Twenty years on from Calman Hine …

four covers
The new Cancer Strategy is a remarkable piece of work for its breadth and depth of detailing. This could, and deserves to be, as far reaching and valuable in terms of patient benefit as the Cancer Plan of 2000. If you look back to Calman Hine in 1995, through the Cancer Plan, then the 2007 Cancer Reform Strategy you get documents from very different times in the evolution of cancer care all of which help provide the foundations for the new Strategy. The 2011 Cancer Outcomes Strategy is probably best forgotten as rooted in post-election political nonsense.

The important thing about this plan is that it is grounded in well researched and understood realities. It is do-able and it can shift the quality of care upwards as well as handle the growing numbers of patients. The 2000 Cancer Plan had some lofty ambitions; the 2007 CRS trod into unfamiliar territory; this is going to put real buildings on the secure foundations these two pieces of work created.

The six headline priorities map out clearly some key targets and the Government cannot ignore the value that these offer.
A radical upgrade in prevention and public health. Smoking and obesity are the high prioritiy targets.
A national ambition to achieve earlier diagnosis. The ambition set out is that, by 2020, 95 per cent of patients referred for testing by a GP are definitively diagnosed with cancer, or
cancer is ruled out, and that patients get this result within four weeks.
Patient experience on a par with clinical effectiveness and safety. Improving the use of IT, making CNS more accessible, and making the National Cancer Patient Experience Survey an annual event.
Transformation in support for people living with and beyond cancer. By 2020 every person
with cancer should have a comprehensive plan that outlines treatment as well as post-treatment support and care. CCGs must commission appropriate End of Life care, in accordance with NICE guidelines and the Choice Review.
Investment to deliver a modern high-quality service. A plan for radiotherapy machines (linacs) covering upgrading and replacement. A permanent and sustainable model for the Cancer Drugs Fund. A national molecular diagnostics service to guide more personalised prevention, screening and treatment. Plans to address critical deficits in the cancer workforce.
Overhauled processes for commissioning, accountability and provision. Most treatment to be commissioned at population sizes above CCG level. By 2016, a network of Cancer Alliances should be established across the country to address service variation and support redesign.

I really like the way that the three strands of what was unfamiliar territory in 2007 now come together as key elements in the Strategy – early diagnosis, data and information, and survivorship. In 2007 we felt we were being bold tackling three completely new strands of of activity. NAEDI, NCIN and the National Cancer Survivorship Initiative all broke new ground and have achieved so much in seven years that their work is being embedded and taken further in the new Strategy.

The treatment chapters are probably the areas where most interest will be shown. Here the big hidden issues about workforce come to the fore strongly – not enough oncologists, radiologists, radiographers, CNS etc and a complete absence (until now) of any meaningful national workforce planning. The importance of new investment in linacs is something we have seen before and will, if there is continuing absence of planning, see again. These two areas are perhaps a shattering condemnation of the last five years – the absence of planning, the slow but obvious decay of service standards and the long term potential for patient harm. By contrast the big headline issue, high cost drugs, can be glossed over. The call for the Cancer Drugs Fund policy review to come up with a sustainable answer to the problem will resonate with NHS England.

At a personal level I am delighted at the new emphasis on palliative care and end of life care. I have long believed that palliative care and oncology practice were not separate disciplines and that this should be recognised clinically. It is in the strategy. Similarly those of us that work with local support groups will be aware that end of life care is far from integrated. It is usually community based, with lack of clear leadership, multiple provider agencies, leaving patients feeling as though they have been dumped. The message is about getting acts together.

For patients perhaps most striking priority is the call to be heard, to be supported through the NHS jungle, and to be given results as of rightn rather than when it is convenient. There is a strong emphases on research, other patient reported measures, and patient involvement. With CQC getting stronger in the regulatory mix (and a friend of cancer patients influential in this) plus the restoration of Peer Review, albeit with a new name, patients will have watchful allies as well. Stratified medicine is another patient friendly development. The full implications are not yet understood so the need for focus on the opportunity and being flexible to explore it is the message.

Talking of restoration. A National Cancer Team! Cancer Alliances! What a damning statement about the NHS reconstruction started by Andrew Lansley and continued by Jeremy Hunt. The National Cancer Action Team and Cancer Networks were only disbanded in 2013. The fact that they need reinventing barely two years later confirms it as the mistake many said it was at the time.

