Life Sciences in the spotlight: Biogen

Niamh: Hi everyone, I’m Niamh O’Donnell, a principal in the Life Sciences team at Gate One and host of our Life Sciences in the Spotlight series. Today’s topic is the evolution of market access today and trends and challenges of tomorrow.

The cost of bringing assets to market has reached an all time high with an average cost of around US $2 billion, but more than a third of all new launches fail to meet expectations. Market access, in its simplest terms, can be summarised as the ability to negotiate effectively with payers to ensure the drug is at the right price and crucially, ensure patients can access the right drug at the right time.

It is without a doubt a critical function in an asset development and commercialization cycle and a key ensure of product launch success. So I’m delighted to be discussing this topic today with Adrian Harrington, senior director of value and access at Biogen, based in Zug in Switzerland. Hopefully I pronounced that correctly. A market access leader with 15 years experience in this space, currently focused on neuromuscular and rare disease treatments, and of course, a fellow irish person.

Welcome, Adrian. Thanks for doing this.

Adrian: Hi Niamh, thanks for inviting me.

Niamh: So I’ve got a good few questions. Shall we get straight into our favourite topic? What does excellent market access mean to you? How is this different today from, say, ten years ago?

Adrian: Well, I think there’s never been a more interesting time to be in market access. The demands that are placed on market access teams today are so much more diverse and challenging than ever before. Whereas maybe in the past it was a question of simply characterising the clinical benefits of a new intervention or a cost effectiveness demonstration on the economic side, now you can really get questions from all sorts of angles and it really does stretch you and challenge you in many different ways, whether that’s questions about epidemiology of a new disease, that there’s a treatment for the first time, for the patient journey, changes that would be required to healthcare system architecture.

How are you going to mitigate uncertainty when you’ve got a new treatment? Every day is different. There are new questions and new fields to become fluent in all the time. And I think the breadth of technical disciplines that you need to master has really expanded in a way that was unthinkable just a few years ago.

So it’s super stimulating, but very, very challenging. And I think that’s a real big change from back when I started out. The second thing that is definitely a necessity today, whereas in the past was maybe a nice to have or the preserve of specific therapeutic areas, is the need to really form a coalition of external stakeholders, all working in unison to generate the momentum that is required to secure reimbursement for a new treatment or a new intervention. All of these innovations are expensive. You can’t just produce a pretty dossier, send it in and hope for the best. It’s not how it works. You need a narrative that everybody is behind. You need clarity of purpose, whether that’s with the clinicians and the clinical community, whether it’s with patient advocacy groups. You also need to take account of policy changes, that macro level, what is going on in the outside world, and really making sure that everything that you do is coordinated and organised and consistent so that you bring that discipline to the effort that is required. You build the momentum and then hopefully you deliver a positive outcome. That’s essential now. And it wasn’t always possibly the case.

Niamh: In the past, and I love that phrase, actually, the coalition of external stakeholders and rallying the troops, if you will, to get that buy in for reimbursement is, as you say, so important in terms of the key customers in that. So the payers, what’s your take on the payer environment today compared to a few years ago?

Adrian: Well, I think the payer environment, the payer has always been one of our most difficult stakeholders, always challenging. But I think if I would characterise it, the environment has never been less forgiving as it is today, because, of course, there are pressures on healthcare budgets and reimbursement.

Agencies are tasked with ensuring that they get value from the investments they make with typically taxpayers money. So they’re under pressure to ensure that the data that they see in support of new interventions is solid. And that’s fair enough. I think what has happened in recent years is now there are a number of channels available through which we can communicate with the payer community, whether that’s early advice with the GBA in Germany, you also now have the office of Market access in the UK.

Even the regulatory agencies are tuned in these days to questions about cost and reimbursement. And so there are lots of ways that you can solicit advice and get feedback on your plans. In recent years, I’ve been fortunate enough to participate in some pilots of the Mocha initiative that stands for the mechanism of coordinated action, and it’s sponsored by Eurodis, which is the federation, the European Federation of Rare Disease Societies.

That’s a voluntary, non binding forum in which manufacturers can come together with payers from around Europe and patient advocacy groups and in a very open and frank environment, discuss their plans for data generation and development of an asset, and essentially what their market access strategy looks like, as much or as little as they feel comfortable with sharing.

So there are forums through which you can get this very frank and constructive feedback. Payers are very challenging, but they would also say, look, don’t come crying to us if you hear something you aren’t expecting, because we could have told you so, and that’s what we need to avoid.

Niamh: Absolutely. And incorporating that voice of the customer in any industry really is so important. And it’s no different here with the VOP or the voice of the payer, for want of another acronym. Moving on then, to practicalities then, Adrian, I suppose the so what for pharma companies, what do you think are the top three actions that pharma companies can take today to deliver that market access excellence?

Adrian: Well, I think the first thing for market access excellence is to have market access front and centre really at the core of the organisation. We really want to avoid a world in which market access professionals like us are in a silo away from the beating heart of the company, if you will, populated by highly technical individuals who can’t really communicate what it is that they’re bringing. So it would be great, in my opinion, if we had organisations built around market access. So we’re the leaders, but we’re not the only participants in a really highly motivated group of functions, all working in unison to deliver an outcome. Because if we don’t have good access of reimbursement outcomes, then what are we all doing? So putting market access at the centre of the organisation would be great.

Related to that, a second thing is to do with data generation and how we think about what is required in support of an asset that we may be bringing to market, or developing clinical evidence for. Historically, I guess, this was the preserve of research and development, and they were focused on delivering regulatory approval with a minimally feasible data set, if you want to think of it that way, in many cases, also with cost implications.

Now, the nature of the scrutiny on our data is changing, and it means that we’re going to have a different level of challenge over a longer time horizon. And so I think the shift that is needed is to this concept of the long game of market access, that is generating data that will sustain reimbursement and sustain value demonstration over a much longer period. And that’s a big shift in the way that companies operate, but I think it’s something that we are learning and people are open to hearing about it and learning about, but it requires a lot of structural change.

The third piece that I think market access people uniquely are able to deliver into a company is that real objectivity about where does your asset sit in the sort of pantheon of all of the other things that are coming to market, that are coming across the agenda of payers at any given moment in time. It’s understandable that you’re working on developing what you hope will be a new treatment, bringing great benefits to patients, you’re working with patient advocates, you’re working with the principal investigators in your study.

Everybody is getting excited about this new step forward that you’re going to take, but that might not be exactly the same as the external perspective. And one of the things that market access allows you to do is to bring that cold reality internally, to refine the plan, to understand where you’re strong, where you’re not as strong as you thought you were, and to ensure that in the end, when you do bring that innovation to the tension of payers, that you’re putting your best foot forward and that you’re telling the story in the best way so that patients get the benefit of this new treatment you’re bringing.

So having a way in which that feedback can be heard and internalised and actioned within development teams is something that market access can really bring.

Niamh: Absolutely, and I totally agree with you. Heard and internalised is one thing, but actioned is, for some folk, a lot easier said than done, but certainly crucial to incorporate that upfront, that healthy challenge from an access standpoint, for sure. So, Adrian, if that’s what can be done today, if we flip ahead and look to the future for a minute, what do you see as trends and challenges in the access space, and what will you think the key drivers of success for pharma companies will be?

Adrian: Well, I think the trend that will continue, and I think the one that’s top of mind, is that the complexity of our roles will continue to increase. The threshold for payers or reimbursement agencies to accept and approve new treatments will continue to be raised. The level of detail just grows every year as we understand therapies and disease better, and the science that goes with new treatments, so that complexity is here to stay.

There are some new initiatives, like the joint clinical assessment in Europe, which is coming in over the next few years. The objective there is to standardise and simplify the job of manufacturers in terms of bringing an evidence package and getting the benefits of it assessed in a coherent way. But I think in the short term, that’s just going to mean more complexity. It’s just one more thing that market access teams will need to be aware of and take account of in their planning and in the work that they’re doing.

So the complexity is just the nature of the industry that we’re in, and I don’t see any fall off in that anytime soon. In terms of looking forward at the challenges, and this is a perfect world that I’ve painted of how market access is going to be at the centre of everything and people are going to listen to us as never before, but the reality is that we are working in a super risky business. It’s the nature of what we do. Scientific innovation is hard, it’s unpredictable and it’s extremely costly even today to make the changes that I’m talking about. To have this long game approach to data generation for market access, that’s going to require even more investment and more resources, and shifting the structure of companies around market access as the key function.

Not everybody will have the means or the desire to do that. The risk appetite within companies might just not support putting even more money behind these kind of development programmes. And we also have investors and shareholders to satisfy, and they might not be on board with that new paradigm either. So it’s not going to be for everybody. But I think it’s incumbent on us in market access to make the case for why this is the way to maximise value, this is the way to avoid those points in time where you can destroy the potential value over the long term of an asset. If you put it that way, it can be a really compelling story and I hope that those of us working in the field who have the opportunity to make the case for the value that can be brought by market access can be successful in communicating that, in getting the buy in from internal stakeholders and really making a transformational change in the industry.

Niamh: Absolutely, and it’s certainly an exciting time for you guys in market access and beyond. Adrian, thanks so much. Those points were so informative and thought provoking. So thank you for sharing your insights and leaving us with some food for thought.

Adrian: Thanks so much. It was a pleasure.

Niamh: So that draws this episode to a close. Thank you for joining and thank you for listening.