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 Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
Notes:
1. Please refer to Appendix 11 of the BHT Medicines Policy for full details of policies and procedures for the prescribing, preparation and administration of chemotherapy (including intrathecal chemotherapy)

2. Use chemotherapy in accordance with NHSE National dose banding tables. For latest version see here.
 Details...
08.01.05  Expand sub section  Other antineoplastic drugs
Cytotoxic Drug Abemaciclib 50mg, 100mg, 150mg
(film-coated tablets)
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1. Prescribing by the Oncology team with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer in accordance with NICE TA 563.


2. Prescribing by the Oncology team in combination with fulvestrant for treating hormone receptor-positive, HER2-negative advanced breast cancer in accordance with NICE TA 579. CDF funded for this indication until December 2021.

 
Link  NICE TA 563: Abemaciclib with an aromatase inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer
   
Alectinib 150mg (Alecensa®)
(capsules)
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Restricted to prescribing by Oncologists only for untreated ALK-positive advanced non-small-cell lung cancer in accordance with NICE TA 536.

 
   
Atezolizumab 1200mg/20mg
(concentrate for solution for infusion)
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BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

1. Prescribing by Consultant Oncologists only for the treatment of locally advanced or metastatic urothelial cancer in accordance with NICE TA 492 and NHSE SSC 1805, November 2017. CDF funded for this indication until December 2020.

2. Restricted to prescribing by Consultant Oncologists for treating locally advanced or metastatic non-small-cell lung cancer after chemotherapy in accordance with NICE TA 520.

3. Restricted to prescribing by Oncologists only for treating locally advanced or metastatic urothelial carcinoma after platinum containing chemotherapy in accordance with NICE TA 525.

4. Restricted to prescribing by the Oncology team for the treatment of metastatic non-squamous non-small-cell lung cancer in accordance with NICE TA 584 in combination with bevacizumab, paclitaxel and carboplatin.

5. Restricted to prescribing by the Oncology team for untreated extensive-stage small-cell lung cancer in accordance with NICE TA 638 in combination with carboplatin and etoposide.

6.  Restricted to prescribing by the Oncology team for untreated PD-L1-positive, locally advanced or metastatic, triple-negative breast cancer, in accordance with NICE TA 639 in combination with nab-paclitaxel.

7. Restricted to prescribing by the Oncology team for treating advanced or unresectable hepatocellular carcinoma in accorance with NICE TA 666 in combination with bevacizumab.

 
Link  NICE TA 492: Atezolizumab for untreated locally advanced or metastatic urothelial cancer when cisplatin is unsuitable
Link  NICE TA 520: Atezolizumab for treating locally advanced or metastatic non-small-cell lung cancer after chemotherapy
Link  NICE TA 525: Atezolizumab for treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy
Link  NICE TA 584: Atezolizumab in combination for treating metastatic non-squamous non-small-cell lung cancer
Link  NICE TA 638: Atezolizumab with carboplatin and etoposide for untreated extensive-stage small-cell lung cancer
Link  NICE TA 639: Atezolizumab with nab-paclitaxel for untreated PD-L1-positive, locally advanced or metastatic, triple-negative breast cancer
Link  NICE TA 666: Atezolizumab with bevacizumab for treating advanced or unresectable hepatocellular carcinoma
   
Avelumab 200mg/10mL
(concentrate for solution for infusion)
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    • For the treatment of metastatic Merkel cell carcinoma in accordance with NICE TA 517.
    • Use with axitinib for untreated advanced renal cell carcinoma in accordance with NICE TA 645. 
 
Link  NICE TA 517: Avelumab for treating metastatic Merkel cell carcinoma
Link  NICE TA 645: Avelumab with axitinib for untreated advanced renal cell carcinoma
   
Cytotoxic Drug Axicabtagene ciocleucel (Yescarta®)
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For use at commissioned CAR-T treatment centres only in accordance with NICE TA 559 and NHSE SSC 1953. CDF funded for this indication until February 2022.

 
Link  NICE TA 559: Axicabtagene ciloleucel for treating diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma after 2 or more systemic therapies
   
Cytotoxic Drug Axitinib 1mg, 3mg, 5mg, 7mg
(tablet)
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Restricted - prescribing to be initiated by Consultant Oncologist (renal) or their SDU Lead, with continuation by all Consultant Oncologists in accordance with NICE TA 333.

 
Link  NICE TA 333: Axitinib for the treatment of advanced renal cell carcinoma after failure of prior systemic treatment
   
Binimetinib 50mg, 75mg
(hard capsules)
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BlueTeq

FOR ALL PRESCRIBING - NICE Compliance form required via Blueteq


Prescribing by the Oncology team in combination with Encorafenib for the treatment of unresectable or metastatic BRAF V600 mutation-positive melanoma in adults in accordance with NICE TA 562.

 
Link  NICE TA 562: Encorafenib with binimetinib for unresectable or metastatic BRAF V600 mutation-positive melanoma
   
Cytotoxic Drug Brigatinib 30mg, 60mg, 90mg
(film-coated tablets)
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BlueTeq

FOR ALL PRESCRIBING - NICE Compliance form required via Blueteq

Restricted - prescribing by the Oncology team;

1. for the treatment of ALK-positive advanced non-small-cell lung cancer after crizotinib in accordance with NICE TA 571.

2.  for ALK-positive advanced non-small-cell lung cancer that has not been previously treated with an ALK inhibitor in accorance with NICE TA 670.

 
Link  NICE TA 571: Brigatinib for treating ALK-positive advanced non-small-cell lung cancer after crizotinib
Link  NICE TA 670: Brigatinib for ALK-positive advanced non-small-cell lung cancer that has not been previously treated with an ALK inhibitor
   
Cytotoxic Drug Carfilzomib 10mg, 30mg, 60mg
(powder for solution for infusion)
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BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

Restricted- prescribing by Haematology team.   For previously treated multiple myeloma in accordance with NICE TA657.

 
Link  MHRA Drug Safety Update - August 2019: Carfilzomib (Kyprolis▼): reminder of risk of potentially fatal cardiac events
Link  NICE TA 657: Carfilzomib for previously treated multiple myeloma
   
Cemiplimab 350mg
(vial)
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Formulary
Red
High Cost Medicine
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BlueTeq

FOR ALL PRESCRIBING - PRIOR APPROVAL VIA BLUETEQ REQUIRED


Restricted to prescribing by consultant Oncologists for treating metastatic or locally advanced cutaneous squamous cell carcinoma in accordance with NICE TA 592


CDF funded for this indication until July 2021.

 
Link  NICE TA 592: Cemiplimab for treating metastatic or locally advanced cutaneous squamous cell carcinoma
   
Cytotoxic Drug Crizotinib 200mg,250mg (Xalkori®)
(capsule)
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BlueTeq

FOR ALL PRESCRIBING: NICE compliance form required - see link from Formulary homepage or via Blueteq. NICE compliance to be verified if form not available
Restricted - prescribing by consultant Oncologists (Lung) only, for:
1. Untreated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer in accordance with NICE TA 406
2. Previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer, in accordance with NICE TA 422 and NHSE SSC 1680.
3. For treating ROs1-positive advanced non-small-cell lung cancer in accordance with NICE TA 529. CDF funded for this indicaton until April 2023.


 

 
Link  NICE TA 422: Crizotinib for previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer
Link  NICE TA406: Crizotinib for untreated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer
   
Dacomitinib (Vizimpro®)
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FOR ALL PRESCRIBING - a completed and approved NICE compliance form, via BLUETEQ, is required.
Restricted to prescribing by the Oncology  team for the treatment of untreated EGFR mutation-positive non-small-cell lung cancer in accordance with NICE TA 595.


https://www.nice.org.uk/guidance/TA595

 
   
Daratumumab 100mg/5mL, 400mg/20mL
(concentrate for solution for infusion)
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BlueTeq

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1. Restricted to prescribing by Consultant Haematologists in accordance with NICE TA 510. CDF funded for this indication until November 2020.


