Moving MAPPs into Practice through ADAPT SMART’s Legacy

Duane Schulthess (DS): It’s only been a 30 months project, but how do you think ADAPT SMART has done in meeting those objectives?

Solange Rohou (SR): In regard to such politically loaded topic, I – as the deputy project lead – am satisfied as I know where we were two years ago when it was difficult to discuss or even mention ‘adaptive pathways’ to where we are now, a period during which we have addressed some key operational and strategic challenges that adaptive pathways raises. I believe ADAPT SMART has been instrumental in shifting people’s mindset. Of course, one could question what we’ve achieved, and we do not shy away this reality, but looking at the big picture, we’ve made tremendous progresses, and are looking for what will come next. ADAPT SMART has helped bringing pragmatism on a hot topic in a challenging environment, and this is what I am the proudest of.

Hans-Georg Eichler (HGE): Allow me to rephrase the question; I would argue that the objective was to help enable MAPPs in Europe, and there is a very subtle but important difference. As I look at the entire healthcare ecosystem, and particularly the pharmaceutical ecosystem, it is so complex and interdependent that no single player in that ecosystem has the power or ability to change anything on their own. If you look at the European Medicines Agency (EMA), of course we’re influential, but we rely upon others if we want to stimulate a change in approach. To expect that we could change the world in two and a half years would be totally unrealistic, but to change mindsets, to bring to the attention of everybody solutions that are realistic, that was the aim of this project, and I would argue that we have achieved that goal.

If you can go back in time five years, people thought that everything has to be known about the products on the day of product approval. That was always unrealistic. We have created awareness that learning about a product is gaining an understanding of how it performs over its entire lifespan. As well, ADAPT SMART has highlighted that some patients have a window of opportunity that is closing, and that time to market is of the essence. This was not widely discussed before, and patients brought it up first.

Now, we have collaboration and discussion between stakeholders. We have made tremendous advances in the thinking and interacting between the stakeholders in that ecosystem. ADAPT SMART has achieved its objectives.

DS: Regarding that implementation development of wider stakeholder engagement, do you see that ADAPT SMART has actually developed processes that can be rolled out across multiple countries to improve stakeholder interaction in the Member States?

SR: It’s a work in progress. A lot has been done, but a lot remains to be done. Given the structure of healthcare in Europe, the fragmentation of decision making does pose challenges. We’ve begun the process to discuss issues together, to interact together, but there is still room for improvement. It’s quite clear that we need to do more to facilitate interaction, and this is something that will need to be achieved in the coming years.

HGE: I totally agree with what Solange just said. We established formal processes, for example a platform that facilitates joint consultations between drug developers, regulators and EUnetHTA. ADAPT SMART can’t take the credit for this process, but I do think the whole debate that we stimulated gave the bandwagon a push. We had the first formal interaction at the EMA with European payers organisations late last year. That was the first time, and I think I’m correct in saying that part of this was triggered by the whole debate around timely access and adaptive pathways or MAPPs. Before, payers were unhappy and so they said, “Okay, we have to talk to these guys.” So, ADAPT SMART triggered the first initial formal contacts and that will be followed up in future.

DS: ADAPT SMART is wrapping up next month in Budapest; what are the final steps? Do you think the findings that you’re going to deliver in the conference and in the final reports will continue to be integrated into processes across the EU?

SR: Something that is quite unique is the opportunity to foster dialogue which goes beyond the conventional scientific discussion. There are, of course, challenges to be addressed across the ecosystem as a whole, but the project has managed to reduce some of the barriers between stakeholders. In addition, the MAPPs approach has started to spread beyond Europe, which is quite interesting, as companies develop products globally.

DS: In fact, Solange, there is a legislative package with the US House Ways and Means Committee called the Pharmaceutical Information Exchange (PIE) Act which would allow for the sharing of economic and scientific information on an investigational drug with insurers, pharmacy benefit managers, and other groups 12 to 18 months ahead of FDA approval. Do you see the work in ADAPT SMART having an influence; it seems to be directly related?

