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 Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
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08.02.04  Expand sub section  Other immunomodulating drugs
Daclizumab (Zinbryta®)
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Formulary
Red
High Cost Medicine
  • 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
 
 
Diroximel fumarate (Vumerity®)
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Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • 231mg capsules
    • Approved for treating relapsing-remitting multiple sclerosis in line with NICE
 
Link  NICE TA794: Diroximel fumarate for treating relapsing–remitting multiple sclerosis
 
Osimertinib (Tagrisso)
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Formulary
Red
  • 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 

 

 
Link  NICE TA 653: Osimertinib for treating EGFR T790M mutation-positive advanced non-small-cell lung cancer
Link  NICE TA654: Osimertinib for untreated EGFR mutation-positive non-small-cell lung cancer
Link  NICE TA761 Osimertinib for adjuvant treatment of EGFR mutation-positive non-small-cell lung cancer after complete tumour resection
 
Ponesimod (Ponvory®)
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Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • 20mg tablets
    • Approved for treating relapsing–remitting multiple sclerosis with active disease defined by clinical or imaging features in adults in line with NICE


 

 
Link  NICE TA767: Ponesimod for treating relapsing–remitting multiple sclerosis
 
Siponimod (Mayzent®)
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Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • 0.25mg and 2mg tablets
    • approved for treating secondary progressive multiple sclerosis in adults in line with NICE


 
Link  NICE TA656: Siponimod for treating secondary progressive multiple sclerosis
 
08.02.04  Expand sub section  Interferon Alfa
Interferon Alfa-2b
(IntronA)
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Formulary
Red
 
 
Interferon Alfa-2b (Roferon-A®)
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Formulary
Red
High Cost Medicine
 
 
Peginterferon Alfa (Pegasys®, ViraferonPeg®)
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Formulary
Red
  • Approved  for hepatitis B and C in accordance with NICE guidelines and NHS England Commissioning Policies. 
 
Link  NICE CG165: Hepatitis B (chronic): diagnosis and management
Link  NICE TA106: Hepatitis C - peginterferon alfa & ribavirin
Link  NICE TA200: Hepatitis C - peginterferon alfa & ribavirin
Link  NICE TA300: Hepatitis C - peginterferon alfa
Link  NICE TA75: Hepatitis C - pegylated interferons, ribavirin & alfa interferon
Link  NICE TA96: Hepatitis B - peginterferon alfa
 
08.02.04  Expand sub section  Interferon beta
Interferon Beta (Avonex®)
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Formulary
Red
High Cost Medicine
NHS England
Homecare
 
Link  MHRA Drug Safety Update (Oct 2014): risk of thrombotic microangiopathy and risk of nephrotic syndrome
Link  NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
 
Interferon Beta (Betaferon®)
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Formulary
Red
High Cost Medicine
NHS England
Homecare
 
Link  MHRA Drug Safety Update (Oct 2014): risk of thrombotic microangiopathy and risk of nephrotic syndrome
Link  NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
 
Interferon beta (Extavia®)
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Formulary
Red
High Cost Medicine
NHS England
Homecare
 
Link  MHRA Drug Safety Update (Oct 2014): risk of thrombotic microangiopathy and risk of nephrotic syndrome
Link  NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
 
Interferon Beta (Rebif®)
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Formulary
Red
High Cost Medicine
NHS England
Homecare
 
Link  MHRA Drug Safety Update (Oct 2014): risk of thrombotic microangiopathy and risk of nephrotic syndrome
Link  NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
 
Peginterferon Beta-1a (Plegridy®)
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Formulary
Red
High Cost Medicine
NHS England
Homecare

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

 
Link  NICE TA624: Peginterferon beta-1a for treating relapsing–remitting multiple sclerosis
 
08.02.04  Expand sub section  Interferon gamma
08.02.04  Expand sub section  Aldesleukin to top
08.02.04  Expand sub section  BCG bladder instillation
BCG 81mg vial (connaught)
(bladder instillation)
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Formulary
Red
 
 
08.02.04  Expand sub section  Canakinumab
08.02.04  Expand sub section  Dimethyl fumarate
Dimethyl fumarate (Tecfidera®)
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Formulary
Red
High Cost Medicine
NHS England
Homecare

  • 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. 

 
Link  Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)
Link  MHRA Drug safety Update (April 2016): Dimethyl fumarate (Tecfidera): updated advice on risk of progressive multifocal leukoencephalopathy.
Link  MHRA Drug Safety Update (January 2021): Dimethyl fumarate (Tecfidera): updated advice on the risk of progressive multifocal leukoencephalopathy (PML) associated with mild lymphopenia
Link  MHRA Drug Safety Update (March 2015): Dimethyl fumarate (Tecfidera): fatal PML in an MS patient with severe, prolonged lymphopenia
Link  NICE TA320: Dimethyl fumarate for multiple sclerosis
 
08.02.04  Expand sub section  Fingolimod
Fingolimod
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Formulary
Red
High Cost Medicine
NHS England
Homecare

  • 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.