2. Restricted to prescribing by Consultant Haematologists with bortezomib and deamethasone for previously treated multiple myeloma in accordance with NICE TA 573. CDF funded for this indication until January 2021.

 
Link  MHRA Drug Safety Update - August 2019: Daratumumab (Darzalex▼): risk of reactivation of hepatitis B virus
Link  NICE TA 510: Daratumumab monotherapy for treating relapsed and refractory multiple myeloma
Link  NICE TA 573: Daratumumab with bortezomib and dexamethasone for previously treated multiple myeloma
   
Cytotoxic Drug Durvalumab 120mg/2.4mL, 500mg/10mL (Imfinzi®)
(concentrate for solution for infusion)
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BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via Blueteq, is required


Restricted to prescribing by Consultant Oncologists for the treatment of locally advanced unresectable non-small-cell lung cancer after platinum-based chemoradiation in accordance with NICE TA 578. CDF funded for this indication until September 2021

 
Link  NICE TA 578: Durvalumab for treating locally advanced unresectable non-small-cell lung cancer after platinum-based chemoradiation
   
Encorafenib 50mg, 75mg
(hard capsules)
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NHS England
BlueTeq

FOR ALL PRESCRIBING - NICE Compliance form required via Blueteq

Restricted - prescribing by the Oncology team;

1. in combination with Binimetinib for the treatment of unresectable or metastatic BRAF V600 mutation-positive melanoma in adults in accordance with NICE TA 562.

2. in combination with Cetuximab for previously treated BRAF V600E mutation-positive metastatic colorectal cancer in accordance with NICE TA 668.

 
Link  NICE TA 562: Encorafenib with binimetinib for unresectable or metastatic BRAF V600 mutation-positive melanoma
Link  NICE TA 668: Encorafenib plus cetuximab for previously treated BRAF V600E mutation-positive metastatic colorectal cancer
   
Cytotoxic Drug Eribulin 0.88mg, 1.32mg
(solution for injection)
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Restricted- prescribing by consultant Oncologists (Breast). For locally advanced or metastatic breast cancer after 2 or more chemotherapy regimens in accordance with NICE TA 423 and NHSE SSC 1701.  
Link  NICE TA 423: Eribulin for treating locally advanced or metastatic breast cancer after 2 or more chemotherapy regimens
   
Cytotoxic Drug Gemtuzumab ozogamicin 5mg
(vial)
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BlueTeq

FOR ALL PRESCRIBING - NICE Compliance form required via Blueteq


Prescribing by consultant Haematologists for untreated acute myeloid leukaemia in accordance with NICE TA 545.

 
Link  NICE TA 545: Gemtuzumab ozogamicin for untreated acute myeloid leukaemia
   
Cytotoxic Drug Inotuzumab ozogamicin 1mg (Besponsa®)
(powder for concentrate for solution for infusion)
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BlueTeq

FOR ALL PRESCRIBING - NICE compliance form via BLUETEQ required - see link from Formulary homepage.


Restricted to prescribing by Haematology team. For the treatment of relapsed or refractory B-cell acute lymphoblastic leukaemia in accordance with NICE TA 541.

 
   
Ixazomib 2.3mg, 3mg, 4mg
(capsule)
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BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required. 


Restricted - Prescribing by consultant Haematologists in accordance with NICE TA 505.


CDF funded for this indication until December 2019. 

 
Link  NICE TA 505: Ixazomib with lenalidomide and dexamethasone for treating relapsed or refractory multiple myeloma
   
Lenvatinib 4mg, 10mg
(capsule)
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NHS England
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.


1. Restricted to prescribing by Oncology team in combination with everolimus for the treatment of previously treated advanced renal cell carcinoma in accordance with NICE TA 498.


2. Restricted - prescribing by Oxford University Hospitals (OUH) Consultant Oncologists for treating differentiated thyroid cancer after radioactive iodine in accordance with NICE TA 535.


3. Restricted to prescribing by Oncologists for untreated advanced hepatocellular carcinoma in accordance with NICE TA 551.

 
Link  NICE TA 498: Lenvatinib with everolimus for previously treated advanced renal cell carcinoma
   
Cytotoxic Drug Liposomal cytarabine-daunorubicin 44mg/100mg (Vyxeos®)
(powder for solution for infusion vial)
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BlueTeq

FOR ALL PRESCRIBING - NICE Compliance form required via Blueteq


Prescribing by the Haematology team for the treatment of untreated acute myeloid leukaemia in accordance with NICE TA 552.

 
Link  NICE TA 552: Liposomal cytarabine-daunorubicin for untreated acute myeloid leukaemia
   
Lutetium (177Lu) oxodotreotide (Lutathera®)
(Intravenous infusion)
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BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.


Restricted - prescribing by Oxofrd University Hospital (OUH) Consultant Oncologists. For the treatment of unresectable or metastatic neuroendocrine tumours.

 
   
Midostaurin 25mg (Rydapt®)
(capsules)
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NHS England
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required. 


Restricted to prescribing by Haematologists only for untreated acute myseloid leukaemia in accordance with NICE TA 523.

 
Link  NICE TA 523: Midostaurin for untreated acute myeloid leukaemia
   
Niraparib 100mg (Zejula®)
(capsules)
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Red
High Cost Medicine
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BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

Restricted - prescribing by Consultant Oncologists only;

1. for the maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube and peritoneal cancer in accordance with NICE TA 528.  CDF funded for this indication until 2020.

2. for maintenance treatment of advanced ovarian, fallopian tube and peritoneal cancer after response to first-line platinum-based chemotherapy in accordance with NICE TA 673.

 
Link  NICE TA 528: Niraparib for maintenance treatment of relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer
Link  NICE TA 673: Niraparib for maintenance treatment of advanced ovarian, fallopian tube and peritoneal cancer after response to first-line platinum-based chemotherapy
   
Cytotoxic Drug Nivolumab 40mg/4mL, 100mg/10mL
(concentrate for solution for infusion)
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Red
High Cost Medicine
Cancer Drugs Fund
NHS England
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

1. Restricted - prescribing by Consultant Oncologists (Melanoma) at OUH only in accordance with:
i. NICE TA 384 for treating advanced (unresectable or metastatic) melanoma and in accordance with NHS England Specialised Services Circular (SSC 1617)
ii. In combination with ipilimumab for treating advanced melanoma in accordance with NICE TA 400, Jul 16 and NHSE Letter ref 1640 from end Oct 2016.
iii. NICE TA 684 for adjuvant treatment of completely resected melanoma with lymph node involvement of metastatic disease. 

2. Restricted - prescribing initiation by Consultant Oncologists (Renal) only. For treatment of previously treated advanced renal cell carcinoma in line with NICE TA 417 and NHSE SSC 1663, Oct 16.

3. Restricted - prescribing by haematology team. For the treatment of relapsed or refractory classical Hodgkin lymphoma in adults in accordance with NICE TA 452 and NHSE SCC 1752.

4. Restricted - prescribing by Oxford University Hospitals (OUH) Consultant Oncologists. For the treatment of squamous cell carcinoma of the head and neck in accordance with NICE TA 490 and NHSE SSC 1799. CDF funded for this indication until September 2019.

5. Restricted - prescribing by Consultant Oncologists (Renal) only. For treatment of untreated advanced renal cell carcinoma in accordance with NICE TA 581.

6. Restricted - prescribing by Consultant Oncologists (Lung) only. For advanced squamous non-small-cell lung cancer after chemotherapy in accordance with NICE TA 655.

