the rate of all medicines approvals.

•  Limited availability is prevalent within the oncology medicines with over 20% of oncology medicines having a restriction placed upon them after SmPC in England (40%), Sweden (26%), Scotland, (21%), and Poland (21%)

•  The average delay between market authorisation and patient access for Oncology products varies 2.5 months to over 2.5 years

Key observations

100% 50% 75% 25%

5% Charcoal



Orphans medicines Availability by approval year Rate of availability Channels of availability Time to availability

100% 50% 75% 25%

5% Charcoal


30

Orphan availability by approval year (2015 - 2018)

12 12 11 9 11 9 10 8 9 9 9 9 8 6 7 7 7 7 6 6 5 5 7 4 6 4 4 6

3 4 2

9 8 7

6 7

8 7 7 5 3

7 5 6 5 3 3 4 4

3 4 6 3

3 4

3 2 2

2 1

12 12 10

10 9

8 10 8 9

7

6 7 5

6 7 7 5 6 5 4 3

3 3

4 3 4 4 2

3 2

21 19

15 16 13

13 9

10 8 11 7 8

5 7 6 5 5 2 5 3

3

2

0 5

10 15 20 25 30 35 40 45 50 55

Icel

and

Finl

and

EMA

appr

oval

s

Italy

22

Ger

man

y

23

1 0

Fran

ce

30

Den

mar

k

Sw

itzer

land

29

Eng

land

Alb

ania

Hun

gary

14

Net

herla

nds

40

Sco

tland

14

12

Nor

way

Bel

gium

Por

tuga

l

Sw

eden

Spa

in

Slo

vaki

a

Gre

ece

EU A

vg.

24

Cze

ch

*Mac

edon

ia

1

Slo

veni

a

Cro

atia

1 1

Pol

and

Bul

garia

Irela

nd

Rom

ania

51

1

33

Est

onia

38

Turk

ey

Lith

uani

a

*Bos

nia

29

Latv

ia

31

*Ser

bia

41

54

Aus

tria

36

19

24 21

19 17 15

12

43

11 10 9 7

0 0 0 0

11

2017 2015 2016 2018


Num

ber o

f pro

duct

s

100% 50% 75% 25%

5% Charcoal


31

The rate of availability, measured by the number of medicines available to patients in European countries as of 2019: for most countries this is the point at which the product gains access to the reimbursement list, inc. limited availability

Orphan rate of availability (2015 - 2018)

Data N/A- data is not provided by associations (companies have not sent data or are not members of the association) Oncology products flagged using IQVIA MIDAS Oncology market definition*

54

0 5

10 15 20 25 30 35 40 45 50 55

EMA

appr

oval

s

94%

22%

74%

Italy

Ger

man

y

26%

12

76%

Alb

ania

Bul

garia

Spa

in

Den

mar

k

Fran

ce

Cze

ch

26%

Aus

tria

70%

20%

Eng

land

13% 0

24

67% 61%

28%

Icel

and

Sw

itzer

land

Rom

ania

Por

tuga

l

57%

19 N

ethe

rland

s

22% 31%

56%

Pol

and

Sco

tland

41%

54%

Sw

eden

Finl

and

54%

0 N

orw

ay

Turk

ey

44%

Est

onia

Bel

gium

44% 43%

Gre

ece

39%

4%

EU A

vg.

35%

*Bos

nia

Slo

vaki

a

35%

Cro

atia

Irela

nd

Slo

veni

a

20%

Hun

gary

19% 17%

Lith

uani

a

Latv

ia

33

*Mac

edon

ia

*Ser

bia

51

43 41 40

38

80%

31 30 29 29

24 23 22 21

15 19

17

36

14 12 11 11 10 9

7

2 0 0 0

14

Num

ber o

f pro

duct

s

Availability

100% 50% 75% 25%

5% Charcoal


32

Orphan rate of availability (%, 2015 – 2018)

