Only a few days to go: We’re raising £25,000 to keep TheyWorkForYou running and make sure people across the UK can hold their elected representatives to account.Donate to our crowdfunder
I am grateful to have secured this Adjournment debate on a very specific issue that was originally raised with me by my constituent Liz Barron, who felt sufficiently strongly and sufficiently affected that she brought supporters from Walsall and Northampton to my Twickenham constituency. I then discovered that the health issue that concerns her affects some 50,000, and possibly 70,000, people across the country —an average of around 100 people per parliamentary constituency.
Those people suffer from a condition called hypothyroidism—an underactive thyroid—which leads to a variety of conditions, including chronic fatigue. There is a link to cardiac symptoms and diabetes, and in some cases to mental illness. For many of these people, the condition leads to the absence of a full life, and in some cases it leads to serious disability, leaving those affected on benefits and unable to live life to the full.
Eighty-five per cent. of sufferers, at the very least, are women. Hypothyroidism is very gender-specific. Underlying the issue is a policy failure by Government. I do not mean this particular Government—this is a long-standing problem going back at least 10 years under successive Governments. The problem is a paradoxical one that is rather different from what we normally see in health debates. Typically the argument in health debates is that something should be done but there is not enough money, whereas in this particular case far too much money has been spent on over-expensive drugs, leading to a correction in the form of severe rationing, which is now causing a great deal of hardship.
I have sought the right hon. Gentleman’s permission to intervene. Does he agree that lab tests are just one part of the diagnostic puzzle and that other steps have been taken to address the fact that between 40% and 50% of patients are either over-treated or under-treated, which massively affects their quality of life?
There is a lack of precision in this area, and there are questions both on the number of people affected and on the dosages required. I fully take the hon. Gentleman’s point.
We are predominantly dealing with the questions of cost and of physical availability, but let me develop the argument a little. It is estimated that one in 20 of the UK population have a thyroid condition of one kind or another. The figures vary considerably, and within that aggregate there are people who suffer from hyperthyroidism—an overactive thyroid—and the opposite, hypothyroidism, an underactive thyroid, and then there are people with thyroid cancer, who suffer considerably.
There is a standard treatment for hypothyroidism, and I will attempt to pronounce the drug’s name once—levothyroxine—before referring to it by its more common name of T4. The drug is broadly accepted to be fairly uncontroversial, at least in the UK. It has been seriously controversial in France, where the drug company Merck varied the composition, leading to considerable side effects. There were large-scale protests by hundreds of thousands of people in France, but there has been relatively little controversy about this particular drug in the UK.
What is controversial is where the standard T4 treatment does not work, or does not work adequately, for a fraction of hypothyroidism sufferers, estimated to be roughly 12%—the range goes from 5% to 20%. It has been established by tests over the years, and by successful treatment, that those people benefit from an additional drug, liothyronine, known as T3. We are talking about 50,000 people in this position and, as far as we can establish, only about 6,000 of them are getting the treatment they should have, which would substantially alleviate their condition.
The roots of this problem lie in the charging and costings for this drug. There is a monopoly supplier, Concordia, a company that was originally called Goldshield. The word “gold” was probably so obviously embarrassing, given the way it treated this as a goldmine, that it changed the name to Mercury Pharma, and it has subsequently been changed to Concordia. Some 10 years ago, this company originally produced a packet of these drugs for about £4.50, but the cost then increased to £258 for the same product, which is an escalation of about 6,000%. The NHS was originally spending some £600,000 a year on this drug, but I established through parliamentary questions that in the past three years it has spent successively £22 million, £33 million and £30 million. There has been an enormous increase in cost and an enormous burden to the health service as a result of the extraordinary pricing that this company has adopted. The consequence is that a large number of clinical commissioning groups have stopped supplying the drug and a large number of people no longer have access to it.
The Government, to their credit, have responded in the past year or so with two specific interventions, the first of which was referring the matter to the Competition and Markets Authority so that it could examine the abuse of pricing. The CMA has provisionally reported that the drug company has been seriously abusing the market and charging excessively. In addition, the Government have engaged in a consultation exercise on limiting the availability of the drug. There was a strong negative reaction and some 30,000 people petitioned the Government on those potential restrictions, but they have proceeded with guidance, at least in England, and the drug has been removed in many situations. The guidance is somewhat ambiguous but, in essence, it says that the drug should be made available only through secondary care—through hospitals. A user has to obtain a consultation with an endocrinologist in order to have the drug prescribed, and often this is difficult to secure. What are the consequences of that? In some 23 to 25 CCG areas in England the drug is no longer available on prescription, and 90% of CCGs have said that they wish to stop supplying it, so we have a postcode lottery.
In addition, a lot of users have realised that they can get round these restrictions by going on the internet or travelling to Europe, because in many European countries the drug is available at cost. Remarkably, the NHS is paying some £9 per tablet, whereas in Germany it is available for 25p. People who have become aware of that can order it on the internet or go to Italy, Germany or Greece, where the drug is freely available. We are dealing with a combination of a postcode lottery, some well-off people able to pay the full market cost, and others who are using the drug unsupervised through internet purchases.
I shall round off what I want to say by posing questions on a series of issues to the Minister, the first of which relates to the history. We have had 10 years of a scandal that may well have cost the taxpayer some £200 million in overcharging, so I want to ask him whether he has any plans to retrieve that money. I established through parliamentary questions that the Government have been active in the High Court in cases of this kind and have recovered money for the taxpayer in previous cases of seriously abusive charging by companies. Do the Government have any plans to do the same in this case?
Why did it never occur to anybody in the NHS over the past 10 years to bring in these drugs from overseas? They are produced in Europe at standard quality, so there is no problem. Why is that not NHS policy? Perhaps I can recall a former Member of the House who was recently remembered because of his infamous “rivers of blood” speech: Mr Enoch Powell, who was once a highly respected Secretary of State for Health. One thing that he did in his period in office was to help the NHS to overcome issues of scarcity and cost by bringing in imported drugs in situations of this kind. There is a long precedent and I cannot understand why that option was not used on this occasion.
My second concern relates to current supply. Why are the Government not using the powers recently acquired through Parliament—in the Health Service Medical Supplies (Costs) Act 2017—under which they can force companies to cut their costs? That appears not to have happened in this case, and I am intrigued to know why. Two other companies have been licensed to break the monopoly; are they now producing the drugs, and at European-level costs? Are those drugs being made available to the NHS so that the problem can be resolved?
Finally, on the availability of the drugs to patients, will the Government introduce revised guidance to help a much larger number of patients to obtain prescriptions through their GP, as they did before, rather than having to go to a hospital? It is often not possible to get a consultation and, even if there is one, a prescription is difficult to obtain. Will the Government therefore issue revised guidance to help the large number of people who currently do not have access to the drug?
I conclude by quoting Sir Anthony Toft, a former physician to Her Majesty the Queen who was for many years president of the British Thyroid Association. He summarises the case from the point of view of an experienced professional:
“Experience of managing more patients with thyroid disease than most over a period of some 40 years is being trumped by inflexible guidelines;
truly a remarkable state of affairs. Others hide behind guidelines to avoid the cost of prescribing liothyronine, which in the UK is exorbitantly priced by the sole supplier…when well-travelled patients can obtain supplies for a few euros in Italy and Greece and beyond.”
He strikes me as an authoritative and reliable source of advice. I do not know whether the Minister is aware, but
I thank Sir Vince Cable for giving us the opportunity to debate this issue. It is unusual for a party leader to lead an Adjournment debate; indeed, this is certainly a first for me. I just note that point. I pay tribute to him and Jim Shannon, who as always is in his place and intervened in the debate. They spoke passionately on behalf of their constituents affected by this condition.
Hypothyroidism—hypo is different from hyper, as the right hon. Gentleman rightly said—is a debilitating condition, caused by a deficiency of thyroid hormone that affects at least two in every 100 people. It is therefore not rare, and it can lead to depression, severe tiredness and weight gain, with all the associated health implications that we know about. The symptoms can affect every area of someone’s life, affecting their ability to work, to play a role in society and to lead any sort of full social and personal life.
It is important for people to have the drug that is most effective in treating their condition. Levothyroxine is beneficial for the majority of patients with the condition but does not treat the condition in all patients. For some, the alternative drug at the centre of the right hon. Gentleman’s opening remarks—liothyronine—better alleviates symptoms.
Let me say up front that, if people have a clinical need for a medicine, it is right that they get the most appropriate medicine for their condition. It is certainly not the Government’s intention to deny someone the correct treatment. Indeed, the basic principles of our national health service are based on the provision of the right care and treatment, free at the point of delivery, paid for by general taxation. That is correct and how it will remain.
Under their terms of service, GPs are allowed to prescribe any product, including any unlicensed product, that they consider to be a medicine necessary for the treatment of their patients under the NHS, subject to three provisos, the first of which is that the product is not included in what is commonly referred to in the NHS as the grey and black lists—the list of drugs which have national prescribing restrictions placed on them. The second proviso is that the local clinical commissioning group is prepared to fund the treatment. They are the commissioners of treatment, which the House decided through the Health and Social Care Act 2012, under the Government in which the right hon. Gentleman served. The third proviso is that the GP is prepared to provide a clinical justification to any challenges to their prescribing.
Although prescribers such as GPs should consider the cost of a medicine, their first consideration is the individual clinical needs of patients and the most effective options for meeting those needs. However, it is in all our interests that the NHS drives maximum value in delivering its essential services, including by using the most cost-effective and safe medicines for patients. As has been mentioned this evening, NHS England guidance following its consultation on
“items which should not be routinely prescribed in primary care” said that liothyronine should not be prescribed routinely due to its significantly higher cost. I should make it clear that that decision was also based on insufficient evidence of the clinical effectiveness of liothyronine, either alone or in combination with levothyroxine.
The NHS England guidance was developed, as we would expect, in partnership with NHS clinical commissioners on behalf of the clinical commissioning groups that they represent, based on the latest clinical evidence, including that from the National Institute for Health and Care Excellence. Practising doctors and pharmacists were involved in the development of the guidance throughout.
The proposal that liothyronine should not be routinely prescribed caused significant and understandable concern among patients who had been prescribed it. NHS England listened carefully to those concerns during its consultation on the guidance, and as a result, the NHS England board has decided that liothyronine should continue to be prescribed for a small cohort of patients for whom the first-line treatment—levothyroxine—does not alleviate symptoms and has advised that it should be initiated in secondary care only.
NHS England’s final commissioning guidance is addressed to clinical commissioning groups to support them to fulfil their duties on the appropriate use of prescribing resources. As part of issuing the final guidance, I am assured by NHS England that careful consideration was given to all responses to the consultation to ensure that particular groups of people are not disproportionately affected and that principles of best practice on clinical prescribing are adhered to.
NHS England expects, as do the Government, clinical commissioning groups, which have responsibility for commissioning services, to take account of the guidance when determining their local prescribing policies. I cannot comment on the situation in Strangford, but I understand that the south-west London clinical commissioning groups are reviewing local arrangements. The review will include close working with consultants in south-west London hospitals and build on the recent NHS England guidance. It will consider whether GPs as well as hospital consultants—primary as well as secondary care—should initiate prescribing of the drug. It will also consider which categories of patients should be prescribed it. I am sure the local clinical commissioning groups will ensure that the right hon. Gentleman is fully apprised of the outcome. I will ask them to ensure that he is fully apprised every step of the way.
Let me now turn to the other issue raised this evening concerning liothyronine: the significant increase in its price. Liothyronine is an unbranded generic medicine. For unbranded generics, the Government encourage competition between suppliers to keep prices down. However, as we know, Concordia—the manufacturer—is currently the subject of an investigation by the Competition and Markets Authority over how much it was charging the Government and taxpayers. As the right hon. Gentleman said, the CMA has provisionally found that Concordia abused its dominant position, overcharging the NHS millions of pounds for its tablets.
As the right hon. Gentleman rightly put on the record, the CMA’s findings are provisional at this stage. There has been no definitive decision that there has been a breach of competition law, and the CMA will carefully consider any representations from the companies concerned before deciding whether the law has in fact been broken. Where companies have breached competition law, the Department of Health and Social Care will seek damages and invest that money back into the NHS. That was one of the right hon. Gentleman’s questions, and the answer is an unequivocal yes. This is why we refer such issues to the CMA.
I am pleased to note that there are now multiple marketing authorisations for this drug. Increased competition usually leads to a more resilient supply chain and lower prices—one of the right hon. Gentleman’s other concerns. However, we will watch this carefully and will consider referring the matter to the CMA again if competition does not bring the price down.
It is not often that we hear a Liberal in this House quote the qualities of Enoch Powell—he is not often talked about in new Richmond House—but I take the right hon. Gentleman’s point. I will look into the issue of overseas imports and write back him on it. He also mentioned the Health Service Medical Supplies (Costs) Act 2017, which does not come into force until this summer. Officials who report to me are very much ready to go when that legislation comes into force. I thank the right hon. Gentleman for speaking on behalf of his constituents and many others. This subject has not had a hearing in this House during my time here.
The total medicines spend in England for the years 2016-17 was £15.4 billion. That is the second biggest area of NHS spending after pay. Access to treatment is, and always will be, a priority for this Government. I hope that some of the answers that I provided tonight have helped the right hon. Gentleman in his investigations; I will write to him with more.
Question put and agreed to.