General characteristics, economic burden, causative drugs and medical errors associated with medical damage litigation involving severe cutaneous adverse drug reactions in China.

WHAT IS KNOWN AND OBJECTIVE: To investigate the general characteristics, economic burden, causative drugs and medical errors associated with litigation involving severe cutaneous adverse drug reactions (SCADRs) in China, with the aims of improving rational medication use and reducing the extent of damage from SCADRs. METHODS: This study analysed 150 lawsuit judgements involving SCADRs from 2005 to 2019, collected from China Judgments Online. RESULTS AND DISCUSSION: In total, 50% of lawsuits stemmed from SCADRs occurring in general hospitals. The average time elapsed from the date of occurrence of the SCADRs to the end of litigation procedures was 1055 days. Of the patients involved, 51% were female and more than two thirds (69%) were under 60 years old. The most common outcome of SCADRs was death (39%), followed by disabilities (30%). The average responsibility of the medical provider was 48 ± 29%. The average amount of compensation was $43 424. Of the cases studied, 51% of SCADRs were Stevens-Johnson syndrome or toxic epidermal necrolysis, which together accounted for 75% of cases with known clinical subtype. The overall average economic burden of SCADRs was $99 178, of which indirect costs made up the largest proportion (more than 60%). The most common causative drug groups were antimicrobial drugs (49%), Chinese patent medicine and Chinese herbal medicine (17%), and antipyretic analgesics (16%). Finally, 61% of medical errors were found to stem from violation of duty of care, 20% from violation of informed consent and 18% from violations related to the medical record writing and management system. WHAT IS NEW AND CONCLUSION: Severe cutaneous adverse drug reactions not only severely affect patient survival and quality of life, but also impose a heavy economic burden in terms of health care and societal costs. Medical providers should be better educated on strategies to reduce risk to patients and establish mechanisms of risk sharing and management.

Predictors of 30-day readmission in Stevens-Johnson syndrome and toxic epidermal necrolysis: A cross-sectional database study.

BACKGROUND: The predictors of readmission in Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) have not been characterized. OBJECTIVE: To determine the variables predictive of 30-day readmission after SJS/TEN hospitalization. METHODS: We performed a cross-sectional study of the 2010-2014 Nationwide Readmissions Database. Bivariate and multivariable logistic regression was used to evaluate associations of patient demographics, comorbidities, and hospital characteristics with readmission. Aggregate and per-readmission costs were calculated. RESULTS: There were 8837 index admissions with SJS/TEN reported; of these, 910 (10.3%) were readmitted, with diagnoses including systemic infection (22.0%), SJS/TEN (20.6%), and cutaneous infection (9.1%). Associated characteristics included age 45 to 64 years (odds ratio [OR], 1.88; 95% confidence interval [CI], 1.43-2.49), Medicaid insurance (OR, 1.83; 95% CI, 1.48-2.27), and nonmetropolitan hospital admission (OR, 1.67; 95% CI, 1.31-2.13). Associated comorbidities included HIV/AIDS (OR, 2.48; 95% CI, 1.63-3.75), collagen vascular disease (OR, 2.38; 95% CI, 1.88-3.00), and metastatic cancer (OR, 2.16; 95% CI, 1.35-3.46). The median per-readmission cost was $10,019 (interquartile range, $4,788-$16,485). LIMITATIONS: The Nationwide Readmissions Database lacks the ability to track the same patient across calendar years. The diagnostic code lacks specificity for hospitalizations <3 days. CONCLUSIONS: Thirty-day readmissions after SJS/TEN hospitalizations are common. Dedicated efforts to identify at-risk patients may improve peridischarge continuity.

Cost-effectiveness of screening for HLA-B*1502 prior to initiation of carbamazepine in epilepsy patients of Asian ancestry in the United States.

