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 Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
Notes:

The majority of systemic anti-cancer therapies are not listed in this formulary as they are included in either the Lancashire and South Cumbria Cancer Alliance SACT protocols or the Cancer Drugs Fund list, produced by NHSE. 
Chapter Links...
Link   LSC Breast Chemotherapy Protocols
Link   NHSE: National Cancer Drugs Fund list
Link   NICE NG122 : Lung cancer: diagnosis and management
Link   NICE NG224: Melanoma: assessment and management
Link   NICE NG47: Haematological cancers: improving outcomes
Link   NICE NG52: Non-Hodgkin’s lymphoma: diagnosis and management
 Details...
08.02.04  Expand sub section  Other immunomodulating drugs
Dimethyl fumarate (Tecfidera®)
(Multiple Sclerosis)
View adult BNF View SPC online View childrens BNF 		Formulary
Red
High Cost Medicine
NHS England

Capsules e/c 120mg, 240mg

Also see section 13.05.02.

 
Link  NICE TA320: Dimethyl fumarate for treating relapsing‑remitting multiple sclerosis
 
Fingolimod
View adult BNF View SPC online View childrens BNF 		Formulary
Red
High Cost Medicine
NHS England

Capsules 500 micrograms

 
Link  MHRA: Fingolimod (Gilenya▼): increased risk of congenital malformations; new contraindication during pregnancy and in women of childbearing potential not using effective contraception
Link  MHRA: Fingolimod (Gilenya▼): new contraindications in relation to cardiac risk
Link  MHRA: Fingolimod (Gilenya▼): risks of progressive multifocal leukoencephalopathy, basal-cell carcinoma, and opportunistic infections
Link  MHRA: Fingolimod (Gilenya▼): updated advice about risk of cancers and serious infections
Link  MHRA: Fingolimod (Gilenya▼): updated advice about the risks of serious liver injury and herpes meningoencephalitis
Link  NICE TA254: Fingolimod for the treatment of highly active relapsing–remitting multiple sclerosis
 
Peginterferon beta‑1a  (Plegridy®)
View adult BNF View SPC online View childrens BNF 		Formulary
Red
NHS England

Solution for injection pre-filled pens  63micrograms/0.5ml, 94micrograms/0.5ml 

 
Link  NICE TA624: Peginterferon beta-1a for treating relapsing–remitting multiple sclerosis
 
PonesimodBlack Triangle (Ponvory® )
View adult BNF View SPC online View childrens BNF 		Formulary
Red
NHS England

Tablets 2mg, 3mg, 4mg, 5mg, 6mg, 7mg, 8mg, 9mg, 10mg

 
Link  NICE TA767: Ponesimod for treating relapsing–remitting multiple sclerosis
 
SiponimodBlack Triangle (Mayzent®)
View adult BNF View SPC online View childrens BNF 		Formulary
Red
NHS England

Tablets 0.25mg, 2mg

 
Link  NICE TA656: Siponimod for treating secondary progressive multiple sclerosis
 
 link Link    NICE TA32: Beta interferon and glatiramer acetate for the treatment of multiple sclerosis
08.02.04  Expand sub section  Interferon Alfa
Interferon Alfa
View adult BNF View SPC online View childrens BNF 		Formulary
Red
NHS England

Intron A prefilled multidose pen 30million units in 1.2mL

Roferon-A prefilled syringes 3 million units, 4.5 million units and 9 million units in 0.5mL

 
Link  NICE TA75: Interferon alfa (pegylated and non-pegylated) and ribavirin for the treatment of chronic hepatitis C
 
Peginterferon Alfa (Pegasys®)
View adult BNF View SPC online View childrens BNF 		Formulary
Red
NHS England
BlueTeq

90micrograms, 135micrograms, 180micrograms solution for injection in pre-filled syringe

For the treatment of myleoproliferative neoplasms (See attached NHSE interim clinical commissioning policy).

 
Link  NHSE: Peginterferon alfa-2a and ropeginterferon alfa-2b to treat myeloproliferative neoplasms (all ages) [2420]
Link  NICE TA106: Peginterferon alfa and ribavirin for the treatment of mild chronic hepatitis C
Link  NICE TA200:Peginterferon alfa and ribavirin for the treatment of chronic hepatitis C
Link  NICE TA75: Interferon alfa (pegylated and non-pegylated) and ribavirin for the treatment of chronic hepatitis C
 
Ropeginterferon Alfa-2b (Besremi®)
View adult BNF View SPC online View childrens BNF 		Formulary
Red
High Cost Medicine
NHS England
BlueTeq

For the treatment of myleoproliferative neoplasms (See attached NHSE interim clinical commissioning policy).

 
Link  NHSE: Peginterferon alfa-2a and ropeginterferon alfa-2b to treat myeloproliferative neoplasms (all ages) [2420]
 
08.02.04  Expand sub section  Interferon beta
Interferon Beta (Avonex®)
View adult BNF View SPC online View childrens BNF 		Formulary
Red
NHS England 		 
Link  MHRA: Interferon-beta: risk of thrombotic microangiopathy and risk of nephrotic syndrome
Link  NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
 
Interferon beta (Extavia®)
View adult BNF View SPC online View childrens BNF 		Formulary
Red
NHS England 		 
Link  MHRA: Interferon-beta: risk of thrombotic microangiopathy and risk of nephrotic syndrome
Link  NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
 
