On 16 March 2016, the NICE Board approved the implementation of the new Technology Appraisal process and methods in line with the new operating model of the Cancer Drugs Fund (CDF).
A modified appraisal process for cancer drugs was introduced on 1st April 2016 and now allows NICE to make one of three recommendations:
- Recommended for routine commissioning - 'yes'
- Not recommended for routine commissioning - 'no'
- Recommended for use within the CDF (new)
The Standard Operating Procedure for the new CDF operating model is available on NHS England’s website.
Read our updated methods and processes guides:
NHS England have agreed the new operating model will go live from 29 July 2016 to allow for further work on the operational detail to be completed. However, both organisations are engaged in managing the transition arrangements for drugs that are currently on the CDF. In order to complete the transition quickly and efficiently, NICE has put in place a rapid reconsideration process to decide whether licensed drugs currently in the CDF should remain in it, should be recommended for routine commissioning, or cannot be recommended at all.
In order for NICE to be able to appraise a significant number of drug-indication pairs, during the course of 2016/17, preparatory arrangements for the transition started during the public consultation on the future of the CDF (from Nov 2015 – Jan 2016).
It is in this context that NICE has considered all drugs currently available on the CDF and categorised all drug-indication pairings into 3 groups:
Group 1: Drugs currently in the CDF for which NICE has published guidance, or that are scheduled to complete before 31 March 2016
In order to decide whether drugs currently in the CDF should remain in it after April 2016, NICE will invite an evidence submission from the companies involved. These evidence submissions will need to contain sufficient information to allow the NICE appraisal committee to decide whether the product should receive a recommendation for ‘routine commissioning’, whether it remains in the (new) CDF, or cannot be recommended at all.
NICE will hold additional appraisal committee meetings during 2016 to consider products in group 1.
Products for which no expression of interest or evidence submission is received will not be considered by NICE as part of the transition process.
Group 2: Drugs currently in the CDF and being appraised by NICE
NICE will allow further evidence submissions to address CDF arrangements for these topics at an appropriate point in the relevant ongoing technology appraisals.
Group 3: Drugs currently on the CDF but which have not yet been appraised by NICE.
These products will be subject to a standard technology appraisal, as NICE will need to seek Ministerial referral before starting the appraisal. The appraisal process for each of these will allow for submissions to be invited at an appropriate time for Committee consideration after 1 April 2016.
In November 2015, NICE and NHS England published a joint consultation on the future of the Cancer Drugs Fund. The consultation document presented compelling arguments for change, based on the need to ensure that only those drugs with real promise but uncertainty as to their value to patients and to the wider NHS are admitted to the Fund.
Further information and the consultation documentation is available via the NHS England website.
We'd like to thank everyone who took part in the online survey and those who attended the webinars, events and meetings during the consultation.
Patients in this country will now have access to clinically and cost effective, innovative new cancer drugs faster than ever before. In a first of its kind approach, NICE will issue draft recommendations on the use of cancer medicines before they receive their licence, with funding from NHS England available if approved. No other country in Europe does this.Sir Andrew Dillon, NICE chief executive