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Nottinghamshire Area Prescribing Committee
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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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08.01.05  Expand sub section  Other antineoplastic drugs
08.01.05  Expand sub section  Amsacrine
08.01.05  Expand sub section  Arsenic trioxide
08.01.05  Expand sub section  Bevacizumab
08.01.05  Expand sub section  Bexarotene to top
08.01.05  Expand sub section  Bortezomib
08.01.05  Expand sub section  Brentuximab vedotin
08.01.05  Expand sub section  Cetuximab
08.01.05  Expand sub section  Crisantaspase
08.01.05  Expand sub section  Dacarbazine and Temozolomide to top
08.01.05  Expand sub section  Erlotinib
08.01.05  Expand sub section  Hydroxycarbamide
08.01.05  Expand sub section  Imatinab
08.01.05  Expand sub section  Ipilimumab
08.01.05  Expand sub section  Mitotane to top
08.01.05  Expand sub section  Panitumumab
08.01.05  Expand sub section  Pentostatin
08.01.05  Expand sub section  Platinum compounds
08.01.05  Expand sub section  Porfimer sodium and temoporfin
08.01.05  Expand sub section  Procarbazine to top
08.01.05  Expand sub section  Protein kinase inhibitors
Abemaciclib (Verzenios®)
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Formulary
Red
High Cost Medicine
Cancer Drugs Fund

Tablets

Available at NUH only:

  • Approved in accordance with compassionate use scheme for treating Hormone Receptor (HR) positive, HER2 negative metastatic breast cancer in combination with fulvestrant, pre-treated with aromatase inhibitors. (Existing patients only.
  • Approved in accordance with NICE TA579 with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy
  • Approved in accordance with NICE TA563, with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer
 
Link  NICE TA563:Abemaciclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer
Link  NICE TA579: Abemaciclib with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy
   
Afatinib (Giotrif®)
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Restricted Drug Restricted
Red
Tablets
  • Approved in accordance with NICE TA310 for NSCLC  
  • Link  Link to reviews
    Link  NICE TA310: Afatinib for non-small-cell lung cancer
    Link  SFH: Afatinib protocol in Timely trial
    Link  SFHT: Afatinib protocol in NSCLC
       
    Brigatinib (Alunbrig®)
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    Restricted Drug Restricted
    Red
    Cancer Drugs Fund

    Tablets

    Available at NUH only:

    • Approved as per NICE TA571 for treating ALK-positive advanced non-small cell lung cancer after crizotinib.
    • Approved in accordance with the National Cancer Drugs Fund for treating ALK-positive advanced non-small-cell lung cancer that has not been previously treated with an ALK inhibitor
     
    Link  NICE TA571: Brigatinib for treating ALK-positive advanced non-small-cell lung cancer after crizotinib
       
    Cabozantinib (Cometriq®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine

    Capsule

    NUH: Approved in accordance with NICE TA516 for treating medullary thyroid cancer.

     
    Link  Link to reviews
    Link  NICE TA516: Cabozantinib for treating medullary thyroid cancer
       
    Crizotinib (Xalkori®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine

    Capsule

    Approved in accordance with NICE:

    • TA406 for untreated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer.
    • TA422 for previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer.
    • TA529 for treating ROS1-positive advanced non-small-cell lung cancer.
     
    Link  Link to reviews
    Link  NICE TA406: Crizotinib for untreated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer
    Link  NICE TA422: Crizotinib for previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer
    Link  NICE TA529: Crizotinib for treating ROS1-positive advanced non-small-cell lung cancer
    Link  SFH: Crizotinib regimen in NSCLC
    Link  SFH: Exalt3 trial
    Link  MHRA: risk of cardiac failure with crizotinib
       
    Dasatinib (Sprycel®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Cancer Drugs Fund
    Tablets
    Approved in accordance with NICE:
  • TA426 for untreated chronic myeloid leukaemia (chronic-phase Philadelphia-chromosome-positive)
  • TA425 for treating imatinib-resistant or intolerant chronic myeloid leukaemia (chronic or accelerated-phase Philadelphia-chromosome-positive)
    Approved in accordance with the National Cancer Drugs Fund List for the indication(s) below where the specified criteria are met:
    - The treatment of Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia. Removed from the CDF list 2015. Remains on formulary for patients with funding approved prior to removal.
    - The treatment of lymphoid blast crisis chronic myeloid leukaemia. Removed from the CDF list 2015. Remains on formulary for patients with funding approved prior to removal.
  • Confirm funding approved on BlueTeq for all new starters
  • NUH: For more information, including criteria, see the DTC website; available here
     
  • Link  Link to reviews
    Link  NICE TA425:Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia
    Link  NICE TA426:Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia
    Link  SFHT Dasatinib regimen in CML
    Link  SFHT Dasatinib regimen in Spirit trial
    Link  UKMI Q&A: Which medicines require extra care when switching between liquid and tablet/capsule formulations?
       
