André Lüscher of Gilead Switzerland, reveals how the case of Sovaldi demonstrates the challenges for a healthcare system to handle a truly disruptive medical innovation, the knock-on effect on Gilead´s business model, and ensuring that those affected with hepatitis C are able to receive treatment in Switzerland.

A lot has been written about Gilead´s ground-breaking hepatitis C treatment Sovaldi over the past year. How has this product been received in the Swiss market?

In Switzerland there are three times more people infected with HCV than with HIV and people are still unaware of HCV and the consequences of the infection. Over 30,000 people have been diagnosed with this condition. With the launch of Sovaldi, for the first time a cure was possible within only three months for more than 90 percent of patients. Sovaldi is a uniquely disruptive innovation, of which you will only find one in a medical or professional lifetime. It truly changed the paradigm when it came to treating this potentially deadly disease. Typically, in the pharmaceutical business you have a chronic model where you are continuously treating patients. Treating over a short period of time, and providing a cure to patients, brings a different dynamic. In Switzerland still there remain limits to the access that patients have to hepatitis C

We assume that only 40 percent of people have been diagnosed with HCV. Because of this, since the launch of Sovaldi only between 3 to 4,000 patients have been treated – and the vast majority of them have been cured.

What factors explain such a high level of under-diagnosis in a highly developed market such as Switzerland?

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HCV is frequently stigmatized and not perceived as a potential deadly disease, which can now be cured. The high percentage of under-diagnosis can also be attributed to the fact that patients are not aware when they have had a risk exposure. The chronic infection of the liver affects their health in several ways such as chronic fatigue, but it can also cause other chronic conditions like heart disease and Type II diabetes. The other factor is a system of limitations, with restrictions on treatment for people with higher liver stiffness or fibrosis. As a consequence, only half of the population that is diagnosed can actually be treated. Every week we hear from recently diagnosed or detected patients with cirrhosis starting treatment. This is indicative of the story around HCV, frequently referred to as the silent killer.

In your opinion, does the Swiss system sufficiently reward innovation?

The Swiss healthcare system, like many around the world, struggles to value the benefits of a curative treatment against the long-term costs of advanced liver disease.

It is important for pharmaceutical companies to demonstrate how they are bringing innovation to the healthcare system. The case of Sovaldi showed how challenging it can be too for a healthcare system to handle a truly disruptive medical innovation. The system is much better suited for processing incremental innovation for chronic diseases than treatments like Sovaldi, where liver transplantations can be prevented in the future. What people failed to appreciate was the value of cure and the long-term benefits that Sovaldi brought to the healthcare system.

With regard to Sovaldi the issue of our healthcare system is that numerous stakeholders are involved, for example in Switzerland financing provided at both the cantonal and federal level. This leads to issues around responsibility and accountability. While cantons are responsible for the financing of hospitals, there is also a mandatory, country-wide, basic insurance, which each inhabitant most contribute towards. Alongside this, the Federal Office of Public Health, the national authority in health matters, finances other areas of the healthcare system such as national prevention campaigns for illnesses like HIV. Such a wide range of actors, when compared to a centralized system such a France, with one payer, demonstrates potential conflicts of interests. Regional aspects, with an emphasis on consensus in Switzerland, can create additional hurdles.

What will be more important to the future of HCV, discussions around pricing with the authorities, or increasing the rate of diagnoses?

The real challenge will be to ensure that those which are affected with chronic hepatitis C, and have been diagnosed, are able to receive treatment. In particular, we need to ensure that those that have been diagnosed with severe liver fibroses are treated. In addition, expanding access for treatment to every diagnosed patient is key.

Gilead’s other main revenue source is HIV. What importance do you attach to this domain?

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For nearly 30 years, Gilead has led the development of antiviral therapy especially against AIDS and HIV. We will soon be launching a number of new products in Switzerland, moving into a new era in this domain. HIV remains an important component of Gilead´s business. We invest considerable resources to develop our portfolio in this field, with the long-term goal of finding a cure for HIV.

Recently appointed CEO John Milligan has said he is eager for Gilead develop its nascent oncology platform. Yet oncology is an extremely competitive field in Switzerland, home to the two global oncology leaders in Roche and Novartis. What will be your strategy for building brand-name recognition in this area?

Our first steps in oncology began over 25 years ago, with AmBisome, the first liposomal anti-fungal, to receive an indication to treat systemic antifungal infections in patients with hematological malignancies. Lately we launched with Zydelig in the field of hematology, a product for the treatment of B-cell blood cancers.

Gilead has a particular strategy when moving into a new therapeutic domain: we take deliberately thoughtful small steps. If we find something that fits with our competency and our pipeline, then we are prepared to take additional risks, as was the case with Sovaldi. However, it is important to note that we already had an internal pipeline in HCV, before the development of Sovaldi, which then put us in a position to develop products such as Harvoni and recently Epclusa.

What factors help set Gilead apart from some of the more conventional Big Pharma players?

By focusing where the real unmet medical needs for patients are, Gilead is able to differentiate itself from competitors. Our ambition is to deliver medical breakthrough, not merely incremental innovations. We are known for being lean when compared to pharmaceutical companies of a similar size, which makes the work at Gilead particular interesting. We focus on the areas where we can play an instrumental role, and then maximize our resources. By the end of 2016 Gilead globally will have around 9,000 employees, of which over 50 percent will be in R&D. Our employees are proud to work for Gilead, developing innovative products that are of immense value to patients and the society.