efpia patient w.a.i.t. indicator study 2018 results 030419 · 2019-04-08 · 4 •121 products...

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Copyright © 2017 IQVIA. All rights reserved. 3 April 2019 EFPIA Patient W.A.I.T. Indicator 2018 survey

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Page 1: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

Copyright © 2017 IQVIA. All rights reserved.

3 April 2019

EFPIA Patient W.A.I.T. Indicator 2018 survey

Page 2: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

1

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

• The Patients W.A.I.T. Indicator shows, for new medicines (i.e. medicines including a substance that has not been previously available in Europe) within a (rolling) 3, or 4 year cohort:

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

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

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

Introduction (1)

Page 3: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

2

• The Patients W.A.I.T. Indicator gives a snapshot of the 2 parameters at a cut-off date (19th December 2018) – data from medicines cohorts dropping out of the reference period are not included.

• Waiting times reflected in the Patients W.A.I.T. Indicator include any delay, whether attributable to companies or to competent authorities.

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

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

Introduction (2)

Page 4: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

3

Method for product selection

EMA list of authorisations (September 2018)Step 1

Products in scopeStep 2• Status: Authorised, Withdrawn, Suspended• Non-generic• Non-biosimilar• Remove ATC K, V & T• Include combinations (both products can have already been approved before)• Products with EMA authorisation year 2014, 2015, 2016, 2017

Remove products with an active substance which has an EMA authorisation prior to 2014Step 3

• New combination products (even those containing already approved active substances) are included• New formulations are excluded• New indications of already approved active substances, leading to a separate marketing authorisation only for an orphan drug are included• Duplicates (products launched on the same date, but same company for same indication ) - only one is included but both product names are added on one line

Additional criteria for products with active substances with multiple MA’s between 2014-2017Step 4

Page 5: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

4

• 121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products which were withdrawn between 2015-2017)

• The 2018 study provides an analysis of products approved between 2015-2016-2017, for the following datasets:a) All 121 products: 45 in 2015, 38 in 2016, 38 in 2017b) 38 Orphan products: 13 in 2015, 13 in 2016, 12 in 2017c) 31 Oncology products: 10 in 2015, 12 in 2016, 9 in 2017d) 24 Combination products: 10 in 2015, 8 in 2016, 6 in 2017

• Definitions:- Orphan status from EMA (September 2018)- Oncology products flagged using IQVIA MIDAS Oncology market definition*- Combination products include any product with more than one molecule

• The date of availability cut off point is 19th December 2018 (except for Estonia, Iceland, Czech Republic, Latvia, Slovakia which had a few products with a reimbursement decision on 1st January 2019)

• 30 countries included in the study

* L1&L2&V3C&Revlimid&Xgeva&Proleukin&Pomalyst

Study scope

Page 6: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

5

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

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

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

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

Availability and accessibility date

Reimbursement status of medicine Is the medicine available?

Reimbursed through the 'normal' reimbursement system Available

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

Reimbursed on an individual basis, in some cases whilst reimbursement is pending Available (LA*)

Not reimbursed and only available at the patients expense Not available

Pending reimbursement and only available at the patients expense Not available

In cases where a product has been categorised as “not available”, their dates will not be included in the delay analysis

*LA: product available for limited availability

Page 7: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

6

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

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

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

*Some innovative products can be made available prior to market authorization through early access schemes in countries. As these are not taken into account in the analysis in some countries, the average delay in these countries will be higher than in reality.

Products with particular reimbursement conditions

Reimbursement conditions for medicine

Restricted patient cohort (specific populations)

Individual reimbursement (case by case / named patient program)

Special programs (e.g early access scheme)*

Conditional reimbursement

Page 8: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

7

The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list*.

Rate of Availability

0 3 7 10 7 12 12 11 16 22 17 21 26 23 27 22 25 26 32 31 31 32 32 34 36 38 38 39 38 40 45

1 3 2 5 2 9 8 612 14 15

16 19 16 17 21 2221 19 25 25 24 30 26 29 32 34 32 35

38

01 4 5 5

2 5 69 15 12 9 10 12 23 18 20 17 23 19 18 27

25 32 29 31 29 34 3138

0

20

40

60

80

100

120

140

Macedonia

Serbia

Latvia

Lithuan

ia

Croatia

Turkey

Bulgaria

Poland

Estonia

Czech

Rep.

Hungar

y

Icelan

d

Irelan

d

Portuga

l

Slovakia

Norway

Slovenia

Belgium

Greec

e

France

FinlandSpa

in

Sweden

Switzer

land

Netherla

nds

Italy

Denmar

k

Austri

a

Germany UK

EUROPE

Rate

of A

vaila

bilit

y

2015 2016 2017 Data N/A EMA approved

Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)*See next slide for country specific definitions

Page 9: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

8

Definition of AvailabilityFor most countries a product is available if it gains access to the national reimbursement list. For countries where this differs, the definition of Availability is below:• Austria: A medicine is available if it is included in the reimbursement system (EKO) or available through the Austrian pharmacies list.• Czech Republic: A medicine is available if it is on the reimbursement list, or funded through the hospital

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

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

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

• Lithuania: A medicine is available if it is on the Lithuanian market (the State Medicines Control Agency has data on the sales volume of this medicinal product)• North Macedonia (referred to as Macedonia in the slides): The medicine is included on the positive drug list or reimbursement list. No new medicines have been included on the

reimbursement list for the past 10 years.

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

• Slovakia: Primary data source used is National Health Information Center, but where not available, consumption data recorded through IQVIA is used• Slovenia: A medicine is available if it is reimbursed through the regular system, or automatically reimbursed (e.g. all medicines for TBC)

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

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

• Turkey: A medicine is available if it either gains access to the reimbursement list or is available through a named patient scheme. Delay calculated using local market authorisation dates.

• UK: Two data sources are used- IQVIA sales data and publication of NICE opinion. IQVIA sales data is taken as the main source of information for availability; NICE opinion is used if sales aren’t captured by IQVIA.

