A Non-Surgical and Cost-Effective Treatment Approach Employing Topical Imiquimod, 5-Fluorouracil, and Tretinoin for Primary Non-Melanoma Skin Cancers.

BACKGROUND: Minimally invasive alternative approaches to treat non-melanoma skin cancers remain limited and unproven. OBJECTIVE: We aim to assess the efficacy of varying combinations of anti-tumor agents—imiquimod 5% cream, 5-fluorouracil 2% solution, and tretinoin 0.1% cream—with brief cryotherapy in treating non-melanoma skin cancers. METHODS: This retrospective study included 690 cases of non-melanoma skin cancers in 480 patients who received a diagnosis of a basal cell carcinoma or squamous cell carcinoma during a ten-year period. During treatment period, patients applied 30 applications of one of three combinations (imiquimod/tretinoin, 5-fluorouracil/tretinoin, or imiquimod/5-fluorouracil/tretinoin) and had cryotherapy every 2 weeks. Each patient had a clinical examination at least three years post-treatment or documented treatment failure. Clearance was defined by a lack of persistence or recurrence for 3 years following the completion of treatment. The likelihood of lesion clearance was evaluated using multivariable logistic regression analysis. RESULTS: A total of 186 cases (97; basal cell carcinoma and 89; squamous cell carcinoma) in 133 patients [37% women and 63% men; median (interquartile range) age, 77 (69, 83) years] met the inclusion criteria. Multivariable logistic regression analysis adjusting for clinical and lesion variables demonstrated that, relative to the imiquimod/5-fluorouracil/tretinoin treatment approach, imiquimod/ tretinoin (odds ratio, 0.05; 95% confidence interval, 0.00-0.99) and 5-fluorouracil/tretinoin (0.02; 0.00–0.45) were associated with lower likelihoods of lesion clearance. Likewise, morpheaform basal cell carcinoma had a lower probability of clearance (0.05; 0.00–0.72). CONCLUSIONS: The combination of imiquimod/5-fluorouracil/tretinoin with cryotherapy had high clearance rates and was the most effective treatment regimen. J Drugs Dermatol. 2021;20(3):260-267. doi:10.36849/JDD.5427.

Subxiphoid uniportal thoracoscopic pulmonary segmentectomy for stage I non-small cell lung cancer: Feasibility, quality of life and financial worthiness.

BACKGROUND: Subxiphoid uniportal video-assisted thoracoscopic surgery (SVATS) is more technically challenging than intercostal uniportal video-assisted thoracoscopic surgery (UVATS), especially in more complex procedures such as segmentectomy. We therefore aimed to investigate the worthiness of undertaking the more demanding subxiphoid approach in patients who had undergone anatomical segmentectomy for stage IA non-small cell lung cancer (NSCLC). METHODS: A total of 491 patients were included in our study who had undergone anatomical segmentectomy for stage IA non-small cell lung cancer from September 2014 to April 2018. They were divided into two groups; 278 patients in the UVATS group and 213 patients in the SVATS group. Different perioperative variables, postoperative pain, quality of life and cost were analyzed and compared between both groups. RESULTS: The SVATS group showed a significantly longer operative time (P = 0.007) and more operative blood loss than the intercostal group (P = 0.004). There was no significant difference between both groups regarding postoperative drainage, duration of chest tube, postoperative hospital stay, operative conversion or postoperative complications. The SVATS group showed a significantly lower pain score postoperatively (P < 0.001). In addition, the SVATS group showed a significantly better postoperative quality of life score along the first postoperative year (P < 0.001). UVATS segmentectomy appeared to be significantly cheaper than SVATS segmentectomy (P < 0.001). CONCLUSIONS: SVATS segmentectomy for stage IA lung cancer is a safe procedure that is worth proceeding with as it is associated with better postoperative pain and better quality of life in the first postoperative year. Further studies are recommended to evaluate the actual cost-effectiveness of SVATS segmentectomy. KEY POINTS: • Significant findings of the study Subxiphoid uniportal approach for pulmonary segmentectomy is safe and feasible approach. It has better postoperative pain and better quality of life than the uniportal intercostal approach; however, it is more expensive. • What this study adds Subxiphoid uniportal approach for pulmonary segmentectomy gives a better quality of life in Chinese patients than the intercostal approach; however, it is more expensive.

