co.valueDelta-Dossier

JCA WATCH · EU HTA

Ongoing and completed Joint Clinical Assessments

This overview tracks ongoing Joint Clinical Assessments from the European Commission's current JCA pipeline and provides editorial analysis of completed and discontinued Joint Clinical Assessments. Ongoing assessments are updated from the published EC data. Completed assessments are reviewed based on their PICO scope, available evidence and evidence methods used.

LIVE EC DATA

Ongoing Joint Clinical Assessments by the European Commission

The European Commission currently lists 16 ongoing Joint Clinical Assessments in its published Ongoing JCA list. The table shows substance, indication, product type, orphan status, EMA validation, assessor and co-assessor. The data is imported automatically from the published EC file.

16 assessments

CamizestrantTreatment of adults with locally advanced or metastatic breast cancerChemicalsNoFederation of Social Insurances, AustriaNational Institute for Health and Disability, Belgium
SenaparibMaintenance treatment of advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancerChemicalsNoInstitute for Quality and Efficiency in Health Care, GermanySlovenian Quality Health Care Agency, Slovenia
RelacorilantTreatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancerChemicalsYesNational Authority of Medicines and Health Products, PortugalSwedish Agency for Health Technology Assessment and Assessment of Social Services, Sweden
EnsartinibThe treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).ChemicalsNoFederation of Social Insurances, AustriaSpanish Agency of Medicines and Medical Devices, Spain
Zopapogene imadenovecTreatment of respiratory papillomatosis in adultsATMPYesDanish Medicines Council, DenmarkAustrian Institute for Health Technology Assessment, Austria
SintilimabTreatment of non-squamous non-small cell lung cancer in adultsBiologicalsNoInstitute for Quality and Efficiency in Health Care, GermanyNational Institute for value and technology in health, Slovakia
SonrotoclaxTreatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)ChemicalsNoNational Institute for Health and Disability Insurance, BelgiumDental and Pharmaceutical Benefits Agency, Sweden
TaletrectinibTreatment of adults with ROS1 positive advanced non-small cell lung cancerChemicalsNoDental and Pharmaceutical Benefits Agency, SwedenInstitute for Quality and Efficiency in Health Care, Germany
Zamtocabtagene autoleucelTreatment of adults with large B-cell lymphomaATMPYesDutch National Health Care Institute, The NetherlandsNational Centre for Pharmacoeconomics, Ireland
CosibelimabFor the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinomaBiologicalsNoInstitute for Quality and Efficiency in Health Care, GermanyNational Authority for Health, France
Lunsotogene parvecTreatment of biallelic OTOF variant-associated hearing loss in adults and childrenATMPYesFederal Joint Committee, GermanyNorwegian Medical Products Agency, Norway
RezvilutamideTreatment of high-volume metastatic hormone-sensitive prostate cancer (mHSPC) in adultsChemicalsNoDutch National Health Care Institute, The NetherlandsNational Centre for Pharmacoeconomics, Ireland
MezigdomideTreatment of adult patients with relapsed or refractory multiple myeloma in adultsChemicalsNoInstitute for Quality and Efficiency in Health Care, GermanyAgency for Health Technology Assessment and Tariff System, Poland
Living bilayered bioengineered skin made of an epithelium of autologous keratinocytes and a dermal matrix of bovine collagen hydrogel containing fibroblastsTreatment of adults and children with partial deep dermal and full-thickness burns.ATMPYesNational Authority for Health, FranceNational Institute for Health and Disability, Belgium
Bifikafusp alfa / Onfekafusp alfaNeoadjuvant treatment of adult patients with melanomaBiologicalsNoDental and Pharmaceutical Benefits Agency, SwedenAgency for Health Technology Assessment and Tariff System, Poland
DaraxonrasibMetastatic pancreatic adenocarcinomaChemicalsYesUnder EMA phased reviewInstitute for Quality and Efficiency in Health Care, GermanyDanish Medicines Council, Denmark
EMA validation

Camizestrant

Treatment of adults with locally advanced or metastatic breast cancer

Chemicals Orphan: No

Assessor
Federation of Social Insurances, Austria
Co-assessor
National Institute for Health and Disability, Belgium
EMA validation

Senaparib

Maintenance treatment of advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer

Chemicals Orphan: No

Assessor
Institute for Quality and Efficiency in Health Care, Germany
Co-assessor
Slovenian Quality Health Care Agency, Slovenia
EMA validation

Relacorilant

Treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer

Chemicals Orphan: Yes

Assessor
National Authority of Medicines and Health Products, Portugal
Co-assessor
Swedish Agency for Health Technology Assessment and Assessment of Social Services, Sweden
EMA validation

