Out-of-pocket medical expenses compared across five years for patients with one of five common cancers in Australia.

BACKGROUND: Patient medical out-of-pocket expenses are thought to be rising worldwide yet data describing trends over time is scant. We evaluated trends of out-of-pocket expenses for patients in Australia with one of five major cancers in the first-year after diagnosis. METHODS: Participants from the QSKIN Sun and Health prospective cohort Study with a histologically confirmed breast, colorectal, lung, melanoma, or prostate cancer diagnosed between 2011 and 2015 were included (n = 1965). Medicare claims data on out-of-pocket expenses were analysed using a two-part model adjusted for year of diagnosis, health insurance status, age and education level. Fisher price and quantity indexes were also calculated to assess prices and volumes separately. RESULTS: On average, patients with cancer diagnosed in 2015 spent 70% more out-of-pocket on direct medical expenses than those diagnosed in 2011. Out-of-pocket expenses increased significantly for patients with breast cancer (mean AU$2513 in 2011 to AU$6802 in 2015). Out-of-pocket expenses were higher overall for individuals with private health insurance. For prostate cancer, expenses increased for those without private health insurance over time (mean AU$1586 in 2011 to AU$4748 in 2014) and remained stable for those with private health insurance (AU$4397 in 2011 to AU$5623 in 2015). There were progressive increases in prices and quantities of medical services for patients with melanoma, breast and lung cancer. For all cancers, prices increased for medicines and doctor attendances but fluctuated for other medical services. CONCLUSION: Out-of-pocket expenses for patients with cancer have increased substantially over time. Such increases were more pronounced for women with breast cancer and those without private health insurance. Increased out-of-pocket expenses arose from both higher prices and higher volumes of health services but differ by cancer type. Further efforts to monitor patient out-of-pocket costs and prevent health inequities are required.

Sentinel lymph node biopsy is associated with increased cost in higher risk thin melanoma.

INTRODUCTION: National Comprehensive Cancer Network guidelines recommend that sentinel lymph node biopsy (SLNB) be discussed with patients with thin melanoma at higher risk for lymph node metastasis (T1b or T1a with positive deep margins, lymphovascular invasion, or high mitotic index). We examined the association between SLNB and resource utilization in this cohort. METHODS: We conducted a retrospective cohort study of patients that underwent wide local excision for higher risk thin melanomas from 2009 to 2018 at a tertiary care center. Patients who underwent SLNB were compared to those who did not undergo SLNB with regard to resource utilization, including total hospital cost. RESULTS: A total of 70 patients were included in the analysis and 50 patients (71.4%) underwent SLNB. SLNB was associated with increased hospital costs ($6700 vs. $3767; p < .01) and increased operative time (68.5 vs. 36.0 min; p < .01). This cost difference persisted in multivariable regression (p < .01). Of patients who underwent successful SLN mapping, 3 out of 49 patients had a positive SLN (6.1%). The cost to identify a single positive sentinel lymph node (SLN) was $47,906. CONCLUSION: In patients with a higher risk of thin melanoma, SLNB is associated with increased cost despite a low likelihood of SLN positivity. These data better inform patient-provider discussions as the role of SLNB in thin melanoma evolves.

Association of the Affordable Care Act's Medicaid expansion with the diagnosis and treatment of clinically localized melanoma: A National Cancer Database study.

