8.2.3. Anti-lymphocyte monoclonal antibodies
Restrictions:
- Use for the treatment of B-cell chronic lymphocytic leukaemia is restricted to specialist use according to regional protocol.
Prescribing Notes:
Alemtuzumab for use in CLL is available on a named-patient basis.
Restrictions:
Restricted to specialist use in accordance with regional protocol for use as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
Click here for regional protocol [NHS network access required]
Restrictions:
Restricted to specialist use in accordance with regional protocol for use in combination with pomalidomide and dexamethasone for patients receiving fourth-line therapy (with prior therapies including lenalidomide and a proteasome inhibitor) and have demonstrated disease progression on the last therapy.
Click here for regional protocol [NHS network access required]
Prescribing Notes:
Non-formulary indication:
- In combination with carfilzomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy has not been recommended by SMC for use in NHS Scotland.
Restrictions:
Restricted to specialist use in accordance with regional protocols for the following indications:
- CLL: In combination with chlorambucil, obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy (regional protocol, NHS network access required)
- Follicular Lymphoma: In combination with bendamustine followed by obinutuzumab maintenance is indicated for the treatment of patients with follicular lymphoma who did not respond or who progressed during or up to six months after treatment with rituximab or a rituximab-containing regimen (in development).
Prescribing Notes:
Obinutuzumab is currently non-Formulary for the following indications:
- Follicular Lymphoma: in combination with chemotherapy followed by obinutuzumab maintenance therapy in patients achieving a response, for the treatment of patients with previously untreated advanced follicular lymphoma is not recommended by SMC and remains non-formulary.
Restrictions:
Restricted to specialist use in accordance with regional protocol for the indication below:
- Use in combination with chlorambucil or bendamustine for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy is restricted to specialist use in accordance with regional protocol in patients who would not be considered for bendamustine therapy and who would receive chlorambucil-based therapy
Prescribing Notes:
The treatment of adults with relapsed CLL in combination with fludarabine and cyclophosphamide is not recommended by SMC and is non-Formulary.
Restrictions:
Use in haemato-oncology is restricted to accordance with regional protocols.
- The maintenance treatment of follicular lymphoma in previously untreated patients responding to induction therapy is restricted in accordance with regional protocol.
- The treatment of patients with previously untreated and relapsed/ refractory chronic lymphocytic leukaemia (CLL) in combination with chemotherapy is restricted to use in accordance with regional protocol.
- The use in combination with glucocorticoids for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA) is restricted to specialist use in patients who have relapsed following treatment with cyclophosphamide or who are intolerant to or unable to receive cyclophosphamide.
- The subcutaneous injection formulation is restricted to use only in accordance with regional protocols.
Prescribing Notes:
SMC advice for various indications for rituximab can be found here
Please note: The subcutaneous preparation is not licensed for all the indications that the IV infusion is licensed for.
The following indications are not recommended by SMC and are non-Formulary:
- Use in combination with glucocorticoids, for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA)
- Treatment of patients with moderate to severe pemphigus vulgaris (non-submission to SMC)
Restrictions:
Restricted to specialist use in accordance with regional protocol for use as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
Click here for regional protocol [NHS network access required]