Stephen Ralston describes how having a clear strategy with the correct evidence to support the submission is integral to presenting a compelling value proposition for reimbursement.
The challenge
By Stephen Ralston
Developing a value proposition for reimbursement can be hugely challenging for pharmaceutical companies. You need to gain alignment from your cross-functional team on your reimbursement strategy whilst working with your local operating companies (LOCs) to understand how the data will be interpreted by the health technology assessment body in each country. Sometimes there can be different interpretations of the data from each party and differing views as to the strength of the value proposition.
We have witnessed these challenges with many clients and have seen the problems that arise with the communication and development of global value dossiers (GVDs) that are large, inaccessible, and unnavigable. It’s why we have adopted a two-pronged approach, providing a more succinct GVD and longer reimbursement submission documents (RSDs), which are clear, make sense, are compelling and that give the affiliates what they need to write their submissions.
The objective is to ensure that the large number of people who will access the document can easily understand the strategy, follow the evidence, review the references, and compile all this information to determine what the key pieces of information are to support their submission.
As we know from experience, a typical GVD may well include those crucial elements, but it can often be far longer than is necessary for everyone who will need to access the material. Furthermore, the typical GVD includes several unordered appendices all added to the back of the document, including systematic review reports, network meta-analysis reports and a full cost-effectiveness model report. These documents end up being hundreds of pages long and can be inaccessible and unnavigable. From experience when I worked in an LOC role, your heart sinks when you see just how long these documents are and how the key information you need seems to be spread into different parts of the materials.
That is where the shorter GVD comes to the fore. It’s typically around 50 to 70 pages and is built on strategy, evidence, and referenceable sources. Then we develop the longer RSD, which is laid out as a template HTA submission, so the flow of the document is much easier to follow, making it a useful tool to develop an actual submission, with organized appendices that are easy to navigate.
A clear strategy
We take a modular approach to developing the materials, focusing first on the unmet need and burden of illness, secondly on the clinical data and finally on economic value. Because there can often be quite a significant time lag between each module, we go back to each step to make sure the story flows through all those materials. As a result, the unmet needs story matches the clinical story and matches the economic story. Otherwise, the result is three modules that could be speaking in slightly different tones with different strategic directions which is problematic for the affiliates who require a coherent strategy and aligned evidence.
In addition to developing GVDs and other access materials, we work with companies in the UK and other countries, where English language submissions are accepted, to write the actual HTA dossiers. Where required, we will support the client and meet with the payer to answer questions about the submission. We continually stay up to date with data requirements and processes as well as building payer relationships. This has been invaluable, not just in terms of how it helps the client, but also in terms of building on the deeper insights we had gained from our own previous experiences in industry roles, into payer expectations and the problems that can be encountered when the submission is hard to navigate and doesn’t tell a compelling story.
Having a clear strategy with evidence to support the submission is integral to presenting a compelling argument to HTA bodies and getting reimbursement for your product. An unordered, complex, and unnavigable GVD not only makes the job of the affiliate that much harder but jeopardizes a positive outcome with the payer.
You can contact Stephen Ralston, Executive Vice President and Head of EU Business Development, at solutions@grg.inspya.net.
BY: Stephen Ralston, Executive Vice President and Head of EU Business Development
