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 Formulary Chapter 13: Skin - Full Chapter
Notes:
Please contact EKHUFT Medicines Information ext. 7236001 or 01233 616001 with any queries.NHS
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13.05.03  Expand sub section  Drugs affecting the immune response
 note 

Warning  No F1 (First year foundation programme) doctor may prescribe a cytotoxic drug in the Trust. All other doctors may only prescribe having competency for that cytotoxic drug and route in that indication.

Adalimumab (Humira)
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Restricted Drug Restricted
Red
CCG
Homecare
BlueTeq

Injection: Multiple biosimilar brands Black triangle drug New patients have to use contract brands and most patients will have switched to one of these

NHS status NHS use and access depends upon indication:

  • Psoriasis (as per NICE TA 146)

    1. Dermatologist
    2. PBR excluded drug via Blueteq (CCG commissioned)
    3. Usually supplied via homecare, usually Healthcare at Home
  • Restricted Item NHS England does not commission the Trust to deliver TA392 Adalimumab for treating moderate to severe hidradenitis suppurativa. According for this indication the drug is non formulary and patients will have to be referred to an NHS specialist dermatology service.



Non - dermatological indications include:

 

  • Adult Rheumatoid/Psoriatic Arthritis as per relevant NICE TAs(eg TA199)

    1. Rheumatologist(Dermatologist)
    2. PBR excluded drug via Blueteq (CCG commissioned)
    3. Usually supplied via homecare, usually Healthcare at Home
  • Crohns Disease (as per NICE TA187)

    1. Gastroentrologist
    2. PBR excluded drug via Blueteq (CCG commissioned)
    3. Usually supplied via homecare, usually Healthcare at Home
  • Juvenile arthritis

    1. Initiation by Specialist Centre(NHS England commissioned)
    2. Suitable for shared care between specialist and secondary care via network model (ie initiating Trust would have to subcommission EKHUFT)
  • UPDATE NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis - EKHUFT is not commissioned by NHSE to provide this treatment
  • UPDATE NICE TA375:Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed; These drugs are for adults with severe rheumatoid arthritis who have tried conventional DMARDs only but they have not worked.

    NHS status Uveitis - paediatric

    1. Initiation and supply by Specialist Centre Only(NHS England access via IFR possible)

    NHS status TA262:Unable to recommend NHS use for Ulcerative colitis (moderate to severe, second line). TA terminated due to lack of evidence submission

    UPDATE NICE TA383:TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
 
Link  NICE TA 146: Adalimumab for the treatment of adults with psoriasis
Link  NICE TA 199: Psoriatic arthritis-Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis
Link  NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis
Link  NICE TA375: Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
Link  NICE TA383:TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
   
Cytotoxic Drug Azathioprine
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Restricted Drug Restricted
Amber 1
Tablets
  • Dermatologists
     
  • Link  UKMI QA: Can mothers breastfeed while taking azathioprine?
       
    Cytotoxic Drug Ciclosporin
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    Restricted Drug Restricted
    Amber 2
    Capsules as Neoral, IV infusion as concentrate, Oral solution as Neoral
  • Dermatologists
  • Patients should be stabilised on a particular brand of oral ciclosporin because switching between formulations without close monitoring may lead to clinically important changes in blood-ciclosporin concentration. Prescribing and dispensing of ciclosporin should be by brand name to avoid inadvertent switching. If it is necessary to switch a patient to a different brand of ciclosporin, the patient should be monitored closely for changes in blood-ciclosporin concentration, serum creatinine, blood pressure, and transplant function.
    NHS continuationNHS England transplant immunosuppression only if formal repatriation agreed (contact pharmacy first)




     
  •    
    Etanercept (Enbrel)
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    Restricted Drug Restricted
    Red
    CCG
    BlueTeq

    Injection (most NHS patients will be on new brands Black triangle drug)

    • Dermatologists
    • PBR excluded drug via MM1
    • Usually supplied via homecare, usually Healthcare at Home

      Warning WARNING - There have been rare reports (<0.1%) of new onset heart failure, including in patients less than 50 years of age without pre-existing heart disease.

    • UPDATE: NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis - EKHUFT is not commissioned by NHSE to provide this treatment.
    • UPDATE NICE TA375:Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed; These drugs are for adults with severe rheumatoid arthritis who have tried conventional DMARDs only but they have not worked.

