The EU HTA Regulation (EU) 2021/2282 was designed to transform clinical assessment in Europe through Joint Clinical Assessments (JCAs).

But just over a year into implementation, and just a few weeks after the first report was published, the news has been shared that two JCAs have been discontinued:

• Catequentinib (JCA-MP-2024-03)
• Tacquell (JCA-MP-2025-02)

What Does “Discontinued” Mean?

Discontinued appears to mean:

• No JCA report was finalised
• No EU-level clinical conclusions were issued
• The process stopped at the validation/completeness stage

The root cause:

The submitted dossiers did not meet Article 9 requirements for completeness, transparency, and methodological robustness.

What Went Wrong? Evidence Directly From the Dossiers

A review of the Commission’s “missing information” notices for both products shows consistent, repeat issues:

1. Incomplete evidence base
2. Insufficient methodological transparency
3. Inadequate results reporting
4. Lack of underlying documentation

Missing Information No. 1: Incomplete Evidence Base

Catequentinib

• Lack of transparent and comprehensive identification of all available evidence
• Missing systematic searches across registries, HTA reports, and international sources
• No clear justification for excluding studies

Tacquell

• Missing information retrieval processes for multiple PICOs
• No documented search strategies, including registry and third-party study searches

Assessors could not verify whether the full evidence base had been captured.

Missing Information No. 2: Insufficient Methodological Transparency

Catequentinib

• No clear description of methods used to answer research questions
• Missing justification for:
  • not conducting indirect comparisons
  • excluding studies from feasibility assessments

Tacquell

• Lack of comprehensive method descriptions aligned with evidence-based medicine standards
• No justification for absence of sensitivity analyses

Assessors could not determine whether the analytical approach was valid.

Missing information No. 3: Inadequate Results Reporting

Catequentinib – missing or incomplete:

• relative effectiveness and safety results
• PICO-aligned outputs

Tacquell – missing:

• relative effect measures
• structured reporting aligned with JCA template
• key outputs such as Kaplan–Meier curves and sensitivity results

Even where data existed, it was not interpretable within the JCA framework.

Missing Information No. 4: Lack of Underlying Documentation

Catequentinib

• Missing full documentation of study selection and underlying analyses

Tacquell – missing:

• clinical study reports (CSRs)
• protocols
• statistical analysis plans
• programming code

Assessors were unable to verify, validate, or reproduce findings.

The Critical Threshold: Why They Failed

Under the HTA Regulation, a JCA dossier must be:

✔ Complete

✔ Methodologically sound

✔ Transparent

✔ Reproducible

In both cases, assessors could not:

• confirm completeness of evidence
• assess methodological validity
• reproduce analyses

And that alone was enough to stop the assessment. No clinical judgement was required.

What Happens Next?

Discontinuation is not necessarily permanent:

• JCA re-initiation is possible once deficiencies are addressed (see Flash report from the European commission on https://health.ec.europa.eu/document/download/2d86ae6f-6ac1-4c1b-9f40-9643ff644e7c_en?filename=hta_20260622_htacg_flash_en.pdf)
• However, timelines are delayed
• Operational complexity increases significantly

Implications for National HTA Processes

The consequences extend well beyond the EU level. The purpose of JCA is to provide a single clinical assessment for all Member States. But when a JCA is discontinued, there is no EU-level clinical report.

So countries may:

• Conduct their own clinical assessments
• Request full local submissions
• Potentially reach different conclusions

In practice, this means a reversion to the pre-EU HTA world.

Potential Implications for Industry

These cases redefine where the risks lie in EU HTA.

1) Dossier completeness is launch-critical

Failure is no longer just about weak clinical evidence. It can result from:

• incomplete searches
• missing appendices
• poor documentation

2) EU delays cascade into national access delays

• No JCA → no shared clinical foundation
• National HTAs must rebuild analyses
• Slower pricing and reimbursement decisions

3) Fragmentation returns

Without a JCA:

• Countries assess evidence independently
• Divergent interpretations increase
• The harmonisation objective is undermined

4) Operational burden increases

Companies must:

• Fix and resubmit EU dossiers
• Manage parallel multi-country HTA submissions

Big Picture: A New Reality for EU HTA

These first discontinuations show clearly that every PICO question needs to be addressed.

Success now depends on:

• Strong clinical evidence
• Addressing all PICO questions, when no evidence is available, this needs to proven by an SLR or feasibility assessment

The discontinuation of catequentinib and tacquell may be early examples but they set a clear precedent: If your dossier is not complete, transparent, and reproducible, the assessment may not happen at all.

For EU market access teams, the message is simple: JCA readiness is not just evidence strategy, it is operational excellence.