 
Link  NICE TA 384: Nivolumab for treating advanced (unresectable or metastatic) melanoma
Link  NICE TA 400: Nivolumab in combination with ipilimumab for treating advanced melanoma
Link  NICE TA 417: Nivolumab for previously treated advanced renal cell carcinoma
Link  NICE TA 452: Ibrutinib for untreated chronic lymphocytic leukaemia without a 17p deletion or TP53 mutation
Link  NICE TA 490: Nivolumab for treating squamous cell carcinoma of the head and neck after platinum-based chemotherapy
Link  NICE TA 581: Nivolumab with ipilimumab for untreated advanced renal cell carcinoma
Link  NICE TA 655: Nivolumab for advanced squamous non-small-cell lung cancer after chemotherapy
Link  NICE TA 684: Nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease
   
Cytotoxic Drug Olaparib 100mg, 150mg
(tablets)
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Formulary
Red
High Cost Medicine
Cancer Drugs Fund
BlueTeq

For all prescribing a completed and approved NICE Compliance form via blueteq is required.


Prescribing by consultant Oncologists for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer in accordance with NICE TA 598  and 620. 

 
Link  NICE TA 598. Olaparib for maintenance treatment of BRCA mutation-positive advanced ovarian, fallopian tube or peritoneal cancer after response to first-line platinum-based chemotherapy
Link  NICE TA 620 Olaparib for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer
   
Cytotoxic Drug Panobinostat 10mg, 15mg, 20mg
(capsule)
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Restricted Drug Restricted
Red
FOR ALL PRESCRIBING: NICE compliance form required - see link from Formulary homepage. NICE compliance to be verified if form not available.

Restricted - prescribing by Consultant Haematologists. For the treatment of multiple myeloma after at least 2 previous treatments in line with NICE TA 380 
Link  NICE TA 380: Panobinostat for treating multiple myeloma after at least 2 previous treatments
   
Pegaspargase 750units/ml
(solution for injection /infusion)
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Restricted Drug Restricted
Red
FOR ALL PRESCRIBING - NICE compliance form required - see link from Formulary homepage. NICE compliance to be verified if form not yet available.

Restricted - prescribing by Consultant Haematologists for acute lymphoblastic leukemia in accordance with NICE TA 408 and NHSE SSL 1675. 
Link  NICE TA 408: Pegaspargase for treating acute lymphoblastic leukaemia
   
Cytotoxic Drug Pertuzumab 420mg/14ml
(concentrate for solution for infusion)
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Restricted Drug Restricted
Red
NHS England
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.


1. Restricted - prescribing by consultant Oncologists (Breast). For neoadjuvant treatment of HER2-positive breast cancer in accordance with NICE TA 424 and NHSE SSC 1671.


2. Restricted - prescribing by Consultant Oncologists (Breast) for neoadjuvent treatment of HER2-positive breast cancer with trastuzumab and docetaxel in accordance with trastuzumab and docetaxel in accordance with NICE TA 509.


3. Prescribing by the Oncology team with intravenous trastuzumab and chemotherapy for the adjuvant treatment of human epidermal growth factor receptor 2 (HER2)-positive early stage breast cancer in adults if they have lymph node-positive disease in accordance with NICE TA 569.

 
Link  NICE TA 424: Pertuzumab for the neoadjuvant treatment of HER2-positive breast cancer
Link  NICE TA 509: Pertuzumab with trastuzumab and docetaxel for treating HER2-positive breast cancer
Link  NICE TA 569: Pertuzumab for adjuvant treatment of HER2-positive early stage breast cancer
   
Polatuzumab vedotin 140mg
(powder for solution for infusion vial)
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Formulary
Red

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

Restricted- prescribing by Haematology team. For use in accordance with Polatuzumab vedotin with rituximab and bendamustine for treating relapsed or refractory diffuse large B-cell lymphoma NICE TA 649 

 
Link  NICE TA 649: Polatuzumab vedotin with rituximab and bendamustine for treating relapsed or refractory diffuse large B-cell lymphoma
   
Cytotoxic Drug Ponatinib
(15mg, 45mg capsules)
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Red
High Cost Medicine
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required

Restricted- prescribing by haematology team.

For the treatment of CML and ALL in accordance with NICE TA 451, June 2017


 

 
Link  MHRA Drug Safety Update - October 18: Ponatinib: reports of posterior reversible encephalopathy syndrome
Link  NICE TA 451: Ponatinib for treating chronic myeloid leukaemia and acute lymphoblastic leukaemia
   
Cytotoxic Drug Regorafenib 40mg
(film-coated tablets)
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Restricted Drug Restricted
Red
High Cost Medicine
NHS England
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required. 


1. Restricted to prescribing by Consultant Oncologists for previously treated unresectable or metastatic gastrointestinal stromal tumours in accordance with NICE TA 488 and NHSE SSC 1798, Oct 17.


2. Restricted to prescribing by Oncologists for previously treated advanced hepatocellular carcinoma in accordance with NICE TA 555.

 
Link   NICE TA 488: Regorafenib for previously treated unresectable or metastatic gastrointestinal stromal tumours
Link  NICE TA 555: Regorafenib for previously treated advanced hepatocellular carcinoma
   
Cytotoxic Drug Ruxolitinib 5mg, 10mg, 15mg, 20mg
(Tablets)
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Restricted Drug Restricted
Red
High Cost Medicine
FOR ALL PRESCRIBING: NICE compliance form required - see link from Formulary homepage. NICE compliance to be verified if form not available.

Restricted- prescribing by consultant Haematologists. For treatment of disease-related splenomegaly or symptoms in adults with primary myelofibrosis in accordance with NICE TA386 
Link  NICE TA 386: Ruxolitinib for treating disease-related splenomegaly or symptoms in adults with myelofibrosis
   
Tisagenlecleucel (Kymriah®)
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Restricted Drug Restricted
Red Specialist Centre
High Cost Medicine
Cancer Drugs Fund
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.


For use at commissioned CAR-T treatment centres only:


1. For the treatment of relapsed or refractory B-cell acute lymphoblastic leukaemia in people aged up to 25 years in accordance with NICE TA 554 and NHSE SSC 1947, Nov 18. CDF funded for this indication until June 2023.


2. For the treatment of relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic therapies in accordance with NICE TA 567. CDF funded for this indication until 2023.

 
Link  NICE TA 554: Tisagenlecleucel for treating relapsed or refractory B-cell acute lymphoblastic leukaemia in people aged up to 25 years
Link  NICE TA 567: Tisagenlecleucel for treating relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic therapies
   
Tivozanib 890micrograms, 1340micrograms (Fotivda®)
(capsules)
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Restricted Drug Restricted
Red
High Cost Medicine
NHS England
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.


Restricted to prescribing by Consultant Oncologists for treating advanced renal cell carcinoma in accordance with NICE TA 512.

 
Link  NICE TA 512: Tivozanib for treating advanced renal cell carcinoma
   
Cytotoxic Drug Venetoclax 10mg, 50mg, 100mg
(tablet)
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Restricted Drug Restricted
Red
High Cost Medicine
Cancer Drugs Fund
NHS England
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

Restricted - prescribing by Haematology team.

1. For the treatment of chronic lymphocytic leukaemia, NICE TA 487, Nov 17 and NHSE Spec Comm letter 1795. CDF funded until December 2020.

2. In combination with Rituximab for the treatment of adult patients with Chronic Lymphocytic Leukaemia (CLL) who have received at least one prior therapy in accordance with NICE TA 561.

3. In combination with Obinutuzumab for untreated chronic lymphocytic leukaemia in accordance with NICE TA 663.

 
Link  NICE TA 487: Venetoclax for treating chronic lymphocytic leukaemia
Link  NICE TA 561: Venetoclax with rituximab for previously treated chronic lymphocytic leukaemia
Link  NICE TA 663: Venetoclax with obinutuzumab for untreated chronic lymphocytic leukaemia
   
Isatuximab 100mg/5mL
(concentrate for solution for infusion)
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Restricted Drug Restricted
Red
Cancer Drugs Fund

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

Restricted - prescribing by Haematology team. For use in accordance with Isatuximab with pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma NICE TA658.  CDF funded for this indication until January 2023.

