Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
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Notes: |
For patient information about chemotherapy and chemotherapy regimens, please see the Macmillan cancer support website:
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Chapter Links... |
NICE therapeutic topic: Chemotherapy dose standardisation |
Details... |
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Other antineoplastic drugs |
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Amsacrine |
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Arsenic trioxide |
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Bevacizumab |
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Bexarotene |
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Bortezomib |
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Brentuximab vedotin |
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Cetuximab |
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Crisantaspase |
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Dacarbazine and Temozolomide |
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Erlotinib |
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Hydroxycarbamide |
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Imatinab |
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Ipilimumab |
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Mitotane |
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Panitumumab |
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Pentostatin |
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Platinum compounds |
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Porfimer sodium and temoporfin |
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Procarbazine |
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Protein kinase inhibitors |
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Abemaciclib (Verzenios®)
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Formulary

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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
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NICE TA563:Abemaciclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer
NICE TA579: Abemaciclib with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy
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Afatinib (Giotrif®)
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Restricted
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Tablets Approved in accordance with NICE TA310 for NSCLC
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Link to reviews
NICE TA310: Afatinib for non-small-cell lung cancer
SFH: Afatinib protocol in Timely trial
SFHT: Afatinib protocol in NSCLC
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Brigatinib (Alunbrig®)
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Restricted
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Tablets
Available at NUH only:
- Approved as per NICE TA571 for treating ALK-positive advanced non-small cell lung cancer after crizotinib.
- Approved in accordance with the National Cancer Drugs Fund for treating ALK-positive advanced non-small-cell lung cancer that has not been previously treated with an ALK inhibitor
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NICE TA571: Brigatinib for treating ALK-positive advanced non-small-cell lung cancer after crizotinib
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Cabozantinib (Cometriq®)
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Restricted
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Capsule
NUH: Approved in accordance with NICE TA516 for treating medullary thyroid cancer.
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Link to reviews
NICE TA516: Cabozantinib for treating medullary thyroid cancer
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Crizotinib (Xalkori®)
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Restricted
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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.
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Link to reviews
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
SFH: Crizotinib regimen in NSCLC
SFH: Exalt3 trial
MHRA: risk of cardiac failure with crizotinib
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Dasatinib (Sprycel®)
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Restricted

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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
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Link to reviews
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
SFHT Dasatinib regimen in CML
SFHT Dasatinib regimen in Spirit trial
UKMI Q&A: Which medicines require extra care when switching between liquid and tablet/capsule formulations?
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Everolimus (Afinitor®)
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Restricted

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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
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Link to reviews
NICE TA348: Preventing Rejection in Liver Transplant
NICE TA421:Everolimus with exemestane in advanced breast cancer after endocrine therapy
NICE TA432:Everolimus 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
NUH Drugs and Therapeutics Website
SFH Everolimus Regimen for Renal Cancer
SFH Everolimus-Exemestane in breast cancer
SFH: Everolimus in Manta trial in breast cancer
SFH: Everolimus in Zebra trial
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Everolimus (Votubia®)
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Restricted

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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.
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Everolimus (Votubia®) for treatment of angiomyolipomas associated with tuberous sclerosis
Everolimus for refractory focal onset seizures associated with tuberous sclerosis complex (ages 2 years and above)
Everolimus for subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex
Link to reviews
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Gefitinib
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Restricted
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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.
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Link to reviews
NICE TA192: Lung cancer (non-small-cell, first line) - gefitinib
NICE TA374: Erlotinib and gefitinib for treating non-small-cell lung cancer
SFH Gefitinib regimen in Lung cancer (NSCLC)
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Gilteritinib (Xospata®)
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Restricted
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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.
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NICE TA642: Gilteritinib for treating relapsed or refractory acute myeloid leukaemia
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Imatinib
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Restricted
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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
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SFH: Imatinib NICE approved protocol (Haematology)
SFH: Imatinib CDF approval required protocol (Haematology)
SFH: Imatinib in GIST (Oncology)
SFH: Imatinib in SPIRIT protocol
Link to reviews
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
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Lapatinib (Tyverb®)
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Restricted
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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.
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Link to reviews
NICE TA257: Lapatinib in HER-2 positive metastatic breast cancer
NUH Drugs and Therapeutics Website
SFH oral chemotherapy regimens
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Larotrectinib (Vitrakvi®)
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Restricted

