War on Cancer
System reform needed for UK medicine approval
Paul Catchpole - Value and Access Director, The Association of the British Pharmaceutical Industry
We were talking about the oncology environment and how we’re in the really fortunate position that the pharmaceutical industry pipeline contains so many new cancer medicines which is incredible and really provides us with an opportunity to really change the face of cancer outcomes going forwards. But of course the size of that pipeline presents challenges because there are so many new treatments we really need to start to think about how do healthcare systems prioritise and work out what are the most promising treatments that need to be looked at. There are some helpful developments in the regulatory environment. In the US the FDA signals a breakthrough status for medicines which are perceived to have a very high unmet medical need and potentially deliver promising clinical benefit. Now here in Europe we’ve also got the EMEA’s Prime scheme which is intended to fulfil a similar purpose. Of course, in the UK we also have our own system with the MHRA which is the Early Access to Medicines scheme. So those are some of the things that are happening in the regulatory space and the signals that are coming from that we need to think about in terms of how they are reflected downstream in terms of the evaluation of medicines through HTA bodies like NICE but also with commissioning and funding bodies such as NHS England. How do we create an aligned system, a properly holistic integrated system that lines up end to end in order to get medicines to patients faster? This is what I’m really excited about.
How can ABPI help with this situation?
What we want to see is, as I said, the creation of a joined up holistic system where all of the players are working together. The past has seen a sequencing of operations: we do the regulatory bit, then we do the evaluation piece and then we think about commercial considerations and funding and access in a bit of a sequential process. So there’s a real opportunity going forwards to think about how we can start to do some of those processes in parallel and bring them forward, to start to have earlier dialogues with all of the stakeholders that are relevant, much earlier than we’ve done in the past. So we know when new medicines are coming to the table, we have five, maybe ten, years to plan for that but we don’t react to those signals early enough. So we need earlier dialogues around what we call horizon scanning to enable all players to get together and work out what can be done in parallel and earlier so that patients have the potential to benefit from new innovations much earlier than now. This is the kind of dynamic, responsive, flexible environment that we want to help create.
What do you think the timeline will be for implementation?
There are a few milestones that are clear. The first is that we have a real problem in the UK in the context of the Cancer Drugs Fund. So we created a mechanism that has undoubtedly benefitted many tens of thousands of patients, NHS patients that otherwise would not have been able to get access to innovative new cancer medicines and that has been really important. But the way that we created the system meant that eventually we were going to run out of money. So we had a mechanism which consisted of adding more and more new cancer medicines into a fixed pot so eventually that fund was going to become overspent. Now there’s some quite drastic actions that are having to be undertaken to bring the budget back in line in terms of what can be afforded from the Cancer Drugs Fund. So in a way that creates the first burning platform for change. We need to find a sustainable solution for the Cancer Drugs Fund which aligns the system and brings back key bodies like NICE and NHS England in an aligned way as we create a more sustainable solution. So that’s the first platform which presents an opportunity for change and reform of the environment and we need to do that, really, as quickly as possible because at the minute the fund is closed to any new applications. So there are a number of cancer medicines that are important, that are queued up in the system and currently are in limbo, if you like. So that’s the first platform.
The second platform which has the potential to rewire some of the architecture back together across the different agencies is the Accelerated Access review. This is the government review that’s sponsored by the minister, George Freeman, which is intended to look at how can we create a more effective system that joins up regulatory with medicines evaluation and NICE through to commissioning and funding with NHS England? How can we create a more joined up system that speeds up the pathway for access to new, innovative medicines? That report, there will be an interim report published very shortly, we hope, there will be a set of initial recommendations that hopefully will emerge around Christmas time and then the final report is scheduled for April 2016. So that will hopefully provide a great platform to set the context for some of the system changes that we need to see put in place.
