Breast cancer treatment not value for money says draft NICE guidance
Provisional draft guidance published today (21 March) by the National Institute for Health and Clinical Excellence (NICE) does not recommend the drug everolimus (Afinitor, Novartis Pharmaceuticals) as an NHS-funded treatment for a type of advanced breast cancer.
NICE is currently appraising everolimus (in combination with the drug exemestane) as a treatment for HER2 negative, hormone-receptor-positive advanced breast cancer[i]. The treatment is only licensed for use in postmenopausal women with this type of 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 specific group of people that NICE is developing guidance.
Sir Andrew Dillon, NICE Chief Executive, said: "For a treatment to be recommended by NICE, it must be shown to be cost-effective. That means it must work as well as, or better than, current NHS treatment, taking into account any associated side effects and the cost that the NHS is being asked to pay.
"While the independent Appraisal Committee acknowledged that everolimus may offer a step change in treatment by restoring sensitivity of the tumour to hormone therapy, the evidence highlighted uncertainty relating to how much the treatment extends overall survival. Using the most appropriate estimates, the committee concluded that everolimus is not a cost-effective treatment option for the NHS."
Sir Andrew Dillon added: "NICE has now opened a consultation on this draft guidance for everolimus and we welcome comments which will help the Appraisal Committee develop the guidance further."
Consultees, including the manufacturer, healthcare professionals and members of the public are able to comment on the draft recommendations via the NICE website until 22 April 2013. Comments received during this consultation will be fully considered by the Committee.
NICE has not yet issued final guidance to the NHS. Until this happens, NHS bodies should make decisions locally on the funding of specific treatments.
Notes to Editors
About the draft guidance
- The Appraisal Consultation Document (ACD) 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 Thursday 21 March 2013.
- Everolimus is an oral treatment and works by inhibiting 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 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 the median progression-free survival benefit (the time point in the trial at which the 50%of people experience either disease progression or death) of everolimus (with exemestane) was 4.6 months more than exemestane alone.
- The Appraisal Committee acknowledged that everolimus may offer a step change in treatment by restoring sensitivity of the tumour to endocrine therapy but 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 £67,000 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. It Treatment with everolimus should continue as long as patients benefit clinically, or until they experience unacceptable adverse reactions. Adverse reactions 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). Costs may vary in different settings because of negotiated procurement discounts and the manufacturer has not submitted a patient access scheme for this appraisal.
- The Committee considered whether the treatment could be considered under the Institute's end-of-life the criteria. Given that the manufacturer model estimated a mean overall survival of 28.9 months for exemestane alone, the Committee was not convinced that the life expectancy of women to whom everolimus would be offered was convincingly less than 24 months. It concluded that everolimus did not fulfil the criteria for an end-of-life therapy.
- Around 50,000 women and 400 men are diagnosed with breast cancer each year in the UK[ii]. Although there are different types of the disease, most tumours are hormone-receptor-positive (the cancer depends on female hormones like oestrogen to grow). Treatment options for this type of breast cancer typically include surgery, chemotherapy, radiotherapy and hormone therapies like aromatase inhibitors and tamoxifen. Around 4 in 5 breast cancers are HER2 negative (which means the targeted treatment trastuzumab - Herceptin - will not work). The manufacturer estimates that around 1,500 people would be eligible to receive everolimus, if it were to be recommended.
- The Scottish Medicines Consortium (SMC) has not yet published guidance on everolimus for this indication. For more information, please visit the Scottish Medicines Consortium website.
- NICE has previously published guidance for the NHS on the use of everolimus as a second-line treatment of advanced renal cell carcinoma.
- 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.
1. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.
2. NICE produces guidance in three areas of health:
- public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
- health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
- clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS
- social care - the Health and Social Care Act (2012) sets out a new responsibility for NICE to develop guidance and quality standards for social care. To reflect this new role, from 1 April 2013 NICE will be called the National Institute for Health and Care Excellence (NICE) and it will become a Non-Departmental Public Body.
3. NICE produces standards for patient care:
- quality standards - these describe high-priority areas for quality improvement in a defined care or service area
- Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients
- CCG Outcomes Indicator Set (formerly known as COF) - NICE develops the potential clinical health improvement indicators to ensure quality of care for patients and communities served by the clinical commissioning groups (CCGs).
4. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.
[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 grow and 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 4 in 5 breast cancers are HER2 negative, which means the targeted treatment trastuzumab (Herceptin) will not work.