Scrap the Cancer Drugs Fund, we need a value-based system for all innovative products

Keeping the Cancer Drugs Fund (CDF) is unfair and makes no sense, especially with a ‘bigger picture’ review also underway, argues Andrew McConaghie.

The new plans for a revamped CDF in England, finally released yesterday after a long delay, would create an innovative, value-based, 21st-century approach to paying for cancer drugs – but the fact remains that it is only for cancer drugs, and is therefore patently unfair and still politically-motivated.

The CDF was set up as a stopgap measure in 2010. It created a route to bypass NICE’s frequent rejections of oncology drugs, and stopped the politically untenable stream of stories about cancer patients being denied drugs in The Daily Mail and beyond.

Because it has remained a stopgap, the clear unfairness of cancer drugs being the only treatments to have a ring-fenced fund in England’s NHS seemed like something we could live with – temporarily.

But the proposed new CDF will make this unfairness permanent, enshrining cancer drugs as the first among equals in medicines, and a ‘special case’. This isn’t in the spirit of the NHS, overrides the basic principles of NICE’s health technology assessments, and misses out on the chance to incentivise pharma company innovation outside cancer.

Back in 2010, the plan was for the Fund to be scrapped once a planned Value-Based Pricing (VBP) system for all new drugs was introduced. But the VBP concept foundered because of its complexity and uncertainty of its outcomes, financial and clinical.

Now NHS England and NICE have released detailed plans for the new CDF, which turn it into a novel ‘managed access fund’. This will give promising but unproven drugs two years to generate compelling real-world evidence to complement clinical trial data. The least effective drugs would then be dropped, while companies with more effective treatments could negotiate price and reimbursement based on this combined evidence. A value-based pricing system – but one exclusively for cancer drugs.

The plan is for all cancer drugs to be appraised by NICE, being submitted by pharma companies at the same time as they file for marketing authorisation with Europe’s EMA. NICE would then produce a draft decision before a drug gained EMA approval, and a final recommendation within 90 days of this regulatory approval.

But this would create a ‘twin-speed’ NICE, with cancer drugs zooming through to market, while other drugs, such as those for rare diseases, Alzheimer’s, mental health or heart disease stuck in the slow lane.

What makes this review particularly short-sighted is the fact that it is running in parallel with the Accelerated Access Review (AAR) – another consultation which is trying to look at the ‘big picture’ of life sciences innovation, incentivising the best drugs, medical devices and digital health technology, not just cancer drugs.

The AAR’s chairman, Sir Hugh Taylor explicitly addressed the idea of taking the CDF system and broadening it out to all innovative drugs. The AAR interim report was published in October, and one of its core ideas was that a ‘provisional yes’ approach could be used, very similar to that proposed for the new CDF.

Bizarrely, these two parallel reviews seem to have remained distinct, despite the CDF consultation claiming that is proposals “are consistent with the emerging conclusions of the AAR”.

It seems likely that some, if not all, of the AAR proposals will be taken up – but non-cancer drugs aren’t likely to get their own ring-fenced funding, particularly as the health service is facing a huge budget crisis.

NICE’s own chairman, Dr David Haslam, made it plain this week that he doesn’t want to make cancer a special case.

Speaking at the FT pharma and biotech conference in London, Haslam said he believed that cancer should not be considered more important than other disease areas, such as mental health.

“I certainly feel cancer shouldn’t be treated any differently. You’re just as dead from suicide as you are from cancer,” he stated.

Haslam said part of his duty was to represent those patient groups who ‘don’t shout the loudest’ – a clear reference to how well-funded and well-organised cancer patient organisations can dominate media coverage. He added that, in a recent meeting with patients with the degenerative disease motor neurone disease, they asked him directly why cancer was considered a special case.

Neither is the pharmaceutical industry particularly wedded to the idea of the special cancer drugs fund. Not all companies are big players in oncology, and other therapy areas inevitably lose out if cancer treatments get special funding.

Even those companies who specialise in oncology aren’t convinced. Roche CEO Severin Schwan, also speaking at the FT conference, questioned the need for a dedicated CDF, saying it was a ‘funny concept’. Clearly, a system which can accommodate any novel-but-unproven drug, regardless of its therapeutic area, is most favourable.

There is already an example of a much broader approach, just across the border in Scotland. Its New Medicines Fund was set up in 2014 (replacing the previous Rare Conditions Medicines Fund) and covers the cost of orphan, ultra-orphan and end-of-life drugs for patients.

So why not make a VBP system for all innovative, but as-yet-unproven, medicines?

The fact is that cancer and cancer drugs remain a political hot potato – much more so than any other disease – and David Cameron, with all his instincts for avoiding damaging Daily Mail news stories – has endorsed the long-term future of the CDF.

The case for keeping cancer as a special case rests on the idea that adding extra months or years to the life of someone with cancer is particularly valuable. However this idea has never sat comfortably with NICE, which has always fought to preserve the health economics principle of striving for the maximum health gain for the entire population out of a finite budget. The new CDF consultation proposes relaxing NICE’s ‘end-of-life QALY’ for cancer drugs. This is in place of reviewing NICE’s main QALY threshold for measuring cost effectiveness – the current PPRS pricing deal with pharma stipulates this cannot be altered before the agreement expire in late 2018.

All this is not to say there isn’t a major problem with cancer drugs access in England (and the whole UK) – no-one disagrees that it still lags behind the rest of Western Europe – but it needs to be addressed as part of a broader solution.

If the government/NHS England masterplan is to extend the same approach to all medicines – and then perhaps all interventions – then all well and good. But it is a very disjointed way to create a joined-up system.

Otherwise the new CDF is in danger of being another political quick-fix, and another missed opportunity.

Related link

NHS England and NICE ask for views on the future direction of the Cancer Drugs Fund

Related articles

AAR ‘conditional yes’ deals will speed innovation uptake

Roche and NICE leaders agree: cancer shouldn’t be a special case 

 

Read more from Andrew McConaghie:

Manchester’s devolution revolution: will pharma get a seat at the table?

About the author:

Andrew McConaghie is pharmaphorum‘s Managing Editor, Feature Media.

He can be contacted via: andrew@pharmaphorum.com

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