After mastering the art of the pharmaceutical value dossier, the time may come for you to try your hand at developing a value dossier for a MedTech product. But to what extent does this require a return to the drawing board? Our top tips for a winning value dossier can help you develop an effective value dossier regardless of the product or indication, but the key differences between the pharmaceutical and MedTech industries should not be ignored when developing your MedTech value dossier. We have summarised the key market access challenges associated with MedTech products and our recommendations for how to address them in your dossier below:
Limited clinical budgets coupled with challenges in designing and conducting randomised controlled trials (RCTs) can often limit the evidence base supporting the value of MedTech products. The quantity and quality of evidence available to support value dossier development is typically lower compared with pharmaceutical products, and limitations in the clinical evidence base can also complicate the development of robust economic models.
Starting value dossier development as early as possible is crucial for any product, but especially so for MedTech products where early identification of key gaps within an evidence base can provide an opportunity to develop targeted evidence generation strategies.
Where gaps do exist, it may be feasible to leverage evidence from similar/proxy technologies to supplement the existing evidence base, if such technologies are available. The value dossier narrative should also clearly acknowledge any limitations in the evidence base and highlight ongoing evidence generation. For example, aspirational language and clear marking of aspirational value messages can support dossier users in evaluating whether these messages are ready to be communicated externally.
MedTech value dossiers need to be holistic in their consideration of product value. A diverse range of technologies fall under the ‘MedTech’ umbrella, offering benefits across numerous settings and to different stakeholders. Importantly, MedTech value drivers often go beyond the ‘traditional’ domains of clinical efficacy and cost-effectiveness. Taking surgical devices as an example, short learning curves, ergonomics and usability/human factors may be central to the value of the device to the surgeon and payer and linked directly to the clinical outcomes associated with the product. Effectively communicating these specialist, ‘non-traditional’ outcomes and their implications in a way that is accessible for local teams, payers and other stakeholders who may not be familiar with them can be difficult, and convincing payers of their associated value can also prove challenging.
Ultimately, determining how to position and communicate the value of MedTech across a broad range of value domains should be underpinned by an understanding of what will resonate with key audiences. Engagement work with key stakeholders at an early stage of dossier development is highly effective in defining the problem, current burden and unmet needs that will be addressed by your technology. A clear understanding of this from the perspective of these key audiences then provides a platform to effectively position the technology across all key value domains.
Value dossiers for MedTech products typically serve a slightly different function to those for pharmaceutical products, and this can affect the content and design of the dossier. For example, undergoing a formal health technology assessment (HTA) process is not currently a prerequisite for MedTech products looking to achieve UK market access. Instead, local activities are often essential to drive adoption; a comprehensive value dossier designed to support development of HTA dossiers may not always be required. However, well-evidenced, well-articulated value differentiation remains vital in the highly competitive and innovative MedTech industry, placing an even greater emphasis on high-quality, flexible dossiers that can meet the needs of key stakeholders.
Firstly, clearly defining the purpose and audience(s) for the value dossier as early as possible in its development is critical, as this will largely determine the content to be included. For example, a key purpose of MedTech value dossiers may be to inform the preparation of business cases by local market access teams to guide procurement discussions with healthcare providers. Proactive engagement with internal stakeholders from the outset is key to understanding their requirements, such as the most useful structure for the dossier and the most effective narratives for their purposes. Finally, upon completion of the dossier, rollout workshops that bring together key users of the document can ensure teams are aligned on how best to use it, whilst surveys or subsequent workshops can then collate feedback on real-world use in the field to inform future updates to the dossier.
Rapid, iterative innovation in the MedTech industry often means that the design, features and functionality of technologies evolve quickly over time, including both comparators or your own technology. For example, an ostensibly minor software update to a digital health app can introduce brand-new functionality and add a new dimension to its value. Evolution of your own technology presents a challenge in determining how best to utilise clinical and economic evidence derived from its different ‘versions’. By contrast, iterative developments in an often crowded, competitive landscape might result in a need to re-position your own technology to re-establish its value in new contexts.
Regular horizon-scanning for changes in the competitive environment and regular updates to the value dossier to account for such developments are critical, including any changes to available evidence and refreshing the positioning of your technology relative to key comparators where required.
When determining how best to utilise an evidence package for your product that includes data from different versions, the extent of change between versions and overall size of the evidence base can be important factors to consider. A new product version may supersede its predecessor from a commercial strategic perspective, in which case removing evidence derived from a less relevant predecessor and focusing on the newer version may be preferable. By contrast, in instances of more incremental innovation, the differences between versions may not dramatically change the core value proposition. Utilising the evidence base from multiple versions may therefore be the optimal approach (and especially so where the overall size of the evidence base is limited).
Despite specific challenges that arise from the peculiarities of the MedTech industry versus pharmaceuticals, MedTech value dossier development does not require a return to the drawing board. An appreciation of how MedTech differs from pharmaceuticals and application of the recommendations we outline above will help to deliver a winning MedTech value dossier that separates your product from the rest of the pack.
If you would like any further information on the themes presented above, please get in touch, or visit our Market Access and MedTech pages to learn how our expertise can benefit you. Josh McLuckie and Ben McNally created this article on behalf of Costello Medical. The views/opinions expressed are their own and do not necessarily reflect those of Costello Medical’s clients or affiliated partners.
