1. MM Update on Actinic Keratosis and Emollients Rachel Mackay Head of Medicines Management G&W CCG

2. Established Treatments Efudix® (Fluorouracil 5%) - Decision made May 2009 Aldara® (Imiquimod 5%) – decision made Oct 2009 The committee agreed that both Efudix and Aldara should be a RED drug on the traffic light system if initiated following an out-patient appointment by a secondary care specialist / GPSI as the cost of the drug is included within PbR tariff. GPs may make an individual clinical decision to prescribe for recurrent conditions and where they have sufficient knowledge/experience and feel that a referral to a specialist has not been necessary on that occasion Solaraze® (diclofenac 3%) – Never had a status given to it

3. Ingenol mebutate gel (Picato®) - Green Fluorouracil 0.5% / salicylic acid 10% (Actikerall®) - Green N.B. The above should be considered RED if patient referred to Acute Trust as the whole treatment course is to be supplied if considered appropriate at the outpatient appointment. The PCN does not support the routine use of Imiquimod 3.75% cream (Zyclara®) for actinic keratosis and it should be considered as BLACK on the traffic light system. The PCN supports the use of Aminolaevulinic acid (Ameluz® 78mg/g gel) for Actinic Keratosis as a RED drug on the traffic light system as an option for the treatment of actinic keratosis of mild to moderate intensity on the face & scalp when photodynamic therapy is considered appropriate. Ameluz should only be administered under the supervision of a physician, a nurse or other healthcare professionals experienced in the use of photodynamic therapy. Proposed treatment options discussed and agreed at PCN 29/11/13

4. Cost per treatment cycle of topical treatments for AK Treatment FormulationPriceCourse length Price per course of treatment Solaraze® (Diclofenac 3%) Gel50g = £38.3012 weeks£77.00 Aldara® (Imiquimod 5%) Cream 12 x 250mg single use sachets = £48.50 12 weeks£97.00 Efudix® (Fluorouracil 5%) Cream40g = £32.8312 weeks £33.00 to £65.00 Actikerall® (5-FU/SA) Solution25ml = £38.3012 weeks£77 Picato® ▼ (Ingenol mebutate) Gel 500 microgram/g 2-tube pack or 150microgram/g 3-tube pack = £65 2 or 3 days depending on area £65.00 Zyclara® (imiquimod 3.75 Cream%) 28 x 250mg sachet = £113 6 weeks £226 A maximum of 56 sachets could be used per treatment period Doses are for general comparison and do not imply therapeutic equivalence. Costs are based on treating a 25cm2 area for 12 weeks.

5. Annual expenditure for G&W CCG for 12/13 on AK products Solaraze ® (Diclofenac 3%) gel) - £35,484 Aldara® (Imiquimod 5%) - £2,037 Efudix® (Fluorouracil 5%) - £4,894 Actikerall® (Fluorouracil 0.5% / salicylic acid 10%) - £601 Picato® (Ingenol mebutate) gel - £0 Zyclara® (Imiquimod 3.75% cream) - £0 Total - £43,017

6. Pathway Development Local guidelines to be produced alongside training to enable patients to receive more treatment for AK in primary care thus reducing referrals utilising the Primary Care Dermatology Society (Sept 2012) Treatment Pathway for AK to inform this work.

7. The PCDS recommend that diclofenac 3% is used to treat Grade I lesions, or if this is not suitable then 5-FU, imiquimod 5% or 5-FU/SA. Grade II lesions should preferably be treated with 5-FU/SA, imiquimod 5% or 5-FU. The treatments are not recommended for use in primary care for treating grade III lesions. 5-FU, imiquimod 5% and diclofenac 3% can all be used to treat field changes. These guidelines do not include the use of imiquimod 3.75% or ingenol mebutate, which have only been available since the beginning of 2013. Primary Care Dermatology Society Guidelines Sept 2012

8. 8 Preferred emollients Aquamax cream Cetraben cream Zerobase cream Zerocream Zeroguent cream Emulsifying ointment Zeroderm ointment 50:50 liquid and white soft paraffin Black on traffic light (not routinely recommended for prescribing): Aqueous cream, Diprobase cream, E45 cream, Hydromol ointment, Epaderm ointment, Unguentum M cream

10. Aqueous cream BP Not recommended as a leave-on emollient or soap substitute. Why? Poor emollient Tendency to cause irritant reactions More cost effective products available Aquamax® cream is a suitable alternative