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 Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
Chapter Links...
Link   Cancer Drug Fund List
Link   Northern Cancer Alliance
Link   Northern England Clinical Networks Palliative and End of Life Care Guidelines
 Details...
08.01.05  Expand sub section  Other antineoplastic drugs
08.01.05  Expand sub section  Amsacrine
08.01.05  Expand sub section  CDK inhibitors
08.01.05  Expand sub section  Arsenic trioxide
08.01.05  Expand sub section  Bevacizumab to top
08.01.05  Expand sub section  Bexarotene
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  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
Afatinib
View adult BNF View SPC online View childrens BNF 		Formulary
Red
High Cost Medicine
NHS England

  • Approved as a possible treatment for adults with locally advanced or metastatic non-small-cell lung cancer if their cancer tests positive for the epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation and they have not had an EGFR-TK inhibitor before NICE and additional NHS England criteria.

 
Link  NICE TA310: Afatinib for treating epidermal growth factor receptor mutation-positive locally advanced or metastatic non-small-cell lung cancer
 
Axitinib  (Inlyta®)
View adult BNF View SPC online View childrens BNF 		Formulary
Red
High Cost Medicine
NHS England
  • Approved as treatment for adults with advanced renal cell carcinoma when tyrosine kinase inhibitors or cytokines have not worked in line with NICE.

 

 
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
Link  NICE TA333: Axitinib for treating advanced renal cell carcinoma after failure of prior systemic treatment
Link  NICE TA645: Avelumab with axitinib for untreated advanced renal cell carcinoma
 
Bosutinib (Bosulif®)
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Red
High Cost Medicine
NHS England
  • Approved as an option for the treatment of chronic, accelerated blast phase Philidephia chromosome positive chronic myeloid leukaemia in adults when they have previously had 1 or more tyrosine kinase inhibitor and imatinib, nilotinib and dasatanib are not appropriate in line with NICE.
 
Link  NICE TA401: Bosutinib for previously treated chronic myeloid leukaemia
Link  MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation
 
Cytotoxic Drug Brigatinib (Alunbrig®)
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Red
High Cost Medicine
NHS England
BlueTeq
  • Approved for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults who have already had crizotinib in line with NICE.
  • Approved for treating ALK-positive advanced non-small-cell lung cancer that has not been previously treated with an ALK inhibitor in line with NICE
 
Link  NICE TA571: Brigatinib for treating ALK-positive advanced non-small-cell lung cancer after crizotinib
Link  NICE TA670: Brigatinib for ALK-positive advanced non-small-cell lung cancer that has not been previously treated with an ALK inhibitor
 
Cabozantinib (Cometriq®)
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Red
High Cost Medicine
NHS England
  • Approved for use in the treatment of renal cell carcinoma in line with NICE and NHS England Commissioning Policy
  • Approved for the treatment of medullary thyroid cancer in line with NICE and NHS England Commissioning Policy
  • Approved for use in untreated advanced renal cell carcinoma in line with NICE and NHS England Commissioning Policy
  • Approved with nivolumab (Opdivo) for untreated advanced renal cell carcinoma in adults in line with NICE
 
Link  NICE TA463 Cabozantinib for previously treated advanced renal cell carcinoma
Link  NICE TA516: Cabozantinib for treating medullary thyroid cancer
Link  NICE TA542: Cabozantinib for untreated advanced renal cell carcinoma
Link  NICE TA849: Cabozantinib for previously treated advanced hepatocellular carcinoma
Link  NICE TA964: Cabozantinib with nivolumab for untreated advanced renal cell carcinoma
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Ceritinib
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Red
High Cost Medicine
NHS England
  • Approved for use in previously treated anaplastic lymphoma kinase positive non-small-cell-lung cancer in line with NICE and NHS England Commissioning Policy.
  • Approved for untreated ALK-positive non-small-cell lung cancer in line with NICE and NHS England Commissioning Policy
 
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
 
Crizotinib
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Red
High Cost Medicine
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
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  MHRA Drug Safety Update (Nov 2015): Crizotinib (Xalkori▼): risk of cardiac failure
 
