histamine dihydrochloride (Ceplene)

Following a full submission:

histamine dihydrochloride (Ceplene®) is not recommended for use within NHS Scotland.

Indication under review: maintenance therapy for adult patients with acute myeloid leukaemia in first remission concomitantly treated with interleukin-2. The efficacy of histamine dihydrochloride has not been fully demonstrated in patients older than age 60 years.

In a randomised open-label study, histamine plus interleukin-2 was superior to no treatment for the endpoint of leukaemia free survival (LFS) in a sub-group of patients in first complete remission.  In post hoc analysis of patients in first complete remission and aged less than 60 years, LFS rates at 36 months were 50% versus 30%.

Overall the manufacturer did not present a sufficiently robust clinical or economic case to gain acceptance by SMC.