Market access in Germany

Demonstrating the added clinical benefit of an innovative medicinal product is key for a successful launch

Successful launches demonstrate the clinical benefits of innovative medicinal products 

Benefit assessments as part of market access in Germany

Since the enactment of the Pharmaceutical Market Restructuring Act (AMNOG), a scientifically- demonstrated clinical benefit of an innovative medicinal product has been the key for a successful market launch.

We fully support you in the development and communication of your product’s value story, adapted for the German healthcare system. Our comprehensive, consultative approach integrates our knowledge of the requirements and the information needs of all relevant stakeholders, such as Federal Joint Committee (Gemeinsamer Bundesausschuss [G-BA]) and the Institute for Quality and Efficiency in Health Care.

Considering the ever-changing environment for market access in Germany, your organization will benefit from our 20+ years of wide-ranging experience and our network of decision-makers in the German healthcare system.

Our marketing access team provides a broad array of services including: 

  • Consultation on design of clinical studies for the purpose of German health technology assessment (HTA) 
  • Advice on the interaction with the G-BA 
  • Gap analysis of available clinical evidence
  • Successful preparation of complete value dossiers for the German HTA and all other necessary documentation for successful market launch in Germany
 

Conducting a structured analysis of clinical evidence is an integral part of health technology assessments (HTAs) in Germany 

AMNOG benefit dossiers, an overview  of § 35a SGB V

AMNOG Benefit Dossiers, according to the German Social Code, Book Five (SGB V), section 35a.

In Germany, the Pharmaceutical Market Restructuring Act (AMNOG) of 2011 and the resulting requirements for benefit assessment according to § 35a SGB V have fundamentally changed the conditions for market access and pricing of pharmaceuticals. Almost without exception, all new medicinal products including hospital products, orphan drugs, and advanced therapy medicinal products, fall under regulations for benefit assessment, which trigger mandatory submissions to the Federal Joint Committee (G-BA) for a German health technology assessment (HTA).

All of Xcenda's offerings in this area are based on your individual needs. We develop and prepare complete value dossiers, or only individual modules or sections. We offer strategic advice and support in developing a value dossier for Germany, as well as professional reviews or stress-tests of existing dossiers. 

On every project, we take a well-founded and scientific approach, coupled with a broad understanding of the needs and objectives of your company’s diverse functions and perspectives. Our approach ensures communication with your global function on process-related issues.

Based on experience gained from 200+ AMNOG-related projects, more than 100 different medicinal products, and the preparation of 80 complete dossiers, we have a deep understanding of the opportunities and pitfalls in the German HTA-process. Xcenda’s AMNOG expertise and our highly qualified Market Access Team—staffed with pharmacists, epidemiologists, and experts in biomedicine—form the basis of our consulting work. Previous assignments focused on haemato-oncological indications, orphan drugs, diabetes and various immunological diseases are all represented in our portfolio.

Full support on AMNOG-related market access—from strategy through price negotiation

Dossier preparation is just one of many interlinked tasks to ensure successful market access in Germany

Many other Xcenda services support the successful access of the innovative medicines and devices market in Germany. Tailored to the needs and capacities of our clients, that support starts well before the actual launch date with consulting on the design of studies and continues with adjustments to German health technology assessment (HTA) requirements, and the complete preparation of market access plans for Germany or the joint preparation for Federal Joint Committee (G-BA) consultation meetings.

Before the actual work on a dossier begins, we prepare an early gap analyses of the statistical output of your studies. If necessary, we’ll perform analyses using the raw data from existing clinical trials in accordance with the G-BA and Institute for Quality and Efficiency in Health Care (IQWiG) requirements.

When starting a dossier, it’s important to develop a data-driven value story that communicates strong key messages. To achieve this, we focus on a critical analysis of the relevant results. At this stage, involving experts in their respective clinical fields and practices not only helps identify the unmet need of a disease in the German healthcare context but can also be part of an integrated stakeholder strategy.

Those efforts culminate in price negotiations between the pharmaceutical company and the head organization of statutory health insurance. Xcenda provides comprehensive support in this area, and helps you address other challenges that arise after launch and through the completion of the price negotiations. This includes setting up real-world registers, developing value communication materials, and supporting health economic analyses. To achieve the best result for your needs, we combine Xcenda's expertise in market access, health economics, and real-world evidence in a direct and cross-division effort.
A Good Neighbor Pharmacy managed care expert speaking to legislators

Our portfolio for AMNOG-related market access support includes the following:

A Good Neighbor Pharmacy managed care expert speaking to legislators
  • Support for consultations with the G-BA or the European Medicines Agency (EMA)
  • Advice on study design adjusted to German HTA requirements
  • Pipeline-screening for AMNOG suitability of clinical trials
  • Consulting services for setting up real-world registries 
  • Systematic reviews
  • Preparation of NUB-proposals
  • Support with written statements in response to IQWiG/G-BA assessment reports
  • Support with or in oral hearings of the G-BA
  • Simulation of consultation meetings or oral hearings 
  • Pricing research and other price negotiation support
  • Market access planning
  • Communication and stakeholder management
  • Preparation of value communication materials

A Good Neighbor Pharmacy managed care expert speaking to legislators
 
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Supporting medical devices that are subject to extensive assessment by the G-BA

Market access for medical devices

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The need for an assessment of medical devices in Germany depends on the European market approval and the corresponding risk classification. Launching a product with high-risk classification involves many strategic challenges including an assessment by the G-BA. Additionally, many of these new medical devices are applied in a hospital setting and are not covered by the existing reimbursement.

Once hospitals apply for additional reimbursement (NUB-proposal) and a therapy option becomes available to patients, they will start to submit clinical evidence to the G-BA. This is followed by an examination of the therapy option’s potential for improving daily care. As a result, a G-BA call for clinical studies can be triggered. Setting up such studies might be an obligatory requirement for receiving any reimbursement within the German healthcare system.

We support manufacturers of innovative medical devices in developing a market access strategy, producing complementary documents, and in communicating with individual hospitals and the G-BA throughout the process.

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Systematic reviews: meta-analyses and indirect comparisons 

Addressing data gaps through systematic assessment of existing evidence compared to an innovation  

Systematic screening and evaluation of existing evidence can be an important aid for market access. Clinical study programs rarely clarify all the relevant issues—supplemental information must be collected on a wide range of topics to compile the most precise data and comprehensive analyses available. 

The concrete questioning, existing data-gaps, or regulatory requirements by the G-BA determine which research methods are utilized. Systematic literature reviews can help to fill gaps with the available best-possible evidence—epidemiological data, questions regarding the unmet need in an indication, or the validation of surrogates as part of a value story of a new pharmaceutical. To answer open questions, supportive clinical evidence can be generated with help of meta-analyses of existing study data, indirect treatment comparisons, or real-world data.

Xcenda has extensive experience in addressing data gaps, as well as the resources to develop a data-strategy that best fits your individual needs. Our portfolio of aggregation and evaluation of clinical evidence includes the following:

  • Systematic literature reviews
  • Validation of surrogates based on existing evidence
  • Meta-analyses of different clinical studies
  • Network meta-analyses
  • Historical comparisons
  • Development of synthetic study arms (e.g., based on real-world registry data)

Werner Kulp

Meet our expert

Dr. Werner Kulp, AMNOG Regulation and Market Access 


Werner Kulp