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Cancer Drugs: Licensing and Approval

Volume 815: debated on Monday 8 November 2021


Asked by

To ask Her Majesty’s Government what steps they are taking to align the timelines between cancer drugs being licensed and being approved by the National Institute for Health and Care Excellence.

My Lords, I beg leave to ask the Question standing in my name on the Order Paper and declare an interest as chief executive of the charity Breast Cancer Now.

NICE is committed to publishing draft guidance on cancer drugs around the time of licensing, with final guidance published within three months of licensing wherever possible. The MHRA and NICE work closely together to ensure that licensing procedures and health technology assessments are as streamlined as possible. For cancer drugs, the NHS in England provides funding from the point of draft positive NICE guidance, delivering faster access to promising new cancer treatments.

My Lords, the delay between licensing and NICE technology appraisal has been dealt with in the case of two out of the three drugs approved under Project Orbis, through agreements between NHS England and the drug company concerned. Unfortunately for women with secondary incurable breast cancer, for which there are very few treatment options, no agreement has been made with the drug company Gilead, and this creates a new treatment lottery. Are interim access agreements meant to be the permanent solution, and if not, what can be done to address this lottery and close the gap between Orbis licensing and NICE appraisal?

I thank the noble Baroness for her Question. Clearly, there is distress and concern at the delay between MHRA approval and NICE licensing. The drug Trodelvy was licensed by the MHRA for both unresectable locally advanced and metastatic triple-negative breast cancer through Project Orbis. On NICE’s appraisal of Trodelvy to determine its clinical and cost-effectiveness for use in the NHS, NICE hopes to have guidance next year but, in the meantime, NHS England, NHS Improvement and NICE continue to work with the manufacturer to explore options for interim access to Trodelvy.

My Lords, despite what the Minister says, the fact is that innovative new drugs such as the cancer drugs the noble Baroness mentioned are reaching patients in this country far too slowly. We lag behind many other countries. How can we expect to be a centre of science and research if the NHS is so slow to develop the medicines that are produced?

I think noble Lords will agree with that frustration at the speed of approval and licensing, but in most cases it does happen speedily. One of the central issues is making sure that there is confidence in the ability to purchase. We are looking at a number of different ways to accelerate the process, including through ILAP—the accelerated partnership—while also making sure that MHRA and NICE can speak where they are allowed to, given some of the legal restrictions on their discussions. For example, I went a couple of weeks ago to a board-to-board meeting between MHRA and NICE at which they discussed issues of common concern.

My Lords, picking up on the point of the noble Lord, Lord Hunt, there is a particular problem in the United Kingdom with NICE and MHRA appearing not to talk together as much as they should to help streamline the process, where that is appropriate. An academic paper in March demonstrated that the CDC in America has a much stronger, streamlined system that works, with far fewer drugs being delayed. How can NICE and MHRA learn from what is happening abroad?

It is important that we learn the best lessons from abroad on incredibly important issues such as this. Where NICE and MHRA are allowed to talk to each other and co-operate—there are some restrictions, as I am sure many noble Lords are aware—both clearly recognise that there are great concerns and distress on the part of the many patients who want access to these drugs, and they are trying to work out how they can speed up the process as much as possible.

My Lords, how can we speed up the process once new, innovative medicines have been approved by NICE so that patients get their benefit? Is the Minister aware that other countries, especially Germany and France, are leading the way with cancer drugs while England is near the bottom of the list? That is not good enough, is it?

I thank the noble Baroness. It is important that NICE, MHRA and others hear some of the concerns, and the fact that we are being held to account today shows how important this is. Unfortunately, some existing legislation restricts MHRA’s ability to share information with partners, including NICE, which would help them to plan their processes more efficiently. NICE, MHRA, NHS England and NHS Improvement are talking about the concerns raised by noble Lords and generally about delays in the process. They are talking about how they can improve access, including through initiatives such as the Innovative Licensing and Access Pathway launched in January 2021, and sharing as much information as they can upfront. Both MHRA and NICE are aware of the concerns and made that clear when I met them recently after their board-to-board meeting.

My Lords, I will follow up on questions that noble Lords have already asked. The ongoing NICE methods and processes review missed the opportunity to propose a new process to mirror accelerated regulatory processes. There are concerns that capacity constraints will limit NICE’s ability to publish decisions as close to marketing authorisation as possible, including for oncology drugs, through the new Project Orbis route, as has been the case with the secondary breast cancer drug, Trodelvy. Have the Government assessed whether the system is fit for purpose in achieving the objective which the noble Lord has articulated: to deliver quick patient access to new, clinically effective treatments? What concrete steps have been taken so far to address any concerns?

Both NICE and MHRA are aware of the concerns, particularly regarding the delay between approval and licensing. That is why they are having conversations with NHS England and NHS Improvement to make sure, as far as possible, that they can discuss co-operation to ensure the speedy approval of drugs.

My Lords, regarding the efficacy of cancer treatment, so far this year, six friends of mine have died from cancer; all were under 80 and three were younger than me. I know of many more who have terminal cancer, regrettably. I also knew one person who died from coronavirus aged 55. She had leukaemia, or blood cancer, which destroyed her immune system, and she caught the virus while she was being treated in hospital. To put cancer in perspective, how many people under the age of 80 have died this year from cancer and how many people under the age of 80 have died in this terrible pandemic, which has shut down society, damaged our children’s education and mortgaged their future for decades to come?

I thank my noble friend for his question. The focus was on fighting Covid and making sure that people were vaccinated as quickly as possible. As noble Lords know, economics is about the allocation of scarce resources and there are always trade-offs. Sometimes there are unintended consequences of focusing on one condition rather than another. I will write to my noble friend with an answer to his specific question.

My Lords, so far, we have spoken about England. The drugs are licensed for the whole of the United Kingdom and NICE regulates what happens in England. Wales is aligned to some extent and Northern Ireland much more closely; Scotland applies a different system. Will the Minister undertake to look at whether other parts of the United Kingdom are dealing with this more efficiently? As he does so, will he also take care that NICE is not being used as a back-door way of rationing?

The noble Baroness raises an important point, especially given that health is devolved to the devolved Administrations. As much as possible, we work England-wide, but we also ensure that we co-ordinate UK-wide and that Ministers and officials regularly meet with those from the devolved Administrations.

My Lords, some of the territories in the world which have the cheapest, safest and widest choice of medicines do not have their own regulators. Instead, they automatically recognise the decision made by globally acknowledged licensers. Does my noble friend agree that one way of addressing the question of expedition that the noble Lord, Lord Hunt of Kings Heath, and others raised would be for global Britain to work for the consumer as well as the drugs companies and to recognise automatically drugs licensed by the FDA, the European Medicines Agency and other equivalent bodies?

I thank my noble friend, who has been an advocate for free trade, for his question. Sometimes in the conversation about recognition, there is a debate between harmonisation and mutual recognition but also unilateral recognition. One of the concerns often raised when looking at unilateral recognition is that negotiators feel that, sadly, they are losing a bargaining chip. The other thing to recognise is that one country’s standard is often another country’s non-tariff barrier. MHRA is the UK regulator and I have been told that it thinks it important that we have our own arrangements in place for the regulation of medicines.