    Everolimus (Afinitor®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Cancer Drugs Fund

    Tablets 2.5mg, 5mg, 10mg

    • Approved in accordance with NICE TA421; Everolimus with exemestane for treating advanced breast cancer after endocrine therapy.
    • NUH approved in accordance with NICE TA432; Everolimus for advanced renal cell carcinoma after previous treatment.
    • NUH approved in accordance with NICE TA449 for treating unresectable or metastatic neuroendocrine tumours in people with progressive disease
    • NUH approved in accordance with NICE TA498; Everolimus with lenvatinib (Kisplyx®) for previously treated advanced renal cell carcinoma
     
    Link  Link to reviews
    Link  NICE TA348: Preventing Rejection in Liver Transplant
    Link  NICE TA421:Everolimus with exemestane in advanced breast cancer after endocrine therapy
    Link  NICE TA432:Everolimus for advanced renal cell carcinoma after previous treatment
    Link  NICE TA449:Everolimus and sunitinib for treating unresectable or metastatic neuroendocrine tumours in people with progressive disease
    Link  NUH Drugs and Therapeutics Website
    Link  SFH Everolimus Regimen for Renal Cancer
    Link  SFH Everolimus-Exemestane in breast cancer
    Link  SFH: Everolimus in Manta trial in breast cancer
    Link  SFH: Everolimus in Zebra trial
       
    Everolimus (Votubia®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Homecare

    Tablets 2.5mg, 5mg, 10mg

    Available at NUH only:

    • Approved for the treatment of subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) in line with NHS England commissioning policy.
    • Blueteq submission required
    • Approved in line with NHSE Commissioning Policy for refactory focal onset seizures associated with tuberous sclerosis complex (ages 2 years and above)

    Available through Homecare for NUH patients. Please contact pharmacy medicines homecare team for further information.

     
    Link  Everolimus (Votubia®) for treatment of angiomyolipomas associated with tuberous sclerosis
    Link  Everolimus for refractory focal onset seizures associated with tuberous sclerosis complex (ages 2 years and above)
    Link  Everolimus for subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex
    Link  Link to reviews
       
    Gefitinib
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    Restricted Drug Restricted
    Red
    High Cost Medicine

    Tablets

    • Approved in accordance with NICE TA192 for NSCLC
    • Patient access scheme exists. Further information can be found here
    • Gefitinib (Iressa®) is not recommended for treating non small cell lung cancer that has progressed after chemotherapy as per NICE TAG 374

      At SFH:
    • CANNOT be kept as stock in pharmacy. For first cycle, orders can only be processed after purchasing has received a Patient Registration Form (1) signed by the Oncologist.
    • Read Instructions for Dispensary for more detailed information.
     
    Link  Link to reviews
    Link  NICE TA192: Lung cancer (non-small-cell, first line) - gefitinib
    Link  NICE TA374: Erlotinib and gefitinib for treating non-small-cell lung cancer
    Link  SFH Gefitinib regimen in Lung cancer (NSCLC)
       
    Gilteritinib  (Xospata®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine

    Tablets

    Available at NUH only:

    • Approved in accordance with NICE TA642, for treating relapsed or refractory acute myeloid leukaemia
    • Approved at NUH in accordance with NHS England’s interim treatment options available during the COVID-19 pandemic only. For review post March 2021: For use, instead of chemotherapy, in relapsed or refractory FLT3-mutation-positive Acute Myeloid Leukaemia in adults.
     
