Cancer Drugs Fund assessment to be handed over to NICE
NICE will oversee the evaluation of Cancer Drugs Fund treatments in future, under new plans due for consultation by NHS England.
After significant pressure from the pharma industry and trade bodies including the ABPI, NHS England has proposed that the ‘operational management’ of a new fund should be ‘aligned with adapted NICE processes’. The changes are a bid to curb the ‘escalating overspend’ of the Cancer Drugs Fund (CDF). Its budget has spiralled from £200 million when it was established in 2010, to £340m in 2015/16.
Under the new system, innovative cancer drugs would first be assessed by NICE using its cost effectiveness measure, the quality-adjusted life year (QALY). For drugs where there is not enough evidence for NICE to make a decision, cancer drugs would be given ‘condition approval’ by NICE, and provided through the CDF while real-world evidence was gathered about the drug’s efficacy through its use in the NHS. After a ‘defined period’ the drug would be reassessed by NICE – and either recommended for mainstream NHS funding, or refused by NICE and funded separately by individual patient requests.
The proposals will be discussed at an NHS England board meeting this week. The meeting papers say: “In future the CDF should become a ‘managed access’ fund for new cancer drugs, with clear entry and exit criteria. It would be used to resource those drugs which appear promising, but where NICE indicates that there is insufficient evidence to support a recommendation for routine commissioning, and where additional evidence would be likely to enable a more informed NICE appraisal decision. Instead of a simple failure to recommend, the drug would be given ‘conditional approval’ by NICE and provided through the Fund for a defined period, whilst further evidence from ‘real world’ use was collected.
“At the end of this period, the drug would go through an abbreviated NICE appraisal, using this additional evidence and the company’s offer price, and then either attract a NICE positive recommendation at which point it would move out of the Fund into mainstream commissioning, or a NICE negative recommendation at which point it would move out of the Fund and become available only on the basis of individual patient referral.”
This reflects arrangements hinted at by CDF chair Professor Peter Clark, who argued the CDF has given pharma companies a ‘get out of jail free’ card to avoid a NICE appraisal. The new system will be set out in full for consultation in September, and once agreed will be introduced in April 2016.
NHS England hope the new system will be flexible enough to allow patients to access innovative cancer treatments, including a new wave of immunotherapy drugs that the document acknowledges could be ‘game changers’ for people with cancer.
The ABPI has tentatively welcomed the changes. Paul Catchpole, ABPI director of value and access, says: “In the context of the CDF, these proposals should help speed up NHS patient access to the latest medicines and help patients benefit from innovative cancer drugs that are routinely available in many other European countries.
“We are pleased to see that the new proposals intend to address some of the key areas for change that the ABPI has been calling for and in particular a new system aligned with NICE to deliver a more robust and rapid evaluation process, flexibilities around the use of the current end-of-life criteria and the introduction of conditional NICE approvals for promising medicines until additional evidence can be collected. There is more to be addressed but it is a very encouraging start."
Read the NHS England proposals here.