 
Link  NICE TA 658: Isatuximab with pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma
   
08.01.05  Expand sub section  Amsacrine
Cytotoxic Drug Amsacrine 75mg/1.5mL
(concentrate for intravenous infusion)
View adult BNF View SPC online View childrens BNF  Track Changes
Formulary
Red
 
   
08.01.05  Expand sub section  Arsenic trioxide
Cytotoxic Drug Arsenic Trioxide (Trisenox®)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
NHS England
BlueTeq

FOR ALL PRESCRIBING - NICE compliance form via BLUETEQ required - see link from Formulary homepage.


Restricted to prescribing by Haematology team. For the treatment of acute promyelocytic leukaemia in accordance with NICE TA 526.

 
   
08.01.05  Expand sub section  Bevacizumab
Bevacizumab 100mg/4mL, 400mg/16mL
(concentrate for intravenous infusion)
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Restricted Drug Restricted
Red
High Cost Medicine
FOR ALL PRESCRIBING: NICE compliance form required - see link from Formulary homepage.

Restricted - prescribing by Consultant Oncologists (gastro/colorectal) only in accordance with NICE TA 212. 
Link  NICE TA 212: Bevacizumab in combination with oxaliplatin and either fluorouracil plus folinic acid or capecitabine for the treatment of metastatic colorectal cancer
Link  NICE TA263: Bevacizumab in combination wtih capecitabine for the first-line treatment of metastatic breast cancer
   
08.01.05  Expand sub section  Bexarotene to top
08.01.05  Expand sub section  Bortezomib
Bortezomib 3.5mg
(injection)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
FOR ALL PRESCRIBING: NICE compliance form required - see link from Formulary homepage. NICE compliance to be verified if form not available.

Restricted to prescribing by consultant Haematologists:
1. In accordance with TVCN protocols
2. For multiple myeloma in accordance with NICE TA 228.
3. In combination with dexamethasone or dexamethasone and thalidomide for induction treatment of patients with previously untreated multiple myeloma in accordance with NICE TA 311
4. Treatment for previously untreated mantle cell lymphoma in accordance with NICE TA 370 
Link  NICE TA 228 Bortezomib and thalidomide for the first-line treatment of multiple myeloma
Link  NICE TA 311: Bortezomib for induction therapy in multiple myeloma before high-dose chemotherapy and autologous stem cell transplantation
Link  NICE TA 370: Bortezomib for previously untreated mantle cell lymphoma
   
08.01.05  Expand sub section  Brentuximab vedotin
Cytotoxic Drug Brentuximab 50mg
(powder for concentrate for solution for infusion)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

Restricted - prescribing by Haematology team. For:
1. Treatment of CD30-positive Hodgkin lymphoma in accordance with NICE TA 524, June 17 and NHSE SSC 1744, May 17.
2. Treatment of systemic anaplastic large cell lymphoma in accordance with NICE TA 478.
3. Treatment of CD30-positive cutaneous T-cell lymphoma in accordance with NICE TA 577. 
4. Use in combination for untreated systemic anaplastic large cell lymphoma in accordance with NICE TA 641. 


 

 
Link  NICE TA 446: Brentuximab vedotin for treating CD30-positive Hodgkin lymphoma
Link  NICE TA 478: Brentuximab vedotin for treating relapsed or refractory systemic anaplastic large cell lymphoma
Link  NICE TA 577: Brentuximab vedotin for treating CD30-positive cutaneous T-cell lymphoma in adults
Link  NICE TA 641: Brentuximab vedotin in combination for untreated systemic anaplastic large cell lymphoma
   
08.01.05  Expand sub section  Cetuximab
Cetuximab 100mg/20mL, 500mg/100mL
(intravenous infusion)
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Restricted Drug Restricted
Red
High Cost Medicine
FOR ALL PRESCRIBING: NICE compliance form required - see link from Formulary homepage

Restricted - prescribing by Consultant Oncologists only. For treatment of EGFR-expressing, RAS wild-type metastatic colorectal cancer in accordance with NICE TA 439 and NHSE SSC 1759. 
Link  NICE TA242: Cetuximab, bevacizumab and panitumumab for the treatment of metastatic colorectal cancer after first-line chemotherapy
Link  NICE TA439: Cetuximab and panitumumab for previously untreated metastatic colorectal cancer
   
08.01.05  Expand sub section  Crisantaspase
Asparaginase 10,000units
(injection)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
unlicensedUnlicensed - High Risk
Restricted - Haematology Consultants only 
   
Asparaginase 5,000units
(injection (E.coli))
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
Restricted - Haematology Consultants only 
   
Peg-asparaginase 3750units
(injection )
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Restricted Drug Restricted
Red
unlicensedUnlicensed - High Risk
Restricted - use by Haematology Consultants for Treatment of childhood ALL in MRC UK ALL 2003 and 2011 trials (inpatients only)
Named Patient basis 
   
08.01.05  Expand sub section  Dacarbazine and Temozolomide to top
Cytotoxic Drug Dacarbazine 200mg, 500mg
(injection)
View adult BNF View SPC online View childrens BNF  Track Changes
Formulary
Red
 
   
Cytotoxic Drug Temozolomide 5mg, 20mg, 100mg, 140mg, 180mg, 250mg
(capsules)
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Restricted Drug Restricted
Red
High Cost Medicine

FOR ALL PRESCRIBING - NICE compliance form required - see link from Formulary homepage. NICE compliance to be verified if form not available.

Restricted - prescribing by consultant oncologists for treatment of recurrent malignant glioma and newly diagnosed high-grade glioma in accordance with NICE TA 23 and NICE TA 121.

 
Link  NICE TA 23: Guidance on the use of temozolomide for the treatment of recurrent malignant glioma (brain cancer)
Link  NICE TA 121: Carmustine implants and temozolomide for the treatment of newly diagnosed high-grade glioma
   
08.01.05  Expand sub section  Erlotinib
Erlotinib 25mg, 100mg, 150mg
(tablet)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
FOR ALL PRESCRIBING: NICE compliance form required - see link from Formulary homepage. NICE compliance to be verified if form not available.

NOTE: Erlotinib may only be prescribed following prior approval from CCG.

Restricted - prescribing by Consultant Oncologist (Lung) only:
1. For the treatment of non-small-cell lung cancer that has progressed after prior chemotherapy in accordance with NICE TA 374.
2. As 1st line treatment of locally advanced or metastatic EGFR-TK mutation positive non-SCLC, in accordance with NICE TA258.
 
Link  NICE TA 258: Erlotinib for the first-line treatment of locally advanced or metastatic EGFR-TK mutation-positive non-small-cell lung cancer
Link  NICE TA 374: Erlotinib and gefitinib for treating non-small-cell lung cancer that has progressed after prior chemotherapy
   
08.01.05  Expand sub section  Hydroxycarbamide
Cytotoxic Drug Hydroxycarbamide 100mg, 500mg
(capsule)
View adult BNF View SPC online View childrens BNF  Track Changes
Formulary
Red
 
   
08.01.05  Expand sub section  Imatinab
08.01.05  Expand sub section  Ipilimumab
Cytotoxic Drug Blinatumomab 38.5 micrograms
(powder for concentrate and solution for solution for infusion)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
BlueTeq

FOR ALL PRESCRIBING - a completed and approved NICE compliance form, via BLUETEQ, is required.


