bortezomib (Velcade)

Following an abbreviated submission:

bortezomib subcutaneous injection (Velcade®) is accepted for use within NHS Scotland.

Indications under review: in combination with melphalan and prednisone for the treatment of patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with bone marrow transplant.

As monotherapy for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplantation.

The subcutaneous formulation of bortezomib has been shown to be clinically non-inferior to the intravenous formulation and is the same price.

SMC previously accepted bortezomib intravenous injection as monotherapy in the treatment of multiple myeloma when the benefits of a Patient Access Scheme (PAS) were taken into account.  The Patient Access Scheme Assessment Group (PASAG) has confirmed that this response-based PAS also applies to the subcutaneous formulation when used in this setting. This SMC advice is therefore contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.

Bortezomib intravenous injection has also been accepted for use in NHS Scotland in specific circumstances in the first line treatment of multiple myeloma as Healthcare Improvement Scotland has endorsed NICE MTA No 228 (Bortezomib and thalidomide for the first line treatment of multiple myeloma) in July 2011. The PAS does not apply to the use of bortezomib in this setting.