• 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. 

• 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

• 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

• Approved for the treatment of relapsing-remitting multiple sclerosis in line with NICE
  

   

• 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

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