9% 9% 7% 7% 4% 7% 6% 6% 9%

6%

9%

7%

6% 7%

4%

9% 9% 6%

7%

7% 9%

9%

6% 6%

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

100%

41%

Den

mar

k

20%

EMA

appr

oval

s

15%

94%

24%

43%

Ger

man

y

80%

Eng

land

35%

2%

Fran

ce

30% 28%

74%

59%

17%

Aus

tria

20%

48%

57%

*Mac

edon

ia

46%

22%

54%

30%

67%

33%

33%

Italy

39% 44%

44%

Sw

itzer

land

Slo

vaki

a

Latv

ia

19%

57%

26%

Net

herla

nds

Alb

ania

30%

Finl

and

46%

39%

26%

65%

Nor

way

37%

24%

19%

22% S

cotla

nd

56%

*Ser

bia

Bel

gium

56%

26%

Por

tuga

l

33%

Sw

eden

11%

15%

44%

Gre

ece

20%

85%

Spa

in

Cze

ch

26%

2%

63%

Slo

veni

a

22%

52%

Cro

atia

74%

Irela

nd

94%

19%

78%

24%

22%

2%

76%

Rom

ania

20%

80%

Bul

garia

11%

78%

Hun

gary

76%

Est

onia

78%

Icel

and

19%

69%

Pol

and

15%

81%

Lith

uani

a

93%

*Bos

nia

94%

15%

15%

76%

54

Turk

ey


Full public availability Not available Limited Availability Only available privately Not submitted by association

Avai

labi

lity

brea

kdow

n (%

)

100% 50% 75% 25%

5% Charcoal


33

Orphan time to availability (2015 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).

246

404 413 430 439 458 563

696 739 748 784 815 831 881 887 902 914

0 100 200 300 400 500 600 700 800 900

1,000 1,100 1,200 1,300 1,400 1,500

280

Ger

man

y

403

Sw

itzer

land

345

Est

onia

Aus

tria

194

Den

mar

k

483

Net

herla

nds

Gre

ece

1,138

Turk

ey

678

Sw

eden

***E

ngla

nd

Finl

and

440

**Fr

ance

***S

cotla

nd

Slo

vaki

a

Italy

Icel

and

618

485

Spa

in

Bel

gium

Latv

ia

Lith

uani

a

Cro

atia

Nor

way

Bul

garia

Irela

nd

Hun

gary

111

Rom

ania

Cze

ch

Pol

and

Alb

ania

Por

tuga

l

*Mac

edon

ia

*Ser

bia

Slo

veni

a

535

*Bos

nia

Tim

e (d

ays)


51 43 33 40 31 22 9 23 29 38 30 36 12 19 15 24 41 2 14 19 29 11 14 11 10 24 12 17 7 0 0 0 0 051 43 12 40 31 18 7 23 28 38 30 36 11 19 15 24 22 2 8 19 27 11 13 6 8 14 12 14 6 0 0 0 0 0

100% 50% 75% 25%

5% Charcoal


34

Orphan median time to availability (2015 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).

Tim

e (d

ays)

39 108

158 192 278 305 315 356 361 385 395 415 435 444

519 540 573 648 668 682 687

770 850 869 891 898 925 952

1,236

Finl

and

Net

herla

nds

Pol

and

Ger

man

y

Aus

tria

Est

onia

Turk

ey

Bul

garia

Den

mar

k

Sw

itzer

land

*Bos

nia

Hun

gary

Cze

ch

Italy

***S

cotla

nd

Slo

vaki

a

Gre

ece

***E

ngla

nd

Sw

eden

Por

tuga

l

Bel

gium

Spa

in

Rom

ania

Icel

and

Slo

veni

a

**Fr

ance

Nor

way

Cro

atia

Lith

uani

a

Irela

nd

*Ser

bia

Alb

ania

*Mac

edon

ia

Latv

ia

Median

100% 50% 75% 25%

5% Charcoal


35

Orphan drugs

•  Patient access to new Orphan medicines is highly varied across Europe, with the greatest rate of availability in Northern and Western European countries.