Page 10: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

9

The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.

Rate of Availability (%)

3%9% 13% 14% 16%

19% 20%23%

36% 38% 40% 42% 43% 45%51% 53% 56% 58% 60% 62% 62%

69% 74% 78% 79% 83% 84% 86% 88%

24%

36% 23%

87%

11%

84% 81% 80% 77%64% 62% 60% 58% 57% 55%

49% 47% 44% 41% 40% 38% 38%30%

26% 22% 21% 17% 16% 14% 12%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Macedo

niaSerbi

aLa

tvia

Lithu

ania

Croatia

Turkey

Bulgaria

Poland

Estonia

Czech

Rep

.

Hunga

ry

Icelan

d

Ireland

Portuga

l

Slovak

ia

Norway

Sloven

ia

Belgium

Greece

France

Finland

Spain

Sweden

Switzerl

and

Netherla

nds Italy

Denmark

Austria

German

y UK

Rate

of A

vaila

bilit

y

Available Not Available Data N/A

Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)

Page 11: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

10

The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list*.

Rate of Availability (%)

0% 3% 2%11%

7…5% 0… 1%

3%1%

16%

30%

1%

22% 36%

1% 1% 0%

9%31%

0%2%

31%

15%4% 0%

14%

29%

0%

26%

7%2% 7% 11%

19% 19% 20%35%

22%

10%

41%

21%

9%

50% 52% 56%49%

30%

62% 60%

37%59%

74% 79%

69%

55%

86%

61%

24%

36% 23%

87%

11%

84% 81% 80% 77%64% 62% 60% 58% 57% 55%

49% 47% 44% 41% 40% 38% 38% 30%26% 22% 21% 17% 16% 14% 12%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Macedo

niaSerbi

aLa

tvia

Lithu

ania

Croatia

Turkey

Bulgaria

Poland

Estonia

Czech

Rep

.

Hunga

ry

Icelan

d

Ireland

Portuga

l

Slovak

ia

Norway

Sloven

ia

Belgium

Greece

France

Finland

Spain

Sweden

Switzerl

and

Netherla

nds Italy

Denmark

Austria

German

y UK

Rate

of A

vaila

bilit

y

Available (LA) Available Not Available Data N/A

Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)*Available (LA) - products which have been reimbursed or are pending reimbursement, with specific conditions - see next slide for country specific definitions

Page 12: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

11

Definition of Available with special reimbursement conditions

• Austria: Products only reimbursed on an individual basis• Croatia: Products are available for specific patient cohorts (reimbursement guidelines outline specific criteria describing patient eligibility for treatment).• Czech Republic: Only reimbursed for limited indications (compared to what was approved at market authorisation)• Denmark: Products which don’t automatically receive public reimbursement, however, the patient can obtain an individual reimbursement if the doctors apply on their behalf. • Estonia: Only reimbursed for restricted patient cohort.• France: Some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations• Greece: Only reimbursed for restricted patient cohort, or by case by case reimbursement if the responsible committee judges its use necessary.• Hungary: Medicine is pending reimbursement decision or has not been reimbursed, but is available through a Name Patient Program.• Iceland: Products are available to the patients with full reimbursement, but only through individual reimbursement, which can be applied for on individual basis by the patient’s doctor.• Ireland: Only reimbursed for restricted patient cohort• Latvia: Only available through individual reimbursement• Lithuania: Only reimbursed for limited indications (compared to what was approved at market authorisation)• Netherlands: Only reimbursed under certain therapeutic conditions (annex 2 on the positive reimbursement list).• Norway: Only reimbursed for restricted patient cohort• Poland: Only reimbursed for limited indications (compared to what was approved at market authorisation)• Portugal: Product is only available on a patient by patient basis and after an Exceptional Authorisation has been granted• Serbia: Products are reimbursed with significant restrictions. Sometimes these restrictions are based on number of patients (e.g. for new generation HepC medicines, there is a cap on only 60 patients per year),

sometimes on the number of indications, or there is some other limit.• Slovakia: Drugs included in the Reimbursement List have some limitation (prescription limitation, indication limitation and limitation based on prior insurance company approval), or are reimbursed for individual patients• Slovenia: Only reimbursed for restricted patient cohort• Spain: Only reimbursed for restricted patient cohort• Sweden: Only reimbursed for restricted patient cohort• Switzerland: For products pending reimbursement, patients have restricted reimbursement access. Such restricted access includes ‘individual reimbursement’ regulated by Art. 71a-d of KVV ordinance. • Turkey: Products only available through a “Named Patient Scheme”. These medicines do not require TITCK (Turkish Medical Agency) approval but are reimbursed.• UK: England, Scotland and Wales do not limit reimbursement for medicines for specific groups of patients relative to license. But following a health technology appraisal by the national appraisal body (National Institute

of health and Clinical Evidence, Scottish Medicines Committee, All Wales Medicines Strategy Group) recommended usage of medicines may be restricted to a subgroup of patients relative to the scope of the license under consideration.

Page 13: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

12

The rate of availability, measured by the number of medicines available to patients in European countries as of 2018, compared to the rate of availability in the 2017 W.A.I.T. indicator study

Rate of Availability (%)

Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)Note: there are differences in country scope and methodology for product selection between the 2017 and 2018 studies (26 countries included in 2017 study; 30 countries in 2018 study)

14% 20% 21% 23% 28%31% 37% 39% 40% 41% 47% 49% 51% 53% 53% 55% 59% 68% 69% 71% 73% 77% 79% 82% 85%

33%

86% 80% 79% 77% 72%

3%

60% 61%34%

59% 53% 51% 49% 47%28% 34%

38%32% 31% 29% 27% 23% 21% 18% 15%

0%

20%

40%

60%

80%

100%

Serbia

Latvi

a

Lithu

ania

Estonia

Bulgaria

Croatia

Poland

Hunga

ry

Ireland

Portuga

l

Slovak

ia

Belgium

Sloven

ia

France

Czech

Rep

.

