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 Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
Notes:
Further information on specific drugs available locally and the pathways used is available from the East Midlands Cancer Network.  This includes drugs reviewed as part of NICE technology appraisals


The East Midlands has adopted the Palliative Adult Network Guidelines(PANG) as the single guideline across the region to conform with the requirement for a single guideline within a cancer network.  These are freely available to healthcare professionals.
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08.01  Expand sub section  Cytotoxic drugs
 note  See East Midlands Cancer Network website and Palliative Adult Network Guidelines
08.02.01  Expand sub section  Antiproliferative immunosuppressants
 note  Section in development - currently contains only drugs supported by TAS since 2000
08.02.02  Expand sub section  Corticosteroids and other immunosuppressants
 note  Section in development
Currently includes high cost drugs excluded to tariff only plus drugs considered by TAS since 2000
Basiliximab
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
Specialist prescribing only in Renal Transplant in line with NICE TA 481 and TA 482
High cost drug excluded to tariff, NHSE commissioned  
Link  NICE TA 481: Immunosuppressive therapy for kidney transplant in adults
Link  NICE TA 482: Immunosuppressive therapy for kidney transplantation in children and young people
   
Everolimus
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Red
Immunosupression for the prevention of organ rejection after kidney transplant. In line with NICE TA 481 and 482 
   
Mycophenolic acid (Myfortic®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted Specialist renal use in renal transplant only  
Link  MHRA Advice: Mycophenolate mofetil, mycophenolic acid: new pregnancy-prevention advice for women and men
   
Sirolimus
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Restricted Drug Restricted
Red
Red for immunosuppression post renal transplant 
   
Tacrolimus (Adoport®, Prograf® or Modigraf®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Amber SCA
High Cost Medicine
Immunosuppression post renal transplant - prescribe by brand name only as different brands are not interchangeable. Specialist renal initiation only
Shared care request is mandatory 
Link  SCA: Tacrolimus, maintenance of immunosuppression following Renal transplantation
   
Tacrolimus SR (Envarsus®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
Once daily preparation. Prophylaxis of transplant rejection in adult kidney transplants. Must be prescribed by brand and not interchangeable with other brands. Total required daily dose is different to other brands of tacrolimus so must not be substituted with other brands 
   
Antithymocyte immunoglobulin (rabbit)
View adult BNF View SPC online
Restricted Drug Restricted
Red
High Cost Medicine
Specialist use only
High cost drug excluded to tariff, commissioned by NHSE in line with BCSH Guidelines only 
Link  BCSH Guidelines
   
08.02.03  Expand sub section  Anti-lymphocyte monoclonal antibodies
Rituximab
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Restricted Drug Restricted
Red
Specialist use only
Supported in line with NICE TA 308 only
High Cost Drug excluded to tariff, commmissioned by NHSE for this indication  
Link  NHSE Commissioning Policy: ANCA-positive vasculitis
Link  NHSE Commissioning Policy: Rituximab for second line treatment for anti-NMDAR autoimmune encephalitis
Link  NICE TA 308: Rituximab in combination with glucocorticoids for treating anti-neutrophil cytoplasmic antibody-associated vasculitis
   
08.02.04  Expand sub section  Other immunomodulating drugs to top
 note  For drugs used in cancer please see EM Cancer Network website.
Glatiramer Acetate (Copaxone®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
BlueTeq

Specialist Neurology prescribing only
High Cost Drug excluded to tariff (NHSE)
See HSC 2002/004 below for conditions of use
Co-paxone 40mg/ml 3 x weekly supported by NHSE and TAS
Blueteq prior approval required before initiation

 
   
Interferon alfa
View adult BNF View SPC online
Restricted Drug Restricted
Red
Specialist prescribing only in Hepatitis B&C
High cost drug excluded to tariff. Commissioned by NHSE in line with NICE TA 75 only
 
Link  NICE TA75: Interferon alfa (pegylated and non-pegylated) and ribavirin for the treatment of chronic hepatitis C
   
Interferon beta
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
NHS England
BlueTeq

Specialist Neurology prescribing only
Includes Avonex®,Rebif® and Betaferon ®(Interferon beta-1b)
High cost drug excluded to tariff (NHSE)
Blueteq prior approval required before initiation
See HSC 2002/004 below for conditions of use

 
Link  MHRA Advice: Interferon-beta: risk of thrombotic microangiopathy and risk of nephrotic syndrome
   
Interferon beta-1a (Rebif®)
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Formulary
High Cost Medicine
NHS England
BlueTeq

For Multiple sclerosis in adults in line with NICE TA 527

Blueteq prior approval required before initiation

Implementation Date: September 2018

 
   
Peginterferon alfa
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Restricted Drug Restricted
Red
Hepatitis B&C treatment
High cost drug excluded to tariff. Commissioned by NHSE in line with NICE TA75, TA96, TA106, TA200, TA 300, CG165
 
