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8.2 Drugs affecting the immune response

8.2 Drugs affecting the immune response

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8.2.1 Antiproliferative immunosuppressants

RED           Azathioprine injection 50mg 
AMBER     Mycophenolic acid tablets 180mg, 360mg (Myfortic®)  please prescribe by brand.  
                  (Please see exceptions to use covered by NICE guidance in the black traffic light list) 

Mycophenolate Mofetil -  immunosuppressive therapy for preventing kidney rejection
 -  in adults NICE TA481 (replaces NICE TA85)
 - in children and young people NICE TA482 (replaces NICE TA99)
 
RED            Mycophenolate Mofetil (CellCept®, and non-branded version) 
                  capsules 250mg,  tablets 500mg                                                                                           (NHS England Commissioned)   
 
AMBER      Mycophenolate Mofetil (CellCept®, and non-branded version)  - unlicensed indications only as per shared care guideline
SHARED CARE    [capsules 250mg,  tablets 500mg]
 
 Treatment of Myasthenia gravis 
 AMBER SHARED CARE Azathioprine     link to shared care guideline


8.2.2 Corticosteroids and other immunosuppressants

AMBER      Ciclosporin (Neoral®) 
                   capsules 25mg, 50mg, 100mg
                   solution 100mg/mL
RED           Ciclosporin injection 50mg/mL 
 
NICE Guidance in Immunosuppressive therapy for kidney transplant in adults and children and young people
NICE TA481(replaces TA85) and NICE TA482 (replaces TA99) make recommendations on using the following drugs after kidney transplant.
                                                                                                  
RED          Tacrolimus (immediate release)  
                  (Adoport®, Capexion®, Vivodex, Modigraf®, Prograf®, Tacni®)                                           (NHS England Commissioned) 
RED          Mycophenolate mofetil (Cellcept®, non-branded versions)                                                   (NHS England Commissioned) 
RED          Basiliximiab   (Simulect®)                                                                                                           (NHS England Commissioned) 


8.2.3 
Other Anti-lymphocyte monoclonal antibodies

NICE TAG312  Approved as an option for the treatment of relapsing-remitting multiple sclerosis.
 
Appendix 6      Unlicensed use in Multiple sclerosis
 
RED                 Avelumab, Concentrate for solution for infusion (Bavencio® 200mg/10ml)                (NHS England Cancer Drugs Fund) 
NICE TA517     Recommended as an option for treating metastatic Merkel Cell carcinoma
                       

RED                Blinatumomab Powder for solution for infusion                                                               (NHS England Commissioned) 
NICE TA450    Recommended within its marketing authorisation as an option for treating Philadelphia-chromosome-negative 
                       relapsed or refractory precursor B-cell acute lymphoblastic leukaemia in adults, only if the company provides it with
                       the discount agreed in the patient access scheme.
NICE TA589    Recommended as an option for treating Philadelphia-chromosome-negative CD19‑positive B‑precursor acute
                       lymphoblastic leukaemia in adults with minimal residual disease (MRD) of at least 0.1%, only if:
                                 >    the disease is in first complete remission and
                                 >    the company provides blinatumomab according to the commercial arrangement.
 
RED               Durvalumab solution for infusion                                                                                        (NHS England Cancer Drugs Fund)  
NICE TA578   Durvalumab montherapy is recommended for use within the Cancer Drugs Fund as an option for treating locally
                      advanced unrescetable non-small-cell lung cancer in adults whose tumours express PD-L1 on at least 1% of tumour
                      cells and whose disease has not progressed after platinum-based chemoradiation only if:
                                 >   they have had concurrent platinum-based chemoradiation
                                 >   the conditions in the managed access agreement are followed
 

RED                Idelalisib (Zydelig)
NICE TA359    Recommended, in combination with Rituximab,  for untreated chronic lymphocytic leukaemia in adults with a 17p 
                       deletionor TP53 mutation or for chronic lymphocytic leukaemia in adults when the disease has been treated but has 
                       relapsed within 24 months. Idelalisib is recommended only if the company provides the drug with the discount 
                       agreed in the simple discount agreement.
 
RED                Inotuzumab ozogamicin                                                                                                       (NHS England Commissioned)
NICE TA541    An option for treating relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia in adults.
                       People with relapse or refractory Philadelphia-chromosome -positive disease should have at least 1 tyrosine kinase 
                       inhibitor.
 
