Dienstleistung - Medical Science

AMNOG dossier

Details: Category: Dienstleistung - Medical Science; Published: Thursday, 17 August 2023 11:51

AMNOG benefit assessment

The successful placement of your product on the market is significantly influenced by a professional implementation of all components of the early benefit assessment according to AMNOG. The way to the additional benefit of your medication compared to the standard therapy leads you through the tension between IQWiG, G-BA and the National Association of Statutory Health Insurance Funds (GKV-SV).

Started as pioneers in 2010, AMS is now one of the market leaders in the field of AMNOG benefit assessment. An interdisciplinary team of medical writers and statisticians accompanies you professionally through the entire benefit assessment process. In addition to AMNOG benefit assessments, we are also happy to support you in the area of EU HTA.

Our services

(Early) G-BA consultation
You will receive support with the (early) G-BA consultation regarding the strategic selection and formulation of questions on study design, appropriate comparative therapy, etc.
Strategic formulation of the benefit dossier
Depending on your needs, we prepare all five modules of your benefit dossier or just individual sections. In close cooperation with you, we develop a targeted value story and, based on this, the best suitable strategy that runs through the dossier as a common thread.
Systematic research
We would be happy to help you with systematic literature and study register research in accordance with G-BA requirements.
Successful pricing
Our pricing team advices you on pricing and reimbursement policy issues in order to set up a successful pricing strategy together.
Epidemiology & derivation of patient numbers
We support you in deriving and presenting the patient numbers for Module 3 of the benefit dossier.
Strategic endpoint mapping & biostatistical services
The patient reported outcomes (PRO) are the beating heart of the benefit assessment. How can you, as a company, position yourself strategically here? Our biostatisticians can carry out all relevant analyses for you.
Written Statement
Together with you we identify possible gaps in the evidence and develop a target-oriented strategy for preparing the written statement.
Simulation of the oral hearing
We offer an individual hearing simulation: you will experience a staged G-BA oral hearing and have the opportunity to practice answering critical questions.

Biostatistics

Details: Category: Dienstleistung - Medical Science; Published: Thursday, 17 August 2023 12:00

Biostatistics

Since the introduction of the AMNOG in 2011 in Germany, we provide our clients with comprehensive advice and support on all biostatistical issues concerning German benefit dossiers. We develop strategies to meet the requirements of IQWiG and the G-BA and at the same time achieve the best possible result for your product.

Over 25 biostatisticians support you in all statistical aspects during the entire benefit assessment process.

Our Services

Methodology
- direct and indirect comparisons (adjusted/non-adjusted, historical and external control groups)
- (Network) meta-analyses
- Propensity score matching
- Matching-adjusted indirect comparisons (MAIC)
- Surrogate validations
- Survival time analyses
- Multiple regression
- ...and other methods. Feel free to contact us!
Additional Analyses
For your benefit dossier, we carry out all additionally required statistical analyses according to the current requirements of IQWiG and G-BA and support you in communicating with your global colleagues.
Data Visualization (ShinyViz)
Fast visualization and individualized graphical presentation of analysis results to determine the best possible dossier strategy.

European HTA
At AMS, we have been active in the field of EU HTA since 2015. Among other things, we support you in statistical evaluations around JSCs, rapid REAs and JCAs.
Routine practice data collection (anwendungsbegleitende Datenerhebung, AbD)
As pioneers in the field of routine practice data collection (anwendungsbegleitende Datenerhebung, AbD), we accompany you at every step through this recently established process. We offer strategic consultation, individually tailored workshops, active participation during the stakeholder participation process and preparation of study documents including study protocols and SAP.

Do you have any questions? Our Biostatistics-Team looks forward to hearing from you:

EU HTA

Details: Category: Dienstleistung - Medical Science; Published: Thursday, 17 August 2023 12:07

European HTA

Since 2015, AMS has actively shaped the EU HTA process through regular contributions at conferences, participation in EUnetHTA events, and as a member of EUCOPE. Our practical experience and profound expertise gained during the development and compilation of rapid REA Submission Files during the EUnetHTA Joint Action 3 will ensure that you are well-prepared and guided through the EU HTA process.

