The highly controversial Cancer Drugs Fund will be replaced by a new fund controlled by the National Institute of Clinical Excellence from July this year, NHS England has confirmed.
Following a 12-week consultation that ended just two weeks ago, officials have now waved through proposals that will see the CDF switch to a ‘managed access’ fund, with a fixed annual budget of £340 million.
On April 1 the current CDF list will be rolled over but will remain closed to new drugs pending the start of the new scheme in July.
Under the incoming system, all new cancer drugs will be referred to NICE for appraisal. Any drugs that receive either a draft recommendation for routine commissioning or, where uncertainty exists, a recommendation for use within the CDF will receive interim funding from the CDF from the point of marketing authorisation.
NICE will then normally issue final guidance within 90 days of marketing authorisation. If drugs are recommended for routine commissioning at this point, they will go into the normal commissioning stream. If medicines are recommended for substantive entry into the CDF, a joint NHS England and NICE CDF Investment Group will meet to agree the terms of any commercial access agreement, including evaluation criteria and a timescale for evaluation to complete.
At the end of the CDF evaluation period NICE will re-appraise the drug with the aim of making a final positive or negative assessment as to whether the drug should be routinely commissioned.
The operational detail of the new scheme will be developed over the coming months, but NHS England insists that it will help provide faster access to the most promising new cancer treatments for patients, drive stronger value for money for the taxpayer, and for drug companies willing to price their products “responsibly,” offer a new fast-track route to NHS funding.
However, the Association of the British Pharmaceutical Industry said it is disappointed by NHS England’s decision to “continue to push ahead with largely unchanged proposals” that carry a “very real risk of significantly setting back patient access to cancer medicines, now and for the foreseeable future”.
According to Paul Catchpole, value and access director at the Association, “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 CDF in the first place - we will largely get the same answers as before - the majority of medicines will be turned down”.
“Under the proposals two thirds of existing CDF medicines are likely to no longer be available to NHS patients by the end of the year,” he warned, and noted that this is “in addition to patients who are already waiting for access to around ten new cancer medicines which have been launched since the Fund was closed to new applications in May 2015”.
A previous analysis by the Rarer Cancer Foundation estimated that over 12,000 patients a year could lose out on treatment under the proposals. “The Government needs to come clean about the impact of these proposals on cancer patients by publishing an assessment of their impact,” Andrew Wilson, the charities chief executive, stressed at the time.
Also voicing strong objections to the move, Gary Hendler, chief executive of Eisai EMEA and president of the Global Oncology Business Unit, argues that the decision to implement the new CDF “pretty much as it was proposed in the consultation will put cancer treatment back to where England was prior to the creation of the Fund which is a tragedy for patients. Time is not a luxury that these patients have”.
However, Cancer Research UK has voiced its support. “Cancer Research UK welcomes today’s decision to move forward with reforms to how the NHS makes certain cancer drugs available to patients. We see this as a positive step in creating a more sustainable and flexible system. Importantly, 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," siad its chief executive Harpal Kumar.