Oral evidence: Food and Weight Management, HC 1181

Oral evidence, 25 March 2026.

Witnesses

Dr Simon Doyle, Claire Nevinson and Dr Kieran Seyan.

Chair

Welcome to this evidence hearing of the Health and Social Care Committee on food and weight management. This is the sixth session of this inquiry. Today we are looking specifically at GLP-1 jabs, or weight loss jabs as they are more commonly known. Might the panel introduce themselves and what they do?

Dr Seyan

I am Dr Kieran Seyan, a GP by background. I have worked in digital healthcare for 10 years now, representing Pharmacy2U.

Claire Nevinson

Good morning. I am Claire, the Superintendent Pharmacist for Boots. My remit is to head the professional agenda for Boots pharmacies across the UK. I have been a pharmacist for 30 years and an independent prescriber as well.

Dr Doyle

Good morning. Thank you very much for having us here today. My name is Dr Simon Doyle. I am also a GP, and I lead public policy at Juniper. Today I am representing a new member coalition called the Coalition of Responsible Digital Health—CoRDH for short—made up of Juniper, Numan, SheMed, eMed, Voy and Simple Online Pharmacy. We are all digital-only providers and we have come together to advocate for proportionate and effective regulation that enables safe access to digital care.

Andrew George

Dr Seyan and Claire, could you give us an indication of the scale of demand for GLP-1s in the private sector and how it compares with prescribing through the NHS?

Dr Seyan

We know that demand has increased significantly over the last couple of years, with patient interest in the condition and more availability of information to the patient around this particular set of treatments also being effective as well. Patients are seeking this type of medication, so demand has increased rapidly. NHS access is limited at the moment, so patients are seeking this more in sectors outside of the NHS.

Andrew George

What proportion of those who are obtaining your services do you think would otherwise be eligible for NHS services, were access less restrictive?

Dr Seyan

Going by the licence of the medication, then all the patients who are requesting medication from our service would be eligible through the NHS. That is going by the licence, not by NHS criteria.

Andrew George

Okay—and Claire, through your services?

Claire Nevinson

We know that there are around 1.6 million patients accessing GLP-1s across the UK currently on average. Most of them are accessing them through the private sector because of accessibility and because the wraparound care and what we can provide through the private sector is what they are looking for, with limited access to NHS services. We support thousands of patients every week through the Boots Online Doctor online service. We have just introduced a face-to-face version of that service delivered through our Boots pharmacies as well. We are seeing demand from different parts of the population to access face-to-face care, too, so the demand is definitely increasing.

Dr Doyle

If I may add to that, it is a complex question because NHS eligibility varies from area to area. We have seen it vary over time as well. We saw the initial NICE guidance and then we have seen the funding variation, then we have seen priority groups, and then within different ICBs we are seeing criteria become more stringent, which is part of the problem that has caused the postcode lottery. If we are talking about our member organisations, if we take the original NICE guidance, what was intended to be implemented over the three years, up to around 20% of our patients meet that criteria, having a BMI of more than 35 and an associated condition or a BMI over 40. That shows that the digital providers or the private sector providers are working alongside the NHS to manage the obesity crisis.

Andrew George

You mentioned earlier the creation of a new organisation, the Coalition of Responsible Digital Health. There is a strong emphasis on the word “responsible” there.

Dr Doyle

Deliberately so.

Andrew George

Deliberately so. Does that mean that—obviously by definition—those who are not members of your organisation are irresponsible?

Dr Doyle

Absolutely not. Like I say, we are a relatively new coalition. One of the things we are trying to do is make it clear that not all physical premises are the same, and equally not all digital premises are the same either. I believe there is a role for digital providers to provide responsible and safe care. At the moment, we have set up because we are digital only, and we are working towards three main pillars in our code of conduct. That is around safe prescribing and ongoing care, so we are not just a one-off transaction. We are able to provide ongoing medical support, so that means an element of side effect support, dose titration and education. We are trying to change behaviour alongside the patient’s weight loss experience. The final pillar is around responsible communication. We live in a world where there is, unfortunately, lots of misinformation out there and we are trying to do this correctly. We are keen to work with regulators, with the ASA and with the GPhC to make sure that we are doing it correctly.

Andrew George

We will come on to regulation in a moment, but just in terms of your modus operandi, have you considered applications for membership and rejected them so far?

Dr Doyle

Not at this stage, because we are very new. We have recently launched our website, which lists our code of conduct. If other members meet those criteria and are willing to work towards that code, then we would consider increasing our membership in the future.

Andrew George

Do you have the resources to act as the gatekeeper to your own standards?

Dr Doyle

We are not talking about gatekeeping anything here. We are talking about trying to build an environment of responsible health. If more members want to work to the principles that we have set, then I would welcome that, because it will only mean increased safety for our patients.

Andrew George

It is effectively a kitemark that they can put against their name?

Dr Doyle

It is less about branding and more about how we are working together.

Andrew George

All right. Just coming back to the differentiation, you are a practising GP and therefore you will have patients coming to see you through your surgery who will be eligible for NHS treatment and are able or unable to obtain that treatment. What barriers stand in their way meaning they might seek a private digital provider rather than go through the NHS route?

Dr Doyle

I think there are multiple factors. I reiterate that where I work may be very different to where somebody down the road works, so that is one—

Andrew George

Where do you work?

Dr Doyle

At the moment my main job is with Juniper, but I still work in central London as well. I think one of the main barriers is around the variability in criteria. The other thing that I am seeing in practice, and that lots of my colleagues are seeing in practice, is patients are very keen for treatment. They have tried lots of things over years and years without much success. We are now getting to the point where, unfortunately, because of the way the funding has been allocated, patients are being told, “You are not unwell enough yet.” We are talking about this as a piece of the prevention puzzle. However, it doesn’t make sense to me that we are waiting for patients to become more sick before we can start that prevention piece.

Andrew George

In terms of your experience, Dr Seyan, are you still a practising GP?

Dr Seyan

Not within the NHS.

Andrew George

But you have recent experience.

Dr Seyan

Yes.

Andrew George

For those on the frontline, what changes do you think will be necessary in order to, if you like, facilitate better the access for patients through the NHS? Obviously, you have a private interest in driving patients to your private practice, but on the other hand you must recognise that it would be better if the NHS was better able and patients did not need to fall more ill in order to access NHS services.

Dr Seyan

Yes. I would agree with my colleague. This is very much multifactorial and it does depend on the area, and on the patient themselves. The challenge that we face within the NHS is accessibility, so if the criteria were to change, as per the licence, then more patients would be able to access this medication and the consultation that is available. It is not possible for general practice to cope with the volume of patient demand that there is, so we need wider availability of access to care. That could be through digital, pharmacy, or a combination of both, along with general practice. Unless there are more open avenues, it will be very difficult to serve all those patients.

Andrew George

Could I just be clear on the point? You are saying that you provide a licensed service, and we will come on to the regulatory environment in which you operate, but all those patients you are supporting through private digital supply would otherwise be eligible for NHS services. That is what you are saying. It seems to me that you are taking the vast majority of patients and that the NHS is dealing with a very small proportion overall.

Dr Seyan

Yes.

Andrew George

Approximately what proportions would you say?

Dr Seyan

Per the estimations that I have seen, it is about 80%.

Andrew George

Eighty per cent of the market. Claire, I have left you out of the conversation on these issues. You are obviously a very large supplier of these services. Is this pattern of activity one that has significantly changed in recent times? What proportion of your sales do the GLP-1s represent?

Claire Nevinson

In our online services for weight management, we have definitely seen significant demand over the past couple of years, since the availability of new GLP-1s on the market. We have responded to that demand and developed clinical services, working collectively as digital providers, to make sure that those services are delivered with the right wraparound care and the right support for patients. It is an important part of our healthcare strategy. It feeds into the ambition that the NHS has as part of its 10-year plan to focus on prevention and weight management as a core and key service that we need to look at to support people to prevent longer-term conditions. It is a service that we can provide safely and professionally online. In Boots we can provide that face to face as well, which helps us to meet the ambition of giving people access to services that help them to stay well and to prevent further long-term conditions. It is a significant focus for us currently as a business.

Andrew George

Finally, Dr Doyle, on the role of the coalition, you felt recently compelled to establish it, presumably because you are well aware of poor practice and irresponsible practice elsewhere. Are you prepared to identify where that irresponsible practice is taking place? Are these UK-based organisations or are they suppliers from overseas?

