Interview – THE IMPORTANCE OF DEVELOPING A MARKET ACCESS STRATEGY AS AN INTEGRATED PART OF PRODUCT DEVELOPMENT – ROCHE TISSUE DIAGNOSTICS’ ELIZABETH SHEPPARD
Leading up to NextLevel Life Science’s 7th Annual MedTech Access Leaders Forum 2018, we are conducting interviews with selected members of our prestigious speaker panel to learn more about their thoughts on this vital issue.
*Opinions below are those only of the individual and do not reflect upon corporate strategy or positioning.
For more information regarding NextLevel Life Science’s 7th Annual MedTech Access Leaders Forum 2018 click here!
Elizabeth Sheppard, Senior Director, Market Access, Roche Tissue Diagnostics
NextLevel: How would you describe the work that you do at Roche Tissue Diagnostics?
ES: I am the Head of Market Access for Roche Tissue Diagnostics. This position specifically works around access barriers or products that we develop. We look at any barriers that can be a problem regarding access to a product for the patient as well as for our stakeholders. So, that could mean reimbursement, guidelines, or standards. We also work with external quality assurance organizations and other systems in our business area. We work at the pipeline of products that are running, right through to the features of tissue diagnostics – which also includes companion diagnostics with pharma partners.
NextLevel: What is the main challenge to integrate a market access strategy into the development of a new product in the diagnostics area?
ES: The biggest challenge is understanding what kind of clinical and technical factors are surrounding the product during development. That is critical for downstream success. You have to go beyond efficacy and quality and move forward to understand what exactly are the issues that will affect the business decision to move a product forward, as well as any kind of barriers that might affect uptake to the laboratory.
NextLevel: How well do you generally think the diagnostics & tissue sector is able to address this challenge?
ES: Market access in diagnostics is fairly new, that is, within the past 5 years. Market access in pharma has been embedded into their process for a fairly long time. As the environment changes in countries throughout the world, the reimbursement changes, and so we need to ensure access, and that the product is reimbursed and approved in the different countries. This is a real challenge, especially as we divide and conquer with companions, where there is a drug and a diagnostic that are running together. It would be terrible to have a drug without a diagnostic that wasn’t approved in a country.
NextLevel: Packaging companion diagnostics with drugs is important. Where do you see the value discussion here?
ES: The value is within the essence of the evidence that the product brings. So, is there outcomes evidence? The trials that we do are very important. Clinical validation, clinical utility, and analytical validation have become more important and challenging. This is where the health technology assessments are also looking. They want to make sure that we are providing enough information. The only way to do that, however, is through publication. That can be a challenge for us and it is ongoing to make sure that we get that information out there even before launch.
NextLevel: Have you had any experience working with Scientific Advice & Horizon scanning teams at HTAs and other stakeholders? How did it go? Would you recommend this process?
ES: This is fairly new, especially in the companion diagnostics world. We have had one HTA that came across and a couple in some of the molecular technologies. I think the HTAs are trying to get a good handle on this and about how they are going to be looking at these kinds of diagnostics and as compared to an instrument or a pharma drug. So, this is fairly new. We are trying to work together to assess what they are looking for and making sure we are providing the right information to them.
NextLevel: Sometimes the costs of collecting evidence are prohibitive for smaller companies, do you see any workarounds which can reduce the cost burden?
ES: No matter what, you are going to have to do the evidence gathering. Even if you are a small company you have to show the value of the product. You do that by doing enough trials, or gathering enough evidence, even if it is just in the product development process. The first thing is, do you have that information? That’s required for approval of the process. So why not publish it, why not work with KOLS to get a good understanding and lay the groundwork for the new product? It is better to have a process where the physicians or the laboratory are asking for the product because they have heard about its value, when you’ve already paved a nice evidence road. I think every company should be looking at it that way.
NextLevel: How has the Medical Device Regulation impacted your work?
ES: This regulation will be implemented in 2020, so we are building up a lot more evidence now. There are a lot of products that need a lot more evidence to meet those requirements, which is very costly. So, it is also a way to look at other products that are maybe not needed anymore. We are scrutinising the product portfolio and looking to see if it is worth having those products in our portfolio.
NextLevel: When it comes to your role – What do you enjoy most about your work?
ES: First, that I am making change and that I have the ability to make a difference. It can be as little as getting an important product out there and a patient having access to a product. When I hear that because of our market access work, patients in a country now have access to our product, even sometimes as a first line, that to me is making a difference. That’s really an incentive to move a product forward and to keep going to make sure that we are validating the opportunity for a patient to have access to drugs and to products that help their lives.
NextLevel: What are you looking forward to most, in regards to our upcoming event in Berlin?
ES: I think different symposiums are wonderful. I love meeting all the people, the networking is always amazing to me, and hearing what everyone else is doing to meet some of the challenges that we all have, and also I love Berlin.
For more information about this MedTech Access Leaders Forum please click here!