As we settle in to the New Year Shire has already hit the headlines in a big way, thanks to its planned acquisition of Baxalta, a $32bn deal that it says will make it a global leader in rare diseases.
However, with attention deficit hyperactivity disease (ADHD) treatment Vyvanse accounting for more than a quarter of its revenues it’s clear that, even after its combination with Baxalta is completed, neuroscience will remain high on the company’s agenda.
Late last year, when the companies were still dancing around offers and conditions, I sat down with Shire’s Alvaro Herreros to talk about approaches to ADHD, working with patients and applying technology.
Appointed international neuroscience portfolio strategy team lead last summer, Alvaro has responsibility for all of Shire’s neuroscience business, with the exception of the US, and leading its cross-functional team in the therapy area. Before relocating for his new role in Switzerland, he spent nearly five years as a business unit director for neuroscience for Spain and Portugal.
While his current role is not his first international position, having previously served at Merck & Co as an international brand manager for migraine, this time around the global responsibility is much bigger.
We try to be recognised as patient-centric by supporting and helping the overall ADHD community
A complex and difficult condition
Given his experiences in neuroscience to date, Alvaro is keenly aware of the differences in how countries approach a condition like ADHD – the most commonly diagnosed child psychiatric disorder in the world. A complex and difficult condition to identify, there’s both over- and under-diagnosis of ADHD in different geographies around the world – not to mention a dose of controversy about medicating what some can see as the exuberance of children. Nevertheless, according to World Health Organization figures its prevalence currently stands at about 5% of all adolescents, with boys accounting for three-quarters of those diagnosed.
“It’s a big mental health condition, with different levels of severity, though that doesn’t mean that everyone requires a treatment,” acknowledges Alvaro. “I would say the US is clearly the leading country in terms of its treatment. It’s where the cutting edge science is. And then I would say Canada, because of the influence of the US, is the second country in terms of leading the way or in terms of having a history of treatment and approach in a way to ADHD. And then Europe is behind them.”
Just how far behind Europe comes depends on which part of the continent you’re looking at, with a north-south divide often evident. The UK, Sweden, Denmark and other Nordic countries have “a very good understanding of ADHD and a very high diagnosis rate, which is getting closer to the prevalence”, Alvaro says, but often the picture in places like Italy and his home country Spain is rather different.
“In Spain, for example, the physicians that have started diagnosing and treating ADHD were physicians that 10, 15 years ago worked in the US or in the UK – the UK, because of its relationship with the US and Canada has always been a little bit more advanced compared to its European peers.
“However, in Italy there are very few doctors really treating ADHD. There is a cultural thing. Sometimes there is a feeling or misperception that ADHD is just that the kid moves a lot, and it is purely an educational thing.
“We as, let’s say, Latins, we talk a lot. We move a lot, and that’s it. Or it’s just bad parenting. Of course, a hyperactive child is going to move a lot, but if it’s more than what would be normal to his age – and for this he needs to be diagnosed by a physician – then it could be a functional disorder for the child.”
Treating the disorder
Where it is determined to be a functional disorder, the US again has led the way in terms of availability of different types of treatments, with Europe – until very recently – having only two approved types of medications to the three on the US market.
These classes were methylphenidate-based products like Johnson & Johnson’s Concerta (methylphenidate hydrochloride) and Lilly’s non-stimulant Strattera (atomoxetine). Meanwhile, the US also has the amphetamine-based class – Shire’s historic territory with Adderall and its flagship product Vyvanse.
“With both classes of medications you can treat many patients, but not every patient responds to both of them. So it’s important to ensure that the patient can get the medications that will work better for them,” says Alvaro.
Shire also has a foot in the non-stimulant camp with Intuniv (guanfacine), which was approved in Europe in September having been available in the US for some time – long enough in fact that it now faces generic competition there and in Canada. The company’s portfolio saw another boost when its Elvanse Adult treatment received European approvals in the UK, Sweden and Denmark, opening up a new avenue for the company in this region.