      UPDATE NICE TA383:TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
     
    Link  NICE TA103: Psoriasis - Etanercept and efalizumab for the treatment of adults with psoriasis
    Link  NICE TA373: Abatacept, adalimumab, etanercept and tocilizumab for treating juvenile idiopathic arthritis
    Link  NICE TA375: Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
    Link  NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
       
    Hydroxychloroquine
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    Restricted Drug Restricted
    Amber

    Tablets - Not approved for use as specific COVID-19 treatment except in RECOVERY trial - see FAQs on Prescribing Appendix 5 for dosing regime in RECOVERY trial. 

    • Dermatologist and Rhematologist initiation only

    Warning  All patients on long term treatment need ophthalmic monitoring

     
       
    Infliximab (Remicade, Inflectra)
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    Restricted Drug Restricted
    Red
    CCG
    BlueTeq

    Injection.(many of new branded biosimilars used on NHS patients are Black triangle drug)
    note Once patient started on one brand they should continue with same brand. From June 2015 patients in the Trust will start on Inflectra®.

    NHS continuation

    • CCG commissioned for NICE Adult TA's

      • Rheumatologists(TA130, TA140,TA163, TA199)
      • Gastroenterologists(TA187)
      • Dermatologists, for NICE TA134 indication, HCD locally funded via MM1 for hydradenitis supprativa
      • PBR excluded drug via Blueteq
    • NHS England commissioned services (paediatrics) for NICE TA's (TA130, TA134, TA140, TA143, TA163, TA199) if sub-commissioned (always contact pharmacy)

      NHS statusNot routinely commissioned for:
    • Connective tissue disease - interstitial lung disease
    • Renal autoimmune indications
    • Sarcoidosis
    • Uveitis - paediatric
    • Other dermatological conditions including pyoderma gangrenosum as of April 2013 in Kent and Medway. Business case for use in pyoderma gangrenosum if submited will be considered in next prioritisation round
    • UPDATE NICE TA375:Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed; These drugs are for adults with severe rheumatoid arthritis who have tried conventional DMARDs only but they have not worked.

      UPDATE NICE TA383:TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
     
    Link  NICE TA134: Infliximab for the treatment of adults with psoriasis
    Link  NICE TA375: Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed
    Link  NICE TA383: TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
    Link  Not Routinely Commissioned Clinical Commissioning Policy 1673 for Infliximab for Progressive Pulmonary Sarcoidosis in Adults
       
    Ixekizumab  (Taltz)
    (injection pre-filled pen)
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    Restricted Drug Restricted
    Amber
    CCG
    BlueTeq
     
    Link  NICE TA537 Ixekizumab for treating active psoriatic arthritis after inadequate response to DMARDs
       
    Cytotoxic Drug Methotrexate
    (Dermatologists)
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    Restricted Drug Restricted
    Amber

    Warning The drug is only given weekly in its immunosuppressive indications. Internal drug charts must be scored out on the days it is not to be administered. Those administering the drug on an internal script must first check that the script has been endorsed as safe by a pharmacist. Exceptionally out of hours administration is possible on scripts endorsed by a ST3 level or above trainee in GIM or specialist physician. Note that inappropriate administration of daily oral methotrexate (even without harm) using an electronic prescribing/administration system is regarded as an NHS Never Event.
    Warning Withhold during antibiotic courses and in acute kidney injury.

    • Consultant initiation only
    • Patients should have a methotrexate diary
    • Methotrexate is available as 2.5mg and 10mg tablets. This is a potential cause of confusion and has led to patients taking accidental overdoses. To avoid this only 2.5mg tablets should be prescribed and specified on the prescription.
       
        F2 doctors can only prescribe or transcribe for immunosuppression if competency formally established and signed off. All other doctors may only prescribe having competency for drug and route in that indication.
       