Norway

Sweden

Spain

Finland

Switzer

land

Netherla

nds Italy

Austria

Denmark UK

German

yRate

of A

vaila

bilit

y

2017

stu

dy

(201

4-20

16)

3% 9% 13% 14% 16%19% 20% 23%

36% 38% 40% 42% 43% 45% 51% 53% 56% 58% 60% 62% 62% 69% 74% 78% 79% 83% 84% 86% 88%

24%36% 23%

87%

11%

84% 81% 80% 77%64% 62% 60% 58% 57% 55% 49% 47% 44% 41% 40% 38% 38% 30% 26% 22% 21% 17% 16% 14% 12%

0%

20%

40%

60%

80%

100%

Macedo

nia

Serbia

Latvi

a

Lithu

ania

Croatia

Turkey

Bulgaria

Poland

Estonia

Czech

Rep

.

Hunga

ry

Icelan

d

Ireland

Portuga

l

Slovak

ia

Norway

Sloven

ia

Belgium

Greec

e

France

Finland

Spain

Sweden

Switzer

land

Netherla

nds Italy

Denmark

Austria

German

y UK

Rate

of A

vaila

bilit

y

Available Not Available Data N/A

2018

stu

dy

(201

5-20

17)

Page 14: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

13

The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes

Length of market access delays (average)

925

726

634 618 612 603547 539

498 492 486449 445 428 426 417 402 401 395 385

333292 291 288 269

220 209171 146 119

0100200300400500600700800900

1000

Serbia

Lithu

ania

Portug

al

Czech

Rep.

Poland

Estonia

Bulgari

a

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ia

Franc

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EU29 av

erage

Sloven

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ly

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Norway

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y

Finlan

d

Austria

Sweden

Netherl

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nd

Denmark

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y

Aver

age

dela

y (da

ys)

In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.

• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.

• Average of 29 European countries in the analysis (excludes Macedonia)

Page 15: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

14

The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes

Length of market access delays (average)

925

726

634 618 612 603547 539

498 492 486449 445 428 417 402 401 395 385

333292 291 288 269

220 209171 146 119

0

10000

20000

30000

40000

50000

60000

70000

80000

0100200300400500600700800900

1000

Serbia

Lithu

ania

Portug

al

Czech

Rep.

Poland

Estonia

Bulgari

a

Slovak

ia

Franc

eLa

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land

Hunga

ry

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Greece

Sloven

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ly

Icelan

d

Belgium Spa

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Norway

Turke

y

Finlan

d

Austria

Sweden

Netherl

ands UK

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nd

Denmark

German

y GDP

per c

apita

, PPP

(cur

rent

inte

rnat

iona

l $),

2017

Aver

age

dela

y (da

ys)

Average delay (days) GDP per capita, PPP (current international $)

Source: GDP per capita, PPP (current international $), 2017 - World Development Indicators, World Bank

Page 16: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

15

The average time between marketing authorisation and patient access - compared to the average delay in the 2017 W.A.I.T. indicator study

Length of market access delays (average)

Note: there are differences in methodology for product selection between the 2017 and 2018 studies; chart only shows countries overlapping both studies

979

563

637

356

632

436

535

419

500467

408 391

479 494

383411

374

291250

329281

228

111 123155

106

925

726

634 618 612 603547 539

498 492 486449 445

417 402 395 385333

291 288 269220 209

171 146 119

0

200

400

600

800

1000

1200

Serbia

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ania

Portug

al

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Rep.

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2017 study: 2014-2016 2018 study: 2015-2017

Page 17: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

16

The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes

Length of market access delays (average, maximum, minimum)

925

726634 618 612 603

547 539 498 492 486 449 445 428 417 402 401 395 385333 292 291 288 269

220 209 171 146 119

0

200

400

600

800

1000

1200

1400

1600

0

20

40

60

80

100

120

Serbia

Lithu

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Rep

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Poland

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Del

ay (d

ays)

No. o

f pro

duct

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sam

ple

# of Products with accessibility date Maximum delay Minimum delay Average

• In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.

• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.

Page 18: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

17

The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes

Length of market access delays (median)

969

677

585 577 547 534493 492 457

418 411 407 398 382 369 352 351 344 340 320 303 272 259196 167 138 128

75 67 47

0

200

400

600

800

1000

1200

Serbia

Lithu

ania

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rage

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lySpa

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ian

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y (da

ys)

In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.

• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.

• Average of 29 European countries in the analysis (excludes Macedonia)

Page 19: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

18

The average time between marketing authorisation and patient access - compared to the average delay in the 2017 W.A.I.T. indicator study

Length of market access delays (median)

1,021

525

638601

316

534

374 383

460429

387454

282

419378

343 347

235288

216

0

163

44 56 73 51

969

677

585 577547 534

493 492457

418 411 407 382351 344 340 320

272 259196

167138 128

75 67 47

0

200

400

600

800

1000

1200

Serbia

Lithu

ania

Poland

Portug

al

Czech

Rep.

Bulgari

a

Slovak

ia

Estonia

Franc

e

Croatia

Hunga

ry

Sloven

iaIre

land

Latvia

Belgium Ita

lySpa

in

Norway

Austria

Sweden

Finlan

d

Netherl

ands UK

Switzerla

nd

Denmark

German

y

Aver

age

dela

y (da

ys)

2017 study (2014-2016) 2018 study (2015-2017)

Note: there are differences in methodology for product selection between the 2017 and 2018 studies; chart only shows countries overlapping both studies

Page 20: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

19

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

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

• The average delay between market authorisation and patient access can vary by a factor greater than x 7 across Europe, with patients in Northern /Western Europe accessing new products 100-200 days after market authorisation and patients mainly in Southern/ Eastern Europe between 600-1000 days.

• Countries with more products available tend to have faster access to medicines.

• Even within a country there is a large variation in the speed of patient access to different products. Often the level of variation within a country is greater than between countries e.g. shortest versus longest delays in Estonia (21 vs. 1443 days), Ireland (0 vs. 1321 days) and Austria (33 vs. 1383 days).

