Michaela Latzelsberger, country manager of Coloplast Austria, a Danish medical device company focused on ostomy, continence and wound care, discusses the challenges of launching innovative medical devices on the Austrian market, especially considering the system’s undervaluation of quality of life data. Furthermore, she provides an overview of how Coloplast Austria is improving prevention in their select therapeutic fields and explains what must be done to ensure a sustainable long-term healthcare system.
Since taking up the country manager role in 2014, what differences have you noticed from previously working in the pharmaceutical sector, in companies such as AstraZeneca and Grünenthal, compared to the medical devices field?
“As long as we have the patients’ consent and give support and not promotion, a medical device company is able to contact patients. This is of paramount importance for Coloplast as if one of our patients has concerns, we can easily provide them with the required assistance and link them to a specialized nurse.”
The key difference, and a huge surprise, was the very interactive nature between the patients, medical professionals and companies within the medical device sector. Due to strict laws, the European pharmaceutical community is unable to heavily interact with patients, with the exception of areas such as multiple sclerosis and diabetes. As long as we have the patients’ consent and give support and not promotion, a medical device company is able to contact patients. This is of paramount importance for Coloplast as if one of our patients has concerns, we can easily provide them with the required assistance and link them to a specialized nurse. This interaction is not a one off, and in the case of some patients can last the entirety of their life.
When I took up the position in 2014 my goal was to bring the medical device community closer to a deep medical understanding on quality of life (QOL), a concept used throughout the pharmaceuticals industry. Normally medical devices do not require such thorough clinical trials – although – we require this data as evidence when we need to argue which particular products should be reimbursed or not. Furthermore, Coloplast Austria is heavily involved in QOL studies to understand the real significant differences our products offer, and what specific improvements of patients’ lives is required to fill a need in the market.
The company globally is focused around three core areas; ostomy care, continence care and wound care. What have been the growth drivers for Coloplast Austria?
Ostomy care and continence care, with the former being the majority share of our business. The most important thing is that we are able to deliver to our patients our innovative products easily by achieving fast market access. Since taking up this role, my team and I have been able to launch at least one new product each year, namely; SpeediCath Compact® Eve, a new stylish and discreet compact catheter for women, SpeediCath® Flex, the new catheter for men designed for easy and hygienic insertion and practical disposal and SenSura® Mio, which provides fit to individual body shapes, giving discretion for all types of ostomies while providing skin protection, a real milestone in ostomy care.
Due to a very complex and sometimes opaque medical device reimbursement system, it is not easy to launch innovations at a fair price on the Austrian market. For some products, it took us years to release them and Austrian patients needed to wait, while other European markets had already introduced these brands.
The key rule is when a new product is launched onto the market it must cost less than a similar older product, even by a single cent. This makes it extremely difficult for innovative companies to launch a product that contains new technologies and has been backed by large R&D investments. This is a significant inhibiting factor to promoting medical device innovation within Austria.
How are you then able to manage these concerns and gain market access?
You must price the new products less than the current offering, or we must take one product off the reimbursement list in the same area. This has secondary effects as patients who have used the same catheter for many years must then instantly change to the new product. The correct approach would be to have the old and new product simultaneously on the market, while in the meantime educating the patient population how to utilize the more innovative treatment. Under the current ruling patients do not always have this choice, and do not have control of their own treatments that have a direct impact on their daily lifestyle.
One of the great innovations of medical devices is the improved QOL they bring to patients, especially important for Coloplast’s patients who may have to use the product for their entire life. How is this taken into consideration during negotiations?
In Austria, there is no health economic assessment during the reimbursement process. Coloplast is a global company that generates this data, but when we present this information, it is quite simply not always taken into consideration; for example, SpeediCath Compact® Eve ensures a discreet life, the catheter is extremely easy to use and carry so that it ensures patients normal, but despite this clear indication of innovation it is not looked at it correctly and we are still told products must enter the market without a premium.
This is why Austromed, the Austrian medical device industry organization, in which we are a member, is lobbying to change this. We need innovation to be assessed correctly, allowing companies to gain market access with fair pricing, so in the end Austrian patients benefit.
Despite the challenging circumstances, Austrian healthcare is considered a developed market. What are the benefits for an innovative medical device company doing business here?
Firstly, the loyalty of the patients is excellent as medical care is extremely well appreciated within the population. The medical device community cares a huge amount for Austrians well-being, despite the challenges associated with pricing.
Secondly, the excellent services that Austrian medical professionals and Care-givers offer to ensure patients receive care when they need it most.
Prevention is valuable part of the treatment chain and is considered in Austria as being overlooked. What is Coloplast Austria doing to promote prevention within the company’s select therapeutic areas?
This is a topic I am extremely passionate about. The healthcare community is always talking about constructing a long-term sustainable healthcare system, but fail to look at the great potential of prevention. Based on Coloplast’s products, our patients are at the end of the treatment chain; therefore, we take a different approach, but are equally as influential.
We support the “Long Day of Intestines”, displaying examples of how to prevent living with a stoma and the benefits of early detecting conditions through conducting an early colonoscopy and also inform the public about a normal life with a stoma.
For catherization our role is to prevent infections. Austria has one of the highest rates of permanent catheter use in Europe with more than 30 percent of all catheter patients, which over time can cause tumours and serious infections. Patients with infections are then required to take more antibiotics, and when they become resistant to them, it becomes even more complicated. It is a vicious cycle we observe way too often. Nevertheless, all this can be easily prevented by patients being properly educated on how to utilize intermittent catheters when it is possible; a simple, non-invasive habit.
Where do you see Coloplast Austria integrating itself further into the Austrian healthcare environment in the future?
We will continue to be the leader in ostomy care and grow in continence care. We must also continue to represent the voice of nurses and care-givers as they are our eyes and ears at the hospital level in giving us information about current patient needs.
Above all, it is our duty to not stop talking about the issues of our patients, that really are our long-term partners. This voice is especially important when assisting them in obtaining the right services from the sick funds, even if it is about our patients being given two more intermittent catheters a day. Each little step is as important as the last, and this is encompassed in our campaign “stronger together”; linking patients, physicians, nurses and the company to ensure Austrians are healthier well into the future.