Restricted to prescribing by the Oncology team for the treatment of acute lymphoblastic leukaemia in remission with minimal residual disease activity in accordance with NICE TA 589.


https://www.nice.org.uk/guidance/TA589


Blinatumomab for treating acute lymphoblastic leukaemia in remission with minimal residual disease activity


 


 

 
Link  NICE TA 450: Blinatumomab for previously treated Philadelphia-chromosome-negative acute lymphoblastic leukaemia
   
Cytotoxic Drug Ipilimumab 50mg/10mL, 200mg/40mL
(concentrate for intravenous infusion)
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Restricted Drug Restricted
Red
High Cost Medicine
Restricted:
1. Prescribing by ORH Oncology consultants in accordance with TVCN protocol and NICE TA 268
2. Prescribing by Oxford University Hospitals (OUH) only, in accordance with NICE TA 319.
3. Prescribing by consultant oncologists (Melanoma) at OUH only. To be used In combination with nivolumab for treating advanced melanoma in accordance with NICE TA 400, Jul 16 and NHSE Letter ref 1640 from end Oct 2016. 
Link  MHRA Drug Safety Update - January 2019: Ipilimumab (Yervoy): reports of cytomegalovirus (CMV) gastrointestinal infection or reactivation
Link  NICE TA 268: Ipilimumab for previously treated advanced (unresectable or metastatic) melanoma
Link  NICE TA 319:Ipilimumab for previously untreated advanced (unresectable or metastatic) melanoma
Link  NICE TA 400: 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
Panitumumab 100mg/5mL, 400mg/20mL
(intravenous infusion)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine

FOR ALL PRESCRIBING: NICE compliance form required - see link from Formulary homepage


Restricted - prescribing by Consultant Oncologists only. For treatment of EGFR-expressing, RAS wild-type metastatic colorectal cancer in accordance with NICE TA 439 and NHSE SSC 1759. 


 
Link  NICE TA 242: Cetuximab, bevacizumab and panitumumab for the treatment of metastatic colorectal cancer after first-line chemotherapy
Link  NICE TA 439: Cetuximab and panitumumab for previously untreated metastatic colorectal cancer
   
08.01.05  Expand sub section  Pentostatin
Cytotoxic Drug Pentostatin 10mg
(injection)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
Restricted - Initiation by Consultant Haematologists or in specialist centres 
   
08.01.05  Expand sub section  Platinum compounds
Cytotoxic Drug Carboplatin 50mg/5mL, 150mg/15mL, 450mg/45mL, 600mg/60mL
(injection)
View adult BNF View SPC online View childrens BNF  Track Changes
Formulary
Red
 
   
Cytotoxic Drug Cisplatin 10mg/10mL, 50mg/50mL, 100mg/100mL
(injection)
View adult BNF View SPC online View childrens BNF  Track Changes
Formulary
Red
 
   
Cytotoxic Drug Oxaliplatin 50mg, 100mg
(injection)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
Restricted - in accordance with NICE guidelines 
Link  NICE CG131: Colorectal cancer management and diagnosis
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 50mg
(capsule)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
 
   
08.01.05  Expand sub section  Protein kinase inhibitors
Afatinib 20mg, 30mg, 40mg, 50mg
(tablet)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
FOR ALL PRESCRIBING: NICE compliance form required - see link from Formulary homepage.

Restricted - prescribing by Consultant Oncologist (Lung) only for treatment of adults with locally advanced or metastatic non-SCLC if tests positive for EGFR-TK mutation. Patients has not previously had a EGFR-TK inhibitor in line with NICE TA 310 
Link  NICE TA310: Afatinib for epidermal growth factor receptor mutation-positive locally advanced or metatstatic non-small-cell lung cancer
   
Cytotoxic Drug Bosutinib 100mg, 500mg (Bosulif®)
(film-coated tablets)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
BlueTeq

FOR ALL PRESCRIBING: NICE compliance form via Blueteq required.

Restricted - prescribing by consultant Haematologists. For previously treated chronic myeloid leukaemia in accordance with NICE TA 401 and NHSE SSC 1661.


 

 
Link  NICE TA 401: Bosutinib for previously treated chronic myeloid leukaemia
   
Cytotoxic Drug Cabozantinib 20mg, 40mg, 60mg
(film-coated tablets)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
NHS England
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

1. Restricted- prescribing by Oncology team. For treatment of advanced renal cell carcinoma in accordance with NICE TA 463.


2. Restricted - prescribing by Oxford University Hospitals (OUH) only, for the treatment of medullary thyroid cancer in accordance with NICE TA 516


3. Prescribing by Consultant Oncologists for the treatment of untreated advanced renal cell carcinoma in accordance with NICE TA 542.

 
Link  NICE TA 463: Cabozantinib for previously treated advanced renal cell carcinoma
Link  NICE TA 516: Cabozantinib for treating medullary thyroid cancer
Link  NICE TA 542: Cabozantinib for untreated advanced renal cell carcinoma
   
Cytotoxic Drug Ceritinib 150mg
(capsules)
View adult BNF View SPC online View childrens BNF  Track Changes
Formulary
Red
High Cost Medicine
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required. 

1. Restricted - prescribing by Consultant Oncologists (lung) only. As an option for treating advanced anaplastic lymphoma kinase positive non small cell lung cancer in adults who have previously had crizotinib in accordance with NICE TA 395 and NHSE SSC 15 38.


2. Restricted - prescribing by Consultant Oncologists (lung) only. For the treatment of untreated ALK positive non small cell lung cancer in accordance with NICE TA 500.

 
Link  NICE TA 395: Ceritinib for previously treated anaplastic lymphoma kinase positive non-small-cell lung cancer
Link  NICE TA 500: Ceritinib for untreated ALK-positive non-small-cell lung cancer
   
Dabrafenib 50mg, 75mg
(capsule)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
NHS England
BlueTeq

FOR ALL PRESCRIBING - NICE compliance form via BLUETEQ is required


1. Restricted - prescribing by Oxford University Hospitals (OUH) only, in accordance with NICE TA321.


2. Restricted - Prescribing by Consultant Oncologists for adjuvant treatment of resected BRAF V600 mutation-positive melanoma in accordance with NICE TA 544.

 
Link  NICE TA 321: Dabrafenib for treating unresectable or metastatic BRAF V600 mutation-positive melanoma
Link  NICE TA 544: Dabrafenib with trametinib for adjuvant treatment of resected BRAF V600 mutation-positive melanoma
   
Dasatinib 20mg, 50mg, 80mg, 100mg, 140mg
(film-coated tablets)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required in accordance with NHSE SSC 1670. NICE compliance to be verified if form not yet available.

1. Restricted - prescribing by Consultant Haematologists for treating imatinib-resistant or intolerant CML in accordance with NICE TA 425.
2. Restricted- prescribing by Consultant Haematologists for untreated CML in accordance with NICE TA 426.  
Link  NICE TA 425: Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia
Link  NICE TA 426: Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia
   
Entrectinib 100mg, 200mg
(capsules)
View adult BNF View SPC online View childrens BNF  Track Changes
Formulary
Red

FOR ALL PRESCRIBING : prior funding approval required via NICE compliance form (Blueteq).

For treating;

    • ROS1-positive advanced non-small-cell lung cancer in accordance with NICE TA 643
    • NTRK fusion-positive solid tumours in accordance with NICE TA 644
 
Link  NICE TA 643: Entrectinib for treating ROS1-positive advanced non-small-cell lung cancer
Link  NICE TA 644: Entrectinib for treating NTRK fusion-positive solid tumours
   
Cytotoxic Drug Everolimus 2.5mg, 5mg, 10mg
(tablet)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required
Restricted to:
1. Prescribing by consultant Oncologists (Breast). For treatment with exemestane of advanced breast cancer after endocrine therapy in accordance with NICE TA 421.
2. Prescribing by Oncology team. For treatment of advanced renal cell carcinoma that has progressed during or after treatment with vascular endothelial growth factor targeted therapy in accordance with NICE TA 432
3. Prescribing by Oncology team. For treatment of unresectable or metastatic neuroendocrine tumours in adults with progressive disease, in accordance with NICE TA 449, NHSE SSC 1757. Approval by MDT. 
Link  NICE TA421: Everolimus with exemestane for treating advanced breast cancer after endocrine therapy
Link  NICE TA 432: Everolimus for advanced renal cell carcinoma after previous treatment
Link  NICE TA 449: Everolimus and sunitinib for treating unresectable or metastatic neuroendocrine tumours in people with progressive disease
   
Cytotoxic Drug Gefitinib 250mg
(tablet)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine

FOR ALL PRESCRIBING: NICE compliance form required - see link from Formulary homepage

Restricted - prescribing by Oncologists only in accordance with NICE TA 192.

