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 Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
08.02.04  Expand sub section  Other immunomodulating drugs
Axicabtagene ciloleucel  (Yescarta®)
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Red
NHS England

For treating diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma after 2 or more systemic therapies as per NICE TA559.

Funded by specialised commissioning.

APCO March 2019.

 
Link  NICE TA559: Axicabtagene ciloleucel for treating diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma after 2 or more systemic therapies
   
Daclizumab (Zinbryta®)
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Formulary
Red
NHS England

For treating relapsing-remitting multiple sclerosis as per NICE TA441. Funded by specialised commissioning. 

APCO July 2017. 

 
Link  NICE TA441: Daclizumab for treating relapsing–remitting multiple sclerosis
   
Dimethyl fumarate (Tecfidera®)
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Formulary
Red
High Cost Medicine
NHS England

For the treatment of relapsing-remitting multiple sclerosis, as per NICE TA320 and in line with Monitoring Protocol 

APCO July 2016.

Funded by specialised commissioning. 

 
Link  NICE TA320: Dimethyl fumarate for multiple sclerosis
Link  NICE TA475: Dimethyl fumarate for treating moderate to severe plaque psoriasis
Link  EMA advice re minimising risk of PML
Link  MHRA: Fatal PML with dimethyl fumarate
Link  MHRA: Updated advice on risk of PML with dimethyl fumarate
   
Dinutuximab Beta (Qarziba®)
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Formulary
Red
NHS England

For treating neuroblastoma as per NICE TA538.

Funded by specialised commissioning.

APCO November 2018.

 
Link  Dinutuximab beta for treating neuroblastoma
   
Fingolimod
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Formulary
Red
High Cost Medicine
NHS England

For the treatment of highly active relapsing-remitting multiple sclerosis as per NICE TA254.

Funded by specialised commissioning.

APCO May 2012.

 
Link  NICE TA254: Fingolimod for highly active relapsing remitting multiple sclerosis
Link  MHRA: Risks of PML, basal-cell carcinoma, and opportunistic infections
Link  MHRA: Update on bradycardia and heart block
   
Lenalidomide (Revlimid®)
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Formulary
High Cost Medicine
Cancer Drugs Fund
NHS England

Red Traffic Light

  • For treating myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality as per NICE TA322 (APCO November 2014).
  • Plus dexamethasone for multiple myeloma after 1 treatment with bortezomib as per NICE TA586 (APCO September 2019). 
  • Plus dexamethasone for previously untreated multiple myeloma in line with NICE TA587 (APCO September 2019). 

Funded by specialised commissioning. 

Black Traffic Light Not recommended for with bortezomib and dexamethasone for untreated multiple myeloma (NICE TA603 - terminated appraisal).

APCO November 2019.

 
Link  MHRA investigation of second primary malignancies update
Link  MHRA: Risk of thrombosis and thromboembolism
Link  NICE TA322: Lenalidomide for treating myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality
Link  NICE TA586: Lenalidomide plus dexamethasone for multiple myeloma after 1 treatment with bortezomib
Link  NICE TA587: Lenalidomide plus dexamethasone for previously untreated multiple myeloma
Link  NICE TA603: Lenalidomide with bortezomib and dexamethasone for untreated multiple myeloma (terminated appraisal)
   
Nivolumab (Opdivo®)
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Formulary
High Cost Medicine
Cancer Drugs Fund
NHS England

Red Traffic Light For the treatment of:

  • Advanced (unresectable or metastatic) melanoma in adults as per NICE TA384 (APCO March 2013).
  • Advanced melanoma in combination with ipilimumab as per NICE TA400 (APCO September 2016)
  • Previously treated advanced renal cell carcinoma as per NICE TA417 (APCO January 2017).
  • Relapsed or refractory classical Hodgkin lymphoma as per NICE TA462 (APCO September 2017).
  • Previously treated squamous non-small-cell lung cancer as per NICE TA483 (APCO January 2018).
  • Previously treated non-squamous non-small-cell lung cancer as per NICE TA484 (APCO January 2018).
  • Treating squamous cell carcinoma of the head and neck after platinum-based chemotherapy as per NICE TA490 (APCO January 2018).
  • For adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease as per NICE TA558 (APCO March 2019).
  • With ipilimumab for untreated advanced renal cell carcinoma as per NICE TA581 (APCO July 2019).

