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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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Red
NHS England
  • Alemtuzumab 30mg in 1ml concentrate for IV infusion is approved for use in, lymphocytic leukaemia & prevention of graft vs. host disease in bone marrow transplant patients, and high-risk kidney and pancreas transplantation.
  • Alemtuzumab 12mg in 1.2ml concentrate for IV infusion is approved for treating adults with active relapsing– remitting multiple sclerosis in line with NICE and NHS England commissioning policy. 

 

 
Link  NICE TA312: Alemtuzumab for relapsing‑remitting multiple sclerosis
Link  MHRA Drug Safety Update (Feb 2020): Lemtrada▼ (alemtuzumab): updated restrictions and strengthened monitoring requirements following review of serious cardiovascular and immune-mediated reactions
Link  MHRA Drug Safety Update (May 2019): Lemtrada (alemtuzumab) and serious cardiovascular and immune- mediated adverse reactions: new restrictions to use and strengthened monitoring requirements
 
Cytotoxic Drug AvelumabBlack Triangle (Bavencio®)
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Formulary
Red
High Cost Medicine
NHS England
  • Approved for  for maintenance treatment of locally advanced or metastatic urothelial cancer after platinum-based chemotherapy in adults in line with NICE
  • as an option for treating metastatic Merkel cell carcinoma in adults who have not had chemotherapy for metastatic disease in line with NICE
 
Link  NICE TA645: Avelumab with axitinib for untreated advanced renal cell carcinoma
Link  NICE TA691: Avelumab for treating metastatic Merkel cell carcinoma
Link  NICE TA788: Avelumab for maintenance treatment of locally advanced or metastatic urothelial cancer after platinum-based chemotherapy
 
Obinutuzumab
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Red
High Cost Medicine
NHS England
  • Approved for use in chronic lymphocytic leukaemia in combination with chlorambucil in patients who have co-morbitities that make full‑dose fludarabine‑based therapy unsuitable for them, only if bendamustine‑based 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).
  • Approved for the treatment of rituximab-refractory follicular lymphoma in combination bendamustine in line with NICE and NHS England Commissioning Policy
  • Approved with bendamustine for follicular lymphoma that has not responded or has progressed up to 6 months after treatment with rituximab or a rituximab-containing regimen in adults in line with NICE
  • Approved to prevent immune immune Thrombotic Thrombocytopenic Purpura (TTP) relapse in patients who are refractory or intolerant
    to rituximab (adults) in line with NHSE Commissioning Policy
    • Only available at The Newcastle upon Tyne Hospitals NHS Trust
 
Link  NHSE Clinical Commissioning Policy: Obinutuzumab elective therapy to prevent immune Thrombotic Thrombocytopenic Purpura (TTP) relapse in patients who are refractory or intolerant to rituximab (adults)
Link  NICE TA343: Obinutuzumab with chlorambucil for CLL
Link  NICE TA629: Obinutuzumab with bendamustine for treating follicular lymphoma after rituximab
 
Ocrelizumab (Ocrevus®)
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Red
High Cost Medicine
NHS England
BlueTeq
  • Approved for the treatment of relapsing-remitting multiple sclerosis in line with NICE

     

 
Link  NICE TA 533: Ocrelizumab for treating relapsing–remitting multiple sclerosis
Link  NICE TA585: Ocrelizumab for treating primary progressive multiple sclerosis
 
Ofatumumab  (Kesimpta®)
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Formulary
Red
NHS England
BlueTeq
  • 20mg/0.4ml solution for injection (pre-filled pens)
    • Approved for the treatment of relapsing-remitting multiple sclerosis in adults with active diseases defined by clinical or imaging features in line with NICE

 

 
Link  NICE TA699: Ofatumumab for treating relapsing multiple sclerosis
 
Rituximab
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Red

NICE have approved rituximab for the following indications:

