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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
Acalabrutinib
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Capsules : Unlicensed medicine - named patient use only

Available at NUH only:

  • Approved in accordance with the Early Access Programme as monotherapy for adults with previously untreated CLL
 
Link  SFH: Acalabrutinib regimen in CLL
   
Cytotoxic Drug Aflibercept (Zaltrap®)
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Cancer Drugs Fund
Infusion
Was approved in accordance with the National Cancer Drugs Fund List for the second line treatment of metastatic colorectal cancer. 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  
Link  Link to reviews
Link  MHRA Drug Safety Update (April 2016)
Link  NICE TA307: Aflibercept in combination with irinotecan and fluorouracil-based therapy for treating metastatic colorectal cancer that has progressed following prior oxaliplatin-based chemotherapy
Link  Visual impairment due to mycopic choroidal neovascularisation: afibercept
   
Alectinib (Alecensa®)
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Capsules

NUH only: Approved in accordance with compassionate named patient programme for advanced (incurable) non-squamous ALK +ve NSCLC who have progressed/are intolerant to crizoinib or ceritinib.

NUH only: Approved in accordance with NICE TA536, for untreated ALK-positive advanced non-small-cell lung cancer

 
Link  NICE TA536: Alectinib for untreated ALK-positive advanced non-small-cell lung cancer
   
Atezolizumab (Tecentriq®)
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Cancer Drugs Fund

Infusion

Available at NUH only:

  • Approved, in accordance with the Cancer Drugs Fund and NICE TA492 for untreated locally advanced or metastatic urothelial cancer when cisplatin is unsuitable.
  • Approved, in accordance with NICE TA520 as an option for treating locally advanced or metastatic non-small-cell lung cancer after chemotherapy
  • Approved, in accordance with NICE TA525 for treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy.
  • Approved in accordance with NICE TA584 in combination for treating metastatic non-squamous non-small-cell lung cancer
  • Approved, in accordance with NICE TA638 with carboplatin and etoposide for untreated extensive-stage small-cell lung cancer
  • Approved, in accordance with NICE TA639 with nab-paclitaxel for untreated PD-L1-positive, locally advanced or metastatic, triple-negative breast cancer
  • Approved, in accordance with Early Access to Medicines Scheme 00031/0012 in combination with bevacizumab for the treatment of adult patients with unresectable hepatocellular carcinoma who have received no prior systemic therapy.
 
Link  NICE TA492: Atezolizumab for untreated locally advanced or metastatic urothelial cancer when cisplatin is unsuitable
Link  NICE TA520: Atezolizumab for treating locally advanced or metastatic non-small-cell lung cancer after chemotherapy
Link  NICE TA525: Atezolizumab for treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy.
Link  NICE TA584:Atezolizumab in combination for treating metastatic non-squamous non-small-cell lung cancer
Link  NICE TA638: Atezolizumab with carboplatin and etoposide for untreated extensive-stage small-cell lung cancer
Link  NICE TA639: Atezolizumab with nab-paclitaxel for untreated PD-L1-positive, locally advanced or metastatic, triple-negative breast cancer
Link  EAMS 00031/0012: Atezolizumab in combination with bevacizumab for the treatment of adult patients with unresectable hepatocellular carcinoma who have received no prior systemic therapy
   
Axitinib (Inlyta®)
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Tablet

Available at NUH only

  • Approved for the treatment of advanced renal cell carcinoma after failue of a first-line kinase inhibitor or cytokine in accordance with NICE TA333.
  • Approved for use in combination with Avelumab in accordance with the Cancer Drugs Fund for untreated advanced or metastatic renal cell carcinoma
 
Link  Link to reviews
Link  NICE TA333: Axitinib for advanced renal cell carcinoma
Link  SFH axitinib pharmacy screening procedure
   
Bosutinib (Bosulif®)
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Tablets
  • Approved in accordance with NICE TA401 for use in chronic, accelerated and blast phase Philadelphia chromosome positive chronic myeloid leukaemia in adults if they have previously had 1 or more tyrosine kinase inhibitors, imatinib/nilotinib/dasatinib are not appropriate and it is discounted.  
  • Link  SFH: Bosutinib in CML
    Link  Link to reviews
    Link  NICE TA401: Bosutinib for previously treated chronic myeloid leukaemia
       
    Cabozantinib (Cabometyx®)
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    Film-coated tablets
    NUH Only

    • Approved in accordance with NICE TA463 for previously treated advanced renal cell carcinoma
    • Approved in accordance with NICE TA542 for untreated advanced renal cell carcinoma
     
    Link  NICE TA463:Cabozantinib for previously treated advanced renal cell carcinoma
    Link  NICE TA542: Cabozantinib for untreated advanced renal cell carcinoma
    Link  SFH: Cabozantinib (Cabometyx brand only) in renal cancer
       
    Cytotoxic Drug Carfilzomib (Kyprolis®)
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    Infusion
  • NUH approved in line with NICE TA457 for previously treated multiple myeloma 
  • Link  NICE TA457:Carfilzomib for previously treated multiple myeloma
       
    Ceritinib (Zykadia)
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    Capsules

    • NUH: Approved in accordance with NICE TA395 - for previously treated anaplastic lymphoma kinase positive non-small-cell lung cancer
    • NUH: Approved in accordance with NICE TA500 - for untreated ALK-positive non-small-cell lung cancer
     
    Link  NICE TA395: Ceritinib for previously treated anaplastic lymphoma kinase positive non-small-cell lung cancer
    Link  NICE TA500: Ceritinib for untreated ALK-positive non-small-cell lung cancer
       
    Dabrafenib (Tafinlar®)
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    Capsule

    NUH only

    Approved in accordance with: 
    -NICE TA321 for treating unresectable or metastatic BRAF V600 mutation‑positive melanoma. 
    -NICE TA396 for treating unresectable or metastatic melanoma in combination with trametinib.
    -the National Cancer Drugs Fund (until Jan 2019) and NICE TA544 with trametinib for adjuvant treatment of resected BRAF V600 mutation-positive melanoma, where specified criteria are met.

