National Health Insurance Reimbursement Research Articles

Medical Device Reimbursement Coverage and Pricing Rules in Korea: Current Practice and Issues with Access to Innovation

The development of health funding policy in Korea has followed the country’s rapid economic development, with a comprehensive National Health Insurance (NHI) system in place by 1989. The funding of medical devices has followed this progression, with incorporation into the NHI reimbursement system in 2000 (several years later than pharmaceuticals), but important issues affecting patient access remain. Although the effect of devices on the NHI budget is relatively modest (only about 4%), because of concerns about NHI sustainability, attention has increasingly been paid to their management and funding. Unlike pharmaceuticals, however, it has been quite challenging to develop clear and fair criteria for reimbursement coverage and pricing of medical devices. The two key and longstanding issues around the reimbursement of medical devices in Korea are how to expedite market entry of improved or innovative medical devices at appropriate prices, and how to satisfactorily lower the reimbursement levels of older devices, thereby making headroom for new technologies to be reimbursed. Despite protracted discussions over the last decade, industry and government have been unable to reach full agreement. There has been some progress (e.g., introduction of the Value Appraisal and the Revaluation Systems), but there remains urgent need for productive discussion and consensus between government and industry regarding reasonable funding rules, transparency, and clarity in the reimbursement pricing process for medical devices.

Patterns of dental services and factors that influence dental services among 64–65‐year‐old regular users of dental care in Denmark

To describe the pattern of dental services provided to 64-65-year-old Danes who are regular users of dental care over a 5-year period, to analyse whether this pattern is associated with socio-demographic and/or socioeconomic factors, and if different uses of dental services are related to dental status and caries experience. Finally, to discuss the future planning of dental services aimed at the increasing population of elderly citizens. [Correction made on 21 March 2014, after first online publication: The sentence 'Data on elderly's dental service are scarce, although increased use is seen and more teeth are present in this age group.' was removed.] A cross-sectional study of all aged 64-65 (n=37234) who received a dental examination in 2009 was conducted. Clinical data comprised dental services received under the National Health Insurance reimbursement scheme, dental status and DMFT. Geographical, socio-demographic and socioeconomic data derived from public registers. Almost all received restorations, while periodontal treatment was received by <50% during 5years. Heavy use of dental services was dominated by periodontal services. Periodontal services were most prevalent in the capital and the most affluent areas. Relatively more extractions were related to low income and persons in least affluent areas. Total number of services was highest among women, persons with ≥20 teeth, persons living in the capital, and where the ratio user per dentist was low. For future planning of dental care for elderly, dental status, geographical and social area-based factors and to some degree gender, income, and education must be taken into consideration as all these factors seem to influence the future demand for dental services.

Usage of Anti-TNFα Agents in Patients with Rheumatoid Arthritis and Korean National Health Insurance Reimbursement Criteria

Usage of Anti-TNFα Agents in Patients with Rheumatoid Arthritis and Korean National Health Insurance Reimbursement Criteria

A Nationwide Plan for Postacute Care of Stroke in Taiwan

To the editor, Taiwan’s government is proud of its universal-coverage National Health Insurance (NHI) program (1). Stroke is among the top five critical illnesses covered by the NHI (2). About 26 098 patients were hospitalized for acute stroke in 2011; 16·2% had prolonged hospital stay (PHS, >30 days), which cost 56·4% of the NHI reimbursement for inpatient stroke care. To reduce the financial burden of PHS, the NHI program initiated a nationwide postacute care (PAC) plan for stroke in 2013. Its major goal is to develop a seamless system transfers for stroke patients from acute-care units to subacute rehabilitation or long-term care facilities. The Taiwan Stroke Society (TSS), coordinating with allied disciplines, took responsibility for the PAC plan from the NHI Administration in March 2013. Through infrastructure reforms, the plan is anticipated to improve patient outcome and reduce costs. During the TSS annual meeting this September, interest groups of stroke patients were invited to explain their unmet need for rehabilitation and other postacute care. Physical, occupational, and speech therapy associations were also invited to present their updated evidencebased guideline for stroke rehabilitation. For the first time, busy strokologists in Taiwan took a first step by shifting focus from acute care (e.g., thrombolytic therapy) to postacute care of stroke patients. Topics about stroke rehabilitation, social welfare, and the continuum of care have garnered more attention. We hope that we would not forget ‘the other 97%’ (3).

Continuation of statin therapy and a decreased risk of atrial fibrillation/flutter in patients with and without chronic kidney disease

BackgroundTo contain cost, Taiwan's previous National Health Insurance Reimbursement Policy requested that physicians discontinue their patients' statin therapy once the serum cholesterol had reached appropriate levels. This allowed us to evaluate the association between statin continuation and the occurrence of atrial fibrillation/flutter and whether it was modified by chronic kidney disease (CKD) status. MethodsPatients who initiated statin therapy between January 1, 2001 and December 31, 2009 were identified from a random sample of one million subjects in the Taiwan National Health Insurance Research Database. The outcome was atrial fibrillation/flutter. A proportional hazard regression model with time-varying statin use was applied to estimate the hazard ratios (HR) and 95% confidence intervals (CIs) for atrial fibrillation/flutter according to current statin use versus treatment discontinuation, adjusted for baseline disease risk scores and time-varying covariates. ResultsA total of 6767 CKD and 63,678 non-CKD patients initiating statin therapy were included and followed for an average of 4.0 years. A total of 1118 participants experienced new-onset atrial fibrillation/flutter. The incidence of atrial fibrillation/flutter was approximately 2 fold higher in the CKD patients. Continuation of statin therapy was associated with a 22% (adjusted hazard ratio 0.78; 95% CI: 0.65–0.93) and 57% (adjusted HR 0.43; 95% CI: 0.27–0.68) decrease in atrial fibrillation/flutter hazard as compared with discontinuation in non-CKD and CKD patients, respectively. ConclusionsContinuation of statin therapy was associated with a decreased risk of atrial fibrillation/flutter among CKD and non-CKD patients. However, further randomized studies are still needed to assess the association.

Brand name or generic? What are the health professionals prescribed for treating diabetes? A longitudinal analysis of the National Health Insurance reimbursement database

This study aimed to explore whether physicians prescribe more brand-name oral hypoglycemic agents (OHA) for diabetic patients with medical training background (MP) than for general patients (GP). A longitudinal analysis of 1,000,000 National Health Insurance cohorts of 1998-2008 was conducted. Univariate and multivariate models were performed to assess the associations of the outcome (the ratio of brand-name/generic odds in the MP group to that in the GP group) and the covariates, including patient medical training background, characteristics of patient, prescriber, and medical settings, and market competition. A generalized estimating equation method was used to control the dependency of longitudinal data. A total of 46,850 diabetic patients were prescribed with 2,703,149 OHA prescriptions during the study period. Compared with GP, MP had 1.37 times greater odds of being prescribed with brand-name instead of generic OHA, among whom pharmacists and physicians had the highest odds ratios of 2.78 (95%CI, 1.05-7.36) and 1.68 (95%CI, 0.99-2.85), respectively. Patients' diabetes severity, prescribers' level of experience, medical settings that were publicly owned, had a higher accreditation level, and were located in a higher urbanized area, lower market competition, and earlier dates of prescription were positively associated with brand-name prescription. Among all medical sub-specialties, cardiologists were more likely to prescribe brand-name OHA. This study is the first to demonstrate how a patients' medical training background, in addition to the characteristics of patients, prescribers, and medical settings, and market competition might influence physicians' prescribing choice of brand-name or generic OHA.

Papillomavirus vaccine coverage and its determinants in South-Eastern France

ObjectivesWe wanted: (i) to assess vaccine coverage (VC) for papillomavirus (HPV) (one and three doses of the vaccine, VC1 and VC3) and compliance with the recommended vaccination regimen (3rd dose within 1year after the 1st dose) among 14–16 year-old girls; and (ii) to identify the factors independently associated with VC and compliance with the recommended vaccination regimen. MethodsWe conducted a descriptive longitudinal study, using the National Health Insurance reimbursement database, for years 2007 to 2009, in South-Eastern France. We performed a multivariate analysis (Cox proportional hazards model). ResultsVC1 was 35.5%, with 68.8% of those who started vaccination having completed the 3-dose regimen, 64.1% within one year. VC1 and VC3 were positively associated with the girl's age. Girls covered by the complementary social welfare healthcare program and those living in rural areas had lower VC1 and VC3. Being covered by the complementary social welfare healthcare program was also associated with lower compliance with the recommended vaccination regimen. VC1 and VC3 were positively associated with the number of medical consultations during the study period. Important geographical variations were noted regarding VC1. ConclusionsOur study confirms that VC for HPV is insufficient in our region, and that there are socio-economic and geographical inequalities. Even though the vaccine is reimbursed for all girls, efforts must be made to improve VC, particularly for girls covered by the complementary social welfare healthcare program and those living in rural areas.

Clinical Characteristics of Korean Rheumatoid Arthritis Patients with Indications for TNF-α Blocker

Objective. The aim of this study was to examine clinical characteristics of Korean rheumatoid arthritis (RA) patients with clinically indications for TNF-α blocker, and to compare their clinical parameters with the Korean National Health Insurance reimbursement criteria. Methods. Data were obtained from a registry of RA patients who visited rheumatology clinics of Hallym University affiliated hospitals. Among patients who were previously prescribed DMARDs for more than three months, rheumatologists selected patients clinically indicated for TNF-a blocker. The clinical characteristics at the time TNF-α blocker use was deemed indicated were examined. Radiographic damage was quantified by Modified Sharp van der Heijde score in hand and foot simple AP radiograph. Results. From August 2010 to January 2013, five rheumatologists in four hospitals selected 109 patients clinically indicated for TNF-α blocker. When TNF-α blocker was considered, mean DAS28 was 5.2 (range 2.1∼8.05), mean swollen joint count was 6 (range 0∼22), mean tender joint count was 10.6 (range 0∼28), mean ESR was 43.2 mm/hr (range 1∼140) and mean CRP was 2.5 mg/dL (range 0.1∼ 18.3). The mean total modified Sharp van der Heijde score was 32.72 (range 0∼240). Eighty one percent of subjects did not have enough active joints to satisfy the Korean National Health Insurance reimbursement standard. Conclusion. Our results show that patients with clinically indications for TNF-α blocker had a broad range of disease activity and clinical parameters, and the majority did not meet the Korean National Health Insurance reimbursement criteria

Practical Experience of Thromboprophylaxis After Lower Limb Replacement – Rivaroxaban Versus Enoxaparin

AbstractAbstract 4369 BACKGROUNDSince October 2010, rivaroxaban has been approved by Korean government to be covered by national health insurance reimbursement system as thromboprophylaxis after total hip arthroplasty and total knee arthroplasty. However, there is no available data on outcomes of rivaroxaban as thromboprophylaxis in Korea. We performed a retrospective study to compare the efficacy and safety of venous thromboembolism prophylaxis with enoxaparin or rivaroxaban in 195 consecutive patients undergoing major orthopaedic surgery at our center. METHODSThis study retrospectively reviewed the medical records of the 195 patients who underwent a total hip replacement arthroplasty or total knee replacement arthroplasty and received thromboprophoylaxis with enoxaparin or rivaroxaban at Soonchunhyang University Hospital between March 2009 and May 2012.Each patient's medical records included information on age, sex, comorbidities (active malignant disease, renal insufficiency), treatment details (type of surgery, type of anesthesia, duration of surgery,), duration of prophylaxis, efficacy (death, pulmonary embolism, deep vein thrombosis), safety (major bleeding, cerebrovascular accident), cause of drug interruption. RESULTSOf 195 patients, 129 patients received thromboprophylaxis with enoxaparin (group 1; our hospital standard since March 2009), 66 received rivaroxaban (group 2; our hospital standard since February 2011). Symptomatic venous thromboembolism was found in 0.7 % of patients in the group 1 (1/129 patients) compared to 1.5 % of group 2 (1/66 patients; p=0.627). No significant differences in the rates of symptomatic VTE were found. However, patients with received rivaroxaban had significantly more rates of major bleeding (0 in group 1 vs 3% (2/66 patients) in group 2; p=0.047). Although group 1 patients were planed receiving thromboprophylaxis with rivaroxaban from day one post operatively, mean time from the end of surgery to first rivaroxaban intatake was 4.2 days. CONCLUSIONSDespite lower compliance in rivaroxaban group, venous thromboembolism prophylaxis with rivaroxaban is not inferior to prophylaxis with enoxaparin with regard to the prevention of symptomatic venous thromboembolisms. But, more bleeding complications and wound problems revealed in rivaroxaban group. Further studies and experiences are needed to assess the efficacy and safety of rivaroxaban in clinical practice.Table 1Incidence of Events for Efficacy AnalysisEnoxaparinRivaroxabanEventsTKRA (N=67)THRA (N=62)Total (N=129)TKRA (N=39)THRA (N=27)