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NICE gives green light to two new 'breakthrough' breast cancer drugs in draft guidance

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Discount price deals for two similar new breast cancer drugs have seen them approved for routine NHS use, under draft guidance from the National Institute for Health and Care Excellence.

NICE has today published draft guidance recommending palbociclib (Ibrance) and ribociclib (Kisqali) for routine funding on the NHS. Their development has been described by oncologists as “one of the most important breakthroughs for women with advanced breast cancer in the last two decades”.

“These drugs have allowed women to live a normal life for longer”

Nicholas Turner

As a result, they are set to become options for patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or secondary breast cancer.

Palbociclib, made by Pfizer, and ribociclib, which was developed by Novartis, are the first of a new type of drug that slows the progression of cancer by inhibiting two proteins called CDK 4 and 6.

Both drugs are given once-daily with an aromatase inhibitor, which block the production of the hormone oestrogen, therefore, stopping its ability to fuel some breast cancers.

Women diagnosed after the disease has begun to spread will be eligible for palbociclib, while those who have also undergone the menopause will be eligible for ribociclib.

The list price of one cycle of treatment with palbociclib and ribociclib is £2,950 – the cost of a 21 tablet pack of 125mg capsules or a 63 tablet pack of 200mg tablets, respectively. However, the discounted price that was agreed remains confidential.

“The current system is taking too long and prices still remain high”

Paul Workman

The draft approval comes, despite uncertainties about how long they extend overall survival, noted NICE. Its review committee looked at palbociclib and ribociclib taken with an aromatase inhibitor for patients who have not been treated for their locally advanced or secondary breast cancer.

The committee concluded that both palbociclib and ribociclib stalled cancer growth for an extra 10 months on average and it was likely that this would result in some improvement in overall survival, though this could not be quantified from current trial data.

There are around 45,000 new diagnoses of breast cancer each year in England. It is estimated that around 8,000 people in England would be eligible for treatment with either palbociclib or ribociclib.

NICE’s initial draft guidance on palbociclib, published in February did not recommend the drug because its cost was too high in relation to its clinical effectiveness.

If there are no appeals against the draft recommendations during the consultation period, NICE will publish final guidance to the NHS in December. Until then, NHS bodies should make decisions locally on the funding of specific treatments.

Professor Carole Longson, director of NICE’s centre for health technology evaluation, said that, as well as delaying cancer progression, the drugs may reduce the number of patients exposed to the “often unpleasant side effects of chemotherapy” and delay the need for its use in others.

“We are pleased, therefore, that the companies have been able to agree reductions to the price of palbociclib and ribociclib to allow them to be made routinely available,” she added.

The Institute of Cancer Research said it welcomed the approval by NICE of a new type of treatment for women with previously untreatable advanced breast cancer.

Professor Carole Longson

Professor Carole Longson

Carole Longson

The institute’s Professor Nicholas Turner, a consultant medical oncologist at the Royal Marsden NHS Foundation Trust, said: “The development of this brand new class of cancer drug is one of the most important breakthroughs for women with advanced breast cancer in the last two decades.

He said: “In clinical trials, palbociclib and ribociclib have made a huge difference to women’s lives – slowing down tumour growth for nearly a year, and delaying the need for chemotherapy with all its potentially debilitating side-effects. These drugs have allowed women to live a normal life for longer.

“I’m delighted that NICE and the manufacturers have managed to come to an agreement over the price and economic modelling of palbociclib and ribociclib, so that many more women can access this much-needed new type of treatment on the NHS,” added Professor Turner, who was involved in trialing the drugs.

Professor Paul Workman, chief executive of the institute, which is based in London, said: “It’s great news that this innovative new type of cancer treatment has been approved for use on the NHS.

“These two new drugs target weaknesses in cancer cells specifically, and so have far fewer side-effects than conventional chemotherapy,” he said.

“Using them alongside an aromatase inhibitor gives us just the sort of innovative combination treatment that we need more of,” said Professor Workman.

ICR

Professor Paul Workman

Paul Workman

But he added that it was “frustrating” the NHS approval of palbociclib had been “such a long, drawn-out process”, even though the manufacturer had made the drug available for free in the meantime.

“We need NICE to work together with industry on a new process for evaluation where companies are encouraged to come forward with their best price much earlier in discussions,” he said. “The current system is taking too long and prices still remain high.”

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