     
    Link  Link to reviews
    Link  NICE TA321:Dabrafenib for BRAF V600 +ve melanoma
    Link  NICE TA396:Trametinib in combination with dabrafenib for treating unresectable or metastatic melanoma
    Link  NICE TA544: Dabrafenib with trametinib for adjuvant treatment of resected BRAF V600 mutation-positive melanoma
       
    Dacomitinib monohydrate (Vizimpro®)
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    Tablets

    Available at NUH only:

    • Approved in accordance with NICE TA595 for untreated EGFR mutation-positive non-small-cell lung cancer
     
       
    Daratumumab (Darzalex®)
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    Infusion
    Subcutaneous Injection

    Available at NUH only:

    • Approved in accordance with the National Cancer Drugs Fund List and NICE TA510 as monotherapy for treating relapsed and refractory multiple myeloma.
    • Approved in accordance with the National Cancer Drugs Fund List and NICE TA573 for use with bortezomib and dexamethsone for previously treated multiple myeloma.
    • Subcutaneous Injection: Approved for the above indications in accordance with NHS England guidance during the Covid-19 pandemic.
     
    Link  Risk of reactivation of hepatitis B virus, HCP letter (2019)
    Link  NICE TA510: Daratumumab monotherapy for treating relapsed and refractory multiple myeloma
    Link  NICE TA573: Daratumumab with bortezomib and dexamethasone for previously treated multiple myeloma
       
    Encorafenib (Braftovi®)
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    Capsules

    Available at NUH only:

    • Approved in accordance with NICE TA562 with binimetinib for unresectable or metastatic BRAF V600 mutation-positive melanoma
     
    Link  NICE TA562: Encorafenib with binimetinib for unresectable or metastatic BRAF V600 mutation-positive melanoma
       
    Cytotoxic Drug Eribulin (Halaven®)
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    Injection

    • Approved in accordance with NICE TA423 for treating locally advanced or metastatic breast cancer after two or more chemotherapy regimens
    • Not recommended for treating locally advanced or metastatic breast cancer after one chemotherapy regimen (in accordance with NICE TA515)
     
    Link  Link to reviews
    Link  NICE TA423: Eribulin for treating locally advanced or metastatic breast cancer after 2 or more chemotherapy regimens
    Link  NICE TA515: Eribulin for treating locally advanced or metastatic breast cancer after 1 chemotherapy regimen
       
    Gemtuzumab ozogamicin  (Mylotarg®)
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    Infusion

    NUH only: Approved in accordance with NICE TA545 for untreated acute myeloid leukaemia in people 15 years and over.

     
    Link  NICE TA545: Gemtuzumab ozogamicin for untreated acute myeloid leukaemia
       
    Ibrutinib (Imbruvica®)
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    Cancer Drugs Fund

    Tablets (140mg, 280mg, 420mg and 560mg) available at NUH, Capsules (140mg) (no longer available at NUH)

    Only to be prescribed by Consultant Haematologists for Lymphoma (See protocol for funding requirement)
    NUH and SFH: Approved in accordance with NICE TA429 for previously treated chronic lymphocytic leukaemia and untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation
    NUH and SFH: Approved in accordance with NICE TA491 for treating Waldenstrom’s macroglobulinaemia
    NUH: Approved in accordance with NICE TA502 for treating relapsed or refractory mantle cell lymphoma in adults only if they have had only 1 previous line of therapy
    NUH and SFH: Approved in accordance with the National Cancer Drugs Fund List for the indications below where the specified criteria are met:

    • the treatment of relapsed/ refractory Mantle Cell Lymphoma
     
    Link  MHRA Drug Safety Update (August 2017)
    Link  NICE TA429: Ibrutinib for previously treated chronic lymphocytic leukaemia and untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation
    Link  NICE TA491: Ibrutinib for treating Waldenstrom’s macroglobulinaemia
    Link  NICE TA502: Ibrutinib for treating relapsed or refractory mantle cell lymphoma
    Link  SFH: Flair study
    Link  SFH: Ibrutinib in CLL & Mantle Cell Lymphoma protocol
       
    Idelalisib (Zydelig®)
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    Tablet-NUH and SFH
    Approved for use from Feb 16 in accordance with:

    • NICE TA359 for treating chronic lymphocytic leukaemia.
      Previous use via Cancer Drug Fund approval switches to routine commissioning from Feb 16.

    NUH Only: Approved in accordance with compassionate use scheme for:

    • Adult patients with follicular lymphoma that is refractory to two prior lines of treatment 
     
    Link  SFH: R- Idelalisib in CLL
    Link  MHRA Drug Safety Update (Sept 2016)
    Link  NICA TA359: Chronic lymphocytic leukaemia - Idelalisib
    Link  NICE TA604: Idelalisib for treating refractory follicular lymphoma (not recommended)
       
    Cytotoxic Drug Inotuzumab Ozogamicin  (Besponsa®)
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    Powder for solution for infusion

    Approved in accordance with NICE TA541 for treating relapsed or refractory B-cell acute lymphoblastic leukaemia.

     
    Link  NICE TA541: Inotuzumab ozogamicin for treating relapsed or refractory B-cell acute lymphoblastic leukaemia
       
    Ixazomib (Ninlaro®)
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    Capsules

    • Approved in accordance with the National Cancer Drugs Fund List and NICE TA505 with lenalidomide and dexamethasone for treating relapsed or refractory multiple myeloma.
     
    Link  SFH: Ixazomib-Lenalidomide in Myeloma
    Link  SFH: Myeloma 12 trial (Accord) (Haematology)
    Link  NICE: Ixazomib with lenalidomide and dexamethasone for treating relapsed or refractory multiple myeloma (TA505)
       
    Lenvatinib (Kisplyx®)
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    Capsule (Prescribe by brand)

    NUH: Approved with everolimus (Afinitor®) for previously treated advanced renal cell carcinoma in accordance with NICE TA498.

     
    Link  NICE TA498: Lenvatinib with everolimus for previously treated advanced renal cell carcinoma
       
    Lenvatinib (Lenvima®)
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    Capsules (Prescribe by brand)

    Approved in accordance with NICE TA535 for treating differentiated thyroid cancer after radioactive iodine.

    Approved in accordance with the Cancer Drugs Fund and NICE TA551 (expected entry in to baseline commissioning on 19th March 2019) for untreated advanced hepatocellular carcinoma

     
    Link  NICE TA535: Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine
    Link  NICE TA551: Lenvatinib for untreated advanced hepatocellular carcinoma
       
    Lorlatinib (Lorviqua®)
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    Tablet

    Available through NUH only:

    Approved as per NICE TA628 for previously treated ALK-positive advanced non-small-cell lung cancer.

    For Oncology patients only at SFH and NUH

     
    Link  NICE TA628: Lorlatinib for previously treated ALK-positive advanced non-small-cell lung cancer
    Link  SFH: Lorlatinib in Lung cancer protocol
       
    Midostaurin (Rydapt®)
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    Capsules

    NUH only: Approved in accordance with NICE TA523, for untreated acute myeloid leukaemia

     
    Link  NICE TA523 - untreated acute myeloid leukaemia
       
    Cytotoxic Drug Panitumumab (Vectibix®)
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    Infusion
    NUH Only: approved in accordance with TA439 for previously untreated metastatic colorectal cancer.
    NUH Only: approved in accordance with the National Cancer Drugs Fund List for the indications below where the specified criteria are met:
  • The third or fourth line treatment of metastatic colorectal cancer as a single agent To be removed from the CDF list on 4th November 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 CDF starters 
    Link  Link to reviews
    Link  NICE TA439: Cetuximab and panitumumab for previously untreated metastatic colorectal cancer
       
    Cytotoxic Drug Panobinostat (Farydak®)
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    Formulary
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    Capsule
    Approved by NICE as per TA380 from May 16. Final NICE guidance recommends panobinostat with bortezomib and dexamethasone for adults with relapsed and/or refractory multiple myeloma who have received ≥2 prior regimens including bortezomib and an immunomodulatory agent, if the company provides it with the discount agreed in the Patient Access Scheme.
     
    Link  NICE TA380: Panobinostat for treating multiple myeloma after at least 2 previous treatments
       
    Pembrolizumab (Keytruda®)
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    Infusion -

    Available at NUH only in accordance with:

    - NICE TA357 for advanced melanoma after disease progression with ipilimumab
    - NICE TA366 for advanced melanoma not previously treated with ipilimumab. Patient access scheme exists
    - National Cancer Drugs Fund List for the treatment of PD-L1-positive non small-cell lung cancer after chemotherapy where the specified criteria are met then approved in accordance with TA428 for treating PDL1- positive non-small-cell lung cancer after chemotherapy.
    - National Cancer Drugs Fund for first line treatment of locally advanced or metastatic urothelial cancer in patients who are ineligible for cisplatin-based chemotherapy according to specified criteria.
    - NICE TA519 for treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy
    - NICE TA522 for untreated PD-L1-positive locally advanced or metastatic urothelial cancer when cisplatin is unsuitable.
    - NICE TA531 for untreated PD-L1-positive metastatic non-small-cell lung cancer
    - NICE TA553 for adjuvant treatment of resected melanoma with high risk of recurrence
    - National Cancer Drugs Fund for classical Hodgkin lymphoma according to specified criteria.
    - NICE TA557 for untreated, metastatic, non-squamous non-small-cell lung cancer with pemetrexed and platinum chemotherapy
    - NICE TA600 and National Cancer Drugs Fund with carboplatin and paclitaxel for untreated metastatic squamous non-small cell lung cancer
     
    Link  MHRA Drug Safety Update (July 2017)
    Link  NICE TA357: Pembrolizumab for melanoma after ipilimumab
    Link  NICE TA366: Pembrolizumab for advanced melanoma not previously treated with ipilimumab
    Link  NICE TA428: Pembrolizumab for treating PD-L1-positive non-small-cell lung cancer after chemotherapy
    Link  NICE TA522: Pembrolizumab for untreated PD-L1-positive locally advanced or metastatic urothelial cancer when cisplatin is unsuitable
    Link  NICE TA531: Pembrolizumab for untreated PD-L1-positive metastatic non-small-cell lung cancer
    Link  NICE TA600: Pembrolizumab with carboplatin and paclitaxel for untreated metastatic squamous non-small-cell lung cancer
    Link  Early access to medicines scheme (EAMS): pembrolizumab for non-small cell lung cancer
       
    Ponatinib (Iclusig®)
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    Tablet
  • NUH approved in accordance with NICE TA451for treating chronic myeloid leukaemia and acute lymphoblastic leukaemia
     
  • Link  SFH: Ponatinib regimen in CML
    Link  MHRA Drug Safety Update (Apr 2017)
    Link  NICE TA451: Ponatinib for treating chronic myeloid leukaemia and acute lymphoblastic leukaemia
       
    Ruxolitinib (Jakavi®)
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    Tablet

    • Approved in accordance with NICE TA386 for treating disease-related splenomegaly or symptoms in adults with primary myelofibrosis, post-polycythaemia vera myelofibrosis or post-essential thrombocythaemia myelofibrosis in people with intermediate-2 or high risk disease only.
    • Use in people with intermediate-1 disease was removed from the Cancer Drugs Fund on 7th June 2016 and will no longer be available from that date. People with intermediate-1 disease already receiving ruxolitinib via the CDF have the option to continue treatment until they and their clinician consider it appropriate to stop.
      NUH only: Approved in accordance with compassionate use scheme for:
      • Acute and Chronic Graft-versus-Host-Disease (unlicensed indication). Compassionate use scheme now closed for new patients. Remains on formulary for existing patients.
      • Polycythaemia Vera resistant to hydroxycarbamide or in patients intolerant to hydroxycarbamide.
     