Dr Doyle

I think that is probably a role for the regulator to identify or call out specific companies, rather than a role for myself. However, a core principle of what we are trying to do is to show that broad brushstrokes aren’t always correct. There is lots of attention, rightly so, in the media around bad actors in this space, whether that be through regulated providers or unregulated providers through social media, etc. What we are trying to do is to show that that is not the case for all digital providers.

Andrew George

Is there a problem of overseas supply? Is that one of your areas of concern?

Dr Doyle

To clarify, do you mean patients in the UK obtaining from overseas?

Andrew George

Yes, that is right.

Dr Doyle

My point of view is that medications in this country should be obtained from a regulated provider in this country so that patients have reliable access to ongoing support, which again is the wraparound part that all our member organisations provide.

Gregory Stafford

First, I have a relatively general question. When it comes to your GLP-1 services, what could the NHS learn from your experience?

Dr Seyan

The NHS would perhaps gain some knowledge around the scalability and efficiency that digital services can provide, the access to structured longitudinal data, identifying risk at early stages, and the ability to create an environment where patients can access care early. It very much fits in with the digital age that we live in as well.

Claire Nevinson

Yes, I agree. I think what we have learned through our provision and through online services, and through our experience of providing preventive-type services through community pharmacy, is that we know that what is important to patients is access. It is important to be able to access services where people live, delivered by people who can relate to them and build a relationship with them. We have, as I say, supported thousands of patients every week through our online services and we are seeing the support delivered through our bricks and mortar pharmacies also playing a very important role. It is mostly about new pathways of care that allow patients to access these important treatments in a way that works for them and ensuring that wraparound care is available for everybody, regardless of how they want to access these services.

Dr Doyle

I would emphasise Claire’s point around new pathways and build on that, to be honest. If we look at what the original modelling was for how this roll-out could work in the NHS, we were looking at the equivalent of 21 GP appointments across a year. I think what the NHS could learn from digital providers is that we are in a position to rethink what a model of care looks like. We are able to provide patients more flexibility and more choice. Instead of having one blocked 15-minute appointment, patients may prefer to interact with their point of care throughout the week through asynchronous messaging, which provides a lot more flexibility. The reality of that is if we look from January this year, our member organisations have treated more than 250,000 patients already or have more than 250,000 active weight loss patients. When we compare that with the NHS ambition to treat 220,000 patients over three years, I think it shows what can be achieved by changing the model of delivery.

Gregory Stafford

That is very helpful. Moving on, we have heard in our evidence—indeed, you have re-emphasised it now—about the potential for digital services to improve access to GLP-1s. What are the practical changes that need to come about to unlock that potential?

Dr Doyle

I think one of the key things is that trust part between the public sector and the private sector. We have spent years building these platforms, learning from the process and creating a large evidence base. All our member organisations are very proud of their evidence and show that they work. For example, Juniper has a paper showing that patients are twice as likely to achieve clinically significant weight loss compared with medications on their own. Voy has similar results, with 21% weight loss versus 17% weight loss at 12 months. I think we have shown that we are credible. The thing that can unlock that is also interoperability. A simple example of that is private companies are blocked out by default from access to summary care records from the NHS. I would point out that doesn’t inherently make private providers dangerous. That is very similar to how a patient may go to a private GP practice and that GP would not have access to the summary care record either. Even NHS services such as sexual health don’t have immediate communications with general practitioners. I think there is something around the interoperability that we would love to see change.

Gregory Stafford

That is really helpful. Ms Nevinson?

Claire Nevinson

I agree on the interoperability point. From a community pharmacy perspective, there is a real opportunity for the Government and the NHS to look at the role of community pharmacy in supporting people to access this type of service—so, delivery through the community pharmacy setting, with the capability of the healthcare professionals who work in our community pharmacies, which is growing over time as we see independent prescribing becoming more mainstream. This type of holistic, preventive service is perfectly placed to be delivered through the community pharmacy network.

Gregory Stafford

Just so I am clear, are you suggesting that the first presentation is the community pharmacy and then they are somehow managed through a digital means, or are you talking solely through the community pharmacy?

Claire Nevinson

There is definitely an opportunity to do both. There is a hybrid model that we should look at, and we have evidence to show that people have very successful weight loss journeys using digital means. Of course, the way people are accessing information, advice and support is typically through digital channels now, so there is a role for community pharmacy to play a bigger part here, but I think listening to what patients are choosing to do and how they are choosing to access healthcare is very important too. There is an opportunity to look at a hybrid approach.

Dr Seyan

I will only support what my colleagues have said: the interoperability is very important, and a single patient record, which we are looking forward to. Again, I would agree with Claire with regard to the support from pharmacy. If we think of it from a patient perspective, there needs to be access to healthcare from different means. That could be community, or that could be via digital, but it needs to be a hybrid model.

Gregory Stafford

Thank you. You have expressed that you are doing about 80% of the market already, but do you feel you have the capacity to scale up to meet the potential demand if we were to move to the model that you are describing?

Dr Seyan

The sector is not new. As I mentioned, I have been working in this for about 10 years now and this digital model has been around for at least 20 years in the UK. This is an established way of delivering healthcare and we are very aware of the risks that are associated with it and how to run an operation. I think that, yes, we are able to scale. There will be several other providers that will be able to do the same, but Pharmacy2U is absolutely ready for that.

Gregory Stafford

You would agree with that?

Dr Doyle

Yes, I would agree with that.

Claire Nevinson

I would agree with that, yes.

Gregory Stafford

Okay, thank you very much. Have you done any modelling to understand how many more NHS patients digital providers could support, or are you suggesting, Dr Seyan, that you have an almost infinite capacity to deal with as many people as possible, given the model you are describing?

Dr Seyan

I wouldn’t say an infinite model, because there is still a limited number of clinicians, but what digital can do is allow for scale and efficiency, and different to the—

Gregory Stafford

What I am trying to do is get a practical idea of numbers. Have any of you done any modelling to say, “We could treat X number more patients if we did this,” just so the Committee can get some idea of the numbers we are talking about here?

Dr Seyan

This is something we could provide afterwards, because some of my colleagues will have done that work, but I don’t have those details to hand.

Chair

Please write to us afterwards. That is fine.

Gregory Stafford

That is very helpful. This is slightly on a tangent, but in your opinion is the Obesity Pathway Innovation Programme ambitious enough to meet the current demand for GLP-1s?

Dr Doyle

The first thing I would say is the programme is a great start. It shows thinking differently, which I think is what we would all welcome. I think involving different Government Departments is very helpful, so the Department for Science, Innovation and Technology, rather than just Health and Social Care. I would welcome more of that cross-Department thinking and joined-up thinking, and maybe even bringing in the Department for Work and Pensions as well. The Tony Blair Institute has done some brilliant modelling with Frontier Economics around how different Government Departments can all benefit from this. If you have not seen that, we are more than happy to provide that report for you.

Chair

Do not worry.

Dr Doyle

In terms of the limitations of the OPIP programme, as it is known, my concern is that we already have a postcode lottery. There will be some brilliant pockets of innovation for those who have been successful in the OPIP programme. However, I know lots of ICBs have put a lot of work into their bids and unfortunately have been unsuccessful. I think it is a great start. Do I think it has gone far enough to level the playing field? I am not convinced yet, but I am very excited to see what comes out of it.

Gregory Stafford

If no one else has anything to add to that, I am going to jump a question I had, because you have touched on it, Dr Doyle. In our evidence gathering, we have heard some very strong calls for the weight management services and treatments like GLP-1s to be nationally commissioned. Is that something you support, and what would it mean for your business if that did happen, Dr Seyan?

Dr Seyan

Pharmacy2U would absolutely support national commissioning but with local flexibility, though. Pharmacy2U would be able to support any commissioned service. We have experience with providing commissioned sexual health services in London and across England. We would absolutely support it.

Claire Nevinson

Similarly, we would welcome the conversations to co-create and establish a commissioned service that will work through community pharmacies and, as I say, give people access to this type of treatment and care in their communities, delivered through community pharmacy.

Gregory Stafford

Do you have a model in your mind of how that service would be designed in terms of the way you operate?

Claire Nevinson

We have introduced an in-pharmacy prescribing service in recent months and we will roll that out. It is private pay because we don’t have a commissioned service to offer. We have plenty of experience and learning. We work with Government regularly on the design of services that work in community pharmacies, so we would have a model that we could share that could be commissionable.

