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NICE promises UK to lead Europe for cancer drug approvals

But industry says running the new CDF will present NICE with a ‘hugely challenging’ task

Cancer Drugs FundNICE has finalised the new version of the UK's Cancer Drugs Fund and says the arrangements will give the UK the fastest approvals of effective cancer drugs in Europe.

The cost-effectiveness watchdog will start overseeing the Fund from July, when - for the first time - it will issue draft guidance on new cancer drugs and licence indications before they've received UK marketing approval.

But until then no new drugs will be considered for CDF funding and, though patients currently receiving treatment through the existing CDF will continue to do so, from 1 April all of these drugs will be reappraised by NICE.

When the new arrangements do come online, drugs that earn a positive draft recommendation will receive NHS funding from the point of licence under the new regime.

Sir Andrew Dillon, NICE's chief executive, said this draft recommendation process will make the UK unique in Europe.

He added: “Patients in this country will now have access to clinically and cost effective, innovative new cancer drugs faster than ever before.”

The revised CDF will also introduce a conditional recommendation designation for drugs where evidence of their cost effectiveness is not yet strong enough to warrant induction into routine use.

Such medicines will also be made available to NHS patients through CDF funding, but will have an expiry date of two years during which the manufacturer will need to gather further evidence.

An expedited review process will subsequently determine whether the treatment will become a part of the CDF budget or restricted to use on an 'exception basis only'.

The changes will bring 'clarity to decisions about which new cancer drugs will receive NHS funding', according to NICE.

“The new CDF will be fair,” Sir Andrew said. “Companies will be given the opportunity to demonstrate their drugs will benefit patients and bring value to the NHS."

However, the proposals confirmed by NICE's board have been met with disappointment in the pharmaceutical industry.

The ABPI's value and access director Paul Catchpole said: "Today's now finalised proposals for the new Cancer Drugs Fund confirm a seemingly reduced level of ambition from NHS England for providing NHS patients in England with access to the latest cancer medicines because the NICE decision making process remains largely unchanged.

"When the new CDF opens for new applications in July there will be a significant backlog of cancer medicines waiting to be evaluated – some for over a year. Prioritising this backlog appropriately, whilst at the same time evaluating cancer medicines already nearing launch will be hugely challenging and resource intensive."

The trade association has previously estimated that under the new scheme two thirds of medicines currently funded by the CDF will no longer be available to NHS patients by the end of 2016 - a concern that does not seem to have been eased by the new arrangements.

Article by
Rebecca Clifford

17th March 2016

From: Regulatory



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