    Link  Link to reviews
    Link  NICE TA386: Ruxolitinib for treating disease-related splenomegaly or symptoms in adults with myelofibrosis
    Link  SFH: Majic trial protocol
    Link  SFH: Ruxolitinib regimen in haematology patients (non trial)
       
    Trametinib (Mekinist®)
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    Tablets

    • Approved in accordance with NICE TA396 for treating unresectable or metastatic melanoma in combination with dabrafenib.
    • Approved in accordance with the National Cancer Drugs Fund (until Jan 2019) and NICE TA544 with dabrafenib for adjuvant treatment of resected BRAF V600 mutation-positive melanoma, where specified criteria are met.
    • Monotherapy with trametinib alone is non-formulary
     
    Link  Letter sent to healthcare professionals in February 2016
    Link  NICE TA396: Trametinib in combination with dabrafenib for treating unresectable or metastatic melanoma
    Link  NICE TA544: Dabrafenib with trametinib for adjuvant treatment of resected BRAF V600 mutation-positive melanoma
    Link  Risk of gastrointestinal perforation and colitis
       
    Trifluridine-tipiracil (Lonsurf®)
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    Tablets
    NUH only:
  • In accordance with NICE TA405 for previously treated metastatic colorectal cancer. 
  • Link  SFH: Trifluridine and Tipiracil in Colon Cancer protocol
       
    Venetoclax (Venclyxto®)
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    Tablets 

    Approved in accordance with compassionate use scheme for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) according to specified criteria.
    Approved, in accordance with the Cancer Drugs Fund and NICE TA487 for treating chronic lymphocytic leukaemia, that is, in adults:

    • with a 17p deletion or TP53 mutation and when a B‑cell receptor pathway inhibitor is unsuitable, or whose disease has progressed after a B‑cell receptor pathway inhibitor or
    • without a 17p deletion or TP53 mutation, and whose disease has progressed after both chemo‑immunotherapy and a B‑cell receptor pathway inhibitor and
    • only if the conditions in the managed access agreement are followed.

    Approved in accordance with NICE TA561 in combination with rituximab for previously treated chronic lymphocytic leukaemia.

     
    Link  SFH: Venetoclax in CLL
    Link  NICE TA487: Venetoclax for treating chronic lymphocytic leukaemia
    Link  NICE TA561: Venetoclax with rituximab for previously treated chronic lymphocytic leukaemia
       
    Vosaroxin (Qinprezo)
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    Injection
  • NUH only: Approved in accordance with compassionate use scheme for relapsed or refractory AML as a bridge to transplant. 
  •    
    08.01.05  Expand sub section  Amsacrine
    Cytotoxic Drug Amsacrine (Amsidine®)
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    08.01.05  Expand sub section  Arsenic trioxide
    Cytotoxic Drug Arsenic Trioxide
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    Infusion

    • At SFH: Special approval needed for new starters.Do not authorise before contacting Cancer services pharmacist (3156).
    • NUH only: Approved in accordance with NICE TA526, for treating acute promyelocytic leukaemia
     
    Link  NICE TA526: treatment for acute promyelocytic leukaemia
    Link  NUH Drugs and Therapeutics Website
       
    08.01.05  Expand sub section  Bevacizumab
    Bevacizumab (Avastin®)
    (Oncology)
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    Infusion
    Only approved in accordance with the National Cancer Drugs Fund List for the indications below where the specified criteria are met:
  • The third line treatment of low grade gliomas of childhood
  • The first line treatment of recurrent or metastatic cervical cancer in combination with chemotherapy
  • The first line treatment of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer
  • The treatment of advanced breast cancer.
  • >To be removed from the CDF list on 4th November 2015. Remains on formulary for patients with funding approved prior to this date.
  • The first line treatment of advanced colorectal cancer with a single agent fluoropyramidine. To be removed from the CDF list on 12th March 2015. Remains on formulary for patients with funding approved prior to this date.

  • The first line treatment of advanced colorectal cancer with combination chemotherapy. To be removed from the CDF list on 12th March 2015. Remains on formulary for patients with funding approved prior to this date.

  • The second or third line treatment of advanced colorectal cancer.
  • >To be removed from the CDF list on 4th November 2015. Remains on formulary for patients with funding approved prior to this date.
  • The second line treatment of advanced epithelial ovarian, fallopian tube or primary peritoneal 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 CDF starters. Contact High Cost Drugs or oncology pharmacist for assistance.

  • Link to external medicines reviews here
     
  • Link  Link to reviews
    Link  MHRA advice: Risk of osteonecrosis of the jaw ( 2011)
    Link  NICE Evidence summary: Bevacizumab in combination with paclitaxel and carboplatin for first-line treatment of advanced ovarian cancer
    Link  NICE TA214: Breast Cancer with taxane
    Link  NICE TA263: Breast cancer with capecitabine
    Link  NICE TA285: Ovarian, fallopian tube and primary peritoneal cancer (recurrent advanced, platinum-sensitive or partially platinum-sensitive) - bevacizumab
       
    08.01.05  Expand sub section  Bexarotene to top
    08.01.05  Expand sub section  Bortezomib
    Cytotoxic Drug Bortezomib
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    Injection
    Approved for use in accordance with NICE:

    • TA129 for the treatment of progressive multiple myeloma in people who are at first relapse having received one prior therapy and who have undergone, or are unsuitable for, bone marrow transplantation. This indication is associated with a Patient Access Scheme; details can be found here
    • TA228 for the first-line treatment of multiple myeloma if high-dose chemotherapy with stem cell transplantation is considered inappropriate and the person is unable to tolerate or has contraindications to thalidomide
    • TA311 for induction therapy in multiple myeloma before high-dose chemotherapy and autologous stem cell transplantation
    • TA370 for previously untreated mantle cell lymphoma in adults when haematopoietic stem cell transplantation is unsuitable.
      Also approved in accordance with the National Cancer Drugs Fund List for the indication(s) below where the specified criteria are met:
    • The treatment of bortezomib naive relapsed multiple myeloma. Confirm CDF approval is in place before treatment by reference to Blueteq.
      The following indications were removed from the CDF list on 12th March 2015. Treatment remains available for patients with funding approved prior to this date:
    • The treatment of relapsed/refractory mantle cell lymphoma.
    • The treatment of relapsed multiple myeloma that has previously responded to bortezomib.
    • The treatment of relapsed Waldenstrom's Macroglobulinaemia.
      NUH: For more information, including criteria, see the DTC website; available here
     
    Link  Link to reviews
    Link  NICE TAG129: Multiple myeloma - bortezomib
    Link  NICE TAG228: 1st line treatment of multiple myeloma
    Link  NICE TAG311: Bortezomib for induction therapy in multiple myeloma
    Link  NICE TAG370: Bortezomib for previously untreated mantle cell lymphoma
    Link  NUH Drugs and Therapeutics website
       
    08.01.05  Expand sub section  Brentuximab vedotin
    Brentuximab vedotinBlack Triangle (Adcetris®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Cancer Drugs Fund

    Infusion

    NUH only:

    • Approved in accordance with NICE TA478 for treating relapsed or refractory systemic anaplastic large cell lymphoma.
    • Approved in accordance with NICE TA524 for treating CD30-positive Hodgkin lymphoma
    • Approved in accordance with NICE TA577 for treating CD30-positive cutaneous T-cell lymphoma
    • Approved as per CDF and then NICE TA641 in combination for untreated systemic anaplastic large cell lymphoma. Funding available from CDF for this combination until routine commissioning
    • 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 in adults an paediatrics earlier in the pathway, following one prior therapy, in place of salvage chemotherapy or auto stem cell transplant for relapsed or refractory Hodgkin Lymphoma. Unlicensed indication in paediatrics - for named patient use only.  
    • At NUH, confirm funding approved on BlueTeq for all new starters

    SFH

    • Confirm funding approved by contacting the HCD Team on 4660.
    • Approved in accordance with NICE TA478 for treating relapsed or refractory systemic anaplastic large cell lymphoma.
    • Approved in accordance with NICE TA524 for treating CD30-positive Hodgkin Lymphoma
     
    Link  Link to reviews
    Link  NICE TA478: Brentuximab vedotin for treating relapsed or refractory systemic anaplastic large cell lymphoma
    Link  NICE TA524: for treating CD30-positive Hodgkin lymphoma
    Link  NICE TA641: Brentuximab vedotin in combination for untreated systemic anaplastic large cell lymphoma
       
    08.01.05  Expand sub section  Cetuximab
    Cetuximab (Erbitux®)
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    High Cost Medicine
    Cancer Drugs Fund
    Infusion
    Approved in accordance with NICE:
  • TA145 for the treatment of locally advanced squamous cell cancer of the head and neck where platinum-based treatment is contraindicated

  • TA439 for previously untreated metastatic colorectal cancer

  • TA473 for treating recurrent or metastatic squamous cell cancer of the head and neck - only if the cancer started in the oral cavity
    Also approved in accordance with the National Cancer Drugs Fund List for the indication(s) below where the specified criteria are met:
  • The second or third line treatment of metastatic colorectal cancer with combination chemotherapy. Was removed from the CDF list on 12th March 2015. Remains on formulary for patients with funding approved prior to this date.
  • The third or fourth line treatment of metastatic colorectal cancer as a single agent. Was removed from the CDF list on 4th November 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
  • At NUH, confirm funding approved on BlueTeq for all new CDF starters
  • Patient access scheme exists- at SFH contact Medicines Information for further info 
  • Link  MHRA: importance of establishing wild type RAS (KRAS and NRAS) status before treatment of metastatic colorectal cancer
    Link  NICE TA145: Head and neck cancer - cetuximab
    Link  NICE TA439: Cetuximab and panitumumab for previously untreated metastatic colorectal cancer
    Link  NICE TA473: Cetuximab for treating recurrent or metastatic squamous cell cancer of the head and neck
       
    08.01.05  Expand sub section  Crisantaspase
    Crisantaspase (Erwinase®)
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    Formulary
    Red
    Injection
  • At SFH, not routinely stocked, but may be ordered in if required.
  • NB: See attached letter - vials of Erwinase® from Batch 160G (see also information on sub-lots) contain crisantaspase 9 200 units, NOT 10 000 units as is the case with all other batches.
  • NB: See attached letters - Notice of special handling instructions. VIALS of ERWINASE® from batch 174G* and batch 180G* should be used with a 5-micron filter needle 
  • Link  Letter: ERWINASE® Batch 160G Variation Information (July 2013)
    Link  Letter: ERWINASE® Batch BATCH 174G* use with a 5-micron filter needle (May 2016)
    Link  Letter: ERWINASE® Batch BATCH 180G* use with a 5-micron filter needle (Feb 2017)
       
    08.01.05  Expand sub section  Dacarbazine and Temozolomide to top
    Cytotoxic Drug Dacarbazine
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    Formulary
    Red
    Injection 
       
    Cytotoxic Drug Temozolomide (Temodal®)
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    Formulary
    Red
    High Cost Medicine

    Capsules

    • Licensed for use in glioblastoma. For use in CNS lymphoma please refer to protocol linked below. Contact haematology/High Cost drugs staff at NUH or SFH for more information.
    • Available at NUH only as adjuvant treatment for adults with newly diagnosed anaplastic astrocytoma without 1p/19q codeletion in accordance with the NHS England Clinical Commissioning Policy.
     
