Case study

European HTA Submission Programme

Planning and execution of health technology assessment (HTA), price, and reimbursement submissions in European markets

Situation

A US-headquartered clinical-stage biotech needed to launch its first product in Europe.

The company’s pricing and reimbursement strategy needed tailoring to European markets, in parallel to initiating HTA submission preparation for priority markets with regulatory timelines and investor commitments looming.

Action

AESARA quickly structured a focused and flexible engagement, complementing our distinctive European-level value strategy expertise with a selection of trusted in-country partners to:

  • Define an European-oriented value proposition and value-based price for the product, cognizant of heterogeneous country-level requirements and comparisons
  • Initiate and manage HTA submissions for five priority European markets, ensuring local effectiveness at the same time as consistency with European and global strategy and value evidence
  • AESARA created efficiency and connectivity by using ATLAS, a digital AI-enabled tool, in lieu of a traditional global value dossier.  Using ATLAS, AESARA mapped value messages, evidence and activities, making a flexible, tailored strategy available to country teams for each of their European markets

Value & Access Consulting

  • Enabling Activity
    European HTA Playbook
  • Region
    Europe
  • Client
    Global Head of HEOR

Impact

AESARA acted as the European Market Access function for the client biotech, thinking strategically and operating proactively to ensure

  • Product price and positioning were optimised in line with country clinical practice and available evidence
  • Submission timelines and budgets were tightly managed across priority markets, with synergies identified and client spend carefully minimised
  • Client executive team felt in control of the access programme, while remaining able to focus on their core commercial and medical accountabilities

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