Dr Doyle

Absolutely. The important point would be to design that in partnership with existing providers. If done well, that can form part of the growth agenda. I think if this is done as a static one-off national commissioning, then we risk blocking new innovators, which then reduces the growth agenda. National commissioning in a dynamic way that enables digital providers to showcase what they have and enables local choice, but without too many barriers in terms of multiple competitive tenders for innovators, could be a big piece of this solution.

Gregory Stafford

How could the funding work and how could that be improved for a nationally commissioned service?

Dr Doyle

That is a really difficult question. If it was easy, we would already have a fantastic nationally commissioned service. My recommendation would be to consider how Government Departments can come together to tackle this from different angles. I firmly believe different Government Departments can seek benefits from treating obesity, whether that be reducing absenteeism, reducing long-term sick leave or reducing long-term conditions, so I think pooling the funding and rethinking how we commission it could really help.

Dr Seyan

There probably is learning from existing commissioned services, as I mentioned about the sexual health side of things, but there are others that exist. There is most likely to be learning from them, but I don’t have the answer, I am afraid.

Gregory Stafford

Fair enough. Moving very specifically to you, Ms Nevinson, could you tell me about the decision to pilot an in-store service? What was your thinking behind that, as a company?

Claire Nevinson

We have a good track record of delivering private services within our Boots pharmacies. We have successfully delivered weight loss services specifically through our online Boots Online Doctor service. We recognise that there is an opportunity for people who are perhaps not able to access digital services to access this care. We also have a growing capability within our network of pharmacies of independent prescribers, who are perfectly placed to train and deliver very holistic care to patients, particularly for conditions like weight loss. I think there is room for both. We wanted to give people the opportunity to access these services in-pharmacy. The beauty of the face-to-face consultation is that the pharmacist can also talk to the patient about other conditions. Typically, people living with obesity will have other issues and concerns, and of course we are perfectly placed to support with side effects, nutritional advice and everything else. We knew there was an opportunity there to do face to face. There is definitely room for both. We are seeing different types of patients accessing our in-store service compared with our online service, which proves the point.

Dr Seyan

May I add to that? I absolutely support Claire in what she is saying there. Having previously worked with LloydsPharmacy and LloydsPharmacy Online Doctor, similar models have existed in the past, for example, with the Gardasil 9 vaccine, the HPV vaccine. There is a portion of patients who will not be wanting to have a digital consultation, but want access. This was not freely available on the NHS at that time, so having that access in the community and digitally provides great access to the patient, basically.

Gregory Stafford

You only started this in February, but what is your anticipation of demand? In the short time that you have had, is demand meeting that expectation or is it below or above the expectation you had?

Claire Nevinson

Demand is growing. It relies on people knowing that we are offering the service. There is more work for us to do to invite people in to access the services in our stores. We are seeing the demand as we would have expected for a pilot of this size. By the end of April, we will be in 75 pharmacies, and we intend to roll out further after that. We expect to see the demand will increase, just as it has done with the online services.

Gregory Stafford

Are you able to give me any numbers on that?

Claire Nevinson

I don’t have the exact numbers to hand, but I am happy to share that with you afterwards, if that is okay.

Chair

That would be lovely.

Gregory Stafford

That would be very helpful. This is a final question from me. Again, what we are trying to do is work out what the NHS can learn from all this. From your in-store experience, what do you think the NHS could learn from those pilots? Has there been any input, either from its side or yours, to share that information to improve NHS services?

Claire Nevinson

We, as you might imagine, regularly speak to the NHS and talk to the policymakers about the services we provide. We are always willing to share the information or thought leadership or data to support the development of commissioned services. Like Kieran said, we have years of experience of delivering commissioned services through community pharmacy, so we would like to be able to take our private service and share that with the NHS as a model that could be commissioned. It is being developed in that way. With the success of other services that we provide through community pharmacy—Pharmacy First and the Hypertension Case-Finding Service—it is another service that fits into the service that the pharmacy already provides, so it makes sense for it to be commissionable.

Danny Beales

Good morning. The NICE appraisal talked about the importance of wraparound care associated with the treatments, and the NHS England proposal talked about a number of different appointments that people required. Simon, I think you touched on the number of GP appointments. What does the wraparound care offer look like for your patients as part of the service you provide? I do not know who wants to go first; maybe Kieran and move left.

Dr Seyan

Yes, absolutely. We offer a structured clinical pathway. Every patient goes through a full clinical consultation. We have a multidisciplinary team—nurses, pharmacists, doctors, a nutritionist as well—so there is ongoing support. The patient is able to—

Danny Beales

Is the nutritionist, etc, all included in the cost up front?

Dr Seyan

Yes. We have a patient record, and the patient can access that record at any point. They can ask the questions that they want to. We offer lifestyle guidance and advice during the consultation and post consultation as well. Then there is follow-up with the patient after two weeks. Whether they respond to the follow-up is different, but we offer the follow-up after two weeks.

Danny Beales

Is that one-to-one support or signposted?

Dr Seyan

It is through their patient record, but yes, it is one to one, absolutely.

Danny Beales

Human to human interaction?

Dr Seyan

Yes, that is right. Well, it is digital human interaction, yes. It is through the patient record. On top of that, we are expanding our wraparound service even further. We have a partnership with Reset Health, which is a NICE-approved support wraparound service, and we will be working closely with it to enhance what we have at the moment.

Claire Nevinson

Every patient who accesses our online weight loss treatment service is, as part of that service, offered wraparound care, which includes live webinars, podcasts, resources, information and access to a clinician seven days a week. If they have any queries or questions, they can use our chat functionality to contact somebody and they will get a response pretty quickly. We also have an app that we encourage patients to sign up to, which gives them regular nudge advice on lifestyle, the importance of nutrition and exercise, etc. In addition, people who access our service for the first time have to collect their prescription from a Boots pharmacy, so there is that additional opportunity for the patient to have counselling directly with the pharmacist and again to access any support that they need through the community pharmacy setting. They stay with us for typically up to nine months at a time, and we encourage them to stay with us so that they have that continuity of care.

Dr Doyle

I will just point out at the beginning of my answer that I am representing five different organisations today. However, one of the pillars in our code of conduct is around that ongoing care. The baseline, even though the wraparound care may vary from organisation to organisation, is ongoing medical support or clinical support, so patients similarly have access to side effect support and titration support seven days a week. Some organisations have hotlines, some organisations do that via messaging, and it varies by patient choice as well. The other element that all our organisations supply is education and behaviour change, and that can be in different formats, depending on which company. That could be webinars, it could be one-to-one health coaching, or it could be an exercise programme, but all those programmes include nutritional support and exercise support as well.

Danny Beales

The extra support you provide, is that all benchmarked into the price; there is no additional pricing? Are there additional options you offer to people with varying prices attached?

Claire Nevinson

Everything that I have described is part of the package that everybody gets. We have an additional one-to-one coaching service that people can then add on as an addition to our main service. People have told us that they have had very successful weight loss journeys with that additional one-to-one coaching, so that is also an option if people choose to use it.

Danny Beales

How much is that?

Claire Nevinson

If they tag it on to the treatment pathway, it is £32 a month. If they choose not to use treatment but just to go for coaching, it is about £40 to £42. I would need to double-check that exactly, but it is around about that.

Danny Beales

Kieran and Simon, is there any similarity in additional structured pricing options, depending on the level of support, or is it just one flat price?

Dr Doyle

Again, I am representing five different organisations, so there may be variability. There are extra options and they may include blood tests for some patients to be able to understand what is going on inside their body. That is included at a slightly higher price or as an option for patients to purchase separately. That will then also include an ability to go through those results with a clinician and get some real valuable insights.

Danny Beales

Is a blood test clinically indicated? Are they recommended as part of the normal treatment pathways?

Dr Doyle

As a GP, I would argue anybody who meets the criteria—which all our patients do—for medication would benefit from screening for things like cardiovascular risks, cholesterol and diabetes screening. As a GP, if I was to start somebody on these medications for weight loss, I would be doing those baseline bloods.

Danny Beales

If any of those issues come back indicative of potential low risk or high risk or diagnosed conditions, what happens to the patient then?

Dr Doyle

What do we do? Yes, it is a really fair question. We have really strong clinical protocols in place and we have a strong clinical team. All our results are viewed by our clinicians and we have clear escalation processes to senior doctors, and then we work with patients to manage them in the best possible way, including directing them back to their NHS GP.

Danny Beales

Would that lead to additional services that you would provide and charge for or—

Dr Doyle

No, not at this stage.

Danny Beales

So you just refer back to the NHS to deal with the issues?

Dr Doyle

Lots of the things that we identify are things that patients can action themselves. I would be mindful to point out that these are patients who are on a medication, so we may expect their blood tests to improve over time anyway. If we identify anything that is dangerous, that is beyond the scope or appropriateness of a digital model, then we would refer the patient to their NHS GP.

Danny Beales

Kieran, Pharmacy2U suggested in its evidence that your sector could provide these services for £300 a year, compared with £1,200 a year. What drives that price differential?

Dr Seyan

It is a different model of care. It could not be a like for like comparison with the NHS, because digital offers scalable, efficient ways of working and clinically focused pathways. We ensure our practitioners—mainly independent prescribing pharmacists, but as I mentioned before, also nurses and nutritionists—are working to the top of their skill mix. That then frees time for the doctor, who can deal with more complex clinical cases.

Danny Beales

Is there a sense that you are underpricing—that you are seeking to present quite a low-cost option, perhaps cutting back some things? I an not saying necessarily that this is what you get if you go straight to your GP, but I think NHS England’s guidance talks about the need for five psychologist sessions. We certainly heard in our evidence from people using the services that they would value more mental health support and more nutrition and dietician advice. Some people just want the medications obviously to get on, but in terms of longer-term, sustained change, not just an inject-and-go model is needed but a properly sustained investment in people and lifestyle change.

Dr Seyan

I do agree. We do not advocate for, as you mentioned, a jab-and-go type model. I could not comment exactly on the figures here. I am sure we can follow up with that. That is no problem at all. The challenge that we always have within general practice—again, this is not a new model—is I would diagnose someone with diabetes and I would be referring them on to a wraparound service, the DESMOND scheme, for example, when I was in practice. The engagement from the patient is something different. We would inform them of the benefits, the risks, the importance of carrying on with the wraparound service, but it does not mean that they are going to do so. We cannot mandate that you have to have wraparound service. You are right that it should not be a jab-and-go service, but not all patients will want wraparound. These are very well educated patients. They have been dealing with this chronic condition for a number of years and have been trying to fight against it for a number of years, so they know what their options are. Often the things that we offer in wraparound are things that they have done already, so they think, “Actually, I’m not sure that this will support me further”. I am not sure I agree with that, but that is some of the patient behaviour that we have seen.

Danny Beales

This is perhaps a question for you all. How do you monitor engagement and take-up in the additional services you provide? Are you confident that the videos that you are providing, the consultations, are being utilised by the patient? We have all done online HR mandatory modules, where we click very quickly to get through to get it ticked off potentially, myself included, but how confident are you that the safety advice you are providing—the guidance, the webinars, the videos—is being used by patients?

Dr Doyle

I can speak for Juniper specifically. I do not have the exact numbers, but we have published a peer-reviewed paper on this, where we have split our patients into different cohorts of engagement. We have defined that in terms of their interaction with the wraparound care, basically. What that paper showed was those in the most highly engaged group achieved much better results than those in the lower engaged groups. We can forward that on, if you would accept it.

Chair

Yes, please.

Claire Nevinson

We have done a similar thing. We can see how many people are accessing. Digitally you can see that; you can see how many people are watching the webinars and engaging with the podcasts. We know with our specific coaching service that patients lose more weight more effectively if they engage in coaching. I think the job of work for us all to do is to educate the public. You cannot force people to do these things, as you say, but we need to help people understand the importance of it. It is about offering what we can and encouraging and educating and coaching and counselling people to engage in the wraparound care, because we know that that really matters.

Danny Beales

Can you do that in a light-touch model of prescribing, I guess that more sustained engagement and behavioural change, perhaps dealing with some underlying issues that are quite deep-seated and long term? People might have been battling with, as you say, different diet and exercise programmes, mental health issues or personal issues. Can you do that in a £300 model, where you get some online webinar options and maybe can chat with someone in a chatroom function?

Claire Nevinson

Obesity is a complex condition. People living with obesity, as you say, have typically lots of other challenges that they are living with. Our job is to give them easy access to the support and to educate them through the journey, to provide them with access seven days a week to a clinician for whatever question they might have, to encourage them to come in to community pharmacy to talk to a healthcare professional when they need to. You cannot force people to do this, but you can encourage them to. The benefit of the GLP-1 treatments is that they experience weight loss successfully, more so than they might have done with everything else that they have tried before. What we found with our patients is that gives them confidence, gives them hope and they are more likely to feel engaged because they are seeing the benefits. I cannot comment on prices of different services, but certainly that is our approach—to really stress the importance of lifestyle and engaging in the support that we provide.

Danny Beales

I think Juniper also mentioned that people are twice as likely to achieve weight loss in the model, to your point, Claire. What evidence do you have about the long-term and sustained impacts of your approaches around weight loss? I guess this is one of the common questions about these interventions with GLP-1. Are you seeing a year, two-year, three-year data at this point? What does that show compared with traditional prescribing models?

Dr Doyle

In this entire industry, that is something that we are all very keen to learn more about, whether that be from an academic point of view, clinical or society. I do not have the data right now, but it is something we are conducting at the moment as a research piece. I am not sure if we will have preliminary results by the time this Committee needs it, but if we do, we can send anything.

Chair

We would be interested at any time you get them, even if it is after we have published, yes.

Dr Doyle

Okay, perfect.

Danny Beales

The study and data collection is under way. Do you have any sense—

Dr Doyle

Preliminary results? I don’t have anything that I am able to share at the moment, unfortunately.

Danny Beales

I guess this is the billion-dollar question. With a low-touch model where you can get people access quicker, you might see weight loss quicker, but can a light-touch model keep it off longer?

Dr Doyle

This is a really important question and we really need to have the answer for it. The way I frame this when I have conversations with patients is if you were to do a very good diet with no other changes for six months and then stop that diet, absolutely your weight would regain. I think it is important to note that GLP-1s are not a silver bullet. They are a big piece of the puzzle here, but I do firmly believe that if we are using patients’ positive experience of weight loss to instil behaviour change as well, then my hypothesis is that that is going to have a positive impact in the long term.

Danny Beales

Are you collecting any data that indicates that you are achieving behaviour change in terms of diet and exercise?

Dr Doyle

We have lots of anecdotal stories, and I am sure the other organisations do as well. I can collate some, if it is helpful.

Danny Beales

Have any of you had data based on what your patients are sharing with you around that behaviour change point? I think that would be very interesting for the Committee to see.

Dr Doyle

Would you accept qualitative data?

Chair

Yes.

Dr Doyle

Yes, we can collate some. We have a moderated peer support group, where patients are very keen to share their stories of things that they were unable to do previously but are now able to because of lifestyle changes that they have made, so we can collate some stories for you.

Danny Beales

Thank you. I am conscious of time, so I want to touch a bit more on the data-sharing issues, which you have already touched on to some degree, and access to patient records. Can you briefly talk generally about what patient data you have access to now? Is it variable place to place, GP to GP, patient to patient?

Dr Seyan

It will vary from provider to provider. Independent providers—this is very general—will not have access to the GP record so you are taking a history from the patient and making a clinical assessment as you would do in normal general practice, but you would not have the access to summary care records from that because that is prohibited, as Simon mentioned. It is a risk, and I am sure you are aware of that. It is a risk that has existed within the system for quite some time. For example, you can get a GP referral internally within an insurance company to a consultant but not have access to the GP record there and, as Simon mentioned before, a private GP. It is a known risk, and I think it is becoming more prominent because of the demand.

Danny Beales

So none of you at the moment in any locations would have access to any—

Dr Doyle

Some CoRDH members do have access to the summary care record. There is only a small number of private providers who are granted that through a pilot programme.

Danny Beales

In terms of risk around that and trust in the data you are given by the patient, do you hold that risk? Are you responsible for that risk?

Dr Doyle

Ultimately, yes, if we are providing the care, but that is why we have multilayered processes to verify the information that we receive. If patients meet eligibility based on an associated condition that they are telling us about, then all our member organisations will request proof of that. We are very keen not to increase NHS GP work, so that may include patients uploading their own NHS information, for example, from the NHS app or from their repeat prescriptions, and then one of our UK-registered clinicians will verify that manually through the photographs and cross-reference with the patients.

