Regulatory approval and market access:

A winning combination for drug launch optimization

Marcus Deans, Mark A De Rosch and Emmanuelle Voisin

Published in SCRIP Regulatory Affairs, October 2014

CONTENTS

01 Introduction 3

02 Different angles of Market Access 4

03 Voisin Consulting Life Sciences 5

04 Additional information 6

Introduction

How can a pharmaceutical company anticipate reimbursement requirements during drug development?

Reimbursement challenges have become a major hurdle when launching a product and enabling access to the product by the patients. A new paradigm is occurring in which successful launch requires both marketing approval by the regulator and viable pricing/reimbursement from payers to support recovery of the financial investment of development costs and satisfy investors

Forward-looking companies involve marketing consideration early in development through shaping of the Target Product Profile, described by the FDA as “a format for a summary of a drug development program described in terms of labeling concepts”. Yet, fewer companies consider payer considerations prior to the availability of pivotal clinical data supporting the basis for the marketing application

In this article, we describe the pitfalls of poor planning on the market access side and suggest alternative ways of considering early dialog with payers to support a successful launch of a new drug. We look at how to make the most of scientific advice and examine how best to align progress on that front with market access discussions. While the topics covered in this article are somewhat universal, we focus principally on the US and EU markets

Different angles of Market Access

Company size and understanding Market Access in partnerships Orphan drugs and pricing

Be it potential partners, investors, or other due diligence activities, having a development path informed by both regulators and payers can add value, reduce risk, and lead to a more confident decision-making process

While a larger pharmaceutical company can potentially survive delays on a given product when it has a large number of already marketed products, a small biotechnology company with only one or two products may not so easily persevere long without this revenue

While these smaller, often single-product companies need most to understand the reimbursement situation sooner rather than later, they are also facing tight budget restrictions on what might be considered “unnecessary costs”

Smaller companies tend not to take into account the effort to understand the pricing situation when planning a partnership with a larger company

However, valuation of an asset in any partnership is based on an understanding on return on investment (ROI) by the company providing the payment to the innovator company. ROI calculations include assessment of cost of development, development risks, regulators’ expectations, market penetration (access), and reimbursement

Orphan drugs were traditionally handled via regular pricing and reimbursement channels but are increasingly being managed through dedicated structures, reflecting their increased therapeutic and budget significance

In these schemes, reimbursement requirements can vary dramatically from one country to another, requiring sponsors to navigate a labyrinth of rules, regulations, standard-of-care variations, etc.

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 partners with life science companies across European, North American and international markets

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Dr. Emmanuelle M. Voisin, CEO, created Voisin Consulting Life Sciences to support biomedical companies with fully integrated drug development programs.

Her expertise includes the design and implementation of nonclinical and clinical development plans and harmonized regulatory strategies between Europe and the USA. Learn more about her

VoisinConsulting.com

For more information