OBJECTIVE: Carbamazepine, widely used in the treatment of partial and generalized tonic-clonic seizures, has been associated with life-threatening Stevens-Johnson syndrome/toxic epidermal necrolysis among some Asians. The HLA-B*1502 genotype that occurs with varying frequency among Asians is recommended for screening prior to starting carbamazepine. Our goal is to explore the cost-effectiveness of screening for the presence of this genetic allele. METHODS: We constructed a Markov model in a hypothetical cohort of adult Asian patients with epilepsy in the United States being considered for carbamazepine to investigate the cost-effectiveness of two alternative strategies: (1) no HLA-B*1502 gene allele screening and using carbamazepine and (2) HLA-B*1502 gene allele screening and starting levetiracetam in the case of a positive screen. RESULTS: For the lifetime horizon, HLA-B*1502 gene screening was the cost-effective choice compared to no gene screening, with an incremental cost-effectiveness ratio of $27 058 per quality-adjusted life-year (QALY), below the $50 000/QALY threshold in 99.69% of probabilistic sensitivity analyses. Although gene screening strategy was more expensive than a no screening strategy, it was more effective, yielding more QALYs, across all Asian ethnic groups. SIGNIFICANCE: Our analysis confirms the 2007 US Food and Drug Administration recommendation to screen for HLA-B*1502 allele before starting treatment with carbamazepine in patients of Asian ancestry in the United States.

Direct costs of severe cutaneous adverse reactions in a tertiary hospital in Korea.

BACKGROUND/AIMS: There are only a few reports on the direct costs of severe cutaneous adverse reactions (SCARs), including drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), despite the tremendous negative impact these reactions can have on patients. We estimated the direct costs of treating SCARs. METHODS: Patients admitted to a tertiary teaching hospital for the treatment of SCARs from January 1, 2005 to December 31, 2010 were included. Patients who had experienced SCARs during their admission for other medical conditions were excluded. The direct costs of hospitalization and outpatient department visits were collected. Inpatient and outpatient care costs were calculated, and factors affecting inpatient care costs were analyzed. RESULTS: The total healthcare cost for the management of 73 SCAR patients (36 with DRESS, 21 with SJS, and 16 with TEN) was 752,067 US dollars (USD). Most of the costs were spent on inpatient care (703,832 USD). The median inpatient care cost per person was 3,720 (range, 1,133 to 107,490) USD for DRESS, 4,457 (range, 1,224 to 21,428) USD for SJS, and 8,061 (range, 1,127 to 52,220) USD for TEN. Longer hospitalization significantly increased the inpatient care costs of the patients with DRESS (by 428 USD [range, 395 to 461] per day). Longer hospitalization and death significantly increased the inpatient care costs of the patients with SJS/TEN (179 USD [range, 148 to 210] per day and an additional 14,425 USD [range, 9,513 to 19,337] for the deceased). CONCLUSION: The management of SCARs required considerable direct medical costs. SCARs are not only a health problem but also a significant financial burden for the affected individuals.

Life-threatening dermatoses: Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. Impact on the Spanish public health system (2010-2015).

BACKGROUND: Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are serious mucocutaneous reactions. In Spain, the epidemiology and resulting expenses of these diseases are not well established. METHODOLOGY: Retrospective descriptive study using the Minimum Basic Data Set (CMBD in Spanish) in patients admitted to hospitals of the National Health System between 2010 and 2015 with a diagnosis of SJS and TEN (combination of ICD-9 codes 695.13, 695.14, and 695.15, along with length of hospital stay). PRINCIPAL FINDINGS: A total of 1,468 patients were recorded, 773 were men (52.7%). The mean age (± SD) was 52.25 ± 26.15 years. The mean incidence rate for all diagnoses was 5.19 cases per million person-years (2.96 in SJS, 0.31 in SJS/TEN and 1.90 in TEN). 148 patients died (10.1%), 47 due to SJS (5.6%) and 90 (16.7%) due to TEN. The estimated total medical cost of SJS, SJS/TEN, and TEN in Spain was €11.576.456,18, and the average medical cost per patient was €7.885,86 ± €11.686,26, higher medical cost in TEN (€10352.46 ± €16319,93) than in SJS (€6340,05 ± €7078,85) (p<0.001). CONCLUSIONS: Older patients have a more severe clinical picture and higher mortality rates. The overall mortality of both diseases is approximately 10%, and clinical diagnosis and age were the variables with the greatest influence on mortality. This study describes a stable incidence and a similar prevalence to other European countries. Additionally, the data show a high cost due to hospitalizations. Finally, the CMBD could be a good system of epidemiological analysis for the study of infrequent diseases and hospital management of conditions such as SJS and TEN.

Incidence, outcomes, and resource use in children with Stevens-Johnson syndrome and toxic epidermal necrolysis.

