Area of expertise
Market Access, RWE & Reimbursement
Approval is not commercial success. Reimbursement and price are decided in separate procedures with their own evidence logic, from German AMNOG benefit assessment through HTA dossiers to the EU-wide Joint Clinical Assessment (JCA). We combine value strategy, real-world evidence and pricing into robust market access, aligned with the appropriate comparator and payer requirements.
- Biotech
- IVD
- MedTech
- Pharma
All topics
13 topics in Market Access, RWE & Reimbursement
HEOR & Modeling →
Health economic modeling for pharma, biotech, medtech and IVD: cost-effectiveness (CEA), cost-utility (CUA) and budget impact models, including deterministic and probabilistic sensitivity analyses. Built to the reference cases of NICE, IQWiG and ICER and aligned with the Joint Clinical Assessment under the EU HTA Regulation (EU) 2021/2282: transparent and audit-ready instead of a black box.
HTA Dossier →
Preparation of complete HTA dossiers for the early benefit assessment under AMNOG (G-BA / IQWiG) and for assessment procedures at NICE and HAS. For medical devices, we support the preparation of information documents under § 137h SGB V. Our services range from evidence and comparator strategy through endpoint assessment and mock reviews to support in the applicable commenting and hearing procedures. For pharma, biotech, MedTech and IVD.
Joint Clinical Assessment →
Advisory on the Joint Clinical Assessment (JCA) under the EU HTA Regulation (EU) 2021/2282 and Implementing Regulation (EU) 2024/1381: scope and cut-off dates, preparation for an assessment scope defined by population, intervention, comparator and outcomes, the dossier under Annex I, Joint Scientific Consultation during study planning, and the link to the national benefit assessment under § 35a SGB V.
Market Access Consulting →
Market access consulting for pharma, biotech, medtech and IVD: orientation across the three procedures that decide market access (marketing authorisation, joint clinical assessment under EU 2021/2282, national reimbursement under sections 35a and 130b SGB V), a map of the service areas responsible for each, from the evidence roadmap to the reimbursement price negotiation, and access to the in-depth articles on JCA, reimbursement price and real-world evidence.
Market Access Strategy →
Market access strategy for pharma, biotech, MedTech and IVD: early planning of reimbursement requirements, definition of defensible price corridors, stakeholder positioning toward G-BA, IQWiG and payers, plus alignment with the AMNOG benefit assessment under § 35a SGB V and the EU-wide Joint Clinical Assessment under EU 2021/2282, beginning in early clinical development rather than at market launch.
Medical Science Liaison →
MSL services for pharma and biotech: interim MSL teams, KOL mapping and engagement, advisory board management, plus scientific communication and support for investigator-initiated trials as a non-promotional Medical Affairs function, cleanly separated from commercial activities.
MedTech & IVD Reimbursement →
Reimbursement advisory for medical devices and in vitro diagnostics in German statutory health insurance: choice of route, NUB request under § 6(2) KHEntgG, information submission and assessment under § 137h SGB V as amended by the GKV Contribution Rate Stabilization Act, trial application under § 137e(7) SGB V, outpatient method assessment under § 135 SGB V and listing in the medical aids directory under § 139 SGB V.
Pricing & Reimbursement →
Pricing and reimbursement advisory for medicinal products and medical devices: launch price setting, the AMNOG procedure under §§ 35a and 130b SGB V, management of external reference pricing, performance- and volume-based reimbursement agreements, and the reimbursement pathways for MedTech and IVD, in particular via the hospital remuneration system, NUB charges under § 6(2) KHEntgG and the method assessment under § 137h SGB V.
Real-World Evidence →
Real-world evidence consulting for pharma, biotech, MedTech and IVD: design of methodologically robust registry, observational and secondary-data studies whose evidence meets the requirements of HTA bodies, regulatory authorities and payers. From the directed research question through the data strategy to PMCF and PMPF integration.
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