New arrangements for the Cancer Drugs Fund (CDF), approved today by NICE’s Board, will see patients benefitting as promising new and innovative treatments are considered earlier.
NICE will now be able to make decisions on cancer drugs faster than ever before.
For the first time NICE will issue draft guidance on new cancer drugs or significant new licence indications before they have received marketing approval in the UK. Any drug that receives a positive draft recommendation would then be funded from the point of licence.
NICE will normally issue final guidance within 90 days of licence.
Changes will bring clarity to decisions about which new cancer drugs will receive NHS funding as well as allowing the NHS to go the extra mile in offering conditional funding for those which the evidence for use is uncertain.
Sir Andrew Dillon, NICE chief executive said of the changes: “Patients in this country will now have access to clinically and cost effective, innovative new cancer drugs faster than ever before. In a first of its kind approach, NICE will 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.”
If the case for routine use is not clear cut and more evidence is needed to prove cost effectiveness then NICE can recommend the drug for temporary, conditional use in the new CDF.
Reducing uncertainty, being fair to companies
Drugs that appear promising, but for which the evidence is not strong enough for routine use, will be given a given a conditional recommendation by NICE and made available to NHS patients paid for by the CDF.
The drug will remain available within the CDF for up to 2 years while the manufacturer gathers more evidence to show that the medicine works and is fairly priced.
After 2 years, NICE will conduct a review, using a shortened process, to consider the drug for routine commissioning on the NHS. This will either result in the medicine moving out of the CDF and into routine budgets, or if the company has not been able to demonstrate its case, made available on an exception basis only.
In this way, a flow of new cancer medicines can be made available to NHS patients while costs are controlled in a fair and balanced way.
Transparency and excellence in appraisals
Since 2000, when NICE started to produce cancer guidance, NICE has published 185 individual recommendations on cancer drugs in 138 technology appraisals. Overall, 64% of all recommendations stated that the NHS should use these drugs either in line with their marketing authorisation or in specific circumstances.
NICE has the skills, experience and independence to bring fairness, rigour and transparency to choose which cancer drugs should be available on the NHS.
The current CDF will close on 1 April 2016 and NICE will begin using the new methodology as approved today by the Board. All drugs on the existing CDF list will continue to receive funding until the point that NICE has completed a new appraisal of them.
Any patients currently receiving those drugs will finish their treatment.
Preparations are underway to meet the increased demand for NICE’s technology appraisals. A dedicated team will be put in place to support the new proposals. NHS England is continuing work to finalise the operational details of the new scheme with insight from further analysis of consultation responses.
Drugs transferring from the old CDF will be appraised by NICE over the next 18 months with those that have already been through NICE entered into the process first. Entirely new drugs will be able to enter the CDF from July 2016.
Sir Andrew Dillon added: “The new CDF will be fair. Companies will be given the opportunity to demonstrate their drugs will benefit patients and bring value to the NHS. Taxpayers can be reassured that only those medicines that are clinically and cost effective will be used routinely. We want to ensure the NHS introduces the best of the new innovative cancer treatments while managing its resources carefully.”