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Nottinghamshire Area Prescribing Committee
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 Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
Notes:
For patient information about chemotherapy and chemotherapy regimens, please see the Macmillan cancer support website: 
Chapter Links...
 Details...
08.02.04  Expand sub section  Other immunomodulating drugs
Axicabtagene ciloleucel (YESCARTA®)
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Formulary
Red

Infusion

Available at NUH only: Approved in accordance with NICE TA559 for  treating diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma after 2 or more systemic therapies.  Patients will be referred to an appropriate centre to receive treatment.

Axicabtagene ciloleucel is a chimeric antigen receptor (CAR) T‑cell therapy.

 
   
Cemiplimab (Libtayo ®)
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Formulary
Red
High Cost Medicine

Infusion

Available at NUH only:

  • Approved in accordance with NICE TA592 for treating metastatic or locally advanced cutaneous squamous cell carcinoma
 
   
Daclizumab (Zinbryta®)
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Restricted Drug Restricted
Red
High Cost Medicine
Injection
NUH only:
  • Approved in accordance with NICE TA441 for treating relapsing–remitting multiple sclerosis. 
  • Link  MHRA- risk of severe liver injury
    Link  MHRA: risk of encephalitis persists for 12 months after stopping
    Link  MHRA: suspension of marketing authorisation
       
    Dimethyl fumarate (Tecfidera®)
    View adult BNF View SPC online View childrens BNF
    Restricted Drug Restricted
    Red
    High Cost Medicine
    Homecare

    Capsule

    • NUH: Approved in accordance with NICE TA320 for the treatment of adult patients with active relapsing remitting multiple sclerosis (MS).
    • Available through homecare for NUH patients. Please contact pharmacy medicines homecare team for further information
     
    Link  EMA advice re minimising risk of PML
    Link  Link to reviews
    Link  MHRA Drug Safety Update (April 2016)
    Link  NICE TA320: Dimethyl fumarate for multiple sclerosis
    Link  NICE TA475: Dimethyl fumarate for treating moderate to severe plaque psoriasis
       
    Cytotoxic Drug Dinutuximab beta
    (Qarziba®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine

    Infusion

    NUH: Approved in accordance with NICE TA538 for treating neuroblastoma.

     
    Link  NICE TA538: Dinutuximab beta for treating neuroblastoma
       
    Fingolimod
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Homecare

    Capsules- NUH only

    • Approved for use in line with NICE TA254
    • Available through homecare for NUH patients. Please contact pharmacy medicines homecare team for further information
     
    Link  All MHRA Drug Safety Update
    Link  Link to reviews
    Link  NICE TA254: Fingolimod for highly active relapsing remitting multiple sclerosis
       
    Lenalidomide
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Cancer Drugs Fund

    Capsules.

    • Approved for use in accordance with NICE TA171 and NICE TA322.
    • Available at NUH only in accordance with NICE TA586 with dexamethasone for multiple myeloma after 1 treatment with bortezomib.
    • Available at NUH only in accordance with NICE TA587 with dexamethasone for previously untreated multiple myeloma.
    • Available at NUH only in accordance with NICE TA627 with rituximab for previously treated follicular lymphoma.


    Also approved in accordance with the National Cancer Drugs Fund List:

    • For the second line treatment of multiple myeloma where the specified criteria are met. Was removed from the CDF list on 4th November 2015. Remains on formulary for patients with funding approved prior to this date.
    • For the treatment of myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality where the specified criteria are met.
    • Confirm funding approved on BlueTeq for all new CDF starters.
    • Prescription authorisation and records needed
    • Patient access scheme exists
    • Hepatic disorders: See company mailing and MHRA advice.

    Also approved through NUH only, in accordance with the compassionate access scheme, for relapsed/refractory lymphoma including diffuse large B cell lymphoma, Non-Hodgkin Lymphoma, mantle cell lymphoma.

    At NUH:
    For more information, including criteria, see the DTC website; available here


    At SFH:

    • On receipt of prescriptions contact HCD team (4657) before screening. Please see procedure in S:/staff/HCD folder.
    • Lenalidomide in Myeloma XI trial (See link below for regimens): may be screened by any pharmacist who has completed the oral chemotherapy validation.
     
    Link  Link to reviews
    Link  MHRA Drug Safety Update (Dec 2014)
    Link  NICE: Ixazomib with lenalidomide and dexamethasone for treating relapsed or refractory multiple myeloma (TA505)
    Link  SFH Haematology chemotherapy trials (incl Myeloma XI)
    Link  SFH Oral haematology chemotherapy regimens
       
    Niraparib (Zejula®)
    Restricted Drug Restricted
    Red
    High Cost Medicine
    Cancer Drugs Fund

    Capsules

    NUH only: Approved in accordance with NICE TA528 for maintenance treatment of relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer.

     
    Link  NICE TA528: Niraparib for maintenance treatment of relapsed, platinum-sensitive ovarian, fallopian tube and peritoneal cancer
       
    Nivolumab (Opdivo®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine

    Infusion

    Available at NUH only:

    • Approved in accordance with NICE TA384 for treating advanced (unresectable or metastatic) melanoma
    • Approved in accordance with NICE TA400 for treating advanced melanoma in combination with Ipilimumab. Funding available from CDF for this combination until routine commissioning.
    • Approved in accordance with NICE TA417 for previously treated advanced renal cell carcinoma
    • Approved in accordance with NICE TA462 for treating relapsed or refractory classical Hodgkin lymphoma.
    • Approved in accordance with NICE TA490 for treating squamous cell carcinoma of the head and neck after platinum-based chemotherapy.
    • Approved in accordance with NICE TA483 for previously treated squamous non-small-cell lung cancer
    • Approved in accordance with NICE TA484 for previously treated non-squamous non-small-cell lung cancer
    • Nivolumab is not recommended for treating locally advanced unresectable or metastatic urothelial cancer after platinum-containing chemotherapy as per NICE TA530. 
    • Approved in accordance with NICE TA558 for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease
    • Approved in accordance with the National Cancer Drugs Fund List and NICE TA581 with ipilimumab for untreated advanced renal cell carcinoma
    • Approved in accordance with Early Access to Medicines Scheme (15105/0008) for treating advanced or recurrent gastric or gastroesophageal junction cancer after two or more systemic therapies. Closed to new patients August 2018.
     
    Link  Early access to medicines scheme (EAMS): nivolumab for non-squamous non-small cell lung cancer (NSCLC)
    Link  MHRA Drug Safety Update (July 2017)
    Link  NICE TA384: Nivolumab for treating advanced (unresectable or metastatic) melanoma
    Link  NICE TA400: Nivolumab in combination with ipilimumab for treating advanced melanoma
    Link  NICE TA417: Nivolumab for previously treated advanced renal cell carcinoma
    Link  NICE TA462:Nivolumab for treating relapsed or refractory classical Hodgkin lymphoma
    Link  NICE TA483: Nivolumab for previously treated squamous non-small-cell lung cancer
    Link  NICE TA484: Nivolumab for previously treated non-squamous non-small-cell lung cancer
    Link  NICE TA490:Nivolumab for treating squamous cell carcinoma of the head and neck after platinum-based chemotherapy
    Link  NICE TA530: Nivolumab for treating locally advanced unresectable or metastatic urothelial cancer after platinum-containing chemotherapy (not recommended)
    Link  NICE TA581: Nivolumab with ipilimumab for untreated advanced renal cell carcinoma
    Link  SMC advice (March 2016)
       
    Olaparib (Lynparza®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine

    Tablets (100mg and 150mg) [Capsules 50mg being phased out 2020]

    Prescribe by brand AND formulation. Capsules and tablets are not interchangeable due to differences in dosing and bioavailability of each formulation. See Risk Minimisation Material here

    • Tablets are approved in accordance with NICE TA598 for maintenance treatment of BRCA mutation-positive advanced ovarian, fallopian tube or peritoneal cancer after response to first-line platinum-based chemotherapy
    • Tablets are approved in accordance with NICE TA620 for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer
    • Also available only for prescribing by the oncologists for patients on STOMP trial.
     
    Link  Letter about tablets versus capsules formulation
    Link  NICE TA598: 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 TA620: Olaparib for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer
    Link  SFHT: Olaparib in STOMP trial
       
    Pomalidomide (Imnovid®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Capsules
  • Approved (NUH) in accordance with TA427 for multiple myeloma previously treated with lenalidomide and bortezomib. 
  • Link  Link to reviews
    Link  MHRA Drug Safety Update (May 2016)
    Link  NICE TA427: Pomalidomide for multiple myeloma previously treated with lenalidomide and bortezomib
    Link  SFH: Pomalidomide in myeloma protocol
       
    Rucaparib (Rubraca®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Cancer Drugs Fund

    Tablets

    NUH only: Approved in accordance with NICE TA611 for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer.

     
    Link  NICE TA611: Rucaparib for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer
       
    Talimogene laherparepvac (Imlygic®)
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    Restricted Drug Restricted
    Red
    BlueTeq

    Injection - (NUH only)

    • Approved in accordance with NICE TA410 for treating unresectable metastatic melanoma
     
    Link  NICE TA410: Talimogene laherparepvec for treating unresectable metastatic melanoma
       
    Teriflunomide (Aubagio®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Homecare

    Tablet

    • NUH: Approved in accordance with NICE TA303 for the treatment of relapsing–remitting multiple sclerosis.
    • Available through homecare for NUH patients. Please contact pharmacy medicines homecare team for further information
     
    Link  Link to reviews
    Link  NICE TA 303: Teriflunomide for relapsing remitting MS
       
    Thalidomide (Celgene®)
    (haematology)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Capsules
  • Restricted to use in Multiple Myeloma. Use in other indications is unlicensed.
  • Prescription authorisation and records needed- at SFH see supply procedure below. 
  • Link  MHRA Drug Safety Update (December 2015)
    Link  SFH Haematology chemotherapy trials
    Link  SFH Oral haematology chemotherapy regimens
    Link  SFH Thalidomide supply procedure
       
    Tisagenlecleucel  (Kymriah®)
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    Formulary
    Red
    Cancer Drugs Fund

    Infusion

    Available at NUH only:

    Approved in accordance with NICE TA554 for treating relapsed or refractory B-cell acute lymphoblastic leukaemia in people aged up to 25 years.  Patients will be referred to an appropriate centre to receive treatment.

    Approved in accordance with NICE TA567 for treating relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic therapies. Patients will be referred to an appropriate centre to receive treatment.

    Tisagenlecleucel is a chimeric antigen receptor (CAR) T‑cell therapy

     
    Link  NICE TA554:Tisagenlecleucel for treating relapsed or refractory B-cell acute lymphoblastic leukaemia in people aged up to 25 years
    Link  NICE TA567: Tisagenlecleucel for treating relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic therapies
       
    08.02.04  Expand sub section  Interferon Alfa
    Interferon Alfa-2a (Roferon-A®)
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    Formulary
    Red
    High Cost Medicine

    Injection: as Vial, Cartridge, Prefilled syringe

    • At SFH not routinely stocked, but may be available on request
    • NB. different brands have different licensed indications
    • Roferon-A Prefilled Syringe 3miu and 6miu expected discontinuation date Sep 19
    • Roferon-A Prefilled Syringe 4.5miu expected discontinuation date Nov 19
     
       
    Peginterferon Alfa-2a (Pegasys®)
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    Formulary
    Red
    High Cost Medicine

    Injection: Prefilled syringe

    Pen - NUH only, NB: 180 micrograms in 0.5ml pens are being discontinued from March 18

     
    Link  Pegasys Discontinuation Trade Announcement
    Link  Link to reviews
    Link  NICE TA 200: Hepatitis C - peginterferon alfa & ribavirin
    Link  NICE TA 300: Hepatitis C - peginterferon alfa
    Link  NICE TA 96: Hepatitis B - peginterferon alfa
    Link  NICE TA106: Hepatitis C - peginterferon alfa & ribavirin
    Link  NICE TA75: Hepatitis C - pegylated interferons, ribavirin & alfa interferon
       
    08.02.04  Expand sub section  Interferon beta
    Interferon Beta-1a (Avonex®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Homecare

    Injection

    Approved in accordance with NICE TA527 for treating multiple sclerosis.

    Available through homecare for NUH patients. Please contact pharmacy medicines homecare team for further information

     
    Link  NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
       
    Interferon Beta-1a (Rebif®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Homecare

    Injection:6 mega units in 0.5mL Prefilled syringe

    NUH only: Approved in accordance with NICE TA527 for treating multiple sclerosis.

    Available through homecare for NUH patients. Please contact pharmacy medicines homecare team for further information

     
    Link  Commissioning Policy - Multiple Sclerosis
    Link  MHRA Drug Safety Update (Dec 2014)
    Link  NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
       
    Interferon beta-1b (Extavia®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine

    Injection

    NUH only (via homecare): Approved in accordance with NICE TA527, for treating multiple sclerosis.

     
    Link  NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
       
    Peginterferon Beta-1a (Plegridy®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine

    Injection: 63micrograms in 0.5mL pre-filled pen, 94micrograms in 0.5mL pre-filled pen and 125micrograms in 0.5mL pre-filled pen

    • NUH only (via homecare): Approved for treating relapsing–remitting multiple sclerosis (RRMS) in adults, in accordance with NICE TA624 and the NHS England commissioning policy.
     
       
    08.02.04  Expand sub section  Interferon gamma
    08.02.04  Expand sub section  Aldesleukin to top
    BCG bladder instillation (OncoTICE®)
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    Formulary  
    Link  SFH: BCG (Oncotice) and Mitomycin information in bladder cancer
       
    08.02.04  Expand sub section  BCG bladder instillation
    08.02.04  Expand sub section  Canakinumab
    08.02.04  Expand sub section  Dimethyl fumarate
    08.02.04  Expand sub section  Fingolimod
    08.02.04  Expand sub section  Glatiramer acetate to top
    Glatiramer Acetate
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    Formulary
    Red
    High Cost Medicine
    Homecare

    Injection

    Available at NUH only:

    • Available as 20mg/ml syringes for once daily dosing and as 40mg/ml syringes for three times weekly dosing. Both regimens are cost equivalent and are commissioned.
    • New patients to be initiated on Brabio®, existing Copaxone® patients will remain on Copaxone®.
    • Available through homecare for NUH patients. Please contact pharmacy medicines homecare team for further information
     
    Link  Commissioning Policy - Multiple Sclerosis
    Link  Glatiramer for the treatment of MS
    Link  Link to reviews
       
    08.02.04  Expand sub section  Histamine
    08.02.04  Expand sub section  Lenalidomide, pomalidomide, and thalidomide
    08.02.04  Expand sub section  Mifamurtide
    Mifamurtide (Mepact®)
    View adult BNF View SPC online View childrens BNF
    Restricted Drug Restricted
    Red
    Intravenous infusion
  • Approved in accordance with NICE TA235 for the treatment of high-grade resectable non-metastatic osteosarcoma 
  • Link  NICE TA235: Osteosarcoma - mifamurtide: guidance
       
    08.02.04  Expand sub section  Natalizumab
    Natalizumab (Tysabri®)
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    Formulary
    Red
    High Cost Medicine
    Infusion- NUH only
  • Approved in accordance with NICE TA127 
  • Link  Commissioning Policy - Multiple Sclerosis
    Link  Link to reviews
    Link  MHRA Drug Safety Update (April 2016)
    Link  NICE TA127: Multiple sclerosis - natalizumab
       
    08.02.04  Expand sub section  Teriflunomide to top
     ....
     Non Formulary Items
    Aldesleukin  (Proleukin®)

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    Non Formulary
    Grey
    High Cost Medicine
     
    BCG bladder instillation  (ImmuCyst®)

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    Non Formulary
    Grey
    Vial for bladder instillation
  • Product discontinued 2017
  •  
    Canakinumab  (Ilaris®)

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    Non Formulary
    Grey
    High Cost Medicine
  • GREY for refractory gout.
  • Not routinely commissioned for juvenile arthritis - approval via IFR must be sought before initiation of treatment.
  • Use for cryoporin associated periodic syndrome is only commissioned at The Royal Free Hospital and Great Ormond Street Hospital as highly specialised centres.
  • Link  Link to reviews
     
    Cediranib  (Recentin®)

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    Non Formulary
    Grey
    No formal assessment (APC Nov 2015)
     
    Cobimetinib  (Cotellic®)

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Grey
    No formal assessment (APC Jan 2016)
    Link  NICE TA414:Cobimetinib in combination with vemurafenib for treating unresectable or metastatic BRAF V600 mutation-positive melanoma
     
    Dinutuximab  (Unituxin®)

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Grey
    No formal assessment (Nov 2015 APC)
     
    Fampridine

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Grey
    High Cost Medicine
    • Licensed for improving walking time in MS patients. Not currently routinely commissioned by NHS England.
    • IFR must be approved before initiation.
    • Red Traffic Light NUH only Approved for existing patients following participation in the ENHANCE and ENABLE clinical trials. Supplied via homecare.
    Link  Link to reviews
    Link  NHS England national commissioning policy
     
    Interferon Alfa  (Viraferon®)

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    Non Formulary
    Grey
    High Cost Medicine
     
    Interferon Alfa-2b  (IntronA®)

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    Non Formulary
    Grey
    High Cost Medicine

    Discontinued in UK by manufacturer - December 2018

    Prefilled injection pens

    • 18MU pen delivers contents in doses ranging from 1.5-6 MU (in 0.3 MU increments - See PIL)
    • 30MU pen delivers contents in doses ranging from 2.5-10 MU (in 0.5 MU increments - See PIL)
    • 60MU pen delivers contents in doses ranging from 5-20 MU (in 1 MU increments - See PIL)
    • NB. different brands have different licensed indications
    • Screening information: Pre-filled syringes contain either 18, 30 or 60 MU.
    Link  NICE TA75: Interferon Alfa - Chronic Hepatitis C
     
    Interferon Beta  (Proleukin®)

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    Non Formulary
    Grey
    High Cost Medicine
     
    Interferon Beta-1b  (Betaferon®)

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Grey
    High Cost Medicine

    Betaferon is not recommended within its marketing authorisation as an option for treating multiple sclerosis, as per NICE TA527.

     
    Peginterferon Alfa  (PegIntron®)

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Grey
    High Cost Medicine
    Link  Link to reviews
     
    Peginterferon Alfa  (ViraferonPeg®)

    View adult BNF View SPC online View childrens BNF
    Non Formulary
    Grey
    High Cost Medicine
    Injection: Prefilled syringe, Pen- NUH only
  • For NICE Guidelines please see entries above for Pegasys
    December 2016: Product discontinued
  • Link  Link to reviews
     
      
    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

    Grey

    Grey / Non-Formulary: Medicines, which the Nottinghamshire APC has actively reviewed and does not recommend for use at present due to limited clinical and/or cost effective data.
    Grey / Non-Formulary (undergoing assessment): Work is ongoing and will be reviewed at a future APC meeting.
    Grey / Non-Formulary (no formal assessment): APC has not formally reviewed this medicine or indication because it had never been requested for formulary inclusion. Often used for drugs new to market.
      

    Red

    Medicines which should normally be prescribed by specialists only. eg hospital only.
    For patients already receiving prescriptions in primary care - continue. No new patients to receive prescriptions in primary care.
      

    Amber 1

    Medicines that should be initiated by a specialist and prescribed by primary care prescribers only under a shared care protocol, once the patient has been stabilised.
    Prior agreement must be obtained by the specialist from the primary care provider before prescribing responsibility is transferred. The shared care protocol must have been agreed by the relevant secondary care trust Drugs and Therapeutics Committee(s) (DTC) and approved by the Nottinghamshire APC.
      

    Amber 2

    Medicines suitable to be prescribed in primary care / general practice after specialist* recommendation or initiation.
    A supporting prescribing guideline may be requested which must have been agreed by the relevant secondary care trust DTCs and approved by the Nottinghamshire APC.
    *Specialist is defined by the APC as a clinician who has undertaken an appropriate formal qualification or recognised training programme within the described area of practice
      

    Amber 3

    Primary care/ non specialist may initiate as per APC guideline.
    The supporting prescribing guideline must have been agreed by the relevant secondary care trust D&TC(s) and approved by the Nottinghamshire APC.
      

    Green

    Medicines suitable for routine use within primary care.
    Can be initiated within primary care within their licensed indication, in accordance with nationally recognised formularies, for example the BNF, BNF for Children, Medicines for Children or Palliative Care Formulary. Primary care prescribers take full responsibility for prescribing.   

    OTC

      

    netFormulary