Interview: Milos Zivansky – Operations Manager Czech & Slovak & Medical Director CEE, Eisai, Czech Republic

Milo_ _ivansk_, Operation Manager, Czech and Slovak Republic & Medical Director CEE, EisaiEisai’s Czech Republic’s Operations Manager discusses the role Eisai plays in the country, the transparency of the pharma industry in the region, and his aspirations for the future.

What does the Czech market have to offer Eisai compared to its neighboring countries?

The Czech Republic is one of the most impressive and interesting markets in CEE. It provides a good access for new molecules and reasonable restrictions. Other countries in the CEE are not as permissive and there are more restrictions.

The Czech Republic is one of the most impressive and interesting markets in CEE. It provides a good access for new molecules and reasonable restrictions.

Eisai gained approval for Lenvima in May last year; approximately a year later, how well has the treatment been received in the Czech Republic?

We took a quite complicated and demanding route to market access. The usual length from approval to reimbursement depends on the nature of the case. If it is a generic drug, it might take three months; if it is a new chemical entity, such as Lenvima, it has to be different and relevant to unmet medical needs. There are procedures that need to be followed. If you submit an application, there is a legal deadline of 165 days but applications usually take nine months to a year – depends on the complexity of the case. Along the way, the state might need some additional data or will need to wait to provide reimbursement.

The process took some time but today Lenvima is available for patients through individual approval of health insurances when any other alternative reimbursed treatment is not available. Physicians submit applications to health insurances and when everything is approved, patients get the Lenvima treatment.

Halaven – the next much-needed cancer treatment has been submitted for permanent reimbursement. Can you tell us more about the development of this project in the Czech Republic?

Halaven was approved in Europe in 2011. We have submitted an application for permanent reimbursement in April this year after following the procedure for highly innovative products with the initial temporary reimbursement for three years. During the period of three years, patients who were treated were included to the registry, so information about safety, dosage and applicability of the drug in the real clinical settings were acquired. Using this local data from the registry the state can now really judge whether the drug is cost effective for the Czech market.

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Generally speaking, do you think that the Czech regulatory environment appreciates innovative treatments?

The Czech Republic follows EU health laws and regulations and in terms of market access provides relatively good access for innovative products. Of course we can improve, but when compared to the market access procedures in the whole CEE, it is one of the best countries. The only competition is probably the Slovakian market due to the quicker approval and reimbursement procedures. It only takes 6 months there. Though the Czech market is more permissive, we have better institutions allowing highly innovative drug reimbursement and access for a limited time period even when there is not enough data for a full pharmacoeconomic evaluation.

As member of the AIFP ethics committee, it is clear that ethical behavior is of utmost significance to Eisai. To what extent is it a challenge to comply with CEE rules and regulations and how do you maintain transparency? Would you agree that there are special challenges?

I cannot say that the pharma environment in the CEE is not transparent. It really depends on particular cases and factors such as culture or operational systems of the company. Eisai has strong compliance and regulations and I have never doubted any of the ethics or fairness of our business. Usually doubt arises in a relationship between the pharma industry and healthcare providers. Following the European Federation of Pharmaceutical Industries and Associations (EFPIA) initiative on disclosure, all companies that are part of the AIFP are obliged to disclose all value transfers to health care providers and health care organizations. This transparency data will be published for the first time in the end of June this year. Everybody can have access to names of the physicians and money transfers related to companies. Patients can also use it when selecting their healthcare provider.

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What then is the state of transparency in the industry in general? Where is there room for improvement?

It varies country by country. In the Czech Republic there are some rumors that healthcare providers are paid to prescribe specific drugs to patients. We should show the public and decision makers that the pharma industry is transparent to create trust. I will be a patient one day and I would like to be treated by a drug not because my doctor was provided with an incentive, but because it best suits my health status. If people think that a company is bribing doctors they do not trust the treatment. We need a good relationship with different stakeholders and to remember that at the end of the day our customers are patients and their families. CSR is very important here! The first sign of CSR is to do our job, be knowledgeable and create new treatments to provide the best drugs. We can only do that in absolute transparency

From your perspective, what is the greatest impact that Eisai has on patients, society and the wellbeing of the world at large?

We provide solutions so that people can be healthier for a longer time. The development of health care is very interesting. When I started my medical practice, metastatic breast cancer was killing people within months, today it is a chronic disease. We are able to treat it and keep the quality of life for years in some cases.

As expert with a track record of 24 years in pharmaceuticals, what do you identify as future growth areas in the industry?

The first area is new treatment options for unmet needs. The second is the capacity of healthcare providers. Pharma companies should not just look for a drug which is more effective or safe, but also one which can be easily used. Today’s capacity in oncology is not able to care for every single potential future patient. Therefore, we need to create new solutions to increase effectivity of medical care.

In those 24 years in the industry, what has been your proudest achievement?

In the 90’s, we brought international modern technology, new information and new drugs to the Czech Republic. The drugs were available in Western Germany but not here. Not all people were able to have access to treatments. I was among the people to bring the modern treatment for Allergy and Asthma as well as some preventive projects for Asthma.

What are your ambitions for the next five years?

Companies are merging and restructuring every day so it is hard to say. I would like to launch a new indication in our oncological portfolio. Maybe we will have a new treatment for Alzheimer’s disease. It is a very high risk area to invest in but a great contribution to society. If we can help Alzheimer’s patients to be independent, that would be great.

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