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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.
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NICE TA630: Larotrectinib for treating NTRK fusion-positive solid tumours
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Nilotinib (Tasigna®)
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Restricted
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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
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Link to reviews
NICE TA425: Dasatinib, nilotinib and high dose imatinib for CML
NICE TA425:Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia
NICE TA426: Dasatinib, nilotinib and imatinib for first line treatment of CML
NICE TA426:Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia
SFH:nilotinib regimen in CML refractory/intolerant to imatinib
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Osimertinib (Tagrisso®)
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Restricted
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Tablet
- Approved in accordance with NICE TA653 for treating EGFR T790M mutation-positive advanced non-small-cell lung cancer
- Approved in accordance with NICE TA654 for untreated EGFR mutation-positive non-small-cell lung cancer
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NICE TA653: Osimertinib for treating EGFR T790M mutation-positive advanced non-small-cell lung cancer
NICE TA654: Osimertinib for untreated EGFR mutation-positive non-small-cell lung cancer
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Pazopanib (Votrient®)
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Restricted
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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
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Link to reviews
NICE TA 215: Pazopanib in renal cell cancer
SFH Pazopanib Regimen in renal cancer
SFH: Star trial protocol in renal cancer
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Regorafenib (Stivarga® )
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Restricted
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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
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Link to reviews
NICE TA488:Regorafenib for previously treated unresectable or metastatic gastrointestinal stromal tumours
NICE TA555: Regorafenib for previously treated advanced hepatocellular carcinoma
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Sorafenib (Nexavar®)
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Restricted
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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).
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Link to reviews
NICE TA474: Sorafenib for treating advanced hepatocellular carcinoma
NICE TA535: Sorafenib for treating differentiated thyroid cancer after radioactive iodine.
NUH Drugs and Therapeutics Website
SFH Sorafenib Regimen for Hepatic Cancer
SFH Sorafenib Regimen for Renal Cancer
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Sunitinib (Sutent®)
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Restricted

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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)
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Link to reviews
NICE TA169: Renal cell carcinoma - sunitinib
NICE TA179: Gastrointestinal stromal tumours - sunitinib
NICE TA449:Everolimus and sunitinib for treating unresectable or metastatic neuroendocrine tumours in people with progressive disease
SFH Sunitinib regimen for renal cancer
SFH: Sunitinib regimen for pancreatic cancer
SFH: Star trial protocol in renal cancer
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Temsirolimus (Torisel®)
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Restricted

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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).
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NUH Drugs and Therapeutics Website
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Vemurafenib (Zelboraf®)
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Restricted
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Tablets- NUH only NUH: Approved for use in oncology in accordance with NICE TA269
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Link to reviews
MHRA: Risk of potentiation of radiation toxicity with vemurafenib
NICE TA269: Vemurafenib for treating malignant melanoma
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Entrectinib (Rozlytrek ®)
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Restricted

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Capsule
Available at NUH only:
- Approved in accordance with NICE TA643, for the treatment of ROS1-positive advanced non-small-cell lung cancer. Funding available from the Cancer Drugs fund until routine commisioning.
- Approved in adults and children over 12 years old in accordance with NICE TA644 for treating NTRK fusion-positive solid tumours
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NICE TA643: Entrectinib for treating ROS1-positive advanced non-small-cell lung cancer
NICE TA644: Entrectinib for treating NTRK fusion-positive solid tumours
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Taxanes |
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Topoisomerase I inhibitors |
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Trabectedin |
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Trastuzumab |
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Tretinoin |
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Vismodegib |
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Non Formulary Items |
Vandetanib (Caprelsa®)

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Non Formulary
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Tablets
Removed from the CDF list on 11th February 2019. Remains on formulary for patients with funding approved prior to this date. |
Link to reviews
Patient Alert Card
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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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Cancer Drugs Fund
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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 |

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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. |

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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. |

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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. |

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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 |

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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. |

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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. |

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