2 The technology

2 The technology

Description of the technology

Venetoclax (Venclyxto, AbbVie) is a selective small molecule inhibitor of B‑cell lymphoma 2, an anti-apoptotic protein overexpressed in around 95% of people with chronic lymphocytic leukaemia.

Marketing authorisation

Venetoclax has a conditional marketing authorisation for 'the treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B‑cell receptor pathway inhibitor' and for 'the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemo‑immunotherapy and a B‑cell receptor pathway inhibitor'.

Before the marketing authorisation was granted, venetoclax was designated a promising innovative medicine and was available to patients in the NHS through the early access to medicines scheme.

Adverse reactions

There is a risk of tumour lysis syndrome during the initial 5‑week dose‑titration phase of treatment because venetoclax can cause rapid tumour reduction. Grade 3 or 4 neutropenia has also been reported in patients treated with venetoclax. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

The starting dose is 20 mg once daily for 7 days. The dose must be gradually increased over 5 weeks up to the recommended daily dose of 400 mg. For full details of the dose increase schedule, see the summary of product characteristics.

Price

A 112‑pack of 100 mg tablets (which is enough for 28 days of 400 mg treatment, used at week 5 onward) costs £4,789.47 (excluding VAT).

The pricing arrangement considered during guidance development was that AbbVie had agreed a patient access scheme with the Department of Health. The managed access agreement agreed in August 2017 replaced this patient access scheme. As part of the managed access agreement, the company has a commercial access agreement with NHS England. This makes venetoclax available at a reduced cost. The financial terms of the agreement are commercial in confidence.

  • National Institute for Health and Care Excellence (NICE)