Comparative cost of transoral robotic surgery and radiotherapy (IMRT) in early stage tonsil cancer.

PURPOSE: To compare treatment costs and cost-effectiveness for transoral robotic surgery (TORS) and definitive intensity-modulated radiotherapy (IMRT) in managing early stage tonsil cancer. MATERIALS AND METHODS: Direct treatment costs for surgery and IMRT were calculated from SEER-Medicare data for a cohort with clinically early stage (cT1/2N0) p16+ tonsillar squamous cell carcinoma from Kaiser Permanente Southern California Health Plan between 2012 and 2017. A Markov decision tree model with a 5-year time horizon was then applied to the cohort which incorporated costs associated with treatment, surveillance, and recurrence. RESULTS: IMRT cost up to $19,000 more (35%) than TORS in direct treatment costs. When input into the Markov model, TORS dominated IMRT with lower cost and better effectiveness over a range of values. CONCLUSION: TORS is a more cost-effective treatment method than IMRT in early stage (cT1/2N0) tonsil cancer.

Characteristics of Patients Hospitalized for Cutaneous Squamous Cell Carcinoma.

BACKGROUND: Knowledge regarding the inpatient burden of cutaneous squamous cell carcinoma (cSCC) is limited. OBJECTIVE: To provide nationally representative estimates for hospitalization characteristics due to cSCC and determine predictors for increased length of stay (LOS) and cost of care. METHODS/MATERIALS: A retrospective cohort study of the 2009 to 2015 National Inpatient Sample. Weighted multivariate logistic/linear regression models were created to evaluate sociodemographic factors associated with cSCC hospitalization and to assess characteristics associated with cost of care and LOS. RESULTS: This study included 15,784 cSCC and 255,244,626 non-SCC inpatients (prevalence = 6.2/100,000 inpatients). On average, cSCC hospitalizations lasted 5.8 days and cost $66,841.00. Cutaneous squamous cell carcinoma most often occurred on the scalp (30.57%), face (21.08%), and lower limb (11.93%). Controlling for all other factors, cSCC inpatients presented to larger/urban/teaching hospitals and were most often older non-Hispanic white women. More chronic conditions/diagnoses/procedures and nonwhite race were associated with greater cost of care and LOS. Cost of care and LOS significantly differed between cSCCs of different anatomical sites. The most common procedures performed were skin grafts (27.96%), excisions (25.83%), and lymph node biopsies (11.39%). CONCLUSION: This study highlights the substantial burden of inpatient cSCC in the United States. Further research is necessary to prevent cSCC hospitalizations and improve inpatient dermatologic care for cSCC.

Laparoscopically assisted versus open oesophagectomy for patients with oesophageal cancer-the Randomised Oesophagectomy: Minimally Invasive or Open (ROMIO) study: protocol for a randomised controlled trial (RCT).

INTRODUCTION: Surgery (oesophagectomy), with neoadjuvant chemo(radio)therapy, is the main curative treatment for patients with oesophageal cancer. Several surgical approaches can be used to remove an oesophageal tumour. The Ivor Lewis (two-phase procedure) is usually used in the UK. This can be performed as an open oesophagectomy (OO), a laparoscopically assisted oesophagectomy (LAO) or a totally minimally invasive oesophagectomy (TMIO). All three are performed in the National Health Service, with LAO and OO the most common. However, there is limited evidence about which surgical approach is best for patients in terms of survival and postoperative health-related quality of life. METHODS AND ANALYSIS: We will undertake a UK multicentre randomised controlled trial to compare LAO with OO in adult patients with oesophageal cancer. The primary outcome is patient-reported physical function at 3 and 6 weeks postoperatively and 3 months after randomisation. Secondary outcomes include: postoperative complications, survival, disease recurrence, other measures of quality of life, spirometry, success of patient blinding and quality assurance measures. A cost-effectiveness analysis will be performed comparing LAO with OO. We will embed a randomised substudy to evaluate the safety and evolution of the TMIO procedure and a qualitative recruitment intervention to optimise patient recruitment. We will analyse the primary outcome using a multi-level regression model. Patients will be monitored for up to 3 years after their surgery. ETHICS AND DISSEMINATION: This study received ethical approval from the South-West Franchay Research Ethics Committee. We will submit the results for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ISRCTN10386621.

Impact of the American Tax Payer Relief Act on stereotactic radiosurgery utilization in the United States.

INTRODUCTION: Single-fraction stereotactic radiosurgery (SRS) is delivered predominantly via two modalities: Gamma Knife, and linear accelerator (LINAC). Implementation of the American Tax Payer Relief Act (ATRA) in 2013 represented the first time limitations specifically targeting SRS reimbursement were introduced into federal law. The subsequent impact of the ATRA on SRS utilization in the United States (US) has yet to be examined. METHODS: The National Cancer Database from 2010-2016 identified brain metastases patients from non-small cell lung cancer throughout the US having undergone SRS. Utilization between GKRS and LINAC was assessed before (2010-2012), during (2013-2014) and after (2015-2016) ATRA implementation. RESULTS: In 2013, there was a substantial decrease of LINAC SRS in favor of GKRS in non-academic centers. Over the 3-year span immediately preceding ATRA implementation, 39% of all eligible SRS cases received LINAC. There was a modest decrease in LINAC utilization over the 2 years immediately following ATRA implementation (35%), followed by an increase over the next two years (40%). SRS modality showed differences over the three time periods (unadjusted, p = 0.043), primarily in non-academic centers (unadjusted, p = 0.003). CONCLUSIONS: ATRA implementation in 2013 caused an initial spike in Gamma Knife SRS utilization, followed by a decline to rates similar to the years before implementation. These findings indicate that the ATRA provision mandating Medicare reduction of outpatient payment rates for Gamma Knife to be equivalent with those of LINAC SRS had a significant short-term impact on the radiosurgical treatment of metastatic brain disease throughout the US, serving as a reminder of the importance/impact of public policy on treatment modality utilization by physicians and hospitals.

Frozen section is not cost beneficial for the assessment of margins in oral cancer.

BACKGROUND: Routine use of frozen section (FS) is a costly procedure and sparsely available in resource poor countries. A proper cost benefit analysis may help to reduce its routine use and would empower surgeons to perform oral cancer surgeries without having FS facility. FS is performed to identify microscopic spread beyond gross disease that cannot be assessed clinically. OBJECTIVE: Our primary aim was to determine the cost benefit analysis of FS in the assessment of margins in oral cavity squamous cell carcinoma (OSCC). MATERIALS AND METHODS: Retrospective study of prospectively collected data of 1311 consecutive patients who were operated between January 2012 and October 2013. The gross and microscopic margin status of each patient was extracted from the patient's chart. The cost estimates were performed to calculate the financial burden of FS as well as expenses incurred on adjuvant treatment resulting from inadequate margins. RESULT: Microscopic spread changed the gross margin status in 5.2% (65/1237) patients. Of this entire cohort of 1237 patients, FS helped 29 (2.3%) patients to achieve tumor free margin, and it changed the adjuvant treatment plan in 9 (0.7%) patients. The cost of FS for each patient was INR 11052. The cost-benefit ratio of FS was 12:1. Gross examination alone could have identified majority of the inadequate margins. CONCLUSION: Frozen section for assessment of margin status bears poor cost-benefit ratio. Meticulous gross examination of the entire surgical specimen is sufficient to identify majority of inadequate margins.