Dabrafenib  (Tafinlar®)
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Red
High Cost Medicine
NHS England
BlueTeq
  • Approved for the treatment of unresectable or metastatic BRAF V600 mutation-positive melanoma in line with NICE 
  • Approved for the treatment of BRAF-mutated anaplastic thyroid cancer (ATC) in line with NHSE Specialised Commissioning Policy
  • Approved with trametinib for treating BRAF V600 mutation-positive advanced non-small-cell lung cancer in adults in line with NICE
  • Approved with trametinib (Spexotras) for treating BRAF V600E mutation-positive glioma in children and young people aged 1 year and over in line with NICE

 

 

 
Link  NICE TA321: Dabrafenib for treating unresectable or metastatic BRAF V600 mutation‑positive 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
Link  NICE TA898: Dabrafenib plus trametinib for treating BRAF V600 mutation-positive advanced non-small-cell lung cancer
Link  NICE TA977: Dabrafenib with trametinib for treating BRAF V600E mutation-positive glioma in children and young people aged 1 year and over
 
Dasatinib (Sprycel®)
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Red
  • Approved for use in accordance with NICE and NHS EnglandCommissioning Policy
 
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  MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation
 
Cytotoxic Drug Encorafenib (Braftovi®)
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Red
High Cost Medicine
NHS England

  • Approved in combination with binimetinib for treating unresectable or metastatic BRAF V600 mutation-positive melanoma in adults in line with NICE

  • Approved in combination with cetuximab (Erbitux) for treating BRAF V600E mutation-positive metastatic colorectal cancer in adults who have had previous systemic treatment

 
Link  NICE TA562: Encorafenib with binimetinib for unresectable or metastatic BRAF V600 mutation-positive melanoma
Link  NICE TA668: Encorafenib plus cetuximab for previously treated BRAF V600E mutation-positive metastatic colorectal cancer
 
Everolimus (Afinitor®, Votubia®)
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Red
  • 2.5mg, 5mg & 10mg tablets (Votubia®)
    • Approved for the treatment of angiomyolipomas associated with tuberous sclerosis in accordnace with NHS England Commissioning Policy.
    • Approved for the treatment of subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex in accordnace line with NHS England Commissioning Policy.
  • 5mg & 10mg tablets (Afinitor®)
    • Approved, in combination with exemestane, for the treatment of advanced human epidermal growth factor receptor 2 (HER2)-negative, hormone-receptor-positive breast cancer in postmenopausal women in accordance with NICE.
    • Approved for the treatment of advanced breast cancer after endocrine therapy in line with NICE.
    • Approved for the treatment of advanced renal cell carcinoma after previous treatment in line with NICE.
    • Approved for the treatment of unresectable or metastatic neuroendocrine tumours in people with progressive disease in line with NICE and NHS England Commissioning Policy
 
Link  Clinical Commissioning Policy Statement: Everolimus (Votubia®) for treatment of angiomyolipomas associated with tuberous sclerosis
Link  Clinical Commissioning Policy: Everolimus for subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex
Link  NICE TA348: Everolimus for preventing organ rejection in liver transplantation
Link  NICE TA421: Everolimus with exemestane for treating advanced breast cancer after endocrine therapy
Link  NICE TA432: Everolimus (Afinitor) 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  NICE TA481: Immunosuppressive therapy for kidney transplant in adults
Link  NICE TA482: Immunosuppressive therapy for kidney transplant in children and young people
Link  NICE TA498: Lenvatinib with everolimus for previously treated advanced renal cell carcinoma
 
Gefitinib
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Red
  • Approved for first line use in locally advanced or metastatic NSCLC in line with NICE.
 
