Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
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Chapter Links... |
Cancer Drug Fund List |
Northern Cancer Alliance |
Northern England Clinical Networks Palliative and End of Life Care Guidelines |
Details... |
08.01.05 |
Other antineoplastic drugs |
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08.01.05 |
Amsacrine |
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CDK inhibitors |
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Arsenic trioxide |
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Bevacizumab |
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Bexarotene |
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08.01.05 |
Bortezomib |
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08.01.05 |
Brentuximab vedotin |
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08.01.05 |
Cetuximab |
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08.01.05 |
Dacarbazine and Temozolomide |
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08.01.05 |
Erlotinib |
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Hydroxycarbamide |
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08.01.05 |
Imatinab |
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08.01.05 |
Ipilimumab |
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08.01.05 |
Mitotane |
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08.01.05 |
Panitumumab |
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08.01.05 |
Pentostatin |
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08.01.05 |
Platinum compounds |
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08.01.05 |
Porfimer sodium and temoporfin |
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08.01.05 |
Procarbazine |
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08.01.05 |
Protein kinase inhibitors |
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Afatinib
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Formulary
![High Cost Medicine](images/HCDicon.gif)
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- 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.
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NICE TA310: Afatinib for treating epidermal growth factor receptor mutation-positive locally advanced or metastatic non-small-cell lung cancer
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Axitinib (Inlyta®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
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- Approved as treatment for adults with advanced renal cell carcinoma when tyrosine kinase inhibitors or cytokines have not worked in line with NICE.
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MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
NICE TA333: Axitinib for treating advanced renal cell carcinoma after failure of prior systemic treatment
NICE TA645: Avelumab with axitinib for untreated advanced renal cell carcinoma
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Bosutinib (Bosulif®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
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- 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.
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NICE TA401: Bosutinib for previously treated chronic myeloid leukaemia
MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation
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Brigatinib (Alunbrig®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
![NHS England](images/NHSE.gif)
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- 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
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NICE TA571: Brigatinib for treating ALK-positive advanced non-small-cell lung cancer after crizotinib
NICE TA670: Brigatinib for ALK-positive advanced non-small-cell lung cancer that has not been previously treated with an ALK inhibitor
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Cabozantinib (Cometriq®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
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- 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
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NICE TA849: Cabozantinib for previously treated advanced hepatocellular carcinoma
NICE TA 542: Cabozantinib for untreated advanced renal cell carcinoma
NICE TA463 Cabozantinib for previously treated advanced renal cell carcinoma
NICE TA516: Cabozantinib for treating medullary thyroid cancer
MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
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Ceritinib
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Formulary
![High Cost Medicine](images/HCDicon.gif)
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- 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
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NICE TA395: Ceritinib for previously treated anaplastic lymphoma kinase positive non-small-cell lung cancer
NICE TA500: Ceritinib for untreated ALK-positive non-small-cell lung cancer
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Crizotinib
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Formulary
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- Approved in accordance with NICE and NHS England Commissioning Policy.
