| Formulary Chapter 13: Skin - Full Chapter
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| Notes: |
This chapter of the formulary is under continual development, please let the team know if you have any comments about the contents: mlcsu.lscformulary@nhs.net.
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| Chapter Links... |
 LSCMMG: Guidelines for the Management of Psoriasis in Primary Care |
| LSCMMG: Position Statement: Prescribing of Medical Camouflaging Products |
| LSCMMG: Psoriasis in adults: LSCMMG Biologic and High Cost Drug Commissioning Pathway |
| NICE CG153: Psoriasis: assessment and management |
| NICE CG57: Atopic eczema in under 12s: diagnosis and management |
| NICE NG12: Suspected cancer: recognition and referral |
| NICE NG14: Melanoma: assessment and management |
| NICE NG198: Acne vulgaris: management |
| Details... |
| 13.05.03 |
Drugs affecting the immune response |
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Consultant dermatologist or specialist initiation only.
To be prescribed in accordance with local and NICE guidance.
Medicines are commissioned by NHS England for paediatric indications where an adult NICE TA is in place. |
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Abrocitinib (Cibinqo ®)
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Formulary
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Tablets 50mg, 100mg, 200mg
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 MHRA: Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
NICE TA814: Abrocitinib, tralokinumab or upadacitinib for treating moderate to severe atopic dermatitis
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Adalimumab
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Formulary
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S/C injection 40mg pre-filled syringe, pre-filled pen
Tertiary centre only for hidradenitis suppurativa.
Commissioned in accordance with LSCMMG biologics pathways.
 NHSE commissioned for some indications.
Consult chapter links for more details.
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MHRA: Tumour necrosis factor alpha inhibitors
NICE TA199: Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis
NICE TA392: Adalimumab for treating moderate to severe hidradenitis suppurativa
NICE TA455: Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people
NIE TA146: Adalimumab for the treatment of adults with psoriasis
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Apremilast (Otezla®)
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Formulary
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Tablets 10mg, 20mg, 30mg
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MHRA: Apremilast (Otezla ▼): risk of suicidal thoughts and behaviour
NICE TA419: Apremilast for treating moderate to severe plaque psoriasis
NICE TA433: Apremilast for treating active psoriatic arthritis
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Azathioprine
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Formulary
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Tablets 25mg, 50mg
Some indications are unlicensed  . Please consult product literature for licensing information.
Consultant dermatologist or specialist initiation only.
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LSCMMG: Azathioprine and Mercaptopurine shared care guideline
MHRA: Thiopurines and intrahepatic cholestasis of pregnancy
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Baricitinib
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Formulary
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Film-coated tablets 2mg, 4mg
Treatment of atopic dermatitis
 Treatment of alopecia areata
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MHRA: Baricitinib (Olumiant▼): increased risk of diverticulitis, particularly in patients with risk factors
MHRA: Baricitinib (Olumiant▼): risk of venous thromboembolism
MHRA: Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
NICE TA681: Baricitinib for treating moderate to severe atopic dermatitis
NICE TA926: Baricitinib for treating severe alopecia areata
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Bimekizumab (Bimzelx ®)
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Formulary
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Solution for injection pre-filled pen 160mg/1ml, 320mg/2ml
Solution for injection pre-filled syringe 160mg/1ml, 320mg/2ml
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NICE TA723: Bimekizumab for treating moderate to severe plaque psoriasis
NICE TA916: Bimekizumab for treating active psoriatic arthritis
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Brodalumab (Kyntheum®)
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Formulary
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Solution for injection pre-filled syringes 210mg/1.5ml
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NICE TA511: Brodalumab for treating moderate to severe plaque psoriasis
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Certolizumab pegol (Cimzia®)
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Formulary
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Solution for injection pre-filled pens 200mg/1ml
Solution for injection pre-filled syringes 200mg/1ml
Solution for injection in a dose-dispenser cartridge 200mg/1ml
Commissioned in accordance with LSCMMG biologics pathways.
Consult chapter links for more details.
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MHRA: Tumour necrosis factor alpha inhibitors
NICE TA445: Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs
NICE TA574: Certolizumab pegol for treating moderate to severe plaque psoriasis
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Ciclosporin
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Formulary
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Capsules 10mg, 25mg, 50mg, 100mg
Oral solution 100mg/ml
Consultant dermatologist or specilaist initiation only.
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.
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LSCMMG: Ciclosporin shared care guideline
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Deucravacitinib (Sotyktu®)
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Formulary
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Film coated tablets 6mg
It is not known whether deucravacitinib, an inhibitor of tyrosine kinase 2 (TYK2), is associated with the adverse reactions of Janus kinase (JAK) inhibition. Risks that have been identified as a class effect of JAK inhibitors include major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality.
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NICE TA907: Deucravacitinib for treating moderate to severe plaque psoriasis
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Dupilumab (Dupixent®)
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Formulary
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Solution for injection pre-filled pens 300mg/2ml, 200mg/1.14ml
Solution for injection pre-filled syringes 300mg/2ml, 200mg/1.14ml
NICE TA955: Dupilumab for treating moderate to severe prurigo nodularis
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MHRA: Dupilumab (Dupixent▼): risk of ocular adverse reactions and need for prompt management
NICE TA534: Dupilumab for treating moderate to severe atopic dermatitis
NICE TA955: Dupilumab for treating moderate to severe prurigo nodularis
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Etanercept
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Formulary
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S/C injection 50mg pre-filled syringe, pre-filled pen
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MHRA: Tumour necrosis factor alpha inhibitors
NICE TA103: Etanercept and efalizumab for the treatment of adults with psoriasis
NICE TA199: Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis
NICE TA455: Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people
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Guselkumab (Tremfya®)
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Formulary
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Solution for injection in pre-filled pen 100mg/1ml
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NICE TA521: Guselkumab for treating moderate to severe plaque psoriasis
NICE TA815: Guselkumab for treating active psoriatic arthritis after inadequate response to DMARDs
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Infliximab
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Formulary
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Solution for injection pre-filled pen 120 mg/1ml
Adequate resuscitation facilities must be available when infliximab is used.
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MHRA: Tumour necrosis factor alpha inhibitors
NICE TA134: Infliximab for the treatment of adults with psoriasis
NICE TA199: Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis
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Lebrikizumab (Ebglyss®)
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Formulary
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Solution for injection pre-filled pens 250mg/2ml
Solution for injection pre-filled syringes 250mg/2ml
The MHRA has reviewed the risk of dry eye and serious ocular side-effects associated with dupilumab, an inhibitor of interleukin-4 and interleukin-13 signalling. Lebrikizumab, which similarly inhibits interleukin-13, is also associated with ocular side-effects.
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MHRA: Dupilumab (Dupixent▼): risk of ocular adverse reactions and need for prompt management
NICE TA986: Lebrikizumab for treating moderate to severe atopic dermatitis in people 12 years and over
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Methotrexate
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Formulary
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Tablets 2.5mg
Prefilled syringes and pens (various strengths)
Methotrexate should be prescribed once weekly as a single dose on the same day each week.
If oral methotrexate is prescribed only use the 2.5 mg strength.
See hospital policy for prescribing and supply of oral methotrexate.
Methotrexate subcutaneous injection may be supplied through a homecare arrangement.
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LSCMMG: Methotrexate shared care guideline
MHRA: Methotrexate once-weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing
MHRA: Methotrexate: advise patients to take precautions in the sun to avoid photosensitivity reactions
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Nemolizumab (Nemluvio®)
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Formulary
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30 mg powder and solvent for solution for injection in pre-filled pen
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NICE TA1077: Nemolizumab for treating moderate to severe atopic dermatitis in people 12 years and over
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Omalizumab (Xolair®)
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Formulary
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Solution for injection pre-filled pens 75mg/0.5ml, 150mg/1ml, 300mg/2ml
Solution for injection pre-filled syringes 75mg/0.5ml, 150mg/1ml, 300mg/2ml
Unlicensed use of omalizumab for severe chronic inducible urticarias.
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LSCMMG: Commissioning statement Unlicensed use of omalizumab for severe chronic inducible urticarias
MHRA: Omalizumab: potential risk of arterial thrombotic events
NICE TA339: Omalizumab for previously treated chronic spontaneous urticaria
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Pimecrolimus (Elidel®)
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Formulary
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Cream 1%
Consultant dermatologist or specilaist initiation only.
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NICE TA82: Tacrolimus and pimecrolimus for atopic eczema
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Risankizumab (Skyrizi®)
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Formulary
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Solution for injection pre-filled syringes 150mg/mL
Solution for injection pre-filled pen 150mg/mL
Solution for injection cartridges 180mg/1.2ml, 360mg/2.4ml
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NICE TA596: Risankizumab for treating moderate to severe plaque psoriasis
NICE TA803: Risankizumab for treating active psoriatic arthritis after inadequate response to DMARDs
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Ritlecitinib (Litfulo®)
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Formulary
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Capsules 50mg
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BAD: Professional guidance supplementary to NICE TA958
MHRA: Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
NICE TA958: Ritlecitinib for treating severe alopecia areata in people 12 years and over
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Secukinumab (Cosentyx®)
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Formulary
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Solution for injection pre-filled pens 150mg/1ml, 300mg/2ml
Solution for injection pre-filled syringes 75mg/0.5ml, 150mg/1ml
NHSE commissioned for some indications.
Approved by LSCMMG for palmoplantar psoriasis
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LSCMMG: Secukinumab (Cosentyx▼) NMR
NICE TA350: Secukinumab for treating moderate to severe plaque psoriasis
NICE TA445: Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs
NICE TA734: Secukinumab for treating moderate to severe plaque psoriasis in children and young people
NICE TA935: Secukinumab for treating moderate to severe hidradenitis suppurativa
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Tacrolimus
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Formulary
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Ointment 0.03%, 0.1%
Psoriasis.
Consultant dermatologist or specilaist initiation only.
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MHRA: Tacrolimus ointment (Protopic): possible risk of malignancies including lymphomas and skin cancers
NICE TA82: Tacrolimus and pimecrolimus for atopic eczema
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Tildrakizumab (Ilumetri®)
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Formulary
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Solution for injection pre-filled syringes 100mg/1ml
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NICE TA575: Tildrakizumab for treating moderate to severe plaque psoriasis
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Tralokinumab (Adtralza ®)
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Formulary
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Solution for injection pre-filled syringes 150mg/1ml
Solution for injection pre-filled pens 300mg/2ml
The MHRA has reviewed the risk of dry eye and serious ocular side-effects associated with dupilumab, an inhibitor of interleukin-4 and interleukin-13 signalling. Tralokinumab, which similarly inhibits interleukin-13, is also associated with ocular side-effects.
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MHRA: Dupilumab (Dupixent▼): risk of ocular adverse reactions and need for prompt management
NICE TA814: Abrocitinib, tralokinumab or upadacitinib for treating moderate to severe atopic dermatitis
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Upadacitinib (Rinvoq ®)
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Formulary
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Prolonged release tablets 15mg, 30mg, 45mg
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MHRA: Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality
NICE TA814: Abrocitinib, tralokinumab or upadacitinib for treating moderate to severe atopic dermatitis
NICE768: Upadacitinib for treating active psoriatic arthritis after inadequate response to DMARDs
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Ustekinumab
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Formulary
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Solution for injection pre-filled syringes 45mg/0.5ml, 90mg/1ml
Consultant dermatologist or specialist initiation only.
