The long awaited consultation on the proposals from NICE and NHS England to incorporate the Cancer Drugs Fund into NICE’s processes opened in November last year. So is this the solution to the issue of access to cancer drugs that we’ve all been waiting for?
In this post we take a look back at the Cancer Drugs Fund to date, give a short summary of the proposals in this consultation and provide Breast Cancer Now’s take on the impact that these changes might have.
The Cancer Drugs Fund
The Cancer Drugs Fund (CDF) was a Conservative Party manifesto promise in the 2010 election and was included in the Coalition Government’s coalition agreement. The Fund was introduced in October 2010 and was initially an interim fund intended to enable patient access to cancer drugs that had not been approved by NICE.
The Fund was initially worth £200 million per year and was due to be closed in March 2014, when a reformed NICE (The National Institute for Health and Care Excellence) process would be implemented.
In September 2013, with NICE having failed to deliver the reformed process that was promised, the Government announced that the CDF would be extended until March 2016.
However, by the end of 2014, the Fund was severely overspent and since then, the CDF budget has been increased twice and the Fund is now worth £340 million per year.
Despite this, the Fund is still overspent and ‘reprioritisation’ exercises have been carried out twice, removing drugs from the Fund that were not deemed clinically and cost effective enough for continued funding.
Two of the six breast cancer drugs funded by the CDF were removed through these processes. This consultation NHS England and NICE have joined forces to propose changes to the way that the Fund operates and to integrate the CDF into NICE’s current processes.
There is a lot of detail in the consultation document, which opened for comments in November 2015, but put simply, the CDF as we know it will cease to operate from 1 April 2016.
NICE will now have three options when appraising a new drug for use on the NHS:
- Recommended for routine use
- Not recommended for routine use
- Recommended for use within the CDF The third option is new to NICE and is intended for drugs where the evidence of clinical benefit is unclear.
An example of this could be where the trials for a drug have shown that a drug extends progression free survival (the length of time during which a cancer is not growing or getting worse) but have not yet shown whether or not the drug extends overall survival (extension to overall life).
In this case, NICE could recommend that the drug is used within the CDF. If NICE makes this recommendation, the drug will be made available on the NHS in England for a limited period of time (likely to be around two years) while further data is collected on the clinical effectiveness of the drug.
After this two year period is completed, NICE will re-assess the drug using the new evidence and will make a final decision about whether a drug should be made available for routine use on the NHS.
If a drug is recommended for use it will be removed from the CDF and will be funded through routine NHS budgets (known as baseline commissioning).
If a drug is not recommended for use it will be removed from the CDF and will no longer be available on the NHS in England, although patients already taking the drug are likely to continue taking it until they and their clinicians decide that it is no longer appropriate for them to take it.
The new process
The new process will look roughly like this:
What does this mean?
So, is this the solution to the problem of accessing cancer drugs that we’ve all been waiting for?
Unfortunately, at Breast Cancer Now, we’re doubtful. This consultation does not offer sufficient changes to the way NICE currently operates that we believe are needed to allow drugs to be approved for routine use on the NHS.
In order to be recommended for use within the CDF, the proposals require new drugs to demonstrate that they can, or have the potential to, meet NICE’s current cost effectiveness criteria which will remain unchanged.
In addition, the proposals do not allow for pharmaceutical companies to offer flexible pricing schemes that would make their products cost effective.
Without addressing either of these barriers, we do not believe it is possible for any new breast cancer drugs to be considered cost effective and therefore be approved for use on the NHS, either through the CDF or through routine use.
In fact, we are concerned that these proposals may result in fewer drugs being made available rather than more. In addition, the proposals do not include plans for the transition of drugs currently funded through the Cancer Drugs Fund into routine commissioning.
We are concerned that some of the breast cancer drugs currently available through the Cancer Drugs Fund (specifically trastuzumab emtansine (Kadcyla) and pertuzumab (Perjeta)) would struggle to meet the criteria set out in the new proposals and therefore the future availability of these products is unclear.