NICE medical technologies guidance addresses specific technologies notified to NICE by manufacturers. The ‘case for adoption’ is based on the claimed advantages of introducing the specific technology compared with current management of the condition. This case is reviewed against the evidence submitted and expert advice. If the case for adopting the technology is supported, then the technology has been found to offer advantages to patients and the NHS. The specific recommendations on individual technologies are not intended to limit use of other relevant technologies which may offer similar advantages.

The National Institute for Health and Clinical Excellence (NICE) is producing guidance on using the Ambulight PDT for the treatment of non-melanoma skin cancer in the NHS in England. The Medical Technologies Advisory Committee has considered the evidence submitted and the views of expert advisers.

This document has been prepared for public consultation. It summarises the evidence and views that have been considered, and sets out the draft recommendations made by the Committee. NICE invites comments from the public. This document should be read along with the evidence base (the assessment report and assessment report summary), which is available from www.nice.org.uk/mt.

The Advisory Committee is interested in receiving comments on the following:

• Has all of the relevant evidence been taken into account?
• Are the summaries of clinical effectiveness and resource savings reasonable interpretations of the evidence?
• Are the provisional recommendations sound, and a suitable basis for guidance to the NHS?
• Are there any equality issues that need special consideration and are not covered in the medical technologies consultation document?

Note that this document is not NICE’s final guidance on the Ambulight PDT for the treatment of non-melanoma skin cancer. The recommendations in section 1 may change after consultation. After consultation the Committee will meet again to consider the evidence, this document and comments from public consultation. After considering these comments, the Committee will prepare its final recommendations which will be the basis for NICE’s guidance on the use of the technology in the NHS in England.

For further details, see the ‘Evaluation Pathway Programme process guide’ (available at www.nice.org.uk).

Key dates:

• Closing date for comments: 2 February 2011
• Second Medical Technologies Advisory Committee meeting: 17 February 2011

1. Provisional recommendations

1.1 The Ambulight PDT offers a means of delivering photodynamic therapy in an ambulatory care setting for patients with small non-melanoma skin cancers and its use may be associated with less pain than conventional photodynamic therapy. The case for adoption for using the Ambulight PDT in place of conventional photodynamic therapy, could not be supported at this stage because the Committee was advised that the treatment of choice for non-melanoma skin cancer is complex; that practice varies substantially; and that many of the skin lesions suitable for this type of treatment can be managed conservatively. Therefore, the Ambulight PDT remains one of the options available for non-melanoma skin cancer.

2. The technology

Description of the technology

2.1 The purpose of the Ambulight PDT device is to deliver ambulatory photodynamic therapy to treat non-melanoma skin cancer.

2.2 The 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.

2.3 Before delivery of the photodynamic therapy, 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 generated by the device emits the same dose and wavelength of light as in conventional photodynamic therapy but the intensity is reduced and the light is administered over a longer period of time.

2.4 Two treatments with the Ambulight PDT (with separate cream applications and light-emitting devices) are needed to complete a course. Each treatment lasts 6 hours (3 hours for drug absorption and 3 hours of controlled photodynamic therapy delivery). These two treatments, as with conventional photodynamic therapy, are carried out between 1 week and 1 month apart.

2.5 The device is worn for the full 6 hours. It is programmed so that the light source does not turn itself on until 3 hours after the battery pack isswitched 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 Unlike conventional photodynamic therapy using large static light sources, the Ambulight PDT is designed to enable photodynamic therapy to be delivered in an ambulatory care setting including in the patient’s home. This can avoid the need for a hospital appointment to receive the photodynamic therapy, reduces the need for patients to travel and in some cases allows patients to continue with their normal daily activities.

2.7 The average selling price of the Ambulight PDT, as stated in the manufacturer’s submission, is £200 with a price range of £180–250.

2.8 The cost of the Ambulight PDT may vary because of differences in purchasing contracts.

Current management

2.9 Current practice in the management of non-melanoma skin cancer in secondary care (specifically those lesions intended for treatment with the Ambulight PDT) varies substantially. Some skin lesions are managed conservatively. For patients who are considered suitable for treatment, standard hospital-based photodynamic therapy, topical chemotherapy, topical immunomodulators, surgical excision, curettage, cryotherapy or radiotherapy are all options but the treatment of choice varies between hospitals.

2.10 Conventional photodynamic therapy is currently offered in some ambulatory care settings.

3. Clinical evidence

Summary of clinical evidence

3.1 The main clinical outcomes for the treatment of non-melanoma skin cancer with the Ambulight PDT are tumour response rate (including recurrence rates or need for additional treatment), pain during treatment and adverse events. Full details of all clinical outcomes considered by the Committee are available in the assessment report at http://guidance.nice.org.uk/MT/50.

3.2 There are 2 studies including a total of 28 patients who have been treated by Ambulight PDT.

3.3 Attili et al. (2009) described a pilot study of 12 patients (8 patients with Bowen’s disease and 4 patients with basal-cell carcinoma) with a median lesion diameter of 1.1 cm (range 0.6–1.9 cm) treated using a prototype of the Ambulight PDT device with 5-aminolevulinic acid as the photosensitiser. A complete response was reported in 75% (9/12) of patients at 6-month follow-up. At 12 months, 58% (7/12) of patients had complete tumour response (4 patients had peripheral margin failure; 1 had residual nodular component). In all patients for whom treatment was unsuccessful, the lesion size was > 1.5 cm in diameter.

