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Market Access in Europe: homogenizing or fragmenting further?
Richard Bergström, Director General, EFPIA argued passionately in favor of the homogenization of European HTA bodies and regulation, during a recent interview with Paul Simms, Chairman, eyeforpharma.
Market access for innovative pharmaceuticals is no mean feat – particularly not in the diverse and often highly fragmented European landscape, which can often seem to be cluttered with contradictory and confusing HTA, pricing and reimbursement systems.
This represents a real challenge for pharma executives with global or continental responsibilities. Luckily, the times are changing – European-wide organizations such as EUnetHTA and EFPIA are clearly keen on helping both payer and pharma simplify, where possible and desirable, the market access minefield. eyeforpharma spoke to Richard Bergström, Director General of EFPIA (European Federation of Pharmaceutical Industries & Associations) about the shifting sands of European pharma access & pricing, and how pharma must prepare for an evolving landscape.
eyeforpharma: Is the homogenization of market access and HTAs something you would encourage – and is it achievable?
Richard Bergström: Yes; the industry has expressed very clearly that we see a fragmentation in HTA. There are a couple of important trends to take note of.
One is the realization within the industry that market access is not going well. We still struggle with NICE, which was supposed to be reformed as part of the PPRS deal, but oncology drugs are still mainly being rejected and the Cancer Drugs Fund is running out of money. On the other hand, the German HTA model has gradually improved, and then countries such as Romania have expressed the desire to establish a HTA agency, so we can see that there is a strong desire to have a European collaboration on the clinical aspects of access.
Yet you can't have one Real World Data program for Spain and one for France and one for Italy. People need to work together. Such a post-approval evidence generation plan would be something that the EMA would broker.
Of course, the whole Sovaldi situation and debate has illustrated again that pricing and reimbursement decisions have always been national. It's a question of specific negotiations as we enter a new era – managed-entry schemes, risk-sharing schemes, price-volume agreements, budget caps, perhaps even multi-annual payment agreements. As a result, the pharma industry clearly wants to see some kind of convergence of the non-economic aspects of HTA (i.e., the clinical aspect of HTA).
The second important trend to note is that we have had some collaborations already which are not fulfilling their aims. For example, the EUnetHTA Program partly funded by the European Commission isn’t really delivering. What is delivering, however, is the fact that the EMA is now brokering early advice on HTA and payers. They’ve already had some 40 sessions and many are forecasting that this will be a big thing – when industry approaches the EMA for scientific advice, they will also be getting advice from the HTA agencies and the payers. Then, there will also be combined meetings where the EMA discusses post-approval commitments. Therefore, once approval is within reach, the industry will be having a discussion of post-data generation, which then takes us to the whole domain of Real World Data, which is information that everyone - regulators, HTA, payers and also our customers - is asking for.
Yet you can't have one Real World Data program for Spain and one for France and one for Italy. People need to work together. Such a post-approval evidence generation plan would be something that the EMA would broker. The commission is now preparing another joint action which I think will be looking at patient registries. There will be a need for clinics and even GPs to be able to stratify, so they need to have the right diagnostics, they need to have the right infrastructure, the right framework for patients, etc.
eyeforpharma: When you say 'stratifying', are you talking about stratifying on a disease level or stratifying on an ability to pay, on a reimbursement level?
Richard Bergström: I was initially thinking of stratifying based on a lower level of the disease, the sub-type of disease. You see it in cancer – there is molecular testing regardless of the organ affected, and the choice of medicines is based on that. Down the line the entire healthcare delivery system must be built around this stratification, around multiple targeted tools such as biomarker imaging, diagnostics, access to genomic information. Then the healthcare system also needs a feedback mechanism – real world data, clinical evidence. And everybody agrees that this is where we are going - harmonizing, aligning expectations and data requirements between industry, key opinion leaders, patients groups, regulators and HTA payers. The HTA payers are being added as we speak, but one component which is not really part of this conversation, is the health services. How can we convince the NHS, the French health system and others, to be ready to introduce new medicines in this way?
eyeforpharma: Why is it so important that the health services also fall into line? The health service is not trying to assess the medicine, the health service is using the medicine.
Richard Bergström: If the health services don’t have the ability to do this – to stratify and to target populations correctly – then targeted medicines will be overprescribed. This could mean that the drug is used off-label and that the usage will be so broad that it becomes too expensive for the industry. Doctors should use a number of different options, which means that the logic of marketing and sales will also change.
In that stratification, which may be scientifically driven at first, there will almost certainly be attempts by payers to limit and stratify for maximum value. So it could very well be that you actually have a label targeted at 12% of heart failure patients; but the payer could say “This is too expensive, so we’re going to narrow this down to a certain dose and we will only reimburse that; or we will need proof that other generic medicines have been tested first”. But in Germany, the UK and the Nordic countries, the prescriptions can be tracked. That is why I believe the health services need to embrace innovation, but they also must have the ability to target and feedback with the data.
