2.1 The purpose of the Ambulight PDT device (Ambicare Health Ltd) is to deliver PDT to treat non-melanoma skin cancer in an ambulatory setting, including patients' homes in selected cases.
2.2 Ambulight PDT comprises a small single-use light-emitting device (containing its own red light source generated by a diffuser and a series of light-emitting diodes), which is connected by a lead to a pocket-sized battery. This light-emitting device sticks to the skin using a disposable plaster, 3 cm in diameter, worn directly over the treatment site. The battery can be carried in a pocket, attached to a belt or worn around the neck. The device is designed to treat single lesions that are smaller than 2.4 cm in diameter.
2.3 Before delivering Ambulight PDT, a photosensitising pro-drug is applied as a topical cream to the treatment site, where it is absorbed and metabolised to the active photosensitiser over a 3-hour period. Photodynamic therapy is then delivered for 3 hours. The light source emits the same dose and wavelength of light as in conventional PDT but the intensity is reduced and the light is administered over a longer period of time.
2.4 Depending on the indication, one or two treatments with Ambulight PDT are needed to complete a course (with separate cream applications and light-emitting devices if two treatments are needed). Each treatment lasts 6 hours (3 hours for drug absorption and 3 hours for delivering PDT). As with conventional PDT, these two treatments are carried out between 1 week and 1 month apart.
2.5 The device is worn for the full 6 hours of treatment. It is programmed so that the light source does not turn itself on until 3 hours after the battery pack is switched on, to allow for the drug absorption. A flashing light indicates, after a further 3 hours, when treatment is complete. The device switches itself off and can be removed by the patient.
2.6 Ambulight PDT is designed to enable therapy to be delivered in an ambulatory care setting, which can include the patient's home. This can avoid the need for a hospital appointment to receive the PDT, reducing travel for some patients. It is claimed that in some cases the device may allow patients to continue with their normal daily activities. It is also claimed that using Ambulight PDT may reduce pain compared with conventional PDT.
2.7 The average selling price of Ambulight PDT, as stated in the manufacturer's submission, is £200 with a price range of £180–250. The cost of Ambulight PDT may vary because of differences in purchasing contracts.
2.8 Current practice in the management of non-melanoma skin cancer in secondary care (specifically those lesions intended for treatment with Ambulight PDT) varies substantially. For patients for whom treatment is considered suitable, options are standard hospital-based PDT, topical chemotherapy, topical immunomodulators, surgical excision, curettage, cryotherapy or radiotherapy, but the treatment of choice varies between hospitals. Some patients receive no treatment for their small low-risk skin lesions, based on clinical decisions that there is insufficient risk of progression or harm.
2.9 Conventional PDT is currently offered in some out-of-hospital settings; these may be in primary care, secondary care or in the community, but not in patients' homes.