Cancer Drug License Restrictions Are Costing Lives

The profile of one tumour may throw up similarities to those found in a differently located tumour – and those similarities could be treated the same way, if drugs were licensed differently

In response to the news that there will be a yearly £20 million cut to the Cancer Drugs Fund (set up in 2011 to ensure patients could be prescribed life-extending drugs), until it expires in 2016, Baroness Delyth Morgan – CEO of Breast Cancer Now – said: “The Cancer Drugs Fund was intended to provide a safety net for clinically effective but expensive drugs, but is now bursting at the seams. We know that more drugs are about to be ‘de-listed’ from the fund due to budget constraints and this latest news suggests that further delisting is inevitable. This would be a massive blow for breast cancer patients and it is clear that a complete overhaul of the way in which cancer drugs are priced and funded in the UK is desperately needed.”

Her words were echoed by CEOs from other cancer charities – prostate and bowel particularly – when the announcement that 23 different treatments will cease to be funded from November this year. This will be added to the 35 treatments already de-listed earlier this year, one of which was Kadcyla, a ‘one of a kind drug proven to extend life’, which caused Baroness Morgan to add: “It was a dreadful day for breast cancer patients. The fact is that because government, the NHS and the pharmaceutical industry have failed to agree realistic prices for new drugs, some women will die sooner.”

In response to the announcement Professor Peter Clark, oncologist and chair of the Cancer Drugs Fund, said: “We must ensure we invest in those treatments that offer the most benefit, based on rigorous evidence-based clinical analysis and an assessment of the cost of those treatments.”

However, it seems that finding the right drug is restricted not only by cost, but also by licence. Drugs for one type of cancer are not necessarily licensed to be used for another.

In January last year I wrote a piece about molecular profiling describing the work of Caris Life Sciences, based in Arizona. This research institution has developed ‘Caris Molecular Intelligence’, a system which profiles tumours and measures their biomarkers.

No two people are the same and nor are tumours. Biomarkers – different compounds in the body, like proteins, genes and other molecules – affect how cancer cells grow, multiply and die and how they respond to other compounds in the body. Caris Molecular Intelligence can identify biomarkers in a tumour and then provide a list of cancer drugs that ‘might be of clinical benefit’. This might well mean using a drug normally associated with one type of cancer, for another. Recently, there were reports that the breast cancer drug Herceptin had been used to treat metastasised oesophageal cancer – because the tumour was expressing HER2 (human epidermal growth factor protein).

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With 68,000 profiles already undertaken and the establishment of a network of leading US cancer centres “that have demonstrated a commitment to precision medicine and will work collaboratively to advance the delivery of tumour profiling and establishing standards of care for molecular profiling in oncology”, Caris has now moved to Europe, with a centre in Basel, Switzerland.

In my piece last year, I asked whether or not CMI would be used by the NHS; how, if a drug was suggested by Caris and it was part of a trial, would NICE respond; and whether a patient/clinician would be able to apply to the Cancer Drugs Fund for a drug not licensed for his or her type of cancer. I asked for responses from both the CDF and NICE but – sadly – none were forthcoming.

Last October Caris announced that it was to run a pilot programme at St James’s Institute of Oncology in Leeds, Bradford Royal Infirmary, Huddersfield Royal Infirmary and Airedale General Hospital. ‘Comprehensive tumour profiling’ was to be offered to women with ovarian and other types of gynaecological cancers. The NHS was to support the pilot through the Regional Innovation Fund, which aims to support and promote the adoption of innovation and the spread of best practice across the NHS, and it was to be led by consultant oncologist, Dr Geoff Hall.

At the time of the announcement, Dr Hall said: “We are excited to bring this potentially transformative approach to cancer care into the NHS. Women with ovarian cancer who have run out of standard therapies and those with rarer gynaecological cancers often have few treatment options, so the opportunity to use biomarker data from their tumours to identify new therapy options is invaluable.”

Since then I have tried repeatedly to find out how the programme is developing, but to no avail. Whilst I understand completely that Dr Hall is incredibly busy, there are cancer patients in the UK who are searching for information about future treatments. Perhaps he would be very kind and email me the answers to the questions I left with his Secretary and Caris’ PR company.

As a layman, it would seem that treatment decisions based on tumour profiling might well save the NHS a good deal of money. Not all drugs cost £90,000 and it might be that a reasonably priced drug could replace an ineffective expensive one. How, though, would the NHS deal with the licensing issue?

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Not only will the cuts to the CDF “reduce a clinician’s ability to prescribe treatments according to a patient’s clinical need” as Mark Flannagan, CEO of Beating Bowel Cancer said but, in the words of a group of leading bowel cancer oncologists: “Any further de-listing will prevent patients from participating in a number of international clinical trials, isolating the UK research community.”

Whilst it now rests on pharmaceutical companies, the government and the NHS to come to a realistic agreement about the cost of drugs – and perhaps they might all try to ‘walk a mile in the moccasins of a cancer patient’ while they do so, there does seem to be a very slow introduction of Caris Molecular Intelligence. Yet clinicians are moving towards identifying cancer by its make-up and not by the name of the body part attached to it. The profile of one tumour may throw up similarities to those found in a differently located tumour – and those similarities could be treated the same way, if the drug was licensed differently.

Meanwhile, patients are suffering unnecessarily from unsuitable treatments – while there is a system, proven in the USA, which will deliver totally personalised medicine.

So that we can all understand the situation, please could we have some answers from The Cancer Drugs Fund, The NHS, NICE and Dr Geoff Hall. My email address is judith.potts@telegraph.co.uk


By Judith Potts

Original article:  http://www.telegraph.co.uk/lifestyle/wellbeing/healthadvice/11848294/Cancer-drug-license-restrictions-are-costing-lives.html