The European Medicines Group: focused on UK market access
pharmafile | June 25, 2012 | Feature | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing | ABPI, EMG, NICE, VBP, market access
Maintaining a dialogue with government, NHS organisations and other stakeholder groups is essential for pharma companies in the UK, and firms rely on the ABPI to give them a voice with these key groups.
But because the ABPI is such as a broad church, by definition it cannot represent more specific interest groups. Consequently, spin-off pharma groups have formed over the years, including the European Medicines Group (EMG). It sits alongside other groups such as the American Pharmaceutical Group and the Japanese Pharmaceutical Group.
As its name suggests, the European Medicines Group is made up of companies from non-UK European companies who have a presence in this country. First set up in 2001, the EMG now has 16 members ranging from Roche, one of the biggest global pharma companies, to the medium-sized Novo Nordisk and smaller firms such as Servier and Almirall.
The group says it offers an alternative way of engaging with key stakeholders, with much of its focus on the thorny issue of market access. Membership to the EMG is open only to European R&D-led pharma firms that have headquarters in Europe – this means UK-based firms such as GlaxoSmithKline and AstraZeneca are not members.
The Group has just elected Steve Turley, the UK manager of Lundbeck as its new chair, with the role of vice-chair going to Robin Bhattacherjee, the UK and Ireland manager for Actelion.
How the EMG differs from the ABPI
The obvious question is how the group differs from the ABPI. Steve Turley says that the EMG partners with the ABPI on many issues, but is a separate organisation that offers different benefits to its members.
One of the key points is that because EMG is a smaller organisation, it offers members more direct involvement with stakeholder groups.
“This is what makes us different from the ABPI,” he says. “Where the ABPI have their own staff to talk to politicians and other stakeholders, our members have direct access – we think this can be much more beneficial not just to our members, but to those we are engaging with.”
Members of the EMG meet once a month with key stakeholders from the NHS, the Department of Health and beyond, and these discussions are open to the whole membership.
There are also occasional ad hoc meetings, where a handful of members interested in a particular topic arrange a meeting with the government to put their points across.
Key contact for smaller firms
Bhattacherjee says that this kind of contact is invaluable for smaller firms such as his, which simply wouldn’t be able to establish this level of contact without the EMG.
“Our company is a small firm focusing on rare diseases, and having direct contact gives us the opportunity to have the kind of conversations we want with some of the key stakeholders.
“We would struggle to get that without the EMG because we’re not a Roche or a Novartis or even a Lundbeck in terms of size, so there’s real benefits from the membership there. And hopefully, from the people that we meet and talk to, they will get a different perspective from us,” he adds.
The EMG is also invaluable for those firms not part of the ABPI, which includes Novo Nordisk, Ferring, Roche and Norgine (the latter two having quit ABPI membership in recent years after separate disagreements with the body).
Direct contact for the EMG means speaking to politicians and senior civil servants in the Department of Health, and the Department for Business Innovation and Skills.
“We are certainly not in competition with ABPI, or indeed any other of the regional-based industry groups. We see ourselves as partners with our membership and membership of ABPI offering a different, often complementary, range of benefits,” adds Turley.
He and Bhattacherjee and five other managing directors in the EMG are also members of the ABPI Board of Management, a fact which highlights the close relationship the organisations enjoy.
A European voice
Another benefit is of course the European perspective. Turley says: “We bring particular insights to pan-European issues, because of our European focus. It’s at this level that many companies now look at certain aspects of the business rather than country-specific level. Supply of medicines is one example and how value of medicines could be determined in the UK, and the implications of this on pan-European pricing, is another that will be a key issue over the next couple of years.”
Value-Based Pricing
The new Value-Based Pricing scheme, which is set to change the face of drug pricing in the UK from 1 January 2014, is one of the major topics for the EMG at the moment.
VBP aims to set prices for new medicines based on the value they can bring – but discussion on details – such as what methods to use to decide ‘value’ has yet to be reached.
The government published its response to the consultation on VBP in September 2011, but since then there has been very little progress on the proposals. Questions about many other aspects of the system – such as how it will work alongside NICE – are still unclear.
The top level proposals suggest that the UK would allow higher prices for drugs that could demonstrate benefits in ‘severe’ diseases or in areas with significant unmet medical need.
Under the current PPRS scheme, pharma is allowed to set its own prices at launch, something which the industry values. But the government is proposing direct price discussions for new drugs launched after 2014, which many in the industry fear could be a backwards step.
However, it seems likely that the introduction of VBP will be ‘more evolution than revolution’, with the existing PPRS system remaining in place for most medicines. The EMG was involved in the consultation process with the ABPI, in which it said it welcomes VBP’s objectives, but believes that the plans still require much more clarity.
“We shouldn’t fall into the trap of believing we know what VBP is,” Turley says, adding that not even NICE knows how it will work in the new system.
