There are three big challenges occupying Janssen’s Cyril Titeux at the moment and, though some companies have shied away from taking a direct approach to pricing, access and reputational issues, he and his company are determined to tackle them head-on.
For Titeux, who’s been with Janssen for 18 years, his career has been building up to his current strategy-focused role, he works at a regional level with the company’s global team on shaping Janssen’s strategy. Since joining Janssen in 1997 after a spell in sales and market research at Lilly in France, Titeux has risen from senior product manager, through to sales director to global marketing leader and on to managing director roles in Austria and France.
Now as Janssen’s VP of EMEA Strategy Organisation, Titeux’s role for the last 12 months, his focus is to ensure the company’s strategy is shared and deployed effectively across Europe, the Middle East and Africa. Ultimately the aim, Titeux explains, is to “maximise the value of our medicines for patients, for healthcare systems and for Janssen”.
But, though the word austerity is used slightly less frequently now than it was, say, five years ago, ‘value’ – and explaining the industry’s contribution to patients and healthcare systems – is still a thorny topic for pharma at the moment.
Trust and reputation is an absolute priority for us
Pricing: an unavoidable dialogue
The industry has faced some heavyweight criticism over the cost of its medicines of late, not least from the World Health Organization. Earlier this year a WHO report released attacked pharma’s ‘opaque’ policy on drug pricing and said the industry must be more transparent. The study, released in March by the WHO Regional Office for Europe, found governments are finding it increasingly difficult to afford new treatments and was followed just two months later by a warning from the WHO on the cost of new treatments for hepatitis C, with the likes of Gilead’s Sovaldi (sofosbuvir) in particular having been a lightning rod for the issue over the last 18 months.
A survey of patient groups by PatientView found patients too think pharma often falls short when it comes to drug pricing. Its 2014 study of corporate reputations in pharma revealed that patient groups believe the industry is pricing drugs too aggressively and should be “offering discounts, and pricing their products more affordably” for healthcare systems. So there’s clearly still much work for the industry to do.
“Explaining the value and price of our innovations is a topic we can’t avoid because it’s probably the hottest topic that society has in mind at the moment, and I fully understand that,” Titeux says.
“We need to be humble in this topic, because it’s a very complex one and no one has an easy solution – and the ones who have a magic solution to the problem are not credible.”
For Janssen a key part of how it, as a company, responds to the issue can be seen in an ongoing project to set out its position on pricing and value of innovation.
“The company is commmitted to improving public understanding of our pricing models and the value of innovative medicines within the overall medicines system.”
Taking this line of thinking further Titeux says individual companies need to step up and make their own voice heard in these kinds of debates. “We cannot only rely on the trade associations to do the job,” he says, adding: “It can be even stronger when you have companies themselves speaking about it, because it becomes less anonymous and more personalised.”
We need to be humble over the value and pricing of our innovations
The difficult world of access
But it will take more than just making the companies’ voices heard if Janssen and the wider industry are to prove the value of their new products within the health technology assessment (HTA) setting.
“We keep saying it’s getting harder and harder, because of the budget constraints and all of the things we all know about, and the bar is rising,” Titeux notes. “But, you know, for the majority of the countries you still do get access. It’s not getting easier – it’s getting more difficult, and what we are asked to show and to demonstrate is getting more challenging. But how many products did not get access? For us, very few. The reason is that we are very, very aspirational in terms of the innovation we want to bring.”
Though he would prefer not to be drawn on the specifics of where Janssen finds access more, or less, of a problem, the UK – and its NICE’s approach to oncology in particular – is mentioned several times.
“The UK and NICE’s approach to evaluating oncology medicines is particularly challenging and is less flexible than its European counterparts when it comes to innovative pricing models, particularly for medicines with multiple indications.”
The company actually has a pretty good record of gaining NICE recommendations for its medicines, though is no stranger to the difficult decisions needed to wrest a positive outcome from the cost and clinical effectiveness body. Just last month it was a ‘patient access scheme’ that brought Stelara (ustekinumab) NICE approval in psoriatic arthritis after the company agreed to provide the 90 mg dose (two vials) of Stelara at the same cost as the 45 mg dose (one vial) for patients that require the higher dose.
Meanwhile, for Olysio (simeprevir) – one of several new oral drugs that mark a major step forward in hepatitis C treatment – it was an innovative ‘pay-if-you-clear’ scheme that persuaded NHS England to reimburse the drug.
But in oncology Zytiga (abiraterone) was last year not recommended for an early use indication in final draft guidance from NICE, but that appraisal process is currently on hold after Janssen proposed submitting further evidence and an amended patient access scheme for its prostate cancer drug.
In the case of blood cancer drug Imbruvica (ibrutinib) – a key new product for the company – Janssen has requested its single technology appraisal for CLL and MCL be rescheduled to start later this year, so that more evidence can be included in the appraisal. The final piece, for now, in this picture can be found in the shape of two reports, commissioned by Janssen and launched in the British Parliament in March, which concluded that the delays and rejections associated with NICE’s current appraisal system are both delaying and preventing patients from accessing new cancer medicines in the UK.
However, despite the diversion to the UK, Titeux is at pains to note that “each [country’s HTA] system has its advantages and disadvantages. What is most challenging for us is that the appraisal of medicines across the region is not consistent.
An EU system is something that has been on his mind for some time and he sees some opportunities, but also some risks. Titeux appreciates that, as a company, there is a possibility for collaboration on Relative Efficacy Assessments, but less so for full health technology appraisals.
And he acknowledges that a new European process risks creating an additional, duplicative step and, on top of local health technology assessments, an additional barrier to patient access.
But he adds: “It’s very difficult for us to design a clinical programme that ensures we meet the HTA requirements of all the different bodies in the region. Generally, we have been able to do that from a regulatory standpoint, and see that if you want to get regulatory approval then there are certain steps that normally work. But we can’t say the same thing for pricing, reimbursement and getting HTA appraisal.”
Whether the European Network of Health Technology Assessment (EUnetHTA) – set up to create an effective and sustainable network for HTA across Europe – could fulfil this role remains to be seen. The voluntary network was formed in 2006 but only held its first meeting in 2013, so it’s development has hardly been happening at a lightning pace. Nonetheless, EUnetHTA has been collaborating with the EMA – with parallel regulatory/HTA scientific advice, on-market evidence collection and orphan drugs on the agenda when they met in May.
Responding to pharma’s reputational challenge
Defining its approach with the EMEA region to trust and reputation – another of the industry major challenges – form one of Janssen’s ‘strategic pillars’, “and we are taking a number of concrete steps to achieve this”, Titeux explains.
One of these can be seen in Project YODA, in which the company enlisted Yale University to set a new pharma standard for sharing clinical trial data, asking the academics to act as an independent trial data request review body.
In a bid to become increasingly ‘patient-centric’ is its recruitment of a series of ‘patient officers’ – whose final title is likely to be less ‘militaristic’, Titeux says. Nomenclature aside, Janssen plans to have the roles in place for each of its key countries in the region, ultimately recruiting 15-20 people who will be tasked with ensuring Janssen takes a consistent approach to patient affairs. “We already have some of them in place and it is working well,” Titeux comments.
“Trust and reputation is an absolute priority for us,” he adds. It also feeds into value, pricing and access, bringing us full circle – though whether the conjoined challenges prove to be a vicious or a virtuous circle will depend on the strength of Janssen’s strategy and its success at implementing it.