Market Access in Catalonia: 2022 Trends and What’s Next

What is the 2022 BioRegion report?

Alira Health is a key contributor to the annual benchmark study that analyzes the life sciences and healthcare sector in Catalonia, conducted by BioRegion of Catalonia (Biocat) together with CataloniaBio & HealthTech and ACCIÓ. The report, now in its 13^th year, gives a snapshot of the life sciences and biotechnology sector in Catalonia, one of the leading regions in Europe.

How has Alira Health contributed to the BioRegion report?

We felt that readers of the BioRegion Report could benefit from an analysis of market access in the Catalonian region. Biocat agreed and Alira Health joined the project in 2021. Alira Health is the only consulting company participating in this unique project. Our contribution to the BioRegion Report provides insight for Catalan companies that are looking to open new markets in the EU and maximize their commercial success.

We focused on two aspects – biotech and MedTech; each has its own unique characteristics and implications when it comes to market access. For example, the process of bringing a pharmaceutical product to market is highly designed and defined, so a company that wants to launch a new drug can identify  the steps they need to take, what evidence they need to provide, and how their product will be valued. It’s a transparent process.

Whereas for MedTech companies, there are a number of different ways to reach the market. You have the tendering process. You can send the device for centralized evaluation. You can negotiate pricing. And it’s all much less well defined. So we took a look at both aspects in great details.

Starting with biotech, how did you approach your analysis and what conclusions did you draw?

We looked at Catalonian companies who have created and launched either an innovative drug or a sequential innovation/hybrid drug, and we looked at five major markets – Germany, the United Kingdom, Italy, France, and Spain. Our analysis was done with public data. We compared time to market and price levels, pricing being a major factor in how slow or fast a product can launch. The markets are very different because each country has its own regulations and processes. For example, in Germany, you can begin selling your product as soon as you receive approval, and set your own price for the first year. And although the companies analyzed were local, Spain is where it takes longest to launch into the market: nearly three years. These insights are important for new start-up companies to understand.

When it comes to sequential innovation/hybrid molecules, the picture is much different. Catalonian biotechs are prioritizing the internal Spanish market for hybrids. One ophthalmologic drug launched across four of the five markets in less than 200 days, but otherwise, the focus for companies was on Spain. And the minimum number of days to launch in Spain was only 137 days vs. 349 for innovative drugs, so the strategy is on point. Hybrid drugs are also less expensive to develop, so it makes sense that smaller companies would focus on launch as soon as possible with the least investment required.

Payers do not value hybrid and innovative medicines in the same manner. They find it difficult to value hybrid drugs during price and reimbursement negotiations, and this can delay market access. Investment into generating evidence is another important factor in the difference in access between innovative and hybrid drugs. Both clinical and real-world evidence is normally scarcer for hybrid medicines due to the lower market opportunity. For the hybrid products we analyzed, the evidence was only generated in Spain and, therefore, only this market has generally been accessed.

We predict that while in the past, the pharmaceutical sector was divided pretty evenly between innovative and hybrid molecules, we believe that the enormous number of new biotech startups in Catalonia will lead to more new innovative molecules in the coming years.

What did you discover in MedTech?

For MedTech, we looked at market access from the perspective of those products with regulatory classification and those without. Biocat conducted a survey of Catalonian companies and that was our source of data. Entering the market, whether public or private, is less difficult for those products that do not require regulatory classification, such as digital solutions – in fact, it’s 26% more likely that those products will reach the market. But once in the market, it’s easier for products with regulatory classification to be internationalized and to obtain public reimbursement. So if your product is a watch that tracks your heartbeat and is not classified as a medical device, you’ll be 22% less likely to successfully internationalize that product (see page 42 of the BioRegion Report).

Catalonian companies looking for reimbursement in Catalonia/Spain will have greater success there than in Europe, due to a common language and knowledge of the Spanish system. Working with partners who have the experience and language skills in each country is one solution.

New regulatory changes for MedTech coming in Europe will make it more difficult to enter the public market. Many companies choose to start with the private market and use the resulting revenue for the clinical development required to launch in the public market; this is probably a good strategy given what’s coming.

What is next for the Catalonian market and what should companies looking to enter be aware of?

The overall theme is change at the European level. In addition to the regulatory changes for MedTech, the EUnetHTA initiative is set to create a centralized Health Technology Assessment (HTA) network across Europe by 2025. Companies need to be aware of these changes and develop both short-term and long-term market access strategies.

Our advice is to place your investment in gathering strong evidence for your product or technology. Consider regional market access first, and be aware that Spain is a low price country compared to the rest of Europe.

Armed with the analysis detailed in the 2022 BioRegion Report, pharma and MedTech companies in Catalonia can weigh their options and decide on a market access strategy that makes sense for them.