BACKGROUND/OBJECTIVES: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are life-threatening cutaneous reactions, typically to drugs or infection. The incidence and outcomes of these conditions in children are unknown. The objective of this study was to report the overall burden of Stevens-Johnson syndrome and toxic epidermal necrolysis in children in the United States. METHODS: We performed a retrospective cohort analysis of children and adolescents younger than 18 years of age using the 2009 and 2012 Kids' Inpatient Database. RESULTS: We identified 1486 children and adolescents hospitalized with a diagnosis of Stevens-Johnson syndrome or toxic epidermal necrolysis. The national incidence per 100 000 was 6.3 for Stevens-Johnson syndrome, 0.7 for Stevens-Johnson syndrome/toxic epidermal necrolysis overlap syndrome, and 0.5 for toxic epidermal necrolysis. The highest incidence in children was in those aged 11-15 years (38.4 per 100 000). Toxic epidermal necrolysis and Stevens-Johnson syndrome/toxic epidermal necrolysis overlap syndrome were associated with longer stay, greater mortality, and higher hospital charges than those with Stevens-Johnson syndrome. Hospital mortality was highest in children with toxic epidermal necrolysis and in children aged 0-5 years. CONCLUSIONS: The incidence of Stevens-Johnson syndrome and toxic epidermal necrolysis in children is higher than reported in adults, and there are significant age-based variations in incidence and outcomes across the pediatric population. Further study is needed to determine the most effective treatment strategies to reduce costs and improve outcomes in children hospitalized with severe cutaneous reactions.

Cost-effectiveness analysis of HLA-B*58: 01 genetic testing before initiation of allopurinol therapy to prevent allopurinol-induced Stevens-Johnson syndrome/toxic epidermal necrolysis in a Malaysian population.

OBJECTIVE: Studies found a strong association between allopurinol-induced Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and the HLA-B*58:01 allele. HLA-B*58:01 screening-guided therapy may mitigate the risk of allopurinol-induced SJS/TEN. This study aimed to evaluate the cost-effectiveness of HLA-B*58:01 screening before allopurinol therapy initiation compared with the current practice of no screening for Malaysian patients with chronic gout in whom a hypouricemic agent is indicated. METHODS: This cost-effectiveness analysis adopted a societal perspective with a lifetime horizon. A decision tree model coupled with Markov models were developed to estimate the costs and outcomes, represented by quality-adjusted life years (QALYs) gained, of three treatment strategies: (a) current practice (allopurinol initiation without HLA-B*58:01 screening); (b) HLA-B*58:01 screening before allopurinol initiation; and (c) alternative treatment (probenecid) without HLA-B*58:01 screening. The model was populated with data from literature review, meta-analysis, and published government documents. Cost values were adjusted for the year 2016, with costs and health outcomes discounted at 3% per annum. A series of sensitivity analysis including probabilistic sensitivity analysis were carried out to determine the robustness of the findings. RESULTS: Both HLA-B*58:01 screening and probenecid prescribing were dominated by current practice. Compared with current practice, HLA-B*58:01 screening resulted in 0.252 QALYs loss per patient at an additional cost of USD 322, whereas probenecid prescribing resulted in 1.928 QALYs loss per patient at an additional cost of USD 2203. One SJS/TEN case would be avoided for every 556 patients screened. At the cost-effectiveness threshold of USD 8695 per QALY, the probability of current practice being the best choice is 99.9%, in contrast with 0.1 and 0% in HLA-B*58:01 screening and probenecid prescribing, respectively. This is because of the low incidence of allopurinol-induced SJS/TEN in Malaysia and the lower efficacy of probenecid compared with allopurinol in gout control. CONCLUSION: This analysis showed that HLA-B*58:01 genetic testing before allopurinol initiation is unlikely to be a cost-effective intervention in Malaysia.

Pediatric Stevens-Johnson syndrome and toxic epidermal necrolysis in the United States.

