Diagnosing and characterizing inflammatory myopathies at an Australian tertiary public hospital: Resource utilization and direct healthcare costs.

AIM: To determine the direct health service costs and resource utilization associated with diagnosing and characterizing idiopathic inflammatory myopathies (IIMs), and to assess for limitations and diagnostic delay in current practice. METHODS: A retrospective, single-center cohort analysis of all patients diagnosed with IIMs between January 2012 and December 2021 in a large tertiary public hospital was conducted. Demographics, resource utilization and costs associated with diagnosing IIM and characterizing disease manifestations were identified using the hospital's electronic medical record and Health Intelligence Unit, and the Medicare Benefits Schedule. RESULTS: Thirty-eight IIM patients were identified. IIM subtypes included dermatomyositis (34.2%), inclusion body myositis (18.4%), immune-mediated necrotizing myopathy (18.4%), polymyositis (15.8%), and anti-synthetase syndrome (13.2%). The median time from symptom onset to diagnosis was 212 days (IQR: 118-722), while the median time from hospital presentation to diagnosis was 30 days (8-120). Seventy-six percent of patients required emergent hospitalization during their diagnosis, with a median length of stay of 8 days (4-15). The average total cost of diagnosing IIM was $15 618 AUD (STD: 11331) per patient. Fifty percent of patients underwent both MRI and EMG to identify affected muscles, 10% underwent both pan-CT and PET-CT for malignancy detection, and 5% underwent both open surgical and percutaneous muscle biopsies. Autoimmune serology was unnecessarily repeated in 37% of patients. CONCLUSION: The diagnosis of IIMs requires substantial and costly resource use; however, our study has identified potential limitations in current practice and highlighted the need for streamlined diagnostic algorithms to improve patient outcomes and reduce healthcare-related economic burden.

Duration and determinants of delayed tuberculosis diagnosis and treatment in high-burden countries: a mixed-methods systematic review and meta-analysis.

BACKGROUND: Thirty countries with the highest tuberculosis (TB) burden bear 87% of the world's TB cases. Delayed diagnosis and treatment are detrimental to TB prognosis and sustain TB transmission in the community, making TB elimination a great challenge, especially in these countries. Our objective was to elucidate the duration and determinants of delayed diagnosis and treatment of pulmonary TB in high TB-burden countries. METHODS: We conducted a systematic review and meta-analysis of quantitative and qualitative studies by searching four databases for literature published between 2008 and 2018 following PRISMA guidelines. We performed a narrative synthesis of the covariates significantly associated with patient, health system, treatment, and total delays. The pooled median duration of delay and effect sizes of covariates were estimated using random-effects meta-analyses. We identified key qualitative themes using thematic analysis. RESULTS: This review included 124 articles from 14 low- and lower-middle-income countries (LIC and LMIC) and five upper-middle-income countries (UMIC). The pooled median duration of delays (in days) were-patient delay (LIC/LMIC: 28 (95% CI 20-30); UMIC: 10 (95% CI 10-20), health system delay (LIC/LMIC: 14 (95% CI 2-28); UMIC: 4 (95% CI 2-4), and treatment delay (LIC/LMIC: 14 (95% CI 3-84); UMIC: 0 (95% CI 0-1). There was consistent evidence that being female and rural residence was associated with longer patient delay. Patient delay was also associated with other individual, interpersonal, and community risk factors such as poor TB knowledge, long chains of care-seeking through private/multiple providers, perceived stigma, financial insecurities, and poor access to healthcare. Organizational and policy factors mediated health system and treatment delays. These factors included the lack of resources and complex administrative procedures and systems at the health facilities. We identified data gaps in 11 high-burden countries. CONCLUSIONS: This review presented the duration of delays and detailed the determinants of delayed TB diagnosis and treatment in high-burden countries. The gaps identified could be addressed through tailored approaches, education, and at a higher level, through health system strengthening and provision of universal health coverage to reduce delays and improve access to TB diagnosis and care. PROSPERO registration: CRD42018107237.