    Link  NICE TA642: Gilteritinib for treating relapsed or refractory acute myeloid leukaemia
       
    Imatinib
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    Restricted Drug Restricted
    Red
    High Cost Medicine

    Tablets
    NUH only:

    • Approved in accordance with NICE TA326 & TA209: for the treatment of unresectable and/or metastatic gastrointestinal stromal tumours and the adjuvant treatment.
    • Approved in accordance with NICE TA70 & TA251: for chronic myeloid leukaemia.
    • Approved in accordance with NICE TA425: for high dose therapy for CML - not recommended.
    • Approved in accordance with NICE TA426: for untreated, chronic-phase Philadelphia-chromosome-positive CML in adults
    • Approved for adults and children with newly diagnosed Ph+ acute lymphoblastic leukaemia

    • Glivec® brand must be used for Gastrointestinal Stromal Tumours (GIST)

     SFH

    • Existing patients to remain on homecare and no new patients to be on homecare
     
    Link  SFH: Imatinib NICE approved protocol (Haematology)
    Link  SFH: Imatinib CDF approval required protocol (Haematology)
    Link  SFH: Imatinib in GIST (Oncology)
    Link  SFH: Imatinib in SPIRIT protocol
    Link  Link to reviews
    Link  NICE TA425:Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia
    Link  NICE TA426:Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia
       
    Lapatinib (Tyverb®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Tablets
  • Approved in accordance with the National Cancer Drugs Fund List for the indication(s) below where the specified criteria are met:
  • The treatment of advanced breast cancer. To be removed from the CDF list on 12th March 2015. Remains on formulary for patients with funding approved prior to this date.
  • NUH: For more information, including criteria, see the DTC website; available here
  • Confirm funding approved on BlueTeq for all new starters.
  • At SFH, contact High Cost Drugs team (ext 4657).
  • Direct discount Patient access scheme applies. 
  • Link  Link to reviews
    Link  NICE TA257: Lapatinib in HER-2 positive metastatic breast cancer
    Link  NUH Drugs and Therapeutics Website
    Link  SFH oral chemotherapy regimens
       
    Larotrectinib (Vitrakvi®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Cancer Drugs Fund

    Oral solution

    Available at NUH only:

    • Approved in accordance with the National Cancer Drugs Fund and NICE TA630 for treating NTRK fusion-positive solid tumours in adults and children.
     
    Link  NICE TA630: Larotrectinib for treating NTRK fusion-positive solid tumours
       
    Nilotinib (Tasigna®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Capsule
    Approved in accordance with NICE:
  • TA425 for chronic- or accelerated-phase Philadelphia-chromosome-positive CML in adults
  • TA426 for untreated chronic-phase Philadelphia-chromosome-positive CML in adults
  • Must not be prescribed on FP10s as there is a Patient Access Scheme in operation. Can be supplied via Homecare as long as the PAS is transferred.
  • At SFH patients are supplied via Homecare.
  • See EastMidlands Cancer network guidelines linked above for further information with regards to Nilotinib place in CML therapy
     
  • Link  Link to reviews
    Link  NICE TA425: Dasatinib, nilotinib and high dose imatinib for CML
    Link  NICE TA425:Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia
    Link  NICE TA426: Dasatinib, nilotinib and imatinib for first line treatment of CML
    Link  NICE TA426:Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia
    Link  SFH:nilotinib regimen in CML refractory/intolerant to imatinib
       
    Osimertinib (Tagrisso®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine

    Tablet

    • Approved in accordance with NICE TA653 for treating EGFR T790M mutation-positive advanced non-small-cell lung cancer
    • Approved in accordance with NICE TA654 for untreated EGFR mutation-positive non-small-cell lung cancer
     
    Link  NICE TA653: 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
       
    Pazopanib (Votrient®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Tablets
  • Approved in accordance with NICE TA215 for the first-line treatment of advanced renal cell carcinoma
    Also approved in accordance with the National Cancer Drugs Fund List for the indications below where the specified criteria are met:
  • The treatment of advanced non-adipocytic soft tissue sarcoma. To be removed from the CDF list on 12th March 2015. Remains on formulary for patients with funding approved prior to this date.
    NUH: For more information, including criteria, see the DTC website; available here
  • Confirm funding approved on BlueTeq for all new starters 
  • Link  Link to reviews
    Link  NICE TA 215: Pazopanib in renal cell cancer
    Link  SFH Pazopanib Regimen in renal cancer
    Link  SFH: Star trial protocol in renal cancer
       
    Regorafenib (Stivarga® )
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    Restricted Drug Restricted
    Red
    High Cost Medicine