Our services

Capability matching
To ensure an efficient preparation of your relevant functions (Clinical Development, Regulatory Affairs, Market Access) for the EU HTA process, we will work together to develop an individualized playbook that can be further refined through dry runs.
Training
We are happy to share our expertise through individually tailored workshops, presentations, and publications, equipping you for the EU HTA process.
Preparation of early consultations
We support you in preparing briefing documents for European consultations (JSC), parallel consultations (EMA/HTA bodies), or national consultations, in order to anticipate the requirements of individual EU Member States in advance.
Anticipation of possible assessment scopes
Considering different options for the assessment scope, we work together with you to create the corresponding value story for your product.
Comprehensive understanding of European HTA requirements
We are here to offer guidance on evidence generation (such as study design, endpoints, subgroup or sensitivity analyses).
Scientific, strategic and methodological advice
Together with you, we develop the data strategy and leverage visualization techniques to support and accelerate decision-making processes.
Development of a complete dossier
We support you in deriving and presenting the patient numbers for Module 3 of the benefit dossier.
Parallel development of EU HTA and AMNOG dossiers
With our experience in parallel procedures, we can also provide you with planning support throughout the national and EU HTA processes.

Do you have any questions? Our EU HTA team looks forward to hearing from you:

Transition from national to EU HTA: When will what be switched?

From January 2025, the Regulation on the European Health Technology Assessment will be implemented. The clinical domains of an HTA of newly authorised medicinal products will thereafter be prepared at European rather than national level: the EU HTA. For various medicinal products, the benefit assessment at EU level JCA will become mandatory at different times. From 2030, JCAs will finally be mandatory for all medicines. Graphical representation of the timelines of the entry into force of the EU HTA.

Download: Flyer Timelines Entry into force of the EU HTA

Process of a JCA in the European benefit assessment

The JCA process is overseen by the Member State HTA Coordination Group. The JCA dossier is required 45 days prior to the CHMP Opinion and is published no later than 30 days after the marketing authorisation of the medicinal product by the EMA. A scoping process is carried out before the dossier is submitted. The results of this process form the research question and the scope of assessment for the dossier. The scoping process aims to define the PICOs (Population, Intervention, Comparator, Outcomes), which have the task of setting the framework for the evaluation and the data requirements for the manufacturer.

Ablauf europäischer Nutzenbewertungen Download: Flyer European benefit assessments

Publication List

Original articles in peer-reviewed journals

Schweitzer MK, Dold MN, Genet A, Gossens K, Klein-Hessling T, Löffler N, Rabel M, Rasch A, Reuter EM, Schmelcher J, Wolfram N, Werner S (2023). Shaping a suitable EU HTA dossier template: why the German template is not fit for purpose. Eur J Health Econ. 2023 Oct 16. doi: 1007/s10198-023-01631-5
Schweitzer MK, Dold MN, Genet A, Gossens K, Klein-Hessling T, Löffler N, Rabel M, Rasch A, Schmelcher J, Werner S, Wolfram N (2023). Auswirkungen der neuen Dossieranforderungen Monitor Versorgungsforschung 03/23, p26–30, doi: http://doi.org/10.24945/MVF.03.23.1866-0533.2500
Genet A, Bogner K, Goertz R, Böhme S, Leverkus F (2023). Safety analysis of new medications in clinical trials: A simulation study to assess the differences between cause-specific and subdistribution frameworks in the presence of competing events. Research Square. doi: 21203/rs.3.rs-2475247/v1
Kisser A, Knieriemen J, Fasan A, Eberle K, Hogger S, Werner S, Taube T, Rasch A (2022). Towards compatibility of EUnetHTA JCA methodology and German HTA: a systematic comparison and recommendations from an industry perspective. Eur J Health Econ 23(5):863-878, doi: 1007/s10198-021-01400-2
Wüstner S, Hogger S, Gartner-Freyer D, Lebioda A, Schley K, Leverkus F (2022). Clinical Evidence Informing Treatment Guidelines on Repurposed Drugs for Hospitalized Patients During the Early COVID-19 Pandemic: Corticosteroids, Anticoagulants, (Hydroxy)chloroquine. Front Public Health 18;10:804404, doi: 3389/fpubh.2022.804404
Schomaker M, Hogger S, Johnson LF, Hoffmann CJ, Bärnighausen T, Heumann C (2015). Simultaneous Treatment of Missing Data and Measurement Error in HIV Research Using Multiple Overimputation. Epidemiology. 26(5):628-36. doi: 1097/EDE.0000000000000334