BACKGROUND: Little is known about the epidemiology of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) in children. OBJECTIVE: We sought to determine the morbidity, mortality, and comorbid health conditions of SJS and TEN in US children. METHODS: This was a cross-sectional study of the 2009 to 2012 Nationwide Inpatient Sample, which contains a representative 20% sample of all US hospitalizations. Sociodemographics, inflation-adjusted cost, length of stay, comorbidities, and mortality were analyzed using descriptive statistics and multivariate regression analyses. RESULTS: The incidences of SJS, SJS-TEN, and TEN were a mean 5.3, 0.8, and 0.4 cases per million children per year in the US, respectively. Prolonged length of stay and higher costs of care (SJS: 9.4 ± 0.6 days, $24,947 ± $3171; SJS-TEN: 15.7 ± 1.5 days, $63,787 ± $8014; TEN: 20.4 ± 6.3 days, $102,243 ± $37,588) were observed compared with all other admissions (4.6 ± 0.1 days, $10,496 ± $424). Mortality was 0% for SJS, 4% for SJS-TEN, and 16% for TEN. In regression models, predictors of mortality included renal failure (adjusted OR [aOR] 300.28, 95% confidence interval [CI] 48.59->999.99), malignancy (aOR 54.33, 95% CI 9.40-314.22), septicemia (aOR 30.45, 95% CI 7.91-117.19), bacterial infection (aOR 20.38, 95% CI 5.44-76.36), and epilepsy (aOR 5.56, 95% CI 1.37-26.2). LIMITATIONS: Data regarding treatment were not available. Date of diagnosis of comorbidities was not present, precluding temporal analysis. CONCLUSIONS: Pediatric SJS/TEN poses a substantial health burden in the United States.

Is universal HLA-B*15:02 screening a cost-effective option in an ethnically diverse population? A case study of Malaysia.

BACKGROUND: A strong association has been documented between HLA-B*15:02 and carbamazepine-induced severe cutaneous adverse reactions (SCARs) in Asians. Human leucocyte antigen testing is potentially valuable in many countries to facilitate early recognition of patient susceptibility to SCARs. OBJECTIVES: To determine the cost-effectiveness of universal HLA-B*15:02 screening in preventing carbamazepine-induced Stevens-Johnson syndrome/toxic epidermal necrolysis in an ethnically diverse Malaysian population. METHODS: A hybrid model of a decision tree and Markov model was developed to evaluate three strategies for treating newly diagnosed epilepsy among adults: (i) carbamazepine initiation without HLA-B*15:02 screening (current practice); (ii) universal HLA-B*15:02 screening prior to carbamazepine initiation; and (iii) alternative treatment [sodium valproate (VPA)] prescribing without HLA-B*15:02 screening. Base-case analysis and sensitivity analyses were performed over a lifetime time horizon. Incremental cost-effectiveness ratios were calculated. RESULTS: Both universal HLA-B*15:02 screening and VPA prescribing were dominated by current practice. Compared with current practice, universal HLA-B*15:02 screening resulted in a loss of 0·0255 quality-adjusted life years (QALYs) at an additional cost of 707 U.S. dollars (USD); VPA prescribing resulted in a loss of 0·2622 QALYs at an additional cost of USD 4127, owing to estimated differences in antiepileptic treatment efficacy. CONCLUSIONS: Universal HLA-B*15:02 screening is unlikely to be a cost-effective intervention in Malaysia. However, with the emergence of an ethnically diverse population in many other countries, this may render HLA-B*15:02 screening a viable intervention when an increasing proportion of the population is at risk and an equally effective yet safer antiepileptic drug is available.

Incidence of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis: A Nationwide Population-Based Study Using National Health Insurance Database in Korea.

BACKGROUND: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are life-threatening diseases; however, it is hard to estimate their incidence due to the rarity of these diseases. We evaluated the incidence of SJS and TEN using a nationwide administrative database. METHODS: We used a national medical insurance review system (Health Insurance Review and Assessment) database which contained the claim data of the entire nation from 2009 to 2013 to estimate the accurate incidence of SJS and TEN in Korea. The diagnostic codes of L511 (SJS) or L512 (TEN) from the International Classification of Diseases-10th revision were used to define the target study population. We also retrospectively followed up a 2011 SJS and TEN cohort for 24 months in order to assess the in-hospital mortality, related complications and total claims cost due to SJS and TEN. RESULTS: A total of 1,167 (938 SJS and 229 TEN) cases were newly diagnosed from 2010 to 2013. The age- and sex-standardized annual incidences estimated in this study were 3.96 to 5.03 in SJS and 0.94 to 1.45 in TEN per million. There was no significant change in annual incidence throughout the study periods. When analyzed by 10-year age groups, the annual incidence was the lowest in group 20-29 years and the highest in group 70 for both SJS and TEN. Based on the 2011 cohort analysis, the in-hospital mortality were 5.7 and 15.1% for SJS and TEN, respectively. The mortality increased with age, particularly, after 40 years of age. Among the complications related with SJS or TEN, ocular sequelae was the most common (43.1 and 43.4% of SJS and TEN patients, respectively) followed by urethral sequelae (5.7 and 9.4% of SJS and TEN patients, respectively). CONCLUSION: Overall, our data suggest that SJS, and TEN are infrequent but constantly arise throughout the years.

