- What is the Cancer Drugs Fund (CDF)?
- What does the CDF mean for drugs that we appraise?
- How does the CDF affect people with cancer?
- What has changed in the CDF?
- History of the CDF
- What about drugs previously on the CDF?
What is the Cancer Drugs Fund?
The Cancer Drugs Fund (CDF) is a source of funding for cancer drugs in England, which:
- Provides patients with faster access to the most promising new cancer treatments.
- Helps to ensure more value for money for taxpayers.
- Offers pharmaceutical companies (who price their products responsibly) a new fast-track route to NHS funding.
Read more about the CDF on NHS England’s website.
What does the CDF mean for drugs that we appraise?
It means we can now make 3 recommendations when we appraise cancer drugs:
- YES - Recommended
We have recommended the drug for routine commissioning, as per our usual process, and it will become available on the NHS in England.
- NO - Not recommended
We do not recommend the drug.
- Recommended for use within the CDF (new)
We consider that there is plausible potential for the drug to satisfy the criteria for routine commissioning, but there is significant remaining clinical uncertainty which needs more investigation, through data collection in the NHS or clinical studies. This means the CDF will fund the drug, to avoid long delays, but we need more information on its effectiveness before it can be considered for routine commissioning (when the guidance is reviewed).
For more information about which treatments are eligible for the CDF, see the document produced by NHS England.
How does the CDF affect people with cancer?
The CDF provides interim funding which means faster access to cancer drugs. This saves valuable time – up to 8 months in some cases.
For drugs that have received a draft recommendation for routine commissioning or a draft recommendation for use within the CDF, patients will now be able to access drugs from the point of marketing authorisation (the licence which shows the drug is safe for use).
We also start our technology appraisal process much earlier, with the aim of publishing guidance sooner than before. We now aim to publish:
- draft guidance prior to a drug receiving its marketing authorisation
- final guidance within 90 days of marketing authorisation wherever possible.
Are the drugs safe if NICE hasn’t finished completing its appraisal process?
We only appraise drugs that have a marketing authorisation or are expected to receive one during our appraisal process. We only issue final guidance on drugs that have marketing authorisation.
The CDF means patients can access drugs before we have finished our appraisal process, but clinicians will only prescribe them if they are safe to use and right for the individual.
What has changed in the CDF?
The biggest change is that we now have a new option for technology appraisal recommendations:
- Recommended for use within the CDF
Before this, we could only say ‘yes’ or ‘no’ or ‘only in research’. If a drug looked promising from the evidence we were given, but we didn’t have strong enough clinical evidence to show it was cost-effective – we had to say ‘no’.
Now, if a drug has plausible potential to satisfy the criteria for routine commissioning but there is significant remaining clinical uncertainty which needs more investigation (through data collection or clinical studies), we can help to make it available much earlier to patients via the CDF.
The drug will remain available within the CDF while more evidence is gathered to resolve the key areas of clinical uncertainty and show that the medicine works in the NHS population in England.
For drugs recommended for use within the CDF, a Managed Access Agreement will need to be agreed between the company and NHS England. The CDF Managed Access Agreement consists of two key components:
- Data Collection Arrangement – this sets out the outcomes that need to be collected in order to resolve the key areas of clinical uncertainty.
- CDF Commercial Agreement – this determines the cost of the drug during the managed access period.
Committee decision-making: recommendations for use within the CDF
The appraisal committees use the following process to decide which drugs to recommend for use within the CDF. For further information see the process and methods guide.
Starting point: drug not recommended for routine use.
Proceed down if the answer to each question is yes.
1. Why is the drug not recommended? Is it due to clinical uncertainty?
2. Does the drug have plausible potential to be cost-effective at the current price, taking into account end of life criteria?
3. Could data collection reduce clinical uncertainty?
4. Will ongoing studies provide useful data?
5. Is CDF data collection feasible?
Recommended for use within the CDF
If yes to all questions then the committe recommends the drug to enter the CDF.
Define the nature of clinical uncertainty and its level. Indicate research question, required analyses, and number of patients in NHS in England needed to collect data. See data collection specification for more information.
NICE needs to work closely with NHS England in operating the CDF. Understanding detailed CDF operational issues is crucial to the committee’s decision-making and the timely implementation of its decisions. Some of the issues needing to be discussed are confidential. NICE therefore allows the clinical lead for the CDF, or their nominated representative, to attend the entire committee meeting, including the closed session (‘part 2’). They attend in an advisory role and to ensure rapid execution of the procedures associated with recommendations for use in the CDF. The appropriate confidentiality agreements are in place.
History of the CDF
A previous model of the CDF was set up by the Government in 2011 as a temporary solution to help patients gain access to cancer drugs not routinely available on the NHS.
Because it was not clear how and when drugs should exit the CDF, it created unsustainable financial pressure.
NICE and NHS England worked together to develop a new model for the CDF. Following a 12 week public consultation, the CDF was amended and relaunched in July 2016. The main changes are:
- There is now clear entry and exit criteria.
- Now all new cancer drugs, and significant new licensed indications for cancer drugs, are referred to NICE for appraisal. Previously, cancer drugs were selected for technology appraisal using published elimination and prioritisation criteria. Read about how we select cancer drugs for appraisal.
- Draft guidance can now be issued before marketing authorisation (with funding from point of marketing authorisation if there is a positive recommendation).
- Interim funding can be available for positive draft guidance.
- For drugs that receive a ‘recommendation for use within the CDF’, more evidence is collected on the effectiveness of drugs to resolve the key areas of clinical uncertainty.
What about drugs previously on the CDF?
As some drugs were already being funded by the CDF using the previous model, we made transition arrangements for them. We started a rapid reconsideration process to decide how licensed drugs currently in the CDF should be managed.
In order to complete the transition quickly and efficiently, we started this process during the public consultation, to be ready to start when the consultation finished. We assessed our first drug via the rapid reconsideration process in July 2016.
CDF drug groupings
We categorised all drugs available on the CDF before April 2016 into 3 groups:
Group 1: Drugs currently in the CDF for which NICE has published guidance, or that were scheduled to complete before 31 March 2016
We invited an evidence submission from the companies involved. The evidence submissions needed to contain enough information to allow our appraisal committee to decide whether:
- it should receive a recommendation for ‘routine commissioning’
- it remains in the (new) CDF
- it cannot be recommended at all.
We are holding extra appraisal committee meetings during 2016 to consider these drugs. If companies don’t provide us with an expression of interest or an evidence submission we won’t be able to consider them as part of the transition process.
Group 2: Drugs currently in the CDF and being appraised by NICE
We will allow further evidence submissions to address CDF arrangements for these topics - at an appropriate point in the technology appraisal process.
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. All of the topics in group 3 have been referred to us by ministers and scheduled into our work programme.
Patients in this country now have access to clinically- and cost-effective, innovative new cancer drugs faster than ever before. In a first of its kind approach, we 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