New “managed access” process for Cancer Drugs Fund to go ahead, NHS England confirms

NHS England has confirmed that from 1 July its Cancer Drugs Fund will operate on a “managed access” basis, meaning that it will fund anticancer drugs for up to two years while the National Institute for Health and Care Excellence (NICE) assesses them.

Introduced in 2010, the fund pays for cancer treatments not recommended by NICE for routine use in the NHS. Such drugs include new treatments that NICE has yet to assess; drugs for rare cancers that are not being appraised by NICE; and drugs rejected by NICE because they were not deemed cost effective.

A recent report by the House of Commons Public Accounts Committee said that the fund needed “significant and urgent reform if it is to be sustainable,” after finding that it had spent £1.27bn (€1.6bn; $1.8bn) without collecting data on outcomes of use of the drugs it provided.1

One of the barriers to the routine commissioning of some cancer drugs has been uncertainty about their clinical benefit, and therefore their cost effectiveness, when they are licensed. It was hoped that the Cancer Drugs Fund would provide this information. But there was no systematic approach to collecting relevant data.

In a major review, an independent taskforce has recommended that the fund should adopt a “managed access” procedure for new cancer drugs, with clear entry and exit criteria. After a period of consultation, NHS England has recommended in a board paper that the fund will operate this way from 1 July.2

Under the new arrangements, cancer drugs will be given a conditional recommendation by NICE and provided through the fund for a predetermined period of up to two years while further evidence is collected. At the end of this period, drugs will go through a short NICE appraisal that uses this additional evidence. If approved, a drug would then be funded as part of routine commissioning; but if rejected, it would be available only on the basis of individual patient funding requests.

The charity Cancer Research UK welcomed the decision to move forward with the change. “We see this as a positive step in creating a more sustainable and flexible system,” said Harpal Kumar, the charity’s chief executive, and chair of the independent taskforce.

“We believe the proposals will bring more certainty to patients and doctors about the drugs that can be prescribed and swifter access to promising drugs.”

NHS England said, “Drug companies will need to price their drugs responsibly, and we make no apology for maintaining the pressure on this point on behalf of the public. Companies keen to work with the NHS for patients will get a new fast track route to NHS funding for promising new drugs, backed by a speeded up and more transparent NICE assessment process.”

Paul Catchpole, value and access director at the Association of the British Pharmaceutical Industry, said that there was a “very real risk of significantly setting back patient access to cancer medicines, now and for the foreseeable future.”

“If cancer medicines go through more or less exactly the same NICE appraisal process that was in place five years ago—which necessitated the setting up of the Cancer Drugs Fund in the first place—we will largely get the same answers as before. The majority of medicines will be turned down,” he said.

“Under the proposals two thirds of existing Cancer Drugs Fund medicines are likely no longer to be available to NHS patients by the end of the year.”