 
Link  Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)
Link  Letter sent to healthcare professionals (Jan 2016): Fingolimod (Gilenya▼): risks related to effects on the immune system
Link  MHRA Drug Safety Update (Apr 2016): Fingolimod (Gilenya▼): risks of progressive multifocal leukoencephalopathy, basal-cell carcinoma, and opportunistic infections
Link  MHRA Drug Safety Update (Apr 2017): Multiple sclerosis therapies: signal of rebound effect after stopping or switching therapy
Link  MHRA Drug Safety Update (Dec 2017): Fingolimod (Gilenya▼): new contraindications in relation to cardiac risk
Link  MHRA Drug Safety Update (Dec 2017): Fingolimod (Gilenya▼): updated advice about risk of cancers and serious infections
Link  MHRA Drug Safety Update (Jan 2021): Fingolimod (Gilenya▼): updated advice about the risks of serious liver injury and herpes meningoencephalitis
Link  MHRA Drug Safety Update (Sept 2019): Fingolimod (Gilenya▼): increased risk of congenital malformations; new contraindication during pregnancy and in women of childbearing potential not using effective contraception
Link  NICE TA254: Fingolimod for highly active relapsing remitting multiple sclerosis
 
08.02.04  Expand sub section  Glatiramer acetate to top
Glatiramer Acetate
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Formulary
Red
High Cost Medicine
NHS England
Homecare

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

 
Link  NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
Link  Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)
 
08.02.04  Expand sub section  Histamine
08.02.04  Expand sub section  Lenalidomide, pomalidomide, and thalidomide
Lenalidomide
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Formulary
Red
NHS England
  • 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

 



 
Link  Letter sent to healthcare professionals (Nov 2016): lenalidomide (Revlimid▼): new advice about viral reactivation
Link  MHRA Drug Safety Update (Feb 2011): Lenalidomide: risk of thrombosis and thromboembolism
Link  MHRA Drug Safety Update (Jan 2013): Lenalidomide (Revlimid): risk of serious hepatic adverse drug reactions
Link  MHRA Drug Safety Update (May 2020): Immunomodulatory drugs and pregnancy prevention: temporary advice for management during coronavirus (COVID-19)
Link  MHRA Drug Safety Update (Nov 2011): Lenalidomide (Revlimid▼): update on risk of second primary malignancy
Link  NICE TA171: Lenalidomide for the treatment of multiple myeloma in people who have received at least 2 prior therapies
Link  NICE TA27: Lenalidomide with rituximab for previously treated follicular lymphoma
Link  NICE TA322: Lenalidomide for treating myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality
Link  NICE TA586: Lenalidomide plus dexamethasone for multiple myeloma after 1 treatment with bortezomib
Link  NICE TA587: Lenalidomide plus dexamethasone for previously untreated multiple myeloma
Link  NICE TA680: Lenalidomide maintenance treatment after an autologous stem cell transplant for newly diagnosed multiple myeloma
 
Pomalidomide (Imnovid®)
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Formulary
Red
High Cost Medicine
  • For the treatment of multiple myeloma previously treated with lenalidomide and bortezomib in line with NICE and NHS Commissioning Policy
 
Link  NICE TA427: Pomalidomide for multiple myeloma previously treated with lenalidomide and bortezomib
 
Thalidomide
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Formulary
Red
  • 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.
 
Link  Letter sent to healthcare professionals in June 2016: Thalidomide Celgene®: New important advice regarding viral reactivation and pulmonary hypertension
Link  MHRA Drug Safety Update (December 2015): Thalidomide: reduced starting dose in patients older than age 75 years
Link  MHRA Drug Safety Update (July 2011): Thalidomide: risk of arterial and venous thromboembolism
Link  MHRA Drug Safety Update (May 2013): Thalidomide: risk of second primary malignancies
Link  MHRA Drug Safety Update (May 2020): Immunomodulatory drugs and pregnancy prevention: temporary advice for management during coronavirus (COVID-19)
Link  NICE TA228: Bortezomib and thalidomide for the first‑line treatment of multiple myeloma
 
08.02.04  Expand sub section  Mifamurtide
Mifamurtide
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Formulary
Red
  • Approved for high-grade resectable non-metastatic osteosarcoma in line with NICE.
 
Link  NICE TA235: Osteosarcoma - mifamurtide: guidance
 
08.02.04  Expand sub section  Natalizumab
Natalizumab
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Formulary
Red
High Cost Medicine
NHS England
Homecare

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

 
Link  Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)
Link  MHRA Drug Safety Update (Apr 2016): Natalizumab (Tysabri▼): progressive multifocal leukoencephalopathy— updated advice to support early detection
Link  MHRA Drug Safety Update (May 2011): Natalizumab (Tysabri▼): risk of progressive multifocal leukoencephalopathy is increased in patients who have had previous immunosuppressant treatment
Link  NICE TA127: Natalizumab for the treatment of adults with highly active relapsing–remitting multiple sclerosis
 
08.02.04  Expand sub section  Teriflunomide to top
Teriflunomide
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Formulary
Red
High Cost Medicine
NHS England
Homecare

  • 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.

 
Link  Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)
Link  NICE TA303: Teriflunomide for treating relapsing–remitting multiple sclerosis
 
 ....
Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
Display tracking information
click to search medicines.org.uk
Link to adult BNF
click to search medicines.org.uk
Link to children's BNF
click to search medicines.org.uk
Link to SPCs
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
NHSE
NHS England
Homecare
Homecare
CCG
CCG

Traffic Light Status Information

Status Description

Red

Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment. In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances. For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing.  

Amber

Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber. If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care.  

Green plus

Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs.  

Green

Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care.  

Black

NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria.   

Brown

UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.  

Not Recomended

NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status.  

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