Going on holiday to Greece is no longer just about soaking up the sunshine for Mary Saunders — it’s her lifeline.
The 63-year-old spends much of the trip with her husband Garry, 64, travelling from one pharmacy to another buying a thyroid drug that should be available on the NHS. It helps her avoid the crippling fatigue, weight gain and depression caused by her underactive thyroid, or hypothyroidism.
But after its maker used a loophole to inflate the price by 4,600 per cent over ten years, some local health authorities have stopped prescribing liothyronine for hypothyroidism. Priced at £204.39 for a 28-day course compared to just £4.46 in 2007, the only alternative is to obtain tablets by private prescription.
That is is out of the question for many patients, including Mary, as it is too expensive. Instead she stocks up in Greece, where a packet of 30 of the 25mg tablets costs just £1.
Expense: Liothyronine is currently priced at £204.39 for a 28-day course – compared to just £4.46 in 2007 – after its maker used a loophole to inflate the price by 4,600 per cent
‘It’s a terrible situation,’ says Mary, from Peacehaven, East Sussex, who was diagnosed with hypothyroidism 11 years ago. ‘But I don’t have a choice. Last time I was able to bring back a 15-month supply.’
Both the Competition and Markets Authority (CMA) and a parliamentary inquiry are investigating the huge increase in cost of liothyronine by the maker Advanz Pharma.
The CMA claims the company breached UK and EU competition law between 2009 and 2017 by ‘charging excessive and unfair prices’; the cost of the drug rose from £15.15 to £258.19 over this period ‘a rise of 1,605 per cent, while production costs remained broadly stable.
The company used a regulatory loophole to ‘debrand’ its drug in 2007, meaning it could escape NHS rules that stop companies increasing the price of branded medicines. There are no price caps on unbranded drugs and as Advanz Pharma was then the only company producing the drug it was free to set its own price.
Advanz Pharma told Good Health: ‘NHS England has issued clear guidance to CCGs [clinical commissioning groups] supporting the continued prescribing of liothyronine for patients who need it and we recommend that all CCGs refer to this guidance.
The pricing of liothyronine has been conducted transparently with the Department of Health and Social Care (DHSC) over a period of ten years, with price increases notified in advance and implemented only after approval from the DHSC.’
Up to 20 per cent of the population suffer mild underactive thyroid problems — a third of whom experience no symptoms. Recently, as the Mail reported, a major review in The BMJ concluded these ‘subclinical’ patients do not benefit from hormone medication — although Dr Peter Taylor, an endocrinologist at Cardiff University, says more research is needed as these trials were small (involving only 2,000 patients).
‘Given hypothyroidism is so common, there need to be larger trials, studying whether certain genes are associated with worse symptoms and better response to treatment,’ he says.
Did you know? Most cases of underactive thyroid are caused by the immune system malfunctioning and attacking the thyroid — a small butterfly-shaped gland in the neck that regulates the body’s metabolism
But around 3 per cent of the population have an obviously underactive thyroid — with women over 40 at greatest risk (it’s not known why). And while they do benefit from hormone treatment, many are missing out.
Most cases of underactive thyroid are caused by the immune system malfunctioning and attacking the thyroid — a small butterfly-shaped gland in the neck that regulates the body’s metabolism. This reduces its production of the hormones thyroxine (known as T4) and tri-iodothyronine (known as T3), causing tiredness, weight gain and depression.
The most common treatment is levothyroxine, a synthetic version of T4. However, symptoms persist for around 10 per cent of patients and they may need to also take liothyronine, a synthetic version of T3.
Mary, who was diagnosed with hypothyroidism in 2008 following a routine check, had struggled with her weight despite exercising and eating well.
‘I was put on levothyroxine but it had very little effect. By 2015, I felt I was living half a life — depressed and tired — I’d need a daytime nap and would fall asleep half way through the evening,’ says Mary, who has three grown-up children.