BACKGROUND: The Affordable Care Act's Medicaid expansion is associated with earlier diagnosis and improved care among lower socioeconomic status populations with cancer, but its impact on melanoma is undefined. OBJECTIVE: To determine the association of Medicaid expansion with stage of diagnosis and use of sentinel lymph node biopsy in nonelderly adult patients with newly diagnosed clinically localized melanoma. METHODS: Quasi-experimental, difference-in-differences retrospective cohort analysis using data from the National Cancer Database from 2010 to 2017. Patients from expansion versus nonexpansion states and diagnosed before (2010-2013) versus after (2014-2017) expansion were identified. RESULTS: Of 83,322 patients, 46.6% were female, and the median age was 55 years (interquartile range, 49-60). After risk adjustment, Medicaid expansion was associated with a decrease in the diagnosis of T1b stage or higher melanoma (odds ratio [OR], 0.93; 95% confidence interval [CI], 0.88-0.98; P = .011) and decrease in uninsured status (OR, 0.61; 95% CI, 0.52-0.72; P < .001) but was not associated with a difference in sentinel lymph node biopsy performance when indicated (OR, 1.06; 95% CI, 0.95-1.20; P = .29). LIMITATIONS: Retrospective study using a national database. CONCLUSION: In this study of patients with clinically localized melanoma, Medicaid expansion was associated with a decrease in the diagnosis of later T-stage tumors.

A real-world data approach to determine the optimal dosing strategy for pembrolizumab.

INTRODUCTION: Cancer drug therapy costs continue to rise and threaten the sustainability of Canada's public healthcare system. Previous studies have calculated potential savings utilizing different dosing regimens of cancer treatments. Our objectives were to determine the financial impact of drug wastage and to explore cost-effective dosing regimens for pembrolizumab. METHODS: This was a retrospective study reviewing data for non-small cell lung cancer and melanoma patients at all six BC Cancer Regional Centres during fiscal years 2017 and 2018. Pembrolizumab waste amounts recorded in pharmacy wastage logs were totalled. Estimates of the number of vials used were compared between vial sharing and non-vial sharing practices to determine the cost differences. Costs for dosing regimens used during fiscal years 2017 and 2018 were compared to 2 mg/kg weight-based dosing (to a maximum of 200 mg), 2 mg/kg dosing rounding down within 5% and 10%, and flat dosing of 200 mg. RESULTS: There were a total of 202 non-small cell lung cancer and 182 melanoma patients with 2948 doses dispensed. Documented wastage was valued at $1,829,047.44 (8.65%) and across all six centres, vial sharing could reduce costs by $3,207,600.00 using the 100 mg vials. Compared to fiscal years 2017 and 2018, 2 mg/kg dosing (to a maximum of 200 mg) was the most cost-effective, decreasing costs by $222,719.20; flat dosing of 200 mg was the most expensive, increasing costs by $6,625,260.40. CONCLUSIONS: Having smaller vial sizes, practicing vial sharing, and using weight-based dosing all improve cost savings. Further investigations on the allocation of resources to optimize drug use and minimize wastage are needed.

Economic Evaluation of Systemic Treatments for Advanced Melanoma: A Systematic Review.

BACKGROUND: Many high cost treatments for advanced melanoma have become available in recent years. National health technology assessment agencies have raised concerns regarding uncertainty in their clinical and cost-effectiveness. OBJECTIVE: The aim of this systematic review is to identify economic evaluations of treatments for advanced melanoma and review model assumptions, outcomes, and quality as preparation for a health technology assessment. METHODS: A search of Embase, MEDLINE, EconLit, and the Cochrane Database was conducted. Only studies using decision-analytic models were included. Two authors independently completed full-text review and data extraction. RESULTS: Fifteen studies were identified. There were major differences in the structural assumptions underpinning the models. There was general agreement in study conclusions, although the predicted costs and quality-adjusted life years for each treatment varied. BRAF monotherapy (vemurafenib, dabrafenib) or BRAF/MEK combination therapy (BRAF monotherapy with cobimetinib or trametinib) has not been shown to be cost-effective in any jurisdiction. PD-1 inhibitors (pembrolizumab, nivolumab) are consistently found to be cost-effective compared with ipilimumab, although their cost-effectiveness compared with chemotherapy is not established. Combination therapy with nivolumab and ipilimumab is unlikely to be cost-effective in any setting. One study including all agents found that none of the new treatments were cost-effective relative to chemotherapy. Publication of the study in a health economics journal is associated with better reporting of and higher-quality assessment than those published in clinical journals. CONCLUSION: Despite differences in model structures and assumptions, the conclusions of most included studies were consistent. Health technology assessment has a key role in maximizing value from high-cost innovative treatments. Consideration should be given to divestment from BRAF/MEK inhibitors and ipilimumab in favor of reimbursement of PD-1 inhibitors.

Cost-effectiveness analysis of imaging strategy for an intensive follow-up of patients with American Joint Committee on Cancer stage IIB, IIC and III malignant melanoma.

BACKGROUND: Many follow-up guidelines for patients with high-risk melanoma include expensive imaging studies, serum biomarkers and regular visits to the dermatologist, with little attention to cost-effectiveness. OBJECTIVES: To establish the cost-effectiveness of chest-abdomen-pelvis computed tomography (CT) and brain magnetic resonance imaging (MRI) in a follow-up protocol for patients at high risk of relapse. METHODS: This was a prospective single-centre cohort study of 290 patients with clinicopathological American Joint Committee on Cancer (AJCC) stage IIB, IIC and III melanoma. Patients had a body CT scan and brain MRI every 6 months and were withdrawn from the study after completing a 5-year follow-up or when metastases were detected. A cost-effectiveness analysis for each follow-up radiological procedure was performed. RESULTS: Patients underwent 1805 body CT scans and 1683 brain MRIs. Seventy-six metastases (26·2%) were identified by CT or MRI. CT scan was cost-effective in the first 4 years (cost-effectiveness ratio €4710·70-€14 437·10/patient with metastasis); brain MRI was cost-effective during the first year (cost-effectiveness ratio €14 090·60/patient with metastasis). Limitations included lack of survival analysis and comparisons with willingness-to-pay thresholds. CONCLUSIONS: Six-monthly CT scan of the chest, abdomen and pelvis is a cost-effective technique for the early detection of metastases in the first 4 years of follow-up in patients with AJCC stage IIC and III melanoma, and in the first 3 years in patients with AJCC stage IIB melanoma. In addition, brain MRI has been shown to be cost-effective only in the first year of follow-up in patients with AJCC stage IIC and III melanoma.

How Does Option Value Affect the Potential Cost-Effectiveness of a Treatment? The Case of Ipilimumab for Metastatic Melanoma.

BACKGROUND: Innovations that extend life can generate option value and cost of experiencing future technologies. OBJECTIVES: To understand how consideration of option value may affect the potential cost-effectiveness of a treatment through a case study of ipilimumab for previously untreated metastatic melanoma. METHODS: We estimated the cost-effectiveness of ipilimumab in 2 scenarios: a conventional scenario, for which we constructed the model using the standard methods that rely on efficacy data directly from the phase III trial of ipilimumab, and an option value scenario, where we incorporated future hypothetical improvements in mortality for metastatic melanoma owing to innovations. We developed 2 approaches to incorporate option value. In the first approach, we forecasted mortality trends based on historical trends from the Surveillance, Epidemiology, and End Results (SEER) Program registry. Alternatively, we identified drugs being studied in clinical trials at the time of ipilimumab's approval on clinicaltrials.gov and estimated their likelihood and timing of approval, potential efficacy, and cost. We accounted for increases in overall cancer treatment cost and unrelated medical cost in the option value scenario. RESULTS: In the option value scenario, using the SEER approach, the incremental quality-adjusted life-years (QALYs) gained and the incremental cost increased by 6.2% and 3.8%, respectively, whereas the incremental cost-effectiveness ratio (ICER) decreased by 2.3% compared with the conventional scenario. Using the clinicaltrials.gov approach, the incremental QALY gained and the incremental cost increased by 7.5% and 7.1%, respectively, whereas the ICER decreased by 0.40%. CONCLUSIONS: We developed generalizable approaches to estimating option value in cost-effectiveness analysis.

Mohs micrographic surgery for melanoma: A prospective multicenter study.

BACKGROUND: Single-institution studies show that frozen section Mohs micrographic surgery (MMS) is an effective treatment modality for cutaneous melanoma, but no multi-institutional studies have been published. OBJECTIVE: To characterize the use of MMS in the treatment of melanoma at 3 academic and 8 private practices throughout the United States, to recommend excision margins when 100% histologic margin evaluation is not used, and to compare actual costs of tumor removal with MMS vs standard surgical excision. METHODS: Prospective, multicenter, cohort study of 562 melanomas treated with MMS with melanoma antigen recognized by T cells 1 immunostaining. RESULTS: Primary trunk and extremity melanomas (noninvasive and invasive melanoma) achieved histologically negative margins in 97% of tumors with 10-mm margins, whereas 12-mm margins were necessary to achieve histologically negative margins in 97% of head and neck melanomas. Overall average cost per tumor treated was $1328.46. LIMITATIONS: Nonrandomized and noncontrolled study. CONCLUSIONS: MMS with melanoma antigen recognized by T cells 1 immunostaining safely provides tissue conservation and same-day reconstruction of histologically verified tumor-free margins in a convenient, single-day procedure. When comprehensive margin evaluation is not used, initial surgical margins of at least 10 mm for primary trunk/extremity and 12 mm for head/neck melanomas should be used to achieve histologically negative margins 97% of the time.

Annually over 9 billion dollars less for one-step melanoma surgery: sounds good?

The rules for surgical treatment of cutaneous melanomas are subject to lively discussions without finding a definitive solution to date. We present a short comparison between the American Joint Committee of Cancer (AJCC) and One Step Melanoma Surgery (OSMS) recommendations, proving our thesis that OSMS at present is certainly the most effective methodology .

Skin cancer projections and cost savings 2014-2045 of improvements to the Danish sunbed legislation of 2014.

BACKGROUND: Sunbed use increases the risk of skin cancer. The Danish sunbed legislation (2014) did not include an age limit. AIM: To model skin cancer incidences and saved costs from potential effects of structural interventions on prevalence of sunbed use. MATERIALS AND METHODS: Survey data from 2015 were collected for 3999 Danes, representative for the Danish population in regards to age, gender and region. Skin cancer incidences were modelled in the Prevent program, using population projections, historic cancer incidence, sunbed use exposure and relative risk of sunbed use on melanoma. RESULTS: If structural interventions like an age limit of 18 years for sunbed use or complete ban had been included in the Danish sunbed legislation in 2014, it would have reduced the annual number of skin cancer cases with 455 or 4177, respectively, while for the entire period, 2014-2045 the total reductions would be 3730 or 81 887 fewer cases, respectively. The cost savings from an age limit or ban, respectively, are 9 and 129 millions € during 2014-2045. CONCLUSION: Legislative restrictive measures which could reduce the sunbed use exists. Danish politicians have the opportunity, supported by the population, to reduce the skin cancer incidence and thereby to reduce the future costs of skin cancer.

Cost-of-illness of melanoma in Europe - a systematic review of the published literature.

Malignant melanoma accounts for the vast majority of skin cancer deaths. Primary prevention is used to increase knowledge about skin cancer and set incentives for a change in behaviour, which leads to a decrease in cases. Primary prevention may be cost-effective or even cost saving. Cost-of-illness (COI) studies provide information on such potential savings. The purpose of this study is to give an overview on COI studies in European countries and to compare the COI in total and by cost categories. The results can be used to model potential cost savings from prevention. We conducted a systematic literature research in PubMed using the PRISMA checklist. All costs were converted into Euro and adjusted for the reference year 2012. For the ranking of countries according to their COI, all costs were adjusted for the purchasing power parity. All studies focusing on stage III-IV melanoma include information on hospital, hospice, and outpatient treatment. Costs for the treatment of advanced melanoma range between € 2972 in Italy and € 17 408 in Sweden after adjusting for purchasing power parity. Most studies on stage I-IV melanoma include costs of hospitalization, outpatient treatment and general practitioner consultation. Direct costs range from € 923 in Sweden to € 9829 in Denmark. Three articles also include information on indirect costs. Mortality costs vary between € 3511 in Sweden and € 20 408 in England, morbidity costs between € 103 in Sweden and € 4550 in England. We showed that costs for the treatment of skin cancer are moderately high in the included countries. Since after publication of the articles new costly drugs were approved in Europe, treatment costs of melanoma in Europe may be expected to have risen in the last few years, which means that there is a high expectable potential for prevention programmes to become cost-effective or even cost saving.

Modelling first-year cost-of-illness of melanoma attributable to sunbed use in Europe.

BACKGROUND: Melanoma is a life-threatening disease of the skin with an increasing incidence of approximately 87 000 new cases treated per year in the European Union and the European Free Trade Association states resulting in considerable costs for the society. Since the use of sunbeds is known to be a risk factor, which can be easily avoided, costs of malignant melanoma attributable to sunbed use are modelled in the present study. METHODS: Costs-of-illness of melanoma were calculated and compared for all member states of the European Union and the European Free Trade Association states using an established modelling approach. Calculations were based on a systematic literature research. For countries with no available information on cost-of-illness the gross domestic product, health expenditures and gross national income served as a basis for extrapolation of costs. International comparison was enabled by adjusting costs by the national purchasing power parity. RESULTS: After adjusting melanoma treatment costs for the purchasing power parity, direct costs per patient vary between € 1056 in Romania and € 10 215 in Luxembourg. Costs due to morbidity range from € 102 per patient in Sweden and € 5178 in the UK resulting in total costs of € 1751-€ 12 611 per patient. Average weighted total costs per patient amount for € 6861-€ 6967 annually. In total, in 2012 approximately 4450 new cases of melanoma have been induced by sunbed use in the 31 included countries, which corresponds to 5.1% of all incident melanoma cases. National attributable melanoma costs range from € 1570 in Malta to € 11.1 million in Germany and sum up to an amount of € 32.5-€ 33.4 million for all countries. CONCLUSION: This article provides a first estimation on costs of melanoma in Europe. It illustrates the contribution of exposure to artificial ultraviolet light in the economic burden of malignant melanoma.

Cost-of-illness of melanoma in Europe - a modelling approach.

BACKGROUND: Malignant melanoma is accounting for the vast majority of skin cancer death. The treatment and productivity loss due to morbidity or premature mortality are associated with costs for society. There are few cost-of-illness (COI) studies on malignant melanoma in European countries from societal perspective and currently there is no publication analysing the COI in all European countries. OBJECTIVES: The objective of the present study was to comparatively estimate COI of malignant melanoma in the European countries based on an identical approach. METHODS: Cost information was obtained from results of a systematic literature research. For countries with no available cost information, a model for imputation of cost data was developed. Country-specific costs were modelled on the national gross domestic product, health expenditures, gross national income and epidemiological data. The adjustment for purchasing power parity allowed a comparison across countries. RESULTS: Crude national costs of malignant melanoma ranged between € 1.1 million in Iceland and € 543.8 million in Germany and resulted in € 2.7 billion for all EU/EFTA states. Estimated crude costs per patient were lowest in Bulgaria (€ 6422) and highest in Luxembourg (€ 50 734). The share of direct costs varied from 3% to 26% across countries. After adjustment for the purchasing power parity costs per patient ranged between € 14 420 in Bulgaria and € 50 961 in Cyprus. Treatment expenses and morbidity costs were markedly lower for countries that entered the EU since 2004. By contrast, mortality costs were lower in countries with a high gross domestic product per capita. CONCLUSION: In this first estimation, malignant melanoma induces relevant COI in Europe. There was large variation in the costs per patient due to different health care systems and expenses. Beyond decreasing patient burden, early intervention and prevention of melanoma could have a relevant potential to save costs across Europe.

Early cost-effectiveness of tumor infiltrating lymphocytes (TIL) for second line treatment in advanced melanoma: a model-based economic evaluation.

BACKGROUND: An emerging immunotherapy is infusion of tumor infiltrating Lymphocytes (TIL), with objective response rates of around 50% versus 19% for ipilimumab. As an Advanced Therapeutic Medicinal Products (ATMP), TIL is highly personalized and complex therapy. It requests substantial upfront investments from the hospital in: expensive lab-equipment, staff expertise and training, as well as extremely tight hospital logistics. Therefore, an early health economic modelling study, as part of a Coverage with Evidence Development (CED) program, was performed. METHODS: We used a Markov decision model to estimate the expected costs and outcomes (quality-adjusted life years; QALYs) for TIL versus ipilimumab for second line treatment in metastatic melanoma patients from a Dutch health care perspective over a life long time horizon. Three mutually exclusive health states (stable disease (responders)), progressive disease and death) were modelled. To inform further research prioritization, Value of Information (VOI) analysis was performed. RESULTS: TIL is expected to generate more QALYs compared to ipilimumab (0.45 versus 0.38 respectively) at lower incremental cost (presently €81,140 versus €94,705 respectively) resulting in a dominant ICER (less costly and more effective). Based on current information TIL is dominating ipilimumab and has a probability of 86% for being cost effective at a cost/QALY threshold of €80,000. The Expected Value of Perfect Information (EVPI) amounted to €3 M. CONCLUSIONS: TIL is expected to have the highest probability of being cost-effective in second line treatment for advanced melanoma compared to ipilimumab. To reduce decision uncertainty, a clinical trial investigating e.g. costs and survival seems most valuable. This is currently being undertaken as part of a CED program in the Netherlands Cancer Institute, Amsterdam, the Netherlands, in collaboration with Denmark.

Real-world healthcare costs of ipilimumab in patients with advanced cutaneous melanoma in The Netherlands.

There is limited evidence on the costs associated with ipilimumab. We investigated healthcare costs of all Dutch patients with advanced cutaneous melanoma who were treated with ipilimumab. Data were retrieved from the nation-wide Dutch Melanoma Treatment Registry. Costs were determined by applying unit costs to individual patient resource use. A total of 807 patients who were diagnosed between July 2012 and July 2015 received ipilimumab in Dutch practice. The mean (median) episode duration was 6.27 (4.61) months (computed from the start of ipilimumab until the start of a next treatment, death, or the last date of follow-up). The average total healthcare costs amounted to &OV0556;81 484, but varied widely (range: &OV0556;18 131-&OV0556;160 002). Ipilimumab was by far the most important cost driver (&OV0556;73 739). Other costs were related to hospital admissions (&OV0556;3323), hospital visits (&OV0556;1791), diagnostics and imaging (&OV0556;1505), radiotherapy (&OV0556;828), and surgery (&OV0556;297). Monthly costs for resource use other than ipilimumab were &OV0556;1997 (SD: &OV0556;2629). Treatment-naive patients (n=344) had higher total costs compared with previously-treated patients (n=463; &OV0556;85 081 vs. &OV0556;78 811). Although patients with colitis (n=106) had higher costs for resource use other than ipilimumab (&OV0556;11 426) compared with patients with other types of immune-related adverse events (n=90; &OV0556;9850) and patients with no immune-related adverse event (n=611; &OV0556;6796), they had lower total costs (&OV0556;76 075 vs. &OV0556;87 882 and &OV0556;81 480, respectively). In conclusion, this nation-wide study provides valuable insights into the healthcare costs of advanced cutaneous melanoma patients who were treated with ipilimumab in clinical practice. Most of the costs were attributable to ipilimumab, but the costs and its distribution varied considerably across subgroups.

A Modeling Study of the Cost-Effectiveness of a Risk-Stratified Surveillance Program for Melanoma in the United Kingdom.

BACKGROUND: Population-wide screening for melanoma is unlikely to be cost-effective. Nevertheless, targeted surveillance of high-risk individuals may be. OBJECTIVES: To estimate the cost-effectiveness of various surveillance strategies in the UK population, stratified by risk using a simple self-assessment tool scoring between 0 and 67. METHODS: A decision model comparing alternative surveillance policies from the perspective of the UK National Health Service over 30 years was developed. The strategy with the highest expected net benefit for each risk score was identified, resulting in a compound risk-stratified policy describing the most cost-effective population-wide strategy. The overall expected cost and quality-adjusted life-years (QALYs), the incremental cost-effectiveness ratio, and associated uncertainty were reported. RESULTS: The most cost-effective strategy is for those with a Williams score of 15 to 21 (relative risk [RR] of 0.79-1.60 vs. a mean score of 17 in the United Kingdom) to be offered a one-off full-body skin examination, and for those with a score of 22 or more (RR 1.79+) to be enrolled into a quinquennial monitoring program, rising to annual recall for those with a risk score greater than 43 (RR 20.95+). Expected incremental cost would be £164 million per annum (~0.1% of the National Health Service budget), gaining 15,947 additional QALYs and yielding an incremental cost-effectiveness ratio of £10,199/QALY gained (51.3% probability <£30,000). CONCLUSIONS: The risk-stratified policy would be expensive to implement but cost-effective compared with typical UK thresholds (£20,000-£30,000/QALY gained), although decision uncertainty is high. Phased implementation enrolling only higher risk individuals would be substantially less expensive, but with consequent foregone health gain.

Cost-Effectiveness of Melanoma Screening in Inflammatory Bowel Disease.

BACKGROUND AND AIMS: Inflammatory bowel disease (IBD) patients are at increased risk of melanoma and non-melanoma skin cancers, and preventive care guidelines in IBD favor annual skin examinations. Here we estimate the cost-effectiveness of annual melanoma screening in IBD. METHODS: Melanoma screening was defined as receiving annual total body skin examinations starting at age 40 from a dermatologist. Screening was compared to US background total body skin examination rates performed by primary care practitioners. A Markov model was used to estimate intervention costs and effectiveness. Future costs and effectiveness were discounted at 3% per year over a lifetime horizon. Strategies were compared using a willingness-to-pay threshold of $100,000/quality-adjusted life year (QALY) gained. RESULTS: Annual melanoma screening cost an average of $1961 per patient, while no screening cost $81 per patient. Melanoma screening was more effective, gaining 9.2 QALYs per 1000 persons, at a cost of $203,400/QALY gained. Screening every other year was the preferred strategy, gaining 6.2 QALYs per 1000 persons and costing $143,959/QALY. One-way sensitivity analyses suggested the relative risk of melanoma in IBD, melanoma progression, and screening costs were most influential with clinically plausible variation, leading to scenarios costing < $100,000/QALY gained. Probabilistic sensitivity analyses suggested screening every other year was cost-effective in 17.4% of iterations. CONCLUSIONS: Screening for melanoma in IBD patients was effective but expensive. Screening every other year was the most cost-effective strategy. Studies to identify IBD patients at the highest risk of developing melanoma may assist in targeting a prevention program in the most cost-effective manner.

Estimation of Direct Melanoma-related Costs by Disease Stage and by Phase of Diagnosis and Treatment According to Clinical Guidelines.