     
    Link  Methotrexate Prescribing Safety Checklist
    Link  UKMI Q&A: What is the clinical significance of the interaction between methotrexate and penicillins?
    Link  UKMI QA: Methotrexate and alcohol guidelines
       
    Cytotoxic Drug Mycophenolate Mofetil
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    Restricted Drug Restricted
    Amber
    Capsules/tablets
  • Dermatologists
  • Out of license use in severe refactory eczema
    Mycophenolate mofetil (CellCept) and mycophenolic acid: risk of hypogammaglobulinaemia and risk of bronchiectasis 
  • Link  NICE ESUOM32 Scleroderma: oral mycophenolate
       
    Pimecrolimus (Elidel)
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    Restricted Drug Restricted
    Green
    Cream 1%
  • Dermatologists

    Critical medication: Omission of this medication in some of its indications can lead to serious patient harm of death. Please see continuity of critical medicines guidelines and procedure how to obtain medicines out of hours.  
  • Link  NICE TA82: Pimecrolimus and tacrolimus for atopic dermatitis (eczema)
       
    Risankizumab (Skyrizi)
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    Formulary
    Red
    High Cost Medicine

     

     

    To be prescribed by Consultant Dermatologists only

     
       
    Tacrolimus (Protopic)
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    Restricted Drug Restricted
    Green
    Ointment 0.03% and 0.1%
  • Dermatologists
     
  • Link  NICE- Full Guidance on the management and treatment of Eczema
       
    Thalidomide
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    Restricted Drug Restricted
    Red
    Capsules
  • Dermatologists
  • Out of licensed use in dermatological conditions
  • Will require IFR application
  • PBR excluded drug
  • Must follow pregnancy prevention plan 
  •    
    Cytotoxic Drug Tioguanine
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    Restricted Drug Restricted
    Red
    Tablets 40mg
  • Dermatologists
  • Previously thioguanine 
  •    
    Ustekinumab
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    Restricted Drug Restricted
    Red
    CCG
    BlueTeq

    Injection

    • Dermatologists
    • PBR excluded drug via MM1
    • Usually supplied via homecare, usually Medco

      Star High cost drug reimbursed separately from NHS England tariff (PBR excluded)
     
    Link  NICE TA180: Psoriasis - ustekinumab
    Link  NICE TA340: Ustekinumab for treating active psoriatic arthritis (rapid review of technology appraisal guidance 313)
    Link  Ustekinumab for treating moderately to severely active ulcerative colitis
       
     ....
     Non Formulary Items
    Efalizumab  (Raptiva)

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    Non Formulary Drug was discontinued in 2009
     
      
    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
    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

    Amber

    Requires to be initiated by specialist for repeat GP Prescribing (Purple as per Eclipse East Kent Primary Care Formulary, may be top sliced) If a downloadable EKPG Prescribing Information Sheet exists in the formulary entry for the drug, it, or an URL (shortcut to webpage/document) should be sent to the GP. See also "Hints in how to incorporate documents for medicines information into clinical communications to GPs".  

    Amber 1

    Shared Care (Orange as per Eclipse East Kent Primary Care Formulary). See the Principles of Shared Care Agreements and Shared Care Agreements: Assessment against agreed Principles of Shared Care documents. If a downloadable template document exists in the formulary entry for this drug, it should be sent to the GP (and patient) once patient specific details are incorporated. See "Hints in how to incorporate shared care documents for medicines into clinical communications to GPs".  

    Amber 2

    Shared Care and topsliced (Orange as per Eclipse East Kent Primary Care Formulary) See the Principles of Shared Care Agreements and Shared Care Agreements: Assessment against agreed Principles of Shared Care documents. If a downloadable template document exists in the formulary entry for this drug, it should be sent to the GP (and patient) once patient specific details are incorporated. See "Hints in how to incorporate shared care documents for medicines into clinical communications to GPs".  

    Black

    A decision has been made by either or both the local or national NHS not to routinely commission this preparation for its licensed indications  

    Blue

    No comment on drug in East Kent Primary Care Formulary (Blue as per Eclipse East Kent Primary Care Formulary)  

    Brown

    Exceptional Use Only (Brown as per Eclipse East Kent Primary Care Formulary)   

    Green

    On East Kent Primary Care Formulary (Pink or Green as per Eclipse East Kent Primary Care Formulary)  

    Grey

    Not assessed/Not recommended (As per Eclipse East Kent Primary Care Formulary)  

    Red

    Hospital Only (As per Eclipse East Kent Primary Care Formulary)  

    RedRed

    Known to be commissioned for local NHS patients but only available to them from another provider than EKHUFT  

    netFormulary