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

Review date: January 2022

Non-formulary drugs: Any drug or formulation not listed in the formulary is deemed to be non-formulary.

Off-label use: Drugs are included in the formulary for their licensed indications – where inclusion of off-label use is considered to be included in the formulary this is specifically stated in the formulary entry for the drug N.B. also see Paediatrics note below.

Paediatrics: Drugs are included in the formulary for paediatric use for their BNF for Children recommended indications (indicated by symbol View childrens BNF) which may be off-label, unless otherwise stated. All drugs are deemed to have the same RAG status as they have for adults unless stated otherwise.

NHS England Specialised Commissioning
Drugs carrying the NHS England logo are commissioned by them. Links to key documents, national programmes of care, and clinical reference groups are found below.

NHSE NHS England Specialised Commissioning: Key documents

NHSE NHS England Specialised Commissioning: National programmes of care and clinical reference groups

Medications which are indicated for medically assisted reproduction, including ovulation induction (e.g. clomifene, letrozole and tamoxifen) and assisted reproduction, such as In Vitro Fertilisation or Ex Vitro Fertilisation (e.g. gonadotrophins) are restricted to use by specialist secondary care physicians, and are categorised as RED drugs for these purposes.

Chapter Links...
 Details...
08.03  Expand sub section  Sex hormones and hormone antagonists in malignant disease
08.03.01  Expand sub section  Oestrogens
Diethylstilbestrol
View adult BNF View SPC online
Formulary
Amber Initiated
Tablets 1mg, 5mg 
   
Ethinylestradiol
View adult BNF View SPC online
Formulary
Amber Initiated

Tablets 2 micrograms, 10 micrograms, 50 micrograms, 1mg

 
   
08.03.02  Expand sub section  Progestogens
Medroxyprogesterone Acetate
View SPC online View childrens BNF
Formulary
Amber Initiated
Tablets 100mg, 200mg, 400mg, 2.5mg, 5mg, 10mg 
   
Megestrol Acetate
View adult BNF View SPC online
Formulary
Amber Retained

Tablets 40mg (unlicensed import), 160mg

 
   
Norethisterone
(Breast cancer)
View adult BNF View SPC online
Formulary
Amber Initiated
Tablets 5mg 
   
08.03.03  Expand sub section  Androgens
08.03.04  Expand sub section  Hormone antagonists to top
08.03.04.01  Expand sub section  Breast cancer
Anastrozole (Arimidex®)
View adult BNF View SPC online
Formulary
Amber Recommended

Tablets 1mg

See NICE CG164 for recommendation on use in patients at moderate - high risk in familial breast cancer.

 
   
Exemestane
View adult BNF View SPC online
Formulary
Amber Recommended
Tablets 25mg 
   
Fulvestrant
View adult BNF View SPC online
Formulary
Black
Injection 250mg 
Link   Fulvestrant for the treatment of locally advanced or metastatic breast cancer (TA239), National Institute for Health and Care Excellence Technology Appraisal
Link  Fulvestrant for untreated locally advanced or metastatic oestrogen-receptor positive breast cancer (TA503), National Institute for Health and Care Excellence Technology Appraisal
Link  FULVESTRANT solution for injection (Faslodex®) for untreated locally advanced or metastatic oestrogen-receptor positive breast cancer; Pan Mersey Area Prescribing Committee prescribing policy statement
   
Letrozole
View adult BNF View SPC online
Formulary
Amber Recommended

Tablets 2.5mg

RED Letrozole is RED for fertility treatment (unlicensed)

 
   
Tamoxifen
View adult BNF View SPC online
Formulary
Amber Recommended

Tablets 10mg, 20mg, 40mg; oral solution 10mg/5mL

REDTamoxifen is RED for fertility treatment (unlicensed)
See NICE CG164 for recommendation on use in patients at moderate - high risk in familial breast cancer.

 

 
   
Toremifene
View adult BNF View SPC online
Formulary
Red
Tablets 60mg 
   
08.03.04.02  Expand sub section  Prostate cancer and gonadorelin analogues
08.03.04.02  Expand sub section  Gonadorelin analogues
 note 

Triptorelin is preferred gonadorelin analogue for prostate cancer.

Triptorelin
View adult BNF View SPC online
First Choice
Amber Retained

Decapeptyl® SR Injection, (powder for suspension), m/r, triptorelin (as acetate), 3mg vial (with diluent); Decapeptyl® SR Injection, (powder for suspension), m/r, triptorelin (as acetate/pamoate), 11.25mg vial (with diluent); Decapeptyl® SR Injection, (powder for suspension), m/r, triptorelin (as pamoate), 22.5mg vial (with diluent).

