Liothyronine (LT3) prescribing in England: Are cost constraints inhibiting guideline implementation?

[helvella]

Whatever else, this demonstrates beyond any doubt that the cost of the liothyronine Active Pharmaceutical Ingredient is but a minor part of the price charged to the NHS.

I'd argue that the simple fact that the NHS agrees these prices strongly suggests something VERY wrong with medicines procurement.

I wouldn't be at all surprised if someone, somewhere, argues that the price of levothyroxine is very low (which it is) and that somehow justifies an excess price for liothyronine. A balancing out where overcharge on one is balanced by an undercharge on something else.

Trouble is, that can in no way justify a patient being refused liothyronine.

I am extremely pleased to see some of the authors. At least some UK endocrinologists do seem to understand and appreciate what is happening and are arguing against.

And I have to ask what the BTA is taking such that they can come out with guidelines which increase costs and, quite likely, provide no patient benefit, indeed, in many cases, worsen patient outcomes.

And I have to ask what the MHRA are taking such that all forms of tablet splitting, for all thyroid hormone tablets, is deprecated. (Despite, for one example, Aristo Vencamil being approved for splitting in many countries.)

Clin Endocrinol (Oxf). 2024 May 16.

doi: 10.1111/cen.15061. Online ahead of print.

Liothyronine (LT3) prescribing in England: Are cost constraints inhibiting guideline implementation?

Heald Ah 1 2 , Premawardhana Ld 3 , Taylor Pn 3 , Dasha Depesina 4 , Nadia Chaudhury 5 , Okosieme Oe 3 , Stedman M 6 , Dayan Cm 3

Affiliations

• 1 The School of Medicine and Manchester Academic Health Sciences Centre, University of Manchester, Manchester, UK.

• 2 Department of Endocrinology and Diabetes, Salford Royal Hospital, Salford, UK.

• 3 Thyroid Research Group, Systems Immunity Research Institute, Cardiff University School of Medicine, Cardiff, UK.

• 4 Ukrainian Children's Cardiac Centre, Kyiv, Ukraine.

• 5 Department of Endocrinology and Diabetes, University Hospitals Coventry and Warwickshire, Coventry, UK.

• 6 Res Consortium, Andover, UK.

PMID: 38752469 DOI: 10.1111/cen.15061

Abstract

Background: Primary hypothyroidism affects about 3% of the general population in Europe. In most cases people with hypothyroidism are treated with levothyroxine. In the context of the 2023 British Thyroid Association guidance and the 2020 Competitions and Marketing Authority (CMA) ruling, we examined prescribing data for levothyroxine, Natural desiccated thyroid (NDT) and liothyronine by dose, regarding changes over the years 2016-2022.

Design: Monthly primary care prescribing data for each British National Formulary code were analysed for levothyroxine, liothyronine and NDT.

Patients and measurements: The rolling 12-month total/average of cost or prescribing volume was used to identify the moment of change. Results included number of prescriptions, the actual costs, and the cost/prescription/mcg of drug.

Results: Liothyronine: In 2016 94% of the total 74,500 prescriptions were of the 20 mcg dose. In 2020 the percentage prescribed in the 5 mcg and 10 mcg doses started to increase so that by 2022 each reached nearly 27% of total liothyronine prescribing. The average cost/prescription in 2016 of 20 mcg was £404/prescription and this fell by 80% to £101 in 2022; while the 10 mcg cost of £348/prescription fell by only 35% to £255 and the 5 mcg cost of £355/prescription fell by 38% to £242/prescription. The total prescriptions of liothyronine in 2016 were 74,605, falling by 30% up to 2019 when they started to grow again - most recently at 60,990-15% lower than the 2016 figure, with the result that total costs fell by 70% to £9 m/year.

Conclusions: Liothyronine costs fell after the CMA ruling but remain orders of magnitude higher than for levothyroxine. The remaining 0.2% of patients with liothyronine treated hypothyroidism are still absorbing 16% of medication costs. The lower liothyronine 5cmg and 10 mcg doses as recommended by BTA are 240% the costs of the 20 mcg dose. Thus, following latest BTA guidance which recommends the lower liothyronine doses still incurs substantial additional costs vs the prescribing liothyronine in the no longer recommended treatment regime. High drug price continues to impact clinical decisions, potentially limiting liothyronine therapy availability to a considerable number of patients who could benefit from this treatment.

Keywords: guidelines; hypothyroidism; levothyroxine; liothyronine; natural desiccated thyroid; prescribing costs.

© 2024 The Authors. Clinical Endocrinology published by John Wiley & Sons Ltd.

Abstract:

pubmed.ncbi.nlm.nih.gov/387...

Full paper available here:

onlinelibrary.wiley.com/doi...

[jimh111]

A good part of the BTA is complicit in these price increases. They see the high price as a means of achieving their objective of denying liothyronine. I wrote to them a couple of times, the first time I was ignored, the second time they acknowledged my letter and took some action - there was a change in leadership.A second issue is that the guidance only addresses primary hypothyroidism, they only consider evidence relating to primary hypothyroidism. They then transmute this into recommendations for all prescribing of liothyronine. Nasty work.

A major issue in s endocrine disrupting chemicals. There was an excellent BTF talk on this recently which described the enormous cost arising from a large number of affected patients. However, they refuse to attempt to identify such patients who usually have normal thyroid hormone levels. Indeed the guidance doesn't allow doctors to investigate or treat these patients - they must not diagnose if TSH is normal and not prescribe liothyronine.

The guidance bans investigation and treatment because doctors would have to develop skills.

[arTistapple]

I have had to read a lot of research recently. What confounds me is two things.

One the ‘Holy Grail’ of TSH underpins virtually every piece of subsequent research, without itself being further questioned.

Two the decision to not collect cheap accessible data (presumably a result of both the Holy Grail and cost of testing). I read in a number of places this costs the NHS less than £3 per patient for TSH,T4and T3.

How is it possible to provide actual and accurate research which could ever be able to be applied to patients? Even if this only applies to 20% of patients needing extra help, it’s a massive number.

So much of the research is really of questionable quality. Another waste of money, time and effort.

[helvella Administrator Thyroid UK in reply to arTistapple]

I've repeatedly questioned whether the savings of not doing all three are even as great as might initially appear.

A lone TSH test costs (relatively) quite a bit - because you are loading that with the blood draw, transport of sample, lab management, getting the sample into the machine, etc.

The incremental cost of FT4 and FT3 appear, as you suggest, to be very modest. Partly because they can be done on the exact same sample as TSH. (Doesn't need to be in a different tube.)

Nonetheless, there is an extra cost as things are. And let us accept it is something like £1 for FT4, £1 for FT3. I keep wondering whether that cost would reduce further if the lab contracted with the supplier of the analyser so that they always do all three? With most things we buy, if we buy more we can get a better price. And if we always order all three together, that also simplifies it all round.

Add onto that the savings from never having to repeat recent tests just because they didn't do all three. (And they pretty much universally do the TSH test every time.) This is always going to be difficult to assess unless lab requests have a box for the requester to say that is why it is being done.

And the cost of the lost opportunity to have done FT4 and FT3 and use the data for the immediate and longer-term benefit of an individual, for the benefit of science and research.

The NICE document below mentions phlebotomy costing £3.04. This appears incredibly low and they must be considering only hospital draws. The GP surgery costs of handling the booking phone call, booking and any other admin, doing blood draw, sending it to the lab, etc., must be more than that.

Thyroid disease: assessment and management

[C] Thyroid function tests

NICE guideline

Intervention evidence review underpinning recommendations

1.2.8 to 1.2.10 in the guideline

2019

nice.org.uk/guidance/ng145/...

[clubby29]

Hi

The whole procurement system in the NHS is broken and/or corrupt. My daughter office works for them and some of the stories of how things are managed and run are laughable/ scary. I do think if they had more people who had experience in running a business for themselves in the system it would work in a very different way. Good wages,pension,holidays and GOV paying all the bills makes complacency easy.

[arTistapple]

However it seems like the NHS is prone to looking in the wrong direction for just about anything. Is there something else we don’t know? Procurement staff are allegedly (or should be) highly qualified individuals. Or in this case, are they just untrained civil servants? How did the Liothyronine price hike get past them in the first instance?

However I think jimh111 points out quite rightly that The BTF have utterly c..ked up here too, in their wrong headed approach to make savings and GPs have gone along with this (no doubt being strong armed by other powers) like lemmings. Patient’s concerns as usual, nowhere in sight.

The Guardian article Sparklingsunshine put up today highlights that procurement of medicines seem to be attempting to buy too cheaply and this too is causing huge problems. As usual Govt/NHS/procurement too late off the mark to benefit from (possibly) being the largest market on the planet for medication purchase. How could it get any worse? Well … it seems it can.

[helvella Administrator Thyroid UK in reply to arTistapple]

I find it utterly perplexing that month by month (and likely within each month), we can see things like the price of 28 x 100 microgram levothyroxine tablets bounce around between 69p, to 76p, to 83p, back to 69p. (These are made up - except the 69p - to provide a concrete illustration. But they are realistic.) Individual changes that are utterly insignificant. Sure, across the entire country it adds up. But it seems feasible to me that once you reach a certain point - for simplicity I'll suggest a round single pound - the costs of repeated price changes make them not worth implementing.

[arTistapple in reply to helvella]

There is a system of purchasing (like it or not) where agreements are made in advance. Simply put, it’s along the lines of - you purchase half in advance and agree the price of the ‘future’ half. This can be disadvantageous as well as advantageous. You might win, you might lose. However the main point of it is, you ‘secure’ your purchase. This can be done every year. So you are always literally two years ahead all the time. According to the Guardian our purchases are no longer being secured. So that’s another knock on problem. However this is why professionals are needed for this negotiation. They have other information at their fingertips about the state of the worldwide market.

This nonsense you describe shows that it’s highly likely this is not the system in play, which is probably contributing to the ‘shortages’ and frankly will be creating a hell of an amount of ‘busywork’ and no control. However you can imagine how much control civil servants will be thinking they are getting by this extremely harassing method of purchasing?

Madness for a market the size of the NHS. The companies must be rubbing their hands with glee when the NHS comes looking for medicines. A market with heaps of money and idiots in control. Make way for yet another billionaire!

[jimh111 in reply to arTistapple]

Most large companies tell their suppliers what the price is. I worked in IT, our company told suppliers costs had to be reduced by five percent every year and IT companies had to cut prices by ten percent each year or go elsewhere. At the very least they should have a monthly report that highlights any price increases. Medicines are cheaper to make as time goes by, not new drugs but existing ones.

[BumbleyM]

I didn't know the details until your article, but on a personal level, when my GP refused to add Liothyronine to the Levothyroxine I had been on for a couple of years, I arranged private blood tests, and sought a second opinion from a different NHS consultant, who agreed that I have a clinical need for Liothyronine , and gave me private prescriptions. I was able to source 20ug Liothyronine tablets from Germany using this prescription ( up until Brexit ) , at 36 euros for three months supply, including postage ! I understand from my GP the NHS was being charged in excess of £400= per month for each patient for Liothyronine. I consider that this was a criminal exploitation of NHS funds, ie taxpayer's money, and why something wasn't done about it sooner, I don't understand. It makes you wonder what other malpractice is being practised against the NHS. I don't know if this is what you were looking for, but it was my experience. Fortunately, following an NHS trial, I was put on a combination of the two.

[helvella Administrator Thyroid UK in reply to BumbleyM]

It was regarded as criminal and the companies were fined many millions of pounds.

This post is about the fallout from the issue - and there are quite a few more posts:

Liothyronine prescribing in England: costs versus need (and petition)

healthunlocked.com/thyroidu...

[BumbleyM]

Ah, thank you

[BumbleyM]

It still seems that Liothyronine is being overcharged to the NHS , when much cheaper sourcing is available... Brexit has stopped me as an individual buying it, even with a prescription, but I'm guessing the NHS as an organisation could source it elsewhere.. until the NHS does T4/T3 testing instead of the TSH test as te gold standard, I can't see things improving for patients that much - some GPs do put their hands up and say they're not specialist enough, but not many..

[helvella Administrator Thyroid UK in reply to BumbleyM]

I simply do not know what we can do to influence NHS medicines procurement.

NHS needs to do things like, for one obvious example, go to Sanofi (Henning) in Germany and see if they can negotiate supply to the UK.

Even if quantities supplied weren't huge, it would act as a price comparison point.

[TaraJR in reply to helvella]

I was told that the NHS waits (or has to wait) until a company approaches them, not the other way round. That sounds utter nonsense, but I've heard it several times.

[Hiphypo in reply to TaraJR]

That’s absurd!

[TaraJR in reply to Hiphypo]

Yep!

[helvella Administrator Thyroid UK in reply to TaraJR]

While I completely agree that is what appears to be the expectation, there have been circumstances in which the NHS has proactively gone to get medicines.

[TaraJR in reply to helvella]

It's the wasting of tens of millions of £s (OUR MONEY!) on expensive T3 that is distressing, as well as patients being harmed by not being able to access T3