Clinical Negligence Claims Against Vascular Surgery in the United Kingdom: An Observational Study.

BACKGROUND: Claims for clinical negligence awarded to patients and their families are on the increase. The annual "cost of harm" is approximately £7-9 billion in the United Kingdom. In 2017, the National Health Service (NHS) resolution service reported that they mediated more claims than in their entire history. Vascular surgery is a specialty with a disproportionately higher number of claims for clinical negligence. The aim of this observational study was to review the trends of clinical negligence claims in vascular surgery within the United Kingdom. The costs and the primary cause for the complaint were evaluated. METHODS: A retrospective observational study was performed. Clinical negligence claims in vascular surgery between the financial years of April 2005/2006 to April 2018/2019 were requested from NHS resolution under the Freedom of Information Act. Data were provided on November 8, 2019. All data were anonymized, and any categories containing fewer than five claims were removed to protect the identity of claimants. RESULTS: Over the 13-year period, 1,189 claims in vascular surgery were identified, with the annual mean (range) being 91 (20-134) claims per year. Of 1,189 claims, 875 (74%) are closed with payments made to the claimants. The mean annual total payment was £10,015,373. Delay in treatment was the most common cause for litigation claims in vascular surgery with 157 closed claims costing £33,255,248 over the 13-year period. Lower limb amputation was the most common primary injury claim with 140 closed cases but had a larger financial cost at £64,155,969. CONCLUSIONS: Clinical negligence claims in vascular surgery within the United Kingdom have been increasing steadily over the last 13 years and with a changing claims culture is expected to continue. The most common cause for claims with damages paid was delay in treatment, and lower limb amputation was the most common injury suffered. Improved consent, better communication with patients, and a higher surgical skill level could significantly reduce the number of future claims.

The complex health seeking pathway of a human African trypanosomiasis patient in Côte d'Ivoire underlines the need of setting up passive surveillance systems.

BACKGROUND: Significant efforts to control human African trypanosomiasis (HAT) over the two past decades have resulted in drastic decrease of its prevalence in Côte d'Ivoire. In this context, passive surveillance, integrated in the national health system and based on clinical suspicion, was reinforced. We describe here the health-seeking pathway of a girl who was the first HAT patient diagnosed through this strategy in August 2017. METHODS: After definitive diagnosis of this patient, epidemiological investigations were carried out into the clinical evolution and the health and therapeutic itinerary of the patient before diagnosis. RESULTS: At the time of diagnosis, the patient was positive in both serological and molecular tests and trypanosomes were detected in blood and cerebrospinal fluid. She suffered from important neurological disorders. The first disease symptoms had appeared three years earlier, and the patient had visited several public and private peripheral health care centres and hospitals in different cities. The failure to diagnose HAT for such a long time caused significant health deterioration and was an important financial burden for the family. CONCLUSION: This description illustrates the complexity of detecting the last HAT cases due to complex diagnosis and the progressive disinterest and unawareness by both health professionals and the population. It confirms the need of implementing passive surveillance in combination with continued sensitization and health staff training.

Delayed Diagnosis Is the Primary Cause of Sarcoma Litigation: Analysis of Malpractice Claims in the United States.

