• 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.

a.carls

Dr. med. Alexandra Carls

Director Medical Science
+49 (0) 177 2603 240
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
jaenel

Dr. Gerlinde Jänel

Strategic consultant

+49 (0) 178-6517769

 

 

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).

Now, it is only a matter of time…

Since the political institutions in the European Union (EU) reached a provisional agreement in June 2021, it is set in stone that the Regulation on European health technology assessments (HTA) will be implemented starting in 2025. Meanwhile, the EU Member States are getting ready to prepare Joint Clinical Assessments (JCA) of health technologies thenceforth.

In order to further advance the procedural and methodological basis for these joint assessments, the EU signed a two-year contract with the EUnetHTA 21 consortium. The work of EUnetHTA 21 will explicitly build on the methods and deliverables already implemented in the previous EUnetHTA Joint Actions and will focus on establishing standards for the upcoming EU HTA system defined by the HTA Regulation.

EUnetHTA 21 has already conducted the first open call for Joint Scientific Consultations (JSC) and announced the preparation of 1‑2 JCAs for medicinal products.

Are you also poised to enter the future of EU HTA?

Relying on our many years of hands-on experience with scientific consultations and joint assessments we will provide you with in-depth knowledge and expedient guidance for your successful path through your EU HTA process. With AMS you have not only a service provider but also a partner at your side who will maximize your results for EU HTA.

For more detailed information on the development and the current status of EU HTA and our involvement, please select your topic of interest below or contact us for specific questions:

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History of EU HTA

The diverse national processes and requirements with regard to 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 was 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 were, 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 have prepared the ground for a European HTA process to save resources and overcome nationally divergent assessment outcomes. The methodological framework was the HTA Core Model® to produce a JCA, the Rapid Relative Effectiveness Assessment (REA), for national uptake across the EU Member States. The European Commission proposed a regulation on HTA based on the experiences gained with the EUnetHTA assessments. Meanwhile the ordinary legislative procedure for this EU Regulation on HTA has been completed and thus, its implementation has started in January 2022 and will continue until its application in January 2025.

 

The EU Regulation on HTA

On 22 December 2021, Regulation (EU) 2021/2282 of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU was published in the Official Journal of the European Union. It establishes a permanent framework for joint work and shall apply from 12 January 2025.

 1 Abbildung EU Regulation on HTA

This Regulation establishes:

-        Procedures for the Joint Clinical Assessment (JCA) of health technologies – HTA at Union level.

-        Procedures for Joint Scientific Consultations (JSC) with health technology developers on their development plans for a given health technology.

JCA will be obligatory; for medicinal products it will apply as follows:

-        from January 2025 for new cancer medicines and advanced therapy medicinal products (ATMP),

-        from January 2028 for new orphan medicinal products (OMP),

-        from January 2030 for all new centrally authorised medicinal products.

JSC will be voluntary:

-        Health technology developers may request a JSC. The request shall be made to the Coordination Group. Request periods remain to be published.

-        The clinical studies and clinical investigations of the health technology have to be in the planning stage.

-        The Coordination Group shall select the health technologies that are to be subject to JSCs (there is no legal claim to JSC).

Detailed procedural rules for JSC and JCA will be adopted.

The EUnetHTA 21 consortium

The procedural rules for JSC and JCA are being produced by the EUnetHTA 21 consortium through a service contract with the European Health and Digital Executive Agency (HaDEA) acting on behalf of the European Commission.

On 17 September 2021, the HaDEA signed the Service Contract for the Provision of Joint Health Technology Assessment (HTA) Work Supporting the Continuation of EU Cooperation on HTA. The contract will run for 24 months, until 16 September 2023.

Participating in the EUnetHTA 21 programme is the perfect opportunity to contribute to the structure and procedures of the upcoming EU HTA system, to connect with the relevant European stakeholders and to optimise the structure and the processes of your organisation for the European HTA. Therefore, prepare for the upcoming changes in the European HTA landscape and take advantage of our extensive experience with the EUnetHTA and EMA processes.

 

Our involvement - Your benefit

-        We have been dialogue partner of EUnetHTA for many years and will continue our cooperation as stakeholder of EUnetHTA 21.

-        We carefully observe the activities of EUnetHTA 21 and review its outputs for building up the new EU HTA system: procedural rules and methodological guidance.

-        We are your highly competent and long-standing partner in both, the European (within the EUnetHTA framework) and the German HTA process (AMNOG). AMS is looking forward to continue its successful cooperation with you in the new HTA framework.

Our Services around EU HTA

2 Abbildung AMS Services EU HTA

Early Dialogue (ED)

-        Identification and wording of questions for the EMA and the HTA bodies and agencies.

-        Preparation of the briefing documents for the EMA-EUnetHTA Joint Scientific Advice (parallel consultation)

-        Evidence review and strategic consulting.

 

Further information on Parallel Consultation

 

EU Health Technology Assessment (EU HTA)

-        Strategy-compliant preparation of the submission file and support through the European process

-        Systematic searches in literature databases and study registers

-        Analysis of epidemiological data

-        Direct and indirect comparisons or (network) meta-analyses

-        Broad spectrum of statistical methods i.e. frequentist as well as Bayesian methods

 

Further information on European HTA

Further services

-        Presentations, webinars and workshops on EU HTA

-        Parallel conduction of JCA and AMNOG dossier during EUnetHTA 21

-        Strategic consultation regarding evidence generation for EU HTA (e.g. study design, statistical methods)

Early Dialogue (ED)

-        Identification and wording of questions for the EMA and the HTA bodies and agencies.

-        Preparation of the briefing documents for the EMA-EUnetHTA Joint Scientific Advice (parallel consultation)

-        Evidence review and strategic consulting.

 

Further information on Parallel Consultation

 

Publications

Towards compatibility of EUnetHTA JCA methodology and German HTA: a systematic comparison and recommendations from an industry perspective: https://link.springer.com/content/pdf/10.1007/s10198-021-01400-2.pdf


 

 

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)

 

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