RJ Lasek took on his first country lead position in Portugal in 2016 and has successfully reshaped the affiliate to match global operations, forecasting 40 percent growth for 2018. In this interview, he sheds light on how to excel in the challenging pharmaceutical landscape--particularly with reimbursement restrictions and what characterizes the Iberian Peninsula as a unique destination for understanding European market dynamics.

 What were your priorities on becoming country manager for Takeda almost two years ago?

 My first priority was to build and develop the organization. When I arrived, the team consisted of nine members and the primary focus was ambulatory care and more mature products within the Takeda portfolio. Takeda global, in contrast, has an innovative portfolio of specialty hospital medicines and we, therefore, sought to transform the organization. We considered the company’s vision and a course we would follow, making some tough decisions along the way. We have since been successful in expanding the team from nine to 25 in as little as two years—showing significant growth. Indeed, investing in the talent was unquestionably a priority upon arrival. In recruiting talented experts from highly-regarded companies in the Portuguese pharmaceutical spectrum, we ensured Takeda Portugal has the best possible team.

The first role for which I hired for was naturally market access—a crucial role in Portugal’s challenging market. Following recruitment, we set out to improve the market access situation, primarily for an innovative therapy concerning Hodgkin’s Lymphoma. Patients did not previously have access to this essential medicine. Our top global product, Vedolizumab®, also made its way to Portugal and I was encouraged my experience in bringing this drug to market in the US.

Finally, we prioritized assisting the team in building their capabilities and incorporating the global portfolio. Before my arrival, we promoted older products. Two years ago we shifted the attention of Takeda Portugal to specialty products, moving away from mature, established brands. In Portugal, we are committed to inflammatory bowel disease, hematology and soon lung cancer with our recent global Ariad acquisition and one of our key objectives is to be a leading partner in care.

How does this differ from the global focus of Takeda?

 In essence, we have a portion of the global portfolio available to us here in Portugal. The global focus of Takeda centers on gastroenterology, oncology, the central nervous system and vaccines, and in Portugal, we feature two vital elements to the portfolio: GI and oncology.

Vedolizumab®, is our number one global product and the same rule applies in Portugal; in coming years it will be the primary growth driver in Portugal. We also have valuable drugs helping sufferers of Hodgkin’s Lymphoma and Multiple Myeloma. As a general rule, European affiliates across the continent will feature these products in their portfolio.

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What is high on your agenda for 2018?

 One is to continue growing our specialty products with a series of launches in the pipeline. Secondly, we must improve market access for patients in need. Our philosophy here—and it is a critical challenge in Portugal given that it can take up to three years to receive reimbursement on a product—is to ensure the broadest access for patients, as fast as possible. We want a drug to be used as it’s intended; we do not want to leave patients waiting for treatments that will improve their lives.

The Ministry commits to improving innovation, but the process is slow. The process is exacerbated by the low pricing strategies we observe in Portugal—we see some of the lowest reference pricing for the continent in this market. We have three new therapies for this year, among these medicines is a stem-cell therapy that has recently been approved by the EMA. We intend to provide access to patients as soon as possible.

My third priority for 2018 is building on the excellent team we have in place here. Logically speaking, following effective recruitment, the next focus is to retain the team, keeping them engaged and stimulated on a daily basis in what is renowned for being a challenging marketplace. We were faced with a unique situation in that we hired a large group of experts hailing from different companies across the country, and we now need to focus on talent planning and development to engage their interests.

The good news is that with our portfolio, our exciting new products, and our projected growth, we have vast opportunities for our people— regarding training and development. Ultimately, this combination leads to better treatment for our patients.

Market access in Portugal is renowned for being one of the most challenging in Europe. How have you been successful in bringing new drugs to market?

 Firstly, we have to understand what government objectives are because naturally, their goal is to bring innovations to patients, although their budget constraints somewhat restrict them. As a pharmaceutical company in Portugal and Europe, we have a responsibility to show that our product has value-add and is cost effective. With our two recently reimbursed therapies, we highlighted the value these products brought to the patients. We made clear that they are different, and there is an unmet need that will improve patients’ lives.

