• Medical Science Team – Diverse Thinking

    Medical Science Team – Diverse Thinking

  • Market Access – Your Experts for a Successful Strategy

    Market Access – Your Experts for a Successful Strategy

  • Early Benefit Assessment – From Pioneer to Market Leader

    Early Benefit Assessment – From Pioneer to Market Leader

  • European HTAs – Always one Step Ahead

    European HTAs – Always one Step Ahead

  • Medical Devices – On the Pulse of Time

    Medical Devices – On the Pulse of Time

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  • Medical Science Team
  • Market Access
  • Early Benefit Assessment - AMNOG
  • European HTAs
  • Medical Devices

To realize your goals, we work to develop a common understanding of the objectives and the paths that will lead us to achieve them. We thus strive to align the perspective of our customers with the knowledge of our experts.

In close exchange with the relevant HTA authorities and professional societies, we are at the forefront of current developments to bring your project to fruition. Our multidisciplinary Medical Science Team is characterized by the continuous interaction of more than 60 experts in Medical Writing, Biostatistics, Project Management and Public Health Economics.

Trust our reliable professionals with profound knowledge in numerous indications and statistical methodology, who will communicate the value of your product in line with your expectations. Based on our long-term experience in the fields of global clinical development, drug registration, benefit assessment, price negotiations and reimbursement, we make it our mission to implement your goals through a close and cooperative collaboration.

Take advantage of our expertise and our enthusiasm for new challenges! We are looking forward to your phone call or e-Mail.

jaenel

Dr. Gerlinde Jänel

Director Medical Science
Medical Writing
+49 (0) 178-6517769
dieser

Mike Dieser

Associate Director Medical Science
Account Management and Business Organization
+49 (0) 162-4335186
seemueller

Silke Seemüller

Director Medical Science
Biostatistics
+49 (0) 152-22700506

Contact us

 

In a continuously changing environment, Market Access has become a complex dynamic process. Successful strategies for bringing new products to market require early planning and are ideally already incorporated into the development timeline. Key to success is a benefit-based argumentation of your product's value in order to optimally present the innovative character of your product and positively influence the pricing strategy throughout the process.

Take advantage of our extensive expertise and our exchanges with relevant authorities, agencies, and professional associations to help you establish a successful market access strategy. Open to your needs, we anticipate the input of all stakeholders and remain flexible enough to integrate changing parameters into the procedural framework. We will concentrate on the essentials – to ensure effective price negotiations and the best possible reimbursement outcome.

 

Our Services:

  • Support with the preparation of early consultations with national and European agencies
  • Collaborative development of a target-oriented value demonstration strategy including early risk assessment and feasibility analysis for benefit argumentations
  • Health economic analyses (e.g. cost benefit analyses, budget impact analyses)
  • Assistance in a target-group-specific communication of the added value of your product to various stakeholders
  • Strategic consulting on questions related to pricing and reimbursement as well as preparatory and participating support in price negotiations with payers

The successful launch of your product to the German market is heavily dependent on a professional and successful execution of all components of the benefit assessment process. The demonstration of the added benefit of your drug versus a standard comparator therapy lies at the heart of the process involving the German HTA agency Institute for Quality and Efficiency in Health Care (IQWiG), the Federal Joint Committee (G-BA) as the authority responsible for the assessment, and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) – parties which often have diverging interests.

Starting out as pioneers in 2010, AMS  has become one of the leading service providers in the field of Early Benefit Assessment. To date, we have worked successfully with 9 of the 10 largest pharmaceutical companies and cover a respectively high market share. Our proven expertise allows us to accept all challenges and will guide you throughout the complete process of Early Benefit Assessment. From the early advice request and through the benefit dossier, the hearing procedure through to price negotiations with the payers, we focus on providing the best possible communication strategies to demonstrate the value of your product and gain optimal acceptance in the German market.

 

Our services:

  • Preparation of sessions for early request for consultation regarding study design or inquiries pre-benefit dossier submission
  • Preparation of all modules of the benefit dossier
  • Systematic literature searches and searches of study registries according to the provisions of the German AMNOG law and regulations
  • Preparation and interpretation of adjusted indirect treatment comparisons and (network) meta-analyses
  • Support with the preparations for the Written Statement and Oral Hearing with the G-BA
  • Implementation of alternative biostatistical methodologies (e.g. benefit-risk methodology, propensity score-based methods)

 

  • In evidence-based benefit assessments, the focus is on a detailed presentation of the results of individual patient-relevant endpoints. These analyses usually go beyond of what is required and prespecified in approval studies. For example, in case of more than one study, results need to be presented by meta-analysis. Furthermore, subgroup effects have to be analysed and presented for all endpoints. In many cases, time-to-event analyses are the only adequate and accepted form of evaluation. Finally, an adjusted indirect comparison has to be conducted if no direct evaluation (head-to-head study) to the appropriate comparator is available.
    AMS  provides you with all statistical analyses required for submission of the dossier and supports you in the communication with your company statisticians (e.g. formulation of data requests).

