CDF leader and charities urge government to reform drug pricing and access

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The chairman of England's Cancer Drugs Fund (CDF) Professor Peter Clark has called on the government to fundamentally reform medicines pricing, indicating that the 'rigid' system is no longer fit for purpose.

Prof Clark has been at the centre of huge controversy in recent weeks, having overseen the second de-listing of cancer drugs from the CDF, a process which will deny thousands of patients in England cancer drugs which are freely available in the rest of Europe.

Speaking at the annual dinner of the Ethical Medicines Industry Group (EMIG), Prof Clark said the government had to introduce a far more flexible system to reflect the changing nature of drug development and regulation, especially in cancer.

Echoing comments he made at a recent Economist event, Prof Clark suggested that pharma should be permitted to raise prices post-launch if evidence supported it, something which is unfeasible under the current PPRS pricing system.

He also said drugs should be routinely allowed different prices for different indications, as many cancer drugs show significant benefit in one tumour type, but less significant in another. So-called 'differential pricing' might allow both uses to be approved if a lower price could be applied to the less compelling indication.

However there is no sign that the government is willing to take up such ideas, despite pharma backing for such reforms.

It emerged this week that Prime Minister David Cameron has personally intervened in the review of the Cancer Drugs Fund, a move which has delayed NHS England from putting its own plans out to consultation.

NHS England wants to re-launch the CDF in April 2016 as a 'managed access fund' linked to NICE and real world data, but Cameron's intervention might see this proposal change.

Commenting on the delay following news of Cameron's intervention, charity Breast Cancer Now said a solution was urgently needed.

Dr Caitlin Barrand, Assistant Director of Policy & Campaigns at Breast Cancer Now, said: "We've been waiting for some time now to see how NHS England proposes to reform the Cancer Drugs Fund for the better and are becoming increasingly impatient, as are those we represent that rely on treatments provided by the Fund.

"With just five months left until the Fund is due to expire there is limited time now to undertake any sort of meaningful consultation on these proposals. There are huge challenges facing the access to drugs system as it currently stands. That's why it's vital that there is sufficient consultation time for any proposed changes to the system to be thoroughly assessed as to their likely impact on access for patients to innovative and effective, life-extending cancer drugs. A system that cannot deliver such access routinely is fundamentally a failure."

Mark Flannagan, chief executive of Beating Bowel Cancer, said, "It is clear that further reform is now required to support the millions of real patients who are, and will be, affected by cancer. We urgently need to get all parties back to the table to find a long-term, sustainable alternative to the Cancer Drugs Fund that ensures the benefits delivered by the Fund continue.

"The removal of a raft of treatments has been detrimental to patient care, drastically compromising clinicians' ability to make the best treatment choices for their patients. In a recent letter to The Daily Telegraph, 15 leading bowel cancer clinicians voiced their concern that we are going back to the 'dark-ages'.

"We welcomed the opportunity to work alongside other cancer charities, NHS England, NICE, and the ABPI to co-create a new system to commission cancer medicines, based on patient outcomes and evidence-based solutions. However, following the 'pause' announced in the summer, cancer charities have been excluded from further discussions. Having been shut out of the process, cancer charities must be let back in.

"The tens of thousands of bowel cancer patients who have benefited from the Fund are a real-life case study of the benefit of delivering medicines that had previously been predicted as not worth funding. In an era when patients are meant to be at the heart of NHS decision-making, this is a shocking example of the people who benefit from treatment being kept out of the process of deciding what treatment should be available."

In a witty speech, Prof Clark compared the government's rigid refusal to respond to the changing reality to that of Japan's Emperor Hirohito when declaring defeat at the end of WWII.

"He said: 'the war situation has developed not necessarily to Japan's advantage,'" said Prof Clark. "Well I would say our situation has developed not necessarily to the advantage of patients, the NHS or the pharmaceutical industry," he concluded.

An extraordinary pipeline of new cancer drugs was coming, he went on, and the NHS needed to be ready for it. Prof Clark believed that the CDF's ability to negotiate on price (and potentially risk sharing) was a huge advantage, and should be retained.

While pharma may be nervous about how this works in reality, many in the UK industry are ready to embrace change, such is the impasse in the current system.

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Andrew McConaghie

11 November, 2015