Morbidity and Mortality of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis in United States Adults.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are life-threatening disorders. Our study objective was to describe the incidence, costs of care, length of stay, comorbidities, and mortality of SJS and TEN in US adults. The Nationwide Inpatient Sample 2009-2012, containing a 20% sample of all US hospitalizations, was analyzed. We used a validated approach involving International Classification of Disease, 9th edition, Clinical Modification codes to identify SJS, SJS/TEN, and TEN (n = 2,591, n = 502, and n = 564, respectively). The mean estimated incidences of SJS, SJS/TEN, and TEN were 9.2, 1.6, and 1.9 per million adults per year, respectively. SJS/TEN was associated with nonwhite race, particularly Asians (odds ratio = 3.27, 95% confidence interval = 3.02-3.54) and blacks (odds ratio = 2.01, 95% confidence interval = 1.92-2.10). Significantly prolonged length of stay and higher costs of care (SJS: 9.8 ± 0.3 days, $21,437 ± $807; SJS/TEN: 16.5 ± 1.0 days, $58,954 ± $5,238; TEN: 16.2 ± 1.0 days, $53,695 ± $4,037) were observed compared with all other admissions (4.7 ± 0.02 days, $11,281 ± $98). Mean adjusted mortality was 4.8% for SJS, 19.4% for SJS/TEN, and 14.8% for TEN. SJS, SJS/TEN, and TEN pose a substantial health care burden. Predictors of mortality included increasing age, increasing number of chronic conditions, infection (septicemia, pneumonia, tuberculosis), hematological malignancy (non-Hodgkin's lymphoma, leukemia), and renal failure (P ≤ 0.03 for all). Further studies are needed to confirm mortality findings to improve prognostication of SJS/TEN.

Healthcare utilization and cost of Stevens-Johnson syndrome and toxic epidermal necrolysis management in Thailand.

BACKGROUND: Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are life-threatening dermatologic conditions. Although, the incidence of SJS/TEN in Thailand is high, information on cost of care for SJS/TEN is limited. This study aims to estimate healthcare resource utilization and cost of SJS/TEN in Thailand, using hospital perspective. METHODS: A retrospective study using an electronic health database from a university-affiliated hospital in Thailand was undertaken. Patients admitted with SJS/TEN from 2002 to 2007 were included. Direct medical cost was estimated by the cost-to-charge ratio. Cost was converted to 2013 value by consumer price index, and converted to $US using 31 Baht/ 1 $US. The healthcare resource utilization was also estimated. RESULTS: A total of 157 patients were included with average age of 45.3±23.0 years. About 146 patients (93.0%) were diagnosed as SJS and the remaining (7.0%) were diagnosed as TEN. Most of the patients (83.4%) were treated with systemic corticosteroids. Overall, mortality rate was 8.3%, while the average length of stay (LOS) was 10.1±13.2 days. The average cost of managing SJS/TEN for all patients was $1,064±$2,558. The average cost for SJS patients was $1,019±$2,601 while that for TEN patients was $1,660±$1,887. CONCLUSIONS: Healthcare resource utilization and cost of care for SJS/TEN in Thailand were tremendous. The findings are important for policy makers to allocate healthcare resources and develop strategies to prevent SJS/TEN which could decrease length of stay and cost of care.

Epidemiology and costs of patients with toxic epidermal necrolysis: a 27-year retrospective study.

