The National Health Service (NHS) of England and the National Institute for Health and Care Excellence (NICE) on Thursday introduced a new proposal to transform the £340 million ($520 million) Cancer Drugs Fund (CDF) to allow patients to have earlier access to new treatments while real-world evidence is still being collected.
As many in the UK, like the US, are distraught over the rise of cancer drug prices, NICE and NHS are proposing to turn the CDF, beginning in April 2016, into a “managed access” fund whereby patients would have access to new cancer drugs that appear promising but which don’t have the necessary evidence for routine use.
The original CDF, which is set to expire 31 March 2016, was established in 2011 to fund cancer drugs in England that are not currently approved by NICE. And although the CDF has increased access to cancer treatments for more than 72,000 patients, the current scheme is not designed to reduce uncertainty on the benefits of new treatments or to make a decision about their long-term use, NICE and NHS say, pointing to the Independent Cancer Taskforce’s report, “Achieving World Class Cancer Outcomes: A Strategy for England 2015-2020”.
As a result, the NHS is currently allocating an increasing share of the cancer budget to treatments of uncertain value, they say.
Under the new plan, which is now open for consultation, all new cancer drugs will receive a clear “yes” (meaning baseline commissioning), “maybe” (CDF funding for time limited period), or “no,” within 90 days of market authorization by the European Medicines Agency (EMA).
In order to more effectively manage the CDF budget, drugs given a conditional recommendation by NICE (“maybe” decision) would be used by the CDF for a predetermined period while further evidence is collected.
At the end of this period, the drug would then go through a short NICE appraisal at which point it would receive either a NICE positive recommendation, meaning the drug would move out of the CDF into routine use, or a NICE negative recommendation, meaning it would move out of the CDF and become available only on the basis of individual patient funding requests.
The agencies note that all access to the CDF will use the same pricing control mechanism:
- Recommended for routine use would require the incremental cost effectiveness ratio to fall within the standard NICE range (£20,000 to £30,000 per quality-adjusted life year gained), taking into account the application of the end of life criteria where appropriate.
- Recommended for use within the CDF would require the drug to display “plausible potential for satisfying the criteria for routine use, taking into account the application of the end of life criteria where appropriate.” Entry into the CDF would also be subject to the company agreeing to fund the collection of a pre-determined data set, during a period normally lasting no longer than 24 months, and a commercial access arrangement which is affordable within the available CDF budget.
- Not recommended for routine use would indicate that the drug is unable to satisfy either of the first two conditions.
Chief executive of NICE, Sir Andrew Dillon, explained: “Our joint proposals will ensure that the Cancer Drugs Fund is used to provide patients with promising medicines at a cost which reflects the uncertainty about their effectiveness and cost effectiveness and at the same time, generate additional data to help the NHS make a longer term decision on whether and how to use them.”
How the Proposal Works
Cancer drugs making their way through the normal EMA licensing process will be appraised by a NICE committee before an opinion of the EMA’s Committee for Medicinal Products for Human Use (CHMP) has been published. The NICE Appraisal Committee will meet in private at this stage, as no public EMA decision will have been made, and an Appraisal Consultation Document (ACD) or Final Appraisal Determination (FAD) will only be released when CHMP has published a positive opinion.
In order for this decision to be made by the NICE committee, companies will simultaneously submit evidence on the clinical and cost effectiveness of their products to NICE when they submit data to EMA.
NICE will, in each case, provide the company a date by which they will be required to provide their evidence submission in order for a draft recommendation to be available at the point of marketing authorization by EMA.
The recommendations of the NICE Appraisal Committees for drugs they consider suitable for entry into the CDF will be received by a joint committee of NHS England and NICE (the Cancer Drugs Fund Investment Group), which will be responsible and accountable for confirming that an acceptable commercial access arrangement (the financial arrangements which determine the cost of the drug to the NHS, agreed between the company and NHS England) and data collection arrangements, which together form the managed access agreement, are in place before accepting the drugs into the CDF.
NHS England and NICE say they will have provisional discussions with companies about the implications of the new framework, including existing individual commercial access arrangements or need for data collection, for those products remaining in the CDF in November 2015.
The process of appraising drugs currently in the CDF, in line with the new CDF criteria will be completed during the course of 2016/17. All patients receiving treatment funded through the CDF on 31 March 2016 will continue to receive treatment until the point that they and their consultant agree that it is appropriate to stop.
NHS and NICE are now collecting comments on the proposal.
Consultation on Proposals for a New Cancer Drugs Fund