Branded Health Service Medicines (Costs) Regulations 2018

Lord Turnberg Excerpts

Wednesday 20th June 2018 Lords Chamber

[Lord Borwick (Con)]

My Lords, I declare an interest in this debate, as I am a patron of both the British Thyroid Foundation and the Thyroid Trust. I have heard it said that, somewhere in the Lords, there is always an expert on any subject raised; all I can claim is personal experience. I have suffered from Graves’ disease, which results in an overactive thyroid gland. Once it has had one episode, the thyroid can have an increased incidence of repeated episodes, and I had three in increasing frequency. The cure used often in the UK is to surgically remove the thyroid completely. Suddenly, the patient moves from too much hormone to none at all.

The thyroid, which is a small butterfly-shaped gland in the front of the neck, produces two hormones—levothyroxine and liothyronine—known as T4 and T3. As the noble Lord says, it is much easier to use those words. As T4 is a base stage, T4 makes T3 and the vast majority of patients, perhaps 80% and including me, can convert T4, the inactive hormone, into T3, the active one. Some cannot do so or can only do so inefficiently. The level of research is so low that, alas, we do not know for sure why this is. It may well be a faulty gene.

The trouble with thyroid patients is that their experience of the disease is so varied and the effect on their bodies is sometimes so profound, that they can be “hard to treat”. This is a marvellous medical euphemism that carries a wide range of patients with it, from ones who feel well when they are actually quite close to death, like me, to those whose low thyroid level makes them apathetic, befuddled and exhausted. The latter are the most frequently occurring cases. The majority of them are female and they are often overweight, finding that diets tend not to work for them, however hard they try to lose weight. As the thyroid affects the speed of every single cell in the body, including the brain, a nasty aspect of the disease is known as “brain fog”. That is the inability to think anything through at all, let alone explain what is wrong with you. That aspect, coupled with hormone tests that can declare that everything is within normal limits when they are still wrong, makes some patients particularly “hard to treat”.

With a high level of thyroid activity, life may feel quite pleasant. Even Brexit seems to be simple. A high thyroid level has something in common with being mildly overserved, even tipsy, and yet I know someone who sadly died of this disease and, for a few, the symptoms can be dramatically unpleasant, even as severe as psychosis. With a low level of thyroid, everything can be too complex, too difficult, too depressing or gloriously clear but wrong. Endocrinologists are doctors with immense patience. Overall, any imbalance in thyroid hormones, which can occur rapidly or very slowly, from high to low or low to none, can trigger brain fog and a range of other debilitating and diverse symptoms.

This liothyronine problem affects a group of patients who may appear to have the right level of T4, but who cannot make sufficient quantities of T3 from it. T3 was made by a single supplier for a time, Concordia, a company that I have met and been impressed by. It deals with a wide variety of generic drugs to be supplied to the Department of Health. These drugs are subject to several layers of regulation, including on price and quality. Most important is consistency, as the thyroid patient is peculiarly sensitive to inconsistency. Consistency depends in part on modern methods of manufacture, and the problem that Concordia faced, it tells me, was a need to update the manufacturing equipment with a large capital investment for a small number of patients.

To put the problems into context, the Department of Health buys a vast number of generic drugs. Millions of different patients need thousands of different drugs, and it is amazing how few problems occur. This is because of the great work done by the unsung heroes of the department’s regulatory agencies. All this takes place without much political input, and probably is the better for that, but a price that goes up so much raises an eyebrow or two, particularly compared to a price that is so much lower abroad. Even if the price increases had been agreed with the department, as Concordia informs me they were, the solution is likely to involve negotiation between the manufacturer and the department. Competition is likely to play a part here, and I gather that there are now three manufacturers in the market to provide T3 for UK use and prices are falling.

The bottom line is that, where there is a portfolio of generic drugs, used by different patients for different syndromes, the marginal price of any one drug in any one quantity is somewhat arbitrary. Should it be a loss leader or priced as the star of the portfolio? It is clear to me that the pricing, like thyroid disease, only becomes noticeable when it varies quickly or goes out of control. What caused a problem was misinterpretation of health department advice into suddenly not prescribing T3 to patients who had been happily taking it for years. I am not sure that a referral to the Competition and Markets Authority did anything other than raise the stakes, when negotiation is surely the best way to deal with the problem.

While liothyronine is available at a lower cost from European suppliers, there have been calls for the NHS to source directly from overseas. This initially may seem appropriate, given that patients are currently being told to purchase directly from these overseas suppliers themselves, with a private prescription from their NHS GPs, who tell them that their practice or CCG will not pay.

