2 The technology

2 The technology

Description of the technology

Everolimus (Afinitor, Novartis Pharmaceuticals) is an active inhibitor of the mammalian target of rapamycin (mTOR) protein, a central regulator of tumour cell division and blood vessel growth in cancer cells.

Marketing authorisation

Everolimus has a UK marketing authorisation for 'the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF- [vascular endothelial growth factor] targeted therapy'.

Adverse reactions

Everolimus is contraindicated in people who have hypersensitivity to the active substance, to other rapamycin derivatives or to any of the excipients. The summary of product characteristics lists the following as special warnings and precautions for everolimus use: non-infectious pneumonitis, localised and systemic infections (including pneumonia, other bacterial infections and invasive fungal infections), hypersensitivity reactions and oral ulcerations. For full details of side effects and contraindications, see the summary of product characteristics.

Recommended dose and schedule

Everolimus is administered orally. The recommended dosage is 10 mg once daily, and treatment should continue as long as there is clinical benefit or until there are unacceptable adverse events. Management of severe or intolerable adverse events may need dose reduction to a suggested dosage of 5 mg daily or temporary withholding of everolimus.

Price

The price for a pack of 10‑mg tablets (30 tablets per pack) is £2,673 (excluding VAT; 'British national formulary' [BNF] online, December 2016). The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of everolimus, with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.

  • National Institute for Health and Care Excellence (NICE)