•  In over 80% of the countries, the rate of availability is lower for Orphan drugs compared to all products approved between 2015-2018

•  Only in Germany, England, Switzerland, Greece, and France is the rate of orphan medicines availability higher than all products approved 2015 - 2018

•  Almost 80% of the countries have a longer average delay to EMA authorisation for Orphan drugs compared to all products approved 2015-2017

•  The average delay between market authorisation and patient access for Orphan drugs is between 3.7 months to 3.2 years

•  15% of all countries studied do not have access to any of the orphan medicines approved between 2015 and 2018

Key observations

100% 50% 75% 25%

5% Charcoal



Non-oncology orphans medicines Availability by approval year Rate of availability Channels of availability Time to availability

100% 50% 75% 25%

5% Charcoal


37

Non-oncology orphan availability by approval year (2015 - 2018)

9 9 8 8 6 6 8 7 5 7 7 6 4 4 5 5 6

4 5 4 4 5 2 2 3 4 2 2 2

16

6 5 5 7

4

6 5

5 3 5

3 4 2

4 3

3 2 2 2 3 2

4 2

2

7

7

5 4 4 5

5 4

4 3 2

4 2 4

2 2

3

3 2

1 3 1 1

7

15

11 11 9 11 5

5 7 7 5 6 7 5 3 4 4

2 2 1 1

0

5

10

15

20

25

30

35

40 A

ustri

a

1

EMA

appr

oval

s

26

Ger

man

y

Nor

way

Pol

and

Italy

*Ser

bia

21

Sco

tland

Den

mar

k

Fran

ce

Lith

uani

a

Gre

ece

Eng

land

Sw

itzer

land

Net

herla

nds

1

Por

tuga

l

Bel

gium

EU A

vg.

37

26

1

Sw

eden

Slo

vaki

a

1

Spa

in

29

1

Cro

atia

1

28

1

Bul

garia

Cze

ch

1

Latv

ia

Irela

nd 1

Hun

gary

Turk

ey

1

Slo

veni

a

14

*Mac

edon

ia

1

Icel

and

Alb

ania

1

Rom

ania

1

Est

onia

1

1

9 Fi

nlan

d

*Bos

nia

39

24 21 20 19 19

17 15

13 13 13 10

0

9 9 7 6 6 5 5 5 4 4

1 0 0 0 0

2015 2017 2018 2016


Num

ber o

f pro

duct

s

100% 50% 75% 25%

5% Charcoal


38

The rate of availability, measured by the number of medicines available to patients in European countries as of 2019: for most countries this is the point at which the product gains access to the reimbursement list, inc. limited availability.

Non-oncology orphan rate of availability (2015 - 2018)


39

0

5

10

15

20

25

30

35

40

33%

Ger

man

y

54%

72%

Cze

ch

Bul

garia

EMA

appr

oval

s

Spa

in

95%

Net

herla

nds

Den

mar

k

51% 62%

74%

Lith

uani

a

67%

Eng

land

23% 26%

67%

Fran

ce

Italy

Nor

way

54%

Sw

itzer

land

Sco

tland

Alb

ania

49% Fi

nlan

d 49% 44%

Pol

and

Por

tuga

l 13%

38%

Gre

ece

36%

13%

Bel

gium

33%

EU A

vg.

33%

Slo

vaki

a

10%

Sw

eden

Est

onia

23%

19

Cro

atia

Icel

and

23%

Irela

nd

Slo

veni

a

4 15% 15%

Rom

ania

18%

*Bos

nia

13%

Hun

gary

Turk

ey

10% 3%

Latv

ia

5

*Mac

edon

ia

*Ser

bia

21

37

29 28 26 26

24 21

Aus

tria

19 17

15 14 13 13 13 10 9 9

1

20

6 6 7 5 5 4

0 0 0 0 0

9

Num

ber o

f pro

duct

s

Non-oncology orphans represent 72% of the total orphan medicines group

Availability

100% 50% 75% 25%

5% Charcoal


39

Non-oncology orphan rate of availability (%, 2015 – 2018)

