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

but were afraid to ask..

Introduction
JCA Timeline
Journey to JCA
EU Regulation
JCA Latest Updates
Our JCA solution
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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

Why Saudi Arabia is the next key market for your Pharma Expansion
In this informative conversation, Lavni Varyani from Pharma BP discusses the evolving HTA process in Saudi Arabia. As a GCC market expert, Lavni explains how pharmaceutical companies can strategically engage with the market to navigate the upcoming HTA changes from both local and global perspectives.
Read more
What does the JCA rollout mean for pharma companies?
In this insightful discussion, Timm Volmer, SmartStep shares his insights on the JCA rollout, Germany's influence in shaping JCA methodology, and how pharmaceutical companies can effectively prepare for the upcoming JCA changes from both local and global perspectives.‍
Read more
Meet ISPOR Poster Author : Dhanveer Sandhu
FIECON Associate, Dhanveer Singh Sandhu, shared insights for his co-authored research poster presented at ISPOR Europe 2024, titled "Precedents in decision-making for Highly Specialized Technologies appraised by NICE: key takeaways and recommendations".
Read more

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