Use in accordance with its licensed indications.

 

For Halton CCG and Warrington CCG patients attending Warrington and Halton Hospitals, GPs currently initiate treatment on the advice of the Trust

Amber Patient Retained Decapeptyl® SR 3mg for early breast cancer

 REDSt Helen's CCG for endometriosis and uterine fibroids

 
Buserelin
View adult BNF View SPC online
Formulary
Amber Retained

Injection 1mg/mL; nasal spray 100 micrograms

For Halton CCG and Warrington CCG patients attending Warrington and Halton Hospitals, GPs currently initiate treatment on the advice of the Trust

 
   
Goserelin
View adult BNF View SPC online
Formulary
Amber Retained

Implant 3.6mg, 10.8mg For prostate cancer and breast cancer indications.

For Halton CCG and Warrington CCG patients attending Warrington and Halton Hospitals, GPs currently initiate treatment on the advice of the Trust

RED St Helen's CCG for endometriosis, endometrial thinning and uterine fibroids.

 
   
Leuprorelin acetate
View adult BNF View SPC online
Formulary
Amber Retained

Injection 3.75mg, 11.25mg

For Halton CCG and Warrington CCG patients attending Warrington and Halton Hospitals, GPs currently initiate treatment on the advice of the Trust

RED St Helen's CCG for endometriosis and uterine fibroids.

 
   
Triptorelin (Gonapeptyl)
View adult BNF View SPC online
Formulary
Amber Retained

Injection: 3.75mg depot

For Halton CCG and Warrington CCG patients attending Warrington and Halton Hospitals, GPs currently initiate treatment on the advice of the Trust

 
Link   TRIPTORELIN (Decapeptyl® SR) Pan Mersey Area Prescribing Committee Policy Statement
   
08.03.04.02  Expand sub section  Anti-androgens
Abiraterone acetate
View adult BNF View SPC online
Formulary
Red

Tablets 500mg

NHS NHSE commissioned drug - see Specialised Commissioning: Key documents

 
Link   Abiraterone for castration-resistant metastatic prostate cancer previously treated with a docetaxel-containing regime (TA259), National Institute for Health and Care Excellence Technology Appraisal
Link  NICE TA387: Abiraterone for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated
   
Bicalutamide
View adult BNF View SPC online
Formulary
Amber Initiated
Tablets 50mg, 150mg 
   
Cyproterone Acetate
View adult BNF View SPC online
Formulary
Amber Initiated
Tablets 50mg, 100mg 
   
Enzalutamide
View adult BNF View SPC online
Formulary
Red
Capsules 40mg
NHS NHSE commissioned drug - see Specialised Commissioning: Key documents
 
Link  Enzalutamide for metastatic hormone‑relapsed prostate cancer previously treated with a docetaxel‑containing regimen (TA316), National Institute for Health and Care Excellence Technology Appraisal
Link  NICE TA377: Enzalutamide for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated
Link  NICE TA580: Enzalutamide for hormone-relapsed non-metastatic prostate cancer
   
Flutamide
View adult BNF View SPC online
Formulary
Amber Initiated
Tablets 250mg 
   
08.03.04.02  Expand sub section  Gonadotrophin-releasing hormone antagonists to top
Degarelix
View adult BNF View SPC online
Formulary
Amber Retained

Injection 80mg, 120mg

The 240mg starting dose and the first 80mg maintenance dose will be administered by the specialist.

NB The current Wirral agreement is for the starting dose to be administered by the specialist.

 
Link  Degarelix Prescribing Support Information
Link  Degarelix GP letter template
Link  DEGARELIX subcutaneous (SC) injection (Firmagon®), Pan Mersey Area Prescribing Committee Policy Statement
   
08.03.04.03  Expand sub section  Somatostatin analogues
Octreotide
View adult BNF View SPC online
Formulary
Red
Injection 50 micrograms/mL,
100 micrograms/mL, 200 micrograms/mL,
500 micrograms/mL;
Depot preparation 10mg, 20mg, 30mg

REDOctreotide is RED for acromegaly and neuroendocrine tumour.