Cutaneous melanoma is a major concern in terms of healthcare systems and economics. The aim of this study was to estimate the direct costs of melanoma by disease stage, phase of diagnosis, and treatment according to the pre-set clinical guidelines drafted by the AIOM (Italian Medical Oncological Association). Based on the AIOM guidelines for malignant cutaneous melanoma, a highly detailed decision-making model was developed describing the patient's pathway from diagnosis through the subsequent phases of disease staging, surgical and medical treatment, and follow-up. The model associates each phase potentially involving medical procedures with a likelihood measure and a cost, thus enabling an estimation of the expected costs by disease stage and clinical phase of melanoma diagnosis and treatment according to the clinical guidelines. The mean per-patient cost of the whole melanoma pathway (including one year of follow-up) ranged from €149 for stage 0 disease to €66,950 for stage IV disease. The costs relating to each phase of the disease's diagnosis and treatment depended on disease stage. It is essential to calculate the direct costs of managing malignant cutaneous melanoma according to clinical guidelines in order to estimate the economic burden of this disease and to enable policy-makers to allocate appropriate resources.

Unmet supportive care needs, health status and minimum costs in survivors of malignant melanoma.

We explored the relationship between unmet care needs, health status, health utility and costs in people treated for melanoma via a cross-sectional follow-up survey (N = 455) 3 months to 5 years after complete resection of stage I-III cutaneous malignant melanoma. 51% (n = 232) had unmet care needs. This group had higher mean resource use, estimated conservatively (£28 vs. £10 per person) and worse overall health. Mean health-related utility index (AQoL6D) was 0.763 (95% CI 0.74; 0.79) in those with self-reported unmet need vs. 0.903 (0.89; 0.92) in those with no unmet need. Melanoma survivors with unmet need had worse outcomes in terms of anxiety (HADS 6.86 vs. 4.29), depression (HADS 4.29 vs. 2.01), overall quality of life (QoL: FACT-M 84.2 vs. 96.5). Higher resource use was associated with younger age (rs  = -.29, p < .001), older school-leaving age (rs  = .21, p < .001), reduced health utility (rs  = -.14, p = .005), higher anxiety (rs  = .22, p < .001), higher depression (rs  = .16, p = .001) and lower QoL (overall rs  = -.24, p < .001; melanoma QoL rs  = -.20, p < .001; surgery QoL rs  = -.19, p < .001). Lower health outcomes indicate increased service use, suggesting that interventions to address unmet need and improve health outcomes may reduce health costs. Integrated clinical and economic evaluations of interventions that target unmet need in melanoma survivors are required.

[Immunohistochemistry using clone VE1 is an economic, specific and sensitive method for detecting the presence of BRAFV600E mutations in melanoma]. / L'immunohistochimie (clone VE1) est une méthode économique, spécifique et sensible pour détecter la présence d'une mutation BRAFV600E dans le mélanome.

BACKGROUND: Determination of BRAF mutation status is mandatory in the management of patients with inoperable stage IIIC or stage IV melanoma. Currently, molecular biology (MB) has been validated for detecting the presence of BRAF mutations. OBJECTIVE: To compare the sensitivity, specificity and cost of immunohistochemistry (IHC) (clone VE1) versus BM methods (qPCR and Sanger sequencing). PATIENTS AND METHODS: All the samples for which BRAF mutation status was requested between March 2013 and February 2015 at the cellular and molecular analysis laboratory of the Angers Hospital were included retrospectively and consecutively. The IHC (clone VE1) and BM analyses were performed with the same formalin-fixed paraffin embedded tumour samples. The cost of these two methods was determined on the basis of the cost for the French Health Insurance. RESULTS: Two hundred and seven samples were subjected to a determination of BRAF mutational status in IHC and BM. Only one sample was discordant between these two methods (positive in IHC, negative in BM). The sensitivity and specificity of the IHC was 100% and 99.25% respectively. The ratio of the cost of IHC/BM testing was 1:2.1. CONCLUSION: IHC (clone VE1) is a specific, sensitive and economic method for determining BRAFV600E mutation status. Nevertheless, this method must be validated in order to be integrated into a decisional algorithm, alongside BM methods, to determine whether targeted BRAF-inhibitor therapy is indicated.