Branded Health Service Medicines (Costs) Regulations 2018

Lord Hunt of Kings Heath Excerpts

Wednesday 20th June 2018 Lords Chamber

Moved by

[Lord Hunt of Kings Heath]

That this House regrets that the Branded Health Service Medicines (Costs) Regulations 2018 do not propose any action to be taken in respect of the high cost charged by Concordia and other companies for the drug Liothyronine for the treatment of hypothyroidism, thereby depriving patients of the use of that essential drug, and further do not put an end to the practice of a growing number of Clinical Commissioning Groups refusing to follow the latest guidance from NHS England on making that drug available to NHS patients via referral to thyroid specialists (SI 2018/345).

[Lord Hunt of Kings Heath (Lab)]

My Lords, ensuring that patients get quick access to the most effective drugs ought to be one of the essential aims of any Government in relation to the NHS, yet we know that NHS patients are at a serious disadvantage when compared to patients in, as an immediate example, Germany and France. This of course was a major subject in our debate on the Health Service Medical Supplies (Costs) Bill, from which these regulations emanate. While the eventual Act came about because of concern about certain companies abusing their position in relation to the prices of drugs, we also kept our focus on the overriding need to ensure that patients had access to effective medicines. This becomes ever more important at a time when clinical commissioning groups are being seen to ration services more and more widely. I want to bring to the House’s attention a clear example of clinical commissioning groups ignoring guidelines in relation to this area—an extremely common condition—with many patients suffering as a result.

The regulations before us permit the Secretary of State to control the costs of branded health service medicines for companies that do not belong to the voluntary 2014 Pharmaceutical Price Regulation Scheme, belovedly known as PPRS. The regulations set out details of the new scheme. They do not identify specific companies or branded medicines. No doubt the Minister will point out that they apply only to branded medicines, while the medicine that I am dealing with tonight is a generic medicine. It is a device to enable us to debate this important point. However, the fact that the Government brought the legislation to Parliament and are bringing the regulations here shows that they understand that there was a need to deal with abuse in the case of branded medicines. One of the questions I want to put the Minister is: what about generic medicines? How do we ensure effective early action when it becomes likely, or obvious in fact, that some companies are taking the NHS for a ride?

Liothyronine—or T3, as I will call it, because it is a lot easier to pronounce—is the subject of my Motion. As many as one in 20 people in the UK is affected by thyroid disease. The symptoms of an underactive thyroid, which is the most common condition, are serious and require daily medication. Most patients resolve their symptoms with the standard medication, levothyroxine, otherwise known as T4, but there is a subgroup of patients for whom T3 can be an effective option.

T3 was de-branded in 2007, at which point its cost started to increase. Normally, after de-branding, the cost comes down. By July 2017, the cost had increased by a massive 6,000%. The price per pack had risen from £4.46 to a massive £258 in 10 years. Whereas prices on continental Europe range from 2p to 26p, the NHS pays more than £9 per tablet—this is a tablet that needs to be taken daily.

Concordia was the only manufacturer with UK marketing authorisation until very recently. Throughout the price increases, I understand that there was no intervention by the Department of Health until it referred the matter to the Competition and Markets Authority in 2016. In November 2017, the authority provisionally found that Concordia had abused its dominant position to overcharge the NHS by millions for this essential thyroid drug.

A final decision is still awaited. My understanding—I should be grateful if the Minister could confirm this—is that no intervention will be taken by the Department of Health until the final decision is made. Pace our previous debate about why Governments sometimes hold up making decisions while inquiries are ongoing, that reflects some of the problems in Gosport, which we are now seeing in a totally different area.

The trouble with the delay is that patients are suffering. Because of the high cost, in 2017 NHS England ran a consultation under the title Items which should not Routinely be Prescribed in Primary Care: A Consultation on Guidance for CCGs. T3 was included in the list to be considered as an effective product subject to “excessive price inflation”. The issue was not the effectiveness of the drug; it was the fact that it was costing so much money.

There was a lot of consultation, including submissions by the British Thyroid Association and Thyroid UK that T3 should continue to be prescribed in primary care. However, NHS England’s recommendation was:

“The Joint Clinical Working Group therefore recommended the prescribing of liothyronine for any new patient should be initiated by a consultant endocrinologist in the NHS, and that de-prescribing in ‘all’ patients”—


in other words, patients who were already on T3—should not automatically occur,

“as there are recognised exceptions. The recommendation would therefore be changed to advise prescribers to de-prescribe in all appropriate patients”.

So the consultation led to a change in the guidance.

But you have to read the guidance very carefully to understand what it is saying, and it is clear that, to put it at its kindest, clinical commissioning groups have perhaps misunderstood what the guidance stated. That has led to many of them informing clinicians in both primary and secondary care to withdraw T3 from all patients, some of whom have been prescribed it for years, and not allowing them to initiate a prescription, or to offer to refer it to an endocrinologist, as the latest guidance states that they should.

This is causing many patients a great deal of distress. It is making them ill again and impacting on their social and mental welfare. As the Thyroid Trust has pointed out, that is compounded because many GPs are not following treatment guidelines to fine-tune the dose of the standard medication for these conditions or to refer patients to see a specialist if well-being cannot be restored in primary care.

