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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

10 topics in Market Access, RWE & Reimbursement

EU HTA Regulation (EU) 2021/2282 (Joint Clinical Assessment, Joint Scientific Consultation)

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.

SGB V §35a (Early benefit assessment of medicinal products, AMNOG)

HTA Dossier →

Preparation of complete HTA dossiers for the early benefit assessment under AMNOG (G-BA / IQWiG), the NICE Single Technology Appraisal, the HAS assessment and SGB V §137h: from the choice of comparator through endpoint structure and mock reviews to support during the written commenting phase and the oral hearing. For pharma, biotech, MedTech and IVD.

Section 35a SGB V (early benefit assessment / AMNOG)

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.

§ 35a SGB V (Early benefit assessment / AMNOG)

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.

Arzneimittelgesetz (AMG) - German Medicinal Products Act

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.

Fünftes Buch Sozialgesetzbuch (SGB V) - German Social Code, Book 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 via the NUB application and § 137h SGB V.

EU 2017/745 (MDR)

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.

§ 130b SGB V (agreement on the reimbursement amount between the GKV-Spitzenverband and the pharmaceutical manufacturer)

Stakeholder Management & Negotiation →

Structured negotiation and stakeholder management for market access: preparing the AMNOG reimbursement-amount negotiation under § 130b SGB V using the Harvard Concept, support in the arbitration procedure under § 130b Abs. 4 SGB V, the STIKO stakeholder process for vaccines under § 20i SGB V, and ongoing key account management with payers and professional stakeholders.

Gesetz gegen Wettbewerbsbeschränkungen (GWB), Part 4 (German Act against Restraints of Competition, public procurement)

Tender & Negotiation →

Hands-on tender and negotiation support for pharma, biotech, MedTech and IVD: assessment of tender documents under GWB public procurement law, bid strategy for rebate contracts under SGB V § 130a Abs. 8 and aids supply contracts under SGB V § 127, win/loss analyses, and senior consultants supporting you directly at the negotiating table.

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Case Studies

Projects from adjacent areas

All case studies →
Case StudyMedTech

Regulatory Strategy for 510(k) Clearance and Successful US Market Entry

An international MedTech manufacturer was preparing to enter the US market on a fixed timeline and had no experience with FDA requirements. Entourage developed the regulatory strategy for the 510(k) clearance.

An international MedTech manufacturer

Case StudyPharma

Regulatory Affairs for Accelerated EU Software Approval in the Life Sciences Industry

A global software provider in the regulated life sciences environment needed a strategy to meet complex EU requirements without jeopardizing its product launch through lengthy processing times.

Global software provider in the regulated life sciences environment with multiple subsidiaries

Case StudyMedTech

Design Transfer of Combination Products from Development to Production

A medical device company with combination products needed to make the design transfer from development to production more efficient while overcoming regulatory hurdles under the EU MDR and the FDA.

A medical device company developing combination products

Insights

Current articles

All insights →
Article

Real-World Evidence in Benefit Assessment: Where It Counts

The G-BA and IQWiG do not accept routine-care data as a substitute for randomized trials, yet at one clearly defined point they explicitly require it: the application-accompanying data collection under Section 35a(3b) SGB V. Knowing the difference means planning registries before authorization instead of after the decision.

Section 35a(3b) SGB V (application-accompanying data collection)

Article

The German Reimbursement Amount Is Decided in the Study Design

From the seventh month after market launch, the negotiated reimbursement amount applies. By then the negotiation is no longer about the price but about the consequences of a decision taken long before. And what limits the headroom changed on 30 July 2026: the guardrails in Section 130b(3) SGB V have been restructured and the combination discount is gone.

Section 35a SGB V (early benefit assessment of medicinal products, AMNOG)

Article

JCA and AMNOG: The EU Assessment Does Not Replace the German One

Joint clinical assessments have applied to oncology medicines and ATMPs since 12 January 2025. They do not replace the German benefit assessment under Section 35a SGB V. Added benefit, the appropriate comparator therapy and the price stay national. What changes is timing: the EU dossier falls due before marketing authorization is granted.

Regulation (EU) 2021/2282 (EU HTA Regulation, joint clinical assessment)

Other areas

Product Development & Regulatory Strategy

From classification and regulatory strategy through to development and study planning.

Regulatory Affairs

Approval and conformity under MDR, IVDR and pharmaceutical law, from the technical documentation to the notified body.

Quality Management & Compliance

QM systems, audits, computer system validation and data integrity under ISO 13485, GMP and 21 CFR Part 11.

Supply Chain & Technical Operations

Supply chain, manufacturing, shortage management and technical operations optimization.

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