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 Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
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08.01.05  Expand sub section  Other antineoplastic drugs
08.01.05  Expand sub section  Amsacrine
08.01.05  Expand sub section  CDK inhibitors
08.01.05  Expand sub section  Arsenic trioxide
08.01.05  Expand sub section  Bevacizumab to top
08.01.05  Expand sub section  Bexarotene
08.01.05  Expand sub section  Bortezomib
08.01.05  Expand sub section  Brentuximab vedotin
08.01.05  Expand sub section  Cetuximab
08.01.05  Expand sub section  Dacarbazine and Temozolomide to top
08.01.05  Expand sub section  Erlotinib
08.01.05  Expand sub section  Hydroxycarbamide
08.01.05  Expand sub section  Imatinab
08.01.05  Expand sub section  Ipilimumab
08.01.05  Expand sub section  Mitotane to top
08.01.05  Expand sub section  Panitumumab
08.01.05  Expand sub section  Pentostatin
08.01.05  Expand sub section  Platinum compounds
08.01.05  Expand sub section  Porfimer sodium and temoporfin
08.01.05  Expand sub section  Procarbazine to top
08.01.05  Expand sub section  Protein kinase inhibitors
Afatinib
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Formulary
Red
High Cost Medicine
NHS England
  • Approved in accordance with NICE and NHS England Commissioning Policy.

 

 
Link  NICE TA310: Afatinib for treating epidermal growth factor receptor mutation-positive locally advanced or metastatic non-small-cell lung cancer
 
Axitinib  (Inlyta®)
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Formulary
Red
High Cost Medicine
NHS England
  • Approved in accordance with NICE and NHS England Commissioning Policy.

 

 
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
Link  NICE TA333: Axitinib for treating advanced renal cell carcinoma after failure of prior systemic treatment
Link  NICE TA645: Avelumab with axitinib for untreated advanced renal cell carcinoma
 
Bosutinib (Bosulif®)
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Formulary
Red
High Cost Medicine
NHS England
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
Link  NICE TA401: Bosutinib for previously treated chronic myeloid leukaemia
Link  MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation
 
Cytotoxic Drug Brigatinib (Alunbrig®)
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Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
Link  NICE TA571: Brigatinib for treating ALK-positive advanced non-small-cell lung cancer after crizotinib
Link  NICE TA670: Brigatinib for ALK-positive advanced non-small-cell lung cancer that has not been previously treated with an ALK inhibitor
 
Cabozantinib (Cometriq®)
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Formulary
Red
High Cost Medicine
NHS England
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
Link  NICE TA463 Cabozantinib for previously treated advanced renal cell carcinoma
Link  NICE TA516: Cabozantinib for treating medullary thyroid cancer
Link  NICE TA542: Cabozantinib for untreated advanced renal cell carcinoma
Link  NICE TA849: Cabozantinib for previously treated advanced hepatocellular carcinoma
Link  NICE TA964: Cabozantinib with nivolumab for untreated advanced renal cell carcinoma
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Ceritinib
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Formulary
Red
High Cost Medicine
NHS England
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
Link  NICE TA395: Ceritinib for previously treated anaplastic lymphoma kinase positive non-small-cell lung cancer
Link  NICE TA500: Ceritinib for untreated ALK-positive non-small-cell lung cancer
 
Crizotinib
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Formulary
Red
High Cost Medicine
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
Link  NICE TA1021: Crizotinib for treating ROS1-positive advanced non-small-cell lung cancer
Link  NICE TA406: Crizotinib for untreated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer
Link  NICE TA422: Crizotinib for previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer
Link  NICE TA529: Crizotinib for treating ROS1-positive advanced non-small-cell lung cancer
Link  MHRA Drug Safety Update (Nov 2015): Crizotinib (Xalkori▼): risk of cardiac failure
 
Dabrafenib  (Tafinlar®)
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Formulary
Red
High Cost Medicine
NHS England
BlueTeq
  • Approved in accordance with NICE and NHS England Commissioning Policy.