The diverse national processes and requirements with regard to health technology assessments (HTA) across Europe have led to partly divergent evaluations of a given medicinal product between different EU Member States. Already at the stage of planning clinical studies, sponsors face the challenge to design studies that will ultimately satisfy the requirements of the regulatory authority as well as those of the various national HTA agencies and bodies.

In 2006, the European Commission, supported by EUnetHTA has started an EU-wide cooperation to foster an Early Dialogue between pharmaceutical companies, regulatory authorities, and HTA bodies. The main objective is to generate scientific advice for the further clinical development regarding requirements for both marketing authorisation procedure and HTA process ensuring successful market access for the new medicinal product (e.g. study design, choice of comparators, outcome parameters, and economic aspects). Participants of the Early Dialogue are, besides EUnetHTA Early Dialogue Secretariat, representatives of HTA bodies, the European Medicines Agency (EMA) and other stakeholders like patients, consumers and health professionals.

The EUnetHTA-coordinated assessments for medicinal products prepare the ground for a European HTA process to save resources and overcome nationally divergent assessment outcomes. The methodological framework is the HTA Core Model® to produce a joint clinical assessment, so far called Rapid Relative Effectiveness Assessment (REA), for national uptake across the European Member States. The European Commission proposed a regulation on HTA ( Proposal) based on the experiences gained with the EUnetHTA assessments and the implementation into European Regulations is expected until 2025.

Participating in the EUnetHTA program is the perfect opportunity to contribute to the design and procedures, connect with the European stakeholders and optimize your structure and processes for European HTA. Prepare your company for the upcoming changes in the European HTA landscape and take advantage of our extensive experience with the EUnetHTA and EMA processes.

With AMS you have not only a service provider but a partner at your side who will maximize your results for ED and with European HTA. We will provide you with in-depth knowledge and expediently guidance for your successful path through any ED and HTA process.

 

Our services with regard to Early Dialogue

  • Identification of topics and formulation of questions to EMA and HTA agencies
  • Compilation of briefing documents for EMA-EUnetHTA Parallel Consultation and EUnetHTA multi-HTA Early Dialogue
  • Strategic consulting in choosing the right HTA process and in the identification of relevant contacts

More information on Parallel Consultation

 

process early dialogue

Our services with regard to European HTA

  • Preparation of submission files and support throughout the European HTA process, all in line with your strategy
  • Systematic searches of literature databases and study registries
  • Analyses of epidemiological data
  • Direct and indirect treatment comparisons and (network) meta-analyses
  • Wide expertise in statistical methodologies incl. frequentist and Bayesian approaches
  • Health economic evaluations (e.g. cost effectiveness analyses, budget impact analyses)

More information on european benefit assessment

 

process rapid rea

Our European HTA Team

teamfoto

 

We are always here for you

Would you like to receive more information about our services and expertise, to contact the team regarding a specific enquiry or to receive a non-binding offer?

We look forward to hearing from you!

With the recent adoption of the EU Medical Device Regulation (MDR) and the further development of the EU MEDDEV guidelines, the demands for successful conformity assessment of medical devices have become more extensive The new laws and regulations considerably increase the effort for you as a manufacturer, both in terms of time and expertise, to meet the requirements for the conformity assessment. Once you have obtained a CE certification for your product, market access becomes the next main focus. In most cases, eligibility for reimbursement by statutory health insurers is essential for commercial success. In Europe, this is regulated at a national level.

Together we can successfully bring your medical device to market, using our comprehensive set of skills and services - from initially analysing study data to negotiating a reimbursement price consistent with the value of your product.

 

Our Services:

  • Strategic consulting on reimbursability in Germany
  • Statistical consulting regarding study design, planning of clinical studies and quality assessment of studies
  • Statistical analyses
  • Support in clinical evaluations
  • Preparation of advice request documents to national (G-BA, i.e. Federal Joint Committee) or European (EMA/EUnetHTA) authorities
  • Support throughout the European HTA process, e.g. Early Dialogue and preparation of the Evidence Submission File
  • Preparation of HTA documents for the benefit assessment of medical devices according to German laws and regulations (in accordance with SGB V, section 137h)
  • Preparation of applications for testing examination and treatment methods (in accordance with SGB V, section 137e)
  • Preparation of guidelines for hospitals (e.g. NUB applications for new examination and treatment methods)
  • Compilation of evidence base through systematic searches of literature databases and study registries
  • Support with the preparation for the Written Statement and Oral Hearing in the assessment process with the G-BA in Germany (in accordance with SGB V, sections 135, 137c, 137h)

 

News

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