Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
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Chapter Links... |
Cancer Drug Fund List |
Northern Cancer Alliance |
Northern England Clinical Networks Palliative and End of Life Care Guidelines |
Details... |
08.02.04 |
Other immunomodulating drugs |
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Daclizumab (Zinbryta®)
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Formulary
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- 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
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Diroximel fumarate (Vumerity®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
![NHS England](images/NHSE.gif)
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- 231mg capsules
- Approved for treating relapsing-remitting multiple sclerosis in line with NICE
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NICE TA794: Diroximel fumarate for treating relapsing–remitting multiple sclerosis
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Osimertinib (Tagrisso)
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Formulary
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- 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
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NICE TA 653: Osimertinib for treating EGFR T790M mutation-positive advanced non-small-cell lung cancer
NICE TA654: Osimertinib for untreated EGFR mutation-positive non-small-cell lung cancer
NICE TA761 Osimertinib for adjuvant treatment of EGFR mutation-positive non-small-cell lung cancer after complete tumour resection
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Ponesimod (Ponvory®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
![NHS England](images/NHSE.gif)
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- 20mg tablets
- Approved for treating relapsing–remitting multiple sclerosis with active disease defined by clinical or imaging features in adults in line with NICE
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NICE TA767: Ponesimod for treating relapsing–remitting multiple sclerosis
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Siponimod (Mayzent®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
![NHS England](images/NHSE.gif)
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- 0.25mg and 2mg tablets
- approved for treating secondary progressive multiple sclerosis in adults in line with NICE
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NICE TA656: Siponimod for treating secondary progressive multiple sclerosis
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08.02.04 |
Interferon Alfa |
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Interferon Alfa-2b (IntronA)
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Formulary
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Interferon Alfa-2b (Roferon-A®)
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Formulary
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Peginterferon Alfa (Pegasys®, ViraferonPeg®)
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Formulary
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- Approved for hepatitis B and C in accordance with NICE guidelines and NHS England Commissioning Policies.
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NICE CG165: Hepatitis B (chronic): diagnosis and management
NICE TA106: Hepatitis C - peginterferon alfa & ribavirin
NICE TA200: Hepatitis C - peginterferon alfa & ribavirin
NICE TA300: Hepatitis C - peginterferon alfa
NICE TA75: Hepatitis C - pegylated interferons, ribavirin & alfa interferon
NICE TA96: Hepatitis B - peginterferon alfa
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08.02.04 |
Interferon beta |
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Interferon Beta (Avonex®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
![NHS England](images/NHSE.gif)
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MHRA Drug Safety Update (Oct 2014): risk of thrombotic microangiopathy and risk of nephrotic syndrome
NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
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Interferon Beta (Betaferon®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
![NHS England](images/NHSE.gif)
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MHRA Drug Safety Update (Oct 2014): risk of thrombotic microangiopathy and risk of nephrotic syndrome
NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
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Interferon beta (Extavia®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
![NHS England](images/NHSE.gif)
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MHRA Drug Safety Update (Oct 2014): risk of thrombotic microangiopathy and risk of nephrotic syndrome
NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
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Interferon Beta (Rebif®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
![NHS England](images/NHSE.gif)
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MHRA Drug Safety Update (Oct 2014): risk of thrombotic microangiopathy and risk of nephrotic syndrome
NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
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Peginterferon Beta-1a (Plegridy®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
![NHS England](images/NHSE.gif)
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- Approved treating relapsing–remitting multiple sclerosis in adults in line with NICE.
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NICE TA624: Peginterferon beta-1a for treating relapsing–remitting multiple sclerosis
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08.02.04 |
Interferon gamma |
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08.02.04 |
Aldesleukin |
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08.02.04 |
BCG bladder instillation |
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BCG 81mg vial (connaught) (bladder instillation)
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Formulary
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08.02.04 |
Canakinumab |
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08.02.04 |
Dimethyl fumarate |
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Dimethyl fumarate (Tecfidera®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
![NHS England](images/NHSE.gif)
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- 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.
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Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)
MHRA Drug safety Update (April 2016): Dimethyl fumarate (Tecfidera): updated advice on risk of progressive multifocal leukoencephalopathy.
MHRA Drug Safety Update (January 2021): Dimethyl fumarate (Tecfidera): updated advice on the risk of progressive multifocal leukoencephalopathy (PML) associated with mild lymphopenia
MHRA Drug Safety Update (March 2015): Dimethyl fumarate (Tecfidera): fatal PML in an MS patient with severe, prolonged lymphopenia
NICE TA320: Dimethyl fumarate for multiple sclerosis
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08.02.04 |
Fingolimod |
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Fingolimod
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Formulary
![High Cost Medicine](images/HCDicon.gif)
![NHS England](images/NHSE.gif)
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- 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.