 

 

 
Link  NICE TA321: Dabrafenib for treating unresectable or metastatic BRAF V600 mutation‑positive melanoma
Link  NICE TA396: Trametinib in combination with dabrafenib for treating unresectable or metastatic melanoma
Link  NICE TA544: Dabrafenib with trametinib for adjuvant treatment of resected BRAF V600 mutation-positive melanoma
Link  NICE TA898: Dabrafenib plus trametinib for treating BRAF V600 mutation-positive advanced non-small-cell lung cancer
Link  NICE TA977: Dabrafenib with trametinib for treating BRAF V600E mutation-positive glioma in children and young people aged 1 year and over
 
Dasatinib (Sprycel®)
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Formulary
Red
  • Approved for use in accordance with NICE and NHS England Commissioning Policy
 
Link  NICE TA425: Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia
Link  NICE TA426: Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia
Link  MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation
 
Cytotoxic Drug Encorafenib (Braftovi®)
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Formulary
Red
High Cost Medicine
NHS England
  • Approved in accordance with NICE and NHS England Commissioning Policy.

 

 
Link  NICE TA562: Encorafenib with binimetinib for unresectable or metastatic BRAF V600 mutation-positive melanoma
Link  NICE TA668: Encorafenib plus cetuximab for previously treated BRAF V600E mutation-positive metastatic colorectal cancer
 
Everolimus (Afinitor®, Votubia®)
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Formulary
Red
  • 2.5mg, 5mg & 10mg tablets (Votubia®)
    • Approved for the treatment of angiomyolipomas associated with tuberous sclerosis in accordnace with NHS England Commissioning Policy.
    • Approved for the treatment of subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex in accordnace line with NHS England Commissioning Policy.
  • 5mg & 10mg tablets (Afinitor®)
    • Approved, in combination with exemestane, for the treatment of advanced human epidermal growth factor receptor 2 (HER2)-negative, hormone-receptor-positive breast cancer in postmenopausal women in accordance with NICE.
    • Approved for the treatment of advanced breast cancer after endocrine therapy in line with NICE.
    • Approved for the treatment of advanced renal cell carcinoma after previous treatment in line with NICE.
    • Approved for the treatment of unresectable or metastatic neuroendocrine tumours in people with progressive disease in line with NICE and NHS England Commissioning Policy
 
Link  Clinical Commissioning Policy Statement: Everolimus (Votubia®) for treatment of angiomyolipomas associated with tuberous sclerosis
Link  Clinical Commissioning Policy: Everolimus for subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex
Link  NICE TA348: Everolimus for preventing organ rejection in liver transplantation
Link  NICE TA421: Everolimus with exemestane for treating advanced breast cancer after endocrine therapy
Link  NICE TA432: Everolimus (Afinitor) for advanced renal cell carcinoma after previous treatment
Link  NICE TA449 Everolimus and sunitinib for treating unresectable or metastatic neuroendocrine tumours in people with progressive disease
Link  NICE TA481: Immunosuppressive therapy for kidney transplant in adults
Link  NICE TA482: Immunosuppressive therapy for kidney transplant in children and young people
Link  NICE TA498: Lenvatinib with everolimus for previously treated advanced renal cell carcinoma
 
Gefitinib
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Formulary
Red
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
Link  NICE TA192: Lung cancer (non-small-cell, first line) - gefitinib
Link  NICE TA374: Erlotinib and gefitinib for treating non-small-cell lung cancer that has progressed after prior chemotherapy
Link  MHRA Drug Safety Update (May 2012): Epidermal growth factor receptor (EGFR) inhibitors: serious cases of keratitis and ulcerative keratitis
 
Ibrutinib (Imbruvica®)
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Formulary
Red
High Cost Medicine
NHS England
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
Link  NICE TA429: Ibrutinib for previously treated chronic lymphocytic leukaemia and untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation
Link  NICE TA502: Ibrutinib for treating relapsed or refractory mantle cell lymphoma
Link  NICE TA795: Ibrutinib for treating Waldenstrom’s macroglobulinaemia
Link  NICE TA891: Ibrutinib with venetoclax for untreated chronic lymphocytic leukaemia
Link  MHRA Drug Safety Update (August 2017): Ibrutinib (Imbruvica▼): reports of ventricular tachyarrhythmia; risk of hepatitis B reactivation and of opportunistic infections
 
Imatinib
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Formulary
Red
NHS England
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
Link  NICE TA209: Imatinib for the treatment of unresectable and/or metastatic gastrointestinal stromal tumours
Link  NICE TA326: Imatinib for the adjuvant treatment of gastrointestinal stromal tumours
Link  NICE TA425: Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia
Link  NICE TA426: Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia
Link  NICE TA70: Guidance on the use of imatinib for chronic myeloid leukaemia
Link  NICE TA86: Imatinib for the treatment of unresectable and/or metastatic gastro-intestinal stromal tumours
Link  MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation
 
Lapatinib (Tyverb®)
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Formulary
Red
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
Link  NICE TA257: in combination with an aromatase inhibitor for HER2 positive metastatic breast cancer
 
Lenvatinib (Kisplyx®)
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Formulary
Red
High Cost Medicine
NHS England
  • 4mg & 10mg capsules
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
Link  NICE TA 535: Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine
Link  NICE TA 551: Lenvatinib for untreated advanced hepatocellular carcinoma
Link  NICE TA498: Lenvatinib with everolimus for previously treated advanced renal cell carcinoma
Link  NICE TA858: Lenvatinib with pembrolizumab for untreated advanced renal cell carcinoma
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Mobocertinib
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Formulary
Red
High Cost Medicine
NHS England
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
Link  NICE TA855: Mobocertinib for treating EGFR exon 20 insertion mutation-positive advanced non-small-cell lung cancer after platinum-based chemotherapy
 
Nilotinib (Tasigna®)
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Formulary
Red
NHS England
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
Link  NICE TA425: Dasatinib, nilotinib and high-dose imatinib for treating imatinib-resistant or intolerant chronic myeloid leukaemia
Link  NICE TA426: Dasatinib, nilotinib and imatinib for untreated chronic myeloid leukaemia
Link  MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation
 
Nintedanib
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Formulary
Red
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
Link  NICE TA347: Recurrent non-small-cell lung cancer
Link  NICE TA379: Nintedanib for treating idiopathic pulmonary fibrosis
Link  NICE TA747 Nintedanib for treating progressive fibrosing interstitial lung diseases
Link  NICE TA864: Nintedanib for treating idiopathic pulmonary fibrosis when forced vital capacity is above 80% predicted
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Pazopanib (Votrient®)
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Formulary
Red
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
Link  NICE TA215: Pazopanib in renal cell cancer
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Pemigatinib (Pemaryze®)
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Formulary
Red
  • 4.5mg, 9mg and 13.5mg tablets
  • Approved in accordance with NICE and NHS England Commissioning Policy.

 

 
Link  NICE TA722: Pemigatinib for treating relapsed or refractory advanced cholangiocarcinoma with FGFR2 fusion or rearrangement
 
Ponatinib (Iclusig®)
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Formulary
Red
High Cost Medicine
  • 15mg, 30mg & 45mg film-coated tablets
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
Link  NICE TA451 Ponatinib for treating chronic myeloid leukaemia and acute lymphoblastic leukaemia
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
Link  MHRA Drug Safety Update (October 2018): Ponatinib (Iclusig▼): reports of posterior reversible encephalopathy syndrome
Link  MHRA Drug Safety Update (April 2017): Ponatinib  (Iclusig▼): risk of vascular occlusive events—updated advice on possible dose reduction
Link  MHRA Drug Safety Update (May 2016): BCR-ABL tyrosine kinase inhibitors: risk of hepatitis B reactivation
 
Cytotoxic Drug Regorafenib (Stivarga® )
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Formulary
Red
High Cost Medicine
BlueTeq
  • 40mg tablets
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
Link  NICE TA 488: Regorafenib for previously treated unresectable or metastatic gastrointestinal stromal tumours
Link  NICE TA555: Regorafenib for previously treated advanced hepatocellular carcinoma
Link  NICE TA866: Regorafenib for previously treated metastatic colorectal cancer
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Ruxolitinib
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Formulary
Red
  • Approved in accordance with NICE and NHS England Commissioning Policy.

 

 
Link  NICE TA386: Ruxolitinib for treating disease-related splenomegaly or symptoms in adults with myelofibrosis
Link  NICE TA921: Ruxolitinib for treating polycythaemia vera
 
Sorafenib (Nexavar®)
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Formulary
Red
High Cost Medicine
  • 200mg tablets
  • Approved for treatment of advanced hepatocellular carcinoma only for people with Child-Pugh grade A liver impairment in line with NICE and NHS Commissioning Policy.
  • Approved for the treatment of differentiated thyroid cancer after radioactive iodine in line with NICE.
  • Approved as maintenance for adults with FLT3-internal tandem duplication (FLT3-ITD) acute myeloid leukaemia (AML) undergoing allogeneic haematopoietic stem cell transplantation (allo-HSCT) in line with NHS England Specialised Commissioning Policy
    • Only available at The Newcastle upon Tyne Hospitals NHS Trust
 
Link  NHS England Specialised Commissioning Policy: Sorafenib maintenance for adults with FLT3-internal tandem duplication (FLT3-ITD) acute myeloid leukaemia (AML) undergoing allogeneic haematopoietic stem cell transplantation (allo-HSCT)
Link  NICE TA 535: Lenvatinib and sorafenib for treating differentiated thyroid cancer after radioactive iodine
Link  NICE TA474 Sorafenib for treating advanced hepatocellular carcinoma
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Sunitinib  (Sutent®)
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Formulary
Red
High Cost Medicine
NHS England
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
Link  NICE TA169: Sunitinib for the first-line treatment of advanced and/or metastatic renal cell carcinoma
Link  NICE TA179: Sunitinib for the treatment of gastrointestinal stromal tumours
Link  NICE TA449 Everolimus and sunitinib for treating unresectable or metastatic neuroendocrine tumours in people with progressive disease
Link  MHRA Drug Safety Update (January 2011): Bevacizumab and sunitinib: risk of osteonecrosis of the jaw
Link  MHRA Drug Safety Update (July 2020): Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection
 
Trametinib
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Formulary
Red
High Cost Medicine
NHS England
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
Link  NICE TA396: Trametinib in combination with dabrafenib for treating unresectable or metastatic melanoma
Link  NICE TA544: Dabrafenib with trametinib for adjuvant treatment of resected BRAF V600 mutation-positive melanoma
Link  NICE TA898: Dabrafenib plus trametinib for treating BRAF V600 mutation-positive advanced non-small-cell lung cancer
Link  NICE TA977: Dabrafenib with trametinib for treating BRAF V600E mutation-positive glioma in children and young people aged 1 year and over
Link  MHRA Drug Safety Update (March 2016) Trametinib (Mekinist▼): risk of gastrointestinal perforation and colitis
 
Cytotoxic Drug Tucatinib (Tukysa®)
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Formulary
Red
High Cost Medicine
NHS England
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
Link  NICE TA786: Tucatinib with trastuzumab and capecitabine for treating HER2-positive advanced breast cancer after 2 or more anti-HER2 therapies
 
Vemurafenib
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Formulary
Red
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
Link  NICE TA269: Vemurafenib for treating malignant melanoma
Link  NICE TA414: Cobimetinib in combination with vemurafenib for treating unresectable or metastatic BRAF V600 mutation-positive melanoma
 
Cytotoxic Drug Zanubrutinib (Brukinsa®)
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Formulary
Red
High Cost Medicine
NHS England
  • 80mg capsule
  • Approved in accordance with NICE and NHS England Commissioning Policy.
 
Link  NICE TA1001 : Zanubrutinib for treating marginal zone lymphoma after anti-CD20-based treatment
Link  NICE TA833: Zanubrutinib for treating Waldenstrom’s macroglobulinaemia
Link  NICE TA931: Zanubrutinib for treating chronic lymphocytic leukaemia
 
08.01.05  Expand sub section  Taxanes
08.01.05  Expand sub section  Topoisomerase I inhibitors
08.01.05  Expand sub section  Trabectedin
08.01.05  Expand sub section  Trastuzumab to top
08.01.05  Expand sub section  Tretinoin
08.01.05  Expand sub section  Vismodegib
 ....
 Non Formulary Items
Cytotoxic Drug  Zanubrutinib  (Brukinsa®)

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Non Formulary
Not Recomended
High Cost Medicine
NHS England
  • Zanubrutinib with obinutuzumab for treating relapsed or refractory B-cell follicular lymphoma after 2 or more treatments (terminated appraisal)
Link  NICE TA978: Zanubrutinib with obinutuzumab for treating relapsed or refractory B-cell follicular lymphoma after 2 or more treatments (terminated appraisal)
  
Key
Restricted Drug Restricted Drug
Unlicensed Drug Unlicensed
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Link to SPCs
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
NHSE
NHS England
Homecare
Homecare
CCG
ICB
Green Low Carbon

Low carbon footprint

Amber Medium Carbon

Medium carbon footprint

Red High carbon footprint

High carbon footprint

Status Description

Red

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

Amber

Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. These medicines are considered suitable for primary care prescribing following specialist initiation of therapy and stabilisation, with ongoing communication between the primary care prescriber and specialist as set out in the associated shared care guideline (SCG). Shared care should be initiated by the specialist, which includes consultant, suitably trained specialist non-medical prescriber or GPwER within a secondary, tertiary, or primary care clinic. The specialist should send the primary care prescriber a copy of the NENC Clinical Effectiveness and Governance (CEG) Subcommittee approved SCG to sign. The primary care prescriber should sign the SCG or indicate reasons why they are unable to accept the agreement and return a copy back to the specialist, as soon as possible. SCGs are available or are being developed for most of the drugs listed as AMBER.   

Green plus

Drugs normally recommended or initiated by a hospital specialist who is a prescriber, a GP with an extended role [GPwER], or a specialist within primary care which can be safely maintained in primary care and monitored in primary care. In some cases, a further restriction for use may be defined. The primary care prescriber must be familiar with the drug to take on prescribing responsibility or must obtain the required information from the specialist. Therefore, provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by primary care prescriber or provide information re stopping criteria. These are considered suitable for primary care prescribing following specialist assessment and recommendation of therapy, with ongoing communication between the primary care prescriber and specialist, if necessary. In some case these drugs require specialist initiation and short to medium term monitoring of efficacy or toxicity until the patient’s dose is stable. Following specialist review the patient may be transferred to primary care for ongoing prescribing. Ongoing prescribing by primary care can include, if required, additional dose titrations and assessment of efficacy, with ongoing communication between the primary care prescriber and specialist, if necessary. If the drug requires urgent initiation, it is expected that the specialist undertakes the initial prescribing responsibility for an appropriate period of time, usually a minimum of 28 days. A GREEN+ drug can only be recommended to primary care for initiation if does not need to be initiated within 28 days.  

Green

Medicines suitable for initiation, ongoing prescribing and discontinuation in all care settings, subject to appropriate communication between those responsible.  

Brown

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

Not Recomended

Drugs that have been considered by the NENC Clinical Effectiveness and Governance (CEG) Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria ICS. These may also include all medicines with a “not NHS” or “DLCV” classification in the BNF, those agents as included within the NICE “Do not do” list, and those agents included with the NHS England: Items which should not routinely be prescribed in primary care.  

netFormulary