 
Link  NICE TA192: Gefitinib for the first-line treatment of locally advanced or metastatic non-small-cell lung cancer
   
Gilteritinib 40mg
(tablets)
View adult BNF View SPC online View childrens BNF  Track Changes
Formulary
Red

FOR ALL PRESCRIBING: prior funding approval required via NICE compliance form (Blueteq).


For treating relapsed or refractory acute myeloid leukaemia in accordance with NICE TA 642

 
Link  NICE TA 642: Gilteritinib for treating relapsed or refractory acute myeloid leukaemia
   
Cytotoxic Drug Ibrutinib 140mg
(hard capsules)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
Cancer Drugs Fund
NHS England
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

1. Restricted - prescribing by Consultant Haematologists For previously treated CML and untreated CML with 17p deletion or TP53 mutation in accordance with NICE TA 429 and NHSE SSC 1683.

2. Restricted - prescribing by Haematology team. For the treatment of Waldenstrom's macroglobulinaemia in accordance with NICE TA 491, Nov 17. CDF funded for this indication until September 2020.


3. Restricted - prescribing by Haematology team. For the treatment of relapsed or refractory mantle cell lymphoma in accordance with NICE TA 502. 

 
Link  NICE TA 429: Ibrutinib for previously treated chronic lymphocytic leukaemia and untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation
Link  NICE TA 491: Ibrutinib for treating Waldenstrom’s macroglobulinaemia
Link  NICE TA 502: Ibrutinib for treating relapsed or refractory mantle cell lymphoma
Link  MHRA Drug Safety Update - August 2017: Ibrutinib reports of ventricular tachyarrhythmia; risk of hepatitis B reactivation and of opportunistic infections
   
Idelalisib 100mg, 125mg
(tablet)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
FOR ALL PRESCRIBING - NICE compliance form required - see link from Formulary homepage. NICE compliance to be verified if form not yet available.

Restricted - prescribing by Consultant Haematologists in accordance with NICE TA 359.
 
Link  NICE TA359 - Idelalisib for treating chronic lymphocytic leukaemia
   
Imatinib 100mg, 400mg
(tablet)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
FOR ALL PRESCRIBING - NICE compliance form required - see link from Formulary homepage. NICE compliance to be verified if form not yet available.
1. Restricted - prescribing by Consultant Haematologists in accordance with NICE TA 251.
2. Restricted - prescribing by Haematology/Oncology consultants 1st Line in CML (NICE TA70 Leukaemia (chronic myeloid) and GIST (NICE TA 326 Imatinib for Adjuvant Treatment Gastro-intestinal Stromal Tumours (GIST) -review NICE TA 196).
3. Restricted - prescribing by Consultant Haematologists for treating imatinib-resistant or intolerant CML in accordance with NICE TA 425.
4. Restricted- prescribing by Consultant Haematologists for untreated CML in accordance with NICE TA 426.  
Link  NICE TA 425: Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia
Link  NICE TA 426: Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia
Link  NICE TA209: Gastrointestinal stromal tumours (unresectable/metastatic) - imatinib
Link  NICE TA251: Dasatinib, nilotinib and standard-dose imatinib for first-line treatment of chronic myeloid leukaemia
Link  NICE TA326: Imatinib for Adjuvant Treatment Gastro-intestinal Stromal Tumours (GIST) -review NICE TA 196
Link  NICE TA70: Leukaemia (chronic myeloid) - imatinib
   
Larotrectinib sulfate 20mg/1mL
(oral solution)
View adult BNF View SPC online View childrens BNF  Track Changes
Formulary
Red
High Cost Medicine
BlueTeq

FOR ALL PRESCRIBING: NICE compliance form required via Blueteq. 


Prescribing by the Oncology team;


Larotrectinib for NTRK fusion-positive solid tumours in accordance with NICE TA 630.


NICE TA 630: Larotrectinib for treating NTRK fusion-positive solid tumours

 
   
Lorlatinib 25mg, 100mg
(tablet)
View adult BNF View SPC online View childrens BNF  Track Changes
Formulary
Red
High Cost Medicine
BlueTeq

FOR ALL PRESCRIBING: NICE compliance form required via Blueteq.


Prescribing by the Oncology team
• Lorlatinib for previously treated ALK-positive advanced non-small-cell lung cancer in accordance with NICE TA 628.


NICE TA 628: Lorlatinib for previously treated ALK-positive advanced non-small-cell lung cancer

 
   
Neratinib 40mg tablet
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required


Prescribing by the Oncology team for extended adjuvant treatment of hormone receptor-positive, HER2-positive early stage breast cancer after adjuvant trastuzumab in accordance with NICE TA 612

 
Link  NICE Technology Appraisal (TA) 612
   
Nilotinib 150mg, 200mg
(capsule)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
FOR ALL PRESCRIBING - NICE compliance form required - see link from Formulary homepage. NICE compliance to be verified if form not yet available.

1. Restricted - prescribing by Consultant Haematologists in accordance with NICE TA 251.
2. Restricted - prescribing by Consultant Haematologists for treating imatinib-resistant or intolerant CML in accordance with NICE TA 425.
3. Restricted- prescribing by Consultant Haematologists for untreated CML in accordance with NICE TA 426. 
Link  NICE TA 251:Dasatinib, nilotinib and standard-dose imatinib for the first-line treatment of chronic myeloid leukaemia (part review of TA 70)
Link  NICE TA 425: Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia
Link  NICE TA 426: Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia
   
Nintedanib 100mg, 150mg
(capsule)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
FOR ALL PRESCRIBING - NICE compliance form required - see link from Formulary homepage. NICE compliance to be verified if form not yet available.

Restricted - prescribing by Consultant Oncologists (Lung) for previously treated locally advanced, metastatic, or locally recurrent non-small-cell lung cancer in accordance with NICE TA 347.
 
Link  NICE TA347: Nitedanib for previously treated locally advanced, metastatic, or locally recurrent non-small-cell lung cancer
   
Cytotoxic Drug Olaratumab 190mg/19mL, 500mg/50mL
(concentrate for solution for infusion)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red Specialist Centre
FOR ALL PRESCRIBING - NICE compliance form required - see link from Formulary homepage. NICE compliance to be verified if form not available.

Restricted - prescribing by Oxford University Hospitals (OUH) Consultant Oncologists. To be used in combination with doxorubicin as an option for advanced soft tissue sarcoma in adults in accordance with NICE TA 465.  
Link  MHRA Drug Safety Update - June 2019: Lartruvo▼ (olaratumab): withdrawal of the EU marketing authorisation due to lack of efficacy
Link  NICE TA 465: Olaratumab in combination with doxorubicin for treating advanced soft tissue sarcoma
   
Osimertinib 40mg, 80mg (Tagrisso®)
(film-coated tablets)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

1. Restricted - prescribing by consultant Oncologists (Lung) in accordance with NICE TA 653 for treating EGFR T790M mutation-positive advanced non-small-cell lung cancer.

2.  Restricted - prescribing by consultant Oncologists (Lung) in accordance with NICE TA 654 for untreated EGFR mutation-positive non-small-cell lung cancer.

