A gyógyszerek nemzetközi referenciaárazása és az EURIPID...

A gyógyszerek nemzetközi referenciaárazása és az

EURIPID Együttműködés

META ülés 2017. 04. 11

Németh Gergely

664317 – EURIPID – HP-PJ-2014 Ref. Ares (2015)2197859 – 27/05/2015

National Institute

of Health

Insurance Fund

Management

Disclaimer

“The content of this presentation represents the views of the author only and is his/her sole responsibility; it can not be considered to reflect the views of the European Commission and/or the Consumers, Health, Agriculture and Food Executive Agency or any other body of the European Union. The European Commission and the Agency do not accept any responsibility for use that may be made of the information it contains.”

Tartalom

1. Nemzetközi referencia árazás

2. Az EURIPID Együttműködés bemutatása

3. Az EU támogatáshoz kapcsolódó tevékenység bemutatása

4. Nyitott kérdések

5. EU Parlamenti riport

Tartalom

1. Nemzetközi referencia árazás

2. Az EURIPID Együttműködés bemutatása

3. Az EU támogatáshoz kapcsolódó tevékenység bemutatása

4. Nyitott kérdések

5. EU Parlamenti riport

1.1 Mi a nemzetközi referenciaárazás?

Használt rövidítések: IPR, ERP, EPR

Használt fogalmak: International price comparison, External reference pricing, External price referencing

The practice of using the price(s) of a medicine in one or several countries in order to derive a benchmark or reference price for the purposes of setting or negotiating the price of the product in a given country.

Forrás: WHO-PPRI glossary:

http://whocc.goeg.at/Glossary/PreferredTerms/External%20price%20referencing

Nemzetközi referencia árazás Európában

Sabine Vogler, CAPR meeting, 2017.03.15.

Nemzetközi referencia árazás a világban

Espi, Rovira, Labry: WHO/HAI Project on Medicines Prices and Availability, 2011:

http://haiweb.org/mwg-internal/de5fs23hu73ds/progress?id=xostTqdF9Rl2FHX9YUnItsFCUOAbW8CvBslY84atde4,

A nemzetközi referenciaárazás kritikája

Piaci sajátosságok figyelmen kívül hagyása Marginok, adók, szabadalmi jogok, indikációk, fogyás stb.

Részben nehezen értelmezhetőek, részben figyelembe vannak véve

Kockázatok Késedelmes bevezetés, korlátozott hozzáférés

Nincsenek elfogadható bizonyítékok

Más árazási modellek value based pricing, differential pricing

Az egyéb árazási modelleket is súlyos kritikával lehet illetni*

Módszertani problémák Kiszerelések, árfolyam, eljárások transzparenciája Egyszerű eljárás, nemzeti szinten kezelve

vannak a problémák

*http://www.msfaccess.org/sites/default/files/MSF_assets/Vaccines/Do

cs/VAC_report_TheRightShot2ndEd_ENG_2015.pdf

http://www.efpia.eu/uploads/Principles_for_application_of_international

_reference_pricing_systems_June_2014_Position_Paper.pdf

Tartalom

1. Nemzetközi referencia árazás

2. Az EURIPID Együttműködés bemutatása

3. Az EU támogatáshoz kapcsolódó tevékenység bemutatása

4. Nyitott kérdések

5. EU Parlamenti riport

1.1 What is the EURIPID undertaking?

A voluntary non-profit COLLABORATION of the European P&R authorities for the mutual sharing of price information of medicinal products

A TECHNICAL TOOL to make prices of pharmaceuticals more transparent in Europe

An attempt to create a comprehensive, continuously maintained, easy-to-use online DATABASE of prices of reimbursed pharmaceuticals

1.2 History

CEDD pilot project

OEP

EURIPID project

DG ENTR, OEP,

GÖG/ÖBIG

EURIPID Collaborati

on

national P&R

authorities

EURIPID Collaboration & DG SANTÉ

grant

national P&R authorities

Cooperation with

EUROSTAT

2008-2010 2010-2013

2014-2015

2015 2017

1.3 The EURIPID Collaboration

• Framework Partnership Agreement

• General Terms and Conditions

• Terms and Conditions of Use of the Website Legal issues

• Founders, Partners, Associated Partners, European Commission

• Board of Participants (BoP) (one delegate per country + EC)

• Executive Committee (3 delegates of the BoP + NEAK + GÖG/ÖBIG + EC repr.)

