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Charities express fears over changes to Cancer Drugs Fund

They say clinically effective treatments will now struggle to gain approval

Mark Gould

Monday, 16 May 2016

Fifteen cancer charities have said they are "deeply concerned" about new plans for approving innovative cancer medicines for the NHS in England.

In a letter to the prime minister, the charities, including Beating Bowel Cancer, Prostate Cancer UK and Target Ovarian Cancer, said many drugs would "now struggle to gain approval".

But Sir Andrew Dillon, the chief executive of the medicines regulator the National Institute for Health and Care Excellence (NICE), rejected this saying that the new plans approved by NICE's board would mean that new cancer drugs would be approved faster than anywhere else in Europe.

The charities say the Cancer Drugs Fund (CDF) - a special pot of money set up by Prime Minister David Cameron for cancer medicines deemed too expensive to buy across the NHS - has been victim of its own success and has greatly overspent. Costs have risen to £340m in 2015-16 from an initial annual budget of £200m when it was set up in 2011.

In a letter seen by the BBC, the charities say they are "deeply concerned by the lack of reform proposed to the wider NICE process of appraising cancer medicines".

"Unfortunately the new system does not update the methodology used by NICE, introduced back in 1999, and many clinically-effective treatments will now struggle to gain approval. We urge you to intervene and commit to a review of the outdated mechanisms used to assess cancer medicines," they write.

The new system will start in July, fixing the fund's budget at £340m. NICE will give new medicines a Yes, No or Maybe rating before they come to market. Those given the go-ahead will be routinely offered across the NHS, while those given a Maybe rating can be considered for the Cancer Drugs Fund.

NICE says it will normally issue final guidance within 90 days of licence and that changes will bring clarity to decisions about which new cancer drugs will receive NHS funding as well as allowing the NHS to go the extra mile in offering conditional funding for those which the evidence for use is uncertain.

Sir Andrew Dillon said of the changes: “Patients in this country will now have access to clinically and cost-effective, innovative new cancer drugs faster than ever before. In a first of its kind approach, NICE will issue draft recommendations on the use of cancer medicines before they receive their licence, with funding from NHS England available if approved. No other country in Europe does this.”

If the case for routine use is not clear cut and more evidence is needed to prove cost effectiveness, then NICE can recommend the drug for temporary, conditional use in the new CDF.

Drugs that appear promising, but for which the evidence is not strong enough for routine use, will be given a given a conditional recommendation by NICE and made available to NHS patients paid for by the CDF.

The drug will remain available within the CDF for up to two years while the manufacturer gathers more evidence to show that the medicine works and is fairly priced.

After two years, NICE will conduct a review, using a shortened process, to consider the drug for routine commissioning on the NHS. This will either result in the medicine moving out of the CDF and into routine budgets, or if the company has not been able to demonstrate its case, made available on an exception basis only. In this way, a flow of new cancer medicines can be made available to NHS patients while costs are controlled in a fair and balanced way, NICE says.

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