EU HTA and national HTA
Insights
New analysis, deep dives and practical guidance on European evidence assessment and its connection with national HTA pathways.
The first German benefit assessment after a JCA reveals key differences for tovorafenib in PICO, MAIC, endpoints, data cuts and timing. What this means for the delta dossier.
How manufacturer discounts, price-volume arrangements and rebate contracts affect AMNOG, market access, net revenue and dossier strategy.
How the first JCAs are changing European evidence assessment and what that means for manufacturers, comparator strategy and the Delta Dossier.
Why the first discontinued JCAs show that dossier completeness, PICO coverage, methodological transparency and AMNOG readiness need to be prepared early and together.
Why Germany will need more than references from the JCA dossier — and where PICO, comparator choice, endpoints, evidence updates and timing become critical.
A peer-reviewed publication on how real-world evidence can support JSC, JCA and national HTA submissions, including Delta-Dossiers.
JCA Watch
Follow the medicinal products currently undergoing Joint Clinical Assessment under the EU HTA Regulation.
Metastatic pancreatic adenocarcinoma
EMA validation: Under EMA phased review
Treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post polycythemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis
EMA validation:
Treatment of adult patients with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma (CCA)
EMA validation:
Treatment of Mucopolysaccharidosis Type IIIA, MPS IIIA (Sanfilippo A Syndrome) in children from birth to 18 years old
EMA validation:
European and local expertise
Cytel combines European evidence strategy and JCA expertise with established local market access capabilities in Germany and France.
European clinical assessment creates a common starting point, while national HTA, reimbursement and pricing requirements remain country-specific. Cytel, co.value – A Cytel Brand and stève consultants connect these levels across the evidence and market access pathway.
Cytel supports evidence generation, PICO strategy, statistical methodology and JCA preparation across the European assessment process. The focus is on building evidence that addresses the European assessment scope while anticipating requirements that may become relevant in national HTA.
co.value – A Cytel Brand provides local expertise across the German AMNOG pathway, from early evidence and comparator strategy to benefit assessment and national dossier requirements. This includes translating JCA evidence into the specific requirements of the German benefit assessment.
stève consultants brings established French Market Access, HEOR and RWE expertise to the national pathway. The team has worked on more than 750 dossiers submitted to the Haute Autorité de Santé (HAS) and supports reimbursement strategy, local HTA submissions, early access and evidence generation for the French market.
Local capabilities
European evidence needs to connect with different national assessment, reimbursement and pricing requirements. Local capabilities therefore extend beyond the clinical assessment itself.
Local pricing and reimbursement strategy, HTA gap analysis, early access, reimbursement dossiers and support throughout national assessment procedures.
Cost-effectiveness dossiers, health economic modelling and adaptation of international economic models to national requirements.
Evidence generation using national data sources to address epidemiology, target populations, treatment pathways, effectiveness, safety and healthcare resource use.
Together, these capabilities allow European evidence planning and national HTA preparation to be considered as one connected evidence strategy rather than sequential European and local projects.
Connect European and national HTA
EU HTA creates a shared European framework for clinical assessment, but successful market access still requires country-specific preparation.
Cytel, co.value and stève consultants support manufacturers in identifying where European evidence can be used directly, where national requirements diverge and where additional evidence, analyses or local adaptation may be required.