 
Link  NICE TA 653: Osimertinib for treating EGFR T790M mutation-positive advanced non-small-cell lung cancer
Link  NICE TA 654: Osimertinib for untreated EGFR mutation-positive non-small-cell lung cancer
   
Pazopanib 200mg, 400mg
(tablet)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
FOR ALL PRESCRIBING - NICE compliance form required - see link from Formulary homepage. NICE compliance to be verified if form not yet available.

Restricted - prescribing by Renal Oncologists in accordance with NICE TA 215. 
Link  NICE TA215: Pazopanib for the first-line treatment of adcanced renal cell carcinoma
   
Cytotoxic Drug Sorafenib 200mg
(tablets)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
NHS England
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

1. Restricted- prescribing by Oncology team. For the treatment of hepatocellular carcinoma in accordance with NICE TA 474 and NHSE SSC 1772.


2. Restricted - prescribing by Oxofrd University Hospitals (OUH) Consultant Oncologists for treating differentiated thyroid cancer after radioactive iodine in accordance with NICE TA 535.

 
Link  NICE TA189: Hepatocellular carcinoma (advanced and metastatic) - sorafenib (first line)
   
Sunitinib 12.5mg, 25mg, 50mg
(capsule)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required
1. Restricted - Consultant Oncologist prescribing only, for 1st line treatment of advanced or metastatic renal cell carcinoma in accordance with NICE TA 169 and TVCN protocol.
2. Restricted - in accordance with NICE TA 179.
3. Restriced - Prescribing by Oncology team. For treatment of unresectable or metastatic neuroendocrine tumours in adults with progressive disease, in accordance with NICE TA 449, NHSE SSC 1757. Approval by MDT. 
Link  NICE TA169: Sunitinib for the first-line treatment of advanced and/or metastatic renal cell carcinoma
Link  NICE TA178: Renal cell carcinoma
Link  NICE TA179: Sunitinib for the treatment of gastrointestinal stromal tumours
Link  NICE TA 449: Everolimus and sunitinib for treating unresectable or metastatic neuroendocrine tumours in people with progressive disease
   
Cytotoxic Drug Trametinib 0.5mg, 2mg
(film-coated tablets)
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Formulary
Red Specialist Centre
High Cost Medicine
NHS England
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.


1. Restricted - prescribing by Consultant Oncologists (Melanoma) at OUH only. Use in combination with dabrafenib for treating unresectable or metastatic melanoma in accordance with NICE TA 396, June 16 and NHSE Letter 1639


Red Traffic Light 


2. Restricted - prescribing by Consultant Oncologists. Use in combination with dabrafenib for adjuvant treatment of resected BRAF V600 mutation-positive melanoma in accordance with NICE TA 544.

 
Link  NICE TA 396: Trametinib in combination with dabrafenib for treating unresectable or metastatic melanoma
Link  NICE TA 544: Dabrafenib with trametinib for adjuvant treatment of resected BRAF V600 mutation-positive melanoma
   
Vemurafenib 240mg
(tablet)
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Restricted Drug Restricted
Red
Restricted - prescribing by ORH Oncology consultants in accordance with TVCN protocl and NICE TA 269.  
Link  MHRA Drug Safety Update - November 2015 - Vemurafenib: Risk of potentiation of radiation toxicity
Link  NICE TA 269; Vemurafenib for treating locally advanced or metastatic BRAF V600 mutation-positive malignant melanoma
   
08.01.05  Expand sub section  Taxanes
Cytotoxic Drug Cabazitaxel 60mg in 1.5ml
(concentrate for infusion)
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Restricted Drug Restricted
Red
High Cost Medicine
FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.
Restricted - prescribing by Consultant Oncologists (prostate) only
Treatment of hormone-relapsed metastatic prostate cancer treated with Docetaxel in accordance with NICE TA 391 and NHSE SSC 16 37.  
Link  NICE TA 391: Cabazitaxel for hormone-relapsed metastatic prostate cancer treated with docetaxel
   
Cytotoxic Drug Docetaxel 20mg/0.5ml/80mg/2ml
(infusion)
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Restricted Drug Restricted
Red
1. Restricted - in accordance with NICE guidelines. For nsclc - 2nd line treatment
2. Restricted - prescribing by Consultant Oncologists (Prostate) for the treatment of hormone naïve metastatic prostate cancer in combination with androgen deprivation therapy in accordance with NHS England Clinical Commissioning Policy B15/PS/a 
Link  NHS England Clinical Cimmissioning Policy B15/PS/a - Docetaxel for hormone naive metastatic prostate cancer
Link  NICE TA101: Prostate cancer (hormone-refractory) - docetaxel
Link  NICE TA109: Breast cancer (early) - docetaxel
   
Cytotoxic Drug Paclitaxel 30mg/5mL, 100mg/16.7mL, 300mg/50mL
(infusion)
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Restricted Drug Restricted
Red
FOR ALL PRESCRIBING: NICE compliance form required - see link from Formulary homepage. NICE compliance to be verified if form not available.

Restricted prescribing by:
1. Consultant Breast Oncologists in accordance with TVCN protocol for advanced / metastatic breast cancer as an alternative to docetaxel.
2. Consultant Oncologists for recurrent ovarian cancer in accordance with NICE TA 389 
Link  NICE TA 389: Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer
   
Cytotoxic Drug Paclitaxel albumin 100mg, 250mg
(powder for suspension for infusion)
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Restricted Drug Restricted
Red
High Cost Medicine
FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

Restricted- prescribing by Oncology team. For the treatment of metastatic pancreatic cancer in adults only in accordance with NICE TA 476 and NHSE SSC 1803. 
Link  NICE TA 476: 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 40mg/2mL, 100mg/5mL
(infusion)
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Restricted Drug Restricted
Red
Restricted - in accordance with NICE guidelines 
Link  NICE CG131: Colorectal cancer: diagnosis and management
   
Cytotoxic Drug Topotecan 250micrograms, 1mg
(capsule)
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Restricted Drug Restricted
Red
High Cost Medicine
FOR ALL PRESCRIBING: NICE compliance form required - see link from Formulary homepage

Restricted - prescribing by Consultant Oncologists (Lung) only, in accordance with NICE TA 184.
 
Link  NICE TA183: Cervical cancer (recurrent) - topotecan
Link  NICE TA184: Topotecan (oral) for treatment of relapsed small-cell lung cancer
Link  NICE TA91: Topotecan for ovarian cancer
   
Cytotoxic Drug Topotecan 4mg
(intravenous infusion)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
FOR ALL PRESCRIBING: NICE compliance form required - see link from Formulary homepage. NICE compliance to be verified if form not available.

Restricted - prescribing by Consultant Oncologists for recurrent cervical cancer in accordance with NICE TA 183.
 
Link  NICE TA183: Cervical cancer (recurrent) - topotecan
Link  NICE TA184: Lung cancer (small-cell) - topotecan
   
08.01.05  Expand sub section  Trabectedin
Cytotoxic Drug Trabectedin (Yondelis®)
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Restricted Drug Restricted
Red Specialist Centre
High Cost Medicine

Prescribing by OUH consultant Oncologists in accordance with NICE TA 185 for soft tissue sarcoma.


