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Cancer Drugs Fund: assessing a difficult legacy

Published on 03/02/14 at 08:20am
CDF image
The CDF has undeniably boosted treatment access levels, but its clinical impact is more difficult to determine (credit Nic McPhee)

England’s Cancer Drugs Fund (CDF) is very good at creating division: its lobbyists say that it increases access to new cancer medicines for thousands of patients, whilst its detractors question its cost-effectiveness and the political motives behind its implementation.

That it has increased market access to new oncology products is undoubted. By March this year, it was estimated that around 30,000 people in England had gained access to drugs such as Roche’s Avastin (bevacizumab) and Merck KGaA’s Erbitux (cetuximab) that they otherwise would not have through the NHS. 

It is believed that 16,000 patients would be denied access to cancer medicines every year without the CDF. But many of these treatments - including Avastin and Erbitux, the two most commonly funded through the Fund - have not been deemed cost-effective by NICE.

This is because the CDF, first set up in October 2010, was designed to inject £650 million into the NHS until March 2014 for new cancer drugs that were rejected by NICE, or under appraisal by the watchdog.

Its establishment has been roundly supported by pharma. Paul Catchpole, director of value and access at UK pharma group the ABPI, tells Pharmafile: “The availability of the Fund has enabled tens of thousands of NHS cancer patients to get access to innovative new cancer treatments that otherwise they wouldn’t have been able to. So I think it’s had a very positive and a very helpful effect on NHS cancer care.

“There’s a second benefit as well that’s worth thinking about. It’s allowed patients to get access to some cancer drugs that haven’t been available in the UK for some time because they’ve never been approved by NICE. That means that patients who have become established on those treatments may become suitable for clinical trials of newer treatments because their standard of care has been brought up to date, compared to other countries.”

But does the creation of the Fund indicate a tacit recognition that NICE has failed to deliver when assessing new oncology products? Catchpole says that the Fund was set up as an acknowledgement that access to cancer medicines in the UK was ‘considerably lower’ than in other comparable European countries.

It was also a recognition of the fact that the main process - i.e., the NICE process - of evaluating cancer medicines wasn’t working to everybody’s satisfaction. “We’ve got to find out what isn’t working,” he argues. 

He continues: “There are specific issues to do with cancer medicines that sometimes make it difficult to evaluate them. So, for example, on compassionate grounds patients in cancer studies are often crossed over to the active treatment arm that they can potentially benefit from.” 

He says that crossover in clinical studies is good for patients, but it means that there can be uncertainty in the evidence base that’s generated. That uncertainty means that modelling has to be conducted in order to work out overall survival benefit. It can be difficult to translate short-term data or immature data on progression-free survival into overall survival data. 

“Things like that can start to create uncertainty in the evidence base,” Catchpole explains. “When you then feed that in to an economic model, which you need to look at the cost-effectiveness of the medicine, it can make appraisals challenging. So it needs a certain view on how to deal with that uncertainty. 

“At the end of the day, regulators perhaps take a different view on how to deal with uncertainty than [health technology assessment] bodies do in general. The regulator will approve a medicine for the benefit of patients - to get access. I wonder if there’s a growing imbalance on how we look at uncertainty in evidence for cancer medicine, with the regulator taking one view and the HTA body taking a more conservative view.”

Political motives

There have certainly been problems in terms of market access in England for new cancer medicines, and the Fund has proven popular with the public, several cancer charities and the majority of figures in pharma. It came as no surprise, then, that British prime minister David Cameron said late last year that he would extend the CDF until 2016. 

This means that an extra £200 million will be given to the NHS each year until after the next UK general election, bringing the total spent on these medicines - many of which NICE have deemed not cost-effective - to tip the £1 billion mark. 

In a time of austerity, and with the NHS drugs bill set to be curbed by the government for the next five years, this decision is somewhat perplexing - until you begin to consider the underlying motives for the continued existence of the Fund. 

In making the announcement in September, Conservative health secretary Jeremy Hunt said the government had made an exception for cancer because they considered it ‘the number one killer’. But the biggest killer in the UK remains coronary heart disease, causing almost 74,000 deaths each year in the UK - and yet there is no ‘heart drug’ fund.

This is partly because drugs for heart conditions are much cheaper and relatively easier to produce than biologics for cancer, but also down to the fact that cancer is a bigger fear for the public than heart disease, and politicians understand this. 

The motivation for the government is political: it has managed to quell the ‘nasty NICE’ headline stories that derided the watchdog - and in part politicians - for rejecting ostensibly ‘miraculous’ cancer drugs, whilst also buying itself some extra votes in the next election by being seen as pro-NHS. 

For pharma companies marketing cancer drugs - who lobbied the government hard in the months leading up to the CDF extension in September - it means more money for their UK subsidiaries and greater awareness about their medicines. 

But what about patients? Many cancer patients have received drugs, but there is no guarantee that these have helped in clinical terms - or if they have, it may have come at a high financial price. These patients may have had their lives extended or bettered by these medicines, but the relevant clinical data are not available for public consumption - and NICE has already adjudged for many of these treatments that their benefits were not high enough to justify their cost.

Short-termism

But despite the extension, the Fund is not universally popular with pharma, and its UK voice the ABPI was clear that it cannot be used as a long-term solution. 

Catchpole says: “It’s a sticking plaster, if you like. It’s a temporary solution that’s definitely worked and been effective but I think we need to sort out the main system that looks at cancer medicines - those are the HTA processes in the UK.” 

