by Janet Fricker

In, out, shake it all about: confusion created by changes to the Cancer Drugs Fund

On November 4, NHS England formally removed 13 drugs for 18 different cancer indications from the Cancer Drugs Fund (CDF) list following a move to add cost effectiveness to clinical effectiveness in the way oncology drugs are scored.

At the last moment, five drugs (for seven different cancer indications) received a reprieve after being ear-marked for withdrawal in the NHS England announcement of 4 September.

Notable drugs to receive a stay of execution included Kadcyla® (trastuzumab emtansine), Adcetris® (brentuximab vedotin) and Imbruvica ® .

In the case of Kadcyla ®, officials reversed the decision after manufacturer, Roche, agreed to drop the price, giving the NHS an undisclosed discount.

The move followed a petition from the charity Breast Cancer Now which attracted more than 42,000 signatures asking Roche to reduce the price.

Adding to the confusion, while Avastin® (bevacizumab) was saved from the axe in cervical cancer, patients with bowel and breast cancer will no longer be able to receive a drug that is routinely available as standard of care across most of Europe.

Professor Paul Workman, chief executive of the Institute of Cancer Research, London, commented, “It’s great news that some drugs that we thought could be lost from the Cancer Drugs Fund are going to remain available for patients and at a more affordable cost to the NHS.

“However, we now have a situation where some cancer drugs have been off, on, off and now back on the list of available drugs.
“It’s extremely confusing, and for people with cancer it’s also distressing, with such uncertainty about which drugs are going to be available for them.”

As many as 4,100 new cancer patients the Rarer Cancer Foundation has calculated, could be affected by the cuts.

“At a time when the Government says it wants to improve cancer outcomes, access to cancer treatments is actually going backwards,” said Andrew Wilson, Chief Executive of the Rarer Cancers Foundation.

Many patient groups feel the move to include cost effectiveness is a direct contradiction of the purpose of the CDF, which was created in 2011 as a pledge from Prime Minister David Cameron that cancer treatments should no longer be denied on the basis of cost.

The fund was intended  to help the NHS provide drugs not deemed cost effective by the National Institute for Clinical Excellence (NICE).

From the outset the fund has never been far from controversy, with critics arguing cancer drugs should be included in a system that ensures innovative and expensive medicines are made available for all with serious illnesses, not just cancer.

Last year, administration of the Cancer Drugs Fund was taken over by NHS England, who realizing that expenditure was spiraling out of control introduced cost assessment into their approval criteria.

Without action, they claim that the annual cost, originally set at £200m, would have grown to £420 m.

Professor Peter Clark, of the Cancer Drugs Forum, said, “We need to ensure we get the maximum benefit for patients from the fixed pot of money available, which is why we robustly assess the evidence on the effectiveness of these drugs alongside their cost.

“In some cases the drugs we proposed to remove were the least effective on the CDF list and we could not continue to fund them.

“In others they were simply too expensive, so we are pleased the pharmaceutical companies worked with us, reducing their prices, ensuring these treatments remain available to patients.”

With the latest removals, 33 drugs for 48 indications currently remain on the CDF list.

All patients receiving any of the drugs which have been removed from the CDF list, NHS England has stressed, will continue to do so until they and their clinician consider it appropriate to stop.

With the CDF du  end in March 2015 the new list is likely to provide just a temporary fix.

NHS England and NICE have promised a consultation to consider proposals for the longer term future of the CDF. However, a consultation document that was expected to be published in September failed to materialize.

“We have not yet seen these proposals and are becoming increasing concerned about future access to cancer drugs,” said Sally Greenbrook, Policy Manager at Breast Cancer Now.

The drugs being removed from the CDF list include:
• Albumin bound paclitaxel for the treatment of pancreatic cancer
• Bendamustine for the treatment of chronic lymphocytic leukaemia
• Bendamustine for the treatment of mantle cell lymphoma
• Bevacizumab for the treatment of breast cancer
• Bevacizumab for the treatment of colorectal cancer (two indications)
• Bosutinib for the treament of chronic phase chronic myeloid leukaemia
• Bosutinib for the treatment of accelerated phase chronic myeloid leukaemia (two indications)
• Cetuximab for the treatment of colorectal cancer (two indications)
• Dasatinib for the treatment of acute lymphoblastic leukaemia (ALL)
• Everolimus for the treatment of kidney cancer
• Lenalidomide for the treatment of multiple myeloma
• Panitumumab for the treatment of colorectal cancer (two indications)
• Pegylated Liposomal Doxorubicin (Caelyx) for the treatment of fibromatosis
• Peptide receptor Radionuclide Therapy for the treatment of neuroendocrine cancers
• Pomalidomide for the treatment of multiple myeloma
• Radium-223 dichloride for the treatment of prostate cancer (subject to appeal by the manufacturer).