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Controversial new CDF promises "clearer, faster decision-making"

However, pharma companies and charities remain concerned over pricing and access

Cancer Drugs FundThe UK's new Cancer Drugs Fund (CDF) started operating last Friday, with four new cancer drugs made available under the scheme.

As expected, the new CDF structure last week puts decisions about access to cancer drugs firmly into the hands of the National Institute of Health and Care Excellence (NICE), a move that has raised concerns among some medical charities and pharma companies.

NICE will appraise all drugs and interim funding will be available for up to two years to give patients access to medicines that have either a draft recommendation for routine use on the NHS or a draft recommendation for use within the CDF.

The appraisal process will start earlier with the aim of delivering a verdict before new drugs are licensed, and NHS England is predicting that access to treatments could be accelerated by 'up to four months', taking the UK ahead of other countries in Europe.

Critics are unimpressed with the changes, saying the new CDF will be hamstrung by underlying issues with NICE's core appraisals process, which according to Richard Erwin, the general manager of Roche UK, "necessitated the creation of the original CDF".

That view was echoed by medical charity Breast Cancer Now, which said: "with the fund's drug assessment now being handed back to NICE, we worry that patients in England will miss out on effective drugs that are available in other countries."

The new CDF will function as a 'managed access fund' - with agreements thrashed out between NHS England and pharmaceutical companies prior to the addition of drugs into the Fund, taking into account any gaps in clinical and cost-effectiveness data. It will also be open to drugs that have potential 'off-label', i.e. outside their approved indications.

It will have a fixed budget - set at £340m in the first instance - and this will be overseen by a panel from NHS England and NICE. An 'expenditure control mechanism' has been introduced to reduce the risk of overspend and prevent the Fund having to close to potential new entrants in future - effectively leaving drugmakers to cover the excess.

The old CDF was set up in April 2011 with a £50m budget that went up to £200m the following year and then steadily increased to £340m in 2015/16. The scheme generally overshot its budget however and was abandoned in March after it went over by £127m - taking the total spent on the programme to £1.27bn.

It was closed to new drugs in October 2015, leaving patients and companies that have brought new drugs to market in what has been described as a 'black hole'.

An independent Cancer Taskforce, the National Audit Office and a separate Commons inquiry into the CDF all concluded it was not being run effectively and was unsustainable without reform.

However, the requirement to absorb 100% of the risk of overpayment has incensed some pharma companies.

David Montgomery - oncology medical director at Pfizer UK - said that developing new cancer drugs "takes an enormous investment of time, money and knowledge with thousands of scientists dedicating years to invent the latest treatments and cures".

"This is a high risk industry and it is not as simple as, or sustainable to, continuously ask companies to drop the price of these specialist medicines. It will impact our ability to make further medical progress if we do so," he added.

The four new drugs added to the CDF are Novartis' Zykadia (ceritinib) for lung cancer and melanoma combination Tafinlar (dabrafenib) and Mekinist (trametinib), and Servier's Lonsurf (trifluridine/tipiracil HCl) for bowel cancer.

Article by
Phil Taylor

1st August 2016

From: Regulatory



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