BACKGROUND: Sarcoma care is highly litigated in medical malpractice claims. Understanding the reasons for litigation and legal outcomes in sarcoma care may help physicians deliver more effective and satisfying care to patients while limiting their legal exposure. However, few studies have described malpractice litigation in sarcoma care. QUESTIONS/PURPOSES: (1) What percentage of sarcoma malpractice cases result in a defendant verdict? (2) What is the median indemnity payment for cases that result in a plaintiff verdict or settlement? (3) What are the most common reasons for litigation, injuries sustained, and medical specialties of the defendant physicians? (4) What are the factors associated with plaintiff verdicts or settlements and higher indemnity payments? METHODS: The national medicolegal database Westlaw was queried for medical malpractice cases pertaining to sarcomas that reached verdicts or settlements. Cases from 1982 to 2018 in the United States were included in the study to evaluate for trends in sarcoma litigation. Demographic and clinical data, tumor characteristics, reasons for litigation, injuries, and legal outcomes were recorded for each case. A univariate analysis was performed to identify factors associated with plaintiff verdicts or settlements and higher indemnity payments, such as tumor characteristics, defendant's medical or surgical specialty, reason for litigation, and injuries sustained. A total of 92 cases related to sarcomas were included in the study, of which 40 were related to bone sarcomas and 52 were related to soft-tissue sarcomas. Eighty-five percent (78 of 92) of cases involved adult patients (mean age ± SD: 40 ± 15 years) while 15% (14 of 92) of cases involved pediatric patients (mean age ± SD: 12.5 ± 5 years). RESULTS: Thirty-eight percent (35 of 92) of the included cases resulted in a defendant verdict, 30% (28 of 92) resulted in a plaintiff verdict, and 32% (29 of 92) resulted in a settlement. The median (interquartile range [IQR]) indemnity payment for plaintiff verdicts and settlements was USD 1.9 million (USD 0.5 to USD 3.5 million). Median (IQR) indemnity payments were higher for cases resulting in a plaintiff verdict than for cases that resulted in a settlement (USD 3.3 million [1.1 to 5.7 million] versus USD 1.2 million [0.4 to 2.4 million]; difference of medians = USD 2.2 million; p = 0.008). The most common reason for litigation was delayed diagnosis of sarcoma (91%; 84 of 92) while the most common injuries cited were progression to metastatic disease (51%; 47 of 92) and wrongful death (41%; 38 of 92). Malpractice claims were most commonly filed against primary care physicians (26%; 28 of 109 defendants), nononcology-trained orthopaedic surgeons (23%; 25 of 109), and radiologists (15%; 16 of 109). Cases were more likely to result in a ruling in favor of the plaintiff or settlement if a delay in diagnosis occurred despite suspicious findings on imaging or pathologic findings (80% versus 51%; odds ratio 3.84 [95% CI 1.34 to 11.03]; p = 0.02). There were no differences in indemnity payments with the numbers available in terms of tumor type, tumor location, defendant specialty, reason for litigation, and resulting injuries. CONCLUSIONS: Many lawsuits were made against primary care physicians, nononcology-trained orthopaedic surgeons, or radiologists for a delayed diagnosis of sarcoma despite the presence of imaging or histologic findings suspicious for malignancy. Although previous studies of bone and soft-tissue sarcomas have not shown a consistent association between time to diagnosis and decreased survival, our study suggests that physicians are still likely to lose these lawsuits because of the perceived benefits of an early diagnosis. CLINICAL RELEVANCE: Physicians can mitigate their malpractice risk while reducing delays in diagnosis of sarcomas by carefully reviewing all existing diagnostic studies, establishing closed-loop communication protocols to communicate critical findings from diagnostic studies, and developing policies to facilitate second-opinion consultation, particularly for imaging studies, with an experienced sarcoma specialist. Musculoskeletal oncologists may be able to help further reduce the rates of malpractice litigation in sarcoma care by helping patients understand that delays in diagnosis do not necessarily constitute medical malpractice.

The NHS visitor and migrant cost recovery programme - a threat to health?

