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Health Technology Assessment (HTA) is becoming an essential part of European market access. These assessments have become the basis for drug reimbursement and budget allocation decisions in many European countries, making the submission process a key component of successful marketability of any new treatment.

But mapping a successful submission process is complicated. Each country is individually developing different HTA systems and methodologies for their assessment, and although agencies publish guidelines, it is unclear how clinical, economic and societal factors are incorporated and weighted by HTA bodies. This makes it difficult for drug developers to understand what appraisers will look for, and to create a submission that will best appeal with their decision-making requirements.

To help better understand the varied HTA landscape throughout Europe, Quintiles conducted an in-depth study into the drivers for HTA decision-making in the key European markets. We conducted the research by reviewing HTA recommendations from agencies in five different European markets – the French National Authority for Health (HAS), the Federal Joint Committee (G-BA) in Germany, the Dutch National Health Care Institute (ZIN) in The Netherlands, and the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) in the UK. We compiled the data from our HTA Accelerator platform and analyzed the impact of more than 60 factors that were identified as potentially important in a preliminary literature research. Through two types of regression analysis, we analyzed which factors enhance positive HTA recommendations, which have little or no impact, and which have a negative impact. Not surprisingly, we found that there are many factors influencing decision-making in these agencies, including how different HTA bodies value drugs, the drug category, how existing competitors affect evaluation, and the priorities of the assessors. In general, our findings are in line with previous research and can be broken down in three themes between markets.

  1. Clinical evidence is valued across all markets. Our research shows that clinical evidence plays an important role in the decision making for all HTA bodies. It had the biggest positive impact in France, followed by Germany, the Netherlands, and SMC. Assessments conducted by NICE were the least affected by clinical evidence, though the research indicates that this evidence still as a positive-to-neutral impact.
  2. The impact of economic evidence varies wildly. As we expected, the different bodies have very different opinions of the value of economic data. While economic issues had a very high positive impact on successful submissions for NICE and SMC, it had virtually no impact in France or Germany. For ZIN hardly any economic data was available, but expert interviews highlighted the importance of economic factors for a positive decision in the Netherlands.
  3. Societal evidence has a neutral impact for all countries surveyed. While HTA assessors in these regions don’t discount societal evidence, societal evidence was not associated a high positive impact on success in any of our models.

Beyond the broad strokes, our results confirmed some other noteworthy trends in the specific countries. .For example, comparative clinical effectiveness was associated with a higher odds of receiving a positive recommendation in both France and Germany, albeit in France also evidence from placebo-controlled trials was associated with a higher odds of receiving a positive recommendation. In the Netherlands, ZIN values data from all categories — clinical, economic and societal — in its assessment process. Though interestingly, we found that being the first to market with a drug was viewed negatively in this country. This was surprising, as most industry leaders assume that being the first to market with a new treatment would be considered a positive attribute.

Not surprisingly, we also found that for NICE and SMC, the incremental cost-effectiveness ratio (ICER) plays a decisive role in their decision-making. Specifically, submissions reporting an ICER below the threshold of £30,000 was a key driver for a positive recommendation by NICE. On the other hand, submissions reporting an ICER above £35.513 for SMC, was shown to have a detrimental effect on the recommendation.

It is important to note that the results shown in this research describe associations, rather than causal relationships, but are backed up by expert interviews and in-depth analyses. And while the results did not uncover a fool-proof model for successful submissions in every country across Europe, it does offer the beginnings of a roadmap for developers on the best types of data to generate and present for HTA assessments in each region. By better understanding the factors driving positive HTA recommendations in these markets, developers can first identify which HTA agencies will be most amenable to their product, then proactively gather and assemble the best submission material to meet the needs of decision makers. Having this knowledge and applying it to the submission process will save them time and money, and improve their odds of success. 

Topics in this blog post: Biopharma, EMA, EU, HTA, Healthcare Cost