1

Regulamento sobre Avaliação das Tecnologias de Saúde e Grupo La Valetta

Heitor Costa, Director Executivo da APIFARMA

2

Cross-Country collaborations

▼▼

Iceland

Norway

Sweden

Finland

Estonia

Latvia

Lithuania

Poland

Hungary

Slovakia

Ireland

Portugal Spain

Italy

Malta

Netherlands

Belgium

Luxembourg

Austria

Czech

Republic

Romania

Greece

Slovenia

Croatia

Denmark

BeneluxA

Valetta Declaration

Baltic Partnership

Nordic Council

Visegrad+

FINOSE

Iberia partnership▼

Cyprus

Nordic Tendering pilot

led by AMGROS⚑

⚑

⚑

⚑

• Historical ties (except Valetta)

• Countries move…IE and LT belong to 2 CCC’s

• Not part of any CCC: FR, UK, DE and… BU, CH

• North vs South/East

4

Cross-Country collaborations

▼▼

Iceland

Norway

Sweden

Finland

Estonia

Latvia

Lithuania

Poland

Hungary

Slovakia

Ireland

Portugal Spain

Italy

Malta

Netherlands

Belgium

Luxembourg

Austria

Czech

Republic

Romania

Greece

Slovenia

Croatia

Denmark

BeneluxA

Valetta Declaration

Baltic Partnership

Nordic Council

Visegrad+

FINOSE

Iberia partnership▼

Cyprus

Nordic Tendering pilot

led by AMGROS⚑

⚑

⚑

⚑

Nordic collaborations

⚑ Nordic tendering pilot (Denmark,

Norway, Iceland) led by AMGROS• September 2018: call for 2 off-patent

products

• Innovative medicines as a second iteration

not excluded

• Combination of strong political will and

expertise

• Industry has been very active already

locally (engagement, legal analysis…)

● FINOSE (Finland, Norway, Sweden)

• Collaboration on HTA/REA

• High-level meeting on 27 March 2018

• Evaluation of the initiative planned late

2020

• Actively reaching out to companies

5

Cross-Country collaborations

▼▼

Iceland

Norway

Sweden

Finland

Estonia

Latvia

Lithuania

Poland

Hungary

Slovakia

Ireland

Portugal Spain

Italy

Malta

Netherlands

Belgium

Luxembourg

Austria

Czech

Republic

Romania

Greece

Slovenia

Croatia

Denmark

BeneluxA

Valetta Declaration

Baltic Partnership

Nordic Council

Visegrad+

FINOSE

Iberia partnership▼

Visegrad (V4+)• 2 March 2018 Bratislava meeting

• 2 competing companies invited,

originally to negotiate prices of their

products

• Hungarian cabinet still committed; no

high-level political impetus yet since last

political reshuffle in April 2018

• Legal framework reportedly competed

(June 2018)

• Next round of discussion 2nd half of

September

Cyprus

Nordic Tendering pilot

led by AMGROS⚑

⚑

⚑

⚑

6

Cross-Country collaborations

BeneluxA

Valetta Declaration

Baltic Partnership

Nordic Council

Visegrad+

FINOSE

Iberia partnership▼

BeneluxA-I• Ireland joined (22 June 2018)

• Horizon Scanning

• Call for tender announced (Sept.

2018)

• EFPIA-Pharma.be outreach (July

2018)

• First positive reimbursement decision

following joint price negotiation with

Belgium and Netherlands (11 July 2018)

• Other pilot joint-negotiations on-going

(expensive medicines)

• Reaching out to companies for joint

assessment

• www.beneluxa.org updated

Nordic Tendering pilot

led by AMGROS⚑

▼▼

Iceland

Norway

Sweden

Finland

Estonia

Latvia

Lithuania

Poland

Hungary

Slovakia

Ireland

Portugal Spain

Italy

Malta

Netherlands

Belgium

Luxembourg

Austria

Czech

Republic

Romania

Greece

Slovenia

Croatia

Denmark

Cyprus

⚑

⚑

⚑

7

First pricing & reimbursement negotiation concluded

Common reimbursement conditions in Netherlands and Belgium

announced on 12 July 2018

Joint HTA assessment

Joint pricing negotiation

Agreement concluded until end-2020

Manufacturer to collect Real World Evidence and carry out further

research

Question for other BeneluxA-I members, where the product is NOT

reimbursed?

