- icatibant acetate (Firazyr), for the treatment of acute attacks of hereditary angioedema in adults;
- everolimus (Afinitor), for the treatment of unresectable or metastatic, well- or moderately-differentiated pancreatic neuroendocrine tumours (pNET) in adults with progressive disease.
Suitable for restricted use
- imatinib (Glivec), for restricted use as adjuvant treatment in patients who are at significant risk of relapse following resection of a KIT (CD117)-positive gastrointestinal stromal tumour (GIST);
- the collagenase product, Xiapex, for the treatment of moderately severe Dupuytren’s contracture in patients with a palpable cord and up to two affected joints per hand. It is restricted to use as an alternative to limited fasciectomy when percutaneous needle fasciotomy is not considered suitable.
The SMC has rejected applications for the following treatments on the grounds that they do not offer value for money:
- abiraterone acetate (Zytiga), for castration-resistant prostate cancer;
- asenapine (Sycrest), for manic episodes in bipolar disorder;
- belimumab (Benlysta), for systemic lupus erythematosus;
- bevacizumab (Avastin), for the first-line treatment of metastatic breast cancer when taxanes and anthracyclines are inappropriate, in combination with capecitabine;
- fingolimod (Gilenya), for relapsing-remitting multiple sclerosis;
- ipilimumab (Yervoy), for advanced melamona.
In addition, tocilizumab (RoActemra) was rejected as monotherapy for the treatment of moderate to severe active rheumatoid arthritis in adults who have responded inadequately to or who were intolerant of previous therapy, including one or more DMARDs or TNF antagonists, as clinical data supporting the case was poor and data for the cost-benefit analysis contained a number of weaknesses.