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 Formulary Chapter 13: Skin - Full Chapter
Notes:

Review date: September 2021

Non-formulary drugs - any drug or formulation not listed in the formulary is deemed to be non-formulary.

Off-label use: Drugs are included in the formulary for their licensed indications – where inclusion of off-label use is considered to be included in the formulary this is specifically stated in the formulary entry for the drug N.B. also see Paediatrics note below.

Paediatrics: Drugs are included in the formulary for paediatric use for their BNF for Children recommended indications (indicated by symbol View childrens BNF) which may be off-label, unless otherwise stated. All drugs are deemed to have the same RAG status as they have for adults unless stated otherwise.

NHS England Specialised Commissioning
Drugs carrying the NHS England logo are commissioned by them. Links to key documents, national programmes of care, and clinical reference groups are found below.

NHSE NHS England Specialised Commissioning: Key documents

NHSE NHS England Specialised Commissioning: National programmes of care and clinical reference groups





Chapter Links...
 Details...
13.05.03  Expand sub section  Drugs affecting the immune response
 note 

 

Pimecrolimus
View adult BNF View SPC online View childrens BNF
Formulary
Amber Initiated

1% (Elidel®) Cream; 30 g, 60 g, 100 g In line with NICE TA 82 - Tacrolimus and pimecrolimus for atopic eczema (see also NICE CG 153 –Psoriasis - off label indication) Topical preparations

 
Link  NICE CG 153 –Psoriasis
Link  NICE TA82: Pimecrolimus and tacrolimus for atopic dermatitis (eczema)
   
Tacrolimus
View adult BNF View SPC online View childrens BNF
Formulary
Amber Initiated

0.03%, 0.1% (Protopic®) Ointment; 30g, 60g In line with NICE TA 82 - Tacrolimus and pimecrolimus for atopic eczema (see also NICE CG 153 –Psoriasis - off label indication) Topical preparation

 
Link  NICE CG 153 –Psoriasis - off label indication
Link  NICE TA82: Pimecrolimus and tacrolimus for atopic dermatitis (eczema)
   
Azathioprine
View adult BNF View SPC online View childrens BNF
Formulary
Purple

Tablets 25 mg, 50 mg Oral preparation Off label

Red Paediatrics

 
Link  Pan Mersey Shared Care Framework for Azathioprine
Link  St Helen’s & Knowsley Hospitals’ Shared Care Framework
   
Ciclosporin
View adult BNF View SPC online View childrens BNF
Formulary
Purple

Capsules 10 mg, 25 mg, 50 mg, 100 mg (Deximune®, Neoral®, Capimune®)

Pan Mersey first line recommended brand is Capimune®

Oral solution 100 mg/mL (Neoral®); 50mL

NB Ciclosporin must be prescribed by brand.

Red Paediatrics

 
Link  Pan Mersey Shared Care Framework for Ciclosporin
Link  St Helen’s & Knowsley Hospitals’ Shared Care Framework
   
Methotrexate
View adult BNF View SPC online View childrens BNF
Formulary
Purple

Tablets 2.5 mg

Metoject® PEN solution for injection in prefilled pens available in a range of doses for subcutaneous administration.

Black 10mg tablets. Do not prescribe – see link below

Red Paediatrics

Red Oral solution sugar-free 2mg/ml paediatrics only

 
Link  Pan Mersey APC (2018). METHOTREXATE: safe prescribing and dispensing
Link  Pan Mersey Shared Care Framework for Methotrexate
Link  St Helen’s & Knowsley Hospitals’ Shared Care Framework
   
Mycophenolate mofetil
View adult BNF View SPC online View childrens BNF
Formulary
Purple

Capsules 250 mg: Tablets 500 mg
Oral suspension 1 g/5 mL

Expert opinion locally is that mycophenolate does not require brand prescribing – significant cost savings are available with generic prescribing Oral preparation Off label

Red Paediatrics

 
Link  MHRA advice: Mycophenolate mofetil, mycophenolic acid: updated contraception advice for male patients
Link  MHRA drug safety alert - risk of hypogammaglobulinaemia and risk of bronchiectasis.
Link  Pan Mersey Shared Care Framework for Mycophenolate mofetil
Link  St Helen’s & Knowsley Hospitals’ Shared Care Framework
   
Adalimumab
View adult BNF View SPC online View childrens BNF
Formulary
Red

Injection 40 mg prefilled pen or prefilled syringe
In line with NICE TA 146 – Adalimumab for the treatment of adults with psoriasis

NHS NHSE commissioned drug for Paediatric indications (in line with NICE TA 455) - see Specialised Commissioning: Key documents

NHS NHSE for treatment of hidradenitis suppurativa
 
NHS NHSE IFR for treatment of uveitis

Cytokine modulator

Amgevita® biosimilar brand

Hulio® biosimilar brand

Hyrimoz® biosimilar brand

Imraldi® biosimilar brand

Humira® originator brand  

Prescribe by brand name

 
Link  NICE (2008) Adalimumab for the treatment of adults with psoriasis [TA146]
Link  NICE (2016). Adalimumab for treating moderate to severe hidradenitis suppurativa [TA392]
Link  NICE (2017). Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people [TA455]
   
