Accelerated Access Review – moving medicine into a higher gear
There is no denying the ambition and scope of the Accelerated Access Review (AAR). If such a review was under way in 2012 Les Halpin may have not felt quite so compelled to start a patient campaign, as much of what is called for in the AAR chimes closely with his original vision.
That said, Empower: Access to Medicine is very much looking forward to engaging in the review and driving forward its recommendations. The very fact the AAR’s starting point is putting patients at the heart of medicine is to be welcomed. Les believed that there were many patients like him that want to help deliver innovation in medicine and take more personal responsibility in the drug development process – in particular participating in early phase trials (even if the risks might be greater).
Putting patients front and centre
Patients are now more accurately stratified, informed, and as the AAR identifies, more willing to take risks. It is widely recognised that many patients, especially in rarer disease categories, often know more about their condition than the people treating them. It therefore makes absolute sense they are brought closer to the centre of decision making in the development of treatments designed for them.
The AAR’s proposal to see a system that keeps patients better informed about the pipeline of new products and treatment and earlier access to trials and pilots is hugely positive. That way they can better influence the processes of prioritisation, which in turn speeds up the evaluation of products. Equally the AAR calls for a platform to press for the uptake of new products, which is important as quite often this is left to a specific charity/pressure group regarding a product that has already run into trouble at NICE. A more suitable platform may lead to more proactive engagement by patients earlier in the process.
In terms of next steps the AAR suggests the creation of ‘I’ statements that represent principles reflecting the patient voice across the pathway, including concerns relating to inequalities, safety, efficacy and transparency. We feel this could be a real opportunity to put the Halpin Protocol at the heart of the process, as the Protocol sought to put a patient’s wishes at the forefront of treatment consideration.
Getting ahead of the curve
For Empower the most important part of the Review is its proposals to get our medical system ahead of the curve. Some of that is about reimbursement and we welcome the concept of a more flexible financial model for drug payment. In a world of more personalised medicine the way we reward companies for their products is going to have to change – as treatments will inevitably become more outcome focussed around ever decreasing patient cohorts.
We are pleased to see the AAR note how existing schemes could and should be built upon. Empower has already reported on how the Early Access to Medicines Scheme doesn’t appear to have got off to a fast start, certainly compared to the popularity of the FDA’s ‘breakthrough’ designation in America.
We are very excited about the Adaptive Pathways Pilot and hope the lessons from it (which are bound to be positive) are rolled-out quickly. The AAR is of course absolutely right that any strategies deployed in the UK are part of wider European Union regulatory changes, and Adaptive Pathways will have to be deployed at EU level to be effective.
Empower also supports their calls for new trial methodologies which could accelerate evidence generation and take cost out of the process. Key to this will be ensuring we make data work for the health service, and that means wider sharing, collection and interrogation of data. We hope that the innovation database being proposed by Chris Heaton-Harris MP in his Access to Medical Treatments Bill will play a role here.
Please engage in the process and feed your thoughts in to the Department of Health on the AAR. You can make submissions until 4th January, here.