    Link  Clinical Commissioning Policy: anaplastic astrocytoma without 1p/19q codeletion
    Link  MHRA: risk of hepatic injury, including fatal hepatic failure
    Link  NICE TA121: Glioma (newly diagnosed and high grade)
    Link  NICE TA23: Guidance on the use of temozolomide for the treatment of recurrent malignant glioma (brain cancer)
    Link  SFH: Temozolomide in CNS lymphoma
       
    08.01.05  Expand sub section  Erlotinib
    Erlotinib
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    High Cost Medicine

    Tablets

    • Approved in accordance with NICE guidelines documented below.
     
    Link  Link to reviews
    Link  NICE TA227: Lung cancer (non-small-cell) maintenance - erlotinib
    Link  NICE TA258: Lung cancer (non-small-cell) 1st line- erlotinib
    Link  NICE TA374: Erlotinib and gefitinib for treating non-small-cell lung cancer that has progressed after prior chemotherapy
    Link  SFH: Erlotinib regimen in lung cancer (NSCLC)
       
    08.01.05  Expand sub section  Hydroxycarbamide
    Cytotoxic Drug Hydroxycarbamide
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    Formulary
    Red

    Capsule, Oral solution: available at NUH only for patients unable to take capsules

    • See East Midlands Cancer network guidelines linked above for further information with regards to Hydroxycarbamide place in CML therapy
     
    Link  SFH Hydroxycarbamide Regimen in Myeloproliferative Disorders and Palliative AML regimen
       
    08.01.05  Expand sub section  Imatinab
    08.01.05  Expand sub section  Ipilimumab
    Ipilimumab (Yervoy®)
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    High Cost Medicine
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    Intravenous Infusion

    Available at NUH only:

    • Approved in accordance with NICE TA268 - for previously treated advanced (unresectable or metastatic) melanoma
    • Approved in accordance with NICE TA319 for previously untreated advanced (unresectable or metastatic) melanoma
    • Approved in line with NICE TA400 for treating advanced (unresectable or metastatic) melanoma in adults in combination with nivolumab. Funding available by CDF for this combination until routine commissioning.
    • Approved in accordance with the National Cancer Drugs Fund List and NICE TA581 with nivolumab for untreated advanced renal cell carcinoma
     
    Link  Link to reviews
    Link  MHRA: risk of CMV gastrointestinal infection with ipilimumab
    Link  NICE TA268: Ipilimumab for previously treated advanced (unresectable or metastatic) melanoma
    Link  NICE TA319: Ipilimumab for previously untreated advanced (unresectable or metastatic) melanoma
    Link  NICE TA400: Nivolumab in combination with ipilimumab for treating advanced melanoma
       
    08.01.05  Expand sub section  Mitotane to top
    08.01.05  Expand sub section  Panitumumab
    08.01.05  Expand sub section  Pentostatin
    Cytotoxic Drug Pentostatin (Nipent®)
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    Formulary
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    Injection- NUH only 
       
    08.01.05  Expand sub section  Platinum compounds
    Cytotoxic Drug Carboplatin
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    Formulary
    Red
    Injection
    NUH – Also purchase unlicensed pre-filled bags 
       
    Cytotoxic Drug Cisplatin
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    Formulary
    Red
    Injection 
    Link  Link to reviews
       
    Cytotoxic Drug Oxaliplatin
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    Formulary
    Red
    Injection 
    Link  NICE TA100: Colon cancer (adjuvant) - capecitabine and oxaliplatin
       
    08.01.05  Expand sub section  Porfimer sodium and temoporfin
    08.01.05  Expand sub section  Procarbazine to top
    Cytotoxic Drug Procarbazine
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    Formulary
    Red
    Capsule 
       
    08.01.05  Expand sub section  Protein kinase inhibitors
    Abemaciclib (Verzenios®)
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    Formulary
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    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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    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.
     
    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
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    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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    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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    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  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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    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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    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  Link to reviews
       
    Gefitinib
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    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
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    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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    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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    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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    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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    Tablet
  • Approved in accordance with NICE TA416 for treating locally advanced or metastatic EGFR T790M mutation-positive non-small-cell lung cancer. 
  • Link  NICE TA416: Osimertinib in non-small-cell lung cancer
       
    Pazopanib (Votrient®)
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    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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    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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    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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    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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    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
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    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.
     
    Link  NICE TA643: Entrectinib for treating ROS1-positive advanced non-small-cell lung cancer
       
    08.01.05  Expand sub section  Taxanes
    Cytotoxic Drug Cabazitaxel (Jevtana®)
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    Infusion
  • NUH approved in line with NICE TA391 for hormone-relapsed metastatic prostate cancer treated with docetaxel.
    Confirm funding approved on BlueTeq for all new starters 
  • Link  Link to reviews
    Link  NICE TA391: Cabazitaxel for hormone-relapsed metastatic prostate cancer treated with docetaxel
       
    Cytotoxic Drug Docetaxel (Taxotere®)
    View adult BNF View SPC online View childrens BNF
    Formulary
    Red
    Infusion
     
    Link  NICE TA101: Prostate cancer (hormone-refractory) - docetaxel
    Link  NICE TA509: Pertuzumab with trastuzumab and docetaxel for treating HER2-positive breast cancer
       
    Cytotoxic Drug Paclitaxel
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    Formulary
    Red
    Infusion 
    Link  Link to reviews
    Link  NICE TA101: Prostate cancer (hormone-refractory) - docetaxel
    Link  NICE TA389 - Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer
    Link  SFH: IV drugs which need special giving sets
       
    Cytotoxic Drug Paclitaxel - Albumin Bound Formulation (Abraxane®)
    View adult BNF View SPC online View childrens BNF
    Restricted Drug Restricted
    Red
    High Cost Medicine
    Intravenous Infusion
    NUH: Approved for the treatment of breast cancer in patients who have documented Taxane hypersensitivity, in accordance with routine NHSE commissioning.
    NUH approved in accordance with TA476 for untreated metastatic pancreatic cancer
  • Confirm funding approved on BlueTeq for all new starters 
  • Link  NICE TA476: Paclitaxel as albumin-bound nanoparticles with gemcitabine for untreated metastatic pancreatic cancer
       
