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NICE: Breast cancer drug everolimus not cost-effective

London, UK, (August 29, 2013) – The National Institute for Health and Care Excellence (NICE) has found that a breast cancer treatment should not be recommended for use by the NHS because it is not a good use of limited NHS money. The new guidance advises that the drug everolimus (also called Afinitor and manufactured by Novartis Pharmaceuticals) should not be routinely provided as a treatment for postmenopausal women[1] with HER2 negative, hormone-receptor-positive advanced breast cancer[2].

Sir Andrew Dillon, NICE Chief Executive, said: “NICE assesses treatments and recommends those which are found to be the most clinically and cost effective. With limited NHS funds, it’s important we make recommendations based on how well a treatment works compared to alternative treatments in the NHS, as well as any associated side effects and the cost that the health service is being asked to pay.

“The independent appraisal committee, which reviewed everolimus, acknowledged it could delay the growth and spread of breast cancer by around four months, but there were uncertainties relating to how long it could extend a person’s life compared with the drug exemestane alone.

“Using the evidence that was available, the committee concluded that everolimus is not a cost-effective option for the NHS.”

Despite not recommending the treatment, the guidance does say that women already receiving everolimus should continue with it until they and their doctor thinks it’s appropriate to stop.

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Notes to Editors

• The final guidance for everolimus in combination with exemestane for treating locally advanced or metastatic HER2 negative hormone-receptor-positive breast cancer after endocrine therapy is available on the NICE website.
• Breast cancer is the most common cancer in the UK with nearly 50,000 women and 400 men diagnosed each year[3]. Everolimus is an oral treatment that works by blocking a protein in the body that regulates the division of tumour cells and growth of blood vessels. This can help stop cancer cells from multiplying and spreading. The manufacturer estimates that around 1,500 people would be eligible to receive everolimus, if it were to be recommended.
• The recommended dosage of everolimus is 10mg taken once a day. Treatment should continue for as long as it stops the growth and spread of cancer cells or until the patient cannot tolerate the side effects. Side effects that are severe and/or intolerable may be managed by reducing the dosage to 5mg daily or temporarily stopping treatment followed by reintroduction at 5mg daily. The price for a pack of 10mg tablets (30 tablets per pack) is £2,970 (excluding VAT; ‘British National Formulary‘ [BNF] edition 64).
• The independent Appraisal Committee assessed the evidence submitted to this appraisal, including clinical trial data and evidence by clinical experts and patient representatives. The evidence submitted to the committee by the manufacturer highlighted that median progression-free survival (the time point in the trial at which the 50% of people experience either disease progression or death) with everolimus (with exemestane) was 4.6 months longer than with exemestane alone. However, the committee concluded that the clinical trial data generated uncertainty relating to the efficacy of the treatment compared with relevant chemotherapy regimens and how much the treatment may extend overall survival.
• The manufacturer of everolimus had agreed a patient access scheme with the Department of Health and this was included in the calculation of cost-effectiveness. However, this did not alter the Committee’s conclusion that everolimus is not cost effective as a treatment for HER2 negative, hormone-receptor-positive advanced breast cancer.
• The Scottish Medicines Consortium (SMC) published guidance in July 2013 which does not recommend everolimus as a treatment for hormone receptor-positive, HER2 negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.
• In 2009, NICE published a clinical guideline on the care of people with early and locally advanced breast cancer and another for advanced breast cancer. Both guidelines include recommendations for clinicians on a range of treatment options for patients.

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services.

1. Everolimus is only licensed for use in postmenopausal women with HER2 negative, hormone-receptor-positive advances breast cancer if their disease has returned or progressed following initial treatment with a non-steroidal aromatase inhibitor (a type of hormone therapy) and if they have no symptoms from visceral disease (when the cancer has spread to the body’s soft organs). It is for this group of people that NICE has developed guidance.
2. There are different types of breast cancer but hormone-receptor-positive breast cancer is the most common form. These tumours depend on female hormones like oestrogen to growand can be treated with hormone therapies that target the production of these hormones or reduce the tumour’s ability to respond to them. Some of these tumours may also be HER2 negative. Around four in five breast cancers are HER2 negative, which means the targeted treatment trastuzumab (Herceptin) will not work.
3. Data were provided to the charity, Cancer Research UK by the Office for National Statistics, the Northern Ireland Cancer Registry, Welsh Cancer Intelligence and Surveillance Unit and ISD Scotland on request in September 2012. Full details can be found on the Cancer Research UK website.

This page was last updated: 28 August 2013

National Institute for Health and Care Excellence (NICE), 29.08.2013 (tB).