Dr Seyan

It goes the other way as well—that we should be informing the GP of any medication that we have prescribed as we would do in a private consultant consultation.

Danny Beales

Is it standard practice that GPs would be kept informed?

Dr Doyle

We operate on a consent-based model across the group. Different organisations may interpret that differently, so some organisations automatically inform general practitioners; however, some operate on patient consent. Again, that is similar to how an NHS sexual health service might prescribe very high-risk drugs needing monitoring but the NHS GP may have no idea because of the patient’s consent. It is an inherent risk. It is not unique to digital or private providers but it is something that we have processes in place to mitigate.

Chair

You mentioned a pilot programme. I do not think we are aware of this pilot programme. Would you send us some details about it?

Dr Doyle

You mean the summary care record?

Chair

Yes.

Dr Doyle

Absolutely we can send you the information.

Chair

That would be very helpful. I do not think we have that.

Danny Beales

That is helpful. Are you aware of any instances where the incomplete records or medical records have created any issues around prescribing or complications, or any challenges for any of your patients? Has that been an issue?

Dr Doyle

I cannot think of specific examples or talk to specific examples. However, across all healthcare settings we operate in risk. That is why healthcare professionals exist—to be able to help patients navigate the risk and benefits and make choices that are correct for them. To reiterate the point, that is why we are really strong on multilayered processes of making sure that we have the right patient, making sure that we are happy that their BMI lines up with what they have told us, and making sure that we have as much information as possible to reduce that risk.

Danny Beales

I understood from your earlier discussion that you are keen to get wider access, having the single patient record access in future. Is your general position that that would be helpful?

Dr Doyle

As a GP I would always welcome more information. The more information the better and it would certainly reduce friction for the patient. Ultimately, we are asking patients to do that work for us in the meantime to provide that proof because we will not prescribe without the satisfaction that the patients meet the criteria.

Danny Beales

A couple of you have leant upon sexual health services as an example. One of the common complaints in sexual health services is that there is inappropriate testing by private providers that would not be recommended and increased referrals to the NHS through inappropriate tests that are conducted. These could be genetic tests and other things that are not clinically indicated that the private sector often do or tests that are not recommended. Secondly, the private sector also cherry picks the easiest patients—the most educated, I think you talked about—for profit, and the more complex patients, or if there are complications, are then referred back into the NHS system. Do you recognise any of those concerns or questions in this space if the model develops further?

Dr Doyle

I understand where the concern comes from and it is probably myself who has leant on the sexual health analogy because I used to work in sexual health so I am just very familiar with it. In terms of the question around whether things are indicated, all our organisations do things that are in a patient’s best interest so, as I mentioned earlier, the tests that we may offer to patients would be clinically reasonable to do. That is where I would stand on that point.

Danny Beales

Do you have any data around the number of patients you will refer back to the NHS or their GP about matters that you have looked into and tested for? If someone was struggling with their mental health, do you refer them back? I am not saying you should not do that, but do you have any sense of the number? I think someone said you were supporting a quarter of a million people on GLP-1s. What level of additional referrals come from the patients you are seeing?

Dr Doyle

I do not have that data, but as a group I can go back to the other organisations and see if we can aggregate some numbers for you.

Danny Beales

That would be helpful. Thank you very much.

Chair

Thank you all for coming. I am now going to talk about the people who probably would never have come had we even asked them and these are the unregulated prescribers and people who are doing inappropriate prescribing. There is huge public concern about this. I have taken a particular interest in it and have met families who have quite literally lost loved ones to receiving illegal jabs. We have had disturbing evidence from organisations such as PrescQIPP CIC that talk about people who have a history of anorexia being prescribed jabs to obtain the bikini body. They have also raised concerns about post pregnancy, especially with mothers who are still breastfeeding—obviously counter-indicated by any of the licence but nevertheless they are getting them. What more needs to be done to ensure that organisations that are prescribing to the licence are not inadvertently tainted by those who are not? Can I urge you to not hold back? You are covered by privilege as we are in these sessions. Earlier you declined to talk about some people who you might be aware are doing this. Please do not hold back. Privilege means that you can speak freely because if we do not get to the bottom of this unregulated wild west market everyone is at risk, in some cases fatally so. I will start with Dr Kieran Seyan.

Dr Seyan

The challenge that the regulators face is that the scale of innovation for digital providers is so fast, and there is a lot of funding that is behind that as well and able to provide the models that we have been talking about. It is difficult for the regulators to keep up. We do have engagement with them. A similar coalition to what Simon mentioned before is DiCE, Digital Clinical Excellence, which is an industry forum with regular interaction with the regulators to inform them of what, dare I say, good providers feel is best practice. We should be working closely with them on what those guidelines are looking at. The challenge that they face is the speed to be able to look at all the unregulated providers that are out there. That could be from a GPhC perspective, a pharmacy perspective or from an MHRA perspective as well in getting the illicit drugs. My personal concern, which may not be shared across the group just yet, is we have just seen semaglutide, Wegovy, go off licence in places like India. This is going to be manufactured on a wide scale—not that it is a dodgy drug, but access to that illicit market may increase then as a result. Are we going to see more of this and are the regulators ready for this? We have seen it before. We saw it with PrEP. PrEP was not freely available in the UK and even healthcare practitioners were advising patients to get their medication from abroad. We have precedent there that it is going to happen—less likely so because it is cold chain, but that may be removed in the future so it makes it more difficult. I would say it is a regulator challenge without doubt and the resource there and the engagement—

Chair

I am looking for specific things that we need to recommend to Government to get ahead of this. Right now we are way behind and the number of families and people who are affected by this, young girls who are finding a way to get this—I will come to how they do that in a moment, but they are getting it illegally from abroad and some people have died. Give me three things that you want to see the Government do, whether it is more resource to the MHRA, which is one I heard. What are another two?

Dr Seyan

It is across all the regulators, I would say.

Chair

All of them?

Dr Seyan

The regulators keeping up to date with digital practice. We are going to see more and more, things such as artificial intelligence and so on, coming across the board and they are not keeping up to date with that as far as I am aware. Those are my top two, I would say.

Claire Nevinson

Something important that we can all do is cut through the misinformation and the noise on social media by providing better information for patients and educating the public to identify what is the right way to access weight loss medicines and what is not. We need to help the public to understand and identify where they are finding this information and to nip it in the bud through the regulator, but we need to be able to educate people better about obesity and safe weight loss. We all have in our organisations channels to be able to talk about these things responsibly, but we need the Government to bring this to the forefront.

Chair

What specifically do you want the Government to help to do?

Claire Nevinson

Better patient and public education on safe weight management services.

Chair

Is one of the issues here that the way we see obesity is almost like a beauty issue rather than a medical issue? Many of the people at the roundtables that we heard wanted us to—I think Kieran called it a chronic condition earlier, and one of the conversations we have been having is whether it should be called a condition or a disease. Would you all agree that it should be classified by Government as either a condition or a disease or either/or? What is your preference?

Dr Seyan

That would be my third thing.

Claire Nevinson

Stop talking about weight loss drugs and talk about obesity.

Chair

Obesity as a disease?

Claire Nevinson

As a disease or a chronic condition.

Chair

Do you prefer condition or disease? Which one do you prefer? Does it matter?

Claire Nevinson

It depends how the public will relate to it, I suppose, and understand it.

Dr Doyle

I think the patient voice is very important in that. We have probably fallen into that trap previously with things such as chronic kidney disease, and that causes problems for the patient in how they interpret their own condition. I think involvement from patients rather than just us as providers would be the important missing bit there.

Chair

How about you, Simon? What else needs to happen?

Dr Doyle

To build on those, I think avoid broadbrush strokes, so avoid tarring us all with the same brush. It is about working with responsible providers to build proportionate and effective evidence-based regulation so that we can do things correctly, which leads into Claire’s point around making sure that we are putting out proper and reasonable information so that patients have an alternative choice. If providers like ourselves are removed from that conversation in contemporary media, whether that be online or adverts, then that only leaves space for bad actors who will fill that gap and patients will still find a route to that. The recent report from Lilly UK and the Patients Association a few weeks ago showed that the no. 1 reason patients choose the black market is because of reduced access, so my concern would be that regulation falls on the wrong side of responsible and shuts down the opportunity to provide responsible information and access.