3.4 Attili et al. (2009) reported pain immediately after treatment that was recorded using a numerical rating scale (1–10; higher score indicates worse pain). All 12 patients reported a pain score ≤ 2 (range 0–2). No patients required pain relief in the form of local anaesthesia or cool air treatment during therapy. One patient who reported excessive pain during previous photodynamic therapy commented on the lack of discomfort with the Ambulight PDT. These scores were compared retrospectively with those of 50 patients who had received conventional photodynamic therapy using an inorganic light-emitting diode static lamp source (dose 75 J/cm²). The static lamp cohort had a median numerical rating scale score of 6 (range 1–10). Eleven of these 50 patients needed local analgesia and all needed cool air treatment.

3.5 Ibbotson et al. (in press) presented data on the use of a light-emitting diode light source and methyl aminolevulinate cream (Metvix). These data included 5 patients with single lesions treated using the Ambulight PDT and 11 patients with multiple lesions whose lesions were treated with different photodynamic therapy treatments (at least one lesion site was treated with the Ambulight PDT: other sites were treated using conventional photodynamic therapy or different light-emitting diode sources). Pain immediately after treatment was recorded on a visual analogue scale (1–10; higher score indicates worse pain). For single lesions treated using the Ambulight PDT the pain score ranged from 1.5 to 7, with the second treatment often being more painful than the first. For patients with multiple lesions treated using the Ambulight PDT the pain scores ranged from 0 to 7.5 and for multiple lesions treated with other photodynamic therapy, pain scores ranged from 1.5 to 10.

3.6 No adverse events have been reported with the Ambulight PDT.

Committee considerations

3.7 The Committee considered that there was some evidence for efficacy of the Ambulight PDT but that the quantity of evidence was very limited and that only small tumours could be treated.

3.8 The Committee noted that the manufacturer of this technology claims that it is equivalent to, but not more effective than, conventional photodynamic therapy. The claims of advantage focus therefore on the reduction in pain experienced during treatment. The manufacturer’s submission described various techniques that have been developed to reduce pain during photodynamic therapy and presented studies demonstrating that reduced irradiance is associated with reduced pain.  

3.9 The Committee considered that treatment with the Ambulight PDT may reduce the pain associated with conventional photodynamic therapy in some patients.

3.10 The Committee considered that the Ambulight PDT offers one treatment option for non-melanoma skin cancer in the community.

3.11 The Committee was advised that patient selection is important in use of the Ambulight PDT. Small non-melanoma skin cancers are common and most have a low risk of progression, but because of incomplete coverage of case reporting, the true incidence is unknown. The Committee was advised that practice varies substantially when deciding on treatment for these lesions. Some patients are offered conservative management while others are offered one of a range of treatments including topical chemotherapy, surgical excision, radiotherapy or standard hospital-based photodynamic therapy. There are no good studies comparing the range of possible treatments with treatment using the Ambulight PDT.

3.12 The Committee was also advised that patient choice plays a significant part in the decision to treat low-risk non-melanoma skin cancers and that local service configuration influences the range of treatments that can be offered.

3.13 The Committee considered that the ambulatory nature of the device offers the potential to increase convenience of treatment for patients with impaired mobility.

3.14 The Committee debated the usefulness of a device that treats only single lesions when many patients have multiple lesions requiring treatment, and that is suitable only for treating lesions of a small size.  They also noted the different opinions of experts about pain experienced by patients having photodynamic therapy; not all agree that pain is an issue with conventional photodynamic therapy.

3.15 The Committee recognised that the Ambulight PDT is a new device at a relatively early stage of development with a consequently small evidence base but that the manufacturer is collecting more data. However, the Committee considered the clinical evidence and judged that it was insufficient to support the case for adopting the Ambulight PDT for the treatment of non-melanoma skin cancers in the NHS in place of current management.

4. NHS considerations

System impact

4.1 The Ambulight PDT enables photodynamic therapy to be delivered in a community setting. This could reduce the demand on NHS transport services, hospital outpatient services as well as improving access to treatment and potentially reducing waiting times.

4.2 NICE cancer service guidance CSGSTIM ‘Improving outcomes for people with skin tumours including melanoma (update): the management of low-risk basal cell carcinomas in the community’ states that the management of basal cell carcinomas imposes a significant workload on both primary- and secondary-care service. It recommends that treatment and care should take into account patients’ needs and preferences, and recognises that there is a need to provide high-quality care close to a patient’s home. A device that offers ambulatory photodynamic therapy could be an attractive treatment option for some patients who express a strong desire to continue with their normal daily activities while receiving treatment. 

Committee considerations

4.3 The Committee recognised the potential for the system advantages on which the cost model described in section 4.1 were based.

