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 Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
Notes:
For patient information about chemotherapy and chemotherapy regimens, please see the Macmillan cancer support website: 
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08.03.04.02  Expand sub section  Prostate cancer and gonadorelin analogues
08.03.04.02  Expand sub section  Gonadorelin analogues
08.03.04.02  Expand sub section  Anti-androgens
Abiraterone (Zytiga)
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Restricted Drug Restricted
Red
High Cost Medicine

Tablets.

  • Approved in line with NICE TA259 for use by an oncologist for castration resistant metastatic prostate cancer, previously treated with docetaxel.
    Commissioners have confirmed that abiraterone in the above indication is not routinely commissioned in England in patients who have received prior enzalutamide therapy. An exception will be where enzalutamide has had to be stopped within 3 months of its start solely as a consequence of dose-limiting toxicity and in the clear absence of disease progression.
  • Approved in line with NICE TA387 for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated
  • At SFH, see link below.
  • Patients commenced on the drug prior to 1st May 2011 are eligible for free of charge stock via a compassionate use programme.
 
Link  Link to reviews
Link  NICE TA387:Abiraterone for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated
Link  NICE TAG 259: Abiraterone for castration resistant prostate cancer
Link  SFH: Abiraterone in Prostate Cancer Regimen
Link  SFH: Abiraterone in Stampede trial (See arm G and J)
   
Bicalutamide
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Formulary
Amber 2
Tablet
  • If needed tablets can be dispersed in water, but this should be avoided by women of child bearing potential. Carers should wear protective clothing to minimise contact with dispersed tablets More Info
  • Amber 2 for advanced prostate cancer
     
  • Link  Link to reviews
       
    Cyproterone
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    Formulary
    Amber 2

    Tablet

    • If needed tablets can be dispersed in water, but this should be done in a closed system- put the tablet in an oral syringe and suck up some water to dissolve it. More Info
     
    Link  MHRA Drug safety update- advice regarding meningioma risk with cyproterone
       
    DarolutamideBlack Triangle (Nubeqa )
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    Restricted Drug Restricted
    Red

    Tablet

    Available at NUH only:

    • Approved in accordance with the National Cancer Drugs Fund with androgen deprivation therapy for treating non-metastatic hormone-resistant prostate cancer where the specified criteria are met.

     

     

     
       
    Enzalutamide (Xtandi)
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    Restricted Drug Restricted
    Red
    High Cost Medicine

    Tablets (NB: Capsules discontinued Sept 2019)

    • Approved in line with NICE TA377 for treating metastatic, hormone-relapsed prostate cancer before chemotherapy is indicated.
    • Enzalutamide is routinely commissioned for metastatic hormone-relapsed prostate cancer previously treated with a docetaxel-containing regimen in accordance with NICE TA316.
    • NB: The use of enzalutamide for treating metastatic hormone-relapsed prostate cancer previously treated with abiraterone is not covered by this guidance.
    • Enzalutamide requires National Cancer Drugs Fund approval (until April 2016) for the treatment of chemotherapy naïve castrate-resistant Metastatic Prostate Cancer. Confirm funding is approved on BlueTeq for all new CDF starters.
    • NUH: For more about CDF approved indications, including criteria, see the DTC website; available here
    • SFH: For all new starters contact the oncology pharmacy team (3156) or the HCD Team (4660) to confirm whether CDF approval is required or not.
     
    Link  Enzalutamide in Stampede trial (See arm J)
    Link  Link to reviews
    Link  NICE TA316: Enzalutamide for prostate cancer
    Link  NICE TA377: Enzalutamide for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated
    Link  SFH: Enzalutamide in prostate cancer regimen
       
    Flutamide
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    Formulary
    Amber 2
    Tablet
  • Amber 2 for advanced prostate cancer 
  •    
    Triptorelin (Decapeptyl)
    (Malignancy)
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    Formulary
    Amber 2

    Injection MR 3mg - 1 monthly
    Injection MR 11.25mg - 3 monthly
    Injection MR 22.5mg - 6 monthly