Link  NICE TA192: Lung cancer (non-small-cell, first line) - gefitinib
Link  NICE TA374: Erlotinib and gefitinib for treating non-small-cell lung cancer that has progressed after prior chemotherapy
Link  MHRA Drug Safety Update (May 2012): Epidermal growth factor receptor (EGFR) inhibitors: serious cases of keratitis and ulcerative keratitis
 
Ibrutinib (Imbruvica®)
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Red
High Cost Medicine
NHS England
  • Approved for previously treated chronic lymphocytic leukaemia and untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation in line with NICE and NHS Commissioning Policy.
  • Approved for treating relapsed or refractory mantle cell lymphoma in line with NICE and NHS England Commissioning Policy if:
    • they have had only 1 previous line of therapy
  • Approved for untreated chronic lymphocytic leukaemia in line with NICE
 
Link  NICE TA429: Ibrutinib for previously treated chronic lymphocytic leukaemia and untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation
Link  NICE TA502: Ibrutinib for treating relapsed or refractory mantle cell lymphoma
Link  NICE TA795: Ibrutinib for treating Waldenstrom’s macroglobulinaemia
Link  NICE TA891: Ibrutinib with venetoclax for untreated chronic lymphocytic leukaemia
Link  MHRA Drug Safety Update (August 2017): Ibrutinib (Imbruvica▼): reports of ventricular tachyarrhythmia; risk of hepatitis B reactivation and of opportunistic infections
 
Imatinib
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Red
NHS England
  • Approved for the first-line management of people with KIT (CD117)- positive unresectable and/or KIT (CD117)-positive metastatic gastrointestinal stromal tumours (GISTs) in line with NICE. 
  • Approved for the adjuvant treatment of gastrointestinal stromal tumours (GISTs) after surgery when there is a high risk relapse of tumour NICE. 
  • Approved for Philadelphia-chromosome-positive CML in the accelerated phase or with blast crisis in line with NICE.
  • A standard-dose imatinib is recommended as an option for the first-line treatment of adults with chronic phase Philadelphia-chromosomepositive CML in line with NICE.
 
Link  NICE TA209: Imatinib for the treatment of unresectable and/or metastatic gastrointestinal stromal tumours
Link  NICE TA326: Imatinib for the adjuvant treatment of gastrointestinal stromal tumours
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 TA70: Guidance on the use of imatinib for chronic myeloid leukaemia
Link  NICE TA86: Imatinib for the treatment of unresectable and/or metastatic gastro-intestinal stromal tumours
Link  MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation
 
Lapatinib (Tyverb®)
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Red 		 
Link  NICE TA257: in combination with an aromatase inhibitor for HER2 positive metastatic breast cancer
 
Lenvatinib (Kisplyx®)
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Red
High Cost Medicine
NHS England
  • 4mg & 10mg capsules
  • Approved with everolimus for previously treated advanced renal cell carcinoma in line with NICE
  • Approved to the treatment of differentiated thyroid cancer after radioactive iodine in line with NICE
  • Approved for untreated advanced hepatocellular carcinoma in line with NICE
 
Link  NICE TA 535: Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine
Link  NICE TA 551: Lenvatinib for untreated advanced hepatocellular carcinoma
Link  NICE TA498: Lenvatinib with everolimus for previously treated advanced renal cell carcinoma
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Mobocertinib
View adult BNF View SPC online View childrens BNF 		Formulary
Red
High Cost Medicine
NHS England 		 
Link  NICE TA855: Mobocertinib for treating EGFR exon 20 insertion mutation-positive advanced non-small-cell lung cancer after platinum-based chemotherapy
 
Nilotinib (Tasigna®)
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Red
NHS England
  • Approved for the first-line treatment of adults with chronic phase Philadelphia-chromosome-positive CML in line with NICE and NHS Commissioning Policy
 
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  MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation
 
Nintedanib
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Red
  • Approved for the treatment of locally advanced, metastatic or locally recurrent non-small-cell lung cancer who have previously been treated been with first-line chemotherapy in accordance with NICE.
  • Approved for treating idiopathic pumonary fibrosis in line with NICE
 
