A key priority for NICE this year is to increase the flexibility and capacity of its technology appraisal programmes through a more proportionate approach to assessments that will enable it to continue to consistently deliver timely guidance on new medicines. From April 2023, NICE aims to expand its capacity for technology appraisals by 20% to respond to increasing numbers of new medicines.
I thank the Minister for his Answer and for writing to me on this. NICE does a really important job in our health system and I pay tribute to it for that. However, one thing that I have observed recently is that, in some of the more tricky technology appraisals, sometimes you have a first rejection, then another committee meeting, then possibly another reappraisal. This puts a huge amount of stress on patients, often at the end of life, when they are really worrying about whether they will have access to the treatments under review. Is there anything more that the Government can do to help ease the passage of these interim access agreements that patients can have?
I am sure that the noble Baroness appreciates that this was a new process, because of the Orbis trial. In some ways, NICE was not exactly prepared for that. NICE has learned from that lesson and 100% of its guidelines are issued within 90 days of licensing. It has learned the lesson but, sadly, there was a confluence of factors: one was Orbis and the other was that the committee meeting regarding recommendations ran over because there were a number of other cancer drugs that it was trying to look at. It has put this on the agenda for the next meeting.
One of the ambitions in the life sciences vision is to enable early diagnosis and treatment, including immunotherapies such as cancer vaccines. However, last year, 20 treatment evaluations were paused because of lack of capacity at NICE. If successful R&D cannot be translated into treatments because of lack of NICE evaluations, how will that impact on commercial incentives and the ambitions set out in the life sciences vision?
The noble Baroness makes an important point about how this fits into the life sciences vision, and NICE is very aware of it. In fact, only last week, I saw a draft business case for NICE for future years, and it takes on board the very point the noble Baroness refers to. NICE is looking at making sure that is has more timely advice and that it can respond quickly; it has also increased capacity, not only for conditions like this but for more digital devices.
Can the noble Lord explain what he means by a more proportionate response? Does that mean that NICE is reducing the number of stages that are involved in this process? Is it going to increase the capacity it has? How is it going to actually deliver the improvements that the noble Lord has explained?
NICE has recently concluded a comprehensive review of its methods. It wants to introduce greater flexibility in the appraisal of medicines for more severe diseases but is also reviewing the criteria for highly specialised technologies, to make them clearer and more specific. We hope this will benefit medicines for patients with rare diseases and improve equitable access to new and innovative treatment. On the exact detail, I am afraid I am going to have to write to the noble Lord.
My Lords, would my noble friend agree with me that the publication by NICE last month, about its work on evaluating new treatments for severe drug-resistant infection, was really valuable, in that it looked at the benefits across the health system as a whole as the basis for an assessment of what an annual subscription for such drugs might be? Can my noble friend say how the Government are taking this work—which is a world first—and working with other countries to try to ensure that, collectively, that kind of subscription can incentivise the drugs industry to bring new treatments for antimicrobial resistance to the market?
I thank my noble friend for the question but also for highlighting the fact that NICE is trying to change the way it works to be more flexible and responsive. The new subscription-style payment model that the NHS is developing has been designed to try to address the lack of new antimicrobials being developed and the growing threat posed by antimicrobial resistance, or AMR. The recent guidance from NICE on the two new AMRs is a world first and an important step forward. What NHS England has now got to do is enter into negotiations with the manufacturer, with a view to making them available to NHS patients.
My Lords, NICE is a remarkably effective organisation, but is the Minister aware of the gross inefficiencies in the system which operates in order for health technology assessment approvals to occur? There is a huge number of committees through which this process has to go. Is there any way of reducing this nightmare?
I am aware of some of those issues, but I wonder whether the noble Lord could write to me with some more specific examples. In my meetings with various organisations, including the Health Technology Alliance and others, wherever they have raised these issues we have looked at them. The NHS, the department, NICE and others are trying to work with suppliers, manufacturers and providers to see how it can be more responsive. If we are going to realise the life sciences vision, we have to make sure that we make the best of the NHS as a global centre of excellence and show that we are at the forefront of research.
I think my noble friend will find that lots of departments and lots of public bodies are working within budgets at the moment, given the financial situation. NICE is very aware of this, and has looked at how it can do more with the same money to increase capacity and be more responsive.
My Lords, NICE is a critical participant in the Innovative Licensing and Access Pathway, launched over a year ago. It aims to make use of regulatory freedoms post Brexit to speed up access for NHS patients to new drugs, including cancer treatments. Can the Minister tell the House how many treatments have been or are being considered through ILAP and when we might expect to see the first ILAP treatment being made available on the NHS?
My Lords, can the Minister kindly inform NICE and the Department of Health that they are misleading the nation and have done for years in telling them that all the calories we eat are used up in exercise? That is not true and has never been true. Only a fraction of the calories we eat are used up in exercise. Could the Minister do something about NICE and the Department of Health?
I will try my best. If I may, I shall use this opportunity to respond to the noble Baroness’s earlier question. We have seen horizon scanning in regulatory science, which means that ILAP is at the forefront of cutting-edge developments. It is open to commercial and non-commercial, and UK-based and global developers of medicines. As I said, I will write to the noble Baroness with more detail. On doing something about NICE and the NHS, I have constant meetings with the NHS, as do other Ministers. One of the challenges that came up during the passage of the Health and Care Bill—I know that noble Lords who have been Ministers previously made this point—was that Ministers here have to respond on issues but decisions are quite often taken at NHS level.
My Lords, I am yet another doctor. In defence of NICE, it has, despite the financial constraint, delivered 50% more appraisals in 2020-21 and is likely to do an extra 20% this year. The important point I want to make is the point made by the noble Baroness, Lady Morgan of Drefelin: patients need to have access to effective treatment sooner. If the appraisals are causing delay, for whatever reason, that is the place where NICE needs help, to get patients early access. For instance, a breast cancer drug that treats patients with triple-negative breast cancers, with a higher mortality, is available in one part of the United Kingdom now, but it is not available in England.
The noble Lord makes a very important point. One of the things we are looking at, so that we will not only be a centre for life sciences but make sure that our NHS is at the forefront of healthcare worldwide, is to make sure that we look at the different stages of medicines when they are approved, if they have conditional marketing, and the different stages of approval to see whether we can get them to patients earlier. As the noble Lord says, we should share the good news about NICE. It issued guidance within 90 days for licensing of 100% of new active substances in 2021-22 and has the highest number of technology appraisals in any year since appraisals began. There is some good news, but NICE recognises that it has to do more and we are in conversation about that.