• Approved for use in previously treated Philadelphia-chromosome-negative acute lymphosblastic leukaemia in line with NICE and NHS England Commissioning Policy.
• Approved for the treatment of acute lymphoblastic leukaemia in remission with minimal residual disease activity in line with NICE
• Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

• Approved for treating advanced non-small-cell lung cancer (NSCLC) with METex14 skipping alterations in adults in line with NICE.

• For Transplant indications  unless from a Trust/speciality that hasn't formaly repatriated it's patients or for patients who require weekly scripts for MDS boxes .            
• An azathioprine 50mg in 5ml suspension (unlicensed) is also available.

• For Transplant indications  unless from a Trust/speciality that hasn't formaly repatriated it's patients or for patients who require weekly scripts for MDS boxes . 

• Approved as second-line therapy in patients who do not tolerate mycophenolate mofetil.
• For Transplant indications  unless from a Trust/speciality that hasn't formaly repatriated it's patients or for patients who require weekly scripts for MDS boxes . 

• 200mg tablets
• Approved for chronic graft-versus-host disease in people 12 years and over after 2 or more systemic treatments in line with NICE

• Approved formulations include:
  • 10mg, 25mg, 50mg, and 100mg capsules;
  • 100mg in 1ml sugar free oral solution (oily).
  • Should be prescribed by brand for transplant indications   
• For Transplant indications  unless from a Trust/speciality that hasn't formally repatriated its patients or for patients who require weekly scripts for MDS boxes . 

• Approved for renal transplantation in children and adolescents in line with NICE.
• For Transplant indications  unless from a Trust/speciality that hasn't formally repatriated its patients or for patients who require weekly scripts for MDS boxes . 

Approved tacrolimus formulations include:

• 500 microgram, 1mg & 5mg capsules (Prograf® & Adoport®).
• 1mg in 1ml oral suspension (unlicensed) - this replaces 0.5mg/ml oral
  suspension. 
• 5mg in 1 ml concentrate for preparing IV infusion - approved for renal transplantation in children and adolescents in line with NICE.
• 500microgram, 1mg, 3mg & 5mg MR capsules (Advagraf®) approved for use for prophylaxis of organ rejection in kidney and liver transplantation. Advagraf® is also approved for use in patients who are currently prescribed Prograf®, and de novo patients should be prescribed Adoport®.
• 750microgram, 1 mg and 4 mg m/r tablets (Envarsus®)
  
  • approved for the treatment of renal and liver transplant patients who are suffering from neurotoxicity with other formulations or for patients requiring large doses of tacrolimus. 
• For Transplant indications  unless from a Trust/speciality that hasn't formally repatriated its patients or for patients who require weekly scripts for MDS boxes . 

• 7.9mg capsules
• Approved with mycophenolate mofetil for treating lupus nephritis in adults in line with NICE and NHSe Specialised Commissioning Policy (SSC2540)
• Only available from:
  
  • North Cumbria University Hospital NHS Trust
  • South Tyneside and Sunderland NHS Foundation Trust
  • South Tees Hopsitals NHS Foundation Trust
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust

• NETAG approved for aplastic anaemia in adults (unlicensed).

• Used in the management of transplant rejection.

• Approved for limited use in adult renal transplant patients with high risk of acute organ rejection.
• Approved for severe graft versus host disease post haematopoietic stem cell transplantation.
• Approved for induction therapy in renal transplantation in children and adolescents in with combinations that include ciclosporin in line with NICE.

• 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

• 150mg subcutaneous injection
  • Approved for the treatment of highly active relapsing-remitting mutiple sclerosis that has failed to respond to other treatment in adults in line with NICE and NHS England Commissioning Policy. 
  • Subject to restricted use by EMA

• 231mg capsules
  • Approved for treating relapsing-remitting multiple sclerosis in line with NICE

• 40mg and 80mg tablet
• Approved for the treatment of EGFR mutation-positive non-small-cell lung cancer in line with NICE
• Approved for treating epidermal growth factor receptor (EGFR) T790M mutation-positive locally advanced or metastatic non-small-cell lung cancer (NSCLC) in adults in line with NICE 

• 20mg tablets
  
  • Approved for treating relapsing–remitting multiple sclerosis with active disease defined by clinical or imaging features in adults in line with NICE
  
  
  

• 0.25mg and 2mg tablets
  
  • approved for treating secondary progressive multiple sclerosis in adults in line with NICE
  
  
  

• Approved  for hepatitis B and C in accordance with NICE guidelines and NHS England Commissioning Policies. 

• Approved treating relapsing–remitting multiple sclerosis in adults in line with NICE.

• Approved as a option for treating adults with active relapsing-remitting multiple sclerosis that isn’t highly active or rapidly evolving severe relapsing-remitting multiple sclerosis NICE and NHS England Commissioning Policy. 

• Approved for the treatment of highly active relapsing–remitting multiple sclerosis in line with NICE and NHS England Commissioning Policy.


• Approved for patients who have progressed on glatiramer acetate and for those patients who are at high risk of progressive multifocal leukoencephalopathy (PML) in line with NHS EnglandClinical Commissioning Policy.

• Approved for treating multiple sclerosis in line with NICE and NHS Engand commissioning policy.

• Approved for multiple myeloma in line with NICE - approved for myelodysplastic syndrome with 5q deletion in line with NICE. 
• Approved in combination with dexamethasone for previously untreated multiple myeloma in line with NICE 
• Approved in combination with dexamethasone for multiple myeloma after one treatment with bortezomib
• Approved for maintenance treatment after an autologous stem cell transplant for newly diagnosed multiple myeloma in adults in line with NICE
• Approved with rituximab for previously treated follicular lymphoma (grade 1 to 3A) in adults in line with NICE

• For the treatment of multiple myeloma previously treated with lenalidomide and bortezomib in line with NICE and NHS Commissioning Policy

• Approved in combination with an alkylating agent and a corticosteroid for the first-line treatment of multiple myeloma in line with NICE. 
• Approved for the treatment of bleeding from bowel angiodysplasia in patients with an inherited/acquired bleeding disorder on specialist advice only.
• Approved for the treatment of severe epistaxis as a result of hereditary haemorrhagic telangiectasia (HHT) who have failed all other treatments.

• Approved for high-grade resectable non-metastatic osteosarcoma in line with NICE.

• Approved for rapidly evolving severe relapsing remitting multiple sclerosis in line with NICE and NHS England commissioning policy.

• Approved as a option for treating adults with active relapsing-remitting multiple sclerosis that isn’t highly active or rapidly evolving severe relapsing-remitting multiple sclerosis NICE and NHS England Commissioning Policy.