Funded by specialised commissioning.

Black Traffic Light Not recommended for treating locally advanced unresectable or metastatic urothelial cancer after platinum-containing chemotherapy as per NICE TA530.

APCO September 2018.

 
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 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
Link  NICE TA558: Nivolumab for adjuvant treatment of completely resected melanoma with lymph node involvement or metastatic disease
Link  NICE TA581: Nivolumab with ipilimumab for untreated advanced renal cell carcinoma
Link  NICT TA483: Nivolumab for previously treated squamous non-small-cell lung cancer
Link  SMC advice (March 2016)
   
Olaparib (Lynparza®)
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Formulary
High Cost Medicine
NHS England

Red Traffic Light For maintenance treatment of:

  • BRCA mutation-positive advanced ovarian, fallopian tube or peritoneal cancer after response to first-line platinum-based chemotherapy, in line with NICE TA598 (APCO November 2019).
  • Relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer as per NICE TA620 (APCO March 2020).  

Funded by specialised commissioning. 

Black Traffic Light Not recommended for maintenance treatment of relapsed, platinum-sensitive, BRCA mutation-positive ovarian, fallopian tube and peritoneal cancer after response to second-line or subsequent platinum-based chemotherapy, in line with NICE TA381.

 

 
Link  NICE TA381: Olaparib for maintenance treatment of relapsed, platinum-sensitive, BRCA mutation-positive ovarian, fallopian tube and peritoneal cancer after response to second-line or subsequent platinum-based chemotherapy
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
   
Osimertinib (Tagrisso®)
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Formulary

Red Traffic Light For treating locally advanced or metastatic EGFR T790M mutation-positive non-small-cell lung cancer as per NICE TA416.

APCO November 2016.

Black Traffic Light Not recommended for untreated EGFR mutation-positive non-small-cell lung cancer as per NICE TA621.

APCO March 2020.

 
Link  NICE TA416: Osimertinib for treating locally advanced or metastatic EGFR T790M mutation-positive non-small-cell lung cancer
Link  NICE TA621: Osimertinib for untreated EGFR mutation-positive non-small-cell lung cancer
   
Pomalidomide (Imnovid®)
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Formulary
High Cost Medicine
Cancer Drugs Fund
NHS England

Red Traffic Light For the treatment of multiple myeloma previously treated with lenalidomide and bortezomib as per NICE TA427.

Funded by specialised commissioning.

APCO March 2017.

Black Traffic Light Not recommended with bortezomib and dexamethasone for treating relapsed or refractory multiple myeloma (NICE TA602 - terminated appraisal).

APCO November 2019.

 
Link  NICE TA427: Pomalidomide for myeloma
Link  NICE TA602: Pomalidomide with bortezomib and dexamethasone for treating relapsed or refractory multiple myeloma (terminated appraisal)
Link  MHRA: Risk of cardiac failure, ILD & hepatoxicity with pomalidomide
Link  MHRA: Risk of Hepatitis B Reactivation
   
Rucaparib (Rubraca®)
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Formulary
Red
NHS England

For maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer in line with NICE TA611. 

Funded by specialised commissioning.

APCO January 2020.

 
Link  NICE TA611: Rucaparib for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer
   
Teriflunomide (Aubagio®)
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Formulary
Red
High Cost Medicine

For treating relapsing-remitting multiple sclerosis as per NICE TA303.

APCO March 2014.

