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

Market 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

Case study

European HTA Submission Programme

Changing a US-oriented evidence generation program for European success

Situation

A US-headquartered biotech was developing a novel molecule in a pain indication.

Placebo-controlled pivotal studies met primary endpoints, consistent with FDA expectations, and the product was on track for NDA submission.

However, European payers expect evidence of value versus currently used therapies, so our client needed AESARA’s European access experts to inform their European access strategy

Action

The key activities to provide guidance on the optimal access strategy were

  • Conduct EU5 landscape assessment based on desk research, European access experience & expertise
  • Use digital market access decision tool to characterize risks and opportunities of each option
  • Lay out the strategic options with cross-functional stakeholders for access in Europe
  • Use our direct industry experience to shape recommendations to inform executive decisions on access investments for Europe

Market Access Consulting

  • Product Strategy
    Market Access & Value Strategy
  • Region
    Europe
  • Client
    Global Product Team

Impact

  • US-based client brand team and executive stakeholders educated on price, access and reimbursement in key European markets

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