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UK market access issues put on hold during election

NICE appraisals and Cancer Drugs Fund appeals will not be undertaken until May

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The market access system in England has been put on hiatus during the six-week General Election campaign. 

England's health technology assessor will not be releasing any guidance until after the 7 May election while appeals from the Cancer Drugs Fund will also be suspended.

In a statement, England's HTA body NICE said this was to: “Avoid providing a focus for political debate or detracting attention from the General Election campaign. [Therefore] NICE will not publish any guidance document, in either draft or final form, during the election campaign.”

The watchdog is essentially removing itself and its decisions - which can be controversial when it rejects new medicines, notably cancer drugs - from the public's eye when its decisions could be seized upon for political gain. 

NICE added: “Consultations that began before the election was called will continue as planned. Not publishing guidance during the election period will not significantly lengthen NICE's decision-making for guidance currently in development.

“Factual information will continue to be made available to members of the public, parliamentary candidates, political organisations and journalists in the usual way, in accordance with the 'Code of Practice on Openness' in the NHS."

A similar situation is also occurring with England's Cancer Drugs Fund, which in March was set to axe 16 oncology drugs from its approved list of medicines in an attempt to save money.

Three companies complained that their medicines should not be cut, and were given a potential reprieve when NHS England, which manages the £280m a year Fund, said it would hear an official appeal. 

An appeals board considered Lilly's lung cancer treatment Alimta (pemetrexed), Eisia's breast cancer medicine Halaven (eribulin) and Bayer's Stivarga (regorafenib) for gastrointestinal cancer - all of whom hoped they could convince NHS England to keep funding the treatments. 

But a decision on the appeal could not be made before the end of March, and as the British Parliament has now been dissolved and the General Election campaign has formally started, the three drugs will continue to be paid for until after the election. This is because civil servants cannot undertake any work in an official capacity, which includes making a recommendation on the drugs, because of the potential political connotations.

This will have given the three drugs an extra two months of funding from the CDF by May - a final formal decision on the appeals is now not expected until after the election.

Article by
Ben Adams

13th April 2015

From: Regulatory

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