“All we know for sure is that we are coming to the end of the current PPRS pricing system and are now entering into a new negotiation for a future pricing scheme. Our main challenge from a EMG perspective is to make sure that we can put our members at the heart of that negotiation.”
Turley says the ABPI are doing a good job of keeping the objectives behind VBP high on the agenda, and representing the industry in discussions with health secretary Andrew Lansley, his ministers and Department of Health officials.
He said that the ABPI has been conducting an industry-wide consultation on the plans, something the EMG was also a part of. But the time for internal discussions are coming to an end: “We’re now at that point where we just need to get to the table and see what the government is really proposing,” Turley says.
Bhattacherjee agrees: “No-one is really sure what the end result will be, so we need further clarification. Andrew Lansley said that VBP is meant to reward innovation and encourage uptake of new medicines, but we are unsure as to how those elements will be assessed; there are a lot of things that need to be cleared up.”
Turley adds that whatever the final VBP scheme will look like, it will only succeed if the NHS undergoes a change in attitudes, and becomes more open to new and innovative medicines.
“The NHS should be asking itself: ‘how do we best use these new medicines?’ as opposed to the current attitude, which is: ‘look at this new medicine, how can I avoid using it’”?
NICE – the difference between ‘guidance’ and clinical ‘guidelines’
NICE decisions – especially negative ones – are always the biggest headlines in the UK, but Turley says many treatments do not go through the NICE appraisal system, making them vulnerable to unequal or low uptake in the UK.
“All of our members – whether they are as big as Roche, or smaller firms like Norgine – they all say that between 50 and 100 per cent of their drugs do not go through a NICE appraisal.”
This is because the treatments do not meet the criteria to be assessed by NICE – such as being for a very rare condition, or are not put onto NICE’s work programme by the Department of Health, or they are being considered within a NICE clinical guideline.
Many people may be focusing on the NICE HTA guidance ‘yes’ or ‘no’ headlines, but a major issue for all EMG members is the fact that many drugs do not go through NICE’s health technology assessment route – and it is these that are particularly vulnerable to poor uptake. Within NICE’s broad work programme, ‘guidance’ and ‘guidelines’ are two very distinct categories.
While NICE guidance on specific drugs and devices has a mandatory status in the NHS – i.e. it must be taken into account by the NHS – its clinical guidelines are non-mandatory. So while NICE considers many drug treatments in guidelines, frontline NHS organisations are free to ignore any recommendations for their use.
Turley says: “NICE is not perfect, and I don’t think even NICE would try and say that they were, but it’s exceptionally blinkered to say that they are the biggest barrier to access.
“Yes, NICE presents some barriers, but I think it’s over simplistic to says NICE is the barrier.” Rather, for the EMG, it is the problems around regional uptake that represent a bigger barrier. And this includes drugs that have also been NICE appraised, but that are not being added to local drug formularies in an effort to save money. This is a major bugbear for the industry as a whole, and a problem they can do little to influence.
Turley says, however, that this situation is slowly changing: “In the past six months, there has been a shift in attitude toward pharma from the NHS – there’s definitely a feeling that we’re all in this together.”
Pharma’s role in QIPP
The QIPP programme – Quality, Innovation, Productivity and Prevention – is aimed at improving patient services while simultaneously promoting rational and evidence-based cost saving. QIPP aims to encourage NHS managers to make efficiency savings but avoid simply cutting medicines budgets (or other services) to make short-term savings.
However, the £20 billion efficiency drive in the NHS is nevertheless producing many stories of frontline rationing – including some PCT blacklisting NICE approved drugs.
Bhattacherjee says these local cost-cutting measures are lamentable, and are not in the best interests of patients. He says he hopes new partnerships with the NHS could help eliminate this behaviour.
The EMG said it agrees with the QIPP agenda’s principles, and understands the need for the NHS to become more efficient. “We’re not isolated from our customers – we understand the economic climate, we understand the pressures there, and we understand the need for them to hit their QIPP targets as well,” Bhattacherjee says.
“I think it’s beholden on the industry to help, and we at the EMG are mindful of what we can do to support the achievement of the QIPP. And we see medicines as a part of helping achieve the QIPP targets, rather than being something that’s going to make it more difficult.
“We have to accept that on occasion, we need to support the NHS in decommissioning of some services and technologies, to allow for the uptake of innovative technologies in the future. So helping the NHS with its QIPP targets is very much a part of what we do,” he added.
A solution to access problems?
The new Innovation Health and Wealth report, published by the government in December, laid out a vision for a new, more pro-innovation mindset in the NHS.
The report was, quite naturally welcomed by the industry, and the EMG says it might just be a new way forward for helping to improve access. But tensions remain, and the many questions surrounding VBP are causing concern across the UK pharma industry.
The next 18 months is likely to see major decisions made which will have a long-term impact on the UK market, and market access. The EMG, alongside the ABPI and other industry groups, will be looking to reach agreement with the government and NHS leaders on the best way to bring together three dynamics – valuable new innovative medicines, a changing NHS and the best interests of patients.
Ben Adams
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