It’s important to ensure that patients get medications work better for them
Harnessing technology
Shire’s communications efforts in ADHD have for some time included digital technology. One new and noteworthy use of this can be seen with the company’s In My Shoes campaign.
It involves virtual reality technology to convey the impact of ADHD on different groups, beginning with three different patients – a child of 10 years old, an adolescent of 16 years old and an adult of 32 years old. They’re each shown performing a normal everyday task, with the technology illustrating the challenges they face and – as the campaign name would suggest – putting viewers ‘in patients’ shoes’. “It’s been a great learning capability because you can really feel yourself much more what type of emotions the patient is having,” Alvaro explains. The next step for the campaign could see Shire add more settings and situations to better illustrate the range of ADHD patients and the challenges they face.
The company has also been active in harnessing online technology as a way to educate and inform patients and the public on ADHD. In Spain, for example, its local language website for non-medical ADHD stakeholders and the general public Tdahytu.es (trans. ADHD and You) gets around 75,000 visits a month and Alvaro hopes this sort of initiative will help counter the varied quality of information that is often available online.
“The issue is that on the internet, even if there is a lot of scientific evidence behind ADHD, there is still some controversy. There are a lot of webpages saying a lot of things that are not appropriate. So, some years ago when we entered the ADHD space in Spain there was a big demand from patients for online information that was good and relevant.”
Some of the most popular sections of the site have been where it provides practical advice for parents and carers, such as how will things change at Christmas time when the child is not at school, because it’s a break in their routine which can often cause them to become a little bit more nervous and excited.
The important thing is not to say, ‘Oh, I want to be patient-centric’ … what is really relevant is what patients think
Patient engagement
“The important thing is not to say, ‘Oh, I want to be patient-centric’, or ‘I consider myself patient-centric’,” Alvaro notes when the conversation turns to the pharma phrase du jour. “What is really relevant is what patients think,” he adds.
“The way we try to be recognised as patient-centric is on supporting and helping the overall ADHD community, and this is not just patients and their parents for example, but as well, I mean, the physicians that treat them, even the school system.
“The school system is key for a child that has ADHD because, of course, they spend a lot of time at the school and there are things that at the school can be done, to raise the flag when there is something that is not going well, and maybe potentially pre-screened for diagnosis. For example, this is something that Sweden, for example, is doing in an active way.”
There are inevitable tensions to be worked out between a company’s core business of bringing effective new medicines to market (arguably one of the most patient-centric things pharma can do) and a desire to ‘put the patient first’.
“There are two domains of education where we try to work, because we believe that’s the right approach for the patient. One is we need to ensure physicians diagnosing and treating ADHD know our drugs, their attributes, what are their characteristics, in which type of patients they would work. Maybe for this type of patient this could be the right approach, while for this other type of patient or type of needs, this other medication would be the right approach.
“But that’s very brand-specific or business-oriented. We have also always gone further than that to ensure physicians have the right education on ADHD, not only on how to diagnose it, but as well on how to differentiate it from other mental health issues, for example, autism.
“Internally we ensure all our employees have a good knowledge of the different diseases where we are working – not just from a scientific standpoint but from a patient perspective.”
Future focus
Turning to Shire’s future plans in ADHD one of the things it is focusing on is patient registries, with work in Sweden underway to collaborate with existing registries, for example of adult ADHD patients. “We are providing support to have a greater understanding of adult ADHD newly-diagnosed patients anwd get information on many domains of their life to better understand how the condition is impacting their life,” says Alvaro. This particular registry collects information on areas such as: socioeconomic status, educational level, quality of life, symptoms of previous mental diseases (such as depression) and co-morbidities. The company is currently analysing the data collected and hopes that its publication later this year will provide new evidence for the scientific community. Beyond that Alvaro’s priorities include “ensuring that our treatments are available in as many countries as possible”.
“At European level there is the adult ADHD indication – we are continuing to launch Elvanse adult in UK, Denmark and Sweden. But could we extend that to other European countries? I would hope so, and like it to be a good option for patients, of course.”