Interferon Beta (Rebif®)
View adult BNF View SPC online View childrens BNF 		Formulary
Red
NHS England 		 
Link  MHRA: Interferon-beta: risk of thrombotic microangiopathy and risk of nephrotic syndrome
Link  NICE TA527: Beta interferons and glatiramer acetate for treating 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 bladder instillation (OncoTICE®)
View adult BNF View SPC online View childrens BNF 		Formulary
Red 		Bladder instillation 12.5mg 
 
08.02.04  Expand sub section  Canakinumab
08.02.04  Expand sub section  Dimethyl fumarate
08.02.04  Expand sub section  Fingolimod
08.02.04  Expand sub section  Glatiramer acetate to top
Glatiramer Acetate (Copaxone®)
View adult BNF View SPC online View childrens BNF 		Formulary
Red
NHS England

pre-filled syringe 20mg/1ml, 40mg/1ml

 
Link  NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
 
08.02.04  Expand sub section  Histamine
08.02.04  Expand sub section  Lenalidomide, pomalidomide, and thalidomide
08.02.04  Expand sub section  Mifamurtide
08.02.04  Expand sub section  Natalizumab
NatalizumabBlack Triangle (Tysabri®)
View adult BNF View SPC online View childrens BNF 		Formulary
Red
NHS England

Concentrate for intravenous infusion 20mg/mL (15mL vial)

Pre-filled syringe 150mg

All anti-lymphocyte monoclonal antibodies should be given under the supervision of an experienced specialist, in an environment where full resuscitation facilities are immediately available.

 
Link  MHRA: Natalizumab (Tysabri▼): progressive multifocal leukoencephalopathy—updated advice to support early detection
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
 ....
Key
Restricted Drug Restricted Drug
Unlicensed Drug Unlicensed
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
SMC
 Scottish Medicines Consortium
Cytotoxic Drug
 Cytotoxic Drug
CD
 Controlled Drug
High Cost Medicine
 High Cost Medicine
Cancer Drugs Fund
 Cancer Drugs Fund
NHSE
 NHS England
Homecare
 Homecare
CCG
 ICB
Green Low Carbon

Low carbon footprint
Amber Medium Carbon

Medium carbon footprint
Red High carbon footprint

High carbon footprint
Status Description

Green

 Green: Appropriate for initiation and ongoing prescribing in both primary and secondary care. Generally, little or no routine drug monitoring is required.  

Green Restricted

 Green (Restricted): Appropriate for initiation and ongoing prescribing in both primary and secondary care provided: Additional criteria specific to the medicine or device are met, or The medicine or device is used following the failure of other therapies as defined by the relevant LSCMMG pathway. Generally, little or no routine drug monitoring is required.   

Red

 Red medicines: Medicine is supplied by the hospital for the duration of the treatment course. Primary care initiation or continuation of treatment is not recommended unless exceptional circumstances such as specialist GP. Red medicines are those where primary care prescribing is not recommended. These treatments should be initiated by specialists only and prescribing retained within secondary care. They require specialist knowledge, intensive monitoring, specific dose adjustments or further evaluation in use. If however, a primary care prescriber has particular specialist knowledge or experience of prescribing a particular drug for a particular patient it would not always be appropriate for them to expect to transfer that prescribing responsibility back to secondary care. There should be a specific reason and a specific risk agreement, protocol and service set up to support this. Primary care prescribers may prescribe RED medicines in exceptional circumstances to patients to ensure continuity of supply while arrangements are made to obtain ongoing supplies from secondary care.  

Amber 0

 Amber level 0: Suitable for prescribing in primary care following recommendation or initiation by a specialist. Little or no specific monitoring required. Patient may need a regular review, but this would not exceed that required for other medicines routinely prescribed in primary care. Brief prescribing document or information sheet may be required. Primary care prescribers must be familiar with the drug to take on prescribing responsibility or must get the required information. When recommending or handing over care, specialists should ask primary care prescribers to take over prescribing responsibility, and should give enough information about the indication, dose, monitoring requirements, use outside product licence and any necessary dose adjustments to allow them to confidently prescribe.  

Amber 1

 Amber level 1 (with shared care): Suitable for prescribing in primary care following recommendation or initiation by a specialist. Minimal monitoring required. Patient may need a regular review, but this would not exceed that required for other medicines routinely prescribed in primary care. Full prior agreement about patient’s on-going care must be reached under the shared care agreement. Primary care prescribers are advised not to take on prescribing of these medicines unless they have been adequately informed by letter of their responsibilities with regards monitoring, side effects and interactions and are happy to take on the prescribing responsibility. A copy of locally approved shared care guidelines should accompany this letter which outlines these responsibilities. Primary care prescribers should then tell secondary care of their intentions as soon as possible by letter so that arrangements can be made for the transfer of care.  

Amber 2

 Amber level 2 (with shared care and enhanced service): Initiated by specialist and transferred to primary care following a successful initiation period. Significant monitoring required on an on-going basis. Full prior agreement about patient’s on-going care must be reached under the shared care agreement. Suitable for enhanced service. These medicines are considered suitable for GP prescribing following specialist initiation of therapy, as per shared care document which will be sent out with the request to prescribe, with on-going communication between the primary care prescriber and specialist. Amber Level 2 medicines require significant monitoring for which an enhanced service may be suitable. (Subject to local commissioning agreements).  

Do Not Prescribe

 Do not prescribe: NOT recommended for use by the NHS in Lancashire and South Cumbria. Includes medicines that NICE has not recommended for use and terminated technology appraisals, unless there is a local need.  

Grey

 Grey medicines: Medicines which have not yet been reviewed or are under the review process. GPs and specialists are recommended not to prescribe these drugs. This category includes drugs where funding has not yet been agreed.   

Multiple

 Refer to local guidance.  

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