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      VENETOCLAX WITH OBINUTUZUMAB FOR UNTREATED CHRONIC LYMPHOCYTIC LEUKAEMIA

       

      SMC accepted for restricted use1

      Venetoclax (Venclyxto®) is accepted  for restricted use within NHSScotland, in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

      SMC restriction: for use in (1) patients without del (17p)/TP53 mutation who are not fit to receive FCR (fludarabine, cyclophosphamide and rituximab) chemo-immunotherapy and (2) patients with del (17p)/TP53 mutation.

      This advice applies only in the context of approved NHSScotland Patient Access Scheme (PAS) arrangements delivering the cost-effectiveness results upon which the decision was based, or PAS/ list prices that are equivalent or lower.

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

       

      VENETOCLAX WITH RITUXIMAB FOR PREVIOUSLY TREATED CHRONIC LYMPHOCYTIC LEUKAEMIA

       

      SMC ACCEPTED2

      Venetoclax is accepted for use in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.

      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 NHSScotland or a list price that is equivalent or lower.

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

       

      References

      1. Scottish Medicines Consortium (SMC) Medicines Advice. SMC No. SMC2293: https://www.scottishmedicines.org.uk/medicines-advice/venetoclax-venclyxto-full-smc2293/ (accessed December 2020)
      2. Scottish Medicines Consortium (2019). Venetoclax (Venclyxto) in combination with rituximab. SMC2166. https://www.scottishmedicines.org.uk/medicines-advice/venetoclax-venclyxto-full-smc2166/ (Accessed: December 2020)

       

      Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk.

      Adverse events should also be reported to AbbVie on GBPV@abbvie.com

      UK-VNCCLL-200436.  Date of preparation: December 2020.