Beneluxa-I

8

European SnapshotCross-Country collaborations

▼▼

Iceland

Norway

Sweden

Finland

Estonia

Latvia

Lithuania

Poland

Hungary

Slovakia

Ireland

Portugal Spain

Italy

Malta

Netherlands

Belgium

Luxembourg

Austria

Czech

Republic

Romania

Greece

Slovenia

Croatia

Denmark

BeneluxA

Valetta Declaration

Baltic Partnership

Nordic Council

Visegrad+

FINOSE

Iberia partnership▼

BeneluxA

• Ireland joined - 22 June 2018

• Horizon Scanning: Call for tender announced Sept. 2018

• Reaching out to companies for joint assessment

• First successful joint pricing negotiations BE-NL July

2018

• www.beneluxa.org updated

V4+

• No known development since 2 March 2018 Bratislava

meeting

• Hungarian cabinet still committed; no high-level political

impetus yet since last political reshuffle in April 2018

Nordic Tendering (Led by AMGROS) ⚑• Pilot for joint tendering (Denmark, Norway, Iceland) to

materialise in September 2018 – off-patent products

• Innovative medicines as a second iteration not excluded

Valetta Declaration

• 3-4 May 2018 meeting in Lisbon – Croatia now a

member

• 11 July 2018 meeting in Athens (November meeting in

Bucharest)

• 2 products reportedly under consideration

• Methodological issues under resolution

Baltic Partnership

• Currently limited to joint tendering of vaccines

Cyprus

Nordic Tendering pilot

led by AMGROS⚑

⚑

⚑

⚑

9

Cross-Country collaborations

▼▼

Iceland

Norway

Sweden

Finland

Estonia

Latvia

Lithuania

Poland

Hungary

Slovakia

Ireland

Portugal Spain

Italy

Malta

Netherlands

Belgium

Luxembourg

Austria

Czech

Republic

Romania

Greece

Slovenia

Croatia

Denmark

BeneluxA

Valetta Declaration

Baltic Partnership

Nordic Council

Visegrad+

FINOSE

Iberia partnership▼

Valetta Declaration• 3-4 May 2018 meeting in Lisbon

• Croatia now a member

• 11 July 2018 meeting in Athens

• November meeting in Bucharest

• 2 products reportedly under consideration

• Methodological issues under resolution –

(legal framework)

• Internal divergences among membership

Cyprus

Nordic Tendering pilot

led by AMGROS⚑

⚑

⚑

⚑

10

5th Meeting 10-11 July 2018, Athens

✱ Attendance

• Ministers from Portugal, Romania, Greece, Cyprus, Malta + a secretary of state from Italy

• Valetta Technical Committee met in parallel

✱ MoH Xanthos reportedly made a proposal intending to address most gaps

• International Convention

• Roadmap

✱ Bilateral cooperation between Cyprus and Greece considered (pricing)

✱ Non-alignment between members reported informally following the meeting

✱ Next meeting in Bucharest, Romania (November 2018)

Valetta Declaration

11

Greece MoH Xanthos’ proposed next steps

✱ “International convention” to set a regulatory framework to "armour" the procedure in legal terms as well as the result of the negotiation; proposed

• Clear process for horizon scanning and negotiations

• Clear rules for transposition of decisions at national level

• Impartiality and confidentiality

✱ Overcome companies' "unwillingness”, e.g. no parallel procedure

✱ Reinforce technical workstream (VTechnicalCommittee) ; better exchange of information (clinical trials, epidemiological data, target populations, comparable clinical evaluations etc.)

✱ Roadmap with ultimate target of common negotiation to overcome internal divergences and technical issues, e.g. maximum or minimum price, prices range or fixed price, ability or not to conduct negotiations at a national level after the conclusion of the procedure within the "Valletta").

Valetta Declaration

12

Greek MoH Xanthos’ quote

“ We are forced to break the limits. "Valletta" can and must constitute the successful "example" of voluntary co-operation that will affect the present negative correlations in Europe in a catalytic manner (mainly to the opposition of Germany and the other countries, to any idea of common policies for Health and Medicinal products). We have nothing to lose, we do not have the luxury of the "loner course" against "coalitions of interests" with a huge financial and political influence, we are obligated to maintain a climate of high – and not least –expectations for the citizens of our countries. “

VALETTA DEclaration

13

Declarations following 5th Meeting 10-11 July 2018, Athens

VALETTA Declaration

RomaniaMoH Sorina Pinteaand State Secretary Octavian Alexandrescu.

• Interest in access to innovative medicines, common mechanisms for HTA and common negotiations.