Amber Initiated  Octreotide is AMBER Initiated in palliative care, although in some circumstances may be initated in primary care

NHS NHSE commissioned drug - see Specialised Commissioning: Key documents
 
   
Pasireotide
View adult BNF View SPC online
Formulary
Red

Injection 300 micrograms/mL, 600 micrograms/mL, 900 micrograms/mL

Powder and solvent for suspension for injection 10mg, 20mg, 30mg

Pasireotide for the treatment of Cushings Disease and acromegaly
NHS NHSE commissioned drug - see Specialised Commissioning: Key documents

 
Link  NHS England Key Documents
   
Lanreotide
View adult BNF View SPC online
Formulary
Red
Injection 30mg, 60mg, 90mg, 120mg

REDLanreotide is RED for acromegaly and neuroendocrine tumour

NHS NHSE commissioned drug - see Specialised Commissioning: Key documents
 
   
 ....
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
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
CCG

Traffic Light Status Information

Status Description

Green

Medicines considered suitable for non-specialist prescribing in primary or secondary care.  

Amber Recommended

Requires specialist assessment to enable patient selection.  Amber Recommended medicines must meet criteria: (1) Requires specialist assessment to enable patient selection (2) Following specialist assessment, the medicine is suitable for prescribing in Primary Care.  

Amber Initiated

Amber Initiated. Requires specialist initiation of prescribing. Prescribing to be continued by the specialist until stabilisation of the dose is achieved and the patient has been reviewed. Amber Initiated medicines must meet criteria: (1) Requires specialist assessment to enable patient selection (2) Medicine is suitable for on-going prescribing in Primary Care (3) Requires short to medium term specialist prescribing and monitoring of efficacy or toxicity until the patient’s dose and condition is stable   

Amber Retained

Amber Patient Retained. Requires specialist initiation of prescribing. Prescribing to be continued by specialist until stabilisation of the dose is achieved and the patient had been reviewed. Patient remains under the care of specialist (ie not discharged) as occasional specialist input may be required. Amber Patient Retained medicines must meet criteria: (1)Requires specialist assessment to enable patient selection (2)Medicine is suitable for on-going prescribing in Primary Care (3) Requires short to medium term specialist prescribing and monitoring of efficacy or toxicity until the patient’s dose and condition is stable (4) May require occasional specialist input indefinitely and therefore the patient should not be discharged from specialist care   

Amber

Medicines recommended or initiated by specialists in primary or secondary care. Non-specialist prescribing in primary care may follow according the RAG criteria. In process of being superceded by Amber Recommended, Amber Initiated and Amber Patient Retained.  

Purple

Shared Care. Medicines are considered suitable for Primary Care prescribing and/or management, following specialist initiation of therapy, with on-going communication between the Primary Care prescriber and specialist, within the framework of a Shared Care Agreement. Medicines designated as requiring Shared Care require on-going input from both Specialist and Primary Care clinicians and patients should not be discharged from Specialist care. Where prescribing and monitoring are required under shared care, it is implicit that the responsibility for both of these tasks rests with the prescriber. A Shared Care Agreement will always be available for Shared Care medicines and this document will include a Shared Care Agreement pro-forma which will be completed by all involved clinicians. This pro-forma will record agreement to take on defined aspects of care e.g. monitoring and/or on-going prescribing for the individual patients. A policy detailing clinician responsibilities in Shared Care Agreements must be referred to in all cases of Shared Care. All drugs to be included in this category must meet Shared Care criteria 1 to 3: SC1 Requires specialist assessment to enable patient selection and also initiation, stabilisation and review of treatment and the patient`s condition. SC2 Prescribing and/or management of the drug in Primary Care with specialist support and input, within the framework of the Shared Care Agreement is safe and convenient and that there is an appropriate mechanism for individual patient access in Primary Care. SC3 Requires specific long-term monitoring (blood test or other measurement) for adverse effects and / or efficacy of the drug to be completed in Primary Care, and requires on-going specialist support for the dose changes or management of adverse effects. Monitoring is required on a regular basis (typically four times a year). Implicit in any shared care agreement is the understanding that participation is at the discretion of the Primary Care prescriber subject to their clinical confidence.   

Red

Primary care prescribing of these medicines is NOT recommended. These treatments should be initiated by specialists only; ongoing prescribing is retained within secondary care.   

Black

Not recommended for use. Deviation from the policy may be considered on an individual basis where exceptional circumstances exist.   

Grey

Not recommended for use at this time. Deviation from the policy may be considered on an individual basis where exceptional circumstances exist. Further guidance will be issued when more information or evidence is made available.  

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