BACKGROUND: In April 2014 the UK government launched the 'NHS Visitor and Migrant Cost Recovery Programme Implementation Plan' which set out a series of policy changes to recoup costs from 'chargeable' (largely non-UK born) patients. In England, approximately 75% of tuberculosis (TB) cases occur in people born abroad. Delays in TB treatment increase risk of morbidity, mortality and transmission in the community. We investigated whether diagnostic delay has increased since the Cost Recovery Programme (CRP) was introduced. METHODS: There were 3342 adult TB cases notified on the London TB Register across Barts Health NHS Trust between 1st January 2011 and 31st December 2016. Cases with missing relevant information were excluded. The median time between symptom onset and treatment initiation before and after the CRP was calculated according to birthplace and compared using the Mann Whitney test. Delayed diagnosis was considered greater or equal to median time to treatment for all patients (79 days). Univariable logistic regression was used to manually select exposure variables for inclusion in a multivariable model to test the association between diagnostic delay and the implementation of the CRP. RESULTS: We included 2237 TB cases. Among non-UK born patients, median time-to-treatment increased from 69 days to 89 days following introduction of CRP (p < 0.001). Median time-to-treatment also increased for the UK-born population from 75.5 days to 89.5 days (p = 0.307). The multivariable logistic regression model showed non-UK born patients were more likely to have a delay in diagnosis after the CRP (adjOR 1.37, 95% CI 1.13-1.66, p value 0.001). CONCLUSION: Since the introduction of the CRP there has been a significant delay for TB treatment among non-UK born patients. Further research exploring the effect of policies restricting access to healthcare for migrants is urgently needed if we wish to eliminate TB nationally.

Malpractice Litigation for Compartment Syndrome.

BACKGROUND: The aim of this study was to analyze litigation involving compartment syndrome to identify the causes and outcomes of such malpractice suits. A better understanding of such litigation may provide insight into areas where clinicians may make improvements in the delivery of care. METHODS: Jury verdict reviews from the Westlaw database from January 1, 2010 to January 1, 2018 were reviewed. The search term "compartment syndrome" was used to identify cases and extract data on the specialty of the physician defendant, the demographics of the plaintiff, the allegation, and the verdict. RESULTS: A total of 124 individual cases involving the diagnosis of compartment syndrome were identified. Medical centers or the hospital was included as a defendant in 51.6% of cases. The most frequent physician defendants were orthopedic surgeons (45.96%) and emergency medicine physicians (20.16%), followed by cardiothoracic/vascular surgeons (16.93%). Failure to diagnose was the most frequently cited claim (71.8% of cases). Most plaintiffs were men, with a mean age of 36.7 years, suffering injuries for an average of 5 years before their verdict. Traumatic compartment syndrome of the lower extremity causing nerve damage was the most common complication attributed to failure to diagnose, leading to litigation. Forty cases (32.25%) were found for the plaintiff or settled, with an average award of $1,553,993.66. CONCLUSIONS: Our study offers a brief overview of the most common defendants, plaintiffs, and injuries involved in legal disputes involving compartment syndrome. Orthopedic surgeons were most commonly named; however, vascular surgeons may also be involved in these cases because of the large number of cases with associated arterial involvement. A significant percentage of cases were plaintiff verdicts or settled cases. Failure to diagnosis or delay in treatment was the most common causes of malpractice litigation. Compartment syndrome is a clinical diagnosis and requires a high level of suspicion for a timely diagnosis. Lack of objective criteria for diagnosis increases the chances of medical errors and makes it an area vulnerable to litigation.

Impact of Endometriosis Diagnostic Delays on Healthcare Resource Utilization and Costs.

