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Everolimus/Afinitor

Breast cancer drug not cost effective for NHS, says draft NICE guidance

London, UK (July 8, 2013) – The cancer drug everolimus (also called Afinitor and manufactured by Novartis Pharmaceuticals) is not recommended as an NHS-funded treatment for a type of advanced breast cancer because it is not good value for money, says latest draft guidance from the National Institute for Health and Care Excellence (NICE).

NICE is currently assessing everolimus (in combination with the drug exemestane) as a treatment for HER2 negative, hormone-receptor-positive advanced breast cancer[i] for a particular group of postmenopausal women[ii]. Despite not recommending the treatment, the draft guidance goes on to say that women who are already receiving everolimus should continue with the treatment until they and their doctor thinks it’s appropriate to stop.

Sir Andrew Dillon, NICE Chief Executive, said: “We are committed to making sure the NHS provides the treatments that can make the greatest difference to people’s lives. This means weighing up how well a treatment works and comparing it to similar treatments in the NHS while also taking into account any associated side effects and the cost that the health service is being asked to pay.”

“Unfortunately, while the evidence presented to the independent Appraisal Committee suggested that everolimus with exemestane could delay the growth and spread of breast cancer by four to five months, the evidence did not allow the Committee to establish how long everolimus could actually extend a person’s life for, compared with exemestane alone. Using the evidence available, the committee concluded that everolimus is not a cost-effective treatment option for the NHS.”

Sir Andrew Dillon continued: “We are disappointed that the evidence for everolimus isn’t stronger, especially as we acknowledge that the drug could represent a new way of treating HER2 negative, hormone-receptor-positive advanced breast cancer by restoring a tumour’s sensitivity to hormone therapy.”

Consultees, including the manufacturer, healthcare professionals and members of the public, now have the opportunity to appeal against the recommendations if they believe there are sufficient grounds to do so. If no appeals are received, NICE expects to publish its final guidance next month.

Notes to Editors

• The draft guidance (called a Final Appraisal Determination, or FAD) for everolimus in combination with exemestane for treating locally advanced or metastatic HER2 negative hormone-receptor-positive breast cancer after endocrine therapy will be from the NICE website from Monday 8 July 2013. Embargoed copies of the draft guidance are available from the NICE press office on request.
• Breast cancer is the most common cancer in the UK with nearly 50,000 women and 400 men diagnosed each year[iii]. 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 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 Committee concluded that an estimate of the Incremental Cost Effectiveness Ratio (ICER) of £68,000 per QALY gained for everolimus compared with exemestane alone was the most plausible estimate.
• 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 manufacturer of everolimus has agreed a patient access scheme with the Department of Health, in which the first month of treatment is free (including the option to offer the 5 mg tablet pack if there is a need to reduce the dose). This patient access scheme was taken into consideration and 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) is due to publish its guidance on everolimus for this group of women on 8 July 2013.
• 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.

To find out more about what we do, visit our website: www.nice.org.uk  

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[i] 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.

[ii] 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 is developing guidance.

[iii] 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:

http://www.cancerresearchuk.org/cancer-info/cancerstats/types/breast/incidence/

This page was last updated: 05 July 2013

National Institute for Health and Care Excellence, 08.07.2013 (tB).