Ensartinib

The treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

Chemicals Orphan: No

Assessor
Federation of Social Insurances, Austria
Co-assessor
Spanish Agency of Medicines and Medical Devices, Spain
EMA validation

Zopapogene imadenovec

Treatment of respiratory papillomatosis in adults

ATMP Orphan: Yes

Assessor
Danish Medicines Council, Denmark
Co-assessor
Austrian Institute for Health Technology Assessment, Austria
EMA validation

Sintilimab

Treatment of non-squamous non-small cell lung cancer in adults

Biologicals Orphan: No

Assessor
Institute for Quality and Efficiency in Health Care, Germany
Co-assessor
National Institute for value and technology in health, Slovakia
EMA validation

Sonrotoclax

Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)

Chemicals Orphan: No

Assessor
National Institute for Health and Disability Insurance, Belgium
Co-assessor
Dental and Pharmaceutical Benefits Agency, Sweden
EMA validation

Taletrectinib

Treatment of adults with ROS1 positive advanced non-small cell lung cancer

Chemicals Orphan: No

Assessor
Dental and Pharmaceutical Benefits Agency, Sweden
Co-assessor
Institute for Quality and Efficiency in Health Care, Germany
EMA validation

Zamtocabtagene autoleucel

Treatment of adults with large B-cell lymphoma

ATMP Orphan: Yes

Assessor
Dutch National Health Care Institute, The Netherlands
Co-assessor
National Centre for Pharmacoeconomics, Ireland
EMA validation

Cosibelimab

For the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma

Biologicals Orphan: No

Assessor
Institute for Quality and Efficiency in Health Care, Germany
Co-assessor
National Authority for Health, France
EMA validation

Lunsotogene parvec

Treatment of biallelic OTOF variant-associated hearing loss in adults and children

ATMP Orphan: Yes

Assessor
Federal Joint Committee, Germany
Co-assessor
Norwegian Medical Products Agency, Norway
EMA validation

Rezvilutamide

Treatment of high-volume metastatic hormone-sensitive prostate cancer (mHSPC) in adults

Chemicals Orphan: No

Assessor
Dutch National Health Care Institute, The Netherlands
Co-assessor
National Centre for Pharmacoeconomics, Ireland
EMA validation

Mezigdomide

Treatment of adult patients with relapsed or refractory multiple myeloma in adults

Chemicals Orphan: No

Assessor
Institute for Quality and Efficiency in Health Care, Germany
Co-assessor
Agency for Health Technology Assessment and Tariff System, Poland
EMA validation

Living bilayered bioengineered skin made of an epithelium of autologous keratinocytes and a dermal matrix of bovine collagen hydrogel containing fibroblasts

Treatment of adults and children with partial deep dermal and full-thickness burns.

ATMP Orphan: Yes

Assessor
National Authority for Health, France
Co-assessor
National Institute for Health and Disability, Belgium
EMA validation

Bifikafusp alfa / Onfekafusp alfa

Neoadjuvant treatment of adult patients with melanoma

Biologicals Orphan: No

Assessor
Dental and Pharmaceutical Benefits Agency, Sweden
Co-assessor
Agency for Health Technology Assessment and Tariff System, Poland
EMA validation

Daraxonrasib

Metastatic pancreatic adenocarcinoma

Chemicals Orphan: Yes

Assessor
Institute for Quality and Efficiency in Health Care, Germany
Co-assessor
Danish Medicines Council, Denmark

Data as of: 10 September 2026 · Source: European Commission

EDITORIAL JCA ANALYSIS

Completed Joint Clinical Assessments: PICO scope and evidence compared

Completed Joint Clinical Assessments differ in the number of PICOs, available comparative evidence and evidence methods used. Published assessments show different combinations of direct and indirect evidence.

JCA-MP-2024-06COMPLETED

Tovorafenib / Ojemda

Paediatric low-grade glioma

8 PICOs · Comparative evidence for 1 PICO

  • 3 patient populations
  • PICO 5 addressed using an unanchored MAIC
  • No suitable comparator data for 6 PICOs

Our analysis

Broad assessment scope, but very limited comparative evidence.

JCA-MP-2024-17COMPLETED

Tarlatamab / Imdylltra

Extensive-stage small cell lung cancer (ES-SCLC)

7 PICOs · Direct and indirect evidence

  • 4 patient populations
  • Direct RCT evidence for PICOs 1, 4 and 6
  • Further comparisons using MAIC, NMA and ITC

Our analysis

Broad evidence base with varying methodological robustness.