The Independent Taskforce, chaired by Harpal Kumar CEO of Cancer Research UK, should be congratulated on a remarkable piece of work. It was all done in six months, there was wide consultation,evidence was sought and analysed. The work is detailed and considered. If only every policy had this kind of report behind it.

Update – a view from the sunshine

The idea of getting away for the worst of the winter has always been very attractive. This year, for the very first time, we have been able to do it and we have gone to the Costa Blanca. The weather here is like an early summer’s day at home. Temperature out of the wind is in the mid-20s, though the wind has a chill to it and the official shade temperature comes down to 17 degrees. Its hard not to gloat, knowing the UK is in the grip of snow and ice with temperatures below zero for most of the day.

Going away however has other dangers. Everything seems to be happening. The Cancer Drugs Fund debacle, Harpal Kumar’s Task Force, at Sarcoma UK we are about to publish our study into gynae sarcoma, and NICE is about to publish (later this week) the Quality Standard for Sarcoma – the first of the rare cancers to have a Quality Standard. We also have the British Sarcoma Group Conference at the end of February. And then there is a General Election in May – although with the intensity of the campaigning which is already underway you’d think it was in early March.

So where do we stand on all these happenings?

Two weeks on from its controversial announcement CDF is revealed as a tawdry beast, built by politicians then deserted by them, taken on by a strong oncology commitment with patient interests at heart, unsupported by mandarins and then dumped by them when the heat built up. CDF will have spent over £1.2bn by the time it is meant to finish in 2016 and it has not gathered a single bit of efficacy data to support its spend. It has distorted the research community as new indications have been funded immediately off-label rather than real evidence being developed in an academic trial – a letter from Professor Matt Seymour of NIHR to Sean Brady, National Clinical Director for Cancer revealed that issue. Above all it is quite clear that the pharmaceutical industry has been benefitting, some companies being exploitative in their approach to it. The one thing it has achieved is to get people thinking evidence, research, new methods in research, and rational approaches to drug regulation.

Harpal Kumar’s Task Force is a welcome development. Not only is he the right person to be undertaking such a sweeping review it is going to be done quickly. The aim is clearly to have something approaching a new Natonal Cancer Plan by the time there is a new government. The new emphasis on early diagnosis will clearly be a key part of whatever comes out of the discussions.

Sarcoma UK”s report on gynae sarcomas deserves close attention. it is sub-titled ‘The Hidden Cancer’. We have long believed these patients are among the worst treated in the whole cancer community and this survey, of over 50 patients, shows just how poorly treated some of them are. There will be attempts to deride this study as too small to be representative. Consider however the sample size and the incidence of the disease. It is equivalent to an 8500 patient study in lung cancer – that would never be ignored, it would get front page treatment. Available on Sarcoma UK’s website from Tuesday.

The NICE Quality Standards programme is something of a treadmill for those involved in it. The process for a standard in sarcoma started in spring 2014, finished before Christmas and is being published at the end of January. The aim is a set of clear statements which define a quality service in the NHS and together with defined measures allow commissioners to assess quickly whether they are getting value for money. The NICE standing committee was supplemented by six people with an interest – two surgeons, an oncologist, a radiologist, a specialist nurse and a patient (me). There was lots of detailed debate, including some passionate episodes from a member or two. We agreed that diagnosis and the pathway to first treatment were the priority so when you read them (published on Friday 29th) do not be put off by the tight focus on the early stages of disease. More on this in due course.

The BSG Conference is from February 25th at the East Midlands Conference Centre in Nottingham. It is the annual educational event of the UK sarcoma community and provides the best all round view of developments from treatment, nursing care, through NHS structure, to regulation and of course sarcoma community affairs. If you are interested see the BSG wesbite at

As for the General Election – I leave that to others.

Cast into oblivion

Among the cancer drugs refused continuing funding through the revised Cancer Drugs Fund are three treatments for sarcoma, one of the groups of rare cancers.

Sarcoma patients are used to discrimination through rarity – they have suffered for decades. When a drug company decides to test its new treatments in sarcoma it is welcomed, but few drugs survive the trials process. When one does survive, showing benefit to patients, it is fair to expect it to be accepted by funding bodies such as the NHS.

Two recent drugs that have come through this process are pazopanib (Votrient) for advanced soft tissue sarcoma and regorafenib (Stivarga) for 3rd line use with GIST. Another drug, pegylated doxorubicin (Caelyx) had shown real value for the treatment of cardiac sarcoma patients.

