It takes a long time – around 12 years – for drugs to get from the lab to patients. This could, and should, be quicker. But speeding up the process, while still making sure that drugs are safe, effective and affordable for the NHS, needs Government action. And the same goes for innovations in radiotherapy and surgery.
Recently, there have been some encouraging signs that the Government has acknowledged this, and in previous posts we’ve discussed two ideas for speeding things up specifically for drugs: the Government’s Early Access to Medicines Scheme and the European Adaptive Licensing pilot. But although they look promising, these initiatives have yet to deliver concrete benefits to patients.
We’ve also recently written at length about the need for a better system for assessing drugs for routine use in the NHS. The system is not up to scratch and needs an overhaul.
So we were pleased to hear that the Government will be carrying out an in-depth review of this whole area, which will consider how to get new and cost-effective medicines, devices and diagnostics to patients more quickly.
This will be a welcome opportunity for the medical research community, patients and patient groups, to highlight the changes that we all want to see – and for Government to take action.
Let’s look at what was announced, and what is likely to happen next.
Making the UK the best place to conduct clinical trials
Treatment options for some cancer patients can be very limited, so it’s important that they’re given the option to take part in clinical trials that could give them faster access to new treatments.
Making the UK a good place to run trials will support the trials funded by our supporters. It will also encourage international pharmaceutical companies to follow suit and set up their trials here too, which will increase the overall number of trials available to UK patients.
So it’s important that the NHS is research-ready to support the quick set up and smooth running of UK trials.
We think there’s more the Government could do to make this happen – for example, by reducing the amount of red tape and making sure those trials are set up quickly – so that patients can be recruited as soon as possible. A new organisation called the Health Research Authority is working to speed up the time it takes to set up trials, and we hope that the Government will continue to support its work.
But we also want the Government to make sure that there is a strong culture of research in the NHS. In the new five year plan for the NHS, NHS England has made a welcome commitment to improve its ability to carry out research. We hope that new review will outline how the Government plans to achieve this.
Improving drug assessment
At the moment, after testing in trials it can take a further year for regulatory agencies – like the Medicines and Health Regulatory Authority and the European Medicines Agency – to approve a drug as safe and effective.
And then it can take a further 18 months (and sometimes longer) for the National Institute of Health and Care Excellence (NICE) to assess whether it is cost-effective and can be made routinely available on the NHS.
But as well as streamlining this process, as newer generations of drugs are developed, NICE needs to be fit for purpose for the future. We don’t think that the process is set up to take this into account.
The review is also likely to look at how to speed up drug assessment through better collaboration between companies, regulatory agencies and NICE. We think this could have real benefits for patients.
And, as well as speeding up drug approval, if done properly it could help make sure that companies and regulators consider a drug’s affordability at an earlier stage in its development.
Other treatments and techniques
The review will also look at another important issue: how the NHS adopts ‘innovations’ (e.g. medical devices) or techniques (such as a new way of doing surgery).
The route drugs follow – from being developed in a lab, to clinical trials – is reasonably well understood. But we’re becoming increasingly concerned that targets are being missed for how the NHS is using tests which can identify the genetic faults in patients’ tumours and indicate whether they would be suitable for certain new, targeted cancer drugs.
For devices and techniques, the route from discovery to routine NHS use is even less clear. This is a concern for us given, for example, the vital role of radiotherapy and surgery in curing cancer.
A potential problem is that some new devices, such as machines used to deliver radiotherapy, are often further developments of existing devices. So what sort of evidence is needed to prove they are effective, and whether the NHS should pay for them? Obviously, the answer will depend on the type of device, so the answer to this question can be very variable.
We’ve committed to putting much more funding into radiotherapy and surgery trials in our new research strategy, so we hope the way these treatments are assessed and incorporated into NHS care improves in the future – and we hope this review will clarify how this will work in practice.
An independent organisation is likely to be appointed to lead the review, and we expect that it will be launched fully in early 2015, when members of the public, patients, research organisations, funders and industry will be invited to comment.
Once these comments have been collated, and debated, we should see the main conclusions of the review – including the Government’s recommendations for change – in late 2015.
And, of course, Cancer Research UK will be contributing to this review. So we welcome any comments you would like to make below.
Hollie Chandler is a senior policy advisor at Cancer Research UK