I read a book on marketing once called “Getting everything you can out of all you’ve got” (worth a read by the way, particularly if you’re interested in cognitive biases and how humans perceive value).
Anyway, the title got me thinking recently, particularly around the topic of early scientific advice and its value for pharma and biotech. Because I’ve seen a fair few posts, webinars and white papers over the years that provide a pretty dry and logical overview of the process.
- Who you can go to for advice (answer: lots of HTA and regulatory agencies, often in combinations that provide parallel input across a similar timeframe. I’ll cover optimising who you go to for advice, and when, in another post)
- When you should seek advice(answer: typically when you’re developing the protocol(s) for your pivotal/registrational study or studies)
- What can you ask about (answer: plenty, but not price, and – while advice typically isn’t binding – it’s generally not ideal to ask for advice and then ignore it)
- What the process looks like(answer: write a briefing book, answer clarifications, attend an advice meeting and review/clarify the final report)
And there’s plenty of information out there that means – with limited in-house experience – you can navigate the advice process relatively smoothly.
But – and this is my bugbear – are you getting everything you can out of that process? Because I think many clients aren’t.
And if not, why not?
Because for me, there are a few things that don’t get talked about enough for early scientific advice, and they’re absolutely critical for success.
You’ve got to ask the right questions
First up is asking the right questions. The old adage is true here. If you put rubbish in, you’ll get rubbish out. Ask the wrong questions, and you’ll get the wrong – or unhelpful – answers. And this typically means that – for scientific advice related to HTA – you need a team with in-depth experience in access mechanisms in that market.
Take NICE for example. Very specific parameters on what is an acceptable data package at assessment, and experience shows that – particularly in oncology (where we work at lot) – it’s very challenging to put together an “ideal” evidence package for HTA (I’ll leave [lack of] ability to generate robust long-term efficacy data for oncology therapies by MHRA approval for another blog).
The point is that you need to be asking very specific questions about how NICE will view your evidence package in 2-3 years’ time. That requires in-depth knowledge of NICE assessment methods and processes. Of required evidence types and hierarchies. Of methods for indirect treatment comparisons. Of methods for correcting for cross-over in clinical trials. And so on.
And that means that you need a team – whether internal only, or using an external vendor – who understands these processes. And who – importantly – is willing and able to push you in defining your questions clearly and succinctly (you can’t ask very many by the way, so you need to be selective).
You need a team who can really push you to define what your intended positioning is. Why that primary endpoint was selected. Why that comparator and not this one, or that one. Why exclude those patients and not these ones. How will you extrapolate longer-term outcomes data? How are you intending to generate control data for your single-arm trial?
And they need to push and cajole for answers even at a stage of clinical development that’s very much in flux (itself something of a challenge when trying to nail down a version of the working trial protocol to develop a briefing book from).
It’s not just about the advice
One other point that’s often overlooked is around the tangential internal benefits of the advice process. Of all the projects we work on, scientific advice projects are some of the most satisfying for bringing together a diverse range of stakeholders (in country and above) for a common purpose. Rarely do you otherwise see R&D interacting with country market access teams.
And therein lies an important opportunity. The opportunity to demonstrate the real value of considering access EARLY.
A few years ago I think there was a real lack of communication – and possibly even appreciation – between early-stage clinical stakeholders, and later-stage commercial/access stakeholders in pharma. Thankfully those days have largely gone, and there’s much more of an appreciation throughout cross-functional teams of the importance of market access.
A gentle reminder once in a while doesn’t go amiss though. And it can be a sobering reminder of the potentially catastrophic implications of a misstep in clinical trial design years before launch.
Forewarned is forearmed
Of course, there’s also the opportunity for country teams to have clear and early sight of the likely evidence package that they’ll be working with in future.
And with knowledge of the likely evidence package, plus knowledge of what NICE – or other agencies – will require for HTA, there is a critical window where in-country teams (or above country) can work to generate the evidence to address those gaps
So there you have it. A few thoughts on getting everything you can out of your next scientific advice engagement. Sure it’s fairly easy to put together a 50-page briefing book (or at least it is for our team of brilliant market access writers).
But to really maximise value from the interaction – to get everything you can out of the process – make sure you consider the points above when assembling your project team.