The Fund was in fact meant to be a stopgap before the government’s new Value-Based Pricing (VBP) scheme came into force, as that was originally designed to stop the need for specialist funding of new cancer medicines. 

But as Pharmafile reported recently VBP has made way for value-based assessments that shall be led by NICE. Catchpole says: “At one point, it might have been the case that Value-Based Pricing might have helped explore some of those issues, but that hasn’t been the case.

“So, we’re not yet in a position to say what might be done by NICE to fix the problem but we’ve got two years to do that job. Ideally, we want to get into a position where the CDF is not needed anymore and we can use mainstream evaluation systems after they’ve been changed so that they’re more supportive of innovation in new cancer medicines.” 

By extending the Fund and effectively dropping VBP, the government has tacitly acknowledged that it was never going to increase access to cancer medicines, and that the new PPRS scheme will not be able to either. 

Catchpole goes on: “The ABPI have been clear: we’ve said that the CDF should be extended until a time that whatever replaces it is able to demonstrably show levels of patient access equivalent to what we have with the current system. We’ve made some good progress, so we don’t want to go backwards. 

“This needs to be done in dialogue with all of the relevant stakeholders who’ve got an interest in this. So, that’s NICE, patient groups, clinicians and industry. As stakeholders with an interest in this, we need to get our heads together in dialogue and try to work out what’s needed to be done.”

Outcomes

The primary issue at hand is whether the medicines rejected by NICE and paid for by the CDF have improved outcomes, as well as access, and this revolves around whether patients taking these NICE-rejected medicines have seen increased overall survival, progression-free survival, or better outcomes in other measurable ways. 

If the criterion of success was increased access, then the CDF is an unbridled triumph: but what use is having a health technology assessor in NICE if it is undermined by a device such as the Fund, which intentionally ignores clinical outcomes and cost-effectiveness, and simply pays whatever price pharma asks for from British taxpayers’ money? 

There is also the ongoing question of equality: why are there no funds for MS, dementia, manic depressive disorder, and so on? These are all conditions which have an unmet medical need for many patients, create major disability and affect patients for decades - are these not worth a silo fund as well? 

The answer from the government is clearly ‘no’, as no other fund of this type has been created since 2010, and there are seemingly no plans for any on the horizon.

Catchpole says: “Yes, the CDF is a ring-fenced fund and, yes, that means it favours cancer over other disease areas which is why, in the longer term, it’s not sustainable. But at the end of the day, it’s been a very practical and straightforward mechanism and it’s had a big impact. So, until we have something else that’s better, I think we’ve got to support it.”

Cost-effective use of NHS resources

In November’s issue of Pharmafocus, columnist and chief executive of cancer charity Myeloma UK Eric Low said that the CDF “doesn’t make for a good use of limited NHS resources”.

Responding directly to Low’s comments, Catchpole says: “That’s not quite true. NHS England administers the Fund and the chemotherapy clinical reference group (CRG) is responsible for it. A CDF panel was established and that panel uses a structured evaluation approach to decide which medicines to put on the Fund. So there is a level of scrutiny placed on all of the medicines that go through the CDF.”

He says that there are two important features of the process - the first is that it is clinically driven. “The original intent of the fund was to allow individual commissions to prescribe the drugs that they thought would most benefit their cancer patients. So, it’s a panel that’s composed of clinicians largely, which is positive.” 

Secondly, they use an evaluation approach which has lots of different criteria - and those criteria are clinically driven as well, he says. This means that data are looked at to assess what drugs are worthy of being used via the Fund, and it is therefore not simply waving every treatment through.

“So, yes, they look at overall survival, they look at quality of life; they look at toxicity and side effects. So it’s not fair to say that these medicines are not being scrutinised - they are. There’s an evaluation process that’s administered in a very structured way to decide which medicines should go on.”

But is this a duplication of what NICE does, or is it simply more liberal in its approach to assessing these drugs, only barring those that are deemed beyond the pale in terms of expense or clinical outcomes? 

Another significant consideration is that there is no way for the public to access central data on outcomes and costs, meaning it is hard to hold these bodies accountable for their decisions, or to assess the genuine success of the Fund. 

Legacy: editor’s comment

Overall, the Cancer Drugs Fund has a difficult legacy and it is hard to evaluate just how many cancer patients have had increased survival as a direct result of it. Similarly, it is not clear whether the scheme should be replicated in other countries such as Wales or Scotland, where no such funding is in place.

As Catchpole states, however, the CDF should not be seen as a long-term solution; in the autumn, NICE’s remit will be extended in medicine assessment and this should translate into more oncology medicines being used in the NHS.

But the problem still comes back to price and cost-effectiveness. Pharma is quick to deride NICE when it rejects a new oncology product, but many of these medicines cost tens of thousands of pounds per patient and may only increase survival by mere weeks, with the added potential of nasty side effects.

Just because a drug has been deemed safe and effective by the European Medicines Agency does not mean that it should automatically be paid for by the British taxpayer. In effect, this is what the Fund does, undermining the HTA process in England along the way.

The introduction of the patient access scheme in the 2009 PPRS deal has done much to allow cancer drugs (as well as other medicines) to be used in the NHS, as NICE essentially pushes pharma into offering a price cut, ending the stalemate of a rejection or the time-consuming re-admission of
a product.

But the real change to help get these drugs into the market in the UK will not come from siloed funds, but rather from these drugs costing less in the first place. 

Both the government and pharma play on the fear surrounding cancer for their own ends, but pricing a cancer drug artificially high simply because it treats a feared disease does not seem fair to the NHS or, more pertinently, to patients. 

Ben Adams and Hugh McCafferty

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