    Tablets

    • Approved in accordance with NICE TA488 for previously treated unresectable or metastatic gastrointesrinal stromal tumors
    • Approved in accordance with NICE TA555 for previously treated advanced hepatocellular carcinoma
    • SFH: Confirm funding by contacting the HCD Team on 4660
     
    Link  Link to reviews
    Link  NICE TA488:Regorafenib for previously treated unresectable or metastatic gastrointestinal stromal tumours
    Link  NICE TA555: Regorafenib for previously treated advanced hepatocellular carcinoma
       
    Sorafenib (Nexavar®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine

    Tablets

    NUH approved in accordance with:

    • NICE TA474 for treating advanced hepatocellular carcinoma - only for people with Child-Pugh grade A liver impairment
    • NICE TA535 for treating differentiated thyroid cancer after radioactive iodine

    At SFH: Do not authorise before contacting High Cost Drugs team (4657) or Cancer services pharmacist (3156).

     
    Link  Link to reviews
    Link  NICE TA474: Sorafenib for treating advanced hepatocellular carcinoma
    Link  NICE TA535: Sorafenib for treating differentiated thyroid cancer after radioactive iodine.
    Link  NUH Drugs and Therapeutics Website
    Link  SFH Sorafenib Regimen for Hepatic Cancer
    Link  SFH Sorafenib Regimen for Renal Cancer
       
    Sunitinib (Sutent®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Cancer Drugs Fund
    Capsules
  • Approved in accordance with NICE for the treatment of gastrointestinal stromal tumours and for the first-line treatment of advanced and/or metastatic renal cell carcinoma.
  • NUH approved in accordance with NICE TA449 for treating unresectable or metastatic neuroendocrine tumours in people with progressive disease
  • Risk of osteonecrosis of the jaw (MHRA advice 2011)  
  • Link  Link to reviews
    Link  NICE TA169: Renal cell carcinoma - sunitinib
    Link  NICE TA179: Gastrointestinal stromal tumours - sunitinib
    Link  NICE TA449:Everolimus and sunitinib for treating unresectable or metastatic neuroendocrine tumours in people with progressive disease
    Link  SFH Sunitinib regimen for renal cancer
    Link  SFH: Sunitinib regimen for pancreatic cancer
    Link  SFH: Star trial protocol in renal cancer
       
    Cytotoxic Drug Temsirolimus (Torisel®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Cancer Drugs Fund
    Only approved in accordance with the National Cancer Drugs Fund List for the treatment of advanced renal cell carcinoma
  • At NUH, confirm funding approved on BlueTeq for all new CDF starters. For more information, including criteria, see the DTC website; available here
  • At SFH: Do not authorise before contacting High Cost Drugs team (4657) or Cancer services pharmacist (3156).
     
  • Link  NUH Drugs and Therapeutics Website
       
    Vemurafenib (Zelboraf®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Tablets- NUH only
  • NUH: Approved for use in oncology in accordance with NICE TA269
     
  • Link  Link to reviews
    Link  MHRA: Risk of potentiation of radiation toxicity with vemurafenib
    Link  NICE TA269: Vemurafenib for treating malignant melanoma
       
    Cytotoxic Drug EntrectinibBlack Triangle (Rozlytrek ®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Cancer Drugs Fund

    Capsule

    Available at NUH only:

    • Approved in accordance with NICE TA643, for the treatment of ROS1-positive advanced non-small-cell lung cancer. Funding available from the Cancer Drugs fund until routine commisioning.
    • Approved in adults and children over 12 years old in accordance with NICE TA644 for treating NTRK fusion-positive solid tumours
     
    Link  NICE TA643: Entrectinib for treating ROS1-positive advanced non-small-cell lung cancer
    Link  NICE TA644: Entrectinib for treating NTRK fusion-positive solid tumours
       
    08.01.05  Expand sub section  Taxanes
    08.01.05  Expand sub section  Topoisomerase I inhibitors
    08.01.05  Expand sub section  Trabectedin
    08.01.05  Expand sub section  Trastuzumab to top
    08.01.05  Expand sub section  Tretinoin
    08.01.05  Expand sub section  Vismodegib
     ....
     Non Formulary Items
    Cytotoxic Drug  Vandetanib  (Caprelsa®)

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    Non Formulary
    Grey

    Tablets

    Removed from the CDF list on 11th February 2019. Remains on formulary for patients with funding approved prior to this date.

    Link  Link to reviews
    Link  Patient Alert Card
     
      
    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

      

    netFormulary