Tashia Lentz of Biogen outlines what she sees as an increasingly tough market access environment for new treatments in Denmark and calls for greater stakeholder openness to innovative pricing schemes. Lentz also makes a comparison between the life sciences ecosystems in Sweden, where she spent three years heading up Astellas’ affiliate, and Denmark, highlighting several areas in which Denmark could improve.
Having worked across Sweden, Norway, and Finland, I can say that, unfortunately, Denmark has become the most difficult Nordic market in which to launch new medications. The Danish Medicines Council’s data demands are extremely tough, which results in fewer approvals
As you are fairly new in this role, can you tell us why it was the right time to take on a new challenge as managing director of Biogen Denmark?
For the past three years, I have headed up the Swedish affiliate of Astellas as country manager and really got into the nitty-gritty of introducing new medicines to Sweden. I sat on the board of the national industry association Lif and worked closely with the 21 Swedish regions. During this period, I gained a deep knowledge of what it takes to be a successful pharma company in Sweden.
Prior to that, I led the Astellas marketing organization for sales across the Nordics, meaning that I interacted very closely with all the Nordic markets, including Denmark. I was actively involved in building go-to-market models and strategies, both from a marketing and access point of view, through active engagement and dialogue with key stakeholders across the four markets.
My new role at Biogen represents a fantastic opportunity to get into the details of Denmark. Although I grew up here as an adoptee in my Danish family and started my career in pharma here; I have never had the chance to head a local Danish affiliate as general manager before. Bringing my knowledge and skillset from my time working across the Nordics – including in markets like Sweden that are in many ways more challenging than Denmark – will stand me in good stead here.
Moreover, I was attracted by Biogen’s product portfolio, which is unique and hugely exciting. The company has a lot of very promising compounds for neurological diseases in development, many in areas with huge unmet needs.
Biogen stands out within the world of Big Pharma in its 100 percent focus on neuroscience, an area where many other players have divested or shelved research. What are the challenges and advantages of this neuroscience focus?
I started out my career and spent six years at Lundbeck, which had decided to concentrate the company’s existing and future portfolio on CNS. I was a part of that transformation and witnessed the benefits that Lundbeck reaped from it.
Of course, focusing on a single therapeutic area and a niche population does lead to vulnerability. Lundbeck was rather vulnerable for a long period of time because of its focus on anti-depressants and the psychiatric arena, but I do not see the same vulnerability in Biogen. Even though we are focused on neuroscience, our scope is quite wide within that. We have been pioneers in the treatment of multiple sclerosis (MS) for over a decade, have a medication in spinal muscular atrophy (SMA) and are researching and developing within neurologic areas with great patient need like Alzheimer’s Dementia, amyotrophic lateral sclerosis (ALS), Parkinson’s, and Lupus. Our pipeline also holds promising compounds within ophthalmology, post-partem depression, pain, and stroke. Another key element for Biogen is our biosimilar franchise, which provides a good value proposition to payers alongside our innovative drugs.
Have your first few months in the job been focused on firefighting COVID-related challenges, or has business performance allowed you to set longer term goals?
Thankfully, the Danish affiliate has been growing well over the last five years, and even beyond that. Our MS franchise has been an excellent source of solid growth. However, it is no secret that we have faced difficulties in getting an agreement in place to introduce our SMA product here. While it is a costly treatment, it only serves a very small patient population, meaning that the challenges around its full approval have not caused a big disturbance in terms of delivering on our numbers.
Another important point is that we are a very lean organization and in fact the most lucrative Biogen affiliate per head in Europe. Biogen Denmark has just under 20 full time staff, with five or six regional roles supporting the country.
Biogen’s Alzheimer’s treatment achieved regulatory approval from the US FDA earlier this year, despite some ambiguous clinical trial results around its efficacy, and has generated a lot of headlines in the process. How have you attempted to manage expectations around what this drug can bring to Danish patients and what are the timelines in terms of bringing it to Denmark?
The situation in the US is particular to that country and while we are part of the same company, the market there is so different to those in Europe that it is difficult to draw too many parallels. We are awaiting EMA approval, and until that happens, I am not able to share perspective on our expectations for Europe, nor Denmark.
Biogen’s SMA treatment, as you have mentioned, has been the subject of heated debate with the Medicines Council and is currently only approved for paediatric patients in the country. What is your take on Danish government stakeholders’ openness to dialogue and innovative agreements with the industry around new and potentially expensive products?
There is significant room for improvement. Biogen has submitted six different offers to the Danish authorities on our SMA compound. I was involved in submitting the sixth offer to the Medicines Council, which was also rejected. And Denmark has of course not been treated any differently by Biogen than all the other EU countries, that have basically all approved the treatment for a wider usage than Denmark. In terms of treating SMA, the Danish Medicine Council is extremely restrictive. For the sake of the patients, I had hoped for our competitors to succeed and prove my perception wrong, but unfortunately, it has become heart-breakingly clear, that the Medicine Council does not believe in treating older individuals with SMA with the treatments at hand, neither Biogen’s, nor our competitors’.
Especially for a company like Biogen with so many products targeting rare diseases, there is a huge gap in the current Danish system and structure, where down-pressured flat pricing seems to be the main target for the system and there’s only little taste for innovative pricing schemes. Additionally, the models being used to determine the quality-adjusted life year (QALY) values of a treatment do not leave any room for flexibility. Many rare disease trials lack hard endpoints in the way that cancer trials, for example, have in terms of mortality reduction rates. Without these hard endpoints, it is very difficult to strike deals. Denmark needs to open up to more innovative pricing schemes and models to ensure better patient access.
