Patients living in Scotland with actinic keratosis are one step closer to accessing Picato® (ingenol mebutate) gel following acceptance by the SMC. Picato®, manufactured by LEO, is a new, two or three day treatment for actinic keratosis** that can be applied by patients once-daily to the affected area. The SMC concluded that as ingenol mebutate has a short treatment duration (either two or three days) it is likely to be convenient for the patient, promoting a high degree of patient adherence.(1)
Actinic keratosis – also known as solar keratosis – is a potential precursor to non-melanoma skin cancer that can develop where unprotected skin has been exposed to the sun over time.(2,3) It often appears as red, rough, sandpapery patches of skin(4) on areas that are more exposed to sun,(3) such as the face, head, arms and legs. One in five patients aged over 60 years has one or more actinic keratoses.(5)
In Scotland, skin cancer (melanoma) is the fifth most common type of cancer for women and the seventh for men.(6) A recent survey showed that a worrying 80% of Scottish people have experienced sunburnt skin and 28% did not try to protect their skin from sun damage last summer.(7)
Dr Girish Gupta, Consultant Dermatologist, Monklands District General Hospital, Glasgow, commented: “As a dermatologist it is interesting that Scots will have access to a new treatment applied just once a day, for two or three days, for actinic keratosis, a common skin condition caused by sun damage. Other currently available patient applied therapies can require weeks or months of treatment.” Dr Gupta added: “To minimise the risk of developing into skin cancer early detection and treatment of actinic keratosis is important and Picato® now offers us a new option, with a strong evidence base and high levels of adherence (>98%) in clinical studies, to discuss with our patients.”
The SMC positive advice for Picato® is supported by clinical trial data from four randomised, double- blind, phase III studies, which demonstrated that a significantly greater proportion of adults with actinic keratosis achieved complete clearance when treated with ingenol mebutate gel compared with a vehicle control.(8)
Commenting on the news, Leigh Smith, Chair of Melanoma Action and Support Scotland (MASScot) said: “It is really positive news for patients in Scotland that Picato® has been approved by the SMC as it offers a simple, short, two or three day treatment for actinic keratosis. Scotland has a high proportion of people with fair skin, which burns quickly in the sun, these people are at a particularly high risk of developing actinic keratosis, and possibly even skin cancer. It is therefore very important for Scots to be aware of changes to their skin and obtain an expert opinion on anything that does not heal and disappear within a few weeks. Preventing sunburn is an important step to help prevent skin cancer, while getting 10 to 20 minutes’ sun exposure around lunch time each day is thought to give adequate vitamin D levels.”
**Indication: Non-hyperkeratotic, non-hypertrophic actinic keratosis in adults
- Scottish Medicines Consortium, March 2013 ingenol mebutate, 150 & 500 micrograms/g, gel (Picato®). SMC No. (851/13). Available at www.scottishmedicines.org.uk.
- Mittelbronn MA et al. Int J Dermatol. 1998; 37:677-81
- Feldman SR and Fleischer AB, Jr. Cutis. 2011; 87:201-7
- Stockfleth E et al. Eur J Dermatol. 2008; 18:651-59
- Memon A et al. Br J Dermatol. 2000; 142:1154-9
- Information Services Division Scotland, Summary statistics for malignant melanoma of the skin 2010. Available at http://www.isdscotland.org/Health-Topics/Cancer/Cancer-Statistics/Skin/#squamous.
- Opinion Matters: Sun Awareness survey (carried out between:03 / 08 / 2012 – 09 / 08 / 2012) Data on File SISD-001 (2010/11030, August 2012).
- Lebwohl M et al. N Eng J Med. 2012; 366:1010-9