• Comparison to 2017 W.A.I.T. indicator study: of the countries overlapping both analyses, 65% countries have a higher rate of availability, and 58% countries have a longer delay in the 2018 study.

Key observations

Page 21: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

20

Orphans

Page 22: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

21

The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.

Rate of Availability

0 0 0 1 2 1 2 3 5 6 5 6 4 6 5 5 6 8 7 10 8 8 11 9 10 11 12 12 12 13 13

0 00 1 0

3 1 1 4 54

5 7 46

6 87

6 98

8 810 10 10 13 12 13

0 0 1 0 3 31 1

2 42 2 5

5 3 4 2 6

8 7 10 98 8 9

10 11 12

0

5

10

15

20

25

30

35

40

Macedonia

Serbia

Croatia

Latvia

Lithuan

ia

Poland

Turkey

Bulgaria

Czech

Rep.

Estonia

Icelan

d

Irelan

d

Hungary

Portuga

l

Slovenia

Norway

Slovakia

Spain

Belgium

Finland

Sweden

Switzerl

and

Greece

France

Netherla

nds

Italy

Austria

Denmark UK

Germany

EUROPE

Rate

of A

vaila

bilit

y

2015 2016 2017 Data N/A EMA approved

Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)Orphan status from EMA (September 2018)

Orphans

Page 23: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

22

The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.

Rate of Availability (%)

3% 3% 5%13%

13%18%

18% 18%29% 29% 32% 34% 37% 37%

45% 45% 50% 50% 53%66% 68% 71% 71% 76% 79% 82%

92% 95%

18%26%

13%

26%

95%87% 87% 82% 82% 82%

71% 71% 68% 66% 63% 63%55% 55% 50% 50% 45%

34% 32% 29% 29% 24% 21% 18%8% 5%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Macedo

niaSerbi

a

Croatia

Latvia

Lithu

ania

Poland

Turkey

Bulgaria

Czech

Rep

.

Estonia

Icelan

d

Ireland

Hunga

ry

Portuga

l

Sloven

ia

Norway

Slovak

iaSpain

Belgium

Finland

Sweden

Switzerl

and

Greece

France

Netherla

nds Italy

Austria

Denmark UK

German

y

Rate

of A

vaila

bilit

y

Available Not Available Data N/A

Rate of availability for Orphans is at least 10% lower than all products approved 2015-2017

Rate of availability for Orphans is at least 10% higher than all products approved 2015-2017

Orphans

Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)Orphan status from EMA (September 2018)

Page 24: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

23

The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes

Length of market access delays (average)

1,141

940

802 775736

693 690 677

551 537 512 493 493 477 469 464 435 428 399 373 368 351272 262 248 239 207

156113

0

200

400

600

800

1000

1200

Poland

Estonia

Czech

Rep.

Irelan

d

Portug

al

Bulgari

a

Slovak

ia

Lithu

ania

Franc

e

Icelan

dSpa

in

EU28 Ave

rage

Croatia

Finlan

d

Sloven

ia

Belgium

Greece Ita

ly

Hunga

ry

Norway

Sweden

Latvia

Turke

y

Austria UK

Netherl

ands

Switzerla

nd

Denmark

German

y

Aver

age

dela

y (da

ys)

In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in

the analysis, the average for France is higher than in reality.• Average of 28 European countries in the analysis (excludes Macedonia, Serbia)• Orphan status from EMA (September 2018)

Average delay for Orphans is at least 100 days longer than all products approved 2015-2017

Average delay for Orphans is at least 100 days shorter than all products approved 2015-2017

Orphans

Page 25: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

24

The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes

Length of market access delays (median)

1,141

1,038

769 740 713 685 677 651597

554 519 493 466 459 444 420 396 385 376 351 329 323272

206140 132 126

7434

0

200

400

600

800

1000

1200

Poland

Estonia

Portug

al

Irelan

d

Czech

Rep.

Bulgari

a

Lithu

ania

Slovak

ia

Finlan

d

Franc

e

Icelan

d

Croatia

EU28 av

erage

Sloven

iaSpa

in

Hunga

ry

Greece

Belgium

Norway

Latvia Ita

ly

Sweden

Turke

y

Netherl

ands UK

Switzerla

nd

Austria

Denmark

German

y

Med

ian

dela

y (da

ys)

In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.

• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.

• Average of 28 European countries in the analysis (excludes Macedonia, Serbia)• Orphan status from EMA (September 2018)

Orphans

Page 26: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

25

Oncology

Page 27: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

26

The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.

Rate of Availability

0 1 1 25 4 4 5 4 6 5 7 6 6 7 6 7 8 7 7 9 8 7 8 10 9 9 10 9 10

1 03 2

1 1 2 2 46

55 5

8 7 9 9 8 10 88 10 10

1110 12 12 12 12 12

0 0

1 2 1 1 1 1

1 6 4 63 4 4 4 5 4 7

6 5 87 7

8 8 8 9 9

0

5

10

15

20

25

30

35

Macedonia

Latvia

Serbia

Poland

Croatia

Estonia

Lithuan

ia

Turkey

Czech

Rep.

Bulgaria

Irelan

d

Hungary

Icelan

d

Norway

Slovakia

Portuga

lSpa

in

Slovenia

Belgium

Finland

Sweden

France

Greece

Italy

Denmark

Switzerl

and

Austria

Netherla

nds

Germany UK

EUROPE

Rate

of A

vaila

bilit

y

2015 2016 2017 Data N/A EMA approved

Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)Oncology market definition: L1&L2&V3C&Revlimid&Xgeva&Proleukin&Pomalyst

Oncology

Page 28: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

27

The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.

Rate of Availability (%)

3%16%

19% 19%19% 23%

26% 29%42%

52% 52% 55% 55% 58% 61% 65% 68% 68% 71% 74% 74%81% 84% 87%

94% 94% 97% 97%

19%

45%55%

84%

26%

81% 81% 77% 74% 71%58%

48% 48% 45% 45% 42% 39% 35% 32% 32% 29% 26% 26%19% 16% 13%

6% 6% 3% 3%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Macedo

niaLa

tviaSerbi

a

Poland

Croatia

Estonia

Lithu

ania

Turkey

Czech

Rep

.