JCA-MP-2024-16COMPLETED

Lurbinectedin / Zepzelca

Maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC)

1 PICO · Direct RCT evidence

  • One population and one comparator
  • Direct comparison from IMforte
  • PFS benefit accompanied by higher toxicity

Our analysis

A methodologically focused JCA with a differentiated benefit-risk profile.

COMPLETED

Onasemnogene abeparvovec / Itvisma

5q spinal muscular atrophy

14 PICOs · Selective evidence coverage

  • Multiple populations and comparators
  • Comparative evidence for PICOs 1–3 and 8–11
  • Evidence gaps and limited population overlap

Our analysis

A broad PICO scope does not automatically mean broad evidence coverage.

EDITORIAL JCA ANALYSIS

Discontinued Joint Clinical Assessments and reasons for discontinuation

Editorially selected cases with our analysis of why the assessment was discontinued.

JCA-MP-2024-03DISCONTINUED

Catequentinib

Synovial sarcoma and leiomyosarcoma

Discontinued · Incomplete JCA dossier

  • Incomplete identification of available evidence
  • Insufficient documentation of PICO coverage and methods
  • Gaps in relative effectiveness and safety evidence

Our analysis

JCA completeness encompasses evidence, methods and traceable documentation.

JCA-MP-2025-02DISCONTINUED

Tacquell

Melanoma

Discontinued · Incomplete JCA dossier

  • Missing evidence retrieval for several PICOs
  • Incomplete reporting of indirect comparisons
  • Missing sensitivity analyses, RoB documentation and programming code

Our analysis

The case illustrates the JCA requirements for transparency and reproducibility.

DISCONTINUED

Sasanlimab / Zumrad

High-risk non-muscle invasive bladder cancer

Discontinued · EMA application withdrawn

  • Marketing authorisation application withdrawn on 13 February 2026
  • EMA had substantial methodological and clinical concerns
  • Discontinuation was not driven by an incomplete JCA dossier

Our analysis

The JCA ended following withdrawal of the parallel EMA marketing authorisation application.

Frequently asked questions about Joint Clinical Assessments

When does the JCA process begin?

The JCA process runs in parallel with the EMA centralised marketing authorisation procedure. The EMA notifies the HTA Secretariat when a marketing authorisation application has been received. The JCA formally begins when the JCA Subgroup appoints an assessor and co-assessor. Preparatory work starts even earlier: health technology developers may share information from their letter of intent with the HTA Secretariat to support the identification of the assessor, co-assessor and relevant external experts.

How long does the JCA process take?

There is no single fixed duration for a JCA because the JCA process is linked to the parallel EMA marketing authorisation process. The JCA Subgroup finalises the JCA report no later than the date on which marketing authorisation is granted. The HTA Coordination Group must endorse the report no later than 30 days after marketing authorisation is granted. The HTA Regulation does not specify a fixed number of days for publication after endorsement. The European Commission aims to publish the report as soon as possible following completion of its procedural review.

What are the main milestones in the JCA process?

The JCA process comprises five main phases: initiation, PICO scoping, submission of the JCA dossier, preparation of the JCA report, and finalisation and publication. Following receipt of the EMA marketing authorisation application, an assessor and co-assessor are appointed. The assessment scope and relevant PICO questions are then finalised. The health technology developer generally submits the JCA dossier within 100 days of the request; this period is reduced to 60 days in certain accelerated procedures and for variations. The assessor and co-assessor subsequently prepare the draft JCA report. The HTA Coordination Group endorses the finalised report no later than 30 days after marketing authorisation is granted.

Which Joint Clinical Assessments are currently ongoing?

The European Commission currently lists 16 ongoing Joint Clinical Assessments in its published Ongoing JCA list. JCA Watch automatically incorporates the current assessments and shows the substance, indication, product type, orphan status, EMA validation, assessor and co-assessor. The complete current list is shown above.

Which medicinal products are subject to JCA?

Since 12 January 2025, Joint Clinical Assessments have applied initially to new oncology medicinal products and advanced therapy medicinal products (ATMPs). From 13 January 2028, the scope expands to orphan medicinal products. From 13 January 2030, all new medicinal products falling within the relevant scope of the centralised marketing authorisation procedure will be covered. New therapeutic indications for medicinal products for which a JCA report has already been published may also be subject to JCA.

What is published after a JCA is completed?

Following completion of a JCA, the European Commission publishes the JCA report and a summary report on its publicly accessible website. As a general rule, the most recent version of the underlying JCA dossier and certain external comments received during the assessment process are also published. Where a JCA is discontinued, the Commission's public webpage must also contain a statement explaining the reasons for discontinuation.

Which sources does JCA Watch use?

Sources: European Commission, Joint Clinical Assessment for Medicinal Products (January 2025); FAQ on the publication of JCA reports (14 May 2026).