Chair

Let’s get to the AI point. One of the ways that we know people get through the various gateways is that they are able to manipulate digital images. It is much easier to manipulate a digital image—although I have yet to work out how to make myself look skinny in real life without some filter on everyone else—so this is the big issue that I think we are concerned about currently. How are we going to get ahead of this? In your own organisations you have given us evidence about what you do. Pharmacy2U spoke about sophisticated algorithms that gather the complete medical history and then scan. Can you give me just one example of how exactly those algorithms work?

Dr Seyan

Are you talking about verification or the clinical assessment?

Chair

Yes, to get it in the first place. Let’s focus on just that very first prescription. How does someone access it? What does that algorithm do exactly?

Dr Seyan

The structured clinical pathway is basically where the patient would be—if I was doing a history for a patient one answer would lead to the next question that I would have. Our algorithms work in a very similar way. The most important thing I think you touched on, which I feel very passionate about and have for years on this, is around the identification side of things. How do we know who we are treating? Robust identification verification is very important there. As far as the body mass index is concerned, we only do video verification, so real-time video verification where the patient must upload it live. There is no ability to manipulate it at all so we have not come across the issues that I know some other providers have had with AI manipulation.

Chair

Did you always do that?

Dr Seyan

Yes.

Chair

Yes, but Boots did not always do that. Was it Which? that looked at how people could access a consultation and it was an upload of a photo, so has that changed?

Claire Nevinson

Yes, it has. That technology allows us to introduce better safeguards. We have exactly the same, live photograph upload so it cannot be manipulated. We have also introduced—

Chair

Wait. Live photograph upload—what does that mean?

Claire Nevinson

You must take the photograph live and upload it into the system, just as Kieran has described, so you cannot take an image and modify it and then upload it. It must be done at the time, so it is real time.

Chair

It is done through your app or whatever so you can control it?

Claire Nevinson

We also have an additional safeguard. Certainly, for people accessing it for the first time they must go into a community pharmacy, and should a clinician from our online service have any queries or concerns about a patient’s BMI, then they will be asked to weigh them again in the pharmacy. We have introduced that as an additional safeguard.

Dr Doyle

Similarly, just to be really clear around the difference between video and live photo, all our organisations have also implemented live photos to reduce the chance for patients to be able to upload from their gallery or a photograph from two years ago or something that has been edited by AI. With all our organisations they must open the camera within the flow of the app or the website and take different photos there and then. That cannot be modified by AI. What we have found is that it is different to having a live video with somebody Facetiming, for example. However, we find that to be safe because it reduces or eliminates the chance of AI. That is the type of thing we want to work on with the regulator so that they understand the nuance of digital health and introduce proportionate and appropriate regulation.

Josh Fenton-Glynn

Your coalition represents what you are referring to as the responsible pharmacists, which I assume means that they follow both the letter and the spirit of the various regulators’ guidance. Is that right?

Dr Doyle

Correct, yes.

Josh Fenton-Glynn

I was a bit confused because the Advertising Standards Authority does not allow direct to customer advertisement of prescription medication; is that correct?

Dr Doyle

Of prescription medications, yes.

Josh Fenton-Glynn

When I google weight loss drugs, one of the sponsored results is the pharmacy Numan, which is one of your coalition, and it advertises on the basis of a discount for the initial few months that people do it. The headline, when you google, is, “Now £55, was £139. Lose weight from £55 a month.” Do you think that is following the spirit of the guidance?

Dr Doyle

I think the thing to be mindful of is all our providers are offering a service. We are not a transaction; we are not offering a medication and then no further follow-up. I think if there is any concern that any breaches have happened then we all have processes in place to redact any adverts that the ASA is concerned about. Again, we are very happy and want to work with the ASA to get that right.

Josh Fenton-Glynn

You would wait for the ASA to flag it rather than having concerns about what appears to be direct to customer advertisement when you google weight loss drugs?

Dr Doyle

In terms of advertising a service, I do not think there are any breaches in advertising a service. The concern is around advertising medications. I am not sure of the specifics of the advert you are referencing, but if there is any concern that that is advertising a specific prescription medication, then that should be redacted. However, if it is advertising a service, this is the type of thing where we want to work with the ASA to make sure patients are informed of reliable providers who are regulated rather than being pushed down alternative routes.

Chair

Kieran, your written evidence suggested that we need stronger action to prevent unregulated operators. We talked about the top three, but should we not be taking a much more cautious approach to this, where someone must prove that they are doing things properly otherwise they are not allowed to sell these drugs? That would make it so much easier for social media companies and the advertisers to know who to allow to advertise and who to allow to sell it. What we seem to have is a market that is rapidly innovating and we do not even know the size of the unregulated market, but by the sounds of it from the number of whistleblowers and stories that we are getting it is potentially huge. I do not know if you guys have done any work about this because it is a direct issue, I would imagine, for your companies and we would love to hear about it if you have. Should we not just be taking an ultra-cautious approach until we have reached a stage where we know what it is that we are doing and we can properly safeguard people?

Dr Seyan

Could you clarify ultra-cautious for me? What do you mean?

Chair

I am looking to you guys. At the moment the default position for a consumer is that anyone who can sell this is doing it in a way that is right. If you had far fewer people doing it but with a much stronger kitemark endorsed in a way by Government, then they would be able to sort the wheat from the chaff. At the moment there is so much noise out there and there is so little access that they are getting it from anywhere and just assuming that it is a medicine and is therefore regulated and that is the end of it. There is a lot of onus—I think Claire mentioned this—about education on the public. I wonder if that is fair at the moment because there is so much that is new that they are going to the first place that seems to be doing it well. What would you say to that?

Dr Seyan

In principle I would agree. I go back to what Simon mentioned. It is not a broadbrush approach. Actually it is about working with Government or the regulators on what a good service looks like—what is best practice, basically, within the digital healthcare field, because we are the experts. Reputable providers have been doing this for a number of years, so we should be working together to see what that looks like. Unless you meet these certain criteria, then you should not be practising. Absolutely I would agree with that. That is a challenge and we do not—

Chair

What about it is challenging?

Dr Seyan

The acceptance of innovation. Where we worked with regulators in the past, because the advisers are not necessarily very well informed about the work that digital healthcare providers do, they can go more conservatively, whereas, as I mentioned, we have been practising for 20 years and we know what is safe. We have good risk analysis and robust clinical governance around it. As long as that clinical governance exists and we can advise the regulators on this, then I think the risk reduces.

Chair

So you think the regulators are too cautious and by being too cautious they are not allowing the innovation that would be safe to increase access, which itself is a thing that is going to make it all safer. Have I understood that correctly?

Dr Seyan

Yes.

Claire Nevinson

I think we have definitely moved some way in this space, particularly with the GPhC and the CQC, which regulate our services. The GPhC has issued standards for online pharmacies and for the provision of services such as the services we are talking about, so the rules are there and the standards are there. We have challenged them; we have co-created them; we have presented examples of good practice. We have done that as a collective through the Digital Clinical Excellence network, so I think the regulators are definitely learning and trying to keep up with the innovation. The challenge that they have, to your point, is that there is such a rapid rise in people setting up services and the regulators require resource and capacity to catch up with them. What we do regularly is meet with the regulators as a group and we will tell them where we are seeing or picking up poor practice, or it has been reported or we have noticed it, and we do flag it to them.

Chair

Do you know how many companies you have reported?

Claire Nevinson

Not off the top of my head.

Chair

Can you get us that number?

Claire Nevinson

We can have a look at that for you.

Chair

And write to us about who they are. Could you do that and could your coalition do that, too?

Dr Doyle

Yes, I can speak to the coalition.

Chair

That would be very helpful.

Claire Nevinson

It is about helping the regulator to understand what good practice is and isn’t, and being really clear and helping them on this journey of understanding how technology is evolving and how we need to use it but, as you say, taking quick action when we have a concern.

Dr Seyan

I think it is about quick action. I agree with that.

Chair

Quick action and I am hearing resource as well. Okay. We must end there because we have to speak to the regulators, so thank you very much. Examination of witnesses

Witnesses

Andy Morling, Neha Ramaiya and John Spoors.

Chair

Welcome to the hearing. Thank you also for being in the room and I think hearing most of the first panel. Can we start with who you are and your organisation?

John Spoors

Good morning. I am John Spoors, the programme director for commercial, managed access and medicines policy at NICE. It is lovely to be here.