Bulgaria

Ireland

Hunga

ry

Icelan

d

Norway

Slovak

ia

Portuga

lSpain

Sloven

ia

Belgium

Finland

Sweden

France

Greece Ita

ly

Denmark

Switzerl

and

Austria

Netherla

nds

German

y UK

Rate

of A

vaila

bilit

y

Available Not Available Data N/A

Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)Oncology market definition: L1&L2&V3C&Revlimid&Xgeva&Proleukin&Pomalyst

Rate of availability for Oncologics is at least 10% lower than all products approved 2015-2017

Rate of availability for Oncologics is at least 10% higher than all products approved 2015-2017

Oncology

Page 29: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

28

The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes

Length of market access delays (average)

988 981902

761 755665

586 573536 519 496

445 428 425 418 413 395 389 368318 309 295 281 253 232 198 163

12482 67

0

200

400

600

800

1000

1200

Estonia

Latvia

Lithu

ania

Czech

Rep.

Portug

al

Slovak

ia

Bulgari

a

Irelan

dFra

nce

Serbia

Sloven

ia

EU29 av

erage

Greece

Croatia

Icelan

d

Belgium Spa

in

Norway Ita

ly

Poland

Switzerla

nd

Hunga

ry

Sweden

Turke

y

Finlan

d

Austria

Netherl

ands UK

German

y

Denmark

Aver

age

dela

y (da

ys)

In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in

the analysis, the average for France is higher than in reality.• Average of 29 European countries in the analysis (excludes Macedonia)• Oncology market definition: L1&L2&V3C&Revlimid&Xgeva&Proleukin&Pomalyst

Average delay for Oncologics is at least 100 days longer than all products approved 2015-2017

Average delay for Oncologics is at least 100 days shorter than all products approved 2015-2017

Oncology

Page 30: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

29

The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes

Length of market access delays (median)

997 987 981

855771

706623

559 538 519443 436 420 418 388 381 348 348 343 318

264 251211 187

10058 58 52 33 0

0

200

400

600

800

1000

1200

Estonia

Lithu

ania

Latvia

Portug

al

Czech

Rep.

Slovak

iaIre

land

Bulgari

a

Franc

eSerb

ia

Croatia

Sloven

ia

EU29 av

erage

Norway

Icelan

d

Greece

Belgium Spa

inIta

ly

Poland

Turke

y

Hunga

ry

Sweden

Switzerla

nd

Netherl

ands

Austria UK

Denmark

German

y

Finlan

d

Med

ian

dela

y (da

ys)

In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.

• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.

• Average of 29 European countries in the analysis (excludes Macedonia)• Oncology market definition: L1&L2&V3C&Revlimid&Xgeva&Proleukin&Pomalyst

Oncology

Page 31: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

30

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

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

between 2015-2017

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

- The average delay between market authorisation and patient access for Orphan drugs is between 4 months to 3 years

• Oncology drugs- In 73% of the countries, the rate of availability is higher for Oncology products compared to all products approved

between 2015-2017

- The average delay between market authorisation and patient access for Oncology products is between 2 months to over 2.5 years

Key observations: Orphan and Oncology drugs

Page 32: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

31

Combination products

Page 33: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

32

The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.

Rate of Availability

0 1 2 2 3 2 3 3 3 4 4 5 7 6 7 5 6 7 6 7 6 7 7 6 7 8 9 9 8 9 10

13 3 3 3 2 4 3

6 6 4 56

6 6 6 6 6 8 7 7 7 68 7 7 8 8 8

0

1 1 33 4

3 2 3 43 6 5 4 5 5 4 4 4 6 6

5 5 6 6 6 6

0

5

10

15

20

25

30

Macedonia

Serbia

Turkey

Croatia

Bulgaria

Poland

Latvia

Lithuan

ia

Estonia

Hungary

Icelan

d

Portuga

l

Slovakia

France

Greece

Belgium

Germany

Irelan

d

Slovenia

Czech

Rep.

FinlandSpa

in

Switzerl

and

Norway

Netherla

nds

Austria UK

Italy

Sweden

Denmark

EUROPE

Rate

of A

vaila

bilit

y

2015 2016 2017 Data N/A EMA approved

Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)

Combinations

Page 34: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

33

The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.

Rate of Availability (%)

8%21%

25% 25%29% 33% 42% 46%

54% 54% 58% 63% 67% 71% 71% 71% 71% 75% 75% 75% 75% 79% 79%88% 88% 92% 92% 96%

29%

46%

92%

8%

75% 75%

13%

67%58% 54%

46% 46% 42%38% 33% 29% 29% 29% 29% 25% 25% 25% 25% 21% 21%

13% 13% 8% 8% 4%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Macedo

niaSerbi

aTurk

ey

Croatia

Bulgaria

Poland

Latvia

Lithu

ania

Estonia

Hunga

ry

Icelan

d

Portuga

l

Slovak

ia

France

Greece

Belgium

German

y

Ireland

Sloven

ia

Czech

Rep

.

Finland

Spain

Switzerl

and

Norway

Netherla

nds

Austria UK

Italy

Sweden

Denmark

Rate

of A

vaila

bilit

y

Available Not Available Data N/A

Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)

Rate of availability for Combinations is at least 10% lower than all products approved 2015-2017

Rate of availability for Combinations is at least 10% higher than all products approved 2015-2017

Combinations

Page 35: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

34

The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes

Length of market access delays (average)

969

640

509 501446 444 430 423 410 407 404 402 388 386 369 355 336 332 324 319

273 271 266220

181 157 153 130 12172

0

200

400

600

800

1000

1200

Serbia

Lithu

ania

Latvia

Portug

al

Hunga

ryTu

rkey

Croatia

Greece

Bulgari

a

Franc

e

Czech

Rep.

