Market Access in Europe: Bridging Regulatory and Health Technology Assessment (HTA) Gaps

Daniel Muscionico, Paloma Grasser, Rosa Mouchotte and Anne Rambaud

Published in RAPS: Regulatory Focus, April 2016

CONTENTS

01 Introduction

02 Different Formats of Early Dialogues with European HTA Bodies

03 Voisin Consulting Life Sciences

04 Additional information

Introduction

The rapid diffusion of health technologies has presented governments with unprecedented challenges to provide high quality and innovative care 1: Health policy must effectively meet population health needs while managing budgets and safeguarding the basic principles of equity, access and choice of treatments. Risk/benefit assessments required by the regulators are no longer sufficient and the elements of value for money are carefully considered during Health Technology Assessment (HTA) bodies’ appraisals. In addition, the lack of harmonization between European HTA bodies’ expectations makes the exercise even more difficult. Undoubtedly, evidence requirements are more and more challenging and evolving toward risk management. Outcome or non-outcome based real world data play an important role in tailoring uncertainty and should be carefully considered by companies as being part of the HTA process.

This article introduces the roles of HTA bodies within the EU member states healthcare system and provides key elements to consider for manufacturers, which would like to enter such geographical market, on key elements to consider. In addition solutions to maximize the product development strategy are discussed, with the intention of bridging regulatory and market access gaps.

Different Formats of Early Dialogues with European HTA Bodies

Voisin Consulting Life Sciences

Cambridge, MA, San Francisco, CA & Somerville, NJ, USA London, UK Paris & Rennes, France Lausanne, Switzerland Bangalore, India

Founded in 1997 by Dr. Emmanuelle M. Voisin, VCLS is a team of over 100 life science professionals located in the US, Europe and Asia.

VCLS supports Biotech, Pharma and Medtech manufacturers to:• Design global product development

strategies• Engage with local regulators & payers

We believe that product development must be driven by a solid understanding of the environment within which the product will be launched, and the criteria by which elements of the development will be assessed by both regulators and payers.

VCLS prtners with life science companies across European, North American and international markets.

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Daniel Muscionico, Pharm.D., MBA, is the Chief Operating Officer at VCLS, specialized in healthcare economics and public health. He has over 25 years of experience in the Life Sciences Industry and led

many high level price and reimbursement negotiations with payers at national level. Learn more about him

VoisinConsulting.com