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 Fall 2019


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In this issue, Xcenda's HTA Quarterly editors examine cost-effectiveness assessments for innovative but high-cost treatments, market access for cell and gene therapies in key European countries, and the newest joint HTA assessment agency, FINOSE.




"Understand the ideas, concerns, and expectations of whoever you are talking to. You have to recognize that around the world, there are some really good people who want to make a difference."


- Sir David Haslam's advice to the new Chair at NICE as he prepares to step down after 6 years in the role. PharmExec.com: Looking Back at NICE: Sir David Haslam


3 or 3:1 or 3 in 1


The number of agencies concurrently approving combination Keytruda plus Lenvima for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation. The approvals from the US FDA, the Australian Therapeutic Goods Administration, and Health Canada mark the first collaboration between the agencies under Project Orbis. The collaboration aims to reduce the burden and delays associated with regulatory reviews of cancer therapies and identify regulatory divergence across review teams.

Source: Simultaneous review decisions for pembrolizumab plus lenvatinib in Australia, Canada, and US


Examining Curative Therapies and Risk-Sharing at ISPOR Europe 2019


More than 650 attendees gathered to hear global industry leaders from Germany, France, Italy, the UK and the US provide perspectives on HTA and affordability challenges of curative therapies during Xcenda's recent symposium at the ISPOR Europe 2019 conference in Cophenhagen.

Xcenda's Jay Jackson, PharmD, MPH, Senior Vice President of Consulting Services, and Dr. Thomas Mittendorf, Managing Director of Xcenda GmbH, led an insightful discussion around value assessment and risk-sharing for new and innovative curative therapies

Download the symposium presentation titled, Can We Afford Curative Therapies Without Sharing Risks? Perspectives on HTA and Affordability in This New Innovation Era.


For 25 years, companies have turned to Xcenda's leading team of value experts, transforming evidence and market intelligence into effective global market access strategies and solutions. Founded in the application of health outcomes and reimbursement, it's our goal to help prove the inherent worth of client products and services, maximize patient access, and enhance overall brand performance.

Explore our solutions >


Subscribe to the newsletter written specifically by and for Global HEOR and Market Access professionals.


Kellie Meyer, PharmD, MPH
Vice President,
Global Health Economics & Outcomes Research, Xcenda

Kimberly Riggs, MPH
Global Health Economics & Outcomes Research, Xcenda



Josep Darba, PhD
Professor | Department of Economics | University of Barcelona | Spain

George Papadopoulos, BSc(Hons), GradDipEpi
President | Emerald Corporate Group | Australia

Ken Redekop, PhD
Associate Professor | Erasmus University Rotterdam | The Netherlands

Eldon Spackman, BA, MA, PhD
Assistant Professor | Community Health Sciences | University of Calgary | Canada

Keith Tolley, MPhil, BA
Director | Tolley Health Economics | United Kingdom

Thomas Mittendorf, MSc, PhD
Vice President | Xcenda GmbH | Germany

Trent McLaughlin, BSc(Pharm), PhD
Vice President, Real-World Evidence | Xcenda | United States

Michael Eaddy, PharmD, PhD
Vice President, Scientific Consulting | Xcenda | United States

Jay Jackson, PharmD, MPH
Senior Vice President, Consulting Services | Xcenda | United States


Vishwas R. Agashe, MSc, PhD | Clémence Arvin-Berod, PharmD | David Campbell, PharmD, MS | Akash Danavar, PharmD, MS, MPH, MA | Kimberly Gittings, PharmD, MS | Anne Loos, MA | Kristen Migliaccio-Walle | Ulf Persson, PhD | Kyler Tormey, PharmD Candidate | Joris van Stiphout, MSc



Laurie Kozbelt | Ellen Olson | Tia O'Brien | Jackie Britton | Vanessa Vega | Elana Gruen


 Fall 2019


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