Chair

It is lovely to meet you.

Neha Ramaiya

I am Neha Ramaiya, lead clinical adviser at the GPhC.

Andy Morling

Good morning. I am Andy Morling, head of the criminal enforcement unit at the Medicines and Healthcare products Regulatory Agency. It is good to see you all.

Dr Beccy Cooper

Thanks, panel, for being here. I am going to focus on questions around side effects and NICE appraisal. I will start with Andy and the MHRA. GLP-1s as we know have a long-standing history. They have been used for more than a decade to treat type 2 diabetes so we are well aware of their profile in that regard. In terms of side effects that we are seeing for GLP-1s being used specifically for weight loss, is the side effect profile similar to the side effect profile you have seen for type 2 diabetes or different, and if different how so?

Andy Morling

My understanding is it is similar, primarily gastrointestinal—vomiting, diarrhoea, constipation and those kinds of things—generally not severe, although that can be the case in rare cases. Broadly it is the same side effects—in most cases not severe but in exceptional cases there can be severe diarrhoea and gastrointestinal issues. But that is very rare, I am pleased to say.

Dr Beccy Cooper

Okay, so just to be clear, you are not seeing any difference in the side effect profile from a type 2 diabetes patient using GLP-1s to a non-type 2 diabetes person using it for weight loss? The side effect profile is reasonably similar?

Andy Morling

That is correct.

Dr Beccy Cooper

Given that GLP-1 products have not been used as weight loss tools for nearly as long as they have been used for diabetes type 2, are you concerned about an increase in side effects being reported as GLP-1s are used more frequently for weight loss?

Andy Morling

We have had many reports and those are, one would imagine, to some extent related to the publicity surrounding GLP-1s for weight loss. We tend to find that when new medicines come on to the market or for new indications reports into us of adverse effects go up.

Dr Beccy Cooper

Just to be clear there, you are not seeing more side effect reporting for the new use of this established medicine than you would expect? Is it within expected parameters?

Andy Morling

Yes. There is no normal, sadly. I wish I could give you a bit more—

Dr Beccy Cooper

You have data across a wide variety of medicines so you can see the parameters of what you may expect.

Andy Morling

We do, but to some extent this is a self-selecting audience of reportees. It does not necessarily indicate prevalence, but we have had a high number, as I said possibly because of the fact that this is widely known and now widely used. It is hard to get causality from this data.

Dr Beccy Cooper

I appreciate that and I appreciate the prevalence issue. While you cannot take an accurate indicator of prevalence from reporting, again given the extensive licensing that MHRA has done over the years, is the reporting that you are seeing, taking into account the self-reporting nature of it and the private prescribing of this medicine, broadly what you would expect to see in terms of the side effect profile and reporting?

Andy Morling

It is not outside of the parameters.

Dr Beccy Cooper

Okay. That is helpful. Let’s talk about how you are getting this information. As we have talked about, there is currently large private use of GLP-1s and we have the yellow card system to monitor side effects. Is the private use of GLP-1s having any effect on the return on yellow cards or are you seeing other ways of it being reported in?

Andy Morling

We certainly encourage yellow card reporting regardless of the prescribing route. We do not regulate the prescribers, as you are well aware. We would certainly encourage that reporting and we do go out looking for it. We do encourage private prescribers.

Dr Beccy Cooper

When you say you go out looking for it, what do you do?

Andy Morling

We speak to the trade bodies to make sure that they are aware of yellow cards. We promote yellow card more broadly within the professions, so we encourage reporting where we can to the yellow card and we have seen that. I do not have figures as to the level, but certainly we do have—

Dr Beccy Cooper

It would be interesting to see those figures.

Andy Morling

I will see if we can get those.

Dr Beccy Cooper

The yellow card reporting has been around for a long time and there have been conversations about whether it is fit for purpose or they need to use something else. Your opinion is yellow card reporting is still the best way of assessing side effects coming forward or adverse impact?

Andy Morling

I think I would probably say the least worst.

Dr Beccy Cooper

We have heard that before.

Andy Morling

It is what it is and I hate that expression normally but it gives us access to information. How reliable that information is, what conclusions can be drawn from it, is another matter but I would certainly rather it was there than not.

Dr Beccy Cooper

That is interesting. We will not go down this rabbit hole too much, but over the years have you found the yellow card reporting system by and large with your licensing of different medications a reasonably reliable indicator of when there are issues that need to be acted upon?

Andy Morling

Yes, it has certainly given us signals that we have acted upon in the past.

Dr Beccy Cooper

Neha, do you have any reflections on that from a pharmacy point of view, in terms of the monitoring of side effects and how you are able to report it?

Neha Ramaiya

Are you asking in relation to the yellow card?

Dr Beccy Cooper

Yes.

Neha Ramaiya

In relation to the yellow card system, as my colleague mentioned we have had conversations with the MHRA about it quite recently as well; not related to weight loss but more broadly we have included it in our emerging concerns letter, which was sent out in December to encourage pharmacy professionals to report any side effects that they see. The last point in relation to yellow card that I had was in our updated guidance for online pharmacies we mentioned yellow card reporting within that, particularly because quite a few of the weight management medicines—and correct me if I am wrong—are black triangle medicines, so they are newer to the market. With the extensive monitoring that is required we felt that it was important to bring that yellow card reporting aspect to the guidance as well.

Dr Beccy Cooper

That is very interesting. In terms of online pharmacies are you seeing a proportionate reporting to the in-person pharmacies or are you seeing lesser reporting?

Neha Ramaiya

That is not data that we have direct access to.

Dr Beccy Cooper

Okay. Does somebody have access to that data?

Neha Ramaiya

I am presuming the MHRA.

Andy Morling

I am afraid I don’t know but I can certainly find out.

Dr Beccy Cooper

If you can find out that would be very interesting. Online pharmacies are becoming more prevalent and people are increasingly using them, so it is good to know if our reporting systems are fit for purpose in the digital world. Thank you. I will move on, John, to NICE appraisals of these weight loss drugs, which are quite interesting in terms of what the understanding is now with NHS provision. For the record, you have basically made a positive recommendation for the use of this medicine now. Just for the record, could you explain very quickly how you have come to make that positive recommendation for GLP-1s?

John Spoors

Yes, sure. I am very happy to do that. We have evaluated three GLP-1s, liraglutide, semaglutide and tirzepatide, which you are referring to. As I am sure the Committee members are aware, NICE uses the QALY, which is the standard health measure that is utilitarian in the way that it resonates with the NHS. So a QALY is a QALY whether it is cancer, whether it is multiple sclerosis or—

Dr Beccy Cooper

Sorry, just to go back, because the public are watching, John, can you explain quickly what a QALY is?

John Spoors

Yes, sure. A quality-adjusted life year, apologies. Then what NICE does is it takes the evidence from the manufacturer on the clinical and cost effectiveness, and then independent and transparent committees assess that evidence with an academic critique of the manufacturer’s submission. We weigh up the health benefits versus what the costs are and the additional costs. I think today we have heard of the importance around the wraparound care that is all included within the appraisal. We also look at things such as the ability for weight gain to come back on post the stopping of the treatment. That is all included in the cost-effectiveness assessment. Then at NICE we have a standard threshold. We say if it is between £20,000 and £30,000 per quality-adjusted life year, that is a cost-effective use of resources. For all three medications we have been able to recommend those for use—

Dr Beccy Cooper

What do they come in at for the QALY?

John Spoors

For the cost per QALY, when the independent committee looks at the evidence it takes a number of things into account. For the weight medications, it looked at the uncertainty of the evidence base. It also looked at the scale of the budget impact. Depending on what that looks like, the committee can go to the top end or the bottom end. To directly answer your question, all three appraisals were at the bottom end of the £20,000 per QALY.

Dr Beccy Cooper

That is very interesting. Again for the record, basically once NICE makes a positive recommendation, NHS service providers are required to make it available to patients within three months as a default, but there is an exception to that. Based on your recommendation, NHS England estimated that 2.8 million patients would become eligible to use Mounjaro within 90 days of the final draft guidance being published. If all these people presented for treatment in the first year it became available, the cost of providing this medicine and wraparound services, as you have indicated, would be £15.2 billion over five years. Going back to your appraisal, John, how much did you take into consideration that particular price tag?

John Spoors

I think particularly at NICE when we create our guidance we are very cognisant of the impact that it has on the NHS. In fact, that is why we have a world-leading process. We involve stakeholders throughout, whether it is patients, clinical experts and indeed NHS commissioners.