Keratinocyte cancer excisions in Australia: Who performs them and associated costs.

BACKGROUND/OBJECTIVE: To describe the clinical settings in which keratinocyte cancers are excised in Queensland and describe the types of practitioners who excise them; to examine costs; and to identify predictors of hospital admission. METHODS: We used linked data for participants from the QSkin study (n = 43 794), including Medicare claims and Queensland hospital admissions relating to treatment episodes for incident keratinocyte cancers from July 2011 to June 2015. We used multinomial logistic regression to measure associations between demographic and clinical characteristics and treatment setting. The median costs of Medicare claims (AU$) were calculated. RESULTS: During 4 years of follow-up, there were 18 479 skin cancer excision episodes among 8613 people. Most excisions took place in private clinical rooms (89.7%), the remainder in hospitals (7.9% private; 2.4% public). Compared with other anatomical sites, skin cancers on the nose, eyelid, ear, lip, finger or genitalia were more likely to be treated in hospitals than in private clinical rooms (public hospital OR 5.7; 95%CI 4.5-7.2; private hospital OR 8.3; 95%CI 7.3-9.4). Primary care practitioners excised 83% of keratinocyte cancers, followed by plastic surgeons (9%) and dermatologists (6%). The median Medicare benefit paid was $253 in private clinical rooms and $334 in private hospitals. Out-of-pocket payments by patients treated in private hospitals were fourfold higher than those in private clinical rooms ($351 vs $80). CONCLUSIONS: Most keratinocyte cancers are excised in primary care, although more than 10% of excisions occur in hospital settings.

Incidence rate of cutaneous squamous cell carcinoma is rapidly increasing in Akita Prefecture: Urgent alert for super-aged society.

Incidence rates of cutaneous squamous cell carcinoma (SCC) are increasing in many countries. To estimate detailed trends of SCC incidence rates in the population of Akita Prefecture as the forerunner of super-aged societies, we conducted a retrospective analysis of patients diagnosed with SCC between 2007 and 2016 in Akita University Hospital. The crude SCC incidence rate increased rapidly between 2007 and 2016 from 2.5 to 10.0/100 000 people. Remarkably, the age-specific incidence rate of people aged 80 years or over increased between 2007 and 2016 from 14.7 to 51.6/100 000 people, suggesting that SCC incidence rates increase possibly due to not only the increased number of aged people but also because of unidentified cancer-prone environments. When the findings of the present study are generalized to other regions entering the era of super-aging, it is clear that we need to prepare for the economic disease burden together with careful monitoring to confirm future trends for SCC.

Cost-effectiveness analysis of pembrolizumab versus standard-of-care chemotherapy for first-line treatment of PD-L1 positive (>50%) metastatic squamous and non-squamous non-small cell lung cancer in France.

INTRODUCTION: In the KEYNOTE-024 trial, pembrolizumab demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) versus Standard-of-Care (SoC) platinum-based doublets for first-line treatment of PD-L1 -positive (≥50%) metastatic Non-Small-Cell Lung Cancer (NSCLC) patients with no EGFR mutations or ALK translocations. This study aims to assess the cost-effectiveness of pembrolizumab versus SoC platinum-based chemotherapy from the French healthcare system perspective. METHODS: A three-state partitioned-survival model was adapted to project outcomes and costs of squamous and non-squamous NSCLC patients respectively, over a 10-year time horizon. Clinical and utility data were collected from the trial. A network meta-analysis was performed to consider platinum-based triplets also used for non-squamous NSCLC. Direct medical costs were considered based on ressources identified from the trial and literature. Costs and outcomes were discounted at 4% per year. Incremental cost-effectiveness ratios (ICERs) were calculated as cost per Life Year (LY) and cost per Quality-Adjusted Life Year (QALY). Sensitivity and scenario analyses were performed to assess the robustness of results. RESULTS: For squamous NSCLC, pembrolizumab was projected to increase life expectancy of patients by 0.93 LY (11 months), and 0.74 QALY (9 months) for an incremental cost of €62,032 compared with platinum-based doublets. The ICER of pembrolizumab versus platinum-based doublets was €66,825/LY and €84,097/QALY. For non-squamous NSCLC, pembrolizumab was projected to increase life expectancy of patients by 0.85-1.32 LYs (10.2-15.8 months) and 0.64-1.02 QALYs (7.7-12.2 months) for an incremental cost varying from €-14,947-+47,064 depending on the specific comparator. The ICER of pembrolizumab versus platinum-based chemotherapy with paclitaxel plus bevacizumab was €62,846/LY and €78,729/QALY; regimens including pemetrexed were dominated. Results were most sensitive to extrapolations of survival outcomes and assumptions for continued effectiveness and treatment duration of pembrolizumab. CONCLUSIONS: Pembrolizumab appears cost-effective versus SoC chemotherapy for first-line treatment of PD-L1-positive (50%) metastatic NSCLC patients in France, assuming willingness-to-pay under 100,000€/QALY (OECD threshold in the discussion section).

Economic Analysis of a Three-Arm RCT Exploring the Delivery of Intensive, Prophylactic Swallowing Therapy to Patients with Head and Neck Cancer During (Chemo)Radiotherapy.

Research advocates for the use of intensive, prophylactic swallowing therapy to help reduce the severity of dysphagia in patients receiving (chemo)radiotherapy ([C]RT) for head/neck cancer (HNC). Unfortunately, the intensity of this therapy, coupled with growing patient numbers and limited clinical resources, provides challenges to many international cancer facilities. Telepractice has been proposed as a potential method to provide patients with greater support in home-practice, whilst minimising burden to the health service. This study investigated the clinical and patient-attributable costs of delivering an intensive, prophylactic swallowing therapy protocol via a new telepractice application "SwallowIT" as compared to clinician-directed FTF therapy and independent patient self-directed therapy. Patients (n = 79) with oropharyngeal HNC receiving definitive (C)RT were randomised to receive therapy via a: clinician-directed (n = 26), patient-directed (n = 27), or SwallowIT-assisted (n = 26) model of care. Data pertaining to health service costs (service time, consumables, therapy resources), patient-attributable costs (travel and wages) and patient-reported health-related quality of life (QoL) (AQoL-6D) were collected. SwallowIT provided a cost-efficient model of care when compared to the clinician-directed model, with significant cost savings to both the health service and to HNC consumers (total saving of $1901.10 AUD per patient; p < 0.001). The SwallowIT model also proved more cost-effective than the patient-directed model, yielding clinically significantly superior QoL at the end of (C)RT, for comparable costs. Overall, when compared to the alternate methods of service-delivery, SwallowIT provided a financially viable and cost-effective method for the delivery of intensive, prophylactic swallowing therapy to patients with HNC during (C)RT.

Real-World Treatment Patterns, Overall Survival, and Occurrence and Costs of Adverse Events Associated With Second-Line Therapies for Medicare Patients With Advanced Non-Small-Cell Lung Cancer.

INTRODUCTION: Real-world data on current treatment practices for non-small-cell lung cancer (NSCLC) are needed to understand the place in therapy and potential economic impact of newer therapies. PATIENTS AND METHODS: This retrospective cohort study identified patients ≥ 65 years old in the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database with first-time diagnosis of stage IIIB/IV NSCLC from 2007-2011 who received second-line therapy after first-line platinum-based chemotherapy from 2007 through mid-2013. Second-line regimens, health care resource use, adverse events (AEs), and associated costs were analyzed descriptively. Overall survival was determined by Kaplan-Meier test. Costs were adjusted to 2013 US dollars. RESULTS: We identified 4033 patients with advanced NSCLC who received second-line therapy (47% of those who received first-line platinum-based chemotherapy). Mean (SD) age was 73 (5) years, 2246 (56%) were male; 1134 (28%) and 2899 (72%) had squamous and nonsquamous NSCLC, respectively. The 4 most common second-line regimens were pemetrexed (22%), docetaxel (12%), carboplatin/paclitaxel (11%), and gemcitabine (7%). Median overall survival from second-line therapy initiation was 7.3 months (95% confidence interval, 7.0-7.7). Dyspnea and anemia were the most common AEs of interest, affecting 29% and 26% of patients, respectively; atypical pneumonia was associated with the highest AE-related costs (mean, $5339). The mean total per-patient-per-month cost was $10,885; AE-related per-patient-per-month costs totaled $1036 (10%). Costs were highest for pemetrexed-treated patients. CONCLUSION: These real-world data illustrate the variety of second-line regimens, poor prognosis, and high cost of second-line chemotherapy for patients with advanced NSCLC treated before the approval of immunotherapies for these patients.

Low-cost, self-made CAD/CAM-guiding system for mandibular reconstruction.

Facial symmetry, as well as function, remains the big challenge for surgeons who attempt mandibular reconstruction. Nowadays several studies recommend the use of computer aided surgery (CAS) and CAD/CAM technology to guide mandibular segmental osteotomies and reconstruction using free fibula flap. Although these systems have radically changed the way of doing mandibular reconstructive surgery, they are expensive and require extended periods of time for prototypation. This may be an important limitation in case of malignant neoplasms which require short-term treatment. The aim of our study is to investigate the reliability and efficiency of a protocol to obtain cutting guides produced in a "homemade" way. This study includes four consecutive patients who underwent a segmental mandibulectomy and fibula osteo-cutaneous free flap reconstruction for oral squamous cell carcinoma between January and September 2016. The CAD/CAM system algorithm proposed was based on the use of free open source software for digital planning and 3D layer plastic deposition printer. A cost of about 3 Euro for each case was estimated. An average mean distance between 3D preoperative and postoperative mesh points of 1.631 mm and a standard deviation of 5.496 mm has been demonstrated by 3D volume overlay analysis. Overlapping results with much shorter prototyping time was required with the in-house procedure described as compared to the available commercial system. In conclusion, we expect that this technique will reduce operative time and cost however further study and large series are needed to confirm our results and better define the applicability in everyday surgical practice.

Ventana ALK (D5F3) in the Detection of Patients Affected by Anaplastic Lymphoma Kinase-positive Non-Small-cell Lung Cancer: Clinical and Budget Effect.

BACKGROUND: To ensure identification of anaplastic lymphoma kinase-positive (ALK+) patients, the Italian Drug Agency suggested a testing algorithm based on the use of fluorescence in situ hybridization (FISH) and/or immunohistochemistry. The aim was to evaluate the clinical and economic effects of adopting an immunohistochemical test (Ventana ALK D5F3) as an option for detecting ALK protein expression in advanced non-small cell lung cancer (NSCLC) patients. MATERIALS AND METHODS: A budget impact model was developed by adopting the Italian National Health Service (NHS) perspective and a 5-year period to compare 2 scenarios: the current use of D5F3 (28%; current scenario) and increased use of D5F3 (60%; alternative scenario). The testing cost and the number and cost of the identified ALK+ patients were evaluated. RESULTS: A more extensive use of D5F3 in the alternative scenario showed a decrease in diagnostic costs of ∼€468,000 compared with current scenario when considering all advanced NSCLC patients. If these savings were allocated to test more NSCLC patients (75% vs. 53%), an incremental cost per identified ALK+ patient of €63 would be required, leading to an overall survival gain for the alternative scenario compared with the current scenario (32.4 vs. 27.1 months; relative increase, 20%). CONCLUSION: The use of D5F3 would provide a cost savings for the NHS owing to a lower acquisition cost than FISH and a comparable detection rate. The savings could be reinvested to test a greater number of patients, leading to more efficient identification, use of targeted therapy, and improvement in clinical outcomes of ALK+ patients.

The Budget Impact of Including Necitumumab on the Formulary for First-Line Treatment of Metastatic Squamous Non-Small Cell Lung Cancer: U.S. Commercial Payer and Medicare Perspectives.

BACKGROUND: Necitumumab (Neci) was the first biologic approved by the FDA for use in combination with gemcitabine and cisplatin (Neci + GCis) in first-line treatment of metastatic squamous non-small cell lung cancer (msqNSCLC). The potential financial impact on a health plan of adding Neci + GCis to drug formularies may be important to value-based decision makers in the United States, given ever-tightening budget constraints. OBJECTIVE: To estimate the budget impact of introducing Neci + GCis for first-line treatment of msqNSCLC from U.S. commercial and Medicare payer perspectives. METHODS: The budget impact model estimates the costs of msqNSCLC before and after adoption of Neci + GCis in hypothetical U.S. commercial and Medicare health plans over a 3-year time horizon. The eligible patient population was estimated from U.S. epidemiology statistics. Clinical data were obtained from randomized clinical trials, U.S. prescribing information, and clinical guidelines. Market share projections were based on market research data. Cost data were obtained from online sources and published literature. The incremental aggregate annual health plan, per-patient-per-year (PPPY), and per-member-per-month (PMPM) costs were estimated in 2015 U.S. dollars. One-way sensitivity analyses were conducted to assess the effect of model parameters on results. RESULTS: In a hypothetical 1,000,000-member commercial health plan with an estimated population of 30 msqNSCLC patients receiving first-line chemotherapy, the introduction of Neci + GCis at an initial market share of approximately 5% had an overall year 1 incremental budget impact of $88,394 ($3,177 PPPY, $0.007 PMPM), representing a 2.9% cost increase and reaching $304,079 ($10,397 PPPY, $0.025 PMPM) or a 7.4% cost increase at a market share of 14.7% in year 3. This increase in total costs was largely attributable to Neci drug costs and, in part, due to longer survival and treatment duration for patients treated with Neci+GCis. Overall, treatment costs increased by $81,812 (13.5%), and disease costs increased by $7,951 (0.4%), whereas adverse event costs decreased by $1,368 (0.5%) in year 1. From the Medicare perspective, the overall year 1 incremental budget impact was $438,056 ($0.037 PMPM, $3,112 PPPY), representing a 3.0% cost increase. The higher incremental budget in Medicare, compared with commercial plans, was due to higher msqNSCLC incidence in the older Medicare patients (154 vs. 30 patients, respectively). Results were most sensitive to Neci drug costs. CONCLUSIONS: Based on projected market shares, coverage for first-line therapy with Neci + GCis appeared to modestly affect overall U.S. health care budgets for msqNSCLC-related care. Given the small eligible patient population, the PMPM budgetary impact on a commercial health plan of reimbursing Neci + GCis in the first year was less than $0.01, rising with increased use of Neci + GCis to $0.025 in the third year. The real-world effect of Neci + GCis needs to be evaluated to validate this analysis; however, these findings may help policymakers in making coverage decisions for Neci + GCis. DISCLOSURES: This study was funded by Eli Lilly and Company. Molife, Brown, Tawney, and Cuyun Carter are equity holders and employees of Eli Lilly and Company. Bly, Cinfio, and Klein are employees of Medical Decision Modeling, which received funding from Eli Lilly and Company to conduct this research and prepare this manuscript.

The economic burden of occupational non-melanoma skin cancer due to solar radiation.

