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Sunderland Joint Formulary
NHS Sunderland Clinical Commissioning Group
South Tyneside and Sunderland NHS Foundation Trust
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 Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
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08.02.03  Expand sub section  Anti-lymphocyte monoclonal antibodies
Alemtuzumab
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Formulary
Red

Concentrate for IV infusion: 30mg in 1ml
- for use in lymphocytic leukaemia & prevention of graft vs. host disease on bone marrow transplant patients
-approved for use in high-risk kidney and pancreas transplantation


Concentrate for IV infusion 12mg in 1.2ml
-approved as an option for treating adults with active relapsing– remitting multiple sclerosis in line with NICE (subject to NHS ENGLAND funding)


 

 
Link  NICE TA 312: Alemtuzumab for treating relapsing‑remitting multiple sclerosis
   
Isatuximab (Sarcusa®)
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Formulary
Red
High Cost Medicine
NHS England

Vill: concentrate for infusion 100 mg/5 mL and 500 mg/25 mL

 
Link  NICE TA 658: Isatuximab with pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma
   
Obinutuzumab (Gazyvaro ®)
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Formulary
Red
High Cost Medicine

Concentrate for IV infusion: 1000mg in 40ml


-for use in chronic lymphocytic leukaemia in combination with chlorambucil in patients who have co-morbitities that make fulldose fludarabinebased therapy unsuitable for them, only if bendamustinebased therapy is not suitable and the company provides obinutuzumab with the discount agreed in the patient access scheme in line with NICE (subject to NHS England funding)

 
Link  NICE TA 343: Obinutuzumab in combination with chlorambucil for untreated chronic lymphocytic leukaemia
Link  NICE TA 513: Obinutuzumab for untreated advanced follicular lymphoma
   
OcrelizumabBlack Triangle (Ocrevus®)
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Formulary
Red
High Cost Medicine
NHS England
Solution for infusion 30mg per 1mL 
Link  NICE TA 533: Ocrelizumab for treating relapsing–remitting multiple sclerosis
Link  NICE TA 585: Ocrelizumab for treating primary progressive multiple sclerosis
Link  NICE TA 629: Obinutuzumab with bendamustine for treating follicular lymphoma after rituximab
   
Rituximab
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Formulary
Red
High Cost Medicine

Concentrate for IV infusion: 100mg in 10ml & 500mg in 50ml


-for musculoskeletal indications see chapter 10
-approved for first line use in NHL in combination with CHOP in line with NICE
-approved for maintenance therapy in follicular NHL that has responded to first line induction therapy with rituximab in combination with chemotherapy in line with NICE
-approved for stage III and IV follicular lymphoma in previously untreated people in line with NICE
-approved for replased or refractory follicular NHL in line with NICE
-approved for Post-transplant lymphoproliferative disease
- approved for first line use in CLL in combination with fludarabine and cyclophosphamide in line with  NICE
-approved for combination with fludarabine and cyclophosphamide for relapsed or refractory CLL in line with NICE
-approved for autoimmune haematological conditions (where conventional treatments have failed)
– Autoimmune haemolytic anaemia
(AIHA), Evans syndrome, pure red cell aplasia (PRCA), acquired haemophilia A & thrombocytopenia purpura (TTP).
- Combination with bendamustine for first line use in CLL (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate.
- a
pproved for vasculitis (including Wegener’s granulomatosis in adults and children) that has not responded adequately to conventional treatment (e.g. corticosteroids, cyclophosphamide) NICE and additional NHS England criteria
-NECDAG approved for the treatment of NLPHL
-NECDAG approved for newly diagnosed mantle cell NHL in patients aged <60 years old approved in combination with bendamustine for first line use in CLL (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate NICE
-NECDAG approved in combination with bendamustine for patients with CLL not fit for FCR chemotherapy or for patients who relapse within 2 years of FCR chemotherapy and not fit for alemtuzumab.
-NECDAG approved with salvage chemotherapy for patients relapsing > 12 months post 1st line -therapy with R-CHOP
-NECDAG approved with a standard NHL induction regimen in patients who cannot be given an anthracycline. Rituximab with other chemotherapy regimens is an alternative treatment option e.g. DECC, CVP for this group of patients, as part of their first line therapy. Also in addition to the MACOP-B regimen for the small number of young patients with DLBCL, subtype Primary Mediastinal B cell Lymphoma
-NECDAG approved for the treatment of hairy Cell Leukaemia (HCL) or Hairy cell Leukaemia varian (HCL-v) who:


        -relapse early after purine analogue therapy (< 2 years post treatment)
        -are refractory to purine analogues.
-NTAG approved for the treatment of immune (idiopathic) thrombocytopenic purpura (ITP) in adults and children NTAG
-approved for the treatment of immunobullous disease in line with NHS England Commissioning Policy



SC injection: 1.4g solution


-approved for use as maintenance single agent therapy in FL, mantle cell lymphoma, marginal zone lymphoma and lymphoplasmacytic lymphoma in line with NHS ENGLAND SSC1434

 
Link  NICE TA 137: Lymphoma (follicular non-Hodgkin’s) - rituximab
Link  NICE TA 174: Leukaemia (chronic lymphocytic, first line) - rituximab
Link  NICE TA 193: Leukaemia (chronic lymphocytic, relapsed) - rituximab
Link  NICE TA 226: Lymphoma (follicular non-Hodgkin’s) - rituximab
Link  NICE TA 243: Follicular lymphoma - rituximab (review)
Link  NICE TA 308: Rituximab in combination with glucocorticoids for treating anti-neutrophil cytoplasmic antibody-associated vasculitis
Link  NICE TA 627: Lenalidomide with rituximab for previously treated follicular lymphoma
   
 ....
Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
Display tracking information
click to search medicines.org.uk
Link to adult BNF
click to search medicines.org.uk
Link to SPCs
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
Cancer Drugs Fund
Cancer Drugs Fund
NHSE
NHS England
Homecare
Homecare
CCG
CCG

Traffic Light Status Information

Status Description

Red

Drugs for hospital use or use by a specialist within specialist centre only. Initiation and monitoring of treatment should remain under the total responsibility of the appropriate hospital clinician or specialist. These drugs should only be prescribed under the direct supervision of that clinician or specialist and are not suitable for shared care arrangements. The drug should be supplied via the hospital or specialist centre for the duration of treatment.   

Amber

These are specialist drugs which must be initiated by secondary care specialist prescribers, but with the potential to transfer prescribing to primary care within written and agreed shared care protocols and according to the agreed process for transfer of care. For these drugs, in order to ensure patient safety, some aspects of care must remain with the specialist due to their complexity e.g. monitoring of disease or drug response. Other more routine aspects can be transferred to the GP e.g. monitoring of adverse effects and supply of the medicine. The specific responsibilities of the specialist and GP are defined in the shared care agreement for each drug. Shared care agreements are still under development for some amber drugs. Until these are available, it would be expected that any shared care request from secondary care to a GP would be accompanied by written information which defines prescribing and monitoring responsibilities. The hospital specialist should also provide the GP with enough information and support to allow the safe transfer and ongoing management of prescribing into primary care.   

Green +

Drugs which should usually be initiated in secondary care, or by a specialist clinician, but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case.  

Green

These are defined as new and established drugs, which may be prescribed, initiated, changed or maintained on FP10 by the GP and, if appropriate, discontinued without recourse to secondary care. N.B. DRUGS NOT IDENTIFIED IN THE FORMULARY BY A RED, AMBER OR GREEN+ SYMBOL ARE CLASSIFIED AS GREEN.   

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