 
Link  NICE TA303: Teriflunomide for relapsing remitting MS
Link  NICE TA405:Trifluridine–tipiracil for previously treated metastatic colorectal cancer
   
Thalidomide (Celgene®)
(Haematology)
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Formulary
Red
High Cost Medicine

For the first‑line treatment of multiple myeloma as per NICE TA228.

APCO September 2011.

 
Link  MHRA: Risk of arterial and venous thromboembolism
Link  MHRA: Risk of second primary malignancies
   
Tisagenlecleucel (Kymriah®)
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Red
  • For treating relapsed or refractory B-cell acute lymphoblastic leukaemia in people aged up to 25 years as per NICE TA554 (APCO March 2019).
  • for treating relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic therapies as per NICE TA567 (APCO May 2019).

Funded by specialised commissioning.

 

 
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
Peginterferon Alfa (Pegasys®)
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Formulary
Red
High Cost Medicine

For the treatment of:

  • Hepatitis B as per NICE TA96
  • Hepatitis C as per TA75, TA106, TA200 and TA300.

Funded by specialised commissioning.

APCO July 2005.

 
Link  NICE TA106: Hepatitis C - peginterferon alfa & ribavirin
Link  NICE TA200: Hepatitis C - peginterferon alfa & ribavirin
Link  NICE TA300: Hepatitis C - peginterferon alfa
Link  NICE TA75: Hepatitis C - pegylated interferons, ribavirin & alfa interferon
Link  NICE TA96: Hepatitis B - peginterferon alfa
   
Peginterferon Alfa (ViraferonPeg®)
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Formulary
Red
High Cost Medicine

For the treatment of:

  • Hepatitis B as per NICE TA96
  • Hepatitis C as per TA75, TA106, TA200 and TA300.

Funded by specialised commissioning.

APCO November 2010.

 
   
08.02.04  Expand sub section  Interferon beta
Interferon Beta-1a (Avonex® )
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Formulary
Red
NHS England

For treating multiple sclerosis as per NICE TA527. 

Funded by specialised commissioning.

APCO July 2018.

 
Link  Commissioning Policy - Multiple Sclerosis
Link  MHRA: Interferon-beta: risk of thrombotic microangiopathy and risk of nephrotic syndrome
Link  NICE TA527:Beta interferons and glatiramer acetate for treating multiple sclerosis
   
Interferon Beta-1a (Rebif®)
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Formulary
Red
NHS England

For treating multiple sclerosis as per NICE TA527.

Funded by specialised commissioning. 

APCO July 2018.

 
Link  Commissioning Policy - Multiple Sclerosis
Link  MHRA: Interferon-beta: risk of thrombotic microangiopathy and risk of nephrotic syndrome
Link  NICE TA527:Beta interferons and glatiramer acetate for treating multiple sclerosis
   
Interferon Beta-1b (Extavia®)
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Formulary
Red
NHS England

For treating multiple sclerosis as per NICE TA527.

Funded by specialised commissioning.

APCO July 2018.

 
Link  Commissioning Policy - Multiple Sclerosis
Link  MHRA: Interferon-beta: risk of thrombotic microangiopathy and risk of nephrotic syndrome
Link  NICE TA527:Beta interferons and glatiramer acetate for treating multiple sclerosis
   
Peginterferon Beta-1a (Plegridy®)
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Formulary
High Cost Medicine
NHS England

Red  For treating relapsing–remitting multiple sclerosis as per NICE TA624. Funded by specialised commissioning.

APCO March 2020. 

 
Link  NICE TA624: Peginterferon beta-1a for treating relapsing–remitting multiple sclerosis
   
08.02.04  Expand sub section  Interferon gamma
08.02.04  Expand sub section  Aldesleukin to top
Aldesleukin (Proleukin®)
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Formulary
Red
High Cost Medicine

Secondary care use only. 

 
   
BCG bladder instillation (ImmuCyst®)
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Formulary
Red

Secondary care use only. 

 
   
BCG bladder instillation (OncoTICE®)
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Formulary
Red

Secondary care use only. 