8% 5% 5% 8% 5%

5%

5%

5% 5%

5% 5% 8%

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

100%

95%

10%

39

100%

74%

Ger

man

y

28% 15%

EMA

appr

oval

s

3%

26%

Alb

ania

36%

Den

mar

k

62%

85%

72%

13%

Slo

vaki

a

67%

100%

15%

46%

Aus

tria

Est

onia

49%

18%

49%

44% E

ngla

nd

23% 33%

33%

26%

33%

Fran

ce

3% 26% 36%

38%

Italy

44%

10% N

orw

ay

15%

18%

46%

Sw

itzer

land

13%

49%

Sco

tland

49%

Finl

and

51% 51%

Net

herla

nds

Pol

and

21%

56%

Por

tuga

l

Gre

ece

36%

64%

23%

Bel

gium

38%

18%

15%

23%

Sw

eden

10%

64% 54%

Spa

in

23%

23%

90%

Cro

atia

18%

10%

67%

Cze

ch

77%

Irela

nd

18%

10%

72%

Slo

veni

a

10%

85%

Icel

and

33%

3%

Rom

ania

3%

85%

3%

10%

85%

Turk

ey

10% 10%

90%

Bul

garia

3%

85%

15%

13%

3%

77%

3%

87%

Lith

uani

a

97%

Latv

ia

10%

*Mac

edon

ia

92%

*Bos

nia

87%

*Ser

bia

Hun

gary


Full public availability Only available privately Limited Availability Not available Not submitted by association

Avai

labi

lity

brea

kdow

n (%

)

100% 50% 75% 25%

5% Charcoal


40

Non-oncology orphan time to availability (2015 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).

329 388

438 440 446 450 451 470 509 518 524

767 794 863 870

927 954 976

0 100 200 300 400 500 600 700 800 900

1,000 1,100 1,200 1,300 1,400 1,500

Net

herla

nds

Den

mar

k

645

Icel

and

106

Ger

man

y

Nor

way

234

Sw

itzer

land

*Bos

nia

118

606

Aus

tria

Latv

ia

399

Gre

ece

Sw

eden

Finl

and

Cze

ch

***E

ngla

nd

***S

cotla

nd

Italy

479

Spa

in

Cro

atia

Por

tuga

l

802

Lith

uani

a

Pol

and

Bel

gium

**Fr

ance

Slo

vaki

a

Hun

gary

*Ser

bia

Turk

ey

Irela

nd

Est

onia

Bul

garia

Rom

ania

821

Alb

ania

*Mac

edon

ia

Slo

veni

a

568

1,017

Tim

e (d

ays)


37 21 29 28 5 15 19 13 19 26 24 6 20 9 1 10 7 14 26 13 21 5 9 5 17 4 6 9 4 0 0 0 0 0 37 6 29 28 4 12 19 13 18 26 24 5 20 3 1 10 7 14 13 13 20 2 8 4 9 4 6 8 3 0 0 0 0 0

100% 50% 75% 25%

5% Charcoal


41

Non-oncologic orphan median time to availability (2015 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).

Tim

e (d

ays)

60 109 143

227 305 308 340 352 395 397 405 405 427 460 486 518 519 540

636 703

770 802 828 841 842 915 933

976

1,207

Cro

atia

Gre

ece

Italy

Sw

eden

Aus

tria

Den

mar

k

Ger

man

y

Slo

vaki

a

**Fr

ance

Sw

itzer

land

Turk

ey

Cze

ch

Por

tuga

l

Finl

and

***E

ngla

nd

Net

herla

nds

***S

cotla

nd

Bel

gium

Spa

in

Alb

ania

Lith

uani

a

Icel

and

Nor

way

Hun

gary

Est

onia

Bul

garia

Pol

and

Irela

nd

Rom

ania

*Ser

bia

*Mac

edon

ia

*Bos

nia

Latv

ia

Slo

veni

a

Median

100% 50% 75% 25%

5% Charcoal


42

Non-oncology orphan drugs

•  Patient access to new Orphan medicines is generally low across Europe versus other segments, with the greatest rate of availability in Northern and Western European countries.

•  In 95% of the countries, the rate of availability is lower for non-oncology orphan drugs compared to all orphan medicinal products approved between 2015-2018

•  Only in Germany, and Norway is the rate of non-oncology orphan medicines availability equivalent to all orphan medicinal products approved 2015 - 2018

•  The average delay between market authorisation and patient access for Orphan drugs is between 3.7 months to 2.8 years

•  15% of all countries studied do not have access to any of the non-oncology orphan medicines approved between 2015 and 2018

Key observations

100% 50% 75% 25%

5% Charcoal



Combination therapies Availability by approval year Rate of availability Channels of availability Time to availability

100% 50% 75% 25%

5% Charcoal


44

Combination therapies availability by approval year (2015 - 2018)

10 9 9 8 8 8 8 7 7 6 8 7 7 6 5

7 6 5 6 5 6 6 5 4 6 5

3 3 4 2 2 2

2 1

8 8 8

8 8 8 8 7 7

6

7 7 7

7 7

8 6

6 6

5 6 5

3 6 4 5

5 5 2 3 2 3

6 6 6

6 5 6 5 5 5

6

5 4 4 5

5 3

5 6 4 4

5 6

5 4 4 4

4 4

3 3

10 8

6 7 7 6

6 8 7

6 4

5 5 4 4 3

4 3 4 5

2

4 2 2 3

0

5

10

15

20

25

30

35

EMA

appr

oval

s

Irela

nd

Sw

itzer

land

22

Den

mar

k

9

Icel

and

Italy

EU A

vg.

