CASE STUDY
European HTA Submission Programme
Planning and execution of health technology assessment (HTA), price, reimbursement submissions in European markets
Situation
A US-headquartered clinical-stage biotech with a limited European footprint needed to launch their first product in Europe
Price and reimbursement strategy needed tailoring to Europe, 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 project, complementing our distinctive European-level value strategy expertise with a selection of trusted in-country partners to:
- Define a European-oriented value proposition and value-based price for the product, cognizant of heterogeneous country-level requirements and comparisons
- Initiated and managed HTA submissions for 5 priority European markets, ensuring local effectiveness at the same time as consistency with European and global strategy and value evidence
Enabling Activity
Training development & delivery
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 Wave 1 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