INTRODUCTION: Endometriosis symptoms are nonspecific and overlap with other gynecologic and gastrointestinal diseases, leading to long diagnostic delays. The burden of endometriosis has been documented; however, little is known about the impact of diagnostic delays on healthcare costs leading up to diagnoses. The purpose of this study was to examine the economic impact of diagnostic delays on pre-diagnosis healthcare utilization and costs among patients with endometriosis. METHODS: This was a retrospective database study of adult patients with a diagnosis of endometriosis from 1 January 2004 to 31 July 2016. Patients had continuous health plan enrollment 60 months prior to and 12 months following the earliest endometriosis diagnosis and ≥ 1 pre-diagnosis endometriosis symptom (dyspareunia, generalized pelvic pain, abdominal pain, dysmenorrhea, or infertility). Patients were assigned to short (≤ 1 year), intermediate (1-3 years), or long (3-5 years) delay cohorts based on the length of their diagnostic delay (time from first symptom to diagnosis). Healthcare resource utilization and costs were calculated and compared by cohort in the 60-month pre-diagnosis period. RESULTS: A total of 11,793 patients were included in the study, of which 37.7% (4446/11,793), 27.0% (3179/11,793), and 35.3% (4168/11,793) had short, intermediate, and long delays, respectively. Patients with intermediate or long diagnostic delays had consistently more all-cause and endometriosis-related emergency visits and inpatient hospitalizations in the pre-diagnosis period than patients with short delays. Pre-diagnosis all-cause healthcare costs were significantly higher among patients with longer diagnostic delays, averaging $21,489, $30,030, and $34,460 among patients with a short, intermediate, and long delay, respectively (p < 0.001 for all pairwise comparisons). Endometriosis-related costs accounted for 12.5% ($3553/$28,376) of all-cause costs and followed a similar pattern. CONCLUSION: Patients with endometriosis who had longer diagnostic delays had more pre-diagnosis endometriosis-related symptoms and higher pre-diagnosis healthcare utilization and costs compared with patients who were diagnosed earlier after symptom onset, providing evidence in support of earlier diagnosis.

Common Reasons for Malpractice Lawsuits Involving Pulmonary Embolism and Deep Vein Thrombosis.

BACKGROUND: Pulmonary embolism and deep vein thrombosis are common clinical entities, and the related malpractice suits affect all medical subspecialties. Claims from malpractice litigation were analyzed to understand the demographics of these lawsuits and the common reasons for pursuing litigation. METHODS: Cases entered into the Westlaw database from March 5, 1987, to May 31, 2018, were reviewed. Search terms included "pulmonary embolism" and "deep vein thrombosis." RESULTS: A total of 277 cases were identified. The most frequently identified defendant was an internist (including family practitioner; 33%), followed by an emergency physician (18%), an orthopedic surgeon (16%), and an obstetrician/gynecologist (9%). The most common etiology for pulmonary embolism was prior surgery (41%). The most common allegation was "failure to diagnose and treat" in 62%. Other negligence included the failure to administer prophylactic anticoagulation while in the hospital (18%), failure to prescribe anticoagulation on discharge (8%), failure to administer anticoagulation after diagnosis (8%), and premature discontinuation of anticoagulation (2%). The most frequently claimed injury was death in 222 cases (80%). Verdicts were found for the defendant in 57% of cases and for the plaintiff in 27% and settled in 16%. CONCLUSIONS: The most frequently cited negligent act was the failure to give prophylactic anticoagulation, even after discharge. The trends noted in this study may potentially be addressed and therefore prevented by systems-based practice changes. The most common allegation, "failure to diagnose and treat," suggests that first-contact doctors such as emergency physicians and primary care practitioners must maintain a high index of suspicion for deep vein thrombosis/pulmonary embolism.

Delayed diagnosis of congenital hypopituitarism associated with low socio-economic status and/or migration.

The clinical presentation of combined pituitary hormone deficiency (CPHD) is variable. Some patients present with hypoglycemia during the neonatal period or during the first few years of life. Others present later in childhood with growth failure. We report on 7 patients with very late diagnosed severe hypopituitarism with pituitary stalk interruption syndrome. Five out of the 7 patients had recently migrated to Belgium and the 2 other patients were from low socio-economic status families. All of them presented to our clinic for short stature and some also complained of lack of pubertal development. Four out of the 7 patients reached final height which was within their target height, despite very delayed treatment.Conclusion: We illustrate the overall good outcome of these children with delayed diagnosed severe hypopituitarism. Adverse life conditions and social deprivation are thought to be the cause of their late diagnosis. In the current global socio-politic context, pediatricians in high-income countries should stay aware that migration and poor socio-economic status can be associated with specific clinical presentations.What is Known:• The clinical presentation of combined pituitary hormone deficiency (CPHD) is variable. Some patients present with hypoglycemia during the neonatal period or during the first few years of life. Others present later in childhood with growth failure.• A few case reports are published with very late diagnosis of congenital hypopituitarism.What is New:• We report on the largest series of delayed diagnosis of congenital hypopituitarism and illustrate the survival of these children with overall good prognosis.• Migration and social deprivation are thought to be the main cause of this late diagnosis.