Link  NICE CG 165: Hepatitis B (chronic): Chronic hepatitis B in children, young people and adults
Link  NICE TA 106: Peginterferon alfa and ribavirin: mild chronic hepatitis C
Link  NICE TA 200: Peginterferon alfa and ribavirin:chronic hepatitis C
Link  NICE TA 300: Peginterferon alfa and ribavirin:chronic hepatitis C in children and young people
Link  NICE TA 75 Interferon alfa (pegylated and non-pegylated) and ribavirin: chronic hepatitis C
   
Peginterferon beta 1a (Plegridy ®)
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Restricted Drug Restricted
Red
Specialist Neurology prescribing only
High cost drug excluded to tariff (NHSE)
Two weekly administration
See HSC 2002/004 for conditions of use  
   
Cladribine (Mavenclad®)
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Restricted Drug Restricted
Red
High Cost Medicine
NHS England
BlueTeq

Specialsit neurologist prescribing only. 
For use in line with NICE TA 493
Blueteq prior approval required before initiation
Date decision added to Formulary: March 2018

 
Link  NICE TA 493: Cladribine tablets for treating relapsing–remitting multiple sclerosis
   
Dimethyl Fumarate
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Restricted Drug Restricted
Red
BlueTeq

Supported in line with NICE TA 320 only.
Specialist neurology prescribing
Blueteq prior approval required before initiation

Date decision added to Formulary: November 2014

 
Link  MHRA Advice: Dimethyl fumarate (Tecfidera): updated advice on risk of progressive multifocal leukoencephalopathy
Link  NICE TA 320: Dimethyl fumarate for Multiple Sclerosis
   
Teriflunomide  (Aubagio®)
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Restricted Drug Restricted
Red
High Cost Medicine
BlueTeq

Specialist Neurology prescribing only in line with NICE TA 303
High Cost Drug excluded to tariff (NHSE)
Blueteq prior approval required before initiation

Date of entry of decision to Formulary: April 2014

 
Link  NICE TA 303:Teriflunomide for treating relapsing–remitting multiple sclerosis
   
Alemtuzumab
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
BlueTeq

Supported by TAS in line with NICE TA 312.

Blueteq prior approval required before initiation

Date decision added to Formulary: August 14

 
Link  MHRA Advice: Alemtuzumab and serious cardiovascular and immune-mediated adverse reactions
Link  NICE TA 312: Alemtuzumab for Multiple Sclerosis
   
Daclizumab
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
Supported by TAS in line with NICE TA 441

Blueteq prior approval required before initiation

Date decision added to Formulary: July 17  
Link  NICE TA 441: Daclizumab for treating relapsing–remitting multiple sclerosis
   
Natalizumab  (Tysabri®)
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Restricted Drug Restricted
Red
High Cost Medicine
NHS England
BlueTeq

Specialist Neurology prescribing only in line with NICE TA 127.
High cost drug excluded to tariff (NHSE)
Blueteq prior approval required before initiation

 
Link  MHRA Advice: Natalizumab (Tysabri▼): progressive multifocal leukoencephalopathy - updated advice to support early detection
Link  NICE TA 127: Natalizumab for the treatment of adults with highly active relapsing–remitting multiple sclerosis
   
Fingolimod (Gilyena®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
NHS England
BlueTeq

Specialist Neurology prescribing only in line with NICE TA 254
High cost drug excluded to tariff (NHSE)
Blueteq prior approval required before initiation

Date of entry of decision to Formulary: July 2012

 
Link  MHRA Advice: Fingolimod (Gilenya▼): risks of progressive multifocal leukoencephalopathy, basal-cell carcinoma, and opportunistic infections
Link  MHRA Advice: Fingolimod (Gilenya): Increased risk of congenital malformations; new contraindication during pregnancy and in women of childbearing potential not using effective contraception
Link  NICE TA 254: Fingolimod for the treatment of highly active relapsing–remitting multiple sclerosis
   
Beta-interferon-1a (Avonex®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
NHS England
BlueTeq

For Multiple sclerosis in adults in line with NICE TA 527

Blueteq prior approval required before initiation

Implementation Date: September 2018 

 
Link  NICE TA 527: Beta interferons and glatiramer acetate for treating multiple sclerosis
   
Beta-interferon-1b (Betaferon®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
NHS England
BlueTeq

For Multiple sclerosis in adults in line with NICE TA 527

Blueteq prior approval required before initiation

Implementation Date: September 2018 

 
Link  NICE TA 527: Beta interferons and glatiramer acetate for treating multiple sclerosis
   
Beta-interferon-1b (Extavia®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
NHS England
BlueTeq

For Multiple sclerosis in adults in line with NICE TA 527

Blueteq prior approval required before initiation

Implementation Date: September 2018 

 
Link  NICE TA 527: Beta interferons and glatiramer acetate for treating multiple sclerosis
   
Glatiramer Acetate (Copaxone®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
NHS England
BlueTeq