The Thyroid Trust has given permission to me to share the alarming case of Maureen Elliott in South Thanet. Maureen was well for 10 years on liothyronine and agreed to stop taking it when her doctor flagged up the high cost to the NHS. Subsequently becoming very unwell without it, she was referred to an NHS endocrinologist, who confirmed that she should have it, yet the instruction she was given was to buy it herself from abroad. With prices from different suppliers varying wildly, from more than £600 to £50 a packet, and inconsistent quality, she has found the whole experience extremely stressful as well as expensive. Why should she and others have to do this as individuals, when the Department of Health could be doing it, presumably with the capacity to drive a better bargain?

However, if the quality control requirements of the UK’s Medicines and Healthcare products Regulatory Agency have triggered prices here to be higher than elsewhere, is the liothyronine from manufacturers that do not hold a UK marketing authorisation of questionable quality? Given the negative effect on patients such as Maureen, perhaps the Minister can help to stress to doctors that T3 has not been banned, that he agrees that some patients need it, that although it is expensive it is valuable to certain patients and that doctors should not restrict access for existing patients prior to clinical assessment by a specialist.

[Lord Turnberg (Lab)]

I want to restrict my observations to the case of the treatment of hypothyroidism, and elaborate just a little on the wise words of my noble friend Lord Hunt of Kings Heath.

We have here an unhappy coincidence of bureaucratic errors on the one hand and what can be described only as corporate greed on the other. The end result is that patients with hypothyroidism are suffering. I suppose that I should just say a little about this condition, in which these patients fail to produce enough of their own thyroid hormone, for one reason or another. Although I am no longer on the medical register, I do not feel too constrained: it causes a range of unpleasant symptoms and can be life threatening. It causes symptoms, some of which may sound familiar to your Lordships, including extreme tiredness and a general slowing down, which makes you gain weight, thickens your skin and makes you lose hair. It comes on insidiously, so that it can sometimes be difficult to diagnose. It is worth noting, as I think my noble friend said, that up to 5% of the population, or one in 20, are said to suffer from hypothyroidism—and, worst of all, it can cause heart attacks, if not treated.

Yet treatment is very easy indeed—just one tablet a day of the hormone thyroxine gets rid of all the symptoms and can make people normal again, which works for the vast majority. But here is the rub: a few patients do not feel better, and they need to take the more active metabolite of thyroxine, liothyronine, or T3, to make them well. There is some controversy over why some patients need that more expensive treatment. Do they have a problem with converting thyroxine to the active principle or not? That has not been resolved scientifically, but there is little doubt that, clinically, some patients get better only on the active metabolite, T3. That being so, clinicians should be able to prescribe it. Certainly, that is the case in many countries around the world.

Prescribing T3 here in the UK was never a problem until 2007, when the Canadian manufacturer, Concordia, got hold of it and was given the sole contract by the NHS to produce it. It was then that, as a monopoly supplier, it put the price up several-thousandfold, as we have heard, so that now the price has risen to over £900 for 100 tablets. Then, of course, NHS England found it increasingly unaffordable. So instead of trying to find cheaper suppliers, it put in draconian conditions on doctors under which it may be prescribed. On top of that, those conditions are so ambiguous that CCGs, GPs and consultants are fearful of prescribing it, so they have stopped. As we have heard, patients who have been on it for years now cannot get it and suffer the consequences. So what do the patients do? They go online and buy it privately in Europe for around €30, instead of £900 for 100 pills.

I have three questions for the Minister. Will the Government try to move the Competition and Markets Authority along after its preliminary hearing that the manufacturers should repay the several million pounds that they owe to the NHS? Will they consider purchasing the medicine from an alternative supplier, possibly elsewhere in Europe, for a fraction of the cost? Will he press NHS England to produce some straightforward, unambiguous guidance for patients and doctors about how it can and should be prescribed? I would be happy to help, if he would like that.

[Lord Lucas (Con)]

My Lords, I ask my noble friend to turn his intelligence and attention to how the NHS can get best value in the purchase of out-of-patent medicines, branded and generic. I have had the pleasure of reading the 2014 pharmaceutical price regulation scheme. If any noble Lord is in need of tickling his belly button with his jaw, I suggest that he does the same. It is the most astonishing system, guaranteed to produce lush profits for manufacturers, giving the NHS almost no purchase whatever on the price being charged. It is done in the name of promoting innovation and promoting the UK industry, but there does not seem to be the level of intelligence—meaning not mental intelligence but investigation and the understanding— that would be necessary to make sure that that was the case.