4.4 The Committee considered that the use of the Ambulight PDT might require both additional staff training for accurate diagnosis and treatment delivery, and additional infrastructure to be set up within ambulatory care settings. Although these would have initial outlay costs, cost savings might be realised once a service is established.

4.5 The Committee was advised that variation in practice is substantial and that photodynamic therapy is used much less in some hospitals than others: this made consideration of any changes in service provision more complex. The Ambulight PDT remains one treatment option for non-melanoma skin cancer.

5. Cost consideration

Cost evidence

5.1 The analysis submitted by the manufacturer evaluated the costs of service configuration in which the Ambulight PDT might be used, compared with the existing NHS service of conventional photodynamic therapy using a static lamp in hospital. The analysis did not include any cost consequences associated with treatment efficacy or adverse events.

5.2 The cost models represented the operating costs of delivering photodynamic therapy with the Ambulight PDT in the community compared with conventional hospital-based photodynamic therapy, for a complete treatment cycle, which consists of two treatments 1 week apart. In the cost analysis it was assumed that patients had already been diagnosed with non-melanoma skin cancer, so no costs associated with the diagnostic stage of management were included.

5.3 Four clinical scenarios were presented in which a GP with special interest in dermatology delivered photodynamic therapy in the community with the Ambulight PDT. These scenarios were presented for comparison against conventional hospital-based photodynamic therapy.

• GP operating in their own practice.
• GP operating in a specialist centre.
• GP operating in an outpatient clinic in secondary care.
• A nurse hybrid service model.

5.4 The costs of three of these clinical scenarios for service delivery were calculated using the analysis of the potential economic impact of the NICE cancer service guidance CSGSTIM (2006 and 2010) on skin cancer. The ‘nurse hybrid service’ scenario refers to nurses delivering treatment in the patient’s home after diagnosis by a GP with specialist interest in dermatology. No overheads or GP costs are required for this model of service delivery.

5.5 The cost analysis did not consider any impact on staff costs for additional training or for support for patients in the use of the Ambulight PDT. Support and advice may be required by patients because the Ambulight PDT is used while they continue with daily activities, outside a clinical setting.

5.6 There was significant uncertainty in the costs presented in the submission therefore it was difficult to determine the cost difference likely to be realised in practice. The cost difference between photodynamic therapy using the Ambulight PDT and conventional photodynamic therapy using a static lamp presented in the manufacturer’s submission ranged from a cost saving of £195 to a cost increase of £535. The cost difference was dependent on the clinical scenario used for delivering photodynamic therapy with the Ambulight PDT and the method of calculating the cost of each scenario.

5.7 The cost analysis presented cost savings associated with the use of the Ambulight PDT in terms of removing the need for staff to administer illumination from a static machine, room hire for the illumination period and the use of anaesthesia, which could translate into resource savings.

Committee considerations

5.8 The Committee considered that the cost models submitted by the manufacturer were complex and difficult to interpret. The range of cost consequences was wide, with some showing an increase in cost to the service and others showing small savings. The Committee was therefore unable to draw firm conclusions on the cost savings associated with the use of the Ambulight PDT in primary care.

5.9 The Committee discussed the potential resource savings to the NHS from using the Ambulight PDT in primary care (see section 5.8). However, it is likely that the level of service provision for photodynamic therapy already established within a community setting is a key factor in whether the use of Ambulight PDT can be associated with a cost saving or cost increase compared to conventional photodynamic therapy with a static lamp. The Committee was mindful of the additional costs involved in setting up the range of facilities to deliver photodynamic therapy in the community and was not convinced that the potential resource savings would confer sufficient advantage.

6. Conclusions

6.1 The Committee concluded that the claimed clinical advantages of treating non-melanoma skin cancer using the Ambulight PDT could not be supported, in the context of the limited evidence available, that variable treatments are used for these lesions, and the fact that many can be managed conservatively. In addition, the pathways of care for the use of the Ambulight PDT in ambulatory care settings are not yet established. The Committee concluded that the cost models did not present a convincing case for advantages to the NHS.

6.2 The Committee concluded that the case for adopting the Ambulight PDT over current management could not be supported. The Ambulight PDT remains one treatment option for people with non-melanoma skin cancer in the community. It is a novel development in the area of photodynamic therapy that shows some promise, but further work is needed to support its case for adoption in the NHS.

7. Implementation

NICE intends to develop tools in association with relevant stakeholders to help organisations put this guidance into practice.

8. Related NICE guidance

Published

• Improving outcomes for people with skin tumours including melanoma (update): the management of low-risk basal cell carcinomas in the community. Cancer service guidance CSGSTIM (2010). Available from www.nice.org.uk/csgstim
• Improving outcomes for people with skin tumours including melanoma. Cancer service guidance CSGSTIM (2006). Available from www.nice.org.uk/CSGSTIM
• Photodynamic therapy for non-melanoma skin tumours Interventional procedures guidance. Interventional procedures guidance 155 (2006). Available from www.nice.org.uk/IPG155

Under development

NICE is developing the following guidance (details available from www.nice.org.uk):

• Providing public information to prevent skin cancer. Public health guidance (publication expected January 2011)
• Resources and environmental changes to prevent skin cancer. Public health guidance (publication expected January 2011)