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venetoclax (Venclyxto)

Advice

following a full submission assessed under the end of life and orphan medicine process:

venetoclax (Venclyxto®) is accepted for use within NHS Scotland.

Indication under review: as monotherapy 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.
     
  • in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.


​In phase II, non-comparative studies of patients with relapsed / refractory CLL, treatment with venetoclax was associated with clinically meaningful overall response rates.


This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of venetoclax. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.

This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.

Drug Details

Drug Name: venetoclax (Venclyxto)
SMC Drug ID: 1249/17
Manufacturer: AbbVie Ltd
Indication: as monotherapy 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. •in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor.
BNF Category:
Submission Type: Full submission
Status: Accepted
Date Advice Published: 7 August 2017

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