2 The technology

2 The technology

Description of the technology

Everolimus (Afinitor, Novartis Pharmaceuticals) inhibits the mammalian target of rapamycin, a protein that regulates the division of tumour cells and growth of blood vessels.

Marketing authorisation

Everolimus has a UK marketing authorisation for the 'treatment of hormone receptor-positive, HER2/neu 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'.

Adverse reactions

The summary of product characteristics lists the most frequently reported grade 3 or 4 adverse reactions including: anaemia, fatigue, diarrhoea, infections, stomatitis, hyperglycaemia, thrombocytopenia, lymphopenia, neutropenia, hypophosphataemia, hypercholesterolaemia, diabetes mellitus and pneumonitis. For full details of adverse reactions 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 patients benefit clinically, or until they have unacceptable adverse reactions. Adverse reactions that are severe and/or intolerable may be managed by reducing the dosage to 5 mg daily or temporarily stopping treatment then reintroducing it at 5 mg daily.

Price

The price for a pack (30 tablets per pack) of 10-mg tablets and 5-mg tablets is £2,673 and £2,250 respectively (excluding VAT; 'British national formulary' [BNF]). 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 would not constitute an excessive administrative burden on the NHS.

  • National Institute for Health and Care Excellence (NICE)