Solar ultraviolet (UV) radiation is the second most prevalent carcinogenic exposure in Canada and is similarly important in other countries with large Caucasian populations. The objective of this article was to estimate the economic burden associated with newly diagnosed non-melanoma skin cancers (NMSCs) attributable to occupational solar radiation exposure. Key cost categories considered were direct costs (healthcare costs, out-of-pocket costs (OOPCs), and informal caregiver costs); indirect costs (productivity/output costs and home production costs); and intangible costs (monetary value of the loss of health-related quality of life (HRQoL)). To generate the burden estimates, we used secondary data from multiple sources applied to computational methods developed from an extensive review of the literature. An estimated 2,846 (5.3%) of the 53,696 newly diagnosed cases of basal cell carcinoma (BCC) and 1,710 (9.2%) of the 18,549 newly diagnosed cases of squamous cell carcinoma (SCC) in 2011 in Canada were attributable to occupational solar radiation exposure. The combined total for direct and indirect costs of occupational NMSC cases is $28.9 million ($15.9 million for BCC and $13.0 million for SCC), and for intangible costs is $5.7 million ($0.6 million for BCC and $5.1 million for SCC). On a per-case basis, the total costs are $5,670 for BCC and $10,555 for SCC. The higher per-case cost for SCC is largely a result of a lower survival rate, and hence higher indirect and intangible costs. Our estimates can be used to raise awareness of occupational solar UV exposure as an important causal factor in NMSCs and can highlight the importance of occupational BCC and SCC among other occupational cancers.

Impact of topical fluorouracil cream on costs of treating keratinocyte carcinoma (nonmelanoma skin cancer) and actinic keratosis.

BACKGROUND: It is unknown whether treatment costs for keratinocyte carcinoma (KC) and actinic keratosis (AK) can be lowered by spending more on chemoprevention. OBJECTIVE: To examine the impact of 1-course treatment with topical fluorouracil (5-FU) on the face and ears on KC and AK treatment costs over 3 years. METHODS: The Veterans Affairs Keratinocyte Carcinoma Chemoprevention trial compared the efficacy of topical 5-FU 5% with that of vehicle control cream for reducing KC risk. Trial data and administrative data on costs and utilization were analyzed to measure postrandomization encounters and treatment costs for KC and AK care. Adjusted models were used to test for statistically significant differences between treatment arms for number of treatment encounters and costs. RESULTS: One year after randomization, the control arm had a higher mean number of treatment encounters for squamous cell carcinoma (0.04) than the intervention arm (0.01) (P < .01). At 1 year, the intervention arm had lower treatment and dermatologic costs: $2106 (standard deviation, $2079) compared with $2444 (standard deviation, $2716) for the control patients (P = .02). After 3 years, the intervention arm incurred a cost of $771 less per patient. LIMITATIONS: Care not provided or paid for by the Department of Veterans Affairs was not included. Results may not be generalizable to other payers. CONCLUSION: We found significant cost savings for patients treated with 5-FU.

Socioeconomic determinants as risk factors for squamous cell carcinoma of the head and neck: a case-control study in Iran.

Our aim was to assess the association between different components of sociodemographic status and the risk of developing squamous cell carcinoma (SCC) of the head and neck after we had adjusted for the influence of the known behavioural risk factors of smoking and drinking alcohol. We selected 146 patients with histopathologically-confirmed SCC of the head and neck, and matched them for age and sex with 266 healthy controls for this case-control study. Personal details, occupation, socioeconomic status, smoking, and alcohol consumption were recorded. The association of sociodemographic variables with oral cancer was evaluated both separately and with a composite socioeconomic index. Chi squared tests, adjusted odds ratios (OR), and 95% CI were computed using logistic regression to estimate the effect. There was a significant difference between the two groups in the composite socioeconomic index (p<0.001). The group with "low" socioeconomic status had the highest risk of oral cancer (OR=3.89, 95% CI 1.28 to 11.82). Better-educated people with higher incomes had a lower risk of SCC of the head and neck after we had controlled for behavioural risk factors. However, marital and employment status and place of residence were not significantly associated with risk. Our findings confirm that some socioeconomic determinants were associated with the development of oral cancer in this study group.