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.

Drug approvals and age discrimination

Cancerworld recently published a debate between Professor Karol Sikora and Dr Ulrich Wedding on using age as a criterion of regulatory decisions on funding new drugs.

The push to use age as a determining factor in drug funding permissions is blatantly discriminatory. There are better methods and measures for discerning eligibility, if only someone researched them properly. The pharma industry is not interested in this research. Its business model (which determines its approach to pricing) is encouraged by the current inadequacy of HTA and political decisions such as England’s Cancer Drugs Fund. Indeed the latter encourages higher prices.

When the current UK government came to power in 2010 they vowed that by 2014 we would have a value-based approach to funding decisions. Its nearly 2015 and there is no sign of it but as there was no research into how value could be defined let alone measured, its no wonder we are back to simplistic thinking about age.

The core issues here are about the holistic treatment of a patient. Just looking at the disease (albeit hosted by a person) does not take into account the needs of the whole person. This debate should be about integrating supportive care into oncology practice, about losing the barriers between palliative care and oncology, about educating patients on the balance between cure and end-of-life care so that when disease is truly incurable patients make rational decisions themselves. Another cycle of chemo given to a dying patient is immoral.

Living and dying have to become palatable points for discussion. This will deliver benefits for individuals and society and could well cut drug costs. While politicians, healthcare administrators, academics and doctors are the main voices on this issue simplistic inward-looking solutions will result. Get patients involved, introduce some earthy common sense.