North East and North Cumbria Formulary


	North East and North Cumbria ICS Formulary

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Formulary Chapter 13: Skin - Full Chapter

Notes:

Most prescribing uses licensed medicines whose safety and efficacy are assured. For many common dermatological diseases including psoriasis and eczema, the range of licensed medicines is limited. As a result, Dermatology prescribing may rely significantly on unlicensed creams and ointments (known as ‘Specials’) containing tars, dithranol, salicylic acid, steroids and other active constituents in a range of concentrations and bases. This is of particular concern in primary care where lack of effective price controls and a mechanism to ensure independent scrutiny of product quality has increased costs and concern about standards. To address these concerns, and help optimise quality of care, adherence to the revised British Association of Dermatologists (BAD) list of preferred Specials (2018) is encouraged.

Details...

13.05.03

Drugs affecting the immune response

Abrocitinib (Cibinqo^®)

Formulary

Approved for the treatment of moderate to severe atopic dermatitis in line with NICE

MHRA Drug Safety Update (April 2023): 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

Adalimumab

Formulary

Approved for psoriasis in line with NICE.
Approved for the treatment of moderate to severe hidradenitis suppurativa in line with NICE and NHS England Commissioning Policy
Approved for the treatment of plaque psoriasis in children and young people in line with NICE

Biosimilars are available – note that indications can differ between different products – prescribe by brand. Consult with individual trust pharmacy department for details of
preferred biosimilar brand.

NICE TA146 Adalimumab for the treatment of adults with psoriasis

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

Apremilast (Otezla^®)

Formulary

10mg, 20mg & 30mg tablets
To be used in accordance with NICE guidance

MHRA Drug Safety Update (Jan 2017): Apremilast (Otezla ): risk of suicidal thoughts and behaviour

NICE TA419: Apremilast for treating moderate to severe plaque psoriasis

Baricitinib (Olumiant^®)

Formulary

Approved for treating moderate to severe atopic dermatitis in adults in line with NICE.

NICE TA681: Baricitinib for treating moderate to severe atopic dermatitis

MHRA Drug Safety Update (Aug 2020): Baricitinib (Olumiant▼): increased risk of diverticulitis, particularly in patients with risk factors

MHRA Drug Safety Update (Mar 2020): Baricitinib (Olumiant▼): risk of venous thromboembolism

Bimekizumab (Bimzelx^®)

Formulary

160mg/ml solution pre-filled pen/syringe
Approved for the treatment of moderate to severe plaque psoriasis in line with NICE

NICE TA723: Bimekizumab for treating moderate to severe plaque psoriasis

Brodalumab (Kyntheum^® )

Formulary

210mg/1.5ml solution for injection in pre-filled syringes.
Approved for the treatment of moderate to severe plaque psoriasis in line with NICE

NICE TA511: Brodalumab for treating moderate to severe plaque psoriasis

Certolizumab pegol

Formulary

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

Ciclosporin

Formulary

Capsules & SF Solution
See section 8.2.2

County Durham and Darlington Shared Care Guideline: Ciclosporin

Tees Valley Shared Care Guideline: Ciclosporin

Deucravacitinib (Sotyktu)

Formulary

6mg tablets
Approved for the treatment of moderate to severe plaque psoriasis in line with NICE

NICE TA907: Deucravacitinib for treating moderate to severe plaque psoriasis

Dimethyl fumarate (Skilarence^®)

Formulary

120mg tablets
Approved for the treatment of moderate to severe plaque psoriasis in line with NICE

NICE TA475 Dimethyl fumarate for treating moderate to severe plaque psoriasis

Dupilumab (Dupixent^®)

Formulary

200mg/1.14ml & 300mg/2ml solution for injection
Approved for treating moderate to severe atopic dermatitis in adults in line with NICE

MHRA Drug Safety Upate (Nov 2022): Dupilumab (Dupixent▼): risk of ocular adverse reactions and need for prompt management

NICE TA534: Dupilumab for treating moderate to severe atopic dermatitis

Etanercept (Enbrel^®, Benapali^® & Erelzi^®)

Formulary

Approved for psoriasis in line with NICE
Approved for the treatment of plaque psoriasis in children and young people in line with NICE

NICE TA103: Psoriasis - efalizumab and etanercept

NICE TA455 Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people

Guselkumab (Tremfya^®)

Formulary

100mg/1mL solution for injection
Approved for the treatment of moderate to severe plaque psoriasis in line with NICE

NICE TA521: Guselkumab for treating moderate to severe plaque psoriasis

Hydroxychloroquine
(Dermatology)

Formulary

MHRA Drug Safety Update (Feb 2022): Hydroxychloroquine, chloroquine: increased risk of cardiovascular events when used with macrolide antibiotics; reminder of psychiatric reactions

NENC Shared Care Protocol - Hydroxychloroquine for patients within adult services

Infliximab (Remsima^®, Inflectra^®, Remicade^®)

Formulary

Approved for psoriasis in line with NICE.

NICE TA134: Infliximab for psoriasis

Ixekizumab (Taltz^®)

Formulary

Approved for the treatment of moderate to severe plaque psoriasis in adults in line with NICE

NICE TA442 Ixekizumab for treating moderate to severe plaque psoriasis

Lebrikizumab

(Ebglyss^®)

Formulary

Approved for treating moderate to severe atopic dermatitis in people 12 years and over in line with NICE

NICE TA986: Lebrikizumab for treating moderate to severe atopic dermatitis in people 12 years and over

Methotrexate

Formulary

See section 08.01.03
2.5mg tablets

County Durham and Darlington Shared Care Guideline: Methotrexate

MHRA Drug Safety Update (August 2023): Methotrexate: advise patients to take precautions in the sun to avoid photosensitivity reactions

MHRA Drug Safety Update (Sept 2020): Methotrexate once-weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing

Tees Valley Shared Care Guideline: Methotrexate

Pimecrolimus cream (Elidel^®)

Formulary

1% cream
- Approved of moderate atopic eczema on the face and neck in children between 2 and 16 years in line NICE.
- Can be initiated by prescribers (including general practitioners) with a special interest and experience in dermatology and only after careful discussion with the patient about the potential risks and benefits of all appropriate second-line treatment options.

NICE TA82: Pimecrolimus and tacrolimus for atopic dermatitis (eczema)

Risankizumab (Skyrizi^®)

Formulary

Approved for the treatment of moderate to severe plaque psoriasis in line with NICE

NICE TA596: Risankizumab for treating moderate to severe plaque psoriasis

Ritlecitinib (Litfulo^®)

Formulary

50mg hard capsules
Recommended as an option for treating severe alopecia areata in people 12 years and over in line with NICE

NICE TA958: Ritlecitinib for treating severe alopecia areata in people 12 years and over

Secukinumab (Cosentyx^®)

Formulary

Approved for the treatment of plaque psoriasis in line with NICE.
Approved for the treatment of moderate to severe plaque psoriasis in children and young people in line with NICE
Approved for treating moderate to severe hidradenitis suppurativa in line with NICE

NICE TA350: Secukinumab for treating moderate to severe plaque psoriasis

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

Tacrolimus ointment (Protopic^® )

Formulary

0.03% & 0.1% ointment
- Approved for moderate to severe atopic eczema in patients over 2 years in line with NICE.
- Can be initiated by prescribers (including general practitioners) with a special interest and experience in dermatology and only after careful discussion with the patient about the potential risks and benefits of all appropriate second-line treatment options

NICE TA82: Pimecrolimus and tacrolimus for atopic dermatitis (eczema)

Tildrakizumab (Ilumetri^®)

Formulary

100 mg solution for injection in pre-filled syringe
Approved for the treatment of moderate to severe plaque psoriasis in line with NICE

NICE TA575: Tildrakizumab for treating moderate to severe plaque psoriasis

Tralokinumab (Adtralza^®)

Formulary

Approved for the treatment of moderate to severe atopic dermatitis in line with NICE

NICE TA814: Abrocitinib, tralokinumab or upadacitinib for treating moderate to severe atopic dermatitis

Upadacitinib (Rinvoq^®)