Dr Beccy Cooper

So what did your world-leading process think about £15.2 billion over five years?

John Spoors

This is why we worked with NHS England and it requested what is called a funding variation. That has been used very exceptionally in our 25-year history. It has only been used four times and we have published over 1,000 pieces of guidance. For the scale of what you said there, the reason that a funding variation was put in place was to ensure that the NHS had a sustainable and manageable plan to not only manage the cost but also the impact on services. As you are aware, tirzepatide can be used in primary care, while liraglutide and semaglutide were limited to specialist weight management services.

Dr Beccy Cooper

Sorry, John, we are time pressured. You came to an understanding with NHS England, which you have only done four times previously, that all the eligible population will be able to be prescribed Mounjaro for obesity within 12 years.

John Spoors

Yes, and then crucially I think what was important with that is we included a three-year review period, so the funding variation had three parts to that. It had an 18-month period and then up to three years, and I think that three-year period is important because what NHS England was saying is it was looking to prioritise the patients with the highest clinical need. I think it was looking to achieve 220,000 patients on treatment at that point, so that was what was agreed.

Dr Beccy Cooper

I understand that, but over the course of 12 years the highest priority people, who may not be high priority now—I am surmising this—may well become much higher priority in those 12 years. At that three-year review period if we have been reasonably unable to spend £15.2 billion over five years, has NICE factored in the fact that, given we have not been able to address the issues immediately, the price tag may be considerably higher?

John Spoors

I think at that three-year review period there will be data available on the various models that NHS England is trying. There will be data available on the uptake of patients and indeed the costs, and all these things will be factored into that three-year review period. The other thing to mention within that three-year review period is, of course, the market in obesity is not static. We are expecting oral GLP-1s to come and we are starting to appraise those at NICE as well. I think there are various factors moving that will be considered at that three-year review period.

Dr Beccy Cooper

Excellent. I know that you do appraisals on all sorts of things, including other weight management programmes and prevention programmes. With that £15.2 billion, has there been any comparison at NICE to the opportunity cost for investing in other effective weight management programmes or prevention programmes?

John Spoors

Is obesity unique in terms of the size and the scale? Absolutely, but NICE has a remit to evaluate all new medicines and new indications that come before it. I think it is a broader question and this is probably one where obesity does straddle the two between public health and treatment. Of course, in our NICE clinical guidelines and our quality statements we take a broader view, but I do not think that within the NICE technology appraisal it is our job to suggest whether that £15.2 billion should be spent elsewhere.

Dr Beccy Cooper

No, I appreciate it is not your job to have an opinion on that, but in terms of an appraisal looking at the opportunity cost, so how much bang for your buck you get in other areas of obesity treatment—other weight management programmes and/or prevention—is that something that NICE has looked at?

John Spoors

For sure. What the NICE appraisal committee says when it reviews it, and it does take into account opportunity cost, is that with the evidence provided in front of it for the drugs, taking into account things such as weight regain, the NHS and NICE think it is a clinical and cost-effective use of NHS resources, taking into account opportunity costs as well.

Dr Beccy Cooper

So taking into account all the other things that could be put in place to prevent or reduce obesity, NICE still thinks that the £15.2 billion should be spent specifically in this area, or the opportunity cost is taken into account?

John Spoors

When NICE does appraisals it is not just the opportunity cost within obesity. We look at the opportunity cost in the whole of the NHS and that is why we have the cost-effectiveness threshold set at £20,000 to £30,000.

Dr Beccy Cooper

The cost-effectiveness appraisals that you have been talking about have taken into account the benefits—well, you have taken into account weight regain and you have looked at that. Have you looked at individuals with more severe or more complex obesity and looked at the fact that the cost effectiveness may be better for those higher-end obesity cases? I think you have alluded to this in your priority case, but it is just to be clear for the record.

John Spoors

Yes. When NICE evaluates a product, you have the licence from my colleagues helpfully at the MHRA and then they look at various subgroups within the cost-effectiveness assessment. In our appraisal, again to give tirzepatide as an example, those with a lower BMI were not cost effective, which is why our recommendation is for 35 and above plus one comorbidity, so that is built into the assessment. The other thing I would say is that if you look at NHS England’s implementation plan, again the cohorts that it utilises prioritises those with the highest clinical need.

Dr Beccy Cooper

Okay. My final question is around service provision, so perhaps coming to Neha. John has alluded to the potentially overwhelming nature of this around service provision. I appreciate you are pharmacy specifically, but does your particular area have thoughts on whether pharmacies, and primary care if you want to speak about it, will be able to provide this level of input for the number of obesity patients coming forward?

Neha Ramaiya

It is difficult to say because as a regulator from a pharmacy perspective the provision of medicine is coming from private sources mainly, so it does not apply to NICE and NICE’s TA. It is difficult to say whether that would be the case.

Dr Beccy Cooper

Given the opening up—the 220,000 patients—it looks like the NHS is saying, “Okay, we will move forward on a cost basis as an agreement with NICE.” Do you think pharmacy providers will be able to undertake some of that?

Neha Ramaiya

It depends. Pharmacy provision is in two formats. There are the private ones, which we have heard from earlier today, but there is also NHS provision, so it is dependent on how much commissioning goes towards the NHS pharmacies and whether they can afford to provide those services, and whether they have the right staffing capacity and training to deliver that is dependent on the funding model that supports that.

Dr Beccy Cooper

Is that funding model clear yet?

Neha Ramaiya

At present I am not sure if that is clear.

Dr Beccy Cooper

Okay. That is very helpful. Thank you.

Danny Beales

India is now rolling out generic Ozempic. What assessment have you made or do you have any general sense of what the availability of generics might mean for that QALY assessment and the £15.2 billion price tag and when that may be applicable?

John Spoors

I am happy to report that I contribute to a biosimilar taskforce, which works across the Department of Health, the MHRA, NHS England and NICE. When the patent expires the prices start to drop, so I think what is really important is that NICE’s guidance is a snapshot at the front end of appraisal, but when a biosimilar becomes available or a generic becomes available, or indeed new clinical evidence for a product—

Danny Beales

Do you get a sense of when biosimilars may be available?

John Spoors

I do not have that data to hand but I would be able to get that for you.

Chair

Could you write to us?

John Spoors

Of course. We would be delighted to.

Danny Beales

Could you give a sense of what that might mean for that £15.2 billion?

John Spoors

Yes. I think there are two elements to that. I think the availability of a biosimilar can produce potential cost savings, but then at the same time, as I mentioned, there are new oral drugs coming on to the market that might offset that. I think liraglutide is coming off patent. The other thing to mention there is that liraglutide is a once daily injection versus semaglutide once weekly, and patient preferences come into account as well. While the potential is there for savings, again there are things that might mitigate that.

Jen Craft

John, if I could turn now to wraparound care and NICE guidance on that, during our inquiry we have heard about the importance of wraparound care from those with lived experience and from myriad professionals. Do you have any insights you can share about where and the extent to which the standards are being met for quality statement 6 for obesity treatment?

John Spoors

NICE does not collect individual patient-level data, but when we put these quality statements out, both in terms of our quality statements and our clinical guidance, we regularly expect the NHS to take those into account when making decisions, but we do not formulaically collect individual data in terms of how that is being adhered to. The one thing I would say is that the wraparound care, as you have heard today, is very important. That is why that is prominent in all our guidance, in all our quality statements, in all our clinical guidelines, in terms of pharmacotherapy being one potential option and the importance of the wraparound care to the holistic patient journey.

Jen Craft

If you do not collect the data on it, where does responsibility lie for monitoring the quality of that wraparound care?

John Spoors

I am happy to take that back to NICE and write to the Committee in terms of what the actual uptake of that data is and adherence to that, if that is okay.

Jen Craft

That would be helpful. Is there more that regulators could do in this space, and what would be needed from the Government to support that?

John Spoors

That is a great question. I would be interested in my colleagues’ views. NICE’s view is that the holistic patient journey is extremely important. What resonated in the last session was the importance of education. NICE is an evidence-based body, and I hope that comes across in our written submissions and what I am talking to you about this morning. Education, and what the evidence shows us, is really important. I was struck by some of the comments made in the first session, and I think support from the Government in terms of what the evidence shows and how we can get that education to potential patients in the NHS is going to be important.