Link  NICE TA347: Recurrent non-small-cell lung cancer
Link  NICE TA379: Nintedanib for treating idiopathic pulmonary fibrosis
Link  NICE TA747 Nintedanib for treating progressive fibrosing interstitial lung diseases
Link  NICE TA864: Nintedanib for treating idiopathic pulmonary fibrosis when forced vital capacity is above 80% predicted
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Pazopanib (Votrient®)
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Red
  • Approved for advanced renal cell carcinoma in line with NICE
 
Link  NICE TA215: Pazopanib in renal cell cancer
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Pemigatinib (Pemaryze®)
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Red
  • 4.5mg, 9mg and 13.5mg tablets
  • Approved for the treatment of relapsed or refractory advanced cholangiocarcinoma with FGFR2 fusion or rearrangement in line with NICE

 

 
Link  NICE TA722: Pemigatinib for treating relapsed or refractory advanced cholangiocarcinoma with FGFR2 fusion or rearrangement
 
Ponatinib (Iclusig®)
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Red
High Cost Medicine
  • 15mg, 30mg & 45mg film-coated tablets
  • Approved for the treatment of chronic myeloid leukaemia and acute lymphoblastic leukaemia in line with NICE and NHS England Commissioning Policy
 
Link  NICE TA451 Ponatinib for treating chronic myeloid leukaemia and acute lymphoblastic leukaemia
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
Link  MHRA Drug Safety Update (October 2018): Ponatinib (Iclusig▼): reports of posterior reversible encephalopathy syndrome
Link  MHRA Drug Safety Update (April 2017): Ponatinib  (Iclusig▼): risk of vascular occlusive events—updated advice on possible dose reduction
Link  MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation
 
Cytotoxic Drug Regorafenib (Stivarga® )
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Red
High Cost Medicine
BlueTeq
  • 40mg tablets
  • Approved for treating unresectable or metastatic gastrointestinal stromal tumours in adults whose disease has progressed on, or who are intolerant to, prior treatment with imatinib and sunitinib in line with NICE and NHS England Commissioning Policy.
  • Approved for treating advanced hepatocellular carcinoma in adults who have had sorafenib in line with NICE
  • Approved as an option for metastatic colorectal cancer in adults who have had previous treatment (including fluoropyrimidine-based chemotherapy, anti‑VEGF therapy and anti‑EGFR therapy) or when these treatments are unsuitable - in line with NICE.
 
Link  NICE TA 488: Regorafenib for previously treated unresectable or metastatic gastrointestinal stromal tumours
Link  NICE TA555: Regorafenib for previously treated advanced hepatocellular carcinoma
Link  NICE TA866: Regorafenib for previously treated metastatic colorectal cancer
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Ruxolitinib
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Red
  • Approved for the treatment of disease-related splenomegaly or symptoms in adults with primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemiaa myelofibrosis, only in people with intermediate-2 or high-risk disease in line with NICE.
  • Approved for treating polycythaemia vera in line with NICE and NHSE Specialised Commissioning guidance

 

 
Link  NICE TA386: Ruxolitinib for treating disease-related splenomegaly or symptoms in adults with myelofibrosis
Link  NICE TA921: Ruxolitinib for treating polycythaemia vera
 
Sorafenib (Nexavar®)
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Red
High Cost Medicine
  • 200mg tablets
  • Approved for treatment of advanced hepatocellular carcinoma only for people with Child-Pugh grade A liver impairment in line with NICE and NHS Commissioning Policy.
  • Approved for the treatment of differentiated thyroid cancer after radioactive iodine in line with NICE.
  • Approved as maintenance for adults with FLT3-internal tandem duplication (FLT3-ITD) acute myeloid leukaemia (AML) undergoing allogeneic haematopoietic stem cell transplantation (allo-HSCT) in line with NHS England Specialised Commissioning Policy
    • Only available at The Newcastle upon Tyne Hospitals NHS Trust
 