Where T4 is not working, it is important that T3, in combination or in its own, can be prescribed. Some patients are appealing against the decision of their CCGs, but this is daunting for an individual patient to do. I have had one description today, who said: “Applying for T3 is like wading through treacle with your legs tied together”. What is particularly difficult for them is that the criteria for being an appropriate patient have not been listed. If you are appealing against a decision by a CCG, what chance do you have?

We know that at a meeting with NHS England fairly recently, it was admitted to patient groups—Thyroid UK and the Improve Thyroid Treatment Campaign—that what happened was not its intention; its intention was to reduce regional prescribing variations. Both organisations have asked for further guidance for CCGs whereby CCGs understand what they should be doing.

In a debate in the other place and in the noble Lord’s Answer to me, Ministers have said that the South Regional Medicines Optimisation Committee has been considering the issue further and that it will issue a statement in due course. Has this august body issued such a statement? You can find this organisation on the web. It is not very transparent. At its January meeting, the matter was discussed and the minutes of that meeting are on the web. The papers have not been made available. There was a further meeting in May when this matter was on the agenda, but the minutes have not been made available, so the latest we have is what happened in January.

The list of members who attended the January meeting is there, and it is noticeable that 21 professionals attended the meeting with one lay member. Yet the terms of reference of these committees is to look at the outcome of medications for the benefit of patients. It is clear to me that it is a rationing body. Let me take one example. We already have guidance, but the committee was most taken by the fact that a sub-part of the south- west had produced its own guidance. Why is a subgroup of the NHS producing its own guidance when guidance is nationally based?

Patients are left in a hopeless position. It is clear that T3 should be initiated by an endocrinologist, but not what happens afterwards. That is being left for CCGs to work out for themselves, often to the detriment of the patient. Some endocrinologists are saying that they cannot prescribe because the CCG has said no. Some are prescribing, but patients have to visit them for their prescriptions thereafter. Some are trying unsuccessfully to pass care on to GPs, but GPs are saying that they cannot take over care without CCG permission. It is a Catch-22 position.

Some clinicians are helping patients by giving them private prescriptions, but these are expensive. The Brighton and Sussex University Hospitals NHS Trust is informing patients that their only option is to obtain the drug privately. For an NHS body to advise patients as such goes against the whole ethos of the NHS. I must say that I am very surprised at the trust doing so.

I received details yesterday through Thyroid UK of a patient who is looking for a price to purchase T3 privately. She contacted Pharmacy2U and asked for a price for 56 T3 tablets. From four suppliers, only one could supply and that price was £774. That was for 56 tablets, one a day.

--- Later in debate ---

[Lord Hunt of Kings Heath]

My Lords, I am very grateful to the Minister and to other noble Lords who have taken part in this interesting debate. The noble Lord, Lord Borwick, really put his finger on it when he said that the key point is the misinterpretation of guidance. As my noble friend Lord Turnberg said, essentially, the system has gone the wrong way about this. Instead of trying to deal with the prices, guidance has been produced that is pretty restrictive and then CCGs have reinterpreted the guidance to make it even more restrictive. As the noble Baroness, Lady Jolly, said, the problem is that if you cannot drive down the cost of T3, the emphasis is almost bound to be on clinical restrictions, which are hard to start with and are then misinterpreted.

On the point raised by my noble friend Lady Wheeler, who asked a number of questions about the regulations before us, I just say to the Minister that I hope that the review, to be published in April 2019, could be shared with noble Lords in one way or another, because I think that there will be general interest in it. I am grateful to the Minister, because he said that the Government are committed to pursuing further with NHS England the way that the guidance has been interpreted. He has also promised me a progress report on the delightful workings of the south regional medicines optimisation committee, which I am sure all noble Lords will be very anxious to see. He has also invited us to send to him details of cases where there is clear evidence that the guidance is not being pursued. We will pursue that; it is all very helpful.

On the issue of pricing and competition, I very much take the Minister’s point about the unbranded generic market generally working well; I agree with him. Clearly there is an issue when it is not working well. One question I will put is whether the department should have intervened earlier; I think it might have done. Hopefully, in the future, it will be able to do so. On PPRS, the noble Lord, Lord Lucas, made a very interesting intervention—but, from my point of view, the PPRS agreement was a good one, as it basically stabilised the costs of branded drugs to the NHS because of the rebate scheme, which meant that, if the costs went above a certain limited level, the extra cost was paid back into the NHS. The problem is that it was not paid back to the NHS—it was paid to the Treasury, because it discounted in advance the likely rebate. The tragedy—and why this is very important in terms of future negotiations on PPRS—is that, if that rebate money had then been routed towards investing in new medicines, we would have had a win-win situation where, essentially, the pharmaceutical industry would have paid for its investment in new medicines. The noble Lord will know that one of the issues facing the branded pharma industry is that the NHS is a lousy customer when it comes to the uptake of new medicines. This is a separate issue, but one that is really important for the future.

Overall, I am very grateful to noble Lords who have taken part in this excellent debate. Considerable progress has been made and the commitments given by the Minister are very welcome indeed. I beg leave to withdraw the Motion.

Motion withdrawn.