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MHRA: Ustekinumab (Stelara): risk of exfoliative dermatitis
NICE TA180: Ustekinumab for the treatment of adults with moderate to severe psoriasis
NICE TA340: Ustekinumab for treating active psoriatic arthritis
NICE TA455: Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people
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Key |
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Restricted Drug |
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Unlicensed |
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Link to adult BNF
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Link to children's BNF
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Link to SPCs
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Scottish Medicines Consortium |
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Cytotoxic Drug |
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Controlled Drug |
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High Cost Medicine
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Cancer Drugs Fund
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Homecare |
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ICB commissioned |
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NHS England commissioned |
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Blueteq form needed |
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Low carbon footprint |
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Medium carbon footprint |
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High carbon footprint |
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| Status |
Description |
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Green:
Appropriate for initiation and ongoing prescribing in both primary and secondary care.
Generally, little or no routine drug monitoring is required. |
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Green (Restricted):
Appropriate for initiation and ongoing prescribing in both primary and secondary care provided:
Additional criteria specific to the medicine or device are met, or
The medicine or device is used following the failure of other therapies as defined by the relevant LSCMMG pathway.
Generally, little or no routine drug monitoring is required.
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Red medicines:
Medicine is supplied by the hospital for the duration of the treatment course.
Primary care initiation or continuation of treatment is not recommended unless exceptional circumstances such as specialist GP.
Red medicines are those where primary care prescribing is not recommended. These treatments should be initiated by specialists only and prescribing retained within secondary care. They require specialist knowledge, intensive monitoring, specific dose adjustments or further evaluation in use. If however, a primary care prescriber has particular specialist knowledge or experience of prescribing a particular drug for a particular patient it would not always be appropriate for them to expect to transfer that prescribing responsibility back to secondary care. There should be a specific reason and a specific risk agreement, protocol and service set up to support this.
Primary care prescribers may prescribe RED medicines in exceptional circumstances to patients to ensure continuity of supply while arrangements are made to obtain ongoing supplies from secondary care. |
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Amber level 0:
Suitable for prescribing in primary care following recommendation or initiation by a specialist.
Little or no specific monitoring required.
Patient may need a regular review, but this would not exceed that required for other medicines routinely prescribed in primary care.
Brief prescribing document or information sheet may be required.
Primary care prescribers must be familiar with the drug to take on prescribing responsibility or must get the required information.
When recommending or handing over care, specialists should ask primary care prescribers to take over prescribing responsibility, and should give enough information about the indication, dose, monitoring requirements, use outside product licence and any necessary dose adjustments to allow them to confidently prescribe. |
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Amber level 1 (with shared care):
Suitable for prescribing in primary care following recommendation or initiation by a specialist.
Minimal monitoring required.
Patient may need a regular review, but this would not exceed that required for other medicines routinely prescribed in primary care.
Full prior agreement about patient’s on-going care must be reached under the shared care agreement.
Primary care prescribers are advised not to take on prescribing of these medicines unless they have been adequately informed by letter of their responsibilities with regards monitoring, side effects and interactions and are happy to take on the prescribing responsibility. A copy of locally approved shared care guidelines should accompany this letter which outlines these responsibilities. Primary care prescribers should then tell secondary care of their intentions as soon as possible by letter so that arrangements can be made for the transfer of care. |
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Amber level 2 (with shared care and enhanced service):
Initiated by specialist and transferred to primary care following a successful initiation period.
Significant monitoring required on an on-going basis.
Full prior agreement about patient’s on-going care must be reached under the shared care agreement.
Suitable for enhanced service.
These medicines are considered suitable for GP prescribing following specialist initiation of therapy, as per shared care document which will be sent out with the request to prescribe, with on-going communication between the primary care prescriber and specialist. Amber Level 2 medicines require significant monitoring for which an enhanced service may be suitable. (Subject to local commissioning agreements). |
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Do not prescribe: NOT recommended for use by the NHS in Lancashire and South Cumbria.
Includes medicines that NICE has not recommended for use and terminated technology appraisals, unless there is a local need. |
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Grey medicines:
Medicines which have not yet been reviewed or are under the review process.
GPs and specialists are recommended not to prescribe these drugs.
This category includes drugs where funding has not yet been agreed.
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Refer to local guidance. |
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