On top of this, we must be intelligent in the way that we price our products. Inevitably, we had to make some concessions in our policy here, but Takeda’s global strategy is to implement a responsible pricing plan because we want the broadest access possible.

What examples can you highlight of this strategy in action?

Vedoluzimab® sits in a market dominated by biosimilars. We approached the authorities regarding the entry of our drug because we want to work within their goals— we do not want to replace their biosimilars or threaten their success. However, our medicine could better manage the impact of chronic and quite devastating bowel diseases. As a government partner, we want them to be able to manage the category better and improve patient outcomes. Consequently, we insisted that the innovation we offer is priced in a way that will enhance the government’s overall cost per outcome. The trick is to strike a balance between innovation, biosimilars (or generics), and collaborate with the government. The government is open to this kind of debate, and there is room for innovation.

What other challenges do MNCs face in Portugal?

One of the challenges in Portugal is that despite the economic revival, the amount spent on healthcare is not increasing. The per capita spend is roughly 2,500 euros, well below the OECD average. Troika is long gone, but the government is not investing more in healthcare. We have a severe debt situation which ebbs and flows with public sector injections periodically. That said, the projection for pharmaceutical growth from IMS is one percent this year.

It all boils down to what companies have of value in the market. We expect 40 percent growth next year: we have innovative therapies in areas of unmet needs. If you can convince authorities that clinically, your medicine brings add value to the existing products, in a cost-effective strategy, then, of course, the drug will receive reimbursement. The issue is that it could take a very long time.

How do you advocate for more resource allocation in Portugal given this difficult reimbursement climate?

 The Takeda global strategy is about long-term commitments. We want to be number one in the markets where we are present, and therefore we must invest long-term. For instance, the Stem-cell therapy that was recently approved by the EMA will hit the markets in a few years, but we are already making investments. The argument made to corporate HQ is that we can be a success in Portugal, as we have proven, it takes time. In the Portugal market, if we have an innovative portfolio, and we are willing to be flexible on our pricing policy, we will achieve reimbursement, it is a question of patience.

Interestingly, a large part of the hospital products in Portugal may be used before reimbursement in a limited way. They are called ‘AUEs’ or Authorisation for Expenditure. For example, the stem cell therapy that we have had recently approved will be sold to hospitals before reimbursement if specific criteria are met. The medicine must be for patients who have no other option, and have reached the end of the line. Of course, we still need reimbursement to open up the drug to a broader pool of patients, but this niche to the market allows for investigation and a better understanding of new medicines. The situation is such: following EMA approval, the law states that after 210 days, you can sell the drug to the hospital if they have their prior procedure approval.

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Our job is, therefore, to bring these innovative therapies to the hospitals, to the patients, and when we can, by using free of charge access programs. We work directly with INFARMED, and we work with a certain number of patients for a period—all beneficial to Takeda. If we consider Takeda’s philosophy: Patient, Trust, Reputation, Business, in this order then we see why. Investing in free patient programs helps us to build trust and earn early clinical experience. Consequently, despite the problematic reimbursement climate where it can take up to two years before pharmaceutical companies see any payback, there are ways of increasing medicinal awareness and making progress. For Takeda, it means we can learn about the impact of the drug, improve partnerships with HCPs and hospitals and ultimately, better serve patients.

What is your take on the Portuguese work ethic?

 I like to say that the Portuguese are ‘buttoned-up’ in that they are focused, professional, and committed. They see the importance of their job and the earnest responsibility it entails. After all, in the past ten years, they have been through a lot, seeing a downturn in the industry, Troika sanctions and for an extended period, there was no reimbursement at all. As a result, the employees left in the sector in Portugal are hardy, resilient and above all, adaptable. In Portugal, we have to do more with fewer resources; there is ample opportunity to grow in this market, but given that margins are tighter, companies must run lean operations.

The people at Takeda in Portugal are pound for pound the best in class. What’s more, they have embraced a vital company facet to company culture: ‘Takadeism.’ We operate an encouraging environment in which challenging the status quo, inspiring one another and making difficult decisions that in the short-term may not be best for revenue-optimization, but when we consider our reputation amongst patient groups, will pay off in the long-term. We make an effort to ask ourselves honest questions and challenge our practices on a regular basis because ultimately we are here to assist patients.