    08.01.05  Expand sub section  Topoisomerase I inhibitors
    Cytotoxic Drug Irinotecan Hydrochloride
    View adult BNF View SPC online View childrens BNF
    Formulary
    Red
    Infusion
    NUH – Also purchase unlicensed pre-filled bags 
    Link  Link to reviews
       
    Cytotoxic Drug Topotecan (Hycamtin®)
    View adult BNF View SPC online View childrens BNF
    Formulary
    Red
    Infusion, Capsule 0.25mg and 1mg
  • Approved in accordance with NICE TA183 and NICE TA184
  • Topotecan is not recommended for treating recurrent platinum resistant or platinum refractory ovarian cancer as per NICE TA389 
  • Link  Link to reviews
    Link  NICE TA183: Cervical cancer (recurrent) - topotecan
    Link  NICE TA184: Lung cancer (small-cell) - topotecan
    Link  NICE TA389 - Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer
    Link  SFH:Topotecan oral Regimen in Small cell lung cancer (SCLC)
       
    08.01.05  Expand sub section  Trabectedin
    Cytotoxic Drug Trabectedin (Yondelis®)
    View adult BNF View SPC online View childrens BNF
    Restricted Drug Restricted
    Red

    Injection-NUH only
    Approved in accordance with NICE TA185 for soft tissue sarcoma by NUH D&T Committee 21/04/10

    • Patient access scheme exists
      Trabectedin in combination with pegylated liposomal doxorubicin is not recommended for treatment of the first recurrence of platinum-sensitive ovarian cancer.
     
    Link  Link to reviews
    Link  NICE TA185: Soft tissue sarcoma - trabectedin
    Link  NICE TA389 - Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer
       
    08.01.05  Expand sub section  Trastuzumab to top
    Cytotoxic Drug Pertuzumab (Perjeta®)
    View adult BNF View SPC online View childrens BNF
    Restricted Drug Restricted
    Red
    High Cost Medicine

    Infusion

    Approved in accordance with NICE TA424 for the neoadjuvant treatment of HER2-positive breast cancer

    Approved in accordance with NICE TA509 with trastuzumab and docetaxel for treating HER2-positive breast cancer. 

    Approved in accordance with NICE TA569 for adjuvant treatment of HER2-positive early stage breast cancer

    Confirm funding approved on BlueTeq for all new starters.
    SFH: Confirm funding by contacting the HCd Team on 4660

     
    Link  Link to reviews
    Link  NICE TA424: Pertuzumab for the neoadjuvant treatment of HER2-positive breast cancer
    Link  NICE TA509: Pertuzumab with trastuzumab and docetaxel for treating HER2-positive breast cancer
       
    Cytotoxic Drug Trastuzumab (Herceptin®)
    (Intravenous)
    View adult BNF View SPC online View childrens BNF
    Formulary
    Red
    High Cost Medicine

    Infusion-NUH only

    See 'trastuzumab for subcutaneous use (Herceptin®)' for subcutaneous use.  

    Note: a managed switch from IV Herceptin® to the biosimilar IV Ontruzant® will take place in September 2018.  Please check which brand should be used before prescribing. 

    At NUH only approved in accordance with:

    • NICE TA34 for the treatment of advanced breast cancer
    • NICE TA208 for the treatment of HER2-positive metastatic gastric cancer
    • NICE TA257 in combination with an aromatase inhibitor for HER2 positive metastatic breast cancer
    • NICE TA509 with pertuzumab and docetaxel for treating HER2-positive breast cancer

    **Care required**

    • Trastuzumab must be prescribed by brand i.e. Herceptin® IV or Ontruzant® IV 
    • To minimise the risk of errors due to the similarity of the product names for trastuzumab: Ontruzant® IV (biosimilar), Herceptin® IV and Herceptin® SC and trastuzumab emtansine: Kadcyla®, recommendations in Risk Minimisation materials and formulary advice should be followed when prescribing, dispensing and administering the product.
     
    Link  NICE TA34: Breast cancer - trastuzumab
    Link  Link to reviews
    Link  NICE TA208: Gastric cancer (HER2-positive metastatic) - trastuzumab
    Link  NICE TA257: in combination with an aromatase inhibitor for HER2 positive metastatic breast cancer
    Link  NICE TA509: Pertuzumab with trastuzumab and docetaxel for treating HER2-positive breast cancer
       
    Cytotoxic Drug Trastuzumab (Herceptin®)
    (Subcutaneous)
    View adult BNF View SPC online View childrens BNF
    Restricted Drug Restricted
    Red
    High Cost Medicine
    Homecare

    Injection 

    See 'trastuzumab (Ontruzant®)' or 'trastuzumab (Herceptin®)' for IV use.  

    Approved at NUH and SFH in accordance with:

    • NICE TA34 for the treatment of advanced breast cancer
    • NICE TA208 for the treatment of HER2-positive metastatic gastric cancer
    • NICE TA257 in combination with an aromatase inhibitor for HER2 positive metastatic breast cancer
    • NICE TA509 with pertuzumab and docetaxel for treating HER2-positive breast cancer

    **Care required**

    • Trastuzumab SC must be prescribed by brand i.e. Herceptin® SC

    At SFH: Prescribed on oncology charts. Stocked in ADU. Prescriptions should be screened ONLY by ADU trained pharmacists.