‘Since I started taking liothyronine in 2016, I have got my life back. I don’t fall asleep during the day, have lost a stone in weight and got fitter.’
Thousands of patients are missing out on liothyronine — because many of the 195 CCGs in England responsible for their local health services are restricting its use because of cost
Thousands of patients are missing out on liothyronine — because many of the 195 CCGs in England responsible for their local health services are restricting its use because of cost. This is despite NHS England guidelines stating it should be available when recommended by a specialist endocrinologist.
The price rises led to sharp drops in prescription rates between 2013 and 2018; variations in prescribing between CCGs have seen some prescribing 49 times less than others.
For example, patients covered by Mary’s health board (Brighton and Hove CCG) are among those with the greatest difficulty accessing liothyronine. The board has seen the biggest drop in prescriptions in England with doctors now prescribing 32 times less than five years ago.
This is followed by Nottingham North and East CCG, with a 14-fold drop; Nottingham West, an 11-fold drop; Croydon, an eight-fold drop; and Mansfield and Ashfield, a seven-fold drop.
Yet despite these figures, the cost to the NHS for the medication has soared.
WHAT IS A THYROIDECTOMY?
A thyroidectomy is the medical term for the removal of the thyroid gland, often as a result of cancer of an overactive thyroid.
The thyroid gland, which is small and shaped like a butterfly, produces hormones which regulate the body’s metabolism.
Patients who have their entire thyroid gland removed need daily treatment with hormones to make up for the loss of function.
The Mayo Clinic, a respected health centre in the US, states that a thyroidectomy is ‘generally a safe procedure’.
However, it warns risks can include bleeding, infection, airway obstruction. Some patients can be left with a hoarse voice.
The operation can last between 45 minutes and three hours – depending on how complex it proves, according to the American Thyroid Association.
Figures suggest nearly 150,000 thyroidectomies are carried out in the US each year – while the number is smaller in the UK.
An analysis in the journal Lancet Diabetes and Endocrinology earlier this year found that while the total monthly cost to the NHS in England of liothyronine prescriptions in August 2013 was £758,975, this increased by almost ten times to £7,018,679 by July 2018 — despite almost two-thirds of areas prescribing less liothyronine.
‘Our findings support the need for urgent measures to reduce the cost of liothyronine to the NHS,’ wrote Dr Taylor, who led this study.
Desperate to continue taking their medication, two-thirds of patients denied the drug now pay privately for the treatment, while one in five goes without.
Combination T4 and T3 therapy is controversial as there is no categorical proof that it is better than T4 alone. However, with some studies showing it to be beneficial, NHS England says it should be available.
In some cases, such as Mary’s, endocrinologists recommend a trial of T3 alone to see if symptoms improved.
‘I was referred to an endocrinologist in February 2016, when the price shot up,’ says Mary. ‘He agreed to trial me on T4 and T3, but my CCG rules meant he couldn’t prescribe it on the NHS. The only way to get it was a private prescription or to source it myself. That’s when I started buying it in Greece.’
Brighton and Hove CCG said liothyronine is available from an NHS specialist only for specific conditions — myxedematous coma (a rare, life-threatening form of hypothyroidism) and pre-radioiodine treatment for thyroid cancer.
Lorraine Williams, director of The Thyroid Trust, said: ‘It’s shocking that endocrinologists are being told that they can’t prescribe liothyronine for patients who need it,’ she says.
‘Too many patients with hypothyroidism are telling us they have no quality of life and are being let down with this vital medicine being denied. It’s time for that to stop.’
Concerns raised about wide variations in prescribing rates have prompted the NHS to announce it is now working to clarify its national guidance.
Until the price comes down, Mary says she has no choice but to stock pile the medicine on her annual holiday to Greece.
Liothyronine is cheap there and is available to buy over the counter, without a prescription. ‘It’s ridiculous,’ she says. ‘I am seen by an NHS specialist who recommends the drugs but I can’t get them in the UK.’
More info at thyroidtrust.org