Aus

tria

27 S

wed

en

Ger

man

y

20

2

Nor

way

23

Slo

veni

a

Finl

and

Net

herla

nds

34

Turk

ey

Spa

in

Pol

and

Eng

land

31

Sco

tland

Cro

atia

9

Por

tuga

l

Bel

gium

15

Fran

ce

Latv

ia

Lith

uani

a

1

29

Cze

ch

Hun

gary

1

Est

onia

Slo

vaki

a

Gre

ece

1

20

Bul

garia

23

1

19

Alb

ania

Rom

ania

1

24

*Bos

nia

19

29

21

1

*Ser

bia

*Mac

edon

ia

28 28 27 26

20

24 21

18 17 16 16 15 13

9

5 5

2016 2015 2018 2017


Num

ber o

f pro

duct

s

100% 50% 75% 25%

5% Charcoal


45

The rate of availability, measured by the number of medicines available to patients in European countries as of 2019: for most countries this is the point at which the product gains access to the reimbursement list, inc. limited availability.

Combination therapies rate of availability (2015 - 2018)


34

0

5

10

15

20

25

30

35

Nor

way

85%

Pol

and

50%

6%

Sw

itzer

land

15%

EMA

appr

oval

s

Italy

Den

mar

k

Cro

atia

71%

91% 82% 85%

Rom

ania

Aus

tria

Net

herla

nds

82%

15%

Sw

eden

Slo

veni

a

79%

Finl

and

79%

Irela

nd

EU A

vg.

62%

76% G

erm

any

Slo

vaki

a

71%

56% S

pain

Eng

land

68%

47%

68%

Est

onia

65%

Sco

tland

Por

tuga

l

62% 59% 59%

Bel

gium

38%

59%

Fran

ce

56%

Gre

ece

Latv

ia

53%

20

Cze

ch

Hun

gary

47% 44%

Bul

garia

44%

Icel

and

26%

Lith

uani

a

26% 26%

Alb

ania

Turk

ey

6%

*Bos

nia

*Ser

bia

*Mac

edon

ia

31 29 29

28 28 27

2

26 24 24

23 23 22

21 21 20 20

19 18

27

19

16 16 15 15

13

9 9 9

5 5

2

17

Total

Num

ber o

f pro

duct

s

100% 50% 75% 25%

5% Charcoal


46

Combination therapies rate of availability (%, 2015 – 2018)

6% 6%

9%

6%

6% 6%

9%

6%

6%

9%

6% 9% 9%

6%

6%

9%

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

100%

76%

12%

56%

Nor

way

Finl

and

44%

100%

15%

53%

EMA

appr

oval

s

59%

Sw

eden

Eng

land

62%

Italy

3%

91%

3% 79%

Den

mar

k

85%

53%

21%

*Ser

bia

15%

24%

Sw

itzer

land

12%

76%

Aus

tria

41%

53%

47%

29%

12%

32%

12%

12%

79%

26% 3%

24%

Ger

man

y

Fran

ce

Por

tuga

l

71%

3%

29%

Spa

in

Net

herla

nds

71%

3%

26%

56%

35%

12%

68%

18%

29%

Irela

nd

41%

24%

*Mac

edon

ia

Sco

tland

35%

Cro

atia

3%

Cze

ch

59%

35% 41%

Bel

gium

44%

3%

41%

Latv

ia

34

38%

53%

38%

47%

3%

Turk

ey

12%

50%

Hun

gary

32%

15%

50%

Est

onia

18%

29%

32%

53%

76%

Slo

vaki

a

44%

15%

41%

Gre

ece

Icel

and

38%

56%

Bul

garia

15%

68%

Lith

uani

a

15%

29%

44%

Pol

and

26%

12%

62%

Rom

ania

15%

Alb

ania

15%

12%

74%

3%

15%

*Bos

nia

35%

65%

Slo

veni

a

50%

38%


Full public availability Limited Availability Not submitted by association Only available privately Not available

Avai

labi

lity

brea

kdow

n (%

)

100% 50% 75% 25%

5% Charcoal


47

Combination therapies time to availability (2015 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).