Slovak

ia

Poland

Estonia Ita

ly

EU29 av

erage

Belgium

Sloven

ia

Norway

Irelan

d

Austria

Spain

Icelan

d

Netherl

ands

Finlan

d

Sweden

Denmark UK

German

y

Switzerla

nd

Aver

age

dela

y (da

ys)

In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in

the analysis, the average for France is higher than in reality.• Average of 29 European countries in the analysis (excludes Macedonia)

Average delay for Combinations is at least 100 days longer than all products approved 2015-2017

Average delay for Combinations is at least 100 days shorter than all products approved 2015-2017

Combinations

Page 36: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

35

The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes

Length of market access delays (median)

969

501 471 444 424 409370 363 351 346 338 337 329 327 319 299 295 279 259 259 231 225 212

15897 84 54 48 43

00

200

400

600

800

1000

1200

Serbia

Portug

al

Lithu

ania

Turke

y

Greec

e

Bulgari

a

Hunga

ry

Czech

Rep

.

Latvi

a

Estonia

Croatia

Sloven

ia

Poland

Slovak

iaIta

ly

Fran

ce

EU29 av

erag

e

Austria

Belgium

Irelan

dSpa

in

Icelan

d

Norway

Nether

lands UK

Sweden

Denmark

Switzerl

and

German

y

Finlan

d

Med

ian

dela

y (da

ys)

In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.

• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.

• Average of 29 European countries in the analysis (excludes Macedonia)

Combinations

Page 37: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

36

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

• Over 40% of these combinations are for HIV or Hep C. One product is an Oncology combination.

• In 87% of the countries, the rate of availability is higher for combination products compared to all products approved between 2015-2017

• Over 80% of the countries have a shorter average delay to EMA authorisation for combination drugs compared to all products approved 2015-2017

• The average delay between market authorisation and patient access for combination products is between 2.4 months to over 2.5 years

Key observations: Combination drugs

Page 38: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

37

- Products approved between 2014-2015-2016-2017 (165 products)

- Products approved between 2014-2015-2016 (127 products)

Appendix

Page 39: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

38

The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.

Rate of Availability

0 7 13 8 13 14 20 19 20 20 28 28 31 31 33 30 32 31 32 28 31 34 36 36 41 42 40 40 38 41 443

7 7 10 12 12 11 16 2122 17

26 23 27 22 25 26 32 31 31 32 32 34 36 38 38 39 38 40 45

01

3 5 2 29 8 6

1512 14

16 19 1617 21 22 21 25 19 25 24 30 26 29 32 34 32 35

38

0

1 5 4 52 5 6

12 9 159 10 12 23 18 20 17 19 23

18 27 25 32 29 31 29 34 3138

0

20

40

60

80

100

120

140

160

180

Macedonia

Serbia

Latvia

Croatia

Lithuan

ia

Turkey

Bulgaria

Poland

Estonia

Icelan

d

Czech

Rep.

Hungar

y

Irelan

d

Portuga

l

Slovakia

Norway

Slovenia

Belgium

Greec

e

Finland

France

Spain

Sweden

Switzer

land

Netherla

nds

Italy

Denmar

k

Austri

a

Germany UK

EUROPE

Rate

of A

vaila

bilit

y

2014 2015 2016 2017 Data N/A EMA approved

Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)

2014-2017

Page 40: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

39

The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.

Rate of Availability (%)

15% 15%18% 20%

26% 26%29%

41% 43% 45%50% 50% 53% 56% 58% 60% 62% 62% 63% 66%

72% 76%82% 84% 85% 86% 86% 89%

29%

36% 24%

12%

82% 80%74% 74% 71%

59% 57% 55%50% 50% 47% 44% 42% 40% 38% 38% 37% 34%

27%24%

18% 16% 15% 14% 14% 11%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Macedo

nia

Serbia

Latvi

a

Croatia

Lithu

ania

Turkey

Bulgaria

Poland

Estonia

Icelan

d

Czech

Rep

.

Hunga

ry

Ireland

Portuga

l

Slovak

ia

Norway

Sloven

ia

Belgium

Greec

e

Finland

France

Spain

Sweden

Switzer

land

Netherla

nds Italy

Denmark

Austria

German

yUK

Rate

of A

vaila

bilit

y

Available Not Available Data N/A

Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)

2014-2017

Page 41: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

40

The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.

Rate of Availability (%)

0% 4% 1% 7% 1… 6% 0… 1%2%

30%

1%

15%

1%

22%

45%

2% 1% 0%

8%

0%

30%

1%

33%

12% 7%0%

14%

29%

0%

24%13%

8%5% 14%

26% 25% 27%

12%

42%

30%49%

28%

8%

53% 58% 60%54%

62%

33%

65%

39%

64% 75% 84%

72%

57%

86%

65%

29%

36% 24%12%

82% 80%74% 74% 71%

59% 57% 55% 50% 50% 47% 44%42% 40% 38% 38% 37% 34% 27% 24%

18% 16% 15% 14% 14% 11%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Macedo

niaSerbi

aLa

tvia

Croatia

Lithu

ania

Turkey

Bulgaria

Poland

Estonia

Icelan

d

Czech

Rep

.

Hunga

ry

Ireland

Portuga

l

Slovak

ia

Norway

Sloven

ia

Belgium

Greece

Finland

France

Spain

Sweden

Switzerl

and

Netherla

nds Italy

Denmark

Austria

German

y UK

Rate

of A

vaila

bilit

y

Available (LA) Available Not Available Data N/A

Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)Available (LA) - products which have been reimbursed or are pending reimbursement, with specific conditions

2014-2017

Page 42: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

41

The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes

Length of market access delays (average)

1,099

838757

682 681 674 658 650

527 519 505 490 484 481 473 451 447 437 437 405 394345 313 308 272

230 229150 148 116

0

200

400

600

800

1000

1200

Serbia

Lithu

ania

Poland

Bulgari

a

Portug

al

Czech

Rep.