HGE: I think what we have written and what we have said in public, both in Europe and also in North America, has resonated with a number of people. Many of these ideas around the MAPPs concept are powerful, and they are being taken up because their time has arrived. So whether it was specifically our efforts or whether we just had the right timing I couldn’t say. But if I read and hear what is currently being discussed in the US I would say that’s 90 percent MAPPs.

DS: If we look back at the last three or four years since the EU began discussing MAPPs, how do you think opinions have evolved?

HGE: Well, it has been a bit of a roller coaster [laughs]. I would say first there was enthusiasm, then came criticism and then came, I would say, a rather cooler assessment. The criticism was probably triggered by the belief that we wanted to dismantle the existing evidence standards and the existing regulations. I think it’s now being realised that this is a genuine attempt to address conundrums that are there, and so I think really the general assessment now is a lot more restrained, and there is an understanding that, yes, many of the things we’ve been discussing have gone mainstream. Let’s face it, if you think of MAPPs as the intelligent combination of building blocks, then many of these building blocks are no longer controversial.

For example, we should focus on transformative treatments for those patients in urgent need. I think nobody disagrees with that anymore. There were discussions about whether payers, HTA bodies, regulators and patients could collaborate in helping industry design an evidence generation plan. That is also no longer a matter of debate, and these building blocks have gone absolutely mainstream.

There are a few things where we are still in the debate stage. For example, real-world data – not everybody is convinced that this will make a major contribution. Also, managed entry agreements – I sense payers still have reservations about these forms of, shall we say, more innovative contracts between payers and industry. So there are a few frontiers still to be refined.

DS: Solange, from industry’s perspective, have you seen an evolution of the thought processes about MAPPs since you’ve been involved in ADAPT SMART?

SR: Yes! As you’ve said, it’s about evolution and adaptation, and what you do outside your comfort zone. There’s inevitably resistance and reluctance when embarking on a new concept or paradigm, and it’s always a challenge. But there’s always the niche you can find where you can explain and engage in dialogue to show the potential benefits of something new. It’s all about adaptation and moving forward in our thinking. I noticed in my company, people I knew who were hesitant are now more open to discuss MAPPs, and I was quite nicely surprised.

DS: Obviously, there’s a treasure trove of information on the ADAPT SMART website regarding how MAPPs has evolved. What’s going to happen come March 23rd when the project’s done and dusted; will the website and its resources live on?

SR: It’s always challenging to consider the future. Lots of material has been produced by the consortium, and it would be a shame not to use it once the project concludes. We are producing an infographic for the home page of adaptsmart.eu as a practical guide for the various stakeholders that will help them navigate the website.

HGE: Our goal must be to make all the information we developed available, and keep it alive for a number of years. Eventually, time will move on, other things will come forward, and much of what we discussed and wrote will become so obvious that it’s probably no longer relevant. But over the next couple of years, we will definitely make an effort to keep the content alive and available to every interested reader.

SR: If I may add, the final project objective is to provide recommendations to the IMI and other stakeholders as well. So, at the end of the day, those consolidated general recommendations will be implemented. It is an opportunity for the consortium to see that what has been accomplished will pay off.

DS: The closing event, in Budapest on March 21st and 22^nd, will be focusing on putting MAPPs into practice. How do you hope that this event will consolidate everything you’ve worked on?

SR: I think this will be the opportunity not only to celebrate, but also help put into practice what has been done by the consortium using a specific case study example. This will prompt new thinking or give ideas to others to move forward harnessing MAPPs, and identify appropriate assets that can go through the pathway.

HGE: The event is being held in Budapest and the hope that seems to be materialising is that a fair share of the audience participating will be experts from Central and Eastern Europe, so we want to spread this word that is a great opportunity.

DS: What’s the one key point that you would like everyone who reads this interview to take away from ADAPT SMART and MAPPs?

HGE: We can use MAPPs to put out some needed new drugs that make a difference in patients’ lives. Many patients are in a state of urgency where they cannot wait for those drugs to come out in five or six years’ time, and this can be achieved without compromising the evidence standards ― without cutting corners. That is what MAPPs is all about.

SR: I would like to say, don’t hesitate to engage once you have identified a transformative therapy that could address a specific patient need. Don’t hesitate, use your common sense, harness the scientific knowledge to navigate the discussions, and move things positively at an early stage of the drug development process.