Joint Clinical Assessment (JCA) Fundaments

European Joint Clinical Assessment is a legal requirement for innovator life sciences companies to make a clinical submission to the European Commission.

These JCA submissions, inclusive of clinical and comparative effectiveness data, will then be reviewed by individual HTA member states in addition to their traditional, standard processes.

FIECON are your trusted partner in the journey to commercialise and launch your pharmaceutical products. Our strategic advice and innovative solutions turn scientific data into compelling evidence that influences stakeholders and drives favourable decisions.

Our JCA Solutions

JCA Timeline

Development Phrase

Implementing act agreed. and advanced therapy medicinal products (ATMP).

Oncology products, ATMPs and medicinal devices

Application for medicinal oncology products and advanced therapy medicinal products (ATMP). Section 1, Article 7.2(a)

Medical devices and in vitro diagnostic medical devices can be selected for joint clinical assessment based on criteria.

1st extension: orphan designation products

Application for medicinal products which are designated as orphan medicinal products. Section 1, Article 7.2(b)

2nd extension: all central authorised medicinal products

Application of Regulation for all other medicinal products. Section 1, Article 7.2(c)

Development Phase
‍

Implementing act agreed.

‍

Oncology products, ATMPs and medicinal devices

Application for medicinal oncology products and advanced therapy medicinal products (ATMP). Section 1, Article 7.2(a)

Medical devices and in vitro diagnostic medical devices can be selected for joint clinical assessment based on criteria.

1st extension: orphan designation products

Application for medicinal products which are designated as orphan medicinal products. Section 1, Article 7.2(b)

2nd extension: all central authorised medicinal products

Application of Regulation for all other medicinal products. Section 1,
Article 7.2(c)

JCA Process

Responsibility:

EU JCA members

Innovator

Local HTA

Mapping the Journey to JCA

We can learn a lot about how heavily JCA submissions will impact local HTA member states in their evaluation processes by looking at the enthusiasm with which they have endorsed the seminal policies leading to JCA. In December 2018, the Health Ministers of Germany, France, Spain, Poland, the Czech Republic and Bulgaria submitted written objections to the European Commission and European Council regarding the Commission’s proposal for joint HTA, opposing:

Mandatory use of joint HTA and prohibition of national assessments.
Simple majority voting on decisions.
Prominent role of the European Commission in decision making.

According to Josef Hecken, the Chairman of the G-BA, Member States fell into three groups with regard to their stance on mandatory use of joint HTAs:

Countries opposed to mandatory joint HTA

Countries in favour of mandatory joint HTA

Countries which stayed neutral

Focus of the EU Regulation

Note: the EUnetHTA model for future HTA cooperation also considers post-launch evidence generation

Joint Clinical
Assessment (JCA)

JCA of new medicines and certain high-risk medical devices result in a JCA report that shall be accompanied by a summary report

Joint Scientific Consultation (JSC)

Engage in JSC to advise technology developers on clinical study designs that generate appropriate evidence

Identification of emerging health technologies

“Horizon scanning” exercises will identify at an early stage promising health technologies to help health systems prepare for them

Voluntary cooperation on HTA

Member States may also engage in further voluntary cooperation, e.g. on health technologies other than medicines and medical devices, or on economic
aspects of HTA

Keeping up to date

Meet ISPOR Poster Author : Laurence Tilley

Laurence Tilley - Senior Associate, HEOR and Access shares insights to his co-authored research poster "Cost-Effectiveness of Icosapent Ethyl in Patients with Recent Acute Coronary Syndrome in Catalonia," featured at ISPOR Europe 2024.

JCA update: FIECON experts keeping you in the loop about JCA.

Stay informed with our analysis of the latest JCA updates and their impact on healthcare policy.

JCA updates: Balancing Act for Spanish HTA

How does the new Spanish HTA process reflect their attitude toward JCA regulation?

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Everything you always wanted to know about Joint Clinical Assessment (JCA)

but were afraid to ask..

European Joint Clinical Assessment is a legal requirement for innovator life sciences companies to make a clinical submission to the European Commission.

JCA Timeline

Development Phrase

Oncology products, ATMPs and medicinal devices

1st extension: orphan designation products

2nd extension: all central authorised medicinal products

Development Phase
‍

Oncology products, ATMPs and medicinal devices

1st extension: orphan designation products

2nd extension: all central authorised medicinal products

JCA Process

Mapping the Journey to JCA

Focus of the EU Regulation

Joint Clinical
Assessment (JCA)

Joint Scientific Consultation (JSC)

Identification of emerging health technologies

Voluntary cooperation on HTA

Keeping up to date

Meet ISPOR Poster Author : Laurence Tilley

JCA update: FIECON experts keeping you in the loop about JCA.

JCA updates: Balancing Act for Spanish HTA

Get in touch

Your contact details

Thank you!

Oops!

Everything you always wanted to know about Joint Clinical Assessment (JCA)

but were afraid to ask..

European Joint Clinical Assessment is a legal requirement for innovator life sciences companies to make a clinical submission to the European Commission.

JCA Timeline

Development Phrase

Oncology products, ATMPs and medicinal devices

1st extension: orphan designation products

2nd extension: all central authorised medicinal products

Development Phase‍

Oncology products, ATMPs and medicinal devices

1st extension: orphan designation products

2nd extension: all central authorised medicinal products

JCA Process

Mapping the Journey to JCA

Focus of the EU Regulation

Joint Clinical Assessment (JCA)

Joint Scientific Consultation (JSC)

Identification of emerging health technologies

Voluntary cooperation on HTA

Keeping up to date

Meet ISPOR Poster Author : Laurence Tilley

JCA update: FIECON experts keeping you in the loop about JCA.

JCA updates: Balancing Act for Spanish HTA

Get in touch

Your contact details

Thank you!

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Development Phase
‍

Joint Clinical
Assessment (JCA)