Why are women STILL denied the 43p pill that can stop breast cancer spreading?
FOR postmenopausal women with early breast cancer — where the tumour hasn’t spread beyond the breast and lymph nodes in the armpit — there are new ‘ wonder’ drugs that could prevent their disease going any further. and unlike other wonder drugs, they’re not expensive: they cost just 43p a day.
It’s estimated that if given routinely to all eligible patients, the drugs, known as bisphosphonates, would prevent one in six breast cancer deaths.
Yet an estimated 22,500 patients in England are missing out on the life-saving medication due to an NHS ‘bureaucratic quirk’ over the question of who should pay for the cheap drug.
As a result while some health authorities have decided to bear the (minimal) cost, others have refused. This means while patients living in Kent and Sheffield are prescribed bisphosphonates, for instance, those in Hertfordshire and Buckinghamshire usually are not.
The problem was highlighted last September and again in November, when 41 NHS breast cancer consultants from all over England called on Jeremy Hunt, Secretary of State for Health, to clarify who is responsible for funding bisphosphonates for their use in breast cancer.
The doctors are yet to receive a satisfactory response, and experts fear that too many women are missing out or facing delays in getting the treatment, which must be given within six months of diagnosis to be effective.
Women such as Caralyn Duignan, 53, a senior account manager from Crewe, who was diagnosed with breast cancer after a routine mammogram detected a small tumour in her left breast.
Caralyn had a lumpectomy in December 2016 and started tamoxifen (a drug to lower oestrogen levels) last month as well as beginning a three-week course of radiotherapy last Wednesday.
But she wasn’t told about bisphosphonates, and learned about them only when a friend sent her a medical article. ‘I was really shocked to discover there’s a treatment my doctors haven’t told me about,’ she says.
‘There’s always that niggle that, despite all the treatments, there could be cancer cells floating round your body that they haven’t picked up. When my life is at stake, I want the complete belt-and-braces approach.’
BISPHOSPHONATES were originally licensed as a treatment for osteoporosis and work by strengthening bone.
Their benefit in early breast cancer was established by a study led by Professor Robert Coleman at the University of Sheffield.
Published in The Lancet in 2015, this involved data on nearly 19,000 women with early breast cancer, and showed that ten years after diagnosis, one in six deaths from breast cancer would be prevented if post-menopausal women were given bisphosphonates.
Professor Coleman believes bisphosphonates are most effective when given to women in the first six months after diagnosis, the time when the bone is most at risk of circulating cancer cells. The drugs are thought to help by changing the chemical environment in the bone so it produces fewer chemicals (known as growth factors) that encourage cancer cells from other parts of the body to ‘seed’ in bone. (Before the menopause, women do not make these chemicals, so bisphosphonates are, therefore, not necessary).
Charity Breast Cancer Now has estimated that if all postmenopausal women with early breast cancer were given bisphosphonates (either as an infusion or tablet), it would save 1,180 lives in the UK over the next ten years.
In the Breast Clinical Reference Group Draft Guidelines, commissioned by the NHS to advise how best services should be provided for breast cancer patients, 20 experts underlined bisphosphonates as being of particular importance.
‘In fact, it was in the top three or four of all our recommendations (including losing weight and taking exercise) and the only treatment we highlighted, which emphasises the importance we placed on it,’ says Professor Ian Smith, chairman of the Breast Cancer Clinical Reference Group, from the Royal Marsden NHS Foundation Trust.
However, he says the Department of Health has been sitting on these recommendations since February 2015 rather than publishing them.
In a UK Breast Cancer Group (UKBCG) survey, published in September, only a quarter of oncologists reported being able to prescribe bisphosphonates to early breast cancer patients.
‘Doctors feel they’re failing patients,’ says Dr Catherine Harper-Wynne, a consultant medical oncologist from the Maidstone and Tunbridge Wells NHS Trust, and secretary of the UK Breast Cancer Group.
‘They’re faced with real ethical dilemmas about trying to give women the full picture about current treatments, but not wanting to worry them by mentioning drugs they can’t get funded.’
A number of factors have converged to prevent women having bisphosphonates, explains Professor Coleman.
First, they are drugs licensed for the treatment of osteoporosis that have been ‘repurposed’ for early breast cancer. Without a licence for preventing the spread of cancer, the National Institute for Health and Care Excellence (NICE) won’t undertake a formal assessment to consider whether they work and are cost-effective.
So bisphosphonates miss out on getting the approval of NICE for breast cancer patients which, in turn, would have meant local clinical commissioning groups (CCGs) and the Cancer Drugs Fund have to fund them.
In the absence of official guidelines, CCGs are left to make their own funding decisions.
‘The reality is that although bisphosphonates are cheap, with large numbers of women involved this adds up to considerable sums of money,’ says Dr Harper-Wynne.
‘Since the NHS is so stretched, the CCGs are often saying “no”.’
PROFESSOR Coleman adds: ‘We have shown that the costs are more than offset by avoiding the need to monitor thousands of breast cancer patients for osteoporosis and avoiding expensive treatments for secondary breast cancer in years to come.’
While doctors could, in theory, write private prescriptions and prescribe them off-licence, Professor Coleman adds, many are reluctant to do so because they would be personally liable if anything went wrong.
Gill Hogarth, 63, who was diagnosed with breast cancer last June, found out about bisphosphonates in November when she read a tiny paragraph in a breast cancer information sheet.
At her next hospital appointment, Gill, a retired civil servant from Aylesbury, raised the subject with her consultant. ‘He told me he couldn’t fund the drugs, but promised to write to my GP.
‘He did, and I was delighted when my GP agreed to write me an NHs prescription,’ Gill says.
‘I just sneaked into the six-month time frame when bisphosphonates are thought to have their most beneficial effects.’
Caralyn also wants to maximise her chances of being alive in ten years’ time. ‘It seem so unfair that this depends on where I live in the UK,’ she says.
FOR information on Breast Cancer Now’s campaign for bisphosphonates, go to breastcancernow.org/43paday