following a full submission:
belatacept (Nulojix®) is not recommended for use within NHS Scotland.
Indication under review: Belatacept, in combination with corticosteroids and a mycophenolic acid, is indicated for prophylaxis of graft rejection in adults receiving a renal transplant. It is recommended to add an interleukin-2 receptor antagonist for induction therapy to this belatacept-based regimen.
Results of two phase III studies have demonstrated comparable graft and patient survival of belatacept versus a calcineurin inhibitor when used as part of a maintenance immunosuppressive regimen. Indirect efficacy data from a mixed treatment comparison are available for belatacept versus another calcineurin inhibitor, considered the key comparator in NHS Scotland.
The submitting company’s justification for the treatment’s cost in relation to its health benefits was not sufficient and in addition, the company did not present a sufficiently robust economic case to gain acceptance by SMC.
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Medicine details
- Medicine name:
- belatacept (Nulojix)
- SMC ID:
- 786/12
- Indication:
- in combination with corticosteroids and a mycophenolic acid (MPA), is indicated for prophylaxis of graft rejection in adults receiving a renal transplant. It is recommended to add an interleukin (IL) - 2 receptor antagonist for induction therapy to this belatacept-based regimen.
- Pharmaceutical company
- Bristol-Myers Squibb Pharmaceuticals Ltd
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Not recommended
- Date advice published
- 11 June 2012