Agnieszka Grzybowska-Zalewska, general manager of Sanofi Genzyme Poland, reflects on the company’s stable growth over the last few years and the market access challenges they have encountered along the way. Moreover, she highlights the importance of achieving reimbursement for three key products for Multiple Sclerosis and Oncology as well as the leading role Sanofi Genzyme plays, as the global pioneer in orphan drugs, in driving forward rare disease awareness within the medical community and throughout the Polish population.

What have been the key milestones in the last two years that stand out for Sanofi Genzyme Poland?

After working at the company since 2005 as product manager for the rare disease area, I was appointed general manager in 2013. At first, we looked after the rare disease area only, and due to decisions made at headquarters, our team now equally controls the oncology business sector. In parallel, we have been growing our multiple sclerosis franchise, and in the future, we will move deeper into immunology.

This focus on rare diseases has been obvious from the moment Genzyme was acquired by Sanofi, and the company – representing the specialty care business unit of the group – has experienced a stable growth over the last couple of years. Nevertheless, we faced many obstacles before achieving market access for our innovative treatments.

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This year we got a great chance as patients have received market access to three innovative drugs from our portfolio, in the fields of multiple sclerosis and colorectal cancer! This huge change demonstrates the Ministry of Health’s willingness to solve issues step by step and make innovative drugs more accessible for Polish patients. These decisions will have a positive impact for patients’ health giving them new treatment options.

Poland is the largest pharmaceutical market in the CEE. What is the strategic importance of Sanofi Genzyme Poland for the company within the region?

Indeed, Poland is the biggest market in the region – nevertheless – our largest challenge still remains access and it is extremely challenging for our pipeline and new therapeutic areas, with new very potent molecules like Dupixent® in atopic dermatitis (AD). This drug may change the lives of severe AD patients within few weeks.

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Another challenge Poland is facing is the diagnosis of rare disease patients within our areas of interest: Pompe disease, Gaucher disease, Fabry disease or Mucopolisacaridosis – as the gap between first symptoms and final diagnosis is usually eight to ten years!

The number of potentially diagnosed patients may be less than many western countries due to our history, though still plenty of cases remain undetected. Poland must ensure they can be active in a patient’s journey from the early stages of the condition, and in some cases even before it has physically affected the individual.

What role is Sanofi Genzyme playing to change the landscape of multiple sclerosis (MS) treatment in Poland?

The dramatic impact in this specific therapeutic area is the result of all stakeholder’s involvement including the entire industry’s contribution, not only that of Sanofi Genzyme. The registration of few new molecules followed by their reimbursement may change completely the history of multiple sclerosis, although current criteria to start innovative treatment is very strict.

First line patients will definitely benefit from having a possibility to continue treatment as long as it is necessary instead of dropping out from treatment after five years of therapy. We still have to remember that only around a quarter of MS patients obtain treatment and treatments such as Lemtrada® may help to solve this issue. The therapy is planned for a few days within a two-year span, and after this time the vast majority of patients are free of symptoms. Such treatment schemes save some funds starting from year three which can be allocated for new patient’s treatment. With Lemtrada® we deliver not only a very effective treatment option, but also the best cost-effective solution.

How do you lead the way in bringing awareness about rare diseases to the government and the Polish society?

We engage in awareness campaigns in a wide range of areas, such as in haematology and neurology, with the overriding aim to show the critical importance of early diagnosis in patients. This in-turn acts as a great way for Poland to not only benefit patients, but be more cost efficient as the government will be spending more in the short term to generate long-term savings.

Additionally, we initiated a campaign to grow public awareness by using the stories of participating patients. It was a great way to demonstrate to Poles that patients live normal lives and are just like anybody else, although it affects many of their daily habits. Furthermore, we organize an exhibition showcasing photos of patients’ lives. It helps people understand innovative treatment is required for them to live a normal life.

In parallel to all these awareness initiatives, we support enzyme replacement therapy (ERT) stations, which demonstrate the willingness from the hospitals to create a place for patients to relax while receiving infusions which they usually get every week or two for their entire life. There are a few hospitals we have supported to offer such ERT stations. All patients, not only patients with rare disorders can benefit from this.

What would be your final message towards the Polish healthcare community to demonstrate the importance of innovative orphan drugs?

Innovative orphan drugs are truly changing the lives of people who in the past did not have any options for therapy. In that perspective, Sanofi Genzyme is clearly the pioneer and market leader in the Polish healthcare ecosystem as we are treating people and giving them hope for the future.

A legacy story of the company is a patient diagnosed over 30 years ago with Gauchers disease. The disease is affecting mainly bone marrow causing severe thrombocytopenia hepatomegaly and/or splenomegaly and finally bone disease. There is a photo taken of this boy with a large, disease-induced, bloated belly. Now, he is over 30 years old and lives a healthy life and you would never realise he carries a condition. Therefore, we are making a significant difference in shaping people’s lives by delivering to them innovative drugs.

What treatment needs have you identified for Sanofi Genzyme Poland, as the nation attempts to value innovation to a larger extent?

We have identified that there is a huge need for the treatment of Fabry disease, an inherited life altering condition which can affect the kidney, heart and nervous system. Manifestations of the disease usually increase in number and severity as individuals age. Our therapy, Fabrazyme®, is reimbursed in all European countries except Poland – and we hope Polish patients will soon also receive access and particularly for this disease early diagnosis is crucial. If we start treatments as early as possible, we can attack the disease before it progresses. The challenge remains in defining what exactly entails “starting early”; meaning, what are considered first symptoms and when should treatment begin after they appear.

Where will we find Sanofi Genzyme Poland by 2020?

We will be constantly involved in rising awareness about diseases underlying that early treatment is beneficial for patients and for the system. The earlier treatment begins the better the long-term outcome. Our wish is to support reference centers of excellence for rare diseases. Not all patients need to be treated in these centers, as factors like distance are an issue, but the aim is to make them centers of expertise that will support treating centers in their everyday practice.

Secondly, to change the approach towards rare diseases, around the reimbursement system and the service quality is needed. We hope to participate as an industry in the dialogue, while assisting in discussion around the development of orphan drugs criteria.

We also plan to enter new therapeutic areas like atopic dermatitis or rheumatoid arthritis, delivering new, very potent treatment options to these patients. Our oncology portfolio will bring new molecules for multiple myeloma and metastatic cutaneous squamous cell carcinoma treatment. We hope to be perceived as a trustable and reliable a partner of Polish medicine.

You have been working with Sanofi Genzyme for over ten years. What is the driving force that pushes you every day?

People! On one side, it is about patients as we are constantly making a critical difference in their lives. On the other side, it is about the people I work with that are extremely passionate in driving forward innovative healthcare in Poland. All in all, the combination of these two key factors inspires me every day to wake up and work with ambition and enthusiasm, so in the end patients can live healthier, improved lives.