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expert reaction to review of drugs paid for by the Cancer Drugs Fund

NHS England has reviewed the Cancer Drugs Fund and announced that twenty five different treatments will no longer be funded by it. The Fund is forecast to be £100m over budget this year.

 

Prof. Hardev Pandha, Professor of Medical Oncology, University of Surrey, said:

“This decision will be hugely disappointing for many patients and their families. In essence, we have to show ‘value for money’ as well as positive outcomes in highly respectable randomised international clinical trials. This is confusing for patients, many of whom altruistically participate in trials without this ‘value’ or health economic discussion.  The Cancer Drugs Fund was never designed as a long term solution: we urgently need to develop an effective, durable and relevant alternative.”

 

Prof. Tony Culyer, Professor of Economics, University of York, said:

“The CDF is a tawdry screen drawn across reality by a government that is either ignorant (which is scarcely believable) or unashamedly a pawn of the pharmaceutical industry. There is no case for it unless there is a case for distorting NHS funding in the specific direction of a particular class of cancer sufferer, namely those who may be able to derive a very small benefit from the most overpriced medicines available. That case does not exist. CDF violates the basic equity of NICE decisions and elevates trivial benefits for some who are desperately ill above more significant benefits to others who are equally gravely ill. NICE makes such comparisons openly and fairly. Not so the CDF. The pharmaceutical industry has produced some wonderful medicines. But it is being encouraged to produce expensive but trivial products because CDF will pay for them. The true payers are NHS patients who go without as a consequence. It is a shameful business. This is not a matter of mere opinion. The evidence is plain. Ask Professor Claxton.”

 

Prof. Karl Claxton, Professor of Economics, University of York, said:

“The decision to increase the CDF to £340m will increase the already considerable net harm done to NHS patients. Evidence from recent research suggests that these resources would make much greater improvements in survival and quality of life if made available for all NHS care; adding over 26,000 Quality Adjusted Life Years to the lives of NHS patients.  An optimistic estimate of the health benefits of the CDF would be less than 6,000 Quality Adjusted Life Years, indicating that over 20,000 QALYs will be lost across the NHS as a consequence of this decision.

“The CDF was originally proposed as a temporary measure until a price negotiation mechanism with manufacturers was in place.  This critical issue of establishing prices for new drugs that reflect how much the NHS can afford to pay for the benefits they offer has not been addressed. The CDF and the steps taken in this review have done nothing to address this fundamental issue. As a consequence the problem that NHS patients face in accessing new drugs continues to be the prices that are being charged by manufacturers.

“The net harm the CDF has done to the health of NHS patients is substantial and will increase over the next two years as the fund takes more resources from the rest of the NHS at a time when it is under increasing pressure. A desire to support a multinational pharmaceutical sector seems insufficient justification for the real harm that has and will continue to be done to NHS patients.”

 

Prof. Richard Sullivan, Director, Institute of Cancer Policy, King’s College London, said:

“Instead of dealing with the issues of delivering an affordable and equitable cancer care system in the UK and fairness for all cancer and non-cancer patients the CDF ‘review’ has continued to march down the path of irrational, inequitable public policy. The lack of transparency and accountability surrounding the review of the CDF is a cause for grave concern in itself, never mind the the ad hoc nature of the ‘decision’ on the one hand to increase monies going into the fund, yet stop some cancer medicines being funded. The review has left us none the wiser as to whether the monies already spent by the CDF have really benefitted patients; in other words whether the amount of benefit they delivered in terms of extra life and / or quality of life justified the costs of due to toxicity. By failing to address the real issues of fair pricing for clinically meaningful benefit, short circuiting  gold standard of NICE, and ignoring issues of fairness where cancer medicines are seen to have more value than surgery, radiotherapy, palliative care, et al, and indeed medicines for any other disease, today’s announcement is a pyrrhic victory.”

 

Mr Stephen Whitehead, CEO of the Association of the British Pharmaceutical Industry (ABPI), said:

“NHS England’s decision to delist 16 cancer medicines with 25 separate clinical uses is extremely disappointing and a significant blow to the health and wellbeing of future NHS patients. These medicines have been proven to be effective through clinical trials and have already provided benefit to thousands of NHS patients through their prior availability on the CDF.

“Whilst we are pleased that treatment for existing patients will be protected as a result of this decision and that some new medicines will be included in the CDF it does not detract from our longstanding belief that the CDF and this re-evaluation process was fundamentally flawed. The CDF remains a sticking plaster. The solution to this issue remains the urgent reform of NICE which will ensure that the right patients get the right medicines at the right time whatever their condition.”

 

Prof. Lesley Fallowfield, Director of the Sussex Health Outcomes Research & Education in Cancer, University of Sussex, said:

“My own views about the CDF are quite clear. I believe that it undermines NICE (even though I am no apologist for the processes that NICE utilises to determine QALYs). The CDF also appears to produce somewhat arbitrary decisions that are even less transparent than those of NICE.

“How to move on? As a passionate advocate for patient access to the best evidence-based treatments, I believe that Pharma and others must fund much more comprehensive evaluations of the patient reported harms and benefits of treatments (that is Quality of Life with the correct measures not just EQ5D) and fund research into the supportive and ameliorative interventions that are needed to control the side-effects of otherwise efficacious treatment. If those data were more widely available (and they usually are not because such studies are not properly designed or funded within clinical trials), then there would be better data to support payments for new, expensive drugs.

“The latest list as far as I can see contains some surprising exclusions and inclusions and I can see why desperate patients, their families and clinicians are outraged.

“This whole issue of who wins when one has infinite demands on a finite budget can only be resolved with sane debate. This is unlikely to happen with a general election in the offing and all parties jostling for position as the most cancer patient friendly.

“My research team feel very sorry for the oncologists and their patients who will soon be having very difficult and uncomfortable conversations about treatment options when they are limited. It really isn’t easy to help focus patients and their families on stark realities about escalating budgets for cancer and the sometimes rather small benefits shown for some of the drugs. What is considered a worthwhile benefit for some is not worth a candle to another especially if the extension in survival comes with side-effects. The cancer conversation is often bad, sad and difficult and all parties involved need help negotiating their way through, things have just become a little bit harder.”

 

Prof. Chris Bunce, Research Director at Leukaemia & Lymphoma Research, said:

“We are very concerned indeed that so many drugs for blood cancers like leukaemia, lymphoma and myeloma have been de-listed from the Cancer Drug Fund. The decision to remove effective drugs from so many patients represents a dramatic step backwards. Many of these treatments can significantly prolong survival times and provide a good quality of life for diseases that can have devastating symptoms. In many cases, patient populations for the drug indication are very small, so the total cost burden to the NHS is actually relatively low.

“A constructive dialogue between all parties is needed to get to a long term and sustainable system that ensures patients can access the treatments they need.”

 

Prof. Christopher Twelves, Professor of Clinical Cancer Pharmacology and Oncology, University of Leeds, said:

“The CDF was always a short-term fix and ultimately not sustainable or equitable as it was established.

“Given that there was a planned time limit to the CDF as established it beggars belief that a process for dealing with the inevitable increase in demands on of the CDF has not been put in place. The whole recent review process was very hasty, with limited scope for interactions or discussions with the NCDF.

“My main concern, however, is around the process of that review. With reference specifically to eribulin, it appears no attempt was made to address the cost side of the equation with the company apparently not given the opportunity to discuss discounting. This seems to be because eribulin was “scored” poorly by the NCDF on clinical efficacy (OS, PFS, toxicity and QOL). This conclusion that eribulin lacks efficacy effectively means the CDF is ignoring good quality clinical trial data and overturning the favourable opinion given by EU and other regulators across the world.

“In the end it will be our patients who are deprived of the only cytotoxic proven to increase survival, albeit modestly, in women with heavily pre-treated metastatic breast cancer.”

 

Declared interests

Prof Christopher Twelves is on the Speaker’s bureau for Eisai.

Prof Richard Sullivan has unrestricted educational grants from Novartis and Pfizer, and has received lecture honararia from Easi, Novartis, and Pfizer – all this goes to the Institute of Cancer Policy.

Prof Karl Claxton is a faculty member of the Roche Payer Evidence Council.

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