This is the sort of conversation that you are going to have with NICE, with the NHS, with the HAS in France, with the GBA in Germany, particularly for targeted medicines and for disruptive medicines such as those for Hepatitis C or immuno-oncology. They will not just talk about the price or the HTA, they will talk about data collection, they will talk about budget guarantees and some kind of implementation model. This will not just be left to the markets to determine volumes.
eyeforpharma: What do you think senior executives within market access should be working on? What should organizations be building in terms of skills, platforms, processes – if this is indeed an inevitable journey that the industry is taking?
Richard Bergström: I think there's been refocusing, certainly in terms of budget. We need to move beyond working with patient groups. It’s important, yes, now everybody is doing it and we know how to do it and we are aware of the right balance; it's transparent and reasonable. We will continue to invest in that, to work with patient groups and patient-centric clinical trials. So that is happening, it's just not new. I think the thing is that what we don’t really understand is healthcare.
I’ll give you an example in cell therapy. So here’s a technology that you manufacture and target at each patient. Now, it's not going to be cheap and these cell therapies are not drugs – they may be regulated by the EMA, but they are not drugs so they won't be reimbursed. There is going to be a clinic that has to pay for this, but it is a clinic which is not used to buying from pharma. Healthcare evolves with science; there will be completely new clinics and the industry will actually be competing with in-house work – the clinic doing this for themselves, for example. With the help of the regulators, I think that there will be some standard. Pharma might sell a licence to a hospital region or individual hospital. This is just one example.
The skill set we need, however, is a combination of further understanding of healthcare: how does it work, who does what and who decides what? How do your stakeholders budget? It’s the understanding of decision-making in healthcare that we don’t currently do properly. There are people with this skill set - but there are so few in the pharma industry.
So, you only need to offer the HTA and the payers some kind of value deal, where you say, 'Okay, guess what? You only pay for responders or we will monitor performance and maybe you don't have to pay as much.'
Then you need to understand who you are going to talk to. It's not the doctor anymore. So, we haven’t really figured out how to really engage with health systems. The UK, Germany and the Nordics are further ahead but in other European states, we are still in the old business model where you just talk to the doctors. The skill set we need, however, is a combination of further understanding of healthcare: how does it work, who does what and who decides what? How do your stakeholders budget?
It’s the understanding of decision-making in healthcare that we don’t currently do properly. There are people with this skill set - but there are so few in the pharma industry. We also need a thorough understanding of the data hierarchy and access points taking into account all the limitations in regular healthcare. As such, it’s not something we are currently doing on a large scale.
eyeforpharma: Going back to the issue of homogenization, are there any changes that individual executives should be making?
The US health plan model was designed a long time and cannot cope with this level of innovation. HTA was primarily introduced by payers in Europe and Canada to judge the worth of incremental innovation. Now it’s different. Now we assume everything in the pipeline is going to be valuable; if everything is going to be innovative, then some form of clinical HTA is a fundamental.
Richard Bergström: Well, it’s interesting to look at the US. What has the underlying grief about the price of cancer drugs led to, alongside the Sovaldi debate? It resulted in the worst ever debate about the industry. And many of the arguments against the industry are not fact-based, nor fair. Now, some of my US colleagues even say, “maybe we need HTAs”. There’s soul-searching going on in the US industry and among payers. The US health plan model was designed a long time and cannot cope with this level of innovation. HTA was primarily introduced by payers in Europe and Canada to judge the worth of incremental innovation. Now it’s different. Now we assume everything in the pipeline is going to be valuable; if everything is going to be innovative, then some form of clinical HTA is a fundamental.
The public authorities, the governments and the health councils met last week in Brussels and for the first time ever agreed that they are going to have more European work on pricing reimbursements. They always resisted this, because this is a national competency. But there was full consensus – including the UK, France and Germany – that they have to work on this, because there needs to be a new framework. There has to be some better interface between the EMA and all these stakeholders. It's about HTA and data generation – the payers, the regulators, the EMA; they all want a new interface. Therefore, the industry needs to also gets its act together in figuring out what this interface looks like and to consider the scope of individual organizations in figuring this out and collaborating on solutions.
HTA cannot be viewed in isolation, so the harmonization of the clinical aspect of HTA is something which is unstoppable and, essentially, a good thing.
In June 2015, the industry will be coming together in Amsterdam to engage in hands-on discussion around the issues at eyeforpharma's Market Access & Pricing Excellence Conference. Richard Bergström's keynote speech (as part of an eight-speaker panel featuring key regulatory and HTA stakeholders from the UK, Spain, Italy, Belgium and the Netherlands) will address this situation in more detail. For more information, click here.
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