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Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)
Letter sent to healthcare professionals (Jan 2016): Fingolimod (Gilenya▼): risks related to effects on the immune system
MHRA Drug Safety Update (Apr 2016): Fingolimod (Gilenya▼): risks of progressive multifocal leukoencephalopathy, basal-cell carcinoma, and opportunistic infections
MHRA Drug Safety Update (Apr 2017): Multiple sclerosis therapies: signal of rebound effect after stopping or switching therapy
MHRA Drug Safety Update (Dec 2017): Fingolimod (Gilenya▼): new contraindications in relation to cardiac risk
MHRA Drug Safety Update (Dec 2017): Fingolimod (Gilenya▼): updated advice about risk of cancers and serious infections
MHRA Drug Safety Update (Jan 2021): Fingolimod (Gilenya▼): updated advice about the risks of serious liver injury and herpes meningoencephalitis
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
NICE TA254: Fingolimod for highly active relapsing remitting multiple sclerosis
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08.02.04 |
Glatiramer acetate |
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Glatiramer Acetate
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Formulary
![High Cost Medicine](images/HCDicon.gif)
![NHS England](images/NHSE.gif)
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- Approved for treating multiple sclerosis in line with NICE and NHS Engand commissioning policy.
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NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)
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08.02.04 |
Histamine |
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08.02.04 |
Lenalidomide, pomalidomide, and thalidomide |
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Lenalidomide
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Formulary
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- 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
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Letter sent to healthcare professionals (Nov 2016): lenalidomide (Revlimid▼): new advice about viral reactivation
MHRA Drug Safety Update (Feb 2011): Lenalidomide: risk of thrombosis and thromboembolism
MHRA Drug Safety Update (Jan 2013): Lenalidomide (Revlimid): risk of serious hepatic adverse drug reactions
MHRA Drug Safety Update (May 2020): Immunomodulatory drugs and pregnancy prevention: temporary advice for management during coronavirus (COVID-19)
MHRA Drug Safety Update (Nov 2011): Lenalidomide (Revlimid▼): update on risk of second primary malignancy
NICE TA171: Lenalidomide for the treatment of multiple myeloma in people who have received at least 2 prior therapies
NICE TA27: Lenalidomide with rituximab for previously treated follicular lymphoma
NICE TA322: Lenalidomide for treating myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality
NICE TA586: Lenalidomide plus dexamethasone for multiple myeloma after 1 treatment with bortezomib
NICE TA587: Lenalidomide plus dexamethasone for previously untreated multiple myeloma
NICE TA680: Lenalidomide maintenance treatment after an autologous stem cell transplant for newly diagnosed multiple myeloma
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Pomalidomide (Imnovid®)
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Formulary
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- For the treatment of multiple myeloma previously treated with lenalidomide and bortezomib in line with NICE and NHS Commissioning Policy
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NICE TA427: Pomalidomide for multiple myeloma previously treated with lenalidomide and bortezomib
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Thalidomide
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Formulary
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- 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.
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Letter sent to healthcare professionals in June 2016: Thalidomide Celgene®: New important advice regarding viral reactivation and pulmonary hypertension
MHRA Drug Safety Update (December 2015): Thalidomide: reduced starting dose in patients older than age 75 years
MHRA Drug Safety Update (July 2011): Thalidomide: risk of arterial and venous thromboembolism
MHRA Drug Safety Update (May 2013): Thalidomide: risk of second primary malignancies
MHRA Drug Safety Update (May 2020): Immunomodulatory drugs and pregnancy prevention: temporary advice for management during coronavirus (COVID-19)
NICE TA228: Bortezomib and thalidomide for the first‑line treatment of multiple myeloma
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08.02.04 |
Mifamurtide |
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Mifamurtide
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Formulary
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- Approved for high-grade resectable non-metastatic osteosarcoma in line with NICE.
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NICE TA235: Osteosarcoma - mifamurtide: guidance
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08.02.04 |
Natalizumab |
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Natalizumab
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Formulary
![High Cost Medicine](images/HCDicon.gif)
![NHS England](images/NHSE.gif)
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- Approved for rapidly evolving severe relapsing remitting multiple sclerosis in line with NICE and NHS England commissioning policy.
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Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)
MHRA Drug Safety Update (Apr 2016): Natalizumab (Tysabri▼): progressive multifocal leukoencephalopathy— updated advice to support early detection
MHRA Drug Safety Update (May 2011): Natalizumab (Tysabri▼): risk of progressive multifocal leukoencephalopathy is increased in patients who have had previous immunosuppressant treatment
NICE TA127: Natalizumab for the treatment of adults with highly active relapsing–remitting multiple sclerosis
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08.02.04 |
Teriflunomide |
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Teriflunomide
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Formulary
![High Cost Medicine](images/HCDicon.gif)
![NHS England](images/NHSE.gif)
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- 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.
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Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)
NICE TA303: Teriflunomide for treating relapsing–remitting multiple sclerosis
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Key |
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Cytotoxic Drug
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Controlled Drug
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High Cost Medicine
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NHS England |
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Homecare |
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CCG |
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Traffic Light Status Information
Status |
Description |
![Red](images/TrafficLightsRedV2.gif)
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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](images/TrafficLightsAmberV2.gif)
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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](images/TrafficLightsGreenPlus.gif)
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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](images/TrafficLightsGreenV2.gif)
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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](images/TrafficLightsBlackV2.gif)
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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](images/TrafficLightsBrownV2.gif)
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UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review. |
![Not Recomended](images/TrafficLightsBlueNR.gif)
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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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