Thousands of women with previously untreatable breast cancer will have access to two “breakthrough” drugs that have been approved for NHS use.



The drugs, called palbociclib and ribociclib, have been shown to slow the progression of advanced cancer by at least 10 months and can delay the need for chemotherapy, giving women the chance to live a normal life for longer. In new draft guidance, the National Institute for Health and Care Excellence (Nice) has approved the drugs for widespread use in the health service in England for the first time.

It is estimated that about 8,000 people in England would be eligible for treatment with either palbociclib or ribociclib each year.

The Institute of Cancer Research (ICR), London, described the drugs as among the “most important breakthroughs” for women with advanced cancer in the last two decades.

Nice had previously rejected palbociclib because its cost was too high in relation to its clinical effectiveness and the new agreement comes after health officials negotiated a lower price with manufacturers.

The treatments are designed to help women with oestrogen-receptor positive breast cancer, where the growth of tumours is fuelled by the hormone oestrogen – about two-thirds of cases of breast cancer. Patients who were diagnosed with this kind of cancer after it had begun to spread to other parts of the body will be eligible for palbociclib – also known as Ibrance and manufactured by Pfizer.

Women who meet these criteria, and who have also undergone the menopause, will be eligible for ribociclib – also known as Kisqali, created by Novartis.

The drugs are given once daily and need to be used in combination with drugs that block the production of oestrogen. Palbociclib and ribociclib help further slow the proliferation of cancer cells by reducing the activity of two enzymes involved in cell division, called CDK4 and CDK6.

Professor Carole Longson, director of the centre for health technology evaluation at Nice, said: “The committee heard from the patient experts that delaying the progression of their cancer for as long as possible and being able to continue with normal activities, including working, is valued very highly by patients and their families.”

“It also heard that by postponing disease progression, palbociclib and ribociclib may reduce the number of people who are exposed to the often unpleasant side effects of chemotherapy, and delay the need for its use in others.

The ICR, along with the Royal Marsden NHS Foundation Trust, led the major clinical trial into palbociclib.



Trial lead Nicholas Turner, professor of molecular oncology at the ICR and consultant medical oncologist at the Royal Marsden, 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.

“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.”

There are around 45,000 new diagnoses of breast cancer each year in England.

The standard price for one cycle of palbociclib is £2,950 for a pack of 21 capsules. The list price for one cycle of ribociclib is also £2,950 but this is for 63 tablets. However, the health regulator has agreed discounts for both of the drugs.

Once health officials approve a drug in England, those in Wales may also choose to follow suit.

Baroness Delyth Morgan, chief executive of the charity Breast Cancer Now, said: “Palbociclib and ribociclib represent an exciting new generation of medicines capable of slowing the spread of incurable breast cancer, and their introduction to NHS care in England is fantastic news for patients and their doctors. Around 8,000 women each year can now be given significant extra time before their condition progresses – time that will be truly invaluable to them and their loved ones.”