Thinking about the challenge you’re trying to solve is critical for selecting the right project type and optimising your return on investment

Timing and information are critical in the pre-launch phase of bringing a new therapy or indication to market. Without a thorough understanding of the therapeutic landscape and – importantly – predicting future direction of travel, it’s not possible to develop a robust strategic plan that optimises price and reimbursement success.

And there’s potentially a lot you need to know.

You need to understand the burden of disease. For patients. For healthcare systems. For carers. You need to understand what’s important for patients. How care pathways work. Where patients are treated. What therapies clinicians use and why. You need to understand current, and future, competitors. Where they add value, and where there is residual unmet need.

And for the purposes of achieving access, you need to understand – in considerable detail – the HTA landscape into which your therapy will launch (note the future tense here).

What’s the difference between an HTA review and a landscape review?

While this can differ depending on who you ask, broadly speaking an HTA review focuses on the specific requirements of achieving positive reimbursement, while a landscape review provides a more general overview of a therapy area.

A typical landscape review will include some assessment of the HTA reimbursement landscape, but may not go into sufficient detail to support early decision making around model structure, data inputs, utilities and previous HTA body critique.

What makes a brilliant landscape review?

Good question, and the answer is “it depends”. Broadly speaking you’ll want it to cover the current treatment landscape (what’s reimbursed, and what may be reimbursed by the time you get to appraisal), patient and healthcare system burden, real-world treatment pattern and epidemiology data, and SWOT analyses for comparator therapies. Treatment guidelines – local, national and regional – are also important, and with the increasing prevalence of targeted therapies, the genetic testing landscape is often key. At redthread, we’d also advocate for primary research to supplement any desk research, to ensure your knowledge reflects the “on the ground” situation in the target indication.

Recent projects at redthread have looked at the genetic testing landscape for various new targeted oncology therapies. And exploring funding pathways and inconsistency of next generation sequencing technology use provided important early insight that contributed both the early economic models, but also to developing an external engagement strategy for healthcare system stakeholders.

Most importantly, any landscape review needs to provide the information client’s need to support their decision making, and it needs to summarise this succinctly. Detail is important, but so is presenting information clearly and concisely. A lengthy data dump helps nobody.

What makes a brilliant HTA review?

Here it means not only understanding ongoing macro trends around reimbursement in your market (like NICE’s proportionate approach to technology appraisal, for example), but also appraising your proposed evidence base against HTA requirements. Reviewing outputs for previous HTAs – both within your indication and for proxy conditions if required – can provide important and timely insights to allow you to plan appropriately.

The devil here is in the detail. Any review of previous HTA needs to be conducted by a team that understands HTA decision making, modelling, utility derivation (including mapping and vignettes), generation of real-world evidence, survival modelling and more. That’s a rare skillset in a communications team.

At redthread, our consultant writers understand how to interpret HTA body reporting and pull out the “so what”. They can pick out the key areas of review group critique, flag differences in modelling approach, and help to identify where previous real-world evidence generation didn’t hit the mark. Brilliant HTA reviews focus on data and methods, both for your therapy and for previous HTA appraisals. And brilliant reviews will pull together a shortlist of recommendations and potential mitigations to help you ensure you pull together an appropriate evidence base for your submission.

Sounds simple. It rarely is, and needs an experienced team that understands HTA inside out, and who can write brilliantly.

What does this mean in practice?

Well, firstly don’t get too hung up on names. Work out what question or questions you’re trying to answer, and then tailor the review to meet that need. A great agency will help you refine the brief here. A cookie-cutter agency will just try to sell you what they sold the last client.

Which obviously brings us to the point around selecting a brilliant agency to support you. Anyone can read the relevant documents and copy and paste certain sections into the slides. In honesty, you can do that yourself. What you need to be looking for is an agency that provides that strategic support and that can distil the “so what” into a succinct narrative, with clear takeaways and actions. An agency that can find your red thread.

Sound like anyone you know?