Kintiga Germany
We support the successful market access both on a strategic and an operational level.
Kintiga Germany
We are partners of internationally operating pharma, biotech and medtech companies, as well as of investors, whom we support as sparring partners, or whom we operationally guide through the entire market access process. As we enjoy facing strategic challenges, we particularly manage projects for orphan drug products, for ATMPs and for products which set new therapy standards.
BeNeLux Insights
Kintiga BeNeLux
Kintiga Germany Expertise:
EU HTA
At Kintiga, we are at the forefront of EU HTA preparedness. Our consultants possess in-depth knowledge of the EU HTA Regulation and provide comprehensive support throughout the entire process—from early strategy development and JCA dossier preparation to interpreting national implications from the final assessment report through to local reimbursement.
Digital Health Applications (DiGA) & Digital Pharma
For digital health applications, the path to reimbursement is the crucial hurdle of the market access process. Kintiga Germany provides comprehensive advice on how manufacturers can overcome the regulatory and market-specific hurdles.
Full Market Access
Full Market Access describes the entire process from the comprehensive, overarching and anticipating development of an overall cross-market strategy to its operational and proactive implementation in a complex and evolving environment with a simple-seeming goal: to help as many patients as possible at a fair price.
Strategic Due Diligence
Health care systems are complex and multi-layered constructs which must be penetrated in depth in order to place products successfully. Knowledge of history, trends and current developments in the industry environment helps innovators to integrate their products into existing systems. Based on this, decisive decisions on sustainability and marketability must be made in the innovation process.
Strategic Pricing
Pricing involves two key aspects: determining the launch price for a new product on the market and defining the reimbursement amount, i.e. the effective price that will be reimbursed by payers in the long term. The task of strategic pricing is therefore to develop the optimal strategy leading to the highest possible economic benefit and simultaneously enabling maximum market penetration.
Market Access Strategy
Value Dossier
The value dossier represents more than a piece of paper. Because only when the evidence-based value arguments are combined with a convincing value story into one unit, new products and drugs can be marketed in a promising manner.
Benefit Assessment (AMNOG, Medical Devices)
New medication and new examination and treatment methods are subject to strict conditions. Manufacturers of medical technology and pharmaceuticals must consider this early for purposes of benefit assessment and must proceed strategically in order to position their products in the best possible manner.
Negotiation Support
Like in most European countries, the prices paid by the healthcare system for products and services in Germany are not administered but negotiated between the individual parties. Despite the highly regulated environment of the market access processes, there is considerable scope for shaping the contractual arrangements and agreeing the respective reimbursement amount.
Stakeholder Management
The success factors for a sustainable market access of innovative drugs and ATMPs are often based on the detailed work and the overall synchronization of all market access activities. The effective integration of relevant stakeholders and key opinion leaders can have a decisive impact on the success of the launch and must be an integral part of a winning market access strategy.
Kintiga Germany Insights
From JCA to AMNOG: What Survives Downstream?
Germany’s New Savings Law Advances: What the Cabinet Draft Means for AMNOG and Market Access
Between Ambition and Reality: Why German Routine Practice Data Collection Often Stalls
Aut-idem Meets Biologics: Mandatory Substitution as a Game Changer in Germany
The EU Pharmaceutical Package: Political Agreement and Strategic Consequences
Structural Shifts in German Pharmaceutical Regulation: Policy Alignment, Data Integration, and Evolving Cost Pressure
Kintiga Germany Publications
Poster Presentation: Individual Therapy or no therapy at all? Impact of patient individual therapies as ACT in the German AMNOG process (HTA 200)
Poster Presentation: Do the guardrails have any effect at all? An analysis of the impact of the 2022 FinStG guardrails on the German AMNOG progress (EE339)
Poster Presentation: Germany: Still a benchmark for ATMP access & pricing? A pricing analysis of Germany’s ATMP landscape compared to other European countries (HTA 163)
Revisiting Transparency: The Role of Confidential Rebates Under Germany’s Medical Research Act
Publication: Market Access Under Agile Conditions – An Update on the Agile German AMNOG Dossier
Repurposed Drugs Launched Under the AMNOG in Germany
Our products
Navigate evolving regulations and market demands confidently with up-to-date insights and guidance from Kintiga’s innovative AI-powered digital tools.
Hive by Kintiga
Access the collective expertise of our consultants and the insights and strategic guidance to simplify approvals across Europe’s healthcare any time and from anywhere.
EPRI
EPRI (EndPoint Result Interpreter) is a cutting-edge AI solution designed to streamline the creation of tailored, high-quality dossiers.
Get in touch with our team now
Contact us to discover how we can support your journey towards pharmaceutical market access & patient access.