The first two have been refused appraisals by NICE because it is judged they are applicable to so few patients that the costs would be disproportionate. The third will never be appraised by NICE because it is an off-label treatment for which a licensed indication is unlikely when only a handful of patients are treated each year.

All have now been refused funding by the Cancer Drugs Fund. I estimate that they account for between £1 to £2m of the CDF budget and more than 10% of the refused drugs.

They have no other route to NHS approval. They represent half of the new generation drugs licensed for sarcoma. Patients have been benefiting but now, using criteria valid for commoner cancers but not for rare situations, they have been de-listed.

This is blatant discrimination against rarity.

Cancer Drugs Fund – inevitable signal for wider change

If I remember correctly the Cancer Drugs Fund was set up at the same time as the Government announced it was to establish a value-added base to NICE drug appraisal which could support and reward innovation. NICE was left to consult on it, which it diligently did. However it became apparent that without an agreed definition of ‘value’ and without agreed means and methods of measuring and quantifying ‘value’ this was a fruitless task. The current Secretary of State has made no comment on this issue and his dis-interest in value/pricing has left the Cancer Drugs Fund exposed in an unsustainable way that means that the Government just has to keep putting more money in.

The re-working of the Cancer Drugs Fund, now underway, is long overdue. Professor Peter Clark, the well respected oncologist who chairs it, has been left with the difficult task. One can argue that he has been left with the problem when the politicians who created the fund, and NHS England, which now owns it, don’t want that profile. Sadly for him, I don’t know of anyone better equipped for the task. He is, however, going to field a lot of criticism and it is going to echo into the l;eval system and the political arena.

The Fund was set up to ensure that people with a rarer cancer got an equal chance at new technology drugs as those with more common cancers. It was also aimed at treatment which had been refused NICE approval. Among rare cancers are drugs which have applicability to 50 or 60 patients a year and which are never going to be appraised by NICE because the cost of doing so is unreasonable. These should get funded. At the other end of the scale it is questionable whether a drug which NICE has rejected on the grounds of cost effectiveness should receive funding. However such drugs quite often already have an applicability outside the strict indication for which they were appraised by NICE. It is a factor of timing as much as anything else and these new indications can carry a badge of rarity because they are off the standard track of treatment.

The CDF budget has inevitably burgeoned and the focus on drugs is also threatening to distort the evolving balance of treatment opportunity as new technologies in radiotherapy and new therapy methods employing techniques such as sound and light, appear.

The review was inevitable, the squeaks of complaint from pharmaceutical companies are inevitable and the protest of patient groups is inevitable.

What is the answer?

There is no easy answer but if we look at the longer term history, which provides the context for the CDF, we can perhaps see a way through. The answer is in NICE which has consistently failed to recognise cancer as anything different from other disease/treatments areas. It uses a generic means of assessing the quality of benefit achieved by a treatment in isolation from the whole patient context in which that treatment takes place. Its former chairman, Professor Sir Michael Rawlins, instructed committee chairs to be ready to use their judgement. However the whole NICE appraisal process is quite rigorously focussed on the new drug and its immediate treatment purpose, not the value a drug can offer in the widest patient sense. The cost per QALY* benchmark has not altered in 18 years, not even to reflect inflation, and bandages put over the process such as “end of life” criteria are just that, bandages.

Peter Clark and his team are not trying to be another NICE but they are trying to identify criteria which allow them, openly, to refuse funding for a drug which offers little or no value. Let us hope they don’t try to evaluate drugs for rare cancers with the same sriteria as those for common cancers.

Rather than wingeing the pharmaceutical industry should be taking steps to illustrate indisputable value in their new agents. The current clinical trials model which industry (and to be fair regulators too) are wedded to does not do that. It’s a broken system. The patient community is not short of ideas on how to change things. The medical oncology community is also beginning to question the endless ‘me too’ drugs, treating yet another tumour pathway and offering another month of life with yet more side effects but only in common cancers of course**. Schemes like Cancer Research UK’s Stratified Medicine programme are welcome developments which will help change the shape of treatment and of drug regulation. Bring ‘em on.


*Quality Adjusted Life Year – a statistically derived measure of patient benefit built on factors which are so opaque you need a degree in Health Economics to argue them.

**Because that’s where you get the quickest payback.