    • Amber 2 for advanced prostate cancer.
    • For gynae and paediatric indications see section see sections 6.7.2
     
    Link  Link to reviews
    Link  Notts APC position statement: Gonadorelin Prescribing in Primary Care
       
    Leuprorelin (Prostap 3)
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    Restricted Drug Restricted
    Amber 2

    Injection 11.25mg- 3 monthly

    • Triptorelin is GnRH analogue of choice for all indications except breast cancer. Leuprorelin is restricted to patients in whom IM injections should be avoided, eg those on anticoagulants (May 2014) as it may be given SC and therefore preferable to IM triptorelin.
     
    Link  Notts APC position statement: Gonadorelin Prescribing in Primary Care
       
     ....
     Non Formulary Items
    Buserelin
    (Prostate)

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    Non Formulary
    Grey
    For infertility treatment see section
    6.7.2
     
    Goserelin  (Zoladex)

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    Non Formulary
    Grey
    Triptorelin is preferred for all indications except breast cancer (see section 8.3.4.1)
    and gender dysphoria (see section 6.7.2)
    Link  Notts APC position statement: Gonadorelin Prescribing in Primary Care
     
    Goserelin  (Zoladex LA)

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    Non Formulary
    Grey
    Triptorelin is preferred for all indications except breast cancer (see section 8.3.4.1)
    and gender dysphoria (see section 6.7.2)
    Link  Notts APC position statement: Gonadorelin Prescribing in Primary Care
     
    Leuprorelin Acetate  (Prostap SR)

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    Non Formulary
    Grey
    Triptorelin is preferred for all indications except breast cancer
    Link  Notts APC position statement: Gonadorelin Prescribing in Primary Care
     
    Leuprorelin Acetate  (Staladex 10.72mg implant )

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    Non Formulary
    Grey

    Implant 10.72mg - no formal assesment 

    Link  Notts APC position statement: Gonadorelin Prescribing in Primary Care
     
    Triptorelin  (Gonapeptyl Depot)

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    Non Formulary
    Grey
    Decapeptyl brand preferred
     
      
    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

    Grey

    Grey / Non-Formulary: Medicines, which the Nottinghamshire APC has actively reviewed and does not recommend for use at present due to limited clinical and/or cost effective data.
    Grey / Non-Formulary (undergoing assessment): Work is ongoing and will be reviewed at a future APC meeting.
    Grey / Non-Formulary (no formal assessment): APC has not formally reviewed this medicine or indication because it had never been requested for formulary inclusion. Often used for drugs new to market.
      

    Red

    Medicines which should normally be prescribed by specialists only. eg hospital only.
    For patients already receiving prescriptions in primary care - continue. No new patients to receive prescriptions in primary care.
      

    Amber 1

    Medicines that should be initiated by a specialist and prescribed by primary care prescribers only under a shared care protocol, once the patient has been stabilised.
    Prior agreement must be obtained by the specialist from the primary care provider before prescribing responsibility is transferred. The shared care protocol must have been agreed by the relevant secondary care trust Drugs and Therapeutics Committee(s) (DTC) and approved by the Nottinghamshire APC.
      

    Amber 2

    Medicines suitable to be prescribed in primary care / general practice after specialist* recommendation or initiation.
    A supporting prescribing guideline may be requested which must have been agreed by the relevant secondary care trust DTCs and approved by the Nottinghamshire APC.
    *Specialist is defined by the APC as a clinician who has undertaken an appropriate formal qualification or recognised training programme within the described area of practice
      

    Amber 3

    Primary care/ non specialist may initiate as per APC guideline.
    The supporting prescribing guideline must have been agreed by the relevant secondary care trust D&TC(s) and approved by the Nottinghamshire APC.
      

    Green

    Medicines suitable for routine use within primary care.
    Can be initiated within primary care within their licensed indication, in accordance with nationally recognised formularies, for example the BNF, BNF for Children, Medicines for Children or Palliative Care Formulary. Primary care prescribers take full responsibility for prescribing.   

    OTC

      

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