Preparing for Successful Market Access and HTA Assessments in Europe
Author(s)
ABSTRACT WITHDRAWN
OBJECTIVES: A successful launch of a pharmaceutical product in across European markets hinges on careful and timely preparation to meet stakeholder requirements and expectations. All preparatory activities are interconnected; therefore, it is important to understand how activities should be timed relative to each other to avoid inefficiencies and gaps in information. This research explores the key activities and associated timelines to consider when preparing for successful market access and HTA assessments in Europe
METHODS: A review of the literature was conducted to analyse key steps required to prepare a drug for European market access while a review of select EU market regulatory/HTA bodies decisions and publications, allowed for an analysis of historical examples of pharmaceutical products that underwent launch over the past 10 years. These insights were consolidated to generate a step-by-step timeline of activities required for successful launch in the EU, highlighting the opportunities and barriers of different European market archetypes.
RESULTS: Successful launch planning has been categorized into five key phases each with an optimal timeframes relative to market entry; these include, (1)
Landscape Analysis (48-months through 24-months pre-launch; with continuous updates), (2) Evidence Generation Planning (24-months pre-launch through 3-months post-launch), (3) Pricing Strategy (24-months through 6-months pre-launch), (4) Payer Engagement Preparation (24-months pre-launch through 3-months post-launch), and (5) HTA Preparation (18-months pre-launch through to launch). Each of these phases have been distilled further to outline critical activities for each preparation phase, highlight key learnings from historical product launches, and generate considerations for each European market archetype.CONCLUSIONS: Systematic and early planning for market access is essential to secure optimal price and access. Understanding the landscape, generating robust evidence, developing pricing strategies, engaging with payers, and preparing for HTA assessments are crucial steps in achieving successful market access in Europe.
Conference/Value in Health Info
Value in Health, Volume 26, Issue 11, S2 (December 2023)
Code
HTA67
Disease
No Additional Disease & Conditions/Specialized Treatment Areas