As Shadow Minister for Public Health, Sharon responded to a debate in Westminster Hall on the recently published Accelerated Access Review and the the impact that implementing these recommendations could have on issues surrounding access to drugs for people with long-term conditions, specifically cystic fibrosis and the drug, Orkambi.
You can read Sharon's speech here: Sharon Hodgson MP Accelerated Access Review Westminster Hall Debate 13.12.16
Speech pasted below:
Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)
It is an honour to serve under your chairmanship, Sir Alan. I thank my hon. Friend the Member for Dudley North (Ian Austin) for securing this important debate. I note that as he said, it is just over a year since he first brought to the House a debate on cystic fibrosis.
I appreciate all hon. Members who have attended and spoken in this debate to show their support for the cause; it is one that we must urgently get right. Members have shared many moving cases involving their constituents whose lives Orkambi could save and would certainly transform. My hon. Friend the Member for Dudley North mentioned Carly Jeavons and Sam and Rob, the parents of Daisy. The hon. Member for Strangford (Jim Shannon) spoke about Evie-May, and my hon. Friend the Member for Bristol East (Kerry McCarthy) mentioned her niece Maisie. My right hon. Friend the Member for Leigh (Andy Burnham) spoke about his office manager Karen Aspinall and her son, as well as Philip and his sister Melissa, who sadly died. Philip believes that Orkambi would have helped his sister and would certainly help him, as he also suffers from cystic fibrosis. Those people believe that their lives would be transformed by Orkambi. I believe that too, and the evidence supports it, as we have heard in detail.
I thank all hon. Members who have spoken in this debate, including the hon. Member for St Ives (Derek Thomas), the hon. Member for Bath (Ben Howlett) and my hon. Friend the Member for Cambridge (Daniel Zeichner), for their excellent contributions, as well as the many others who have made valuable interventions. I also thank the Cystic Fibrosis Trust for its dedicated campaigning on the issue, and the 20,000 people who have been involved in its survey, in the digital debate here in Parliament, and in petitions and e-action. The concerns and the need for action are clear, and it is up to the Minister to give all those people beyond this place the answers that they need.
In my contribution, I will set out why the Opposition want to see the Government do more on innovative drugs, through case studies involving Orkambi. I will touch on issues of access to Orkambi and other drugs for those living with cystic fibrosis and expand into the recommendations of the accelerated access review, which can do much to address many of the issues involving access to new drugs.
Although it is welcome that the prescription drug Kalydeco was given the go-ahead by NHS England last week for two to five-year-olds as part of re-prioritisation, Orkambi remains an issue. There is currently a deadlock in negotiations between the pharmaceutical company Vertex, the Government and NHS England for the drug to be accessible to the 2,700 people who stand to benefit from it. As we have heard in detail today, that is all down to rejection of the drug under NICE’s appraisal system because there is a lack of long-term data. Although it is welcome that NICE recognises the treatment as effective in managing cystic fibrosis, it is clear that we desperately need a new system under which drugs can be better accessed, especially those that show that they can benefit patients. We have also heard about new data that NICE did not take into account and that would have showed 42% effectiveness.
Orkambi has been shown to halve the amount of hospitalisation of cystic fibrosis sufferers, and 96-week data published recently showed that it can help to slow lung function decline by 42%. The data are also backed up by anecdotal evidence from people who have accessed Orkambi through the compassionate use programme and are beginning to report transformations in their health—some are reporting enough improvement to come off the lung transplant list. That information is all positive. It should be made better available for consideration as part of the appraisal process; it should also form part of the negotiations between Vertex, the Government and NHS England. However, when we see a deadlock, all of that information is for naught. Thousands of people are suffering irreversible lung damage that could be stopped if the current impasse between those around the negotiating table was broken. Those who will suffer the most are stuck in the middle.
It is up to the Government to facilitate the end of the deadlock so that people can access Orkambi and see their lives transformed. One way to do that is to begin the job of implementing the recommendations set out in the accelerated access review, which the Opposition welcome. The goal of speeding up access to drugs by cutting four years off the time needed to bring new medicines to patients is something that we should all welcome; we need to see whether it can be achieved. The review has the potential to change the philosophy of the NHS in line with the five-year forward view, but also to help to maintain our global lead in life sciences. The recommendations set out in its final report have the potential to transform how we provide drugs and treatments, ensuring that we see innovation in drugs, diagnostic tools and healthcare developments. However, there still remain issues around thresholds for new drugs, which NICE and NHS England are currently consulting on. I understand that some associations and charities have raised concerns about that, and I hope that the Minister will update us on some of those discussions.
Mark Durkan (Foyle) (SDLP)
My hon. Friend is right to be so positive about many aspects of the accelerated access review. However, as she has mentioned, there are concerns that new definitional ruts could be created by some of the terms of the review, which could lead to some patients and some promising drugs being trapped in exactly the sort of deadlock that she has described.
My hon. Friend is right to raise those concerns. We do not want to move into a new system that will create new unintended consequences. Perhaps the Minister will touch on that in his speech.
Although some are calling for interim solutions to help people who are stuck waiting for the accelerated access review’s recommendations to be implemented, it is also important that the Government get on with implementing those changes. The review was announced more than a year ago and was published two months ago now. It is important to remember that the transformation that we all want to see will not happen straight away, but it is still right that we keep up the pressure for the recommendations to be implemented. There are many such recommendations, and I hope that the Minister will be able to update us today on the progress on each of them. There are two in particular that illustrate what can be done to resolve the deadlock around Orkambi—the immediate establishment of an accelerated access partnership and the setting up of a new flexible strategic commercial unit.
The accelerated access partnership is one way in which, through co-ordination and collaboration across the system, we could see drugs brought on to the market more quickly to benefit patients who need access to them. I would be interested to hear from the Minister what progress has been made on its creation, especially in conjunction with the issues surrounding the deadlock on Orkambi.
It is clear that the strategic commercial unit could help to benefit those who wish to see Orkambi offered on the NHS. The unit could work with those involved in this dispute to end the current deadlock through facilitation of the flexibility and transformational change promised by the accelerated access review. That would go some way towards helping to access data on drugs such as Orkambi and getting them out to patients. There is a willingness out there for that flexibility to be brought into the system; for example, the Cystic Fibrosis Trust has offered to use the UK cystic fibrosis registry to help to provide essential data that can help to prove how effective drugs can be and what more needs to be done. We have already heard how substantial that registry is; it includes 99% of sufferers. I understand that the trust’s offer has been welcomed by all sides in the negotiations but is blocked due to the lack of progress in implementing the changes set out in the review. I hope that the Minister will give us some clarity on when the unit will be created and when we can see a culture shift within the system that will allow for flexibility to accept data and information that show how much effect these drugs have on people’s lives.
Dr Philippa Whitford
Does the hon. Lady share my concern about drugs for other conditions, such as sofosbuvir for hepatitis C? Even after they get NICE approval, those more expensive drugs are now being rationed at the NHS England stage. At the moment we are fighting to get through NICE, but it needs to be a smooth path all the way through.
The cost of drugs sometimes leads the NHS into the terrible and unfortunate situation in which rationing seems to become the norm. There can also be a postcode lottery, which is another element that we need to look at. The price of drugs really is the crux of the issue.
In conclusion, I hope that the Minister will offer some insight into the progress being made on the recommendations of the accelerated access review. The case of Orkambi can help to drive through these changes and to end this deadlock, which, as we have heard, is causing unnecessary suffering for those living with cystic fibrosis. The review has established a space for change and for patients to access new and innovative drugs and treatments. It is important that there is no stalling or delay in transforming the system, because people’s lives depend on the changes called for by the review. I am sure that the Minister will keep that in mind when he goes back to his officials.