The Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the cell and gene therapy and broader advanced therapies sector, is hosting a multi-stakeholder meeting in Brussels on 12 December, focused on European market access to Advanced Therapy Medicinial Products (ATMPs). The event will be webcast live, with full details available here.
Representatives from patient associations, industry, alongside government and regulatory agencies, including the EMA, the European Commission and payers from Germany, the UK and Italy, will share insights through panels and presentations at the event, entitled Getting ready: Act now for access to ATMPs in Europe.
Speakers will discuss their current experience with access to ATMPs in Europe as well as exploring topics such as evidence requirements, registries and innovative payment schemes. In addition, ARM’s CEO Janet Lambert will give an overview of the ATMP landscape in Europe and ARM’s recently published consensus report on the subject. The full schedule of the day is below.
ARM’s European consensus report brings together together the views of European policymakers and experts, developers and manufacturers of ATMPs, patient organizations, and other stakeholder groups. It acts as a comprehensive review of the regulatory and market access framework across major European countries and identifies potential hurdles to adoption. While regulatory frameworks have been implemented to ensure appropriate, rapid approval of ATMPs, the report highlights that payers and health technology assessment bodies have not yet established all the necessary specific mechanisms to capture the full benefits of these therapies, creating potential barriers to timely patient access post-approval. The full list of recommendations can be found below.
Janet Lambert, CEO of ARM, commented: “ATMPs have the potential to offer a durable, life-changing therapeutic effect, possibly with a single administration, for patients who may have few or no alternative treatment options. However, this new approach to treatment has created challenges on how to most effectively get these therapies to patients in a sustainable manner. At ARM, we are committed to the advancement of these life changing therapies and we therefore produced our recommendations, alongside key stakeholders, to help accelerate this in a European consensus report. Organizing a European stakeholder meeting was the natural next step and our hope is that the discussions held on 12th December will facilitate helpful pan-European dialogue and improved access to ATMPs for patients.”
Journalists interested in attending in person should contact firstname.lastname@example.org for further details.
Brussels Event Schedule
|10.30 CET||Opening and introduction: Janet Lambert – CEO, ARM
|Current experiences with access to ATMPs
Presentation: Dick Sundh – Head of Kite Pharma Europe,
a Gilead Company
|Panel session – Real-World-Evidence (RWE): how to standardize evidence requirements, improve acceptance and develop pan-European infrastructure for advanced therapies?
Chair: Ken Genenz – Global Payer Value and Patient Access Lead,
Ana Hidalgo-Simon – Head of Specialised Scientific Disciplines Department,European Medicines Agency
Simone Boselli – Public Affairs Director, Eurordis
Etienne Jousseaume – Head Market Access Cell and Gene Europe, Novartis
Maria Pilar Aguar Fernandez – Head of Unit, DG Research, European Commission
Giovanni Tafuri – Senio Scientific Officer, EUnetHTA and ZIN
|12.30||Lunch and networking|
|13.15||Presentation payer perspective – Dr. Anja Tebinka-Olbrich – GKV|
|Panel session – Innovative payment models for advanced therapies
Chair: James Paton – Reporter, Bloomberg
Tamir Singer – Head of Commercial Access & Value, NHS England
Tresja Bolt – Head of European Public Affairs, Bluebird bio
Bernard Grimm – Healthcare Biotech Director, EuropaBio
Dr. Anja Tebinka-Olbrich – Head of Unit AMNOG EBV, GKV – Spitzenverband
|15.00||Wrap up and conclusions|
Recommendations from European ATMP consensus report
Recommendation 1: Better adapt Health Technology Assessment (HTA) frameworks to ATMPs:
Recommendation 2: Favor wider application of conditional reimbursement schemes:
Conditional reimbursement schemes have the potential to mitigate uncertainty on duration of effect based on data available at time of regulatory approval. This approach is in use in several countries and a wider application in Europe for ATMPs is recommended.
Recommendation 3: Develop pan-European initiatives to create:
Recommendation 4: Favor wider application of innovative access and funding arrangements such as:
New payment models are needed to ensure timely patient access to innovation while preserving sustainability of healthcare systems. Without the adoption of these new models, some transformative therapies may not reach patients in some or all European countries and some may be at risk of withdrawal from the market.
For more information about the report or media requests, please contact Kaitlyn Donaldson Dupont from the Alliance for Regenerative Medicine at email@example.com or Consilium Strategic Communications at firstname.lastname@example.org.
About the Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory, and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. Founded in 2009, ARM works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its 350+ member organizations worldwide. ARM represents the interests of therapeutic developers, academic research institutions, major medical centers, investors, and patient groups that comprise the broader regenerative medicine community and is the prominent international advocacy organization in this field.
ARM has 70+ members across 15 countries in Europe. ARM aims to work closely with European stakeholders, leveraging its membership to create a supportive commercial and regulatory environment to create better conditions for the development and commercialization of ATMPs in Europe; develop strong stakeholder support around proposed solutions to improve patient access to ATMPs; promote clear, predictable and efficient regulatory framework across Europe; and promote international convergence of key regulations and guidances. For more information, visit alliancerm.org.