BACKGROUND: Recently, the importance of reporting the results and principles of management in Toxic epidermal necrolysis (TEN) patients was underscored. Treatment of TEN focuses on supportive care, often provided in a burn centre setting. Mortality in TEN patients can be high; the SCORTEN score is a scoring system that predicts mortality in patients with TEN. The predictive value of the SCORTEN score in our setting is unclear, as are the treatment costs of TEN patients. OBJECTIVE: To describe patient characteristics, treatment, outcome and direct medical costs of patients with TEN treated in one Dutch burn centre in a 27-year period. In addition, determinants of mortality and the predictive value of the SCORTEN score were assessed. METHODS: A retrospective study was conducted in all patients with TEN (including Stevens-Johnson syndrome (SJS) and overlap SJS-TEN) admitted to the burn centre Rotterdam between January 1987 and December 2013. The discriminative value of the SCORTEN score was assessed by receiver-operator characteristics curve analysis. RESULTS: A total of 63 patients were admitted in 27-year period. Overall mortality was 39.7%, mortality in TEN patients (>30%TBSA) was 37.1%. A higher age (OR = 1.04, 95%CI: 1.02-1.07) and comorbidity (OR = 4.25, 95%CI: 1.2-14.7) were associated with mortality. The discriminative value of the SCORTEN prediction model in our population was limited (AUC=0.72, 95%CI: 0.57-0.86). The mean direct medical hospital-based costs was €41.361. CONCLUSION: Toxic epidermal necrolysis is a severe adverse drug reaction, with a high mortality. Elderly patients and patients with comorbidity, especially circulatory comorbidity, have a relatively high risk of decease. The SCORTEN score, a frequently used prediction model in patients with TEN, underestimated the mortality in our study, mainly due to limited availability in patients with a good prognosis. The treatment of patient with TEN is associated with high direct medical hospital-based costs, also compared to burn patients in general.

Real-world efficiency of pharmacogenetic screening for carbamazepine-induced severe cutaneous adverse reactions.

OBJECTIVES: We evaluated the cost and efficiency of routine HLA-B*15 ∶ 02 screening to prevent carbamazepine-induced Stevens-Johnson syndrome and toxic epidermal necrolysis (CBZ-SJS/TEN) in Hong Kong. METHODS: Data were extracted from patients who commenced CBZ as the first-ever AED treatment or tested for HLA-B*15 ∶ 02 allele in three years before policy implementation (pre-policy: 16 September 2005 to 15 September 2008) and three years after (post-policy: 16 September 2008 to 15 September 2011). Using published unit costs, we estimated the cost of screening by comparing the costs to prevent and treat CBZ-SJS/TEN. We compared the number of person-tests needed and the cost to prevent resultant death with cancer screening programs. RESULTS: The number of screening tests needed to prevent one case of CBZ-SJS/TEN was 442, and to prevent one resultant death was 1,474 to 8,840. The screening cost was $332 per person, of which 42% was attributed to an additional consultation to review result and prescribe appropriate medication. HLA-B*15 ∶ 02 screening expended $146,749 to prevent a case of CBZ-SJS/TEN, and $489,386- $2,934,986 to prevent a resultant death. The corresponding numbers of tests and costs for mammography and Pap smear to prevent death due to breast and cervical cancers were 7,150 and 7,000, and $614,900 and $273,000, respectively. Comparing to the SJS/TEN treatment cost, HLA-B*15 ∶ 02 screening would become cost saving if a point-of-care test of less than $37 was available. CONCLUSIONS: HLA-B*15 ∶ 02 screening is as efficient as mammography and Pap smear in preventing death. Development of point-of-care testing will vastly improve efficiency.

Cost-effectiveness analysis of HLA-B*5801 testing in preventing allopurinol-induced SJS/TEN in Thai population.

BACKGROUND: Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), caused by allopurinol therapy, are strongly associated with the human leukocyte antigen (HLA), HLA-B*5801. Identification of HLA-B*5801 genotype before prescribing allopurinol offers the possibility of avoiding allopurinol-induced SJS/TEN. As there is a paucity of evidence about economic value of such testing, this study aims to determine the cost-effectiveness of HLA-B*5801 testing compared with usual care (no genetic testing) before allopurinol administration in Thailand. METHODS AND FINDING: A decision analytical and Markov model was used to estimate life time costs and outcomes represented as quality adjusted life years (QALYs) gained. The model was populated with relevant information of the association between gene and allopurinol-induced SJS/TEN, test characteristics, costs, and epidemiologic data for Thailand from a societal perspective. Input data were obtained from the literature and a retrospective database analysis. The results were expressed as incremental cost per QALY gained. A base-case analysis was performed for patients at age 30. A series of sensitivity analyses including scenario, one-way, and probabilistic sensitivity analyses were constructed to explore the robustness of the findings. Based on a hypothetical cohort of 1,000 patients, the incremental total cost was 923,919 THB (USD 29,804) and incremental QALY was 5.89 with an ICER of 156,937.04 THB (USD 5,062) per QALY gained. The cost of gout management, incidence of SJS/TEN, case fatality rate of SJS/TEN, and cost of genetic testing are considered very influential parameters on the cost-effectiveness value of HLA-B*5801 testing. CONCLUSIONS: The genetic testing for HLA-B*5801 before allopurinol administration is considered a highly potential cost-effective intervention in Thailand. The findings are sensitive to a number of factors. In addition to cost-effectiveness findings, consideration of other factors including ethical, legal, and social implications is needed for an informed policy decision making.

Severe cutaneous adverse reactions to drugs: from patients to the national office for compensation of medical accidents.

BACKGROUND: Administrative bodies for compensating medical accidents were created in France in 2002. OBJECTIVES: To evaluate the knowledge patients with severe cutaneous adverse reactions (SCARs) have of procedures and to compare the rate of compensation for SCARs for France and for our referral center. METHODS: A questionnaire was sent to 247 patients of our SCARs referral center and 225 patients with Stevens-Johnson syndrome and toxic epidermal necrolysis from the patient association AMALYSTE. We calculated the rate of compensation for France and our center. RESULTS: Among the 123 respondents (26%), 28 (23%) knew the compensation procedure; 13 (11%) had received compensation. The Commission of Conciliation and Compensation had received 63 applications for SCARs since 2002 and proposed compensation for 56%. The estimated rate of compensation for France was 2.6% and 2.5% for our referral center (p = 0.9). CONCLUSIONS: The procedure of compensation for SCARs is misunderstood. Better information should be disseminated for patients with threshold disability conditions.

Cost-effectiveness of osteo-odonto keratoprosthesis in Singapore.

PURPOSE: To determine the long-term cost-effectiveness of osteo-odonto keratoprosthesis (OOKP) relative to no treatment among patients with end-stage corneal and ocular surface diseases in Singapore. DESIGN: Cost-effectiveness analysis based on data from a retrospective cohort study. METHODS: From a health system perspective, we calculated the incremental cost-effectiveness ratio of OOKP treatment relative to no treatment over a 30-year horizon, based on data from a cohort of 23 patients who underwent OOKP surgery between 2004 and 2009 at Singapore National Eye Centre. Preoperative and postoperative vision-related quality-of-life values were estimated from patients' visual outcomes and were used to calculate the gain in quality-adjusted life years (QALYs) resulting from OOKP treatment. Unsubsidized costs for surgery, consultations, examinations, medications, follow-up visits, and treatments for complications were retrieved from patients' bills to estimate the total costs associated with OOKP treatment. Sensitivity analyses were conducted to test the robustness of the model. RESULTS: Over a 30-year period, OOKP treatment, compared with no treatment, improved QALYs by 3.991 among patients with end-stage corneal and ocular surface diseases at an additional cost of S$67 840 (US$55 150), resulting in an incremental cost-effectiveness ratio of S$17 000/QALY (US$13 820/QALY). CONCLUSIONS: Based on commonly cited cost-effectiveness benchmarks, the OOKP is a cost-effective treatment for patients with end-stage corneal and ocular surface diseases.

Cost minimization of HLA-B*1502 screening before prescribing carbamazepine in Thailand.

BACKGROUND: Carbamazepine (CBZ) is broadly used for the treatment of epilepsy, neuropathic pain and other neurological diseases, owing to its effectiveness and low price. CBZ can induce Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). There are several studies that found an association between HLA-B*1502 and CBZ-induced SJS/TEN, especially in people of Thai origin. In Thailand the prevalence of HLA-B*1502 was found to be in the range 8.1-14 %. OBJECTIVE: This study aimed to determine if screening for HLA-B*1502 in Thai patients who were to receive CBZ is cost effective. Setting Srinagarind Hospital, Khon Kaen University, Thailand. METHOD: A comparison between treatment cost of CBZ induced SJS/TEN and the HLAB*1502 screening costs in the Thai population. MAIN OUTCOME MEASURE: Comparison of the costs of treatment of CBZ induced SJS/TEN and costs of HLA-B*1502 screening test. Results When persons having the HLA-B*1502 allele receive CBZ, the chance of developing SJS/TEN is as high as 88.1 %, while persons without the HLA-B*1502 allele do not develop SJS/TEN. Therefore, a model was calculated to compare the cost of treatment between HLA-B*1502 testing before giving CBZ and if the patients were not tested for HLAB*1502. It was found that screening 100 patients before giving CBZ would save an amount of 98,549.94 baht per 100 cases of CBZ-prescribed patients. CONCLUSION: The screening for HLA-B*1502 allele before giving carbamazepine is cost effective. The results of the present study may also apply to other populations if the HLA-B*1502 frequency is high enough.