For Multiple sclerosis in adults in line with NICE TA 527

Blueteq prior approval required before initiation

Implementation Date: September 2018 

 
Link  NICE TA 527: Beta interferons and glatiramer acetate for treating multiple sclerosis
   
Ocrelizumab (Ocrevus®)
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
NHS England
BlueTeq

For relapsing-remitting multiple sclerosis in line with NICE TA 533. For primary progressive multiple sclerosis in line with NICE TA 585

 

Blueteq prior approval required before initiation

Date decision added to Formulary: October 2018

 
Link  NICE TA 533: Ocrelizumab for treating relapsing–remitting multiple sclerosis
Link  NICE TA 585: Ocrelizumab for treating primary progressive multiple sclerosis
   
08.03.04  Expand sub section  Hormone antagonists
08.03.04.01  Expand sub section  Breast cancer
Anastrozole
View adult BNF View SPC online  Track Changes
Formulary
Amber Simple

Off label chemoprevention to reduce incidence of breast cancer.
Use in line with NICE CG 164

 
Link  NICE CG 164: Familial breast cancer: managing breast cancer and related risks in people with a family history of breast cancer
   
Exemestane
View adult BNF View SPC online
Formulary
Amber Simple
 
   
Letrozole
View adult BNF View SPC online
Formulary
Amber Simple
 
   
Tamoxifen
View adult BNF View SPC online  Track Changes
Formulary
Amber Simple

For treatment and prevention of breast cancer.

 
   
Fulvestrant
View adult BNF View SPC online
Formulary
Amber Simple
 
Link  Simple amber: Fulvestrant
   
08.03.04.02  Expand sub section  Prostate cancer and gonadorelin analogues
 note 
08.03.04.02  Expand sub section  Gonadorelin analogues
 note 
  • The NICE clinical guidance on prostate cancer does not recommend which GnRHa should be prescribed.
  • There is no conclusive evidence to suggest that one GnRHa is more effective or has fewer side effects than other analogues for the treatment of prostate cancer.
  • Taking this into account, the first line formulary choice in Leicestershire and Rutland is: Triptorelin (Decapeptyl SR® ) every 6 months.
  • Existing patients in primary care with a stable PSA may be switched to Triptorelin pamoate 22.5mg every 6 months (Decapeptyl SR® ) even if this is different from that recommended by secondary care.
Triptorelin
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First Choice
Green
Intramuscular injection available as a one, three and six monthly preparation. Patients in primary care with a stable PSA may be switched to the six monthly preparation even if this is different from that recommended by secondary care. 
Goserelin
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Green
Subcutaneous injection for patients with a contraindication to intramuscular injection 
   
Leuprorelin acetate
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Green
This preparation can be given by subcutaneous injection for patients with a contraindication to intramuscular injection. 
   
08.03.04.02  Expand sub section  Gonadotrphin-releasing hormone antagonists to top
Bicalutamide
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Amber Simple
For prostate cancer 
   
Degarelix
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Amber Simple
Where there is an acute need for immediate testosterone suppression.
Recommended as an option for treating advanced hormone-dependent prostate cancer in patients with spinal metastases in line with NICE TA 404. 
Link  NICE TA 404: Degarelix for treating advanced hormone-dependent prostate cancer
Link  Simple Amber List
   
08.03.04.03  Expand sub section  Somatostatin analogues
Lanreotide
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
For Acromegaly
Red for new patients  
   
Octreotide
View adult BNF View SPC online  Track Changes
Restricted Drug Restricted
Red
High Cost Medicine
For Acromegaly
Red for new patients  
   
 ....
 Non Formulary Items
Tacrolimus SR  (Advagraf®)

View adult BNF View SPC online
Non Formulary
Black
Oral tacrolimus products should be prescribed and dispensed by brand name only
Link  Leicestershire Evaluation: Advagraf® in Rejection
 
  
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
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

Drugs not recommended for use in the Leicestershire Health Community because of lack of evidence of clinical effectiveness, cost prioritization or concerns over safety. All new drugs will be black until they have been through the appropriate approval process - then they will appear as a specific entry   

Red

Drugs which should be prescribed only by hospital specialists (clinical review by specialist as appropriate and annually as a minimum).  

Amber SCA

Drugs which would initially be prescribed by a hospital specialist and then by a GP where full agreement to share the care of each specific patient has been reached under a LMSG Shared Care Agreement (SCA). Specific patient monitoring or intervention required.   

Amber Simple

Drugs suitable to be initiated and prescribed in primary care only after specialist assessment and recommendation. A shared care agreement is not required.  

Green Conditional

Drugs for which GPs are able to take full responsibility for prescribing and monitoring subject to specified conditions e.g. prescribing in line with agreed LMSG guidance or able to demonstrate suitable competence see comments under individual entries.   

Green

Drugs for which GPs would normally take full responsibility for prescribing and monitoring. Drugs included in this list have been specifically considered by LMSG.   

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