Patients in England could have faster access to effective cancer treatments through the reincarnated Cancer Drugs Fund (CDF), the National Institute for Health and Care Excellence (NICE) has announced.
The new fund will replace the existing – and greatly overspent – service, which provides access to cancer drugs that are not routinely available at the National Health Service (NHS) in England. Its costs rose to £340 million between 2015 and 2016, following an annual budget of £200 million when it was set up in 2011.
Devised to counter this overspending, the new system will launch in July, fixing the fund's annual budget at £340 million.
Old CDF Versus New CDF
While the existing CDF can choose to pay for innovative drugs that NICE has rejected for widespread use on the NHS, under the new system the health watchdog will make all the decisions.
In a European first, NICE will issue draft guidance on new cancer drugs or significant new license indications before they have received marketing approval in the UK.
Any drug that receives a positive draft recommendation will be funded from the point of license, with NICE normally issuing final guidance within 90 days of the license. Drugs given a “maybe” rating will be considered for the CDF.
The aim is to bring clarity to decisions about which new cancer drugs will receive NHS funding, as well as to allow the NHS to offer conditional funding for those with uncertain evidence for use.
Sir Andrew Dillon, NICE chief executive, commented in a press release: “Patients in this country will now have access to clinically and cost effective, innovative new cancer drugs faster than ever before.”
He added: “In a first of its kind approach, NICE will issue draft recommendations on the use of cancer medicines before they receive their license, with funding from NHS England available if approved. No other country in Europe does this.”
Impact on the pharma industry
If the case for routine use of a drug is not clear cut and more evidence is needed to prove its cost effectiveness, NICE can recommend the drug for temporary, conditional use in the new CDF.
The drug will remain available in the CDF for up to two years while the manufacturer gathers evidence to show that the medicine works and is fairly priced.
After two years, NICE will conduct a review to consider the drug for routine commissioning on NHS England, with the medicine moving out of the CDF and into routine budgets, or being made available on an exception only basis.
Dillon argued: “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.”
However, concerns about the new fund have been raised, with claims that NICE’s appraisal process could block access to drugs. The Pharma Times reported that the Association of the British Pharmaceutical Industry was disappointed by NHS England’s decision to push ahead with proposals that carry a “very real risk of significantly setting back patient access to cancer medicines, now and for the foreseeable future”.
Paul Catchpole, value and access director of the Association, told the journal: “If cancer medicines go through more or less exactly the same NICE appraisal process that was in place five years ago - which necessitated the setting up of the CDF in the first place - we will largely get the same answers as before - the majority of medicines will be turned down”.
Cancer charities agree. In a letter to the British prime minister published in newspaper The Daily Telegraph, 15 charities wrote that many drugs available the western world would "now struggle to gain approval" in England due to NICE’s “last-century methodology”.
The letter stated: "Unfortunately the new system does not update the methodology used by NICE, introduced back in 1999, and many clinically-effective treatments will now struggle to gain approval.”
The charities highlighted that since 2011, when it was launched, the CDF has paid for 84,000 cancer treatments that NICE turned down. Speaking to the BBC, Baroness Delyth Morgan, chief executive of charity Breast Cancer Now, commented: "Not a single breast cancer drug has been considered cost-effective by NICE in the last seven years and this simply cannot continue." Among the breast cancer drugs NICE has rejected is Kadcyla, a treatment which can prolong a dying patient’s life by six months on average.
Cancer Research UK explains on its website that NICE’s approval process is based on whether a drug works, whether it is cost effective and contributions from patient organizations, health professionals and experts.
The current CDF closed on 1 April 2016. Drugs transferring from the old CDF will be appraised by NICE over the next 18 months. Entirely new drugs will be able to enter the CDF from July 2016.
All drugs on the existing CDF list will continue to receive funding until the point that NICE has completed a new appraisal of them, and any patients currently receiving them will finish their treatment.
The CDF was established in 2011 and covers England.
This article is a synopsis of: Faster access to effective cancer treatments through new Cancer Drugs Fund, Cancer Drugs Fund changes deeply concerning, say charities, and What is NICE and how does it work?
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