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Bedfordshire and Luton Joint Formulary
Bedfordshire Hospitals NHS Foundation Trust
Bedfordshire, Luton and Milton Keynes ICB
Formulary Chapter: 8 - Malignant disease and immunosuppression 
Notes:

Any drug not listed on the Formulary should be considered Non-Formulary - Not recommended for prescribing
08.02.03 Anti-lymphocyte monoclonal antibodies

Alemtuzumab (Lemtrada®)

RED
Restricted Drug Restricted
FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

Approved in accordance with NICE TA312 as a possible treatment for active relapsing-remitting multiple sclerosis

12mg/1.2mL Injection
30mg/1mL Injection
BNF BNFc SPC
MHRA Drug Safety Update: Lemtrada¥ (alemtuzumab): updated restrictions and strengthened monitoring requirements following review of serious cardiovascular and immune-mediated reactions (February 2020) NICE TA312: Alemtuzumab for treating relapsing‑remitting multiple sclerosis SCG: Alemtuzumab for treating relapsing-remitting multiple sclerosis

Dinutuximab (Qarziba®)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

Approved in accordance with NICE TA538.

BNF BNFc SPC
NICE TA538: Dinutuximab beta for treating neuroblastoma

Gemtuzumab (Mylotarg®)
(Infusion)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

Approved in accordance with NICE TA545.

BNF BNFc SPC
NICE TA545: Gemtuzumab ozogamicin for untreated acute myeloid leukaemia

Inotuzumab (Besponsa®)
(Infusion)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

Approved in accordance with NICE TA541.

BNF BNFc SPC
NICE TA541: Inotuzumab ozogamicin for treating relapsed or refractory B-cell acute lymphoblastic leukaemia

Obinutuzumab (Gazyvaro ®)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

Approved in line with NICE TA's below.

BNF BNFc SPC
NICE TA343: Obinutuzumab in combination with chlorambucil for untreated chronic lymphocytic leukaemia NICE TA472: Obinutuzumab with bendamustine for treating follicular lymphoma refractory to rituximab NICE TA513: Obinutuzumab for untreated advanced follicular lymphoma NICE TA629: Obinutuzumab with bendamustine for treating follicular lymphoma after rituximab NICE TA663: Venetoclax with obinutuzumab for untreated chronic lymphocytic leukaemia NICE TA978: Zanubrutinib with obinutuzumab for treating relapsed or refractory B-cell follicular lymphoma after 2 or more treatments (TERMINATED APPRAISAL)

Ofatumumab (Arzerra®)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

Approved in accordance with the following NICE TAs:-

BNF BNFc SPC
NICE TA202: Chronic lymphocytic leukaemia - ofatumumab NICE TA344: Ofatumumab in combination with chlorambucil or bendamustine for untreated chronic lymphocytic leukaemia NICE TA699: Ofatumumab for treating relapsing multiple sclerosis

Rituximab (Rixathon®Truxima®)

RED
Formulary

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

Bedford preferred brand: Rixathon

Luton preferred brand: Truxima

Mabthera (originator brand) for existing patients only
 
Approved for consultant specialist prescribing in accordance with the following NICE TA(s):-

BNF BNFc SPC BlueTeq
NICE TA 649 Polatuzumab vedotin with rituximab and bendamustine for treating relapsed or refractory diffuse large B-cell lymphoma NICE TA110: Follicular lymphoma - rituximab Non-Hodgkin's lymphoma - rituximab NICE TA137: Lymphoma (follicular non-Hodgkin's) - rituximab NICE TA174: Leukaemia (chronic lymphocytic, first line) - rituximab NICE TA193: Leukaemia (chronic lymphocytic, relapsed) - rituximab NICE TA226: Lymphoma (follicular non-Hodgkin’s) - rituximab NICE TA243: Follicular lymphoma - rituximab (review) NICE TA65: Non-Hodgkin’s lymphoma - rituximab
Classifications
GREEN
May be initiated in any care setting
Amber SPA
Specialist to advise therapy and provide first 28 days supply, continuation in Primary Care
Amber SPIS
Specialist to initiate and stabilise medicine prior to continuation in Primary Care
SCG
To be prescribed as per Shared Care Guidance. If no SCG in place status reverts to red.
RED
Red medicines are designated as specialist only medicines which should only be prescribed by a specialist, usually within secondary care (either due to the requirement for specialist knowledge, long-term monitoring requirements, or restrictions that mean medicine supplies are only available to hospitals).
DNP
A decision has been made either locally and/or nationally not to routinely commission this preparation. Do not prescribe.
SELF
To be purchased over the counter. May be prescribed for chronic, long term conditions or on admission to hospital if essential.