Link  NHS England Specialised Commissioning Policy: Sorafenib maintenance for adults with FLT3-internal tandem duplication (FLT3-ITD) acute myeloid leukaemia (AML) undergoing allogeneic haematopoietic stem cell transplantation (allo-HSCT)
Link  NICE TA 535: Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine
Link  NICE TA474 Sorafenib for treating advanced hepatocellular carcinoma
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Sunitinib  (Sutent®)
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Red
High Cost Medicine
NHS England
  • Approved for gastrointestinal stromal tumours (GISTs) in line with NICE.
  • Approved for advanced and/or metastatic renal cell carcinoma in line with NICE.
  • Sunitinib not approved for second line use in advanced and/or metastatic renal cell carcinoma NICE.
  • Approved for the treatment of unresectable or metastatic neuroendocrine tumours in people with progressive disease in line with NICE and NHS England Commissioning Policy
 
Link  NICE TA169: Sunitinib for the first-line treatment of advanced and/or metastatic renal cell carcinoma
Link  NICE TA179: Sunitinib for the treatment of gastrointestinal stromal tumours
Link  NICE TA449 Everolimus and sunitinib for treating unresectable or metastatic neuroendocrine tumours in people with progressive disease
Link  MHRA Drug Safety Update (January 2011): Bevacizumab and sunitinib: risk of osteonecrosis of the jaw
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Cytotoxic Drug Temsirolimus (Torisel®)
View adult BNF View SPC online View childrens BNF 		Formulary
Red
High Cost Medicine
Cancer Drugs Fund 		 
 
Trametinib
View adult BNF View SPC online View childrens BNF 		Formulary
Red
High Cost Medicine
NHS England
  • Approved in combination with dabrafenib for the treatment of unresectable or metastatic melanoma in line with NICE and NHS England Commissioning Policy.
  • Approved for the treatment of BRAF-mutated anaplastic thyroid cancer (ATC) in line with NHSE Specialised Commissioning Policy
 
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  MHRA Drug Safety Update (March 2016) Trametinib (Mekinist▼): risk of gastrointestinal perforation and colitis
 
Cytotoxic Drug Tucatinib (Tukysa®)
View adult BNF View SPC online View SMC online View childrens BNF 		Formulary
Red
High Cost Medicine
NHS England
  • Approved in combination with trastuzumab and capecitabine for HER2‑positive locally advanced or metastatic breast cancer in adults after 2 or more anti‑HER2 treatment therapies in line with NICE
 
Link  NICE TA786: Tucatinib with trastuzumab and capecitabine for treating HER2-positive advanced breast cancer after 2 or more anti-HER2 therapies
 
Vemurafenib
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Red
  • Approved for melanoma (BRAF V600 mutation positive, unresectable metastatic) in line with NICE.
 
Link  NICE TA269: Vemurafenib for treating malignant melanoma
Link  NICE TA414: Cobimetinib in combination with vemurafenib for treating unresectable or metastatic BRAF V600 mutation-positive melanoma
 
Cytotoxic Drug Zanubrutinib (Brukinsa®)
View adult BNF View SPC online View childrens BNF 		Formulary
Red
High Cost Medicine
NHS England
  • 80mg capsule
 
Link  NICE TA833: Zanubrutinib for treating Waldenstrom’s macroglobulinaemia
 
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  Zanubrutinib  (Brukinsa®)

View adult BNF View SPC online View childrens BNF 		Non Formulary
Black
High Cost Medicine
NHS England
  • Zanubrutinib with obinutuzumab for treating relapsed or refractory B-cell follicular lymphoma after 2 or more treatments (terminated appraisal)
Link  NICE TA978: Zanubrutinib with obinutuzumab for treating relapsed or refractory B-cell follicular lymphoma after 2 or more treatments (terminated appraisal)
  
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
Cytotoxic Drug
 Cytotoxic Drug
CD
 Controlled Drug
High Cost Medicine
 High Cost Medicine
NHSE
 NHS England
Homecare
 Homecare
CCG
 CCG

Traffic Light Status Information

Status Description

Red

 Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment. In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances. For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing.  

Amber

 Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber. If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care.  

Green plus

 Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs.  

Green

 Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care.  

Black

 NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria.   

Brown

 UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.  

Not Recomended

 NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status.  

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