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NICE TA406: Crizotinib for untreated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer
NICE TA422: Crizotinib for previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer
NICE TA529: Crizotinib for treating ROS1-positive advanced non-small-cell lung cancer
MHRA Drug Safety Update (Nov 2015): Crizotinib (Xalkori▼): risk of cardiac failure
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Dabrafenib (Tafinlar®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
![NHS England](images/NHSE.gif)
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- 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
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NICE TA321: Dabrafenib for treating unresectable or metastatic BRAF V600 mutation‑positive melanoma
NICE TA396: Trametinib in combination with dabrafenib for treating unresectable or metastatic melanoma
NICE TA544: Dabrafenib with trametinib for adjuvant treatment of resected BRAF V600 mutation-positive melanoma
NICE TA898: Dabrafenib plus trametinib for treating BRAF V600 mutation-positive advanced non-small-cell lung cancer
NICE TA977: Dabrafenib with trametinib for treating BRAF V600E mutation-positive glioma in children and young people aged 1 year and over
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Dasatinib (Sprycel®)
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Formulary
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- Approved for use in accordance with NICE and NHS EnglandCommissioning Policy
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NICE TA425: Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia
NICE TA426: Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia
MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation
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Encorafenib (Braftovi®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
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- 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
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NICE TA562: Encorafenib with binimetinib for unresectable or metastatic BRAF V600 mutation-positive melanoma
NICE TA668: Encorafenib plus cetuximab for previously treated BRAF V600E mutation-positive metastatic colorectal cancer
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Everolimus (Afinitor®, Votubia®)
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Formulary
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- 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
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Clinical Commissioning Policy Statement: Everolimus (Votubia®) for treatment of angiomyolipomas associated with tuberous sclerosis
Clinical Commissioning Policy: Everolimus for subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex
NICE TA348: Everolimus for preventing organ rejection in liver transplantation
NICE TA421: Everolimus with exemestane for treating advanced breast cancer after endocrine therapy
NICE TA432: Everolimus (Afinitor) for advanced renal cell carcinoma after previous treatment
NICE TA449 Everolimus and sunitinib for treating unresectable or metastatic neuroendocrine tumours in people with progressive disease
NICE TA481: Immunosuppressive therapy for kidney transplant in adults
NICE TA482: Immunosuppressive therapy for kidney transplant in children and young people
NICE TA498: Lenvatinib with everolimus for previously treated advanced renal cell carcinoma
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Gefitinib
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Formulary
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- Approved for first line use in locally advanced or metastatic NSCLC in line with NICE.
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NICE TA192: Lung cancer (non-small-cell, first line) - gefitinib
NICE TA374: Erlotinib and gefitinib for treating non-small-cell lung cancer that has progressed after prior chemotherapy
MHRA Drug Safety Update (May 2012): Epidermal growth factor receptor (EGFR) inhibitors: serious cases of keratitis and ulcerative keratitis
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Ibrutinib (Imbruvica®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
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- 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
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NICE TA429: Ibrutinib for previously treated chronic lymphocytic leukaemia and untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation
NICE TA502: Ibrutinib for treating relapsed or refractory mantle cell lymphoma
NICE TA795: Ibrutinib for treating Waldenstrom’s macroglobulinaemia
NICE TA891: Ibrutinib with venetoclax for untreated chronic lymphocytic leukaemia
MHRA Drug Safety Update (August 2017): Ibrutinib (Imbruvica▼): reports of ventricular tachyarrhythmia; risk of hepatitis B reactivation and of opportunistic infections
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Imatinib
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Formulary
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- 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.
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NICE TA209: Imatinib for the treatment of unresectable and/or metastatic gastrointestinal stromal tumours
NICE TA326: Imatinib for the adjuvant treatment of gastrointestinal stromal tumours
NICE TA425: Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia
NICE TA426: Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia
NICE TA70: Guidance on the use of imatinib for chronic myeloid leukaemia
NICE TA86: Imatinib for the treatment of unresectable and/or metastatic gastro-intestinal stromal tumours
MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation
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Lapatinib (Tyverb®)
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Formulary
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NICE TA257: in combination with an aromatase inhibitor for HER2 positive metastatic breast cancer
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Lenvatinib (Kisplyx®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
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- 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
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NICE TA 535: Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine
NICE TA 551: Lenvatinib for untreated advanced hepatocellular carcinoma
NICE TA498: Lenvatinib with everolimus for previously treated advanced renal cell carcinoma
MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
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Mobocertinib
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Formulary
![High Cost Medicine](images/HCDicon.gif)
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NICE TA855: Mobocertinib for treating EGFR exon 20 insertion mutation-positive advanced non-small-cell lung cancer after platinum-based chemotherapy
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Nilotinib (Tasigna®)
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Formulary
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- Approved for the first-line treatment of adults with chronic phase Philadelphia-chromosome-positive CML in line with NICE and NHS Commissioning Policy
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NICE TA425: Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia
NICE TA426: Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia
MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation
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Nintedanib
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Formulary
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- 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
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NICE TA347: Recurrent non-small-cell lung cancer
NICE TA379: Nintedanib for treating idiopathic pulmonary fibrosis
NICE TA747 Nintedanib for treating progressive fibrosing interstitial lung diseases
NICE TA864: Nintedanib for treating idiopathic pulmonary fibrosis when forced vital capacity is above 80% predicted
MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
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Pazopanib (Votrient®)
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Formulary
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- Approved for advanced renal cell carcinoma in line with NICE
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NICE TA215: Pazopanib in renal cell cancer
MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
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Pemigatinib (Pemaryze®)
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Formulary
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- 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
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NICE TA722: Pemigatinib for treating relapsed or refractory advanced cholangiocarcinoma with FGFR2 fusion or rearrangement
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Ponatinib (Iclusig®)
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Formulary
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- 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
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NICE TA451 Ponatinib for treating chronic myeloid leukaemia and acute lymphoblastic leukaemia
MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
MHRA Drug Safety Update (October 2018): Ponatinib (Iclusig▼): reports of posterior reversible encephalopathy syndrome
MHRA Drug Safety Update (April 2017): Ponatinib (Iclusig▼): risk of vascular occlusive events—updated advice on possible dose reduction
MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation
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Regorafenib (Stivarga® )
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Formulary
![High Cost Medicine](images/HCDicon.gif)
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- 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.