• Agreed on the need of having more relevant and tangible solutions, supported the Greek proposal

• Availablity is a key RO EU presidency topic (from January 2018)

Malta “It is in our interest to collaborate since we face common problems, we face the same needs and therefore we can find common solutions through collaborating with the pharma industry – gaining a lot. The Greek proposal is important since it allows for processes acceleration.”

14

External Industry Public Policy Principles (July 2018)

Key principles

✱ Depending on circumstances, there might be instances where cross-country initiatives could improve patient access to medicines and others where the optimal outcome may be reached through national procedure;

✱ Industry would support the option that is bringing the optimal result in terms of timely and effective access to innovative treatments.

Positioning based on 5 key principles on:

✱ Horizon Scanning

✱ Joint Clinical Assessment and HTA

✱ Information Sharing and Price negotiations

✱ Public Procurement

EFPIA/Industry 5 principles for collaboration (Dec. 2016)

1. Broader & accelerated patient access2. No extra process burden (replace equivalent steps in countries)3. For similar/close countries (economic/health/geographic) 4. Voluntary5. Guaranted confidentiality

15

European CommissionCompetition Commissioner Margrethe Vestager made a declaration supportive of joint negotiations at a WHO meeting on 20 August 2018.The EC organized with OECD support a ‘Workshop on Building Capacity for Pharmaceutical Negotiations in the EU’ on 19 October 2018.

BeneluxA-IThe International Horizon Scanning Initiative (IHSI) is moving forward with 16 countries interested, and is to be granted legal personality under the form of a non-profit organisation by end-2018.IHSI will select a third party through tender by May 2019 to run the project.

ValettaThe group has kept reaching out to companies for joint HTA assessment and joint pricing negotiations.Valetta members will meet on 26-27 November 2018 in Bucharest.

AMGROS-led tendering pilotThe first joint tender between Denmark, Norway and Iceland was announced on 11 September 2018, for 11 off-patent products. Declarations from policy leadersconfirm that the vision is to ultimately jointly tender patented products.

FINOSEA pharmaceutical company signed a letter of intent to file a product in the FINOSE framework.

Visegrad+4 countries are reportedly running a joint negotiation for an oncology product covering a ‘fairly large population’, according to Polish Deputy MoH Marcin Czech.

International Framework Agreement (Romania-Bulgaria)On 23 October 2018 the Romanian MoH declared its intention to implement the 2-year old agreement signed with Bulgaria in 2016 and that had not beenratified. The agreement requires both adoption by the 2 parliaments and a change of the legislation to become effective.

Overall Assessment Summary

16

Overall Assessment Summary

• Broaden overall access to therapies for patients

• Commercial opportunity by increasing market size

and volume

• Harmonisation and streamlining of REA, HTA,

pricing negotiations, purchasing and contracting

processes – particularly beneficial for smaller

companies

• Workload sharing among authorities of participating

Member States

• Support for better budgetary forecasts through

horizon scanning

• Opportunity to broaden collaboration beyond price

(e.g focusing on joint patient registries, early

diagnosis)

• Unclear process:

- Lack of governance and methodology to initiate,

conduct and conclude pilot projects

- No obligation for participating Member States to

adopt the outcomes of joint reports

• Unclear legal basis and framework in particular

interactions with current EU (e.g. Transparency

directive, public procurement legislation) and national

legislations

• Duplication and /or no consideration for existing pan-

European initiatives (e.g. EUnetHTA, REA)

• Limited of (successful) real-life experience (two pilots in

BeNeLuxA, one expected pilot in Nordic Council

• Lack of clear impact of horizon scanning activities on

budget forecasts

• Risks of distortion in supply, trade and competition if no

appropriate conditions for purchasing and contracting

(e.g. sound tender criteria)

Potential Opportunities Potential Challenges

174

Fullyvoluntary(ieduplica on)DE/FRnon-paper

Fullintegra on&replacementECProposal

Noduplica onBUTNa onalcomplementsatMSdiscre on

LikelydiscussioninCouncil

Noduplica onBUTNa onalcomplementswithlegally

enforceablesafeguardsEPtextwithlegalcheck

UK

DE

FR

DK

PL

SE

AT

IT

ES

BE

NL

CZ

HUBU

FI

RO

HR

SK

MT

CY

PT

IE

EL

LUX

EE

LT

SI

LV

MSposi onsbasedonlatestintelligence(23.10.18)InfluenceinCouncil

Disclaimer:Thisisasubjec veinterpreta onofvariousintel