158 195

381 471 500 513 552 563 577

631 671 686 714 821

0 100 200 300 400 500 600 700 800 900

1,000 1,100 1,200 1,300 1,400 1,500 1,600

Bul

garia

242 136

Rom

ania

781

138

Sw

eden

151 70

320

***E

ngla

nd

Den

mar

k

350

Sw

itzer

land

Ger

man

y

479

Finl

and

183

Por

tuga

l

***S

cotla

nd

Turk

ey

Icel

and

244 N

ethe

rland

s 307

Est

onia

Aus

tria

Bel

gium

315

Irela

nd

324 338

Slo

veni

a

Spa

in

Nor

way

393

Italy

*Mac

edon

ia

414 411 451

Cze

ch

Alb

ania

Cro

atia

**Fr

ance

Gre

ece

Slo

vaki

a

Latv

ia

Pol

and

Hun

gary

*Bos

nia

Lith

uani

a

*Ser

bia

Tim

e (d

ays)


29 31 26 28 27 23 5 15 24 28 22 23 20 19 24 27 29 18 21 20 5 15 16 16 19 9 17 2 13 21 9 2 9 020 31 26 28 27 23 5 14 24 28 22 22 20 19 24 24 29 18 11 18 5 15 15 15 6 9 16 2 13 20 9 2 8 0

100% 50% 75% 25%

5% Charcoal


48

Combination therapy median time to availability (2015 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).

Tim

e (d

ays)

1 41 53 56

86

169 191 191 201 211 232 253 259 279 284 299 335 337

372 391 396 441 458 463 467 471 490

524 588 595

631

772 781

Italy

*Bos

nia

Finl

and

Pol

and

Ger

man

y

Icel

and

Net

herla

nds

Den

mar

k

Nor

way

Sw

itzer

land

***E

ngla

nd

Sw

eden

Turk

ey

Irela

nd

Gre

ece

***S

cotla

nd

Bel

gium

Spa

in

Aus

tria

**Fr

ance

Cze

ch

Slo

veni

a

Cro

atia

Hun

gary

Est

onia

Slo

vaki

a

Lith

uani

a

Latv

ia

Alb

ania

Por

tuga

l

Bul

garia

Rom

ania

*Ser

bia

*Mac

edon

ia

Median

100% 50% 75% 25%

5% Charcoal


49

Combination therapies

•  Patient access to new combination medicines is highly varied across Europe

•  Over 40% of these combinations are for HIV or Hep-C, two products are Oncology combinations

•  In 82% of the countries, the rate of availability is higher for combination products compared to all products approved between 2015-2018

•  Over 75% of the countries have a shorter average delay to EMA authorisation for combination drugs compared to all products approved 2015-2018

•  The average delay between market authorisation and patient access for combination therapies is between 4.7 months to 2.2 years

Key observations

100% 50% 75% 25%

5% Charcoal


50

Appendix 5-year rolling cohort: 2014-2018

100% 50% 75% 25%

5% Charcoal


51

•  213 products approved by EMA between 1st January 2014 to 31st December 2018

•  The 2019 study provides an analysis of products approved between 2014-2015-2016-2017-2018, for the following dataset: a)  All 213 products: 41 in 2014, 45 in 2015, 35 in 2016, 38 in 2017, 54 in 2018 b)   52 Oncology products: 9 in 2014,10 in 2015, 10 in 2016, 11 in 2017, 12 in 2018 c)  66 Orphan products: 12 in 2014, 12 in 2015, 9 in 2016, 12 in 2017, 21 in 2018 d)   44 Combination products: 10 in 2014, 10 in 2015, 8 in 2016, 6 in 2017, 10 in 2018

•  Definitions:

-  Orphan status from EMA (September 2019) -  Oncology products flagged using IQVIA MIDAS Oncology market definition* -  Combination products include any product with more than one molecule, including branded/generic combinations

•  The date of availability cut off point was 1st January 2020 (to account for Estonia, Iceland, Czech Republic, Latvia, Slovakia which had a few products with a reimbursement decision on 1st January 2020).