 
   
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 (Copaxone®)
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Formulary
Red
High Cost Medicine
NHS England

Red Traffic Light  For treating multiple sclerosis as per NICE TA527.

Funded by specialised commissioning.

APCO July 2018.

 
Link  NICE TA527:Beta interferons and glatiramer acetate for treating multiple sclerosis
Link  Commissioning Policy: Multiple Sclerosis
   
08.02.04  Expand sub section  Histamine
08.02.04  Expand sub section  Lenalidomide, pomalidomide, and thalidomide
08.02.04  Expand sub section  Mifamurtide
08.02.04  Expand sub section  Natalizumab
Natalizumab (Tysabri®)
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Formulary
Red
High Cost Medicine

For the treatment of adults with highly active relapsing–remitting multiple sclerosis as per NICE TA127.

Funded by specialised commissioning.

APCO September 2012.

 
Link  NICE TA127: Multiple sclerosis - natalizumab
Link  Commissioning Policy - Multiple Sclerosis
Link  MHRA: Early detection of progressive multifocal leukoencephalopathy
   
08.02.04  Expand sub section  Teriflunomide to top
 ....
 Non Formulary Items
Canakinumab  (Ilaris®)

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Non Formulary
Black
High Cost Medicine

For treating gouty arthritis attacks and reducing the frequency of subsequent attacks as per NICE TA281 (terminated appraisal).

APCO May 2013.

Link  NICE TA281: Canakinumab for treating gouty arthritis attacks and reducing the frequency of subsequent attacks (terminated appraisal)
 
Cediranib  (Recentin®)

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Non Formulary
 
Cobimetinib  (Cotellic®)

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Non Formulary
Black

Not recommended for treating unresectable or metastatic melanoma in adults with a BRAF V600 mutation as per NICE TA414.

APCO November 2016.

Link  NICE TA414: Cobimetinib in combination with vemurafenib for treating unresectable or metastatic BRAF V600 mutation-positive melanoma
 
Fampridine

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Non Formulary
High Cost Medicine
 
Interferon Alfa
(IntronA)

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Non Formulary
High Cost Medicine
Link  NICE TA75: Interferon Alfa - Chronic Hepatitis C
 
Interferon Alfa  (Roferon-A®)

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Non Formulary
High Cost Medicine
 
Interferon Alfa  (Viraferon®)

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

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Non Formulary
Black
NHS England

 For treating multiple sclerosis as per NICE TA527.

APCO July 2018. 

Link  Commissioning Policy - Multiple Sclerosis
Link  MHRA: Interferon-beta: risk of thrombotic microangiopathy and risk of nephrotic syndrome
Link  NICE TA527:Beta interferons and glatiramer acetate for treating multiple sclerosis
 
Mifamurtide  (Mepact®)

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Non Formulary
Link  NICE TA235: Osteosarcoma - mifamurtide: guidance
 
Pemrolizumab  (Keytruda®)

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Non Formulary
 
  
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

Red

Red: Medicines which should only be prescribed in secondary care by a specialist.  

Amber Continuation

Amber Continuation: Medicines which should be initiated or recommended by a specialist for continuation in primary care. The specialist must notify the GP that the prescribing responsibility has been transferred.   

Amber Shared Care Protocol

Amber Shared Care Protocol: Medicines which are appropriate to be initiated and stabilised by a specialist, once stabilised the medicine may be appropriate for responsibility to be transferred from secondary to primary care with the agreement of a GP and a formal ‘shared care’ agreement. The shared care protocol must be approved by the Area Prescribing Committee Oxfordshire (APCO).   

Green

Green: Medicines which are suitable for initiation and ongoing prescribing within primary care.   

Brown

Brown: Medicines which should only be prescribed in restricted circumstances.  

Black

Black: Medicines which are not recommended for use because of lack of evidence of clinical effectiveness, cost effectiveness or safety.  

OCCG Green

not used  

netFormulary