RED                Obinutuzumab Concentrate for intravenous infusion
NICE TA343    Recommended, in combination with chlorambucil, as an option for adults with untreated chronic lymphocytic leukaemia
                       who have comorbidities that make full-dose fludarabine-based therapy unsuitable for them only if:
                       bendamustin-based therapy is not suitable and the company provides obinutuzumab with the discount agreed
                       in the patient access scheme
NICE TA629   Recommended, within its marketing authorisation, with bendamustine followed by obinutuzumab, as an option for 
                       treating follicular lymphoma that did not respond or progressed up to 6 months after treatment with rituximab or a
                       rituximab-containing regimen. (replaces NICE TA472)                                                             Cancer Drugs Fund
 
RED                Ocrelizumab Concentrate for solution for infusion  (Ocrevus 300mg/10mL)                        (NHS England Commissioned) 
NICE TA533    Recommended as an option for treating relapsing-remitting multiple sclerosis in adults with active disease defined by
                       clinical or imaging features, only if:
                       > alemtuzumab is contraindicated or otherwise unsuitable and
                       > the company provides orcelizumab according to the commercial arrangement
NICE TA585  Recommended as an option, within its marketing authorisation, for treating early primary progressive multiple 
                       sclerosis with imaging features charecteristic of inflammatory activity in adults.
 
 
RED               Ofatumumab, Concentrate for intravenous infusion
NICE TA344   Recommended in combination with chlorambucil as an option for untreated chronic lymphocytic leukaemia only if:
                      >  the person is ineligible for fludarabine-based therapy and
                      >  bendamustine is not suitable and
                      >  the company provides ofatumumab with the discount agreed in the patient access scheme
 
RED               Pembrolizumab  (Keytruda®) for intravenous infusion
NICE TA357   Recommended as an option for treating advanced (unresectable or metastatic) melanoma in adults only:
                      >  after the disease has progressed with ipilimumab and, for BRAF V600 mutation-positive disease, a BRAF or MEK
                          inhibitor and
                      >  when the company provides pembrolizumab in line with the commercial access agreement with NHS England
 
NICE TA366   Recommended as an option for treating advanced (unresectable or metastatic) melanoma that has not been previously
                      treated with ipilimumab, in adults, only when the company provides pembrolizumab in line with the commercial
                      access agreement with NHS England.
RED               Tisagenlecleucel (Kymriah)
NICE TA554   Recommended for use within the Cancer Drugs Fund as an option for treating relapsed or refractory B-cell acute
                       lymphoblastic leukaemia in people aged up to 25 years, only if the conditions in the managed access agreement are
                       followed.                                                                                                                                     (NHS England Cancer Drugs Fund) 
NICE TA567   Recommended for use withing the Cancer Drugs Fund, as an option for treating relapsed or refractory diffuse largeB-
                      cell lymphoma in adults after 2 or more systemic therapies, only if the conditions in the managed access 
                       agreement are followed.                                                                                                           (NHS England Cancer Drugs Fund) 
 
 
 
 
Rituximab 
Rituximab is approved for use in line with NICE guidance. 
 
Rituximab in Idiopathic Thrombocytopenia Purpura (ITP)
Rituximab should only be prescribed by a consultant haematologist for eligible patients as outlined below:
          >     Patients with ITP that require treatment because they are at risk of significant bleeding should initially be treated with 
                 prednisolone at a dose of 1-2mg/kg per day. Treatment is continued until the platelet count exceeds 50 x 109/l or
                 the patient fails to respond by 3-4 weeks.
          >     Patients who are intolerant of, or do not respond to corticosteroids should be treated with intravenous immunoglobulin 
                 (IVIG) 1g/kg per day for 2 days.
          >     Splenectomy should be considered in patients who do not respond to treatment with steroids or IVIG.
          >     Patients who do not respond to steroids or IVIG or who are not considered suitable for surgery may receive treatment
                 with rituximab although unlicenced.
          >     In patients who have relapsed after splenectomy a search should be made for accessory splenic tissue, and rituximab 
                 may then be considered.
 
Whether the use of rituximab in accordance with the above criteria is appropriate in any particular case is a matter for the treating
clinician's professional judgement, having weighed the risks and benefits to the patient and acting in accordance with a
responsible body of medical opinion, following informed consent from the patient.
 

 
Rituximab in ANCA Positive Vasculitis
Rituximab should only be prescribed by a consultant rheumatologist for eligible patients for the management of anti-neutrophil
cytoplasmic antibody (ANCA) positive vasculitis in situations where standard treatment (cyclophosphamide, methotrexate, 
azathioprine, corticosteroids, and plasma exchange) is not appropriate, not tolerated or not effective.
 
A new drug review for rituximab in ANCA Positive Vasculitis is available online - click here to access it
NHS England Clinical Commissioning Policy: Rituximab for Anti-Neutrophil Cytoplasmic Antibody-associated vasculitis is available here
 
Rituximab in unresponsive Systemic Lupus Erythematosis (SLE)
Rituximab should only be prescribed by a consultant rheumatologist for eligible patients for the management of unresponsive SLE
where standard treatment is not appropriate, not tolerated or not effective.
 
Rituximab  for Autoimmune Haemolytic Anaemia
Recommended as an alternative treatment in adults with Autoimmune Haemolytic Anaemia where patients are contraindicated to 
or fail to respond to standard active treatments, such as corticosteroids. Specialist initiation only                   CCG Commissioned  

RED           Rituximab injection 100mg/10ml, 500mg/50mL


8.2.4 Other immunomodulating drugs

RED           Ixekizumab solution for injection 80mg/1mL   (as per NICE TA442)                                                         CCG Commissioned
RED           Interferon Alfa-2a (Roferon-A®) 
RED           Peginterferon Alfa-2b injection 50microgram 
RED           Peginterferon Alfa-2a injection (Pegasys®) 
RED           BCG (Connaught strain) bladder instillation 81mg 
 

RED               Lenalidomide (Revlimid®) capsules 5mg, 10mg, 15mg 25mg                                                    (NHS England Commissioned) 
NICE TA171   Lenalidomide in combination with dexamethasone is recommended, within its licensed indication, as an option for
                       for the treatment of multiple myeloma only in people who have received 2 or more prior therapies.
                       (updated June 2019)
NICE TA322    Recommended as an option for treating transfusion-dependent anaemia caused by low or intermediate-1 risk
                       myelodysplastic syndromes associated with an isolated deletion 5q cytogenic abnormality when other therapeutic
                       options are insufficient or inadequate.  (updated June 2019)
NICE TA586    Lenalidomide plus dexamethasone is recommended as an option for treating multiple myeloma in adults only if:
                            > they have had only 1 previous therapy, which included bortezomib, and
                            > the company provides it according to the commercial arrangement.
NICE TA587    Lenalidomide plus dexamethasone is recommended as an option for previously untreated multiple myeloma in
                        adults who are not eliglbe for a stem cell transplant, only if:
                            > thalidomide is contraindicated (including for pre-existing conditions that it may aggravate) or
                            > the person cannot tolerate thalidomide, and
                            > the company provides lenalidomide according to the commercial arrangement
NICE TA627   Lenalidomide with rituximab is recommended within its marketing authorisation, as an option for previously
                        treated follicular lymphoma (grade1 to 3A). It is only recommended if the company provides lenalidomide according 
                        to the commercial arrangement.


RED           Pomalidomide (Imnovid®) 
                  capsules  1mg, 2mg, 3mg, 4mg as an option in NICE TA427
 
 (Myelodysplasic syndromes associated with an isolated deletion 5q cytogenic abnormality (NICE TAG 322)) 

 (Multiple myeloma (NICE TA171)

RED           Teriflunomide (Aubagio®) tablets 14mg (NICE TA303) 
RED           Thalidomide capsules 50mg 
RED           Fingolimod (Gilenya®) capsules 500mcg (NICE TAG254) 
                   For information about local policy variation please click <here>
RED           Mifamurtide (Mepact®) intravenous infusion 4mg 
RED           Natalizumab (Tysarbri®) intravenous infusion 20mg/mL 
                   For use by specialist services to treat MS 
 
RED           Glatiramer acetate (Copaxone®) prefilled syringe 20mg/mL 
                   For use by specialist services to treat MS 
 
RED           Dimethyl Fumarate (Tecfidara®) capsules 120mg, 240mg NICE TA320 
RED           Nivolumab  intravenous infusion 10mg/mL is recommended as an option by NICE for treating advanced   (unresectable 
                   or metastatic) melanoma. See  NICE TA384       
                   treating advanced (unresectable or metastatic) melanoma in adults, only when the company provides ipilimumab 
                   with the discount agreed in the patient access scheme NICE TA400   

Beta interferons and glatiramer acetate for treating multiple sclerosis NICE TA527
(replaces NICE technology appraisal guidance 32)
 
Interferon beta-1a is recommended as an option for treating MS, only if:
           >     the person has relapsing-remitting MS and
           >     the companies provide it according to commercial arrangements.
 
Interferon beta-1b (Extavia) is recommended as an option for treating MS , only if:
          >     the person has relapsing-remitting MS and has had 2 or more relapses within the last 2 years or
          >     the person has secondary progressive MS with continuing relapses and
          >     the company provides it according to the commercial arrangement.
 
Glatiramer acetate is recommended as an option for treating MS, only if:
          >    the person has relapsing-remitting MS and
         >     the company provides it according to the commercial arrangement.
 
Interferon beta-1b (Betaferon) is not recommended within its marketing authorisation as an option for treating MS.
 
RED        Interferon beta-1a (Avonex®, Rebif®)                                                                                 (NHS England Commissioned)
RED        Interferon beta-1b (Extavia®)                                                                                              (NHS England Commissioned)
RED        Glatiramer acetate (Copaxone®)                                                                                         (NHS England Commissioned)
 
 
 
NICE TA624 - Peginterferon-beta1a
Recommended as an option, within its marketing authorisation, as an option for treating relapsing-remitting multiple sclerosis in 
adults.
RED        Peginterferon-beta 1a (Plegridy®)                                                                                      (NHS England Commissioned)
  
 

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