European deep dive reimbursement review to inform the market access strategy for a product in an orphan indication

Defining evidence requirements for reimbursement in five EU countries


The challenge

Our client wanted to develop a global health economic and outcomes strategy for a new product in development for an orphan disease. There was a need for a greater in-depth understanding of the country-specific evidence requirements to support reimbursement of their product in the key EU markets (UK, France, Spain, Italy and Germany).

The solution

Our in-house research team reviewed local language Health Technology Assessment (HTA) guidance and relevant competitor product appraisals from each country in order to demonstrate how the reimbursement process and requirements were implemented in practice, along with detailed research into the reimbursement pathways and potential approaches for the client’s product.

Key results

We provided insightful, product-tailored conclusions in the following areas:

  • National and regional preferences and guidelines for core clinical and health economic evidence requirements.
  • Imminent and recent healthcare reforms (such as UK value-based pricing and the German AMNOG system implementation), orphan products and requirements for the specific therapeutic area.
  • Analysis of inter-country variations in reimbursement guidelines, criteria and approval processes, highlighting the transferability of data.
  • Evaluation of previous submission appraisals for competitor products across markets, with identification of diverging decisions.

Value to the client

We provided our client with the evidence and recommendations to support their market access strategy in Europe.

This in-depth overview of the reimbursement requirements was also used across their portfolio of products in development to inform value and market access strategy development, providing value beyond the immediate product of interest.

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