Formulary

Approved for the treatment of moderate to severe atopic dermatitis in line with NICE

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

Ustekinumab (Stelara^®)

Formulary

45mg & 90mg SC injections approved for psoriasis in line with NICE.
Approved for the treatment of plaque psoriasis in children and young people in line with NICE

MHRA Drug Safety Update (Jan 2015): Ustekinumab (Stelara): risk of exfoliative dermatitis

NICE TA180: Psoriasis - ustekinumab (Updated March 2017)

NICE TA455 Adalimumab, etanercept and ustekinumab for treating plaque psoriasis in children and young people

NICE CG153: Psoriasis: assessment and management

NICE TA81: Frequency of application of topical corticosteroids for atopic eczema

13.05.03.01

Cytokine modulators (biologic therapies) - eczema

13.05.03.02

Cytokine modulators (biologic therapies) - psoriasis

....

Non Formulary Items

Baricitinib (Olumiant^®)

Non Formulary

Not approved for the treatment of severe alopecia areata

NICE TA926: Baricitinib for treating severe alopecia areata

Dupilumab (Dupixent^®)

Non Formulary

Not approved for treating moderate to severe prurigo nodularis in adults when systemic treatment is suitable

MHRA Drug Safety Upate (Nov 2022): Dupilumab (Dupixent▼): risk of ocular adverse reactions and need for prompt management

NICE TA955: Dupilumab for treating moderate to severe prurigo nodularis

Key

	Restricted Drug
	Unlicensed
	Link to adult BNF
	Link to children's BNF
	Link to SPCs
	Cytotoxic Drug
	Controlled Drug

	High Cost Medicine
	NHS England
	Homecare
	ICB
	Low carbon footprint
	Medium carbon footprint
	High carbon footprint

Status	Description
	Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment. In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances. For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing.
	Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. These medicines are considered suitable for primary care prescribing following specialist initiation of therapy and stabilisation, with ongoing communication between the primary care prescriber and specialist as set out in the associated shared care guideline (SCG). Shared care should be initiated by the specialist, which includes consultant, suitably trained specialist non-medical prescriber or GPwER within a secondary, tertiary, or primary care clinic. The specialist should send the primary care prescriber a copy of the NENC Clinical Effectiveness and Governance (CEG) Subcommittee approved SCG to sign. The primary care prescriber should sign the SCG or indicate reasons why they are unable to accept the agreement and return a copy back to the specialist, as soon as possible. SCGs are available or are being developed for most of the drugs listed as AMBER.
	Drugs normally recommended or initiated by a hospital specialist who is a prescriber, a GP with an extended role [GPwER], or a specialist within primary care which can be safely maintained in primary care and monitored in primary care. In some cases, a further restriction for use may be defined. The primary care prescriber must be familiar with the drug to take on prescribing responsibility or must obtain the required information from the specialist. Therefore, provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by primary care prescriber or provide information re stopping criteria. These are considered suitable for primary care prescribing following specialist assessment and recommendation of therapy, with ongoing communication between the primary care prescriber and specialist, if necessary. In some case these drugs require specialist initiation and short to medium term monitoring of efficacy or toxicity until the patient’s dose is stable. Following specialist review the patient may be transferred to primary care for ongoing prescribing. Ongoing prescribing by primary care can include, if required, additional dose titrations and assessment of efficacy, with ongoing communication between the primary care prescriber and specialist, if necessary. If the drug requires urgent initiation, it is expected that the specialist undertakes the initial prescribing responsibility for an appropriate period of time, usually a minimum of 28 days. A GREEN+ drug can only be recommended to primary care for initiation if does not need to be initiated within 28 days.
	Medicines suitable for initiation, ongoing prescribing and discontinuation in all care settings, subject to appropriate communication between those responsible.
	UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.
	Drugs that have been considered by the NENC Clinical Effectiveness and Governance (CEG) Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria ICS. These may also include all medicines with a “not NHS” or “DLCV” classification in the BNF, those agents as included within the NICE “Do not do” list, and those agents included with the NHS England: Items which should not routinely be prescribed in primary care.