Branded Health Service Medicines (Costs) Regulations 2018

Baroness Wheeler Excerpts

Wednesday 20th June 2018 Lords Chamber

[Baroness Jolly (LD)]

My Lords, I thank the noble Lord, Lord Hunt of Kings Heath, for bringing this slightly interesting regret Motion.

It is clear that the issue at stake is the appropriate treatment of hypothyroidism. We have to trust clinicians to prescribe based on what they consider is best for their patients, as the noble Lord, Lord Turnberg, said. I have done an awful lot of reading about this over the last few days, and, although it depends on which article you read, it seems that a significant number of women have this condition: one figure I was given was 10%. In fact, for the last 25 years I have been diagnosed as hypothyroid. I take T4— levothyroxine—which is cheap as chips and costs the NHS about £1.30 every month. But of course, not everybody responds to that, and the alternative is the very much more expensive T3. Some 10% to 20% of patients diagnosed with hypothyroidism come into this category. It is therefore important that the patient receives the right drug. We have heard completely unacceptable tales of patients, as a result of decisions made by clinical commissioning groups, surfing the internet to see what they can get. I did exactly the same last night—having a look to see what I could get—and, again, the T3 was ridiculously expensive, whereas T4 was hardly worth buying online as you could get it very much more cheaply.

What is to be done about this? I was going to explain what it is like when you develop hypothyroidism, before you are diagnosed, and so I thank the noble Lord, Lord Borwick, because his description was lovely: “pathetic, befuddled and exhausted”. I went to see a doctor because my brain was in a fog. I explained it to him and he said, “What do you expect? You work full time and you have two toddlers”. So I was sent away. Curiously enough, at a family event—a lot of my family are doctors or nurses—my mother-in-law asked me, “How long have you had a thyroid problem?” and I said, “I didn’t know I had a thyroid problem”. I went to see my GP, who said, “No, you haven’t got a thyroid problem at all. Who said you had one? Gosh—what does a paediatrician know about it?” Eventually, I had to leave my practice and go to another one to get a diagnosis. I am sure that that is not normal, but it was quite an interesting experience for me. Since then, I have been as fit as a flea. The medication works like a magic charm; very quickly you feel normal and well again. So I cannot overstate to Members of your Lordships’ House how important that prescription was.

I emphasise to the Minister what other noble Lords have said today. We must use the purchasing power of the NHS to drive down the costs of T3 in order to make the argument go away. That might be done by effective negotiation, as the noble Lord, Lord Lucas, said, or in another way, but it is completely scandalous that patients have to buy their own drugs online, and CCGs should therefore review or rework their guidelines as a matter of urgency. Drug companies must not hold the NHS to ransom over the cost of medication that will make patients feel absolutely well again.

On the issue of the costs of medication, one of the non-medical side-effects of having a diagnosis of hypothyroidism was that any other drug I had became free. It is on a list of conditions which, if you have them, mean that any other medication you need becomes free. At that time I was in my early 30s and working. It was very nice to have free prescriptions; I tried to pay for them but they would not let me. However, it means that for the NHS, an awful lot of money is spent inappropriately. Can the Minister give an indication of whether the department has any indication of how much this costs the NHS? I am happy for the NHS to pay for my levothyroxine, but it should not have paid for all other medication I was in receipt of—although, now that I am old, it comes free anyway. How sustainable is this in the current climate, and when was the principle last reviewed?

My takeaway issue for all this is that, whatever happens, we should ensure that the cost of T3 is driven down. However, I would also like the Minister to take this other issue away and—not as a matter of huge urgency—come back to me with some answers.

[Baroness Wheeler (Lab)]

My Lords, I thank my noble friend for tabling this Motion and for his excellent speech setting out the concerns we all share about NHS patients getting access to the drugs they need and how a number of CCGs are in effect placing a ban on expensive branded medicines—in this case ignoring NHS England’s advice concerning T3 in the treatment of hypothyroidism. I look forward to the Minister’s response to the key questions put forward by noble Lords on this issue.

The Motion has the full support from these Benches. I also commend the work of the British Thyroid Association and Thyroid UK in highlighting this issue, and the very helpful information on their websites, as well as the expert explanation from my noble friend Lord Turnberg on hypothyroidism. The websites include case studies of patient voices which clearly show the impact and suffering of patients who are either denied T3 or who are taken off it because of a decision made by their CCG. It is especially upsetting when patients who have successfully taken the drug for a number of years suddenly have to go back on to a drug, mainly T4, which they already know does not provide them with the treatment they need or will make them ill again. The case studies refer to both the T4 drug and the natural desiccated thyroid—NDT—drug, which I understand is the treatment given before T4 came on to the market but which is not now available in the NHS as it has to go through the Food and Drug Administration process, and it is not known when the branded NDT products will be licensed.

My noble friend and other speakers described their concerns over current CCG decisions that go against NICE guidelines and the advice of NHS England, and the increasing rationing of key services, so I will not repeat them and will await the Minister’s response. The NHS England recommendation and guidance on T3 needs to be clear and unambiguous. I hope that the Minister will acknowledge the confusion and concerns, and will ensure that NHS England informs CCGs that they must both comply with their guidance and amend it to end the scope for CCG misinterpretation. I hope that he will also acknowledge that access to T3 on the NHS is a matter of urgency for many patients and that he will give serious consideration to the call from Thyroid UK and ITT for the procurement of T3 from outside the UK for NHS prescriptions until its UK cost comes down.

On the regulations, I note paragraph 4.7 of the Explanatory Memorandum, which deals with provisions of the Health Service Medical Supplies (Costs) Act 2017 that have been included. This includes the promise of the annual review of the operation and objectives of the statutory scheme which is to be published and put before Parliament. Can the Minister tell the House what the current thinking is in terms of the review process and timing, and say when he would expect the first review to be completed?

The impact assessment also states that the implementation of these regulations will generate a saving of £33 million to the NHS between April 2018 and March 2019. The Department of Health and Social Care says that this will enable the provision of additional treatments and services estimated to provide NHS patients with an additional 2,213 quality-adjusted life years, valued at £133 million. Can the Minister explain to the House exactly how the Government have calculated the savings, and can he give more details of how this money is to be spent in the NHS?

The Explanatory Memorandum also says that the regulations set out other instances when the Secretary of State can give a direction specifying the maximum price of drugs—for example, when there are supply issues with respect to a particular branded health service medicine and the Secretary of State is satisfied that a new temporary minimum price needs to be provided to help resolve the supply issue. Can the Minister explain to the House how the Secretary of State is to decide on the temporary minimum price?

Finally, in respect of the provisions in the regulations for manufacturers and suppliers to pay 7.8% of their net sales income to the Government, the impact assessment provides for those in the PPRS with annual NHS sales above £5 million to make percentage payments based on the difference between allowed percentage and actual percentage growth in NHS expenditure on branded medicines. Can the Minister provide more clarity on how this 7.8% figure has been reached?