Health and Care Bill

Lord Russell of Liverpool Excerpts

Committee stage
Thursday 20th January 2022 Lords Chamber

[Baroness McIntosh of Pickering (Con)]

My Lords, I will speak particularly to Amendments 54, 74 and 97 in this group. I warmly thank the noble Lords, Lord Patel and Lord Hunt, for lending their support to all three amendments, and the noble Lord, Lord Warner, for supporting Amendment 74. I pay particular tribute to the noble Lord, Lord Patel, and his historic work prior to the setting up of NICE; it was a great contribution that deserves to be recognised.

We are all aware of the procedure that, when a medicine is approved, it goes through two processes. First, it goes to the Medicines and Healthcare products Regulatory Agency, known as the MHRA, a body which checks whether a drug is safe and effectively does what it says on the tin. It then goes through a separate process run by the National Institute for Health and Care Excellence, known as NICE, which looks at cost-effectiveness and value for money. After those two hurdles have been passed, the medicines should, theoretically, be accessible to anyone. That is very clear in the NHS constitution, which explains that there is a legal right for people to have access to NHS NICE-approved drugs if it is right in their particular circumstances that they should. Indeed, the NICE guidelines say very clearly that there should be automatic adoption within 90 days of approval, if clinically appropriate and relevant.

For a drug then to be prescribed, it must not only have been approved by NICE but go on to the approved list of drugs in the local health authorities, called a formulary. The problem is that somebody must put the drug on the formulary and, currently, while in theory there is a system under the NHS NICE guidelines, this does not actually happen. Sadly, this results in a postcode lottery where some areas have the product on their formulary and others do not. Sometimes this is a process failure, but sometimes it is to avoid budget overspends. Therefore, I would say that it is at the patient’s expense that they are deprived of the drug.

To give an example of the problem, there is currently a drug for multiple sclerosis that patients are still waiting after 150 days to see go on to the formularies in around 25% of the local health systems across the country. There is a state-of-the-art flash monitor for type 1 diabetes, but the uptake across the country varies between 16% and 65%. What is most worrying is that those parts of the country with the greatest levels of deprivation have the lowest level of uptake.

I make a plea to the Minister: in my view, ICBs should be required to ensure that all NICE-approved medicines and devices are available and promoted to their population, because the cost of these drugs is covered by the VPAS reimbursement scheme agreed between the NHS and the pharmaceutical industry. If a treatment is unavailable in one ICB footprint, they should be required to commission the required treatment from another ICB. The Government should also promote uptake through the ICBs of NICE-approved medicines and report uptake of new medicines annually.

Amendment 54 would require an ICB to arrange for provision of a NICE-approved treatment to any patient whose NHS clinician has recommended it, even if that treatment is not otherwise available to patients in that ICB area. Amendment 74 would require ICBs to ensure that all NICE approvals are available and promoted to their population via a publicly accessible format, normally online, and to report on their uptake annually. Amendment 97 would mandate integrated care boards and healthcare providers, notably hospital trusts, to update their formularies to include all NICE-approved medicines or devices within 28 days of market authorisation, to ensure they are available for healthcare practitioners, through either their physician, for example, or prescribing pharmacist, to make available for suitable patients.

I thank those who submitted briefings to me while I was preparing for today, notably JDRF, which makes a number of recommendations on this issue, particularly in regard to type 1 diabetes. These aim to reduce inequalities, remove the postcode lotteries to which I referred and make sure that treatments, such as those for type 1 diabetes, are uniformly available across the piece. I also thank EMIG, a pharmaceutical trade association for small and medium-sized companies, for its briefing. It says that the uptake of NICE-approved medicines is critical for NHS patients to benefit from the latest and most promising innovations. Finally, I am grateful to Vertex Pharmaceuticals, which submitted a briefing that again supports the conclusions reached. Among the proposals it highlights is the introduction of a modifier to take account of the severity of a disease and efforts to more fairly consider uncertainty in the evidence for highly innovative and complex treatments for rare and severe diseases, including through greater use of real-world evidence.

On this small group of amendments, I look forward to hearing what the noble Baroness, Lady Finlay, has to say in connection with her neat, simple amendment, which would strengthen what we are proposing to do here. I urge the Minister and the department to address these postcode lotteries and make sure that NICE does not just make the guidelines but ensures that treatments reach the formularies and ultimately the patient in question. I beg to move.

[The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)]

My Lords, the noble Baroness, Lady Brinton, is taking part remotely. I invite her to speak now.

[Baroness Brinton (LD) [V]]

My Lords, I wish to speak in support of Amendments 54, 74 and 97, tabled by the noble Baroness, Lady McIntosh, and Amendment 163, tabled by the noble Baroness, Lady Finlay. I too pay tribute to the historic work of the noble Lord, Lord Patel, prior to the setting up of NICE.

While it is not an interest in the formal sense, I declare that I have autoimmune disease and have experience of being on the NICE rheumatoid arthritis care and treatment pathway for 19 years, which has been regularly updated by NICE over that time. Where it has been applied in full and from diagnosis, patients have found it very beneficial and, with new and more effective drugs being approved every few years, many are now in remission. I pay tribute to the consultants trying to do their best for their patients and the National Rheumatoid Arthritis Society and Versus Arthritis helplines which support RA patients in navigating their way through access to their NICE treatments when these have been blocked.

I thank the noble Baroness, Lady McIntosh, for her introduction to this group and for explaining the problem with the formulary list. She is right that this should be addressed formally. However, I want to focus on some of the commissioning practices on NICE-recommended treatments, including those on the formulary, in the current CCGs, because I believe these explain the need for the amendments in this group.

In May 2014, the High Court ruled that Thanet CCG could not disagree with NICE guidance merely because it disagreed with it, even when there is no statutory duty to provide that treatment. This specific case was about access to fertility treatments for a woman who was about to undergo bone marrow transplantation to put her severe form of Crohn’s disease into remission. NICE’s 2013 clinical guidance recommended that

“oocyte or embryo cryopreservation as appropriate”

should be offered

“to women of reproductive age … who are preparing for medical treatment for cancer that is likely to make them infertile”.

This was not cancer, and the CCG’s own policy was to not grant funding unless there were exceptional circumstances.