Cuts to Cancer Drugs Fund condemned by charities

Charities have condemned the decision to cut more treatments from England's Cancer Drugs Fund (CDF) – a move described by one as a 'hammer blow' to patients.

The decision to cut a further 16 medicines across 23 indications was confirmed late on Friday afternoon, including treatments for breast cancer, pancreatic and cervical cancer, multiple myeloma, leukaemia and bowel cancer.

Among the most notable among these are Roche's Kadcyla for breast cancer and Celgene's Abraxane for pancreatic cancer, one of few treatments available for the condition.

A further 16 indications were reviewed but retained on the list, including Janssen's Zytiga in prostate cancer and Pfizer's Xalkori in ALK+ lung cancer.

This is the second tranche of drugs 'de-listed' this year, and now means the number of treatments covered has been halved since January, in an attempt to rein in a repeatedly overspent budget.

The Rarer Cancers Foundation said the decision was a 'hammer blow' and estimated that a total of 5,500 patients would miss out on life-extending treatment.

Professor Peter Clark, oncologist and the chairman of the CDF, had warned earlier this year that further cuts would be necessary, and indicated the de-listed treatments did not offer value for money.

New cancer drugs are often among the most expensive of medicines, but frequently offer just a few extra months of life for patients – making it difficult for England's cost effectiveness watchdog NICE to say yes using its standard criteria.

The CDF was first set up in 2011 with a budget of £200 million to circumvent the NICE problem, an approach which all stakeholders now say was a 'sticking plaster' solution.

After repeated overspends, the CDF budget has been raised to £340 million for this financial year, rising again to £410 million the following year. Nevertheless, the Fund was on course to overspend by £70 million this year, and the latest cuts will only bring it back within budget next year.

Prof Clark said: "There is no escaping the fact that we face a difficult set of choices, but it is our duty to ensure we get maximum value from every penny available on behalf of patients.

"We must ensure we invest in those treatments that offer the most benefit, based on rigorous evidence-based clinical analysis and an assessment of the cost of those treatments."

NHS England said current projections suggest that without de-listing, spend on the fund would rise to around £410 million this year.

The de-listing will take effect on 4 November; patients already receiving treatment through the fund will continue to have access.

Kadcyla row

Several breast cancer drugs were cut in the first de-listing, and now Roche's Kadcyla has also been removed, having survived the January cull.

Kadcyla was one of the most expensive drugs on the CDF, its official price being £90,000 per patient, although confidential discounts agreed between Roche and the CDF will have brought this price down.

It appears that renewed calls for discounts on Kadycla's price have not been met by Roche, resulting in its de-listing. This follows a very public row last year between NICE and Roche over the drug's price.

Charity Breast Cancer Now said it was a 'dreadful day' for patients. Chief executive Baroness Delyth Morgan, said there had been a lack of leadership: "Kadcyla is a one-of-a-kind drug proven to extend life, and the fact is that because government, the NHS and the pharmaceutical industry have failed to agree realistic prices for new drugs, some women will die sooner.

"Despite many families relying on it, the CDF has unfortunately failed, and today's delisting will further reduce the NHS' ability to keep pace with Europe in the treatment of breast cancer."

Unlike many of the other cancer charities, Breast Cancer Now has been clear in blaming the pharma industry for its high prices as equally as the government for not having robust or fair processes.

"It's time that the Government showed leadership on this issue and held the pharmaceutical industry to account. We need a sustainable structure fit for the 21st Century, and we hope that the upcoming CDF consultation will finally make this a reality," she concluded.

The UK pharmaceutical trade body the ABPI said the decision was extremely disappointing and stated that the process was 'fundamentally flawed'.

Alison Clough, acting chief executive said: "We have long voiced the view that the Cancer Drugs Fund is a sticking plaster, albeit one that has enabled thousands of patients to access new and innovative medicines."

Roche said it had worked hard to safeguard access to all four of its CDF-listed drugs. It stated that two of its medicines were selected for re-review – Kadcyla and Avastin, but it offered NHS England £15 million of savings, including on medicines not considered for the review, in order to protect all patients at risk of losing access.

Kadcyla and Avastin in bowel cancer were judged cost effective in January, but ruled to be not cost effective six months later – suggesting that de-listing is a cost-cutting exercise, and not a true cost-effectiveness appraisal.

Dr Daniel Thurley, Roche's UK medical director, said: "Nothing in the clinical effectiveness of our medicines has changed since NHS England last reviewed them in January.

"No matter how much of a saving we offer, some medicines will not be retained on the CDF list from November due to NHS England's review criteria."

The way forward

Roche believes access to these medicines will only be achieved with long-term reform "so that they can be assessed in a pragmatic, flexible and sustainable way".

The ABPI says the distress caused to cancer patients by the de-listing process could have been avoided if NICE and NHS England had moved earlier to a 'more appropriate, sustainable solution for evaluating and approving cancer medicines for routine use'.

NHS England has already unveiled its plans for a long-term solution to the problem of the CDF and cancer drug access in England. It plans to bring the CDF under the auspices of NICE, making it a 'managed access fund' by April 2016. This will involve conditional NICE approval, with drugs given a period in which to prove their value through real-world data, after which time they are given full NICE approval or are de-listed.

Patients waiting for Opdivo access

In this sense, the proposed reforms will involve a de-listing process not dissimilar to the current one – but NHS England says this is necessary to create budget space for new cancer drugs which may prove more clinically and cost effective.

Friday's de-listing will undoubtedly have been made with one eye on two new high-profile treatments such as Bristol-Myers Squibb's Opdivo, one of the first in the PD-1 checkpoint inhibitor class of cancer immunotherapy.

Both it and its rival PD-1, Merck Sharp & Dohme's Keytruda are high cost, but promise to advance treatment significantly in melanoma (both drugs) and non-small cell lung cancer (NSCLC, for which only Opdivo is currently approved), two hard-to-treat tumour types.

The drugs have now been approved in the UK and NICE has today given draft approval for Keytruda's use in melanoma, a month earlier than expected. However guidance on Opdivo's use in NSCLC isn't due until September 2016, meaning patients and doctors will be seeking early access via the CDF.

Read the full statement from NHS England here, and details of all 39 decisions here. Read the reactions of Pancreatic Cancer UK and Beating Bowel Cancer

View Roche's video response to the decision here.