  • First line use in NHL in combination with CHOP.
  • Maintenance therapy in follicular NHL that has responded to first line induction therapy with rituximab in combination with chemotherapy.
  • Stage III and IV follicular lymphoma in previously untreated people.
  • Replased or refractory follicular NHL.
  • Post-transplant lymphoproliferative disease.
  • First line use in CLL in combination with fludarabine and cyclophosphamide.
  • Combination with fludarabine and cyclophosphamide for relapsed or refractory CLL.
  • Autoimmune haematological conditions (where conventional treatments have failed)
  • Autoimmune haemolytic anaemia (AIHA), Evans syndrome, pure red cell aplasia (PRCA), & 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.Vasculitis (including Wegener’s granulomatosis in adults and children) that has not responded adequately to conventional treatment (e.g. corticosteroids, cyclophosphamide) in line with NICE and additional NHS England criteria.

NECDAG have approved rituximab for the following indications:

  • Treatment of NLPHL
  • Newly diagnosed mantle cell NHL in patients aged 
  • 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.
  • Salvage chemotherapy for patients relapsing > 12 months post 1st line therapy with R-CHOP.
  • 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.
  • Treatment of Hairy Cell Leukaemia (HCL) or  HCL varian (HCL-v) who:
    • relapse early after purine analogue therapy (< 2 years post treatment)
    • are refractory to purine analogues.

NTAG have approved rituximab for the following indications:

  • Treatment of immune (idiopathic) thrombocytopenic purpura (ITP) in adults and children.

NHS England have approved rituximab for the following indications:

  • Treatment of immunobullous disease
  • Steroid Sensitive Nephrotic Syndrome in Children
  • Steroid Resistant Nephrotic Syndrome in Children
  • Acquired Haemophilia
  • Cytopenia Complicating Primary Immunodeficiency
  • Maintenance single agent therapy in FL, mantle cell lymphoma, marginal zone lymphoma and lymphoplasmacytic lymphoma in line with (SSC1434) - 1.4g solution for sc injection.
  • Second line treatment for anti-NMDAR auto-immune encephalitis (all ages)
  • Treatment of refractory myasthenia gravis in a specialised neuroscience centre
  • Treatment of nodal/paranodal antibody positive inflammatory/autoimmune neuropathy in adults and post-pubescent children
  • Treatment of IgM paraproteinaemic demyelinating peripheral neuropathy in adults
  • Treatment of Thrombotic Thrombocytopenic Purpura (TTP)
  • Treatment of Idiopathic Membranous Nephropathy (IMN)


North of Tyne, Gateshead and North Cumbria APC have approved rituxumab for the following indication:

  • Autoimmune hepatitis in patients who have failed or who are intolerant of therapies such as azathioprine, mycophenolate mofetil, corticosteroids and tacrolimus.

For musculoskeletal indications see chapter 10

 
Link  NICE TA137: Rituximab for the treatment of relapsed or refractory stage III or IV follicular non- Hodgkin’s lymphoma
Link  NICE TA174: Rituximab for the first-line treatment of chronic lymphocytic leukaemia
Link  NICE TA193: Rituximab for the treatment of relapsed or refractory chronic lymphocytic leukaemia
Link  NICE TA226: Rituximab for the first-line maintenance treatment of follicular non-Hodgkin’s lymphoma
Link  NICE TA243: Rituximab for the first-line treatment of stage III-IV follicular lymphoma
Link  NTAG - Rituximab for ITP in adults and children
Link  MHRA Drug Safety Update (Dec 2014): Rituximab: progressive multifocal leukoencephalopathy in a patient
Link  MHRA Drug Safety Update (Dec 2013): Rituximab: screen for hepatitis B virus before treatment.
 
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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
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Link to adult BNF
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Link to children's BNF
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Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
NHSE
NHS England
Homecare
Homecare
CCG
CCG

Traffic Light Status Information

Status Description

Red

Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment. In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances. For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing.  

Amber

Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber. If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care.  

Green plus

Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), 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. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs.  

Green

Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care.  

Black

NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria.   

Brown

UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.  

Not Recomended

NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status.  

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