Unfortunately, it has become heart-breakingly clear, that the Medicine Council does not believe in treating older individuals with SMA with the treatments at hand, neither Biogen’s, nor our competitors’
Having worked across Sweden, Norway, and Finland, I can say that, unfortunately, Denmark has become the most difficult Nordic market in which to launch new medications. The Danish Medicines Council’s data demands are extremely tough, which results in fewer approvals. For our SMA treatment, Denmark is the only one of all EU countries that has not opened up for all paediatric population. I know, the perception in the Danish system is, that the children are not in fact treated despite approvals in the different countries, but I can assure you, that in the countries I know best: Norway, Sweden and Finland all peds are in treatment.
I am more than willing to transform our approach to become as agile and innovative as possible to find solutions. We have done so with our SMA product, but unfortunately it does not currently fly with the Danish authorities.
Denmark launched the new national Life Sciences Strategy this year, one part of which is bringing about accelerated market access timelines for breakthrough innovations. Do you think this Strategy potentially represents a step change on innovative approaches to access?
It is a bold ambition on paper and definitely the right way to go, but I do not yet see this Strategy flowing down into the system and how it approaches new medications. I know that Lif has been focused on contributing to the goals of this Strategy, which is a good start, but we will have to wait and see its full impact.
Biogen sold off its Danish manufacturing arm to FujiFilm a couple of years ago and – as you have mentioned – Biogen Denmark is a small team in a modest market facing severe access challenges for its new medicines. Against this backdrop, what is the continued relevance of Denmark for Biogen and how do you convince headquarters that it is still a country worth investing in?
It might be argued that a market like Denmark could be managed from a centralised Nordic hub. There are pros and cons to such a model, and I have experienced both sides of that coin. What is important to remember is that although Denmark is small, it is in general an innovative country. Physicians here are willing to try out new medicines and Biogen is very actively engaged in clinical development programs. The country is very technologically advanced and is incorporating this technology into new healthcare solutions. Together with the rest of the Nordics, Denmark is an innovative hub and has a solid welfare structure; meaning that we have the resources to pay for new medicines. However, the system requires a number of tweaks in order to optimise it because today it does not work as well as it could.
How important is raising awareness of the burden that neurodegenerative diseases represent in Denmark and what changes would you like to see at a political level on this front?
We have engaged in a lot of campaigns, the most recent of which was a huge digital push to raise awareness and create more understanding around SMA. Right now, we are working to secure a wider understanding of Alzheimer’s disease, both among the general public and the political system, and highlight the significant burden that it places on patients, caregivers, and society.
In an alliance with other organisations concerned about the fate of AD patients in Denmark, Biogen is at the end of 2021 facilitating a big debate around ensuring that Danish society is geared towards taking care of AD patients in the future. Our joint hope is that we will see a renewed national policy plan for AD in Denmark
Looking to the future, what would you like to achieve in your time at Biogen Denmark?
My key ambition for Biogen Denmark is to deliver solutions beyond the pill. While this is a somewhat over-used phrase, there are several examples of how I have achieved this in my previous roles in the Nordics and in Sweden. I also want to create partnerships that add value to the Danish public healthcare system. If I was to join the board of Lif, which I hope to do in the long-term, my top priority would be ensuring that the right environment is in place to create those partnerships.
We need to break down the perception in the public healthcare system, the media, and among some members of the public that pharma is an unscrupulous industry, interested only in making money. I have been saddened to see that the pharma industry here in Denmark is, in general, perceived much more negatively than in Sweden. Once an understanding of the mutual benefits that public and private stakeholders can bring each other is established, we can start thinking about how relationships and partnerships between the two sides can be strengthened and optimised.
There are already good examples of this in Sweden, where the industry has established a solid and sustainable research partnership at the Karolinska University Hospital in Stockholm. The system in Sweden allows for more than the Danish system has been able to grasp so far, but there are a lot of possibilities here.
My main aim, however, remains creating better market access conditions for rare diseases in Denmark, which still lags behind some other nations in terms of creating innovative access models.
Additionally, patient engagement and enrolment are key focus areas. In addition to breaking down the perception barriers that exist, we need to include the patient voice as early as possible, even in the R&D phase, taking on their points of view and advice. The industry should work towards a world where patients are much more involved at all stages of the drug development process and where they are more empowered to take charge of disease management and coach others on it.
As a woman, and as a woman of colour, what is your take on the level of diversity within Danish pharma and do you have a specific management strategy in place to foster greater diversity?
There is definitely room for improvement on diversity in Denmark and in Danish pharma. Together with some of the other female pharma leaders here, I will aim to raise awareness on why this is a relevant topic that needs to be addressed more actively. I do not know if our industry differs greatly from others, but the fact that there are only five female general managers of pharma companies in Denmark is not a lot when you consider how many companies are present here.
Within the Danish affiliate, I will promote my own core values, which stand for diversity and inclusion. I believe that everyone can contribute, regardless of colour, gender, or religion. This topic ranked much higher on the agenda in Sweden, which tends to be much more politically correct than Denmark. For example, the Swedish Lif board has a 50/50 male/female split, while only one woman sits on the Danish Lif board. Therefore, I can take some good learnings from my time in Sweden.
Organisations where different people, cultures, and values are represented creates a positive work environment. However, I will never legislate that we hire a certain number of women; it should always be based on skill and suitability. Finding the right balance is key.