HTA in Europe: Key Success Factors for Positive HTA Recommendations

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Publication Date:
June 2018
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Is there a magic formula for achieving HTA approvals in Europe?

Securing a HTA approval in Europe makes sound commercial sense but it's proving easier said than done. Negative or restrictive HTA recommendations are on the increase, and market access professionals are scratching their heads wondering what can realistically be done to ease the process.

We spoke to experts at seven top tier pharmaceutical companies to find out their latest thinking on European HTAs, the difficulties faced, and how they are being overcome. We used their detailed responses to collate a fresh perspective on the current trends and to identify the key success factors involved in securing a positive HTA recommendation in Europe. Various issues were identified:

  • One size does not fit all: Why is it imperative to have a strategic approach to HTAs in Europe? What should European MA teams know about fundamental market differences?
  • Difficulty seeing the bigger picture: There's no question that Europe has plenty of potential. Use this report to step back and assess key markets where your HTA strategy can be applied.
  • Lack of clarity around what's really needed: Find out how to think like a HTA agency, gain a better understanding of their requirements, and ultimately improve your strike rate.
  • Insufficient resources: There are no shortcuts to success, which means that significant resources are needed if HTA approvals are to be achieved. Use this report to build internal understanding of the nuances of European agencies and show why more support is vital.

What to expect from this report

The proliferation of HTAs across Europe makes market entry complex to address. [DN: This report doesn't include the US and I don't agree that Europe is less complex so have amended accordingly] This report delivers the overview and specific insights needed for European teams to see their markets in context, and to set the foundation for a more nuanced and more productive HTA strategy.


This is 100% new qualitative research based on expert interviews conducted in April and May 2018. All the experts selected are currently actively involved in securing HTA approval.

  • We identified 13 core issues facing pharma companies seeking European HTAs
  • We explored these via an average of 22 targeted questions put to 7 leading experts
  • Their responses provided 80 unique new insights
  • Insights are supported by 187 directly quoted comments

Example insight included in HTA in Europe: Key Success Factors for Positive HTA Recommendations

Overcoming HTA agencies' concerns about evidence might need particular methodologies such as indirect comparisons and network meta-analysis, particularly in the absence of head-to-head trials, but this is not acceptable to all. In Germany, indirect comparisons and network meta-analysis are not acceptable, whereas they are accepted in the UK and in the Nordic countries.

Example quote included in HTA in Europe: Key Success Factors for Positive HTA Recommendations

"You need to develop your own cost effectiveness model and identify within each product and each indication what are the drivers of cost effectiveness, and those may change. And that's why I cannot give you a straight answer on what is the key driver because it could be price, but it could be something else."
HEOR Expert Switzerland

The expert panel for HTA in Europe: Key Success Factors for Positive HTA Recommendations

  • Associate Director for Health Economics and Outcomes Research (HEOR) at a top 20 pharmaceutical company
  • Director of Market Access at a top 30 pharmaceutical company
  • Global Pricing and Market Access Health Economist at a top 10 pharmaceutical company
  • Head of Market Access & Healthcare Affairs at a top 20 pharmaceutical company
  • Health Economics and Outcomes Research (HEOR) Manager at a top 10 pharmaceutical company
  • Health Technology Assessment Associate at a top 10 pharmaceutical company
  • Senior Manager in Market Access in a top 10 pharmaceutical company

Why buy now?

The pharma industry has not traditionally provided many opportunities for peers to comfortably share their professional experiences and come up with new ideas to combat common problems. Which is why reports like this make such a difference. We've explored the issues, asked the important questions, and got a sense of what the latest thinking is—so you don't have to.

Why FirstWord reports are different

  • 100% new content: Every report is compiled from scratch—so you won't find out-of-date viewpoints you've seen before. And that's a promise.
  • Opinions you want to hear: We work hard to seek out experts with in-depth and current experience, as well as fresh ideas and insider perspectives.
  • Professional researchers: Our interviewers have the knowledge, experience and contacts to ask the right questions and uncover the answers you need.