Advanced Treatment Everolimus

About the draft guidance
Everolimus With or Without Bevacizumab in Treating Patients With Advanced Kidney Cancer That Progressed After First-Line Therapy.

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.