•  34 countries included in the study (including split of UK into England and Scotland).

Study scope

100% 50% 75% 25%

5% Charcoal


52

Total availability by approval year (2014 - 2018)

41 39 35 39 34 41 35 33 33 30 35 34 32 32 28 32 29 31 31 29 28 29 26 25 26 18 22 22 19 18 15 16 10 3 3 2

45 38 38 40 36

39 36 34 33 34 31 27 33 29 28 26 26 29 24 29 25 27

19 16 15 19 19 16 16 10 12 12

4 2

35 32 30

32 30

28 28 29 23 24 22 21 22

18 23 22 19 19 21 15 17 16 18

13 14 14 10 10 12 5 4

1 3 1

2

38 35

35 32

30 32

30 26 33 27 29 25 24

26 23 20 21 17 21 19 20 17 17

17 16 17 13 11 8

7 10 2 3 2

54

40 44 36 36 25

30 31 27 31 26

28 21 22 17 19 18 12 11 9 10 9 16

13 11 8 11

9 3 1 1

0 20 40 60 80

100 120 140 160 180 200 220

EMA

appr

oval

s

Ger

man

y

Sw

itzer

land

Eng

land

Italy

Net

herla

nds

4

Gre

ece

Fran

ce

Nor

way

Sco

tland

Bel

gium

EU A

vg.

Por

tuga

l

Slo

veni

a

Irela

nd

64

Slo

vaki

a

Cze

ch

Cro

atia

Hun

gary

5

Icel

and

Est

onia

5

Pol

and

Rom

ania

5 6

Lith

uani

a

Alb

ania

Bul

garia

Finl

and

Latv

ia

*Ser

bia

Aus

tria

Turk

ey

Spa

in

*Bos

nia

Den

mar

k

166 184

2

182

*Mac

edon

ia

213

179 165 159 153 149 146 143

Sw

eden

132 127 119 119 114 108 108 101 100 98 96

135

82 76 75

55 49 46 37

18 14 11 8

84

2014 2017 2018 2016 2015


Num

ber o

f pro

duct

s

100% 50% 75% 25%

5% Charcoal


53

Rate of availability (2014 – 2018)

213

0 20 40 60 80

100 120 140 160 180 200 220

85%

Ger

man

y

Bel

gium

78%

Sw

itzer

land

Den

mar

k

Gre

ece

Sco

tland

EMA

appr

oval

s

86% 84%

8%

Aus

tria

Por

tuga

l

77%

Italy

75%

Irela

nd

Spa

in

47%

Finl

and

72%

51%

Eng

land

70%

108

Hun

gary

179

Net

herla

nds

69%

45%

14

Fran

ce

67%

Sw

eden

159

63%

Latv

ia

23% N

orw

ay

47%

62%

100

Alb

ania

60%

17%

4%

Slo

vaki

a

114

56%

Cze

ch

EU A

vg.

56% 51% 54%

Slo

veni

a

46%

Cro

atia

39% 38%

Bul

garia

Est

onia

36%

Icel

and

35% 30%

Pol

and

26%

Rom

ania

22%

Lith

uani

a

*Ser

bia

7% 5%

*Bos

nia

*Mac

edon

ia

184 182 166

Turk

ey

153 149 146

55

143 135

84

132 119

127 119

108

165

98 96 82 76 75

64 49 46

37 18 11 8

101

Row Labels Distinct Count of Medicine Name 2014 45 2015 45 2016 37 2017 41 2018 54

The rate of availability is the number of medicines available to patients in European countries (for most countries this is the point at which the product gains access to the reimbursement list*), inc. limited availability

Num

ber o

f pro

duct

s

Availability

100% 50% 75% 25%

5% Charcoal


54

Rate of availability (%, 2014 – 2018)

