What price Life?

Cancer is a common disease affecting one in three of the population at some point in their lives. Nearly all families have been affected.  It is a disease that causes much emotion and fear. Politicians, with their never-ending quest for popularity, have ruthlessly exploited it as a battleground for catching votes. Promises are easy but their delivery fraught with difficulties. And the media, fuelled by press releases from cancer charities, biotech companies, and the increasing volume of litigation, continue to fill column inches with a mix of exaggerated good and bad news. Much of the technology is changing so fast it has become a very challenging field for clinicians at the frontline. And patients are often left bewildered and frightened by the discrepancy between what is being offered to them and what they read and can find on the internet.

This report, written by a series of experts, patient advocates and economists provides a stark conclusion. No healthcare system can simply afford to pay for the huge increases involved in prolonging cancer patients’ lives for a few weeks. We are truly at a crossroads. The aging populations of the Western world together with our increasingly unhealthy lifestyles are dramatically increasing cancer incidence. The cost of the new technology in dealing with this could be just staggering. The last 8 drugs approved this summer by the US Food and Drug Administration cost an average of nearly 10,000 a month and that’s not counting the cost of their administration or treating their side effects.  This is a new level of expenditure for little overall gain.

I have lobbied extensively for better patient access to high cost drugs in Britain. Letters to newspapers, MPs, civil servants and Ministers by my colleagues and I have had some impact. I remember spending an afternoon at a High Court Judicial Review for one patient. It was a surreal experience where men in wigs and gowns and artificial politeness in a stuffy Victorian courtroom were determining the treatment of a patient.  Maybe doctors should become lawyers. The cost of the day could have treated ten patients with the disputed drug. But she won and got it.  

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The report is the result of contributions from many experienced oncologists. Sadly, the pharmaceutical industry declined to participate. This was an error. We all need to be partners if a long term solution is to be found. But 65% of all cancer drugs are sold in one country that is home to less than 5% of the world’s population the USA. What does industry care about Britain and its NHS? But now even the US is baulking at the high cost of the new cancer drugs. Dendreon shares plummeted from $40 to $10 this summer when its vaccine for prostate cancer simply wasn’t selling because of its high cost. Until we can get regulators, payers and providers of care together with those that make and sell the drugs it’s going to be difficult to move on.

We know that Britain is losing ground in keeping up with modern cancer treatment when compared with the rest of Europe. Our outcomes in terms of survival are still poor, and access to sophisticated radiotherapy and innovative cancer drugs far lower than in other European countries. There are still significant delays in diagnosis and staging of patients owing to inadequate provision of imaging and pathology services. In an era of personalised medicine, rapid access to sophisticated pathology and imaging services have become essential in constructing an individual treatment plan.

Over the last decade, an increasing number of cancer drugs have been licensed. In the UK, those responsible for commissioning care in the NHS have been increasingly challenged by patients and their relatives to provide new cancer drugs. Over 40 are now in the final stages of the global development pipeline. These are the products of the molecular revolution triggered by the discovery of the structure of DNA in Cambridge in 1953.  They work by targeting the molecular cogs of that go wrong in cancer.  This is an exciting time for those involved in cancer research and care. 

But the cost of getting a single drug to market now exceeds 700,000 million per compound. More sophisticated molecular diagnostics are also being developed. These are urgently needed to personalise care so increasing its cost-effectiveness. Giving the right medicine to the right patient will eventually drastically reduce the overall costs of care, but we are not there yet.   But these signatures of response are in many cases too late for the current onslaught. We need a panel of companion diagnostics to go with each new drug. Molecular signatures of response to high cost drugs that are easily determined by looking at a sample of a patient’s tumour are urgently needed. 

All hit well defined molecular targets for which measurements are available. After all, such assays are an essential part of how they were. The activity of downstream signalling cascades can now be determined in clinical samples, provided repeat tissue samples can be obtained after drug administration. Such assays could provide not only the very signatures required, but also effective surrogates of early response. And there are examples where translational data could lead to new targeted drug combinations where two pathways are blocked simultaneously. Within the next five years, clinical trials will look very different to today. Only patients whose cancers with the relevant biomarker pattern that suggests responsiveness to a new drug will be entered. After 24 hours of drug administration we will be able to measure signals of response.

And there is much else to do to improve cancer survival. Radiotherapy has until recently been the Cinderella of cancer. Yet over 50% of patients will benefit from it. The level of precision of dose delivery has been revolutionized by massive improvements in imaging and computerization. Intensity modulated (IMRT) and image guided radiotherapy (IGRT) allow dose sculpting to any imaginable shape of cancer. This dramatically increases the effectiveness and reduces the side effects. And earlier diagnosis, public education and prevention can be effective tools at saving lives. Palliative and end of life care are vital to support patients and an essential part of modern cancer technology. What we spend on drugs we don’t have for other strategies.

The National Institute for Clinical Excellence (NICE) was set up over a decade ago to assess new technologies.  However, political expediency has sometimes meant overruling its decisions.

This was first seen with Herceptin for breast cancer when Patricia Hewitt the then Labour Health Minister said all women could have it. This was followed by the saga of Sunitinib for kidney cancer. A huge amount of hassle and worry for patients, doctors and commissioners came from Sunitinib, which NICE after a long delay turned down in their guidance. There are around 5,000 new patients with kidney cancer in the UK every year. The subsequent U-turn on the Government’s stance on top-ups was driven by this one disease. NICE insists it is independent of politicians, but the reversal of the Sunitinib decision within six months, with no new data, suggests political interference.

Sadly, last year, NICE turned down Sorafenib for primary liver cancer. It is the sole drug shown to significantly prolong survival for this group of patients and is widely available in Europe and North America. The only way to access it on the NHS is to use the top-up mechanisms, which have not been uniformly implemented and you have to have the money.

The more recent New Cancer Drugs Fund of 200 million a year is another way of circumventing NICE. But allowing individual commissioners to decide how to spend this fund albeit on the recommendation of the treating oncologist brings inconsistency and post code prescribing. The costs in both financial and emotional terms are enormous. There is too much variation in outcome of applications based on the persuasive powers of a consultant and the persistence of motivated and educated patients. 

We need more honesty and transparency. As doctors we are the servants of society. We all have to face the difficult decision of how to ration healthcare together. It can never be a bottomless pit. If we spend more on cancer then other patients will suffer. Mental handicap, chronic mobility disorders, dementia and the chronic care of older people with multiple illnesses are all deserving recipients of our health funds. Society has to decide how much to put on the price of life. Doing whatever it takes to extend life by a few weeks is not a logical decision. Seeking solutions through better diagnostics and creating a policy that reflects the value of an extended life to an individual is challenging but likely to be the best way forward. That to me was the essence of this report.