8.1 Immune system

8.1.1 Immune system disorders and transplantation

All drugs in this section are classified as RED in the TLS unless otherwise indicated below

NHS England Circular SSC 1466 Renal Transplantation- Use of Immunosuppressants.

NHS England Clinical Commissioning Policy: Haematopoietic Stem Cell Transplantation (HSCT) (All Ages): Revised Reference: NHS England B04/P/a

Immune Sera and immunoglobulins

Immunoglobulins

Antithymocyte globulin (ATG) (rabbit) (TLS Red)

• Renal, Immunology, Haematology and BMT Consultant use only, as per Trust protocol

Antithymocyte globulin (ATG) (horse) (TLS Red)

• NHS England funded as per BCSH guideline

Antimetabolites

Azathioprine (oral & parenteral) (TLS Red)

• TLS Red for malignant conditions

Azathioprine (oral & parenteral) (TLS Amber 3 months)

• TLS Amber for non-malignant conditions
• Neurology SCP click here
• Renal SCP click here
• Autoimmune Hepatitis SCP click here
• See Chapter 1.1 for IBD SCP. Unlicensed for severe acute Ulcerative Colitis
• Also used for conditions requiring immune suppression under the supervision of a neurologist. Unlicensed.

Mercaptopurine (oral) (TLS Amber 3 months) (SCP click here)

• TLS Amber for Adults with Autoimmune Hepatitis who are intolerant of azathioprine

Calcineurin Inhibitors and related drugs

Ciclosporin (oral & parenteral) (TLS Red)

• Prescribe by brand

Sirolimus (oral) (TLS Red)

• Renal Consultant, haematology, BMT physician use only

Tacrolimus (oral & parenteral) (TLS Red)

• Prescribe by brand
• NICE TA481 Immunosuppressive therapy for kidney transplant in adults

Monoclonal Antibodies (Anti-lymphocyte)

Basiliximab (parenteral) (TLS Red)

• Basiliximab may only be prescribed in line with the Renal Unit protocol
• NICE TA481 Immunosuppressive therapy for kidney transplant in adults

Belimumab (TLS Red)

• NICE TA752 Belimumab for treating active autoantibody-positive systemic lupus erythematosus

Purine Synthesis Inhibitors

Mycophenolate mofetil / Mycophenolic acid (oral) (TLS Amber 3 months)

• Rheumatological conditions see Chapter 10.1
• Neurology - see Chapter 10.3.4
• Gastroenterology (IBD) - see Chapter 1.1
• Ophthalmology- see Chapter 11.4
• Dermatology - see Chapter 13
• Respiratory- see Chapter 3.5
• For the induction and maintenance treatment of autoimmune hepatitis for patients intolerant to thiopurines - see Chapter 1.7.3

Mycophenolate mofetil (oral & parenteral) (TLS Red)

NICE TA481 Immunosuppressive therapy for kidney transplant in adults

Also used for immunomodulation / immunosuppression (unlicensed) under the supervision of Specialists in:

• Renal (non-transplant use)

Alternative to mycophenolate mofetil:

Mycophenolic acid (as mycophenolate sodium) (oral) (TLS Red)

Other Immunosuppressants

Imlifidase (TLS Red)

• NICE TA809 Imlifidase for desensitisation treatment before kidney transplant in people with chronic kidney disease

Belumosudil (TLS Red)

• NICE TA949 Belumosudil for treating chronic graft-versus-host disease after 2 or more systemic treatments in people 12 years and over

8.1.2 Multiple Sclerosis

Multiple sclerosis: AL disease modifying drugs; NHS England funded via Prior Approval Scheme on Blueteq

Interferons

Interferon beta (parenteral) NBT only (TLS Red)

• As per NHS England Clinical Commissioning Policy: Disease modifying therapies for patients with multiple sclerosis (D04/P/b)
• NICE TA527 (replaces NICE TA32) Beta interferons and glatiramer acetate for treating multiple sclerosis

Immunostimulants - Other

Glatiramer acetate (parenteral) NBT only (TLS Red)

• As per NHS England Clinical Commissioning Policy: Disease modifying therapies for patients with multiple sclerosis (D04/P/b
• NICE TA527 (replaces NICE TA32) Beta interferons and glatiramer acetate for treating multiple sclerosis

Immunomodulating drugs

Dimethyl fumarate (oral) NBT only (TLS Red)

• NICE TA320 Treatment of adults with relapsing-remitting multiple sclerosis

Diroximel fumarate (oral) (TLS Red)

• NICE TA794 Diroximel fumarate for treating relapsing-remitting multiple sclerosis

Fingolimod (oral) NBT only (TLS Red)

• NICE TA254 for treatment of highly active relapsing-remitting multiple sclerosis
• As per NHS England Clinical Commissioning Policy: Disease modifying therapies for patients with multiple sclerosis (D04/P/b)

Siponimod (oral) (TLS Red)

• NICE TA656 Siponimod for treating secondary progressive multiple sclerosis

Ponesimod (oral) (TLS Red)

• NICE TA767 Ponesimod for treating relapsing-remitting multiple sclerosis

Anti-lymphocyte monoclonal antibodies

Alemtuzumab (parenteral) (TLS Red)

• Pre-transplant immunosuppression and CLL according to NHS England guidance only
• Treatment of relapsed or refractory chronic lymphocytic leukaemia
• 1st line treatment of chronic lymphocytic leukaemia in patients with 17p deletion
• 2nd line treatment of chronic lymphocytic leukaemia in patients with 17p deletion previously treated with chemotherapy but not alemtuzumab
• 1st line treatment of T-cell prolymphocytic leukaemia
• 2nd line treatment of T-cell prolymphocytic leukaemia
• NICE TA312 Neurology for the treatment of relapsing-remitting Multiple Sclerosis

Natalizumab (parenteral) (TLS Red)

• NICE TA127 for treatment of highly active relapsing-remitting multiple sclerosis
• As per NHS England Clinical Commissioning Policy: Disease modifying therapies for patients with multiple sclerosis (D04/P/b)

Ocrelizumab (parenteral) (TLS Red)

• NICE TA533 Ocrelizumab for treating relapsing-remitting multiple sclerosis
• NICE TA585 Ocrelizumab for treating primary progressive multiple sclerosis
• NHSE SSC 2680 Subcutaneous formulation for ocrelizumab 920mg

Ofatumumab (parenteral) (TLS Red)

• NICE TA699 Ofatumumab for treating relapsing multiple sclerosis

Daclizumab - following urgent safety review the MHRA recommend no new patients be started on daclizumab and all patients on daclizumab should be reviewed and have their treatment stopped, see MHRA alert

Pyrimidine Synthesis Inhibitors

Teriflunomide (oral) (TLS Red)

• NICE TA303 Teriflunomide for the treatment of relapsing-remitting multiple sclerosis
• As per NHS England Clinical Commissioning Policy: Disease modifying therapies for patients with multiple sclerosis (D04/P/b)

Cladribine (oral) (TLS Red)

• NICE TA616 Cladribine tablets for treating relapsing-remitting multiple sclerosis

8.1.3 Other

Canakinumab (TLS Red)

• For periodic fever syndromes as per NHSE Commissioning Policy

Anakinra (TLS Red)

• For Haemophagocytic Lymphohistiocytosis as per NHSE Commissioning Policy

Siltuximab (TLS Red)

• NHSE SSC 2598 Siltuximab for idiopathic Multicentric Castleman Disease (iMCD)

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