Tacrolimus 0.03% Ointment ▼ (Protopic® ointment ▼) – Option for 2nd line treatment of moderate to severe atopic eczema in adults and children over 2 years not controlled by topical steroids where there is serious risk of important ADRs further topical steroid use – as per NICE CG 57

NICE recommendations, summary of meeting discussions, links to additional supporting docs etc.

July 2002:

Guidance from local dermatologists was that tacrolimus ointment should only be used when steroid treatment has been tried and shown to fail.

TAG therefore recommended that initial prescribing of tacrolimus topical should be by a consultant specialist or a specialist GP, with subsequent prescribing by GPs. A prescribing  information sheet is available.

Patients on tacrolimus must be reviewed by a specialist after 3 to 4 months.

January 2005: TAG acknowledged NICE TAG No.82 which recommended that:

1.1 Topical tacrolimus and pimecrolimus are not recommended for the treatment of mild atopic eczema or as first-line treatments for atopic eczema of any severity.

1.2 Topical tacrolimus is recommended, within its licensed indications, as an option for the second-line treatment of moderate to severe atopic eczema in adults and children aged 2 years and older that has not been controlled by topical corticosteroids (see Section 1.4), where there is a serious risk of important adverse effects from further topical corticosteroid use, particularly irreversible skin atrophy.

1.4 For the purposes of this guidance, atopic eczema that has not been controlled by topical corticosteroids refers to disease that has not shown a satisfactory clinical response to adequate use of the maximum strength and potency that is appropriate for the patient’s age and the area being treated.

1.5 It is recommended that treatment with tacrolimus or pimecrolimus be initiated only by physicians (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.

January 2008: The TAG acknowledged NICE Clinical Guideline No.75 December 2007 which incorporates previous NICE Technology Appraisal Guidance No. 82.

July 2017:

The TAG noted the local Combined Commissioned Drugs List (May 2017) which had been updated to include NICE “Do Not Do” recommendations. These include NICE CG 57  – Atopic eczema in under 12s: diagnosis and management  which states:

1.5.4.1 Topical tacrolimus and pimecrolimus are not recommended for the treatment of mild atopic eczema or as first-line treatments for atopic eczema of any severity.