HTA Consulting for EU market access, pricing and reimbursement
HTA consulting is becoming a critical part of market access strategy for pharmaceutical, biotech and MedTech companies operating in Europe. Under the new EU Health Technology Assessment Regulation (HTAR), Regulation (EU) 2021/2282, innovative therapies are now subject to a centralised Joint Clinical Assessment (JCA) process involving all EU Member States. This new framework significantly changes how companies prepare clinical evidence, demonstrate comparative effectiveness and plan reimbursement and pricing activities across European markets.
For companies, this creates a significantly more demanding HTA environment. Preparing a JCA dossier requires advanced statistical analyses, indirect treatment comparisons, evidence synthesis and detailed comparisons against existing standards of care, all within strict regulatory timelines. At the same time, organisations must align clinical, regulatory and market access strategies much earlier in development than before.
Billev Pharma East provides strategic and operational HTA consultancy support throughout both the EU and national HTA process. We help clients prepare JCA documentation and clinical evidence packages for EU-level assessments, while also supporting national HTA procedures related to pricing, reimbursement and market access. This includes pharmacoeconomic analyses, budget impact models, reimbursement strategy and adaptation of global evidence to local market requirements.