Image credit: Courtesy of Nadia Bracken Björkquist
This month we spoke with Nadia Bracken Björkquist, European Director of Market Access at ResMed. Nadia discussed with us some of the challenges faced by companies attempting to launch a product in the market, how market access for medical devices compares to that of pharmaceuticals, as well as the importance of evidence requirements for establishing new reimbursement.
I started my professional career in pharmaceuticals. There I worked in various marketing roles and over the past 15 years focused more and more on market access. I’m not a trained health economist but have had plenty of experience in that field across Northern European countries. I joined ResMed five years ago – this was when I entered the area of medical devices. The company originated from developing devices for the treatment of sleep apnoea, and we are a global leader in helping diagnose, treat, and manage that chronic disease for more than 30 years. We focus on respiratory care and the treatment of patients in the home setting. This also makes us one of the global leaders in connected homecare – in-home treatment that can be monitored and managed by in- and out-of-hospital healthcare providers . That is where we linked in to ValueConnected, as we plan to launch various new solutions and services and needed support in the reimbursement arena across Europe.
I am ResMed’s European Director of Market Access. This is a fairly new role – the company has a global Market Access team, but a team specifically for Europe was only created two years ago. Globally, our biggest market is the US. I lead a team working across Europe on many topics, mainly focused on central, northern, and western European countries. France, Germany, and the UK are our largest markets. We have a presence in most European countries and work with local distributors where needed.
Most important is recognising and understanding the task at hand. There is a lot of preparation required for a product launch. Reimbursement authorities have quite high requirements for clinical evidence, as well as differences in requirements from country to country.
Another challenge is making decision makers and authorities understand the differences of medical devices as opposed to pharmaceuticals – they want the same levels of evidence for each. The situation is evolving though. For example, NICE in the UK has now developed a methodology to include medical devices. There are signs that Germany could take similar steps, which would help drive further adoption of innovative home medical devices in that large market. A final challenge is the time it takes to get devices to patients – lengthy assessments can mean it takes a long time for a patient to access valuable treatments. The European Commission recently recognised that it takes too long for access to be granted for patients. At the same time, ResMed does its part by providing evidence needed per country to validate and approve its devices.
The need for market access is similar, but experience from decision makers regarding pharmaceuticals has been there for a longer period. The capabilities in market access were developed earlier in pharmaceuticals. The ability to prove value is more challenging in the medical devices space than in the pharmaceutical space. There is so much clinical evidence already generated for pharmaceutical products, whereas in medical devices you are generating evidence in parallel with implementing.
This is probably the most important question to answer in a market. If you don’t understand it, you won’t be successful. European markets are very value-based – any new technology needs to provide value. But you also need to understand how each country measures that.
For example, there are various ways to prove efficacy of treatment in respiratory health. One measure might be the improvement in a patient’s lung capacity, or another could be enhanced performance in a six-minute walk test. But in some countries, authorities are only interested in patient-relevant outcome measures. You have to prove your product benefits the patient. So instead you need to focus on outcome measures like reduction in hospital stays or reduced mortality. It is crucial to assess carefully what type of evidence each is looking for. In the UK, you might be able to prove you reduce hospitalisations, but they want to see it is being done in a cost-effective way. So here you need to provide health economic data. You might then develop patient-relevant outcomes data as well as health economic data – but you don’t need to do that in Germany. An impact analysis is sometimes needed – i.e. how the product will affect healthcare budgets over a number of years. Each country has its own approach.
I think many companies make mistakes here and end up in a situation where they haven’t been clear to authorities about their value offering. They may have provided evidence, but it wasn’t relevant in that country. This then leads either to no reimbursement or waiting a long time before you get it. However, if you understand exactly what evidence is required, you can both increase the likelihood of reimbursement and shorten the time it takes to receive it.
I was first introduced to ValueConnected via MedTech Europe – they were working on a project with them. I then attended a workshop on value-based procurement organised by MedTech Europe and was placed into the same breakout group as Ernesto Nogueira (ValueConnected’s Managing Director). Our conversation made me realise they could be a suitable partner for us. I went away and compared different options for who could support us, and ValueConnected had a good geographical reach across Europe combined with long experience in the areas we were looking into. We have found that in some places they want to use local providers and can be suspicious of pan-European solutions. We liked that ValueConnected could very clearly show they had local reach across Europe.
Very positive. They have lived up to our expectations and beyond. ValueConnected have been very reliable and consistently delivered both in terms of time and quality. There is always very close contact between us during the development process. They have provided excellent workshops, lent additional expertise, and been very accessible to connect with. Finally, they haven’t been afraid of challenging our assumptions. Sometimes you get a little bit blind and have an assumption in the team that suddenly becomes the truth. Someone external is well placed to challenge those things and ValueConnected are brave enough to dare to do that!
Oh yes - for the reasons I just mentioned. I had worked with another vendor before that was not always accessible and we didn’t always have the support we needed. Working with ValueConnected is the opposite of that. Even if it’s outside the agreed scope, they always help, which is great as you never quite know at the outset what you will need. They are very service oriented – I like that.