Estonia

Latvia

Franc

e

Slovak

ia

Sloven

iaIre

land

Croatia

Greece

EU29 av

erage Ita

ly

Hunga

ry

Belgium

Icelan

dSpa

in

Norway

Turke

y

Finlan

d

Austria

Sweden

Netherl

ands UK

Denmark

Switzerla

nd

German

y

Aver

age

dela

y (da

ys)

In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.

• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.

• Average of 29 European countries in the analysis (excludes Macedonia)

2014-2017

Page 43: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

42

The average time between marketing authorisation and patient access - the number of days elapsing

from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the

day of completion of post-marketing authorisation administrative processes

Length of market access delays (average, maximum, minimum)

1099

838757

682 681 674 658 650

527 519 505 490 484 481 451 447 437 437 405 394345 313 308

272230 229

150 148 116

0

200

400

600

800

1000

1200

1400

1600

1800

2000

0

20

40

60

80

100

120

140

160

Ser

bia

Lith

uania

Pol

and

Bul

garia

Por

tuga

l

Cze

ch R

ep.

Est

onia

Latv

ia

Fra

nce

Slo

vakia

Slo

veni

a

Irelan

d

Cro

atia

Gre

ece

Italy

Hun

gary

Bel

gium

Icelan

d

Spa

in

Nor

way

Tur

key

Finla

nd

Aus

tria

Swed

en

Net

herla

nds

UK

Den

mar

k

Switz

erland

Ger

man

y

Del

ay (d

ays)

No. o

f pro

duct

s in

sam

ple

# of Products with accessibility date Maximum delay Minimum delay Average

• In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.

• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.

2014-2017

Page 44: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

43

The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes

Length of market access delays (median)

1,212

811 774

630 613558 532

487 484 452 446 425 424 410 409 407 376 365 364 348 320 314259

204 199143 118

74 68 50

0

200

400

600

800

1000

1200

1400

Serbia

Lithu

ania

Poland

Portug

al

Bulgari

a

Czech

Rep.

Estonia

Latvia

Franc

e

Greece

Sloven

ia

Croatia

Slovak

ia

Hunga

ry

EU29 av

erage

Icelan

d

Belgium

Irelan

dIta

lySpa

inTu

rkey

Norway

Austria

Sweden

Finlan

d

Netherl

ands UK

Switzerla

nd

Denmark

German

y

Med

ian

dela

y (da

ys)

In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.

• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.

• Average of 29 European countries in the analysis (excludes Macedonia)

2014-2017

Page 45: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

44

- Products approved between 2014-2015-2016-2017 (165 products)

- Products approved between 2014-2015-2016 (127 products)

Appendix

Page 46: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

45

The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.

Rate of Availability

0 7 8 13 13 14 19 20 20 20 28 28 30 31 31 33 32 31 31 28 32 34 36 36 41 38 42 40 40 41 443 7 7 10 12 11 12 16 21

17 22 22 26 23 27 25 26 31 31 32 32 32 3436 38 38 38 39 40

45

01

5 3 2 28 9 6

15 14 12 17 16 19 16 21 22 19 25 21 25 24 30 26 32 29 32 34 3538

0

20

40

60

80

100

120

140

Macedonia

Serbia

Croatia

Latvia

Lithuan

ia

Turkey

Poland

Bulgaria

Estonia

Icelan

d

Hungary

Czech

Rep.

Norway

Irelan

d

Portuga

l

Slovakia

Slovenia

Belgium

France

Finland

Greece

Spain

Sweden

Switzerl

and

Netherla

nds

Germany Ita

ly

Denmark

Austria UK

EUROPE

Rate

of A

vaila

bilit

y

2014 2015 2016 Data N/A EMA approved

Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)The date of availability cut-off point is December 2018 for this study

2014-2016

Page 47: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

46

The rate of availability, measured by the number of medicines available to patients in European countries as of 2018: for most countries this is the point at which the product gains access to the reimbursement list.

Rate of Availability (%)

16% 18% 20% 22%

30% 32%33%

44% 46% 49% 54% 57% 57% 60% 61% 62% 64% 66% 67% 72% 72%79% 81% 85% 86% 87% 89% 91%

28%

33%12%

20%

80% 78%70% 68% 67%

56% 54% 51% 46% 43% 43% 40% 39% 38% 36% 34% 33% 28% 27%21% 19% 15% 14% 13% 11% 9%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Macedo

niaSerbi

a

Croatia

Latvia

Lithu

ania

Turkey

Poland

Bulgaria

Estonia

Icelan

d

Hunga

ry

Czech

Rep

.

Norway

Ireland

Portuga

l

Slovak

ia

Sloven

ia

Belgium

France

Finland

Greece

Spain

Sweden

Switzerl

and

Netherla

nds

German

yIta

ly

Denmark

Austria UK

Rate

of A

vaila

bilit

y

Available Not Available Data N/A

Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)The date of availability cut-off point is December 2018 for this study

2014-2016

Page 48: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

47

The rate of availability, measured by the number of medicines available to patients in European countries as of 2018, compared to the rate of availability in the 2017 W.A.I.T. indicator study

Rate of Availability (%)

Data N/A- data is not provided by associations (companies have not sent data or are not members of the association)Note: there are differences in country scope and methodology for product selection between the 2017 and 2018 studies (26 countries included in 2017 study; 30 countries in 2018 study); For the 2018 study, the date of availability cut-off point is December 2018

14% 20% 21% 23% 28%31% 37% 39% 40% 41% 47% 49% 51% 53% 53% 55% 59% 68% 69% 71% 73% 77% 79% 82% 85%

33%

86% 80% 79% 77% 72%

3%

60% 61%34%

59% 53% 51% 49% 47%28% 34%

38%32% 31% 29% 27% 23% 21% 18% 15%

0%

20%

40%

60%

80%

100%

Serbia

Latvi

a

Lithu

ania

Estonia

Bulgaria

Croatia

Poland

Hunga

ry

Ireland

Portuga

l

Slovak

ia

Belgium

Sloven

ia

France

Czech

Rep

.