• project team (NEAK & GÖG/ÖBIG)

Organisation

• non-profit

• annual contribution fee equally shared

• the budget depends on the number of participants Finances

1.4 Operational model

Information provision by the national authorities

• Only publicly available information

Data standardisation by the project team

• In line with the data standardisation manual

easy to use web platform

• Standard structure

• Relevant clustering of products

1.5 Status of recruitment

Participating countries in 2017:

Austria Italy Belgium Latvia Bulgaria Lithuania Croatia Netherlands Czech Republic Norway Cyprus Poland Denmark Portugal Estonia Slovakia Finland Slovenia France Spain Greece Sweden Hungary Switzerland Ireland United Kingdom Israel

Potential participants for the future: Russian

Federation, FYRM Not participants but data available: Iceland, Romania Former participant: Albania

T W S

O

8 years of experience

Successful operational model

Most EU Member States are participants

Limited in scope (non-reimbursed products, hospital products are not in the focus)

Only official prices

Access is restricted

Bringing together the experts on pricing

Extension of the dataset

Cooperation with other databases/projects (e.g. EMVS)

Geographic extension of the collaboration

Confidential pricing

Managed Entry Agreements

2. SWOT analysis of the EURIPID Collaboration

Tartalom

1. Nemzetközi referencia árazás

2. Az EURIPID Együttműködés bemutatása

3. Az EU támogatáshoz kapcsolódó tevékenység bemutatása

4. Nyitott kérdések

5. EU Parlamenti riport

3.1 DG SANTE call proposal - objectives

SO.1

Determining an optimised dataset and

data lay-out (in collaboration with the stakeholders)

SO.2

Providing the necessary (additional) information

SO.3

Developing a Guidance Document on external

reference pricing (in collaboration with the stakeholders)

Dissemination of information to the public

http://ec.europa.eu/chafea/news/news492.html

Formal collaboration with the stakeholders

EC is member in the Board of Participants and in the Executive Committee

3.3 Novelties under the grant for the EURIPID Collaboration

Optimised dataset and –layout in the EURIPID website and database

Continuous information provision for the national authorities in a sustainable way

Guidance Document

3.4 Expected outcomes

3.5 Grant activities

Tartalom

1. Nemzetközi referencia árazás

2. Az EURIPID Együttműködés bemutatása

3. Az EU támogatáshoz kapcsolódó tevékenység bemutatása

4. Nyitott kérdések

5. EU Parlamenti riport

• Qualitative information on managed entry agreements, patient access schemes, risk sharing agreements

MEA

• Information on volumes/availability

• Potential cooperation with EMVO/NMVOs Volumes

• Hospital only products

• Non-reimbursed but controlled priced products

Product scope

• Who can get access to the website? Access

4.1 Open questions

Preventing free riding

Data ownership issues

Concerns about parallel trade

Concerns about the misinterpretation of prices (sales volumes, pricing structures matters, real prices vs. list

prices)

Incalculable effect on pricing and access to medicines on a global level

The stakeholders have not yet expressed their explicit interest for accessing the EURIPID website

6. Reasons of access restrictions

The Board of

Participants

has the right

to decide

about the

access policy

Tartalom

1. Nemzetközi referencia árazás

2. Az EURIPID Együttműködés bemutatása

3. Az EU támogatáshoz kapcsolódó tevékenység bemutatása

4. Nyitott kérdések

5. EU Parlamenti riport

36. Notes that the EURIPID project needs more transparency from Members States to include the real prices paid by them;

5.1 European Parliament INI Report

Report – EU options for improving access medicines – A8-0040/2017 – Committee on the Environment, Public Health and Food Safety

http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&reference=A8-2017-

0040&format=XML&language=EN

5.2 How real prices could be shared?

Uncoordinated ERP between MS Voluntary agreement with industry on the principles of fair pricing

Wish of full transparency Limited transparency (full transparency for those who agree on the principles)

Focus on prices Prices + contractual conditions

Focus on new MEAs Is fair pricing principles applied for the existing MEAs?

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