NICE-Approved Products: Patient Access

Jim Shannon Excerpts

Tuesday 30th November 2021 Commons Chamber

[Anne Marie Morris (Newton Abbot) (Con)]

I rise to address the challenging issue of access for patients to medicines and medical devices. We all believe absolutely passionately that we should have access to doctors and nurses, good hospitals and operating theatres, but I think the pandemic has shown beyond question that access to medicines and medical devices goes hand in hand, and without that we do not have the NHS that I think we all believe everyone deserves.

What is the problem? The problem, I shall explain, is as follows. When a medicine is approved, it goes through two processes: first, with the Medicines and Healthcare products Regulatory Agency, which checks whether or not a drug is actually safe and does effectively what it says on the tin; and then it goes to a separate process run by the National Institute for Health and Care Excellence, which looks at cost-effectiveness and value for money. The theory goes that, once those two hurdles have been passed, the medicine is then accessible to anyone. It is very clear in the NHS constitution, which explains that there is a legal right for people to have NHS NICE-approved drugs if it is right for their particular circumstances. Indeed, the NICE guidelines say that there should be automatic adoption, if clinically appropriate and relevant, within 90 days of approval. So where is the problem?

The problem is partly in the system and partly in the words. The words in the constitution are effectively caveated: people can have a medicine if it is right for their particular circumstances. Likewise, according to the NICE guidelines, it will be automatically adopted if clinically appropriate and relevant. The challenge is that, in the current system, NICE will approve medicines for the condition for which they are most cost-effective, so in this country we do not have the ability to approve a medicine for multiple conditions—multiple indications, in the jargon. It is what is most cost-effective that gets approved, and others do not, and there is not a system, either than paying privately, to ensure that the medicine that has been approved for the condition for which it is most cost-effective is available to those with other conditions, but that medicine may in fact still be the only possible solution.

Assuming we get over that hurdle, there is a second hurdle, because not only must NICE have approved the drug, but it has to go on the approved list of drugs locally in the local health authorities—now integrated care systems. The problem is that to get on those formularies, somebody has to put it on those formularies. Currently, while in theory under the NHS NICE guidelines there is a system, it does not actually happen. There is currently a drug for multiple sclerosis, and research shows that people are still waiting after 150 days for it to go on the formularies in something like 25% of the local health systems across the country. So the system, fundamentally, does not work.

What does this result in? It results in a postcode lottery. If someone has type 1 diabetes, it is absolutely crucial that they monitor their condition. There is a device, a flash monitor, that is state of the art, and research shows that 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 levels of uptake. We all think we have access to medicines for cancer given that we now have the highly innovative and very welcome cancer drugs fund. However, that drugs fund is only relevant when the particular drug is approved for a particular type of cancer. So there will be some drugs—Avastin, for example—which those with the appropriate cancer can get through the CDF, but those with a different type of cancer or who do not fit the profile again have to pay for it privately, costing £252 to £1,088 per cycle, which is every three months.

Sadly, NICE does not approve much for those with skin conditions. For those with mastocytosis—blotches on the skin and boils causing vomiting and diarrhoea—the only solution is usually NICE-approved food allergy drugs, but they are approved for NICE allergies not skin conditions so they have to be paid for privately. For cystinosis, the accumulation of amino acids, which gives rise to kidney problems and kidney damage, the drug Procysbi has been approved by NICE but, bizarrely, there seems to be no uptake of that to date at all. That is important because that drug is, unlike the existing drug, a slow-release drug and therefore mums and dads do not have to keep waking up their kids in the middle of the night to give them the next dose, which, as we can imagine, takes a real toll on family life.

For those with an obesity problem there is a good solution in Saxenda, but that is approved for diabetes. So those whose obesity does not give rise to diabetes will not get access except by case-by-case approval. I am pleased to say that Imperial has finally accepted and approved.

How are we going to resolve some of these issues to make sure there is no longer a postcode lottery? First, let us look at the simple case of those drugs that are deemed to give the most health benefit and are therefore in theory approved and people can get hold of them. What can we do to make sure they do actually finally appear on those formularies and how can we then make sure the system for take-up is actually in place? One of the problems is that there is nobody sitting in these health bodies who monitors NICE drugs coming up, and therefore no one who looks to see whether in their health community they may be of benefit.

[Jim Shannon (Strangford) (DUP)]

I congratulate the hon. Lady on securing a debate on this topic. As she says, this is about NICE-approved products as well as drugs. One of those products is cognitive rehabilitation therapy, an important intervention for those with dementia, enabling them to live independently for longer. However, despite being listed in the NICE recommendations there is a barrier to delivery. Occupational therapists and other staff in memory clinics do not have the capacity to deliver programmes that are National Institute for Health Research and Alzheimer’s Society-funded. Does the hon. Lady agree that the NICE recommendations must address not just drugs but also products?

[Anne Marie Morris]

I could not agree more. It is crucial to realise we are talking not just about medicines and drugs but also devices and, as the hon. Gentleman says, the processes, which are often the connection between the medicine, the device and the patient.

Within these health bodies, there is no training and nobody specifically focused on monitoring innovation, and there is no obligation to prescribe. Even more peculiarly, for these drugs there is an agreement between the industry and the NHS, the voluntary payment scheme or VPAS, under which manufacturers that are members of the scheme effectively agree with Government when the medicine or device is approved that it will be supplied at a well-discounted price. In addition, there is an agreement that sets a cap so that if, as it happens, more prescriptions are written for that particular drug, it is agreed that the extra cost that the NHS has incurred will be reimbursed by the manufacturer.

So if there is excessive prescribing—we assume that is why there is an attempt to limit how much goes on to formularies—why is that a problem when we have the VPAS scheme? It is a problem because the scheme does not the pass the benefit, other than the reduced price, down to the local health authority. The money is put into a separate pot, and that pot is then used generally to support the NHS writ broadly; it is not ringfenced, either for medicines or to be used, as it could be, to support local health authorities—integrated care systems—when their budgets are put under pressure, which is why they do not want too many things on their formularies. This would help them pay the price.

It seems to me, Minister, that there are some solutions here. You will be aware that I raised three of them in proceedings on the Health and Care Bill. To deal with the imperfections of the current arrangements, if those drugs that were approved by NICE—we are talking about the most cost-effective drugs—were mandated to be on formularies within 28 days automatically, so no one had to decide whether they went on or not, that would be a good system. It would also ensure that the decision was in the hands of the clinician and not of the bureaucracy of the health authority.

It seems to me, Minister, that the second suggestion I made—