Norway

Sweden

Spain

Finland

Switzer

land

Netherla

nds Italy

Austria

Denmark UK

German

yRate

of A

vaila

bilit

y

2017

stu

dy

(201

4-20

16)

9% 16% 18% 20% 22%30% 32%

33%44% 46% 49% 54% 57% 57% 60% 61% 62% 64% 66% 67% 72% 72% 79% 81% 85% 86% 87% 89% 91%

28%33% 12%

20%

80% 78% 70% 68% 67%56% 54% 51% 46% 43% 43% 40% 39% 38% 36% 34% 33% 28% 27% 21% 19% 15% 14% 13% 11% 9%

0%

20%

40%

60%

80%

100%

Macedo

nia

Serbia

Croatia

Latvi

a

Lithu

ania

Turkey

Poland

Bulgaria

Estonia

Icelan

d

Hunga

ry

Czech

Rep

.

Norway

Ireland

Portuga

l

Slovak

ia

Sloven

ia

Belgium

France

Finland

Greec

eSpain

Sweden

Switzer

land

Netherla

nds

German

yIta

ly

Denmark

Austria UK

Rate

of A

vaila

bilit

y

Available Not Available Data N/A

2018

stu

dy

(201

4-20

16)

2014-2016

Page 49: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

48

The average time between marketing authorisation and patient access - the number of days elapsing

from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the

day of completion of post-marketing authorisation administrative processes

Length of market access delays (average)

1,099

910

770

709 707 693 692663

561 547 533 528 519 513 500 490 481 470 464 453429

365335 326

297250 250

160 157123

0

200

400

600

800

1000

1200

Ser

bia

Lith

uania

Polan

d

Cze

ch R

ep.

Por

tuga

l

Eston

ia

Bulga

ria

Latvia

Fran

ce

Slove

nia

Slova

kia

Cro

atia

Ireland

Gre

ece

EU29

ave

rage

Italy

Hun

gary

Belgium

Nor

way

Icelan

d

Spa

in

Turk

ey

Finlan

d

Aus

tria

Swed

en UK

Nethe

rland

s

Switz

erla

nd

Den

mar

k

Ger

man

y

Aver

age

dela

y (da

ys)

In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.

• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.

• Average of 29 European countries in the analysis (excludes Macedonia)• The date of availability cut-off point is December 2018 for this study

2014-2016

Page 50: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

49

The average time between marketing authorisation and patient access - compared to the average delay in the 2017 W.A.I.T. indicator study

Length of market access delays (average)

Note: there are differences in methodology for product selection between the 2017 and 2018 studies; chart only shows countries overlapping both studiesFor the 2018 study, the date of availability cut-off point is December 2018

979

563

632

356

637

436

535

467500 494

419479

408 383 391 411

291

374

250

329281

111

228

123155

106

1099

910

770709 707 693 692

663

561 547 533 528 519490 481 470 464

429

335 326297

250 250

160 157123

0

200

400

600

800

1000

1200

Serbia

Lithu

ania

Poland

Czech

Rep.

Portug

al

Estonia

Bulgari

aLa

tvia

Franc

e

Sloven

ia

Slovak

ia

Croatia

Irelan

dIta

ly

Hunga

ry

Belgium

Norway

Spain

Finlan

d

Austria

Sweden UK

Netherl

ands

Switzerla

nd

Denmark

German

y

Aver

age

dela

y (da

ys)

2017 study (2014-2016) 2018 study (2014-2016)

2014-2016

Page 51: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

50

The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes

Length of market access delays (average, maximum, minimum)

1099

910770

709 707 693 692 663561 547 533 528 519 513 490 481 470 464 453 429

365 335 326 297 250 250160 157 123

0

200

400

600

800

1000

1200

1400

1600

1800

2000

0

20

40

60

80

100

120

140

Serbia

Lithu

ania

Poland

Czech

Rep.

Portug

al

Estonia

Bulgari

aLa

tvia

Franc

e

Sloven

ia

Slovak

ia

Croatia

Irelan

d

Greece Ita

ly

Hunga

ry

Belgium

Norway

Icelan

dSpa

inTu

rkey

Finlan

d

Austria

Sweden UK

Netherl

ands

Switzerla

nd

Denmark

German

y

Del

ay (d

ays)

No. o

f pro

duct

s in

sam

ple

# of Products with accessibility date Maximum delay Minimum delay Average

• In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.

• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.

• The date of availability cut-off point is December 2018 for this study

2014-2016

Page 52: EFPIA Patient W.A.I.T. Indicator Study 2018 Results 030419 · 2019-04-08 · 4 •121 products approved by EMA between 1st January 2015 to 31st December 2017 (excluding 4 products

51

The average time between marketing authorisation and patient access - the number of days elapsing from the date of EU marketing authorisation (or effective marketing authorisation in non-EEA countries) to the day of completion of post-marketing authorisation administrative processes

Length of market access delays (median)

1,212

919

785692 656

587 553 528 506 478 473 458 443 436 434 407 406 403 386 376 354 347259 217 206 183

109 73 70 54

0

200

400

600

800

1000

1200

1400

Serbia

Lithu

ania

Poland

Portug

al

Bulgari

a

Czech

Rep.

Estonia

Franc

eLa

tvia

Greece

Sloven

ia

Croatia

Hunga

ry

Slovak

ia

EU29 av

erage

Icelan

dIre

land

Italy

Belgium

Norway

SpainTu

rkey

Austria

Sweden

Finlan

d

Netherl

ands UK

Switzerla

nd

Denmark

German

y

Med

ian

dela

y (da

ys)

In most countries patient access equates to granting of access to the reimbursement list, except for hospital products in DK, FI, NO, SE where some products are not covered by the general reimbursement scheme and so this shorter delay is artificially declining the median and average.

• In France, some innovative products without competitors can be made available prior to market authorisation under the system of Temporary Authorisations. As these are not taken into account in the analysis, the average for France is higher than in reality.

• Average of 29 European countries in the analysis (excludes Macedonia)• The date of availability cut-off point is December 2018 for this study

2014-2016