A new approach to the appraisal and funding of cancer drugs in England came into force on 29 July 2016.
A number of drugs are now immediately eligible to receive interim funding, subject to agreement from the relevant pharmaceutical companies. They are:
- Bosutinib in the treatment of chronic myeloid leukaemia
- Ceritinib in lung cancer
- Dabrafenib and trametinib as combination therapy in melanoma
- Ipilimumab and nivolumab as combination treatment in melanoma
Up to five other drugs/indications are likely to become available for interim funding in the coming weeks, again, subject to agreement with the companies concerned.
The new system, which includes a new-look Cancer Drugs Fund (CDF), replaces the previous fund, which closed on 31 March 2016.
The previous CDF, which had benefitted over 95,000 patients since its inception in April 2011, had come under unsustainable financial pressure with calls for urgent reform coming from the independent Cancer Taskforce, the National Audit Office and from Parliament’s Public Accounts Committee.
The new system is the product of partnership working between NHS England, NICE, Public Health England and the Department of Health, and was the subject of a 12-week public consultation. The final operational detail has been informed by further engagement with key stakeholders, including patient groups and industry.
Key features of the new system include:
- All cancer drugs/indications expecting to receive a marketing authorisation (license) will now be appraised by NICE;
- Early funding option available, through new interim funding arrangements, for those drugs given either a NICE draft recommendation for routine commissioning use, or a NICE draft recommendation for use within the CDF;
- Clear entry and exit points for drugs in the CDF;
- Managed Access Agreements between NHS England and pharmaceutical companies, setting out the terms of a drug’s entry into the CDF and the means by which data will be collected to resolve any uncertainty relating to a drugs clinical and cost-effectiveness;
- All eligible patients to receive CDF drugs, not just the number of patients needed to resolve uncertainty;
- Expenditure control mechanism to reduce risk of overspend and ensure the fund never needs to close to new entrants;
- A new, joint NHS England/NICE CDF Investment Group to manage the overall CDF budget;
- Similar opportunities for off-label drugs to gain access to CDF funds, if deemed to show clinical promise.
What does the new system mean for patients?
- Faster access to the most promising new treatments
- Clearer, faster decision-making, meaning less uncertainty about a drug’s availability
- Similar opportunities for off-label drugs/indications – often used to treat rarer cancers – to obtain CDF funding
- Access to CDF-funded drugs for all eligible patients
- Any drugs that were in the CDF as of 31 March 2016 will continue to receive funding while awaiting reconsideration or appraisal by NICE
- All patients currently receiving treatment via an existing CDF drug will continue to do so, regardless of the outcome of any NICE appraisal or reconsideration, until their clinician decides otherwise
What does the new system mean for taxpayers?
- A fixed CDF budget of £340m
- Expenditure control mechanism to reduce the risk of overspend, meaning that the fund never has to close to potential new entrants
- The CDF operating as a new, managed access fund designed to resolve any uncertainty around a drugs clinical and cost effectiveness as swiftly as possible
- A joint NHS England/NICE CDF Investment Group to oversee budget management
- Closer working with the pharmaceutical industry to encourage the responsible pricing of cancer drugs, driving stronger value for money in drug expenditure, so that more money can be spent in other areas of cancer care and elsewhere in the NHS
What does the new system mean for industry?
- A new fast-track system, including an accelerated NICE appraisal process
- Earlier funding, from the point of marketing authorisation, for the most promising drugs through new interim funding arrangements
- A managed access approach to rapidly support and resolve any areas of uncertainty for drugs showing clinical promise
- Each drug/indication looked at on an individual basis with bespoke data collection and commercial access arrangements – no ‘one size fits all’ approach
If you need any more information about the Cancer Drugs Fund, please email the Cancer Drugs Fund team.
Individual Funding Requests (IFRs)
Individual funding requests (IFRs) relating to cancer drugs will no longer be considered via the CDF process.
All IFRs relating to cancer drugs will be considered using NHS England’s single, national IFR system, which was updated in January 2016.
Please see the specialised services key documents page for full details of the NHS England IFR system, and how to apply.
Cancer Drugs Fund pre- 31 March 2016
The previous Cancer Drugs Fund closed on 31 March 2016. A new approach to the appraisal and funding of cancer drugs, including a new Cancer Drugs Fund, will begin operating on 29 July 2016.
All previous Cancer Drugs Fund content has been archived: