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8.2 Drugs affecting the immune response

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)  -  
  SHARED CARE      unlicensed indications only as per shared care guideline
                                 [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-lymphpcyte monoclonal antibodies
            RED                 Alemtuzumab solution for infusion [Lemtrada 12mg/1.2ml concentrate]
            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)                
            NICE TA517     Recommended as an option for treating metastatic Merkel Cell carcinoma [partially updated by NICE TA691]
                                                                                                                                                                                       NHS England Commissioned
            NICE TA645     Avelumab with axitnib is recommended for use within the Cancer Drugs Fund as an option for untreated 
                                    advanced renal cell carcinoma in adults. It is recommended only if the conditions in the managed access 
                                    agreement for avelumab with axitinib are followed.
                                                                                                                                                                                       Cancer Drugs Fund
            NICE TA691    Recommended as an option for treating metastatic Merkel cell carcinoma in adults who have not had
                                    chemotherapy for metastatic disease. [updates and replaces recommendation 1.2 in NICE TA517]
                                                                                                                                                                                       NHS England Commissioned
           NICE TA788     Recommended as an option for maintenance treatment of locally advanced or metastatic urothelial cancer
                                    that has not progressed after platinum-based chemotherapy in adults, only if:
                                           > avelumab is stopped at 5 years of uninterrupted treatment or earlier if the disease progresses and,
                                           > the company provides avelumab according to the commercial arrangement
                                                                                                                                                                                       NHS England Commissioned
 

            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                Crizanlizumab 10 mg/ml concentrate for solution for infusion                                   NHS England Commissioned
            NICE TA743    Recommended as an option for preventing recurrent sickle cell crises (vaso-occlusive crises) in people aged
                                    16 years or over with sickle cell disease only if the conditions in the  managed access agreement are followed.


           RED                Durvalumab solution for infusion                                                                                            
            NICE TA578   This guidance has been updated and replaced with NICE TA798
            NICE TA798   Recommended as an option for treating advanced unresectable non-small-cell lung cancer in adults whose
                                   tumours express programmed cell death ligand 1 [PD-L1] on 1% or more of cells and whose disease has not
                                   progressed after platinum-based chemoradiation, only if:
                                              > they have had concurrent platinum-based chemoradiation
                                              > the company provides durvalumab according to the commercial arrangement
                                  This guidance updates and replaces NICE TA578                                                      NHS England Commissioned

            RED                Idelalisib (Zydelig)
            NICE TA359  Recommended, in combination with Rituximab,  for untreated chronic lymphocytic leukaemia in adults with a  
                                 17p deletion or 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 
                                  tyrosine kinase inhibitor.
 
          RED                 Mogamulizumab [Poteligeo]                                                                                             NHS England Commissioned
          NICE TA754     Recommended, within its marketing authorisation, as an option for treating Sézary syndrome in adults who
                                  have had at least 1 systemic treatment. It is recommended only if the company provides mogamulizumab
                                  according to the commercial arrangement.
                                  Mogamulizumab is recommended as an option for treating mycosis fungoides in adults, only if:
                                     > their condition is stage 2Bor above and
                                     > they have had at least 2 systemic treatments and
                                     > the company provides mogamulizumab according to the commercial arrangement
 
          RED               Obinutuzumab Concentrate for intravenous infusion
          NICE TA343  [Gazyvaro]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   [Gazyvaro] 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
          NICE TA699  [Kesimpta] Recommended as an option for treating relapsing-remitting multiple sclerosis in adults with active 
                                disease defined by clinical or imaging features. This is only if the company provides ofatumumab according to 
                                the commercial arrangement.
 
          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   *Approved as an option for use for  for untreated chronic lymphocytic leukaemia  in combination with                                                        chlorambucil or bendamustine.  
                                  *[Guidance withdrawn  because Novartis has discontinued ofatumumab (Arzerra)
                     
          NICE TA699 [Kesimpta] Recommended as an option for treating relapsing-remitting multiple sclerosis in adults with active  
                               disease defined by clinical or imaging features. This only if the company provides ofatumumab according to the 
                               commercial agreement



         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                Ravulizumab (Ultomiris®) concentration for solution for infusion
        NICE TA710    Recommended, within its marketing suthorisation, as an option for treating atypical haemolytic uraemic 
                               syndrome in people weighing 10kg or more:
                                   > who have not had a complement inhibitor before or
                                   > whose disease has responded to at least 3 months of eculizumab treatment
                               It is recommended only if the company provides ravulizumab according to the commercial arrangement.
                                                                                                                                                                            NHS England Commissioned 

         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.                                                                                                                                            Cancer Drugs Fund
         NICE TA567   Recommended for use within 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.                                                                                                                       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 
          treatingclinician'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              Atezolizumab                                                                                                                          NHS England Commissioned 
         NICE TA492  - replaced by NICE TA739
         NICE TA739  Recommended, within its marketing authorisation, as an option for untreated locally advanced or metastatic         
                               urothelial cancer in adults whose tumours express PD‑L1 at a level of 5% or more and when cisplatin-containing
                               chemotherapy is unsuitable. This is only if the company provides atezolizumab according to the commercial   
                               arrangement.
 
          RED             Avacopan                                                                                                                                 NHS England Commissioned
          NICE TA825 Avacopan with a cyclophosphamide or rituximab regimen is recommended, within its marketing authorisation,
                               as an option for treating severe active granulomatosis with polyangiitis or microscopic polyangiitis
                               in adults. It is recommended only if the company provides it according to the commercial arrangement.
 
          RED             Diroximel fumarate                                                                                                               NHS England Commissioned
          NICE TA794 Recommended as an option for treating active relapsing-remitting multiple sclerosis (normally defined as 2
                               clinically significant relapses in the previous 2 years) in adults, only if: 
                                  > they do not have highly active or rapidly evolving severe relapsing-remitting multiple sclerosis and
                                  > the company provides diroximel fumarate according to the commercial arrangement
                                                                                                                                                                                     
          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 f
                                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 eligible 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.
          NICE TA680   Lenalidomide is recommended as maintenance treatment after an autologous stem cell transplant for newly
                                diagnosed multiple myeloma, only if:
                                    > the dosage schedule is 10mg per day on days 1 to 21 of a 28 day cycle and
                                    > the company provides lenalidomide according to the commercial arrangement
 
          RED              Pegcetacoplan
          NICE TA778  Pegcetacoplan is recommended, within its marketing authorisation, as an option for treating paroxysmal  
                               nocturnal haemoglobinuria (PNH) in adults who have anaemia after at least 3 months of treatment with
                               a C5 inhibitor. It is recommended only if the company provides pegcetacoplan  according to the commercial 
                               arrangement.                                                                                                                     NHS England Commissioned

          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   


          RED    Siponimod [Mayzent®]
          NICE TA656   Siponimod is recommended, within its marketing authorisation, as an option for treating secondary progressive 
                                multiple sclerosis with evidence of active disease (that is , relapsed or imaging features of inflammatory activity)
                                in adults. 
 
          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
 
 
  
 

ll material in this section is aimed at health care professionals, but is information currently held in the public domain, members of the  
public seeking advice on medicine-related matters are advised to speak with their GP, pharmacist, nurse or contact NHS111 Service. 
  Email: info.elmmb@nhs.net
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