RARE - Ulf Staginnus

Meet Our Guest: Ulf Staginnus

On this episode of RARE, I’m delighted to welcome Ulf Staginnus. Ulf is an international executive in Market Access, Pricing and Health Economics with nearly 30 years of experience across start up biotech’s, big pharma and consultancy across a range of therapeutic areas, including many orphan diseases, cardiology, oncology and specialty pharma.

Having held various leadership positions within companies such as Endocyte, Shire and Ipsen, Ulf now leads International Market Access and Pricing at Blueprint Medicines, a global biopharmaceutical company that develops life-changing medicines in two core areas, allergy/inflammation and oncology/hematology.

 

Welcome Ulf – can you talk us through your journey so far?

I have been working more than a decade now in Zug, Switzerland focusing on strategies for pricing, reimbursement, and value demonstration for innovative medicines, including many orphan drugs and specialty therapies. During this time, I have been involved in research initiatives aimed at understanding orphan diseases better. This includes studying their prevalence, underlying mechanisms, and potential treatment strategies.

One of the emerging areas and an increasingly critical components of the work in rare diseases is collaborating with non-profit / patient organizations and foundations dedicated to orphan diseases. These partnerships often focus on raising awareness, funding research, and supporting patients and families affected by rare diseases and play a pivotal role in really understanding the burden of disease, the patient experience and what the true unmet need is.

Those insights are particularly relevant for companies like Blueprint Medicines that are launching precision therapies and orphan drugs in Europe, where market access and pricing are highly regulated and require robust value demonstration.

Other focus areas of my work include developing management frameworks that can help healthcare providers and researchers navigate the complexities of orphan diseases, including pricing and reimbursement pathways and patient access schemes to treatments. Direct payer dialogues and elaboration and execution of county specific negotiation strategies form another large part of my daily work.

We also spend significant efforts on educational programs aimed at healthcare professionals and payers raising awareness about orphan diseases and emphasizing the importance of early diagnosis and innovative treatment approaches.

In addition, as healthcare systems are constantly evolving in their framework of evaluating and funding rare diseases, I keep a close eye on developments and frequently speak at industry conferences, attend relevant forums and publish on topics related to pricing, reimbursement, and market access of orphan diseases and beyond.

 

At the start of the year, you published an article called “Breaking into European Biotech” that gained a lot of traction! In it, you provided some of your thoughts on how companies can be successful in their entry into Europe, a topic that has been and still is spoken about a lot! What were the main points you covered in that article?

Indeed, that is still a hot topic even more though with all the most recent discussions of pricing of pharmaceuticals in the US versus Europe under the Most Favorite Nation Policy of the Trump administration. There has been a period of stagnation but most recently we have seen more US Biotech companies setting foot here in Switzerland again, and particularly in Zug, to build out European and International headquarters to enter the European market with innovative pharmaceuticals.

One of the key points from that article is that understanding European HTA requirements, in a couple of years also joint HTA for all rare diseases, is the cornerstone to success in Europe. Clinical trials and evidence generation, even post launch need to be geared towards the reality of those European healthcare systems to be able to be successful as a biotech company in Europe. That goes along with hiring hands on, pragmatic and experienced people, realistic assumptions of the asset at hand, empower teams the right way to be able to operate efficiently from the “Mothership” and keep the company lean and efficient.

The cadence of health policy changes in European market has significantly increased over the years, being close to these developments, forming payer partnerships on access and pricing models that go beyond the price per pill concept and are most likely tailored to RWE over a life cycle will become a common thing in the future I would expect. That needs the right qualifications and a modern innovative ‘in company’ mindset.

A lot is being said about AI these days in our industry, and data will undoubtedly play a much bigger role but in practice; yet a lot needs to happen especially within the healthcare system administrations of each country. As an internationally working executive I personally experienced difficulties, for example, sending a simple MR scan result from one country to another. That is anything but good and the key to success in making partnerships between the biotech industry and payers more efficient and to bring it closer to the often-desired closer link towards a real-world performance drug reward system.

 

Now we’re almost a year on from the article, have you seen any shifts in the European access environment that either present opportunities or additional challenges for companies?  

Overall, while there are promising trends in improving access to biotech drugs across Europe, challenges remain, particularly regarding pricing, reimbursement, and strong regional disparities. Some companies remain reluctant to invest in Europe due to what they perceive as a hostile access environment and inaccessible markets in certain countries. Particularly the UK with the NICE system where prices can be seen that do not support companies seeing the UK as an attractive market for orphan (and other) drugs – a reform of the QALY threshold is being discussed within the NHS to increase funding possibilities.

Hence, continuous efforts are needed to ensure equitable access to innovative therapies for all patients in Europe, which includes stable frameworks for the industry to operate in as well as pricing and reimbursement systems that are set up to accommodate emerging evidence as part of more dynamic payment and reimbursement schemes.

Objectives are clear among all stakeholders in Europe – faster and equitable access to patient access to disease modifying treatments that considers affordability aspects yet also the need to properly reward innovation to keep developing innovative medicines. However, on both sides, administration as industry alike, too much old school thinking and procrastination in bringing key areas forward is taking place and that needs to be overcome to make the EU an attractive place for biomedical research and patient access again. We would come a long way already if we were able to use nowadays the power of data gathering and analytics as well as AI capabilities to instantly track what happens to a patient under a new treatment in real-life and what are the true individual patient outcomes over time – a most important component in rare diseases with very small patient numbers where most often “true” outcomes cannot be determined only by an assessment of a pivotal, most often phase 2 trial. Lots to come I’m sure. Overall, less talk more actions seems indicated as time is of essence, especially in rare diseases.