The first published joint clinical assessment (JCA) hands the innovative pharmaceutical industry a working template for a process that will reshape the access landscape.
Conducted under the EU’s Health Technology Assessment Regulation (HTAR), the debut assessment is a technical relative-effectiveness and safety evaluation of Ipsen’s (France) orphan-designated b-RAF serine-threonine kinase (BRAF) inhibitor Ojemda (tovorafenib) for paediatric low-grade glioma (pLGG) harbouring a BRAF fusion or rearrangement, or a BRAF V600 mutation. Ojemda is set for only a modest EU launch and sales, yet as the JCA trailblazer, it offers a highly prized guide to methodology, to the documentary exchanges between HTA assessors and the marketing authorisation holder (MAH), and to the timelines that govern each stage of the process.
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| Timeline for JCA process |
| 399 days after the JCA for Ojemda was initiated, the EU member state HTA Coordination Group (HTACG) announced that the relative effectiveness and safety evaluation had been completed and was undergoing a final procedural review before being communicated to national authorities and published. |
| HTACG approved the JCA report 10 days after EU marketing authorisation. |
| But it was 49 days after Ojemda received conditional EU marketing authorisation that the European Commission published the assessment report for the relative effectiveness and safety of the orphan-designated drug. |
Technical milestone, but practical benefits for Ipsen are difficult to discern
The goal of the JCA collaboration is to reduce HTA duplication by creating a harmonised clinical evidence picture that all 27 EU member states can accept for use in separate national assessment processes. The JCA process does not have any influence over pricing and Ipsen must still navigate reimbursement access on a country-by-country basis. An analysis of GlobalData’s Drug Pricing (POLI) & HTA database shows no HTA outcome for Ojemda in the wake of the JCA review. Information sourced from POLI reveals that as of July 2026, only German authorities have started an HTA, and only Germany has awarded reimbursement status, which it does automatically for orphan designated drugs. The Netherlands moved in the opposite direction by publishing a preliminary assessment recommending, including Ojemda in a cost-containment mechanism pending pricing and reimbursement negotiations. The open question therefore is how JCAs will influence pricing and reimbursement decisions. A plausible scenario is that small and medium-sized EU member states, with less developed HTA capabilities, may eventually see some acceleration in pricing and reimbursement decision-making, if only because authorities will have a ready-made clinical dossier to rely on. However, for countries with more advanced HTA systems, the payoff from JCAs will probably be smaller.
Incomplete JCA evidence could emerge as a barrier to market access
Perhaps the most instructive aspect of the inaugural report is what the assessors could not answer. Each JCA is built around PICOs, defined sets of Patient, Intervention, Comparator, and Outcome parameters. The Ojemda assessment specified eight PICOs across three populations; six of the eight contained no comparator data, so most of the outcomes the assessment scope had requested went unaddressed. Where comparator data was submitted, confidence was often fragile. For PICO 5, which pitted Ojemda against the dabrafenib–trametinib combination, assessors leaned on an indirect comparison and warned that the results were “associated with a number of major uncertainties” and that the effect estimates “should not necessarily be interpreted as causal”. For PICO 7, comparator data was submitted but excluded, because there was “insufficient information available for the assessment of the study on the comparator”.
A parallel case also underlines the stakes for developers. In June 2026, a JCA for the Netherlands Cancer Institute’s (NKI) Tacquell, an ATMP for melanoma, was discontinued after the developer failed to answer an information request. Assessors cited deficiencies in evidence retrieval, methodological reporting, and supporting documentation across 13 PICOs. Ojemda and Tacquell set important precedents. The first shows how incomplete comparator evidence potentially invites doubts, where it is missing or uncertain, while the second case shows how the JCA process can be terminated by failures to adequately address PICO questions from member states. The risk is that these gaps could push national HTA and pricing and reimbursement negotiations toward tighter usage restrictions, discounts, or delayed market entry.
Outlook
A total of 16 anti-cancer medicines and ATMPs are in the JCA review pipeline, with Iovance Biotherapeutics’ melanoma cell therapy Amtagvi (lifileucel) and Amgen’s bispecific T-cell engager Imdylltra (tarlatamab) for extensive-stage small cell lung cancer among those likely to be evaluated. For technology developers, the early lesson is that centre of gravity in the JCA process is comparator selection, indirect-comparison methodology, and dossier completeness. Although it is just a single data point, the Ojemda case study suggests that JCAs will become a key determinant for market access, with a positive or negative outcome potentially even signposting whether a pricing and reimbursement (P&R) decision is won or lost before a P&R application is started.
