11.1 Managed clinical networks

Managed Clinical Networks (MCNs) are defined as:

‘linked groups of health professionals and organisations from primary, secondary and tertiary care, working in a coordinated manner, unconstrained by existing professional and Health Board boundaries, to ensure equitable provision of high quality clinically effective services throughout Scotland.’ ²⁶²

Managed Clinical Networks allow representatives from relevant specialties to discuss individual treatment plans and be aware of those patients likely to progress from an early stage in their disease. In the case of melanoma, the likely specialists who would be included in a MCN may be GPs, dermatologists, pathologists, surgeons in subspecialties, medical and clinical oncologists and palliative care specialists. Managed Clinical Networks are particularly beneficial for patients being cared for by health professionals unfamiliar with melanoma and they should also ensure that all eligible patients are offered the opportunity to enter into appropriate trials of new therapy. They require an administrative infrastructure and specialist nurse support which means they may have financial implications.

11.2 Economic implications

The development process for this guideline has included explicit consideration of economic and resource issues. This has been achieved through a review of the economics literature on specific recommendations and through the use of the SIGN resource use implications checklist. The aim of considering health economic aspects as an integral part of the guideline was to ensure the efficient use of healthcare resources and to provide information to assist implementation.

11.2.1 COST-EFFECTIVENESS EVIDENCE

A systematic literature review was performed for a number of specific recommendations in the guideline. Each study identified was reviewed according to a standard checklist used to critique economic evaluations.

11.2.2 SCREENING FOR CUTANEOUS MELANOMAS

A well conducted cost-effectiveness analysis using a hypothetical cohort of 50 year old Australians suggested that screening for melanoma by primary care physicians may be relatively cost effective.²⁶³ Comparing an organised programme of screening to the existing opportunistic regime, the model predicted that the cost per life year saved for men was Aus$6,853 to $12,137 for five-yearly and two-yearly screening respectively. The programme was less cost effective in women principally due to lower mortality from melanoma. The cost effectiveness of screening in high-risk populations has also been addressed in two American studies.^{264, 265} The findings suggested that such programmes were cost effective compared to other screening programmes used in the USA. The cost-effectiveness ratios were however sensitive to changes in the cost of the screening test and the prevalence of disease and hence the economic efficiency of screening high-risk individuals in Scotland may differ. No economics evidence was found which would support mass screening programmes.

11.2.3 SENTINEL LYMPH NODE BIOPSY

The key interest here is how the information obtained from the SLNB changes patient management, subsequent outcomes and associated costs. Only one study was identified, a cost analysis of 73 patients in the USA undergoing SLNB or an elective lymph node dissection (ELND).²⁶⁶ The results indicate that significant cost savings could be made by using SLNB rather than ELND. The study was non-randomised and hence subject to potential bias in the distribution of cost drivers between the groups, making the conclusion unreliable. Information on final patient outcomes was also lacking making it hard to be certain of the cost effectiveness of the intervention, particularly when applied to the UK setting.

11.2.4 ADJUVANT INTERFERON THERAPY

Five economic evaluations or cost studies relating to adjuvant interferon therapy were reviewed.^{270, 271, 272, 273, 274} Three studies used the trial results from the E1684 trial and hence investigated the cost effectiveness of adjuvant high-dose interferon therapy versus observation alone.^{270, 271, 272} These studies all found cost per life year gained and cost per QALY (Quality Adjusted Life Years) figures that would be considered broadly acceptable by current conventions. The UK meta-analysis and economic analysis however found insufficient evidence of benefit and thus, given its considerable incremental cost, concluded that it could not be recommended for routine use in the UK.²⁷³ The remaining economic evaluation was a French study examining the cost effectiveness and cost utility of low-dose interferon in patients with surgical resection of AJCC stage II melanoma versus observation alone.²⁷⁴ The cost effectiveness ratios in this study represent reasonable value for money. The majority of economic evaluations were based on the E1684 trial however that had the most positive findings, therefore cost effectiveness will tend to have been overstated. Further, if no significant difference exists in overall survival (as was found in the E1684 and French studies), the use of life years gained as an outcome is not tenable (since obviously no life years have been gained) rendering the cost-effectiveness results invalid. The robustness of the findings of the economic evaluations must be questioned.

