2 The technology

2.1 Everolimus (Certican, Novartis Pharmaceuticals UK) is an analogue of sirolimus. It is an immunosuppressant that inhibits the mammalian target of rapamycin (mTOR) protein and targets the primary causes of progressive allograft dysfunction (also known as chronic rejection) following an organ transplant. It has a marketing authorisation in the UK for 'the prophylaxis of organ rejection in patients receiving a hepatic transplant. In liver transplantation, everolimus should be used in combination with tacrolimus and corticosteroids'.

2.2 Everolimus is taken orally. The recommended starting dosage is 1.0 mg twice daily. The first dose is taken approximately 4 weeks after the transplant. The summary of product characteristics states that for people who have had a liver transplant, exposure to tacrolimus should be reduced to minimise calcineurin‑related renal toxicity. The tacrolimus dose should be reduced starting approximately 3 weeks after initiating administration together with everolimus, based on targeted tacrolimus blood trough levels of 3–5 ng/ml.

2.3 The summary of product characteristics for everolimus lists the most common adverse reactions as infections, anaemia, hyperlipidaemia, new onset of diabetes mellitus, insomnia, anxiety, headache, hypertension, cough, nausea, peripheral oedema and impaired healing. For full details of adverse reactions and contraindications, see the summary of product characteristics.

2.4 The company reported that the acquisition cost for everolimus is £148.50, £297.00 and £445.50 for the 0.25 mg, 0.5 mg and 0.75 mg packs respectively, excluding VAT. Costs may vary in different settings because of negotiated procurement discounts.

  • National Institute for Health and Care Excellence (NICE)