8% 5% 7%

8%

3% 8%

9% 5%

4% 6%

6%

9%

5%

6% 5% 8%

9% 8%

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

100%

85% 86%

14%

33%

EMA

appr

oval

s

Sw

eden

2%

Den

mar

k

51% 57%

Finl

and

Ger

man

y

15%

1%

82%

60%

Eng

land

*Mac

edon

ia

10%

70%

Aus

tria

23%

58%

20%

22%

40%

2%

64%

Sw

itzer

land

77%

23%

37%

Italy

3% 75%

24%

46%

31%

25%

28%

43%

26%

30%

Net

herla

nds

12%

Irela

nd

14%

30%

11%

Fran

ce

21%

12%

48%

1%

Nor

way

5%

Spa

in

16%

33%

Sco

tland

56%

44%

48%

4%

Rom

ania

1%

Por

tuga

l

51%

17%

30%

0%

52%

Slo

vaki

a

44%

44%

Cze

ch

Cro

atia

38%

11%

43%

Gre

ece

34%

11%

13%

42%

30% 25%

2%

58%

Hun

gary

38%

59%

Bul

garia

31%

Icel

and

10%

60%

Est

onia

12%

18%

Bel

gium

48%

Pol

and

25%

68%

19%

72%

Latv

ia

70%

Turk

ey

10%

16%

66%

Lith

uani

a

25%

58%

*Ser

bia

22%

83%

Alb

ania

1% 4%

1%

85%

*Bos

nia

3% 1%

23%

72%

213

48%

2%

45%

Slo

veni

a

10%


Full public availability Not submitted by association Limited Availability Only available privately Not available

Avai

labi

lity

brea

kdow

n (%

)

100% 50% 75% 25%

5% Charcoal


55

Time to availability (2014 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).

485 543 582 597 692 695 726

817 910 930 932 940

0

200

400

600

800

1,000

1,200

1,400

1,600

1,800

2,000

2,200

915

***E

ngla

nd

Net

herla

nds

Cze

ch

Ger

man

y

123 145

Sw

itzer

land

434

Den

mar

k

Aus

tria

165 266 284

Sw

eden

*Bos

nia

305

Bel

gium

Finl

and

322

Lith

uani

a

Por

tuga

l

***S

cotla

nd

372

Cro

atia

466 435

Bul

garia

Nor

way

Spa

in

463 491

Icel

and

485

Pol

and

Slo

veni

a

743

Hun

gary

**Fr

ance

Turk

ey

490

*Mac

edon

ia

665

Italy

Gre

ece

584 540

Irela

nd

Alb

ania

620

Slo

vaki

a

Est

onia

Latv

ia

Rom

ania

1,119

*Ser

bia

Tim

e (d

ays)


182 166 184 149 143 159 179 153 127 132 76 119 108 46 165 98 135 108 146 96 14 84 101 75 49 100 119 82 64 55 37 8 11 18182 117 184 149 143 152 179 153 127 132 71 119 108 42 165 84 125 106 122 67 13 68 100 71 16 97 103 82 60 53 37 7 11 18

100% 50% 75% 25%

5% Charcoal


56

Median time to availability (2014 – 2018) The time to availability (previously know as length of delay) is the days between EMA marketing authorisation and the date of availability to patients in European countries (for most this is the point at which products gain access to the reimbursement list*).

Tim

e (d

ays)

54 75 82

204 206 212 279 312

354 358 379 383 389 408 410 427 446 452 453 454 472 519 547 551 560

596

696 700 701 786 814

918 924

1,021 D

enm

ark

Hun

gary

Aus

tria

Ger

man

y

Sw

itzer

land

***E

ngla

nd

Pol

and

Net

herla

nds

Finl

and

***S

cotla

nd

Rom

ania

Spa

in

Lith

uani

a

Bel

gium

Turk

ey

Italy

Sw

eden

Icel

and

Alb

ania

Slo

veni

a

Irela

nd

Gre

ece

Cro

atia

**Fr

ance

Slo

vaki

a

Latv

ia

*Mac

edon

ia

Est

onia

Cze

ch

Bul

garia

Por

tuga

l

*Bos

nia

*Ser

bia

Nor

way

Median

100% 50% 75% 25%

5% Charcoal



Contact details: General queries: Francois Bouvy, EFPIA [email protected] Additional analyses: Per Troein, IQVIA [email protected] Country-specific insights: Local Associations

Documents

EFPIA Patients W.A.I.T . Indicator 2019 Survey · 2020. 7. 1. · IQVIA Template (V2.0.1) 9 . For countries where this differs, the definition of Availability is below: • Austria: