IGES LifeScience

June 23, 2020

"Fast Track" for Digital Health Applications
Strategic questions and proof of positive healthcare effects - what does a DiGA manufacturer need for successful implementation?

After the publication of the Digital Health Applications Ordinance (DiGAV) and the guide to the "fast-track procedure" for digital health applications (DiGA), manufacturers can now submit their application for inclusion of their product in the positive list managed by the Federal Institute for Drugs and Medical Devices (BfArM). As an alternative to the application for a final inclusion, manufacturers also have the possibility of being provisionally included in the list and to provide proof of positive healthcare effects within the framework of a study. An integral part of the application procedure is a scientific evaluation concept, on the basis of which proof of positive healthcare effects can be provided. The results of the evaluation are then expected to be part of the price negotiations with the GKV-Spitzenverband happening later.
Which strategic questions need to be answered with regard to the decision for or against the fast-track procedure?
Which experiences from previous evaluation and testing procedures can be transferred to the new process?
What considerations must be incorporated into a scientific evaluation concept and what are the options for implementation?

» Read more

June 23, 2020

"Fast Track" for Digital Health Applications
Strategic questions and proof of positive healthcare effects - what does a DiGA manufacturer need for successful implementation?

After the publication of the Digital Health Applications Ordinance (DiGAV) and the guide to the "fast-track procedure" for digital health applications (DiGA), manufacturers can now submit their application for inclusion of their product in the positive list managed by the Federal Institute for Drugs and Medical Devices (BfArM). As an alternative to the application for a final inclusion, manufacturers also have the possibility of being provisionally included in the list and to provide proof of positive healthcare effects within the framework of a study. An integral part of the application procedure is a scientific evaluation concept, on the basis of which proof of positive healthcare effects can be provided. The results of the evaluation are then expected to be part of the price negotiations with the GKV-Spitzenverband happening later.
Which strategic questions need to be answered with regard to the decision for or against the fast-track procedure?
Which experiences from previous evaluation and testing procedures can be transferred to the new process?
What considerations must be incorporated into a scientific evaluation concept and what are the options for implementation?

» Read more

June 09, 2020

Reimbursement of Digital Health Products in Germany

This webinar will present key aspects of the new reimbursement pathway for digital health products in Germany. It will address the current implementation of the process, the stakeholders involved, the rules for decision-making so far and aspects the manufacturers should be aware of when considering this pathway for their product. This includes evidence requirements as well as a perspective on pricing and distribution under the umbrella of the novel reimbursement path. The information provided will help you gain understanding of the preparation required for your market access in Germany. The event is provided for Canadian companies.

June 08, 2020

How will Healthcare Systems Adopt the Post-COVID-19-World?

Thanks to the incredible biomedical innovation taking place today, COVID-19 will hopefully soon be a thing of the past. However, the strain on resources due to the pandemic will be felt by healthcare systems across the globe for years to come. How will countries respond to this new reality to ensure patients maintain access to the latest biotech innovations? This panel will focus on the impact of COVID-19 on healthcare systems and how countries can better respond to the post-pandemic constraints on healthcare systems

Organizer: Biotechnology Innovation Organization (BIO)

Location: Internet

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May 28, 2020

Webinar
Market Access and Commercial Success for Digital Health Products in Germany

Today Germany is playing a leading role in the European digital health landscape by introducing a defined reimbursement path for digital health applications (DiGA). Manufacturers of digital innovations can now submit applications for reimbursement of their supply products and services. If they are successful with this newly created reimbursement procedure, they will have access to a market of around 73 million people covered by statutory health insurance. This is because since the end of 2019 they have been entitled to a DIGA prescribed by their doctor under the motto: "App on prescription". In a webinar “The German Digital Health Care Act – A new path to reimbursement for digital solutions” initiated by „Berlin Partner“, an investment and trade promotion agency, IGES experts will explain how exactly the procedure works and what products are involved. This online offer is aimed primarily at international manufacturers of digital products.

Key information about the webinar:

Event: Live-Webinar

Topic: Market Access and Commercial Success for Digital Health Products in Germany

Background: With its Digital Health Care Act Germany is the only country in Europe to date to have a legal basis for a system dedicated to the reimbursement of digital health care products. This is unique and represents a great opportunity for international providers of digital healthcare products.

Learning Objective: Learn about the exact conditions that German law imposes on the reimbursement of innovative healthcare products and see how international companies can benefit from it.

Speakers: Jean Dietzel, Director of Health Insurance, IGES Institut, Julian Ramirez, Project Manager, Berlin Partner Organizer: Berlin Partner, IGES Institut

Organizer: Berlin Partner and IGES Institut

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May 26, 2020

"Fast Track" for Digital Health Applications
Strategic questions and proof of positive healthcare effects - what does a DiGA manufacturer need for successful implementation?

In mid-May, the time has finally come: After the publication of the Digital Health Applications Ordinance (DiGAV) and the guide to the "fast-track procedure" for digital health applications (DiGA), manufacturers can submit their application for inclusion of their product in the positive list managed by the Federal Institute for Drugs and Medical Devices (BfArM). As an alternative to the application for a final inclusion, manufacturers also have the possibility of being provisionally included in the list and to provide proof of positive healthcare effects within the framework of a study. An integral part of the application procedure is a scientific evaluation concept, on the basis of which proof of positive healthcare effects can be provided. The results of the evaluation are then expected to be part of the price negotiations with the GKV-Spitzenverband happening later.
Which strategic questions need to be answered with regard to the decision for or against the fast-track procedure?
Which experiences from previous evaluation and testing procedures can be transferred to the new process?
What considerations must be incorporated into a scientific evaluation concept and what are the options for implementation?

» Read more

May 26, 2020

"Fast Track" for Digital Health Applications
Strategic questions and proof of positive healthcare effects - what does a DiGA manufacturer need for successful implementation?

In mid-May, the time has finally come: After the publication of the Digital Health Applications Ordinance (DiGAV) and the guide to the "fast-track procedure" for digital health applications (DiGA), manufacturers can submit their application for inclusion of their product in the positive list managed by the Federal Institute for Drugs and Medical Devices (BfArM). As an alternative to the application for a final inclusion, manufacturers also have the possibility of being provisionally included in the list and to provide proof of positive healthcare effects within the framework of a study. An integral part of the application procedure is a scientific evaluation concept, on the basis of which proof of positive healthcare effects can be provided. The results of the evaluation are then expected to be part of the price negotiations with the GKV-Spitzenverband happening later.
Which strategic questions need to be answered with regard to the decision for or against the fast-track procedure?
Which experiences from previous evaluation and testing procedures can be transferred to the new process?
What considerations must be incorporated into a scientific evaluation concept and what are the options for implementation?

» Read more

March 24, 2020

Orphan drug commercialization in Europe, using France as gateway to Europe

It is often a challenge for small and medium-sized biopharmaceutical companies to bring their novel medicines to European patients. Although there is only one centralized approval for innovative drugs in Europe, each European Member State has its own pricing and reimbursement system. This interactive workshop will focus on how small and medium-sized enterprises can best bring their rare disease therapies to European patients. Cell and gene therapies pose particular challenges as many of these therapies target a very small patient population. The higher the expected price, the more complex the price negotiations could become. A particular focus will be on the reimbursement system in France, as France has a unique early access program for life-saving drugs and is often the first country to enter the European market. The workshop will therefore also examine how the French early access program can be leveraged to generate data that can later be used in the regular reimbursement procedures in Europe. This workshop will look at access to orphan drugs from the perspective of patients, reimbursement bodies and industry. Participants are invited to discuss with the experts.

The panelists will also answer questions submitted HERE during the panel discussion.

Time: 14.45 - 15.45

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November 26, 2019

Medical Devices in Europe in 2020: What’s New in Reimbursement and Market Access?

This workshop focuses on reimbursement and market access for Israeli medical device companies. Main topics will be:
The new EU Medical Devices Regulation (MDR). This regulation will enter into full force in May 2020. How will it affect reimbursement and market access?
Coverage with Evidence Development (CED): New laws in Germany aim to improve the CED program. Who is affected? What is new?
Digital technologies: In Germany, a new law on digital technologies (including medical applications) will come into force in 2020. How does a company enroll into the coverage? What clinical data is required?

Organizer: TechnoSTAT

Location: TechnoSTAT Office

Room: Beit Gamla-Bldg B, 5th Floor, 4350108  Raanana, Israel

Time: 10.00 - 13.00

November 13, 2019

Workshop: Market access Europe: How do smaller biotechs interact best with Europes decision makers?How do smaller biotechs interact best with Europes decision-makers?

09.30 - 10.45 Uhr
Congress Center Hamburg, Am Dammtor / Marseiller Straße, 20355 Hamburg, Deutschland
Veranstaltungsraum: Level 1, Hall B1, Rm 7

Participants:
Fabian Berkemeier - Director, Value and Access Strategy, IGES Institute, Berlin
André Berger - Head of the Innovation Office, Paul-Ehrlich-Institute
Paul Neveux - MPH, HealthEcon, Basel
Constantinos Ziogas - Head of SME Office, European Medicines Agency

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November 05, 2019

Epidemiology and Routine Care Treatment Patterns of Petients with Hip/ Knee Osteoarthritis and Chronic Lower Back Pain in Germany

RESEARCH POSTER SESSION 3
Musculoskeletal Disorders | PMS50
AUTHOR DISCUSSION with Dr. Christoph Ohlmeier: 13 – 14h

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November 04, 2019

Long-Acting Gene Therapies: Current Development Activities and Challenges for Germanys Statutory Health Insurance System

RESEARCH POSTER SESSION 1
Long-Acting Gene Therapies: Current Development Activities and Challenges for Germanys Statutory Health Insurance System
No Specific Disease | PNS 122
AUTHOR DISCUSSION with Fabian Berkemeier: 13 – 14h

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November 04, 2019

How the Results of the AMNOG Early Benefit Assessment (EBA) in Germany Have Developed Over Time

RESEARCH POSTER SESSION
No Specific Disease | PNS 144
AUTHOR DISCUSSION with Wioletta Kotowa: 13 – 14h

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July 09, 2019

Reimbursement of Medical Devices in Germany and Beyond

Der Vortrag ist Teil des Seminars "gründerspot: "Regulatorische Anforderungen und Erstattung für Medizinprodukte - kennen, einplanen und umsetzen". Die Präsentation bietet Einblicke in die deutsche Erstattungslandschaft sowie in die größeren europäischen Gesundheitsmärkte.

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June 06, 2019

Innovative Contracting in Cell and Gene Therapies in Europe

Level 100, Room 115A

Panel

Cell and gene therapies have the potential to change the therapy landscape in many therapeutic areas with high unmet medical need. However, financing one-time treatments may also be a challenge for payers worldwide.

This session will focus on pay-for-performance & deferred payment models in Europe for cell and gene therapies. The panel will focus on presenting the various contract models, incentives and challenges for implementation, as well as criteria that drive the attractiveness of such models to industry and payers. Post launch evidence generation is often a critical element of those contracts to provide payers with long-term data. The panel will present and discuss examples of pay-for-performance models implemented with payers across Europe.
You are invited to join and discuss with the experts:

Fabian Berkemeier, Director Value & Access Strategy, IGES Institute (Germany)
Sonalee Agarwal, VP Value Evidence & Strategy, Alnylam Pharmaceuticals (USA)
Jie Zhang, Head of Global Value and Access, Novartis Pharmaceuticals Corporation (USA)
Moderator: Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (Belgium)

June 05, 2019

Referencing European Prices for Medicare Part B Drugs

Session
Referencing European Prices for Medicare Part B Drugs

Referencing European prices for Medicare Part B drugs is a possible approach for drug pricing regulation in the US. If implemented, European health technology assessments will play a central role in defining prices for Medicare Part B drugs.

In this session, IGES Institute will provide an overview of the different types of health technology assessment frameworks in Europe. Key topics will be the differences in pricing results between various European member states and how referencing these prices would affect the pricing of Medicare Part B drugs. EUCOPE will provide an overview on the challenges of the existing European reference price system for European patients and payers and will share experiences that have been gained in Europe since the system was established.
You are invited to join and discuss with the experts:

Fabian Berkemeier, Director Value & Access Strategy, IGES Institute (Germany)
Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs (Belgium)
Moderator: Claudia Englbrecht, Director, Bio Deutschland (Germany)

June 03, 2019

Bio International Convention

April 10, 2019

Moderation Axel Lohse, Exportinitiative Gesundheitswirtschaft

Panel
Dieter Lingelbach, Sirion Biotech GmbH
Tilo Mandry, IGES Institut
Yossi Tal, TechnoSTAT Ltd.

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March 27, 2019

How does Europe set the price for a new drug?

Panel Discussion

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March 05, 2019

Strategies for Implementing value-based pricing and reimbursement for orphan drugs

Panel Discussion

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January 07, 2019

37th Annual J.P. Morgan Healthcare Conference

The annual J.P. Morgan Healthcare Conference is the worlds largest investment conference in the healthcare industry, bringing together biotech and emerging pharmaceutical companies, industry leaders, innovative technology developers and members of the financial community.
Contact us to schedule a meeting with our experts in San Francisco!

December 12, 2018

Seminar

This seminar focuses in particular on reimbursement and market access for complex, innovative medical devices. Who will pay for such devices? What reimbursement and cost-coverage systems exist? What are the necessary pathways for bringing these devices to market? The seminar will focus on Germany, France and the UK. This seminar is by invitation only. Please feel free to contact us if you are interested to join.
Please contact us for further information about this seminar.

December 12, 2018

Seminar

This seminar focuses in particular on reimbursement and market access for complex, innovative medical devices. Who will pay for such devices? What reimbursement and cost-coverage systems exist? What are the necessary pathways for bringing these devices to market? The seminar will focus on Germany, France and the UK. This seminar is by invitation only. Please feel free to contact us if you are interested to join.
Please contact us for further information about this seminar.

November 10, 2018

IGES Aussteller auf der ISPOR - Exhibiting Organization

For further information and scheduling, please feel free to contact us.

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November 05, 2018

IGES Aussteller auf der Bio Europe 2018

For further information and scheduling, please feel free to contact us.

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October 10, 2018

IGES Aussteller auf der Bio Japan 2018

For further information and scheduling, please feel free to contact us.

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