Brodalumab
View adult BNF View SPC online View SMC online View childrens BNF
Formulary
Red

210mg solution for injection (pre-filled syringe)

For treatment of plaque psoriasis

 
Link  BRODALUMAB solution for injection (Kyntheum®▼) for plaque psoriasis: Pan Mersey Area Prescribing Committee Policy Statement
Link  NICE TA511: Brodalumab for treating moderate to severe plaque psoriasis
   
Certolizumab pegol
View adult BNF View SPC online View childrens BNF
Formulary
Red

Subcutaneous injection 200mg (pre-filled syringe, pre-filled pen)

In line with NICE TA574: Certolizumab pegol for treating moderate to severe plaque psoriasis

 
Link  Pan Mersey APC (2019): Certolizumab pegol solution for injection (Cimzia®) for plaque psoriasis
Link  NICE TA574: Certolizumab pegol for treating moderate to severe plaque psoriasis
   
Dupilumab
View adult BNF View SPC online View childrens BNF
Formulary
Red

solution for injection 300mg; pre-filled pen

Treatment of atopic dermatitis

NHS NHS England commissioned for paediatrics (aged 12-17); must be treated within a specialised treatment centre and meet the criteria within NICE TA534 for adults.

 
Link  Pan Mersey APC (2018): DUPILUMAB injection (Dupixent®▼) for atopic dermatitis
Link  NICE TA534 (2018): Dupilumab for treating moderate to severe atopic dermatitis
   
Etanercept
View adult BNF View SPC online View childrens BNF
Formulary
Red

Injection 25 mg, 50 mg
In line with NICE TA 103 – Etanercept for the treatment of adults with psoriasis

Cytokine modulator

Benepali®,biosimilar brand

Erelzi®,biosimilar brand 
Enbrel®, originator brand
Prescribe by brand

NHS NHSE commissioned drug for Paediatric indications (in line with NICE TA 455) - see Specialised Commissioning: Key documents

 

 
Link  NICE TA 103 – Etanercept and efalizumab for the treatment of adults with psoriasis
Link  NICE TA455: Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people
   
Guselkumab
View adult BNF View SPC online View SMC online View childrens BNF
Formulary
Red

solution for injection 100mg; pre-filled syringe (Tremfya®)

For treatment of psoriasis

 
Link  NICE (2018). Guselkumab for treating moderate to severe plaque psoriasis
Link  Pan Mersey APC (2018). GUSELKUMAB solution for injection (Tremfya®▼) for Plaque Psoriasis
   
Infliximab
View adult BNF View SPC online
Formulary
Red

Injection 100 mg
Remicade® - Originator Brand
Flixabi ®, Inflectra®, Remsima® - Biosimilar Brands

Prescribe by brand

In line with NICE TA 134 – Infliximab for the treatment of adults with psoriasis

Cytokine modulator

No BNFc entry; Paediatrics, seek specialist advice 

NHS NHSE commissioned drug for Paediatric indications (where Adult TA available) - see Specialised Commissioning: Key documents

 
Link  NICE TA 134 – Infliximab for the treatment of adults with psoriasis
Link  MHRA Drug Safety Update - Biosimilar Products
Link  London Medicines Evaluation Network - Answers to commonly asked questions about biosimilar versions of ifliximab
   
Ixekizumab
View adult BNF View SPC online
Formulary
Red

80mg solution for injection (Taltz®) prefilled syringe; prefilled pen

No BNFc entry; Paediatrics, seek specialist advice 

 
Link  IXEKIZUMAB solution for injection (Taltz®▼) for Plaque Psoriasis Pan Mersey Area Prescribing Committee Policy Statement
Link  NICE TA442: Ixekizumab for treating moderate to severe plaque psoriasis
   
RisankizumabBlack Triangle
View adult BNF View SPC online
Formulary
Red

75mg solution for injection (Skyrizi®) pre-filled syringe

In line with NICE TA596: Risankizumab for treating moderate to severe plaque psorias

 
Link  Pan Mersey APC (2019): RISANKIZUMAB solution for injection (Skyrizi®▼) for plaque psoriasis
Link  NICE TA596 (2019): Risankizumab for treating moderate to severe plaque psoriasis
   
Secukinumab
View adult BNF View SPC online
Formulary
Red
High Cost Medicine

150mg solution for injection (Cosentyx®) prefilled syringe; prefilled pen.