 
Link  NICE TA 185: Trabectedin for the treatment of advanced soft tissue sarcoma
   
08.01.05  Expand sub section  Trastuzumab to top
Trastuzumab 150mg
(intravenous infusion)
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Restricted Drug Restricted
Red
High Cost Medicine
FOR ALL PRESCRIBING - NICE compliance form required - see link from Formulary homepage.
1. Restricted - to prescribing by Breast Oncologists for use in accordance with NICE TA34.
2. Restricted - to prescribing by Breast Oncologists for use in accordance with NICE 107.
3. Restricted - to prescribing by Consultant Oncologists (Gastro) only in accordance with NICE TA 208.  
Link  NICE TA34: Breast cancer - trastuzumab
Link  NICE TA107: Trastuzumab for the adjuvant treatment of early-stage HER2-positive breast cancer
Link  NICE TA208: Gastric cancer (HER2-positive metastatic) - trastuzumab
   
Trastuzumab 600mg/5mL
(subcutaneous injection)
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Restricted Drug Restricted
Red
High Cost Medicine
FOR ALL PRESCRIBING - NICE compliance form required - see link from Formulary homepage. (NICE compliance to be verified if form not yet available)

Restricted - prescribing by Breast Oncologists for:
1. Use in accordance with NICE TA34.
2. Use in accordance with NICE 107.
 
Link  NICE TA34: Breast cancer - trastuzumab
Link  NICE TA107: Trastuzumab for the adjuvant treatment of early-stage HER2-positive breast cancer
   
Trastuzumab emtansine 100mg, 160mg
(powder for solution for infusion)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
NHS England
BlueTeq

FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form, via BLUETEQ, is required.

Restricted- prescribing by Oncology team, for;


1. The treatment of HER2-positive, unresectable locally advanced or metastatic breast cancer in accordance with NICE TA 458, July 17.


2. Adjuvant treatment of HER2-positive early breast cancer in accordance with NICE TA 632.

 
Link  NICE TA 458: Trastuzumab emtansine for treating HER2-positive advanced breast cancer after trastuzumab and a taxane
Link  NICE TA 632: Trastuzumab emtansine for adjuvant treatment of HER2-positive early breast cancer
   
08.01.05  Expand sub section  Tretinoin
Tretinoin 10mg
(capsule)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
Restricted - as per AML 15 Trial protocol 
   
08.01.05  Expand sub section  Vismodegib
 ....
 Non Formulary Items
Afatinib

View adult BNF View SPC online View childrens BNF
Non Formulary
 
Bevacizumab

View adult BNF View SPC online View childrens BNF Track Changes
Non Formulary
Black

Non formulary when used in accordance with NICE TA 560.

Link  NICE TA 560: Bevacizumab with carboplatin, gemcitabine and paclitaxel for treating the first recurrence of platinum-sensitive advanced ovarian cancer (terminated appraisal)
 
Bexarotene  (Targretin®)

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Non Formulary
 
Dabrafenib

View adult BNF View SPC online View childrens BNF Track Changes
Non Formulary
Black

Non formulary when used in accordance with NICE TA 564

Link  NICE TA 564: Dabrafenib with trametinib for treating advanced metastatic BRAF V600E mutation-positive non-small-cell lung cancer (terminated appraisal)
 
Enzalutamide 40mg  (Xtandi®)
(capsules)

View adult BNF View SPC online View childrens BNF Track Changes
Non Formulary
Black

Non formulary when used in accordance with NICE TA 580.

Link  NICE TA 580: Enzalutamide for hormone-relapsed non-metastatic prostate cancer
 
Eribulin

View adult BNF View SPC online View childrens BNF Track Changes
Non Formulary
Black

Non formulary when used in accordance with NICE TA 515.

Link  NICE TA 515: Eribulin for treating locally advanced or metastatic breast cancer after 1 chemotherapy regimen
 
Cytotoxic Drug  Gefitinib 250mg
(tablet)

View adult BNF View SPC online View childrens BNF Track Changes
Non Formulary
Black
High Cost Medicine
Link  NICE TA 374: Erlotinib and gefitinib for treating non-small-cell lung cancer that has progressed after prior chemotherapy
 
Lapatinib  (Tyverb®)

View adult BNF View SPC online View childrens BNF Track Changes
Non Formulary
Link  NICE TA257: in combination with an aromatase inhibitor for HER2 positive metastatic breast cancer
 
Mitotane  (Lysodren®)

View adult BNF View SPC online View childrens BNF
Non Formulary
 
Porfimer Sodium

View adult BNF View SPC online View childrens BNF
Non Formulary
 
Temoporfin  (Foscan®)

View adult BNF View SPC online View childrens BNF
Non Formulary
 
Cytotoxic Drug  Temsirolimus  (Torisel®)

View adult BNF View SPC online View childrens BNF Track Changes
Non Formulary
Link  NICE TA178: temsirolimus for first-line treatment of advanced and/or metastatic renal cell carcinoma
Link  NICE TA207: Mantle cell lymphoma (relapsed) - temsirolimus (terminated appraisal)
 
Cytotoxic Drug  Topotecan 4mg
(intravenous infusion)

View adult BNF View SPC online View childrens BNF Track Changes
Non Formulary
Black
High Cost Medicine
Named patient only.
Link  NICE TA 389: Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer
 
Cytotoxic Drug  Trabectedin  (Yondelis®)

View adult BNF View SPC online View childrens BNF Track Changes
Non Formulary
Black
High Cost Medicine

Non formulary when used in accordance with NICE TA 389.

Link  NICE TA 389: Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer
 
Vandetanib  (Caprelsa®)
(tablets)

View adult BNF View SPC online View childrens BNF Track Changes
Non Formulary
Black

Negative recommendation as per NICE TA 550.

Link  NICE TA 550: Vandetanib for treating medullary thyroid cancer
 
  
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

Black

Not recommended for use because of lack of evidence of clinical effectiveness, cost effectiveness or safety.
Drugs which have been evaluated and rejected by the Medicines Value Group (MVG)
Drugs defined as ‘Low Priority’ by the South Central Priorities Committee
New drugs which have not as yet been evaluated by the MVG
Any drug not listed in the Buckinghamshire Formulary  

Red

Drugs which should only be prescribed in secondary care by a specialist.
Require specialist knowledge and/or equipment for patient selection and initiation
Require long term on-going monitoring and dose adjustment to ensure efficacy and minimise toxicity by a specialist
Designated as “hospital only“ by product licence, NICE, DoH or BNF
May need further evaluation by a specialist
Are hospital initiated clinical trial materials  

Red Specialist Centre

As for ‘red’ (above) with the addition of the following:
Designated by NHS England to require initiation by or in prior agreement with a Specialist Centre. Continuation where appropriate by BHT (or other secondary care provider)
Detailed requirements for Specialist Centre initiation to be described in the wording of the formulary restriction  

Amber Protocol

Drugs which should be initiated in secondary care by the specialist with follow-on prescription and monitoring according to a drug specific Shared Care Protocol(SCP). Prescribing may be continued in primary care following the SCP
Require specialist knowledge and/or equipment for patient selection and initiation
Require short or medium term (eg. 3 to 6 months) specialist monitoring of efficacy or toxicity. The need for stabilisation will vary with different drugs and patients, but is usually a minimum of 2 months (see principles for shared care)
Require significant long term monitoring
Require ongoing communication between the GP and the specialist
Have clearly defined consultant, GP and patient responsibilities documented in a shared care protocol (see responsibilities for amber protocol drugs)  

Amber Initiation

Drugs suitable for primary care prescribing following specialist initiation
Require specialist knowledge and/or equipment for patient selection
Monitoring does not require specialist knowledge or equipment
If the drug is one with which the primary care prescriber is unfamiliar the specialist is expected to provide sufficient information on the drug indication, dose, duration , monitoring and any further necessary dose adjustments
Require the first prescription to be written by the specialist  

Amber Recommended

Drugs suitable for primary care prescribing following specialist recommendation
As for amber initiation except that:- The first prescription may be written by the GP after specialist recommendation.  

Green

Drugs for which primary care prescribers would normally take full responsibility for prescribing and monitoring
Drugs not included in the Traffic Light list but included on joint formulary.
New drugs classified as red or amber but as greater experience regarding their safety and efficacy is established may move to Green after re-consideration by the MVG and APC.  

netFormulary