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

     
    Link  NICE TA34: Breast cancer - trastuzumab
    Link  NICE TA208: Gastric cancer (HER2-positive metastatic) - trastuzumab
    Link  NICE TA257: in combination with an aromatase inhibitor for HER2 positive metastatic breast cancer
    Link  NICE TA509: Pertuzumab with trastuzumab and docetaxel for treating HER2-positive breast cancer
       
    Cytotoxic Drug Trastuzumab (Ontruzant®)
    (IV Biosimilar)
    View adult BNF View SPC online View childrens BNF
    Restricted Drug Restricted
    Red
    High Cost Medicine

    Infusion-NUH only

    See 'trastuzumab for subcutaneous use (Herceptin®)' for subcutaneous use.  

    Note: a managed switch from IV Herceptin® to the biosimilar Ontruzant® will take place in September 2018.  Please check which brand should be used before prescribing. 

    At NUH only approved in accordance with:

    • NICE TA34 for the treatment of advanced breast cancer
    • NICE TA208 for the treatment of HER2-positive metastatic gastric cancer
    • NICE TA257 in combination with an aromatase inhibitor for HER2 positive metastatic breast cancer
    • NICE TA509 with pertuzumab and docetaxel for treating HER2-positive breast cancer

    **Care required**

    • Trastuzumab must be prescribed by brand i.e. Herceptin® IV or Ontruzant® IV 
    • To minimise the risk of errors due to the similarity of the product names for trastuzumab: Ontruzant® IV (biosimilar), Herceptin® IV and Herceptin® SC and trastuzumab emtansine: Kadcyla®, recommendations in Risk Minimisation materials and formulary advice should be followed when prescribing, dispensing and administering the product.
     
    Link  NICE TA34: Breast cancer - trastuzumab
    Link  NICE TA208: Gastric cancer (HER2-positive metastatic) - trastuzumab
    Link  NICE TA257: in combination with an aromatase inhibitor for HER2 positive metastatic breast cancer
    Link  NICE TA509: Pertuzumab with trastuzumab and docetaxel for treating HER2-positive breast cancer
       
    Cytotoxic Drug Trastuzumab emtansine (Kadcyla®)
    View adult BNF View SPC online View childrens BNF
    Restricted Drug Restricted
    Red
    High Cost Medicine

    NUH only
    Infusion

    • Approved in accordance with NICE TA458 for treating HER2-positive advanced breast cancer after trastuzumab and a taxane
    • Approved in accordance with the National Cancer Drugs Fund List and then NICE TA632 for adjuvant treatment of HER2-positive early breast cancer

    **Care required**
    To minimise the risk of errors due to the similarity of the product name Kadcyla® (trastuzumab emtansine) with that of Herceptin® IV (trastuzumab) and Herceptin® SC (trastuzumab) the recommendations in the Risk Minimisation Plan educational material from the manufacturer should be followed when prescribing, dispensing and administering the product

     
    Link  Link to reviews
    Link  NICE TA458:Trastuzumab emtansine for treating HER2-positive advanced breast cancer after trastuzumab and a taxane
    Link  NICE TA632:Trastuzumab emtansine for adjuvant treatment of HER2-positive early breast cancer
       
    08.01.05  Expand sub section  Tretinoin
    Tretinoin (Vesanoid®)
    View adult BNF View SPC online View childrens BNF
    Formulary
    Red
    Capsule
  • Also known as "All Trans Retinoic Acid" (ATRA). 
  •    
    08.01.05  Expand sub section  Vismodegib
    Cytotoxic Drug Vismodegib (Erivedge®)
    View adult BNF View SPC online View childrens BNF
    Restricted Drug Restricted
    Red
    High Cost Medicine
    Cancer Drugs Fund

    Capsule
    Only approved in accordance with the National Cancer Drugs Fund List for the treatment of locally advanced or metastatic Basal Cell Carcinoma. Was removed from the CDF list on 22nd January 2018. 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.
    SFH: Confirm funding by contacting the HCD Team on 4660
    Note: Patient, prescriber, and supplying pharmacy must comply with the manufacturer’s pregnancy prevention programme

    NICE TA489 states that vismodegib is not recommended for treating symptomatic metastatic basal cell carcinoma, or locally advanced basal cell carcinoma that is inappropriate for surgery or radiotherapy, in adults.

     
    Link  Link to reviews
    Link  NICE TA489: Vismodegib for treating basal cell carcinoma
       
     ....
     Non Formulary Items
    Elotuzumab  (Empliciti®)

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Grey
  • No formal submission (NUH DTC April 2017)
  •  
    Cytotoxic Drug  Irinotecan hydrochloride trihydrate  (Onivyde®)
    (pegylated liposomal)

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Grey
    Not recommended for treating pancreatic cancer after gemcitabine in adults as per TA440
     
    Mitotane  (Lysodren®)

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Red
     
    Necitumumab  (Portrazza®)

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Grey
    High Cost Medicine
    No formal submission (APC May 15)
    Link  NICE TA411: Necitumumab for untreated advanced or metastatic squamous non-small-cell lung cancer
     
    Olaratumab  (Lartruvo®)

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Grey
    High Cost Medicine

    Infusion
    NUH: Was approved, in accordance with NICE TA465 and the Cancer Drugs Fund, in combination with doxorubicin for treating advanced soft tissue sarcoma in adults.

    January 2019 - In line with EMA advice no new patients should start treatment with olaratumab.

    June 2019 - NICE guidance has been withdrawn because olaratumumab (Lartruvo®) no longer has a marketing authorisation.

     
    Porfimer Sodium  (Photofrin ®)

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Grey
    Link  Link to reviews
     
    Ramucirumab  (Cyramza®)

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Grey
    High Cost Medicine
    No formal submission
    Link  NICE TA403:Ramucirumab for previously treated locally advanced or metastatic non-small-cell lung cancer
     
    Rociletinib

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Grey
    No formal assessment (APC Nov 2015)
     
    Sonidegib  (Odomzo®)

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Grey
    No formal assessment
     
    Temoporfin  (Foscan®)

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Grey
     
    Cytotoxic Drug  Vandetanib  (Caprelsa®)

    View adult BNF View SPC online View childrens BNF
    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