Unlocking Value: 5 Top Tips for a Winning Value Dossier

The markets for pharmaceutical and MedTech products are becoming more challenging for manufacturers, with increasingly crowded markets in many areas, evolutions such as the US Inflation Reduction Act (IRA), shake-ups in pricing and reimbursement processes in Europe, and stretched health systems worldwide. At the same time, trends like increasing reliance on surrogate outcomes, combination products, precision medicines, delivery and affordability challenges with gene therapies, and capturing value via “traditional” endpoints for digital technologies, to name but a few, only add to uncertainty for payers.

The evolving landscape, both in the payer environment and product profiles, underscores the importance of a well-prepared value dossier in helping to secure timely reimbursement and access. These documents set the standard for how the value of a product should be communicated in access and reimbursement submissions and pricing negotiations: from explaining the unmet need in a disease area through to describing a product’s unique clinical and economic value, and everything in-between. The need for a good value dossier is more important than ever in ensuring new treatments ultimately reach and are able to benefit patients.

So, what is the recipe for success? Every product has its own considerations and nuances, but we believe that there are a few key principles that are essential to developing a high-quality dossier whatever the product and indication. With careful planning and collaboration, a well-written value dossier can be a powerful tool in helping to secure broad and timely market access.

 

 

1. Develop a compelling, evidence-based narrative

The most crucial element of a value dossier is a compelling narrative. The thread that runs throughout the dossier should draw from a wide range of high-quality sources – from published literature to patient testimonials – to convey the burden of the condition to decision-makers, the unmet needs that remain, and the full range of value that the product can deliver. This compelling narrative needs to run strong throughout all sections of the document, and be aligned to other key resources such as the payer value proposition and scientific communication platform. It can be tempting to include everything and anything in a value dossier, but we’d recommend sticking to what’s needed to substantiate the core narrative, so that the story is reinforced throughout the dossier and readers are clear on the need for and value of a product.

2. Use a good template

When the main purpose of a value dossier is to support reimbursement, using a template aligned with region/country-specific templates as far as reasonably possible can help users in efficiently completing their region/country-specific dossiers. With the introduction of EU Joint Clinical Assessment (JCA) in January 2025, we’ve been keeping on top of the JCA dossier requirements, and making sure that these are considered in the structure of value dossiers we are working on (though not at the expense of other markets). For non-reimbursement dossiers a different structure may be more appropriate, for example conveying the value of the product in sections defined by key value messages each supported by multiple trials, rather than sections defined by trials.

Whatever structure or template is used for a dossier, it should be intuitive, make use of tools to support easy navigation, and signpost where localisation is needed. The content in a GVD can’t perfectly suit the needs of teams in all countries, but it can provide an excellent starting point if the structure is well thought-out and aligns well with what the majority of stakeholders need.

3. Keep it to the point

Wherever possible, we’d advise keeping the length of a value dossier manageable, typically ~100 pages of core content, to keep the document user-friendly and focussed on the core narrative. As mentioned above, it can be tempting to include everything and anything in a value dossier but this can dilute the narrative and impact of the messaging. It’s important to define the purpose of the dossier at initiation and remember this ultimate goal throughout the development process: it can’t be everything to everyone. For example, value dossiers cannot adhere to every country’s reimbursement dossier requirements, or contain burden or epidemiology data specific to every country. However, value dossiers are excellent for communicating the core narrative, key evidence, and signposting to relevant accompanying materials without needing to comprehensively explain or duplicate their content. These materials could include literature review reports/extraction grids that may be helpful for content localisation, and the in-depth health economic modelling reports that are needed by many countries for reimbursement submissions.

4. Start early and consider a phased approach

Developing a value dossier requires careful planning, input from all relevant stakeholders across a business (market access, HEOR, regulatory, medical, affiliates and so on), and multiple iterations to account for refinement of the narrative and evolving evidence base, all of which requires time. Affiliates often request access to value dossiers at an early stage, to support their planning and potentially use content for their early activities. And value dossiers often highlight gaps in the evidence base, so starting their development early can allow time for evidence generation activities if these gaps are important to fill. We’d therefore recommend starting value dossiers well ahead of pivotal trial read-outs, especially when HTA submissions are expected to follow on shortly after the trial read-out. An early “Version 1” can set the scene for the introduction of the product, explaining the burden, unmet needs and key product information, and be rapidly updated  with the trial data (and accompanying health economic and statistical analyses) when these become available, so that the complete dossier (“Version 2”) can be promptly made available to the teams who need it.

5. Keep it up to date

Finalising a value dossier is a big milestone, but it’s important not to leave it there. With learnings from early launch markets, new data cuts, label updates, evolutions in the competitor landscape, refreshed treatment guidelines and new publications, no sooner is the first iteration of a dossier complete than it’s time to start an update. Keeping value dossiers up-to-date facilitates the efficiency of updates, and ensures that they remain useful tools for countries in all launch waves as well as a trusted source for the most up-to-date information on a product.