From Brexit to the snap general election, NICE reforms to the reconfiguration of health services under Sustainability and Transformation Plans, these are transitional times for any pharmaceutical company operating in the UK.
Seasoned observers would be quite right to note that the NHS has always operated in a state of flux as political priorities shift and demand spikes in unpredictable, or more often predictable, ways, but the last 12 months seem unprecedented in terms of the sheer volume of impact of changes in the UK healthcare landscape.
Within the pharma sector one of those leading his company through these challenging times is Sanofi’s general manager for the UK and Ireland Hugo Fry, who officially took the helm in January.
Faced with NHS changes he says the industry is used to, and has got better at, adapting. “No pharmaceutical company can consider itself the most dynamically changing of companies, especially when you see tech companies – massive corporations that never existed five years ago,” he told PharmaTimes.
“But, although we have R&D cycle times of 20-30 years, we’ve become very good at adapting to our environments and the NHS is a good example of this. We adapted when NICE arrived and we adapted when CCGs became budget-holders – whatever is put in front of us we’re able to adapt to it.”
Surveying the current waves of change breaking over healthcare it’s the new approach from NICE and NHS England to highly specialised therapies (HST) – ultraorphan drugs – to Fry said presented the biggest challenge to both patients and the industry. The new policy sees rare disease treatments deemed to provide significant QALY benefits being assessed by its Highly Specialised Technologies (HST) committee against a maximum threshold of £300,000 per QALY. However, many treatments for very rare conditions currently funded by NHS England have costs per QALY in excess of £500,000, including three of the four medicines that have been approved by the HST process to date.
Applying QALYs to ultra-orphan drugs is, Fry said, “not particularly helpful”. “Previously it was widely thought and accepted that QALYs were not the appropriate measure of orphan drugs, when you’re talking about such small groups of patients. And you only have to look at the strong voices of patient associations around this [to see it] could potentially mean innovative ultra-orphan drugs will not get to patients in the UK.”
Indeed, prior to the changes taking effect, a coalition of almost 200 patient groups representing families affected by rare and genetic conditions called for the policy to be halted, saying it would “threaten patients’ ability to access treatment, and work against the government’s goal of accelerating access to innovative medicines”. Fry added: “Those kinds of changes are a real challenge, because we’re producing innovative medicines, but we can’t get them to patients.”
One orphan drug having problems at the moment – though it doesn’t fall under NICE’s new approach – is Sanofi’s Cerdelga (eliglugstat), which treats the rare condition Gaucher’s disease. Knocked back by NICE in provisional guidance in March on the basis of concerns about its ‘true value for money’, Fry said it would be another example of where the company will adapt.
“We do understand the constraints that the NHS is under and we now understand better why NICE has put forward this as a negative draft guidance. We’re going to work with them and we’re going to make something that we think has a very good chance of turning [it] around.”
But looking at the health technology appraisal process as a whole, “there has to be an acknowledgement that bringing drugs to patients [with rare diseases] has a cost” and Fry said industry and health system needs have to be balanced. “It’s about working together, finding the solution that encourages continued R&D and capital investment in these areas, but that also gets to a point where it’s not a complete burden on the health system.”
Transforming Sanofi
As if the changes within the NHS and NICE were not enough, 2017 will also be a transitional year for Sanofi in the UK, where its reorganisation into five distinct business units went live on 1 January. These encompass its units for specialist care (Sanofi Genzyme), diabetes and cardiovascular, general medicines, consumer health and vaccines (Sanofi Pasteur). Within those the vaccines business comes out of the recently broken up Sanofi Pasteur MSD joint venture with Merck & Co, while the consumer health business was bolstered through an asset swap deal, completed earlier this year, that transferred Sanofi’s Merial animal health division to Boehringer Ingelheim, with the German firm’s consumer health arm taken in return by Sanofi.
For Fry, who began the transition to his current role at the end of 2016 but only officially stepped up in January, overseeing these changes and making the most out of each of the five business units are top of his agenda. To do that, of course, requires bringing the company and its people with him on the journey and for that, Fry said, giving them a sense of purpose about the changes is really important.
“It’s clear for Sanofi that we are a company that want to accompany peoples’ healthcare journey throughout their life – we’re not a company that is focusing in on one area. The other thing is that there is a lot of expertise in areas from medical to finance to supply chains and so on – and all sorts of different areas of the business have to come together to make this work, and you have to rely on that expertise. If people feel like they being relied on it gives them purpose, they’re empowered and they can accomplish it.”
It’s a challenge that Fry can look upon with relatively fresh eyes as he settles into his first UK role in 13 years. Originally from Newcastle, he started out 23 years ago as a rep in south east London, following a classic route through regional and project management roles before getting offered an early shot at general management in the Baltic states – arriving as employee number eight and more or less building up the business from scratch. From there he moved to more global strategic roles and finding switches between those kinds of roles and more country leadership/ operational ones to be particularly beneficial for his career.
Drawing on a widely varied career to date – one that encompassed four years in Russia and then acting as commercial head for the whole of the Sanofi Pasteur MSD joint venture – Fry ended the interview by providing PharmaTimes with some advice for the next generation of aspiring pharma managers.
“Don’t be in too much of a hurry to do a pure vertical rise – give yourself some breadth of experience. What might seem like a sideways move at the time often isn’t, really you’ll be giving yourself a better chance of success by broadening your experience.”