11.2.5 FOLLOW UP OF PATIENTS WITH STAGE I AND II DISEASE

A German study used retrospective case note review to examine the relative cost effectiveness of various tests used in the follow up of patients with stage I-III disease.²⁷⁵ The study did not assess the value of surveillance per se nor the cost effectiveness of various frequencies of contact. The results indicated that at any stage of melanoma and follow up the most cost-effective test was physical examination and that lymph node sonography was the best performing imaging procedure, albeit less cost effective than physical examination. Similar conclusions were reached in a French study of patients with stage I melanoma.¹⁸¹ Both studies suffered from methodological weaknesses but they tend to support the recommendations made in section 7.

11.2.6 RESOURCE IMPLICATIONS CHECKLIST

• Are resource implications of implementation of the guideline likely to be significant nationally or locally such that they cannot be absorbed within existing resource allocations?
  It is hard to ascertain whether the implementation of this guideline can be met within existing resources. This is because the guideline contains both recommendations that may require new funds for implementation and recommendations that may halt certain existing practices, thereby freeing up resources. The net effect of this is hard to quantify and will depend on
  current standards, practices and resources in each Health Board area.
• Will the guideline affect outcomes or resource use in other areas of the NHS (such as primary care, other clinical specialties, support departments)?
  By recommending that all health professionals should be encouraged to examine patients for potential melanomas, there is likely to be a potential impact on all areas of clinical practice in NHSScotland. Resources for staff training and education may be required to implement
  this recommendation. Many of the recommendations made in section 2 will have an impact on pathology departments. Similarly, the need for appropriate palliation services recommended in section 8.4 may require investment if adequate services are not already available.
• Will guideline implementation affect outcomes or resource use in partner organisations (eg social work or the voluntary sector)?
  Palliative care services provided by charitable organisations may experience resource effects through the implementation of the guideline. Such organisations may also be involved in the provision of patient/carer information and support groups.
• Will guideline implementation affect costs to patients, for example will they face additional visits to hospital/GPs or have to spend longer in hospital?
  The costs of appropriate primary preventative products recommended in the guideline (sunscreens, hats and clothing) will result in costs to patients.
• Impact on other groups?
  Implementation of the guideline is unlikely to affect other groups.

11.3 Ideas for research

• A quantitative questionnaire study exploring patients’ views of melanoma care in Scotland, focussing on their views on diagnosis, follow up and education for self examination.
• A long term follow up trial to evaluate the Cochran model of survival, using survival statistics from the Scottish Melanoma Group database with reference to the following histological prognostic parameters:
• ulceration
• the relationship between the presence of regression and follow up
• the role of melanoma cell type
• the plasma cell in the inflammatory infiltrate
• sentinel node pathology.
• A study of negative SNLB patients that correlates tumour thickness, negative SNLB status and prognosis.
• A prospective trial to define the role of CT, MRI and PET in staging patients with stage II and III (in both gross- and micro-metastatic) disease.
• The role of specialist melanoma nurses.
• Health professionals’ communications skills in caring for patients with cancer.
• Who uses sunbeds and why?
• The role of PET scanning to identify distant disease.
• Does psychological and emotional support from an early stage of diagnosis influence outcomes for patients?

11.4 Audit

The Scottish Executive publication, Cancer in Scotland: Action for Change, highlighted the importance of prospective clinical audit of cancer services.²⁷⁶ In Scotland, through the Scottish Melanoma Group (SMG), there has been a long tradition of data collection relating to melanoma of all sites other than the eye.²⁷⁷ The development of this guideline provides an opportunity to review the content of the SMG dataset, taking account of the measurable recommendations, as well as the needs of other stakeholders (in relation to clinical standards, waiting times etc). A multidisciplinary group has been convened to review the SMG dataset, with a view to developing a draft dataset and data definitions for consultation through the three cancer networks in Scotland, prior to implementation.