Cost Burden of Crohn's Disease and Ulcerative Colitis in the 10-Year Period Before Diagnosis-A Danish Register-Based Study From 2003-2015.

BACKGROUND: The diagnostic delay in inflammatory bowel disease (IBD) is well known, yet the costs associated with diagnoses before IBD diagnosis have not yet been reported. This study explored societal costs and disease diagnoses 10 years before Crohn's disease (CD) and ulcerative colitis (UC) diagnosis in Denmark. METHODS: This national register study included patients diagnosed between 2003 and 2015 identified in the Danish National Patient Registry (NPR) and controls who were individually matched on age and sex from the general population. Societal costs included health care services, prescription medicine, home care services, and labor productivity loss. Prediagnostic hospital contact occurring before CD or UC diagnosis was identified using the NPR. Average annual costs per individual were calculated before the patient's first CD or UC diagnosis. A 1-sample t test was then applied to determine significance in differences between cases and controls. RESULTS: Among CD (n = 9019) and UC patients (n = 20,913) the average societal costs were higher throughout the entire 10-year period before the diagnosis date compared with the general population. The difference increased over time and equaled €404 for CD patients and €516 for UC patients 10 years before diagnosis and €3377 and €2960, respectively, in the year before diagnosis. Crohn's disease and UC patients had significantly more diagnoses before their CD and UC diagnosis compared with the general population. CONCLUSIONS: Compared with the general population, the societal costs and number of additional diagnoses among CD and UC patients were substantially higher in the 10-year period before diagnosis.

Delays in Coccidioidomycosis Diagnosis and Associated Healthcare Utilization, Tucson, Arizona, USA.

Tucson, Arizona, USA, is a highly coccidioidomycosis-endemic area. We conducted a retrospective review of 815 patients in Tucson over 2.7 years. Of 276 patients with coccidioidomycosis, 246 had a delay in diagnosis; median delay was 23 days. Diagnosis delay was associated with coccidioidomycosis-related costs totaling $589,053 and included extensive antibacterial drug use.

Delayed diagnosis and treatment of pulmonary tuberculosis in high-burden countries: a systematic review protocol.

INTRODUCTION: Countries identified to bear the highest tuberculosis (TB) incidence account for approximately 85% of the global TB burden. TB is curable, yet nearly 40% of TB cases remained undiagnosed hence delaying treatment and perpetuating transmission. This systematic review aimed to review current evidence on factors associated with delayed diagnosis and treatment of TB in the high TB-burden countries. METHODS AND ANALYSIS: This systematic review will incorporate qualitative and observational study designs published between 2008 and 2018. Articles will be retrieved from major databases including PubMed, EMBASE, CINAHL and PsycINFO. Reference lists of key articles, including relevant systematic reviews and meta-analysis, will be screened for additional studies. Two independent reviewers will screen and select studies, extract data and assess the quality and risk of bias of each study. Study-specific estimates will be pooled by meta-analysis, and effect sizes will be presented as OR and their 95% CI. Levels of heterogeneity will be evaluated using chi-square statistic Q and I2. Publication bias will be assessed using forest plots and Egger's tests. Qualitative findings and sample quotes will be extracted. Textual references to the topics of interest will be retrieved and categorised using qualitative thematic analysis. We will triangulate quantitative and qualitative findings for a complete understanding of the reasons for delayed TB diagnosis and treatment. Results will be presented by geographical region. ETHICS AND DISSEMINATION: This study will be conducted based on published data. This systematic review may provide insights into the reasons for delayed TB diagnosis in high-burden countries. These findings will also inform future research and key stakeholders in developing interventions to reach these undiagnosed cases effectively. Findings from this review will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42018107237.