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NICE TA 488: Regorafenib for previously treated unresectable or metastatic gastrointestinal stromal tumours
NICE TA555: Regorafenib for previously treated advanced hepatocellular carcinoma
NICE TA866: Regorafenib for previously treated metastatic colorectal cancer
MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
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Ruxolitinib
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Formulary
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- 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
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NICE TA386: Ruxolitinib for treating disease-related splenomegaly or symptoms in adults with myelofibrosis
NICE TA921: Ruxolitinib for treating polycythaemia vera
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Sorafenib (Nexavar®)
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Formulary
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- 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
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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)
NICE TA 535: Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine
NICE TA474 Sorafenib for treating advanced hepatocellular carcinoma
MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
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Sunitinib (Sutent®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
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- 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
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NICE TA169: Sunitinib for the first-line treatment of advanced and/or metastatic renal cell carcinoma
NICE TA179: Sunitinib for the treatment of gastrointestinal stromal tumours
NICE TA449 Everolimus and sunitinib for treating unresectable or metastatic neuroendocrine tumours in people with progressive disease
MHRA Drug Safety Update (January 2011): Bevacizumab and sunitinib: risk of osteonecrosis of the jaw
MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
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Temsirolimus (Torisel®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
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Trametinib
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Formulary
![High Cost Medicine](images/HCDicon.gif)
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- 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
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NICE TA396: Trametinib in combination with dabrafenib for treating unresectable or metastatic melanoma
NICE TA544: Dabrafenib with trametinib for adjuvant treatment of resected BRAF V600 mutation-positive melanoma
MHRA Drug Safety Update (March 2016) Trametinib (Mekinist▼): risk of gastrointestinal perforation and colitis
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Tucatinib (Tukysa®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
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- 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
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NICE TA786: Tucatinib with trastuzumab and capecitabine for treating HER2-positive advanced breast cancer after 2 or more anti-HER2 therapies
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Vemurafenib
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Formulary
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- Approved melanoma (BRAF V600 mutation positive, unresectable metastatic) in line with NICE.
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NICE TA269: Vemurafenib for treating malignant melanoma
NICE TA414: Cobimetinib in combination with vemurafenib for treating unresectable or metastatic BRAF V600 mutation-positive melanoma
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Zanubrutinib (Brukinsa 80mg capsules®)
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Formulary
![High Cost Medicine](images/HCDicon.gif)
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NICE TA833: Zanubrutinib for treating Waldenstrom’s macroglobulinaemia
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08.01.05 |
Taxanes |
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08.01.05 |
Topoisomerase I inhibitors |
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08.01.05 |
Trabectedin |
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08.01.05 |
Trastuzumab |
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08.01.05 |
Tretinoin |
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08.01.05 |
Vismodegib |
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Key |
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Cytotoxic Drug
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Controlled Drug
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High Cost Medicine
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NHS England |
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Homecare |
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CCG |
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Traffic Light Status Information
Status |
Description |
![Red](images/TrafficLightsRedV2.gif)
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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](images/TrafficLightsAmberV2.gif)
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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](images/TrafficLightsGreenPlus.gif)
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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](images/TrafficLightsGreenV2.gif)
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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](images/TrafficLightsBlackV2.gif)
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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](images/TrafficLightsBrownV2.gif)
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UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review. |
![Not Recomended](images/TrafficLightsBlueNR.gif)
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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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