After years of budget woes and disagreements about its place in the National Health Service (NHS), the Cancer Drugs Fund (CDF) will no longer be conducting reviews of oncology products. The National Institute for Health and Care Excellence (NICE) will now be reviewing all new cancer drugs and significant changes in indications for existing drugs. NICE is amending its technology appraisal (TA) process to provide for some drugs to be temporarily funded through the CDF while companies seek further data to strengthen the evidence in favor of routine use. NICE is also placing greater emphasis on providing rapid access to cancer drugs and intends to publish guidance on cancer drugs within 90 days of marketing authorization.
As before, NICE can recommend a drug for routine use, meaning that it will be available and funded in the same way as other drugs, or NICE can recommend against providing the drug at all if the drug does not demonstrate cost-effectiveness and likely would not demonstrate cost-effectiveness even with more and better data. In cases where there are uncertainties in clinical and cost-effectiveness data, NICE can now recommend a drug for temporary use funded through the CDF to give the company more time to collect data and address these uncertainties. There are several criteria that must be met in order to secure CDF funding:
- A drug’s incremental cost-effectiveness ratio (ICER) must have potential to fall into acceptable ranges for routine use. Where appropriate, these acceptable ranges may be adjusted based on NICE’s end-of-life criteria.
- It must be possible for further data collection to address the clinical uncertainties identified by NICE. The data collection period should not typically exceed 24 months.
- The data collected must be able to inform an update of NICE’s original guidance.
In cases where NICE recommends a drug for use through the CDF, the company will work with NICE to develop a data collection plan to address any uncertainties in the evidence base. NICE will reevaluate the drug at the end of this data collection process. If the company stops data collection before this for any reason, NICE will withdraw its original guidance and cease funding the drug through the CDF.
After data collection, NICE will publish a CDF guidance review that will recommend for or against routine use. Whatever the outcome, the drug cannot remain in the CDF: it will be funded through ordinary means or not at all.
REASONS FOR THE TRANSITION
In March 2016, NICE approved a new process for evaluating cancer drugs and allocating funding under the CDF. The NHS formed the CDF in 2011 to address the rising costs of cancer drugs. Cancer drugs often failed to achieve a sufficient cost-effectiveness to receive positive reimbursement decisions from NICE, and the NHS was under a lot of pressure to find a way to provide these drugs to patients in need.
Since 2013, the CDF has, separately from NICE, conducted health technology assessments of cancer drugs not reviewed or not recommended by NICE. Initially the CDF did not consider cost in their analyses, but they added a cost criterion in December 2014 after overspending their budget by more than £30 million.
Due to concerns about budget and about misalignment with NICE, in late 2015 the board of NHS England launched a three-month consultation with NICE to develop a new operating model for the CDF. Patients, pharmaceutical companies, charities, advocacy groups, and other stakeholders submitted statements during the consultation period, which concluded in February 2016.
The new operating model will go into effect in July 2016. NICE will take over the evaluation of all cancer drugs; the CDF will no longer conduct its own reviews. The goal is to provide access to drugs with potential to offer serious value to patients and to the NHS as a whole in spite of significant uncertainties in their evidence bases. CDF funding will be temporary and will allow patients to access drugs while the companies collect further data with which to make a more compelling case for routine use.
What happens to the current CDF list?
All drugs currently funded through the CDF will be reconsidered based on the new CDF funding criteria. NICE aims to complete this reconsideration process, at least for drugs previously evaluated by NICE, before March 31, 2017. To accomplish this, NICE is establishing a rapid re-consideration process.
For drugs previously reviewed by NICE on the CDF list, NICE will invite evidence submissions from the companies involved. NICE intends to use this evidence to determine whether the drugs can be recommended for routine use, funded through the CDF while the company collects further data, or not recommended at all. Unless there have been significant changes to the clinical evidence, NICE wants the newly-submitted evidence to focus on cost-effectiveness, taking new patient access schemes or commercial access agreements into consideration.
Drugs on the current CDF list that have not previously been appraised by NICE will undergo a full technology appraisal review. These reviews will occur after April 1, 2017.
For drugs currently under review, NICE will allow companies to submit supplementary information as needed based on the changing process.
In the meantime, as the transition is underway, current CDF drugs will continue to receive funding while awaiting NICE reconsideration.
Context Matters and the CDF
Context Matters will track and collect NICE reviews related to the CDF when they become available. The first are expected around October 2016. Context Matters will track both NICE’s technology appraisal final guidance decisions and, where applicable, the results of CDF guidance reviews.