eyeforpharma 2020: Redefining value

eyeforpharma 2020: Redefining value for COVID-19 and beyond

The coronavirus pandemic was front and centre of everyone’s minds at this year’s spring eyeforpharma conferences – not least because the usual locations of Barcelona and Philadelphia had been swapped for completely virtual events. Nevertheless, with most speakers still in attendance, it was clear that the industry is keen to overcome the difficulties of lockdown to work together through these difficult times.

The pandemic didn’t just mean that most speakers were broadcasting from their kitchens – it also resulted in lively discussion on how market access might change in light of COVID-19, and indeed how the various drugs and vaccines that are speeding through trials might best be brought to a global market.

That said, pharma does not just treat COVID-19 patients, and access and reimbursement will remain persistent challenges during and after the pandemic – so many speakers opted instead to discuss ongoing trends like the use of patient reported outcomes and real world evidence (RWE).

Here we highlight some of the most interesting discussions to come out of the events.

Image above: LEO’s Patrice Baudry (left) speaking with eyeforpharma’s Paul Simms

Defining value for COVID drugs

It was inevitable that coronavirus’ effect on market access would be mentioned at some point during the conferences, and this job mostly fell on the Valuing Innovation panel during the Philadelphia stream, hosted by Robert Dubois, who’s CSO and EVP of the National Pharmaceutical Council.

Dubois said he believes the core principles of valuing innovation have not changed despite the worldwide disruption.

“The health economic principles driving how we think about the world today are the same as before, and will remain the same after the pandemic.

“Costs and benefits are time-tested concepts. During COVID-19, we’ll still look at the cost of a treatment or a vaccine compared to the benefits, broadened to include how it could help loosen social restrictions.

“It’s true that the budget impact of a COVID treatment or vaccine are tremendously different to, say, a rare disease drug, but I would assert that the core thinking around value hasn’t changed. It’s still related to the amount we are willing to pay to save a life. We may come to a deeper understanding and say we are willing to spend more than we thought we were to save a life, but that doesn’t change the fundamental principles.”

He added that the productivity benefit of a drug will likely become much more important in the wake of the pandemic.

“Diseases affect productivity. Diseases that are treated may improve productivity. That is one value of a treatment. Historically employers and payers didn’t put a lot of credence in that for value discussions. I think because of social distancing, working at home with three screaming kids and no nanny, people now understand that illnesses affect productivity in ways that they never have before.

“I would assert that productivity has always been important, but now with COVID we are going to deeply appreciate that, and moving forward I hope it becomes a part of the equation in new ways.”

Also on the panel, Sarah Emond, EVP and COO of ICER, said she agreed with Dubois’ points but was struck by how different the paradigm is when payers are trying to incentivise companies to develop coronavirus treatments compared to other drugs.

“One of the ways value assessment traditionally has been used is to signal to the innovator community what kind of incentives they need in order to invest many millions and billions of dollars to develop something. When we think about value assessment in that traditional framework we’re thinking about all of the ways that the manufacturer needs to recoup their investment from the price.

“What’s different about a pandemic is that we don’t really need an incentive to develop something new. Pharmaceutical scientists are working on this because it contributes to the social good of returning life to normal.

“In that regard, do we really need a value assessment framework to tell us what our sale price might be if we don’t need to incentivise the development?”

She said this might be an instance where the industry should think about de-linking the investment manufacturers make in R&D from the price they ultimately need to charge in order to recoup that.

“There have been several ideas passed around – everything from a prize that’s given to the person or the organisation that develops the first vaccine to a Netflix model like they’re using in Louisiana for hepatitis C, where we set a fixed price to get as much of the vaccine as we can to an individual state or country.

“One of the things that value assessment frameworks have forced us to do is have a grown-up conversation about what parts of the social surplus created by the manufacturer accrue to the manufacturer and what parts accrue to society. I think when we’re faced with a global pandemic, it’s worth having a conversation about how that balance might be different, and how social surplus actually accrues to society and not necessarily to the innovator, because we’re solving a bigger problem.”

She warned that the industry should already be thinking about the affordability of coronavirus treatments and how that might affect people across the world.

“This is especially important because value assessment frameworks are typically used in developed nations with significant healthcare budgets, but here we need to send treatments and vaccines to the entire world. Many countries do not have huge healthcare budgets. So affordability is going to be a really important part of this conversation.”

Bringing the patient voice into value

Despite the ongoing pandemic, most speakers opted to stick to their original plans and take a wider look at where market access in pharma might end up in a few years’ time regardless of coronavirus.

In a fireside chat with eyeforpharma CEO Paul Simms during the Barcelona stream, Sunovion’s senior vice president of sales and market access Matt Portch, in keeping with his unusual job title, said there is “a lot of opportunity in taking value-based discussions to physicians and eventually to patients as well”.

“We need to make sure we talk to them about not just the safety and efficacy of our brands but also the value of the product depending on the metrics they’re looking at – whether it’s quality of care, taking costs out of the system, etc.

“You have to be a little bit more unbiased for them to be willing to have this discussion – often you have to say, ‘My product doesn’t work there, let’s identify the places it does, and where it doesn’t let’s figure out what else we can do’. For example, in mental health we might suggest cognitive behavioural therapy (CBT) as an alternative approach.”

Moderating a panel on Access and Affordability during the Philadelphia stream, Sue O’Leary, who leads the market access practice at Prime Global, noted that when her organisation speaks to payers, “they often flag what sort of outcomes they’d like to see in studies”.

“Quite often they’re disappointed when they see product profiles and study designs that don’t really take account of that,” she said.

Similarly, LEO Pharma’s EVP Patrice Baudry, noting that pharma is now trending towards providing solutions more than products, said that companies’ target product profile should “not only be the features of the molecule, but also how it helps patients, how we build different types of support”.

“That has been the case for a while, but now I’m really starting to see that accelerating.”

Asked how companies can have the correct metrics in place to ensure they are not just paying lip service to patient outcomes and values, Baudry highlighted the importance of making sure things are driven by real world data.

“When you are a company of our size you need to be smart because you don’t have the big pockets of larger pharma. It very much needs to be a culture where you track at all levels the opportunities you can have with key opinion leaders and other stakeholders. That gives us the opportunity to compensate for the deficit of size and a lower budget.”

However, EMD Serono’s vice president of global patient insights and advocacy, Hazel Moran, noted during the Access and Affordability panel that pharma needs to help shape the regulatory environment to make these approaches more commonplace.

“It’s great to hear from patients as an individual component but if the regulatory system doesn’t align with allowing us to take into account that voice it’s a challenge,” she said.

“There’s an opportunity for us to shape the environment in which we work.”

She added: “We really need a true cross-functional collaboration because we all play our distinct roles.”

She used an example of her colleagues partnering with an MS patient group to create patient reported outcomes early on in development.

“We’ve seen a tremendous transformation from what we were thinking of initially to where we are landing later on. It has really made a huge impact on the approach we took by making sure we don’t assume anything and ask patients what matters most to them at the end of the day.

“I will probably never again hire a brand lead who doesn’t have market access experience. You need to truly understand and drive a commercialisation strategy behind the value that you’re bringing to each of those stakeholders.”

Real world evidence comes of age

RWE is often brought up as a key factor in helping to measure outcomes that are more reflective of patients’ actual needs – and indeed the topic was one of the most common for presentations during the Barcelona stream.

The various different approaches speakers took to the subject showed that we are now entering an era where RWE has matured and become much more sophisticated.

Christian Born Djurhuus, VP and head of digital transformation, global development at Novo Nordisk, was another speaker who said he advocates for keeping product launch and the patient voice in mind from the earliest stages of development. But, as he explained in his fireside chat, despite being one of the best methods of assessing a drug’s value benefit, RWE is traditionally something that can only be collected post-launch or as part of managed access agreements.

Djurhuus suggested that pharma should be starting to look at methods of gathering what he calls ‘pseudo real world evidence’ early on in development.

“We all aspire to demonstrate the value of our products in a real world setting. Yet, for obvious reasons that’s not possible pre-approval of said drugs,” he said.

“Society, and payers in general, will pay for the value that our products bring to that society. So I don’t think there’s any way around it – we need to figure out how to deal with this.

“I believe that we can move towards that using technology, by having more liberal eligibility criteria for trials and having more real world setups of our studies – hence ‘pseudo’ real world.”

At the same time, he said that it’s important to ensure that RWE gathered in such a way is as close as possible to the integrity of data from randomised clinical trials (RCTs) – which he believes “will always be critical in terms of new drugs and figuring out what the true value is to healthcare”.

Electronic health records (EHR), for example, have been a huge part of why use of real world evidence has accelerated, but Christian said that what is still lacking is an element of randomisation from these sources that can combine “the best of both worlds” in RWE and RCTs.

He provided some examples of how Novo Nordisk is trying to tackle this – for example they have asked some physicians if they are specifically mindful of one drug for a condition, and if the answer is ‘no’ they see if they would be willing to ask their patients to take part in randomisation.

“[We need the mentality that] you can build randomisation into healthcare and electronic health records,” he said.

“We’re engaging with IDNs to run activities where randomisation is built on top of those records – not fully but to a large extent.

“That allows us to capture data in a similar manner to how the value-based contracting will eventually be assessed. Most of that data would be collected through electronic health records, so we need to play into that early on, and we can only do so if we’re catching it in the same environment.”

He said that collaboration was essential to such approaches.

“It’s a matter of having a joint discussion on what actually constitutes clinical value. None of the stakeholders I’ve talked to are reluctant to pay for value to society. It just has to be validated.”

George

George Underwood is a senior member of the pharmaphorum editorial team, having previously worked at PharmaTimes and prior to this at Pharmafocus. He is a trained journalist, with a degree from Bournemouth University and current specialisms that include R&D, digital and M&A.

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