Further publications (Workshops/Webinars/Presentations/Conference abstracts)

AMS (Eberle K), EUCOPE (2022) European HTA: What have we learned, what lies ahead?, Webinar, Information on EUCOPE website
AMS & Vfa (2021) New requirements for AMNOG-dossiers: Investigation of considered evaluations in the context of the benefit assessment by IQWiG and G-BA, Report, Information on Vfa website
Panni, T., Thiele, A., Carls A., Wallstab, A., Eberle, K. & Schleibner S (2018) PHP281 - THE METHODOLOGICAL DIFFERENCES OF EUROPEAN JOINT ASSESSMENT AND GERMAN HTA: AN EMPIRICAL APPROACH. Value in Health 21, p197-S8. https://doi.org/10.1016/j.jval.2018.09.1175
Rüther A, Herrmann K, Hebborn A, Perleth M, Schwarzer R, Schürmann C, et al. HTA und aktuelle Herausforderungen: Harmonisierung, Real World Data und Surrogatparameter. HTA – How to tackle pressing challenges: International Harmonization, Real World Data, and Surrogates. GMS Medizinische Informatik, Biometrie und Epidemiologie. 2018;Vol. 14(1). https://dx.doi.org/10.3205/mibe000180
Panni, T., Eberle, K., Seiler, N., Brüderl, M., Burkert-Kautzsch C, Carls A, et al. (2017) VP181 From National To European Assessment - The German Case. International Journal of Technology Assessment in Health Care, 33(S1), 234-5, https://doi.org/10.1017/S0266462317004147
Hemmerling J, Eberle, K., Hogger S, Gupta M, Ullraum, A, & Seemüller S (2017) PP096 European Union-Health Technology Assessments For Medical Devices - How To Overcome Reimbursement Divergence. International Journal of Technology Assessment in Health Care, 33(S1), 116-117. https://doi.org/10.1017/S0266462317002616
Gerlinde Jänel. Europäisches und nationales HTA – gleiches Ziel, gleiche Methodik? European and National – same aim, same method? HEC 2016: Health – Exploring Complexity. Joint Conference of GMDS, DGEpi, IEA-EEF, EFMI. München, 28.08.-02.09.2016. Düsseldorf: German Medical Science GMS Publishing House; 2016. DocAbstr. 876-2 https://dx.doi.org/10.3205/16gmds100

Pricing

Details: Category: Dienstleistung - Medical Science; Published: Tuesday, 08 August 2023 12:26

Comprehensive support with the negotiation of the reimbursement price according to § 130b SGB V

With the GKV Financial Stabilization Act (GKV-FinStG), which came into force in Germany in 2023, the legal framework for negotiating reimbursement prices has become significantly more complex. Further legislative changes are to be expected in the coming months and years. In this dynamic environment, it is important for pharmaceutical manufacturers, with regards to negotiating the reimbursement price, to pursue the optimal strategy from the very beginning of the AMNOG process.

Our services

Extensive analysis of the reimbursement price
We analyze the price potential in the therapeutic indication of your product early on in the AMNOG process. In doing so, we derive scenarios for the negotiation of the reimbursement price based on the costs for possible comparative therapies and the individual study situation.
Optimal strategy for negotiating the reimbursement price
In close cooperation with you, we develop the best possible strategy for your reimbursement price negotiations. Therefore, we draw on our wealth of experience in price negotiations and extensive knowledge of the German pharmaceutical market.
Targeted negotiation training
We prepare you specifically for each negotiation date. Together we create a negotiation script and simulate the negotiation situation.
Effective collaborations
In order to provide you with the best possible support in achieving your negotiation goals, AMS offers to bring in various cooperation partners such as specialized lawyers or an acting trainer as part of the negotiation training.
Support in the preparation of appendices I-III, IIIa-c for the GKV-SV
We offer support in the preparation of appendices I-III, IIIa-c in accordance with Section 3 of the framework contract.
Strategic and formal preparation for arbitration procedure
If no agreement can be reached with the GKV-SV during the reimbursement price negotiations, one of the negotiating parties will call the arbitration board. In this case, we will continue to advise you strategically and support you in preparing your concretizing request.

Do you have any questions? Our pricing team looks forward to hearing from you:

Price negotiation with the GKV-SV linked to the German AMNOG procedure

Since January 2011, the AMNOG has regulated the market access for drugs in Germany. On the basis of a benefit dossier, which the pharmaceutical manufacturer submits when entering the market or upon market authorization of a new therapeutic indication, the G-BA decides on the additional benefit of the drug. Based on this assessment of the additional benefit, a reimbursement price is negotiated between the pharmaceutical manufacturer and the GKV-SV in accordance with Section 130b of the Social Code - Book V (SGB V). The negotiated reimbursement price applies retroactively from the 7th month after the drug has entered the market in Germany or an approval extension has been granted. The possible amount of the (partial) reimbursement price is regulated by a statutory framework based on the additional benefit as determined by the G-BA.

AbD

Details: Category: Dienstleistung - Medical Science; Published: Monday, 24 July 2023 08:27

Routine practice data collection (anwendungsbegleitende Datenerhebung, AbD)

We bring extensive firsthand experience from actively engaging in multiple AbD procedures. Our services include strategic consultation, individually tailored workshops, active participation during the stakeholder participation process and preparation of study documents including study protocols and SAP. Our interdisciplinary teams are specialized in biostatistics, medical writing, project management, and clinical operations.

With our hands-on experience and multidisciplinary approach, we provide comprehensive support and guidance throughout your entire AbD process.

Our services

Setup
We support you in the strategic planning of the AbD process by offering consultation on budget planning and stakeholder involvement.
Workshops
In individually tailored workshops, we support you to develop the course of action, conduct PICO-Scoping and analyze potential gaps (GAP-Analysis).
Engagement with G-BA and IQWiG
Our experienced consultants proactively guide you during the participation process and support you in creating written statements in response to the IQWiG AbD concept as well as during participation in the stakeholder process.
Study documents
You benefit from our HTA- and Clinical Operations-experts´ extensive experience in writing and revising study documents and SAP.
Methodological and strategic consultation
We share our experience and know-how regarding the challenging methodological aspects of the AbD, including calculation of patient numbers, systematic confounder identification, recording of patient reported outcomes and collaboration with registries.
Implementation of the AbD
Our team also supports you after the start of the routine practice data collection. We generate status reports, interim analyses, and final evaluations and interpretation.

Do you have any questions? Our AbD Team looks forward to hearing from you:

AbD in early benefit assessment

Since 2020 the G-BA can demand a post-launch routine practice data collection (anwendungsbegleitende Datenerhebung, AbD) for new pharmaceutical products with certain approval pathways (conditional approval or approval under exceptional circumstances) or Orphan Drugs. The AbD process is initiated when available evidence for a benefit assessment is insufficient.

AbD course of action: When does what happen?

The AbD process is described in chapter 5 of the G-BA procedural rules (Verfahrensordnung) and encompasses several steps. The development of the AbD concept by IQWiG and the written statement of the pharmaceutical company are essential steps in the process. If an AbD is demanded, the pharmaceutical company is required to submit study documents (SAP and study protocol), which describe the methodology of the AbD. After the completion of the AbD, a new benefit assessment of the pharmaceutical product is conducted.