The Member State Coordination Group on Health Technology Assessment (HTACG) has discontinued the Joint Clinical Assessment (JCA) of sintilimab for non-small cell lung cancer after its revised dossier still failed the requirements of the EU HTA Regulation.
The statutory process gives developers an opportunity to remedy an inadequate submission. Where the Commission's initial completeness check identifies missing information, it issues a second request. Developers normally have 15 days to respond, reduced to ten days for accelerated assessments and seven days where only minor information is missing. Discontinuation follows if the resulting dossier still does not meet Article 9 requirements.
For sintilimab, the deficiencies went beyond omitted documents. All assessment PICOs relied on indirect comparisons, but insufficient information was provided on study characteristics, interventions, outcomes, follow-up and other factors needed to assess whether the contributing studies were sufficiently comparable. The dossier also contained gaps in outcome reporting and evidence retrieval, including searches of ClinicalTrials.gov and national HTA sources.
Some missing information was already available in the ORIENT-11 clinical study report or publications of comparator studies. The case therefore distinguishes evidence availability from dossier completeness: relevant evidence must be identified, mapped to the assessment scope and presented in a form that allows the assessor and co-assessor to verify the methods and comparative estimates.
Sintilimab is the third JCA discontinued because of Article 9 dossier deficiencies. The recurrence makes the second request a substantive compliance gate rather than a routine supplementation stage. Discontinuation also removes the normal restriction preventing national HTA bodies from requesting evidence already submitted at EU level, potentially restoring duplicated evidence requirements across Member States.
Source: European Commission, Directorate-General for Health and Food Safety
Link: Flash report – Member State Coordination Group on HTA meeting of 16 September 2026
Date: 18 September 2026
Source: European Commission
Link: Updated – List of joint clinical assessments
Date: 21 September 2026
Source: European Union
Link: Commission Implementing Regulation EU 2024/1381 laying down procedural rules for joint clinical assessments of medicinal products for human use
Date: 24 May 2024