Delays in Coccidioidomycosis Diagnosis and Relationship to Healthcare Utilization, Phoenix, Arizona, USA1.

We developed an electronic records methodology to programmatically estimate the date of first appearance of coccidioidomycosis symptoms in patients. We compared the diagnostic delay with overall healthcare utilization charges. Many patients (46%) had delays in diagnosis of >1 month. Billed healthcare charges before diagnosis increased with length of delay.

Autoimmune encephalitis: A costly condition.

OBJECTIVE: To assess the inpatient hospitalization burden and costs of patients with autoimmune encephalitis (AE) at a tertiary care institution. METHODS: Adult inpatients with AE were identified retrospectively from July 1, 2005, to June 30, 2015. Demographic and clinical data were collected and analyzed. Billing data were compared to those of patients with herpes simplex encephalitis (HSE). Charges were adjusted for inflation. RESULTS: Of 244 admissions for encephalitis reviewed, 63 patients met criteria for probable or definite AE. Thirty-one (49%) patients were antibody positive, and 27 (43%) were admitted to the intensive care unit (ICU). Median hospital charges per patient with AE were more than $70,000; median length of stay (LOS) was 15 days; and in-hospital mortality was 6%. Patients admitted to the ICU had substantially higher median hospital charges (ICU $173,000 per admission vs non-ICU $50,000 per admission, p < 0.001). LOS was strongly associated with charges and was driven by delay in diagnosis of AE, prolonged treatment courses, and lack of response to therapy. Compared with HSE, median hospital charges per patient with AE were nearly 4 times higher, median AE LOS was 3 times higher, and total charges over the study period were nearly twice as high. CONCLUSIONS: Patients with AE used more inpatient health care resources per patient during a 10-year period than patients with HSE at our institution. ICU-admitted patients with AE were responsible for a substantially higher financial burden than non-ICU-admitted patients with AE. Our data underscore the need for the development of novel diagnostic and therapeutic modalities to improve patient outcomes and to decrease hospital burden in AE.

Economic Analysis of a Noninvasive Molecular Pathologic Assay for Pigmented Skin Lesions.

Importance: A recently described noninvasive gene expression test (the pigmented lesion assay [PLA]) with adhesive patch-based sampling has the potential to rule out melanoma and the need for surgical biopsy of pigmented lesions suggestive of melanoma with a negative predictive value of 99% compared with 83% for the histopathologic standard of care. The cost implications of using this molecular test vs visual assessment followed by biopsy and histopathologic assessment (VAH) have not been evaluated. Objective: To determine potential cost savings of PLA use vs the VAH pathway. Design, Setting, and Participants: This health economic analysis performed from a US payer perspective was based on consensus treatment guidelines and fee schedules from the Centers for Medicare & Medicaid Services. Data for model input were derived from routine use of the test in US dermatology practices and literature. Participants included patients with primary cutaneous pigmented lesions suggestive of melanoma. Data were analyzed from February 8 to December 1, 2017. Main Outcomes and Measures: The primary analysis consisted of the relative reduction in costs of diagnostic surgical procedures for PLA vs VAH management. Additional analyses included stage-related treatment costs associated with delays in diagnosis. Results: In the cost analysis for this economic model, the relative reduction in surgical procedure costs (biopsy and subsequent excision), assuming $0 for the PLA to facilitate multiple comparison scenarios, was -$395 compared with VAH. The relative reduction in stage-related treatment costs associated with the PLA was -$433 compared with VAH, primarily associated with avoidance of delays due to false-negative diagnoses. Surveillance costs were reduced by -$119 with the PLA. The total cost of fully adjudicating a lesion suggestive of melanoma by VAH was $947. At a mean selling price reference point for PLA of $500, cost savings of $447 (47%) per lesion tested could be realized. Conclusions and Relevance: The results of this analysis suggest that the PLA reduces cost and may improve the care of patients with primary pigmented skin lesions suggestive of melanoma.