In line with NICE TA350: Secukinumab for treating moderate to severe plaque psoriasis

No BNFc entry; Paediatrics, seek specialist advice 

 
Link  NICE TA350 - Secukinumab for treating moderate to severe plaque psoriasis
   
TildrakizumabBlack Triangle
View adult BNF View SPC online View childrens BNF
Formulary
Red

100mg solution for injection (Ilumetri®) pre-filled syringe

In line with NICE TA575: Tildrakizumab for treating moderate to severe plaque psorias

 
Link  Pan Mersey APC (2019). TILDRAKIZUMAB solution for injection (Ilumetri®▼) for Plaque Psoriasis
Link  NICE TA575: Tildrakizumab for treating moderate to severe plaque psoriasis
   
Ustekinumab
View adult BNF View SPC online
Formulary
Red

Injection 45 mg, 90mg
In line with NICE TA 180 - Ustekinumab for the treatment of adults with moderate to severe psoriasis

Cytokine modulator

No BNFc entry; Paediatrics, seek specialist advice 

NHS NHSE commissioned drug for Paediatric indications (in line with NICE TA 455) - see Specialised Commissioning: Key documents

 
Link  NICE TA 180 - Ustekinumab for the treatment of adults with moderate to severe psoriasis
Link  NICE TA455: Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people
   
Apremilast
View adult BNF View SPC online
Formulary
Red

Tablet 10 mg, 20mg, 30mg (Otezla®)

 

In line with NICE TA419 - Apremilast for treating moderate to severe plaque psoriasis

No BNFc entry; Paediatrics, seek specialist advice 

 
Link  MHRA alert: Apremilast (Otezla ¥): risk of suicidal thoughts and behaviour
Link  NICE TA419: Apremilast for treating moderate to severe plaque psoriasis (replaces TA368)
   
 ....
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

Green

Medicines considered suitable for non-specialist prescribing in primary or secondary care.  

Amber Recommended

Requires specialist assessment to enable patient selection.  Amber Recommended medicines must meet criteria: (1) Requires specialist assessment to enable patient selection (2) Following specialist assessment, the medicine is suitable for prescribing in Primary Care.  

Amber Initiated

Amber Initiated. Requires specialist initiation of prescribing. Prescribing to be continued by the specialist until stabilisation of the dose is achieved and the patient has been reviewed. Amber Initiated medicines must meet criteria: (1) Requires specialist assessment to enable patient selection (2) Medicine is suitable for on-going prescribing in Primary Care (3) Requires short to medium term specialist prescribing and monitoring of efficacy or toxicity until the patient’s dose and condition is stable   

Amber Retained

Amber Patient Retained. Requires specialist initiation of prescribing. Prescribing to be continued by specialist until stabilisation of the dose is achieved and the patient had been reviewed. Patient remains under the care of specialist (ie not discharged) as occasional specialist input may be required. Amber Patient Retained medicines must meet criteria: (1)Requires specialist assessment to enable patient selection (2)Medicine is suitable for on-going prescribing in Primary Care (3) Requires short to medium term specialist prescribing and monitoring of efficacy or toxicity until the patient’s dose and condition is stable (4) May require occasional specialist input indefinitely and therefore the patient should not be discharged from specialist care   

Amber

Medicines recommended or initiated by specialists in primary or secondary care. Non-specialist prescribing in primary care may follow according the RAG criteria. In process of being superceded by Amber Recommended, Amber Initiated and Amber Patient Retained.  

Purple

Shared Care. Medicines are considered suitable for Primary Care prescribing and/or management, following specialist initiation of therapy, with on-going communication between the Primary Care prescriber and specialist, within the framework of a Shared Care Agreement. Medicines designated as requiring Shared Care require on-going input from both Specialist and Primary Care clinicians and patients should not be discharged from Specialist care. Where prescribing and monitoring are required under shared care, it is implicit that the responsibility for both of these tasks rests with the prescriber. A Shared Care Agreement will always be available for Shared Care medicines and this document will include a Shared Care Agreement pro-forma which will be completed by all involved clinicians. This pro-forma will record agreement to take on defined aspects of care e.g. monitoring and/or on-going prescribing for the individual patients. A policy detailing clinician responsibilities in Shared Care Agreements must be referred to in all cases of Shared Care. All drugs to be included in this category must meet Shared Care criteria 1 to 3: SC1 Requires specialist assessment to enable patient selection and also initiation, stabilisation and review of treatment and the patient`s condition. SC2 Prescribing and/or management of the drug in Primary Care with specialist support and input, within the framework of the Shared Care Agreement is safe and convenient and that there is an appropriate mechanism for individual patient access in Primary Care. SC3 Requires specific long-term monitoring (blood test or other measurement) for adverse effects and / or efficacy of the drug to be completed in Primary Care, and requires on-going specialist support for the dose changes or management of adverse effects. Monitoring is required on a regular basis (typically four times a year). Implicit in any shared care agreement is the understanding that participation is at the discretion of the Primary Care prescriber subject to their clinical confidence.   

Red

Primary care prescribing of these medicines is NOT recommended. These treatments should be initiated by specialists only; ongoing prescribing is retained within secondary care.   

Black

Not recommended for use. Deviation from the policy may be considered on an individual basis where exceptional circumstances exist.   

Grey

Not recommended for use at this time. Deviation from the policy may be considered on an individual basis where exceptional circumstances exist. Further guidance will be issued when more information or evidence is made available.  

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