REFERENCES1. Proposal for a regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU. COM/2018/051 final - 2018/018 (COD)2. https://www.eunethta.eu/national-implementation/national-uptake-and-case-studies

Authors: Pieniążek I, Maciejewska K, Walczak JArcana Institute a Certara Company, Cracow, Poland

A total of 128 implementations in 25 countries have been identified. JA3 includes 10 assessed technologies (3 drug and 7 non-drug technologies) and JA2 includes 15 assessed technologies (7 drug and 8 non-drug technologies).2

RESULTS

The EUnetHTA National Uptake and Case Studies subpage2 was searched and the use of the EUnetHTA JointAction 3 (2016-2020) and Joint Action 2 Archive (2012-2015) assessments were analysed. Based on the EUnetHTAinformation about details of the use of REAs, assessments were categorised into 10 groups: adaptation, summary,translation, update, indexed in NHS evidence database, new items added, background, validation/cross-checking,used in direct decision-making, mentioned in the discussion. This analysis was based on publicly available data.The last verification was performed at the beginning of October 2018.

METHODS

OBJECTIVE

In January 2018, a proposal for a regulation of the European Parliament and of the Council on health technologyassessment and amending Directive 2011/24/EU was adopted.1 The proposed regulation aims to strengthen EUcooperation in terms of joint HTA (health technology assessment). The objective of this analysis is to assess howcurrent EUnetHTA REAs (Rapid Relative Effectiveness Assessments) have been implemented by national agencies.

Chart 1. Technologies Assessed by EUnetHTA

Chart 4. Number of drug technologies implementations

CONCLUSIONThe analysis shows that limited number of countries uses REA implementations, since only a few EU countriessupport their reimbursement processes with comprehensive HTA analyses performed by EUnetHTA. It is alsoconfirmed by the proposal for a regulation of the European Parliament and of the Council, which presented theEUnetHTA concept as unsuccessful in terms of eliminating duplication of work and fragmentation of the internalmarket. Before further legislation steps are taken, it is worth to investigate what the reasons for failing to reach forsuch a comprehensive source of information as EUnetHTA analyses are. The diagnosis may have a positive impacton more prevalent use of EUnetHTA assessments as a relevant source of information supporting reimbursementdecisions on the level of specific countries.

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10

15

3

7

5

15

2

7

0

2

4

6

8

10

12

14

16

JA3 JA2

TECHNOLOGIES ASSESSED BY EUNETHTA

All assessed Drugs assessed

Implementation on country level Implementation of drug assessment

The implementation ratio for drug to non-drug technologies was 45% to 55% (40% to 60% in JA3 and 47% to 53% in JA2).

Chart 2. Implementation ratio for drug to non-drug technologies

45%

55%

IMPLEMENTATION RATIO FOR DRUG TO NON-DRUG TECHNOLOGIES

drug implemented

non-drug implemented

47%53%

JA2

drug implemented

non-drug implemented

40%

60%

JA3

drug implemented

non-drug implemented

Within drug technologies, 2 technologies with 21 implementations in JA3 and 7 technologies with 41implementations in JA2 were identified. The most implementations were found for canaglifozin (12 agencies in 10countries) and ragorafenib (11 agencies in 9 countries).

27

21

41

0

10

20

30

40

50

60

JA3 JA2

Number of implementations

Implemented technologies

RESULTS (cont.)Among the countries which used EUnetHTA REAs most often, Austria (23), Spain (19) and Croatia (19) dominated.Summary (33 cases) and adaptation (29 cases) were the most frequently used types of EUnetHTA assessments.

3031

13

7

5

1726

14

22 3

Adaptation

Summary

Translation

Update

Indexed in NHS Evidencedatabase

New items added

Background

Validation/cross-checking

Used in direct decision-making

Mentioned in the discussion

T Y P E O F I M P L E M E N TAT I O N

Implementation of REA in direct decision-making was identified for 6 countries, of which Austria had the greatestnumber of cases (8). Croatia is the country with implementations for almost all analysed technologies, howeveronly a summary of the report was the most common type of implementation there.

8

5

6

11 1

ASSESSMENTS USED IN DIRECT DECISION-MAKING

Austria Spain Slovakia

Netherlands Portugal Malta

6

4

522

2

2

2

21 1

A DA P TAT I O N

Austria Spain Italy Scotland Portugal Finland Denmark Norway Lithuania Slovenia Ireland

4

19

3

3 1 1

S U M M A RY

Austria Croatia Spain

Italy Belgium Denmark

Chart 5. Implementations in countries

Chart 3. Number of drug technologies implementations

Chart 6. Type of Implementation

Chart 6. Type of Implementation by Country

A U S T R I A 23C R O AT I A 19S PA I N 19I TA LY 8S L O VA K I A 7B E L G I U M 7S C O T L A N D 5U K 5N E T H E R L A N D S 4P O R T U G A L 4F I N L A N D 3D E N M A R K 3F R A N C E 3L U X E M B O U R G 2S W E D E N 3H U N G A R Y 2N O R WAY 2L I T H U A N I A 2M A LTA 1R O M A N I A 1S L O V E N I A 1E S T O N I A 1S W I T Z E R L A N D 1I R E L A N D 1P O L A N D 1

Alcensa:

Vorapaxar:

Immunoglobulins AD:

Hepatitis C:

Zostavax:

Sorafenib:

Midostaurin:

Ramucirumab:

Regorafenib:

Canaglifozin:

N U M B E R O F D R U G T E C H N O LO G I E S I M P L E M E N TAT I O N S

0

1

2

3

6

7

10

10

11

12

ANALYSIS OF THE NATIONAL IMPLEMENTATION OF

EUNETHTA REA AND FULL ASSESSMENTS