ATMPs – Prepare for Successful Access in a Changing Environment

Published on January 19, 2023

In this article, we discuss the expected impact of current trends and healthcare system initiatives on advanced therapy medicinal products (ATMP) Pricing & Market Access and highlight the resulting opportunities and challenges for manufacturers. Read our recommendations on how to best prepare for successful access here.

We have entered a new era of personalized medicine, where one-time treatments can lead to complete eradication of diseases. Advanced therapy medicinal products (ATMPs), encompassing gene therapies, somatic cell therapies, and tissue-engineered products, have different characteristics compared to most existing marketed therapies. They come with a number of access challenges such as single, upfront payments, launching with limited data, and durable/curative claims not proven at the time of launch.

To address the challenges associated with ATMPs, as well as other non-standard medicines, many European markets are undertaking…