Biogen Slovakia's Country Director on being an innovative global biotech in Slovakia, market access in the country, and the company's commitment to improving the lives of patients through MS, Alzheimer's and rare disease treatments.
Ms. Strapkova Boydova, you have been Country Director of Biogen Slovakia since its inception in 2006. Can you please tell us three to five key milestones in the affiliate’s history since then?
The reason behind Biogen’s decision to set up a footprint in our region and in our country in particular, was to ensure that patients and external stakeholders had access to multiple sclerosis products (MS) and professional medical services. In that aspect, the key milestone was achieved early in 2007 through the introduction of a highly effective breakthrough therapy in MS with the first monoclonal antibody approved for MS., natalizumab. The next milestones were achieved in 2014, when Biogen Slovakia successfully launched 2 more innovative molecules in MS, dimetyl fumarate and pegylated form of interferon beta treatment. More will come next year, as we are currently working on preparation of pricing and reimbursement file for daclizumab, the first subcutaneous form of monoclonal antibody drug in MS.
Biogen recently invested one billion USD in a new plant in Switzerland; a significant and very rare commitment to Europe from an American biotech! Where does Slovakia fit into this European and regional picture? What is your footprint here?
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Biogen’s investment in a new plant in Switzerland is further proof that Biogen is committed to constantly improving patients’ lives and bringing innovation in therapeutic areas with high unmet medical need. This covers not just MS, but the plant will set a production base for new therapeutic areas including Alzheimer’s disease, where clinical programs are still ongoing. Biogen Slovakia can contribute and support such investment by being a commercially successful affiliate, but also through careful evaluation of our expenses. Obviously, we are just a small piece in this puzzle, but I believe that every piece counts! It is really important to make people understand and support the overall company strategy and be proud of it.
Biogen has the leading portfolio for treatment of MS globally and is at the forefront of neurological disease. Is this global market leadership reflected in the Slovak market?
Yes, it is. Biogen Slovakia has market share leadership in our country.
In your time with Biogen, what has been your experience in terms of market access and bringing products to market? How do the Slovak authorities recognise the benefits of Biogen’s innovations?
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Entry of new drugs into the reimbursement system is well defined and regulated by the Drug Act. Price of product at the time of price submission to authorities has to be published in minimum 5 EU countries and may not exceed an average of 3 lowest EU prices. Product requested for reimbursement is evaluated for Cost Utility Analysis by the Pharmacoeconomy working group at MoH. Payers are interested also for Budget Impact analysis caused by entry of the new drug into the reimbursement system. So the market access process is rather straightforward, regulated by official methodology and there is no space for negotiations with authorities. Biogen had to stick to the rules too. As I already mentioned, we were successful in bringing new innovative products to the market with the exception of one case. And that was for the product fampridine for symptomatic mobility disorders treatment for MS patients. We applied for reimbursement twice, but with no positive outcome.
Biogen focuses on innovative therapies, which by their very nature, tend to be expensive. How then do you ensure profitability in Slovakia, which has the lowest drug prices in the EU?
We ensure profitability by precise Profit and Loose (P&L) annual and long term planning. We invest only in projects which add value and are meaningful. We had to learn how to be good at it.
Both Natascha Schill in Switzerland and Michaela Hrdlickova in the Czech Republic have promulgated biosimilars as a way to balance access to innovation with affordable pricing. Is the same true in Slovakia? What is the current status of your biosimilars portfolio here?
We are just at the beginning of biosimilar discussions with payers. But payers are already expressing their interest in high quality biosimilar anti-TNF Biogen products.
Almost all of our interviewees tell us that they are now focusing on “Patient-centricity.” Could you tell us more about how Biogen lives up to its slogan of “Caring deeply, changing lives” by addressing areas where unmet need is most acute?
Biogen has a vision to change a world. Go from disability to ability. Make a difference. Be the difference. Be the leader in Multiple sclerosis and do not give up until the cure is discovered.
Biogen has the same vision for therapeutic area like Alzheimer’s disease and rare diseases.
After 10 years at Biogen Slovakia, what keeps you motivated on a day-to-day basis and where do you hope to lead the affiliate in the future?
The role of Country Director keeps me constantly vigilant, as every day is different and the environment is changing all the time. I like it! I am on a long journey together with the people, our team, and with this fabulous company and I know that what we do will improve humans’ lives.
My long term vision is that the pharmaceutical industry will be seen and recognized as a valuable partner for all stakeholders, because we all belong to the same healthcare system we are responsible for. That is the direction I go and lead.
