England's new Cancer Drugs Fund goes live as pharma industry reiterates concerns

LONDON, July 29 (APM) - England's revamped Cancer Drugs Fund (CDF) went live on Friday, although concerns remain about how the new model can improve access to innovative cancer drugs.
The original CDF was launched in 2010 as a fund to pay for drugs not recommended for mainstream reimbursement by drug cost-effectiveness body NICE. However, the scheme proved to be unsustainable, and in March this year changes were approved for a conditional access model run by NICE.
The new rules set a fixed budget of 340 million pounds and established an "expenditure control mechanism" to reduce the risk of overspend.
Drugs that appear promising but do not have the evidence for a NICE recommendation are given a conditional recommendation that means they would be available on the CDF for up to two years while the manufacturer gathers more evidence to show that the medicine works and is fairly priced.
After two years, NICE will conduct an additional, shorter review to consider the drug for routine commissioning on the NHS, which will either result in the medicine being accepted for routine use or made available on an exception basis only if the evidence is still lacking.

Industry concern

Trade body the Association of the British Pharmaceutical Industry (ABPI) noted that under the new CDF rules, pharma companies will have to commit in advance, to 100% of future financial risk if the fund overspends its budget.
In an emailed statement on Friday, Paul Catchpole, ABPI's director of value and access said: "Given the fact that the old Fund consistently overspent significantly on its allocated budget, and that industry already underwrites the majority of expenditure on branded medicines over and above agreed levels, we must work towards a fairer and more equitable system of financial risk."
He cautioned that without a fair system, there is a concern that drugs may not make their way to the market.
David Montgomery, cancer medical director for Pfizer UK told Bloomberg that the new system "feels to me extremely high risk and particularly effective". He added that the new rules could amount to an "uncontrolled price cut on top of what will already be good value for money".
While welcoming the commencement of the new CDF rules, Catchpole highlighted another area of concern around NICE's general appraisal process for cancer drugs.
According to him, medicines are at risk of being "routinely" turned down for use unless there is greater flexibility in NICE's appraisal process citing the case of medicines that have a small patient population which get "held back" for reimbursement under the current system.
In May, this year, 15 cancer charities published a letter to the then UK prime minister David Cameron voicing concerns that because the methodology for appraising drugs has not been updated under the new rules, many clinically effective treatments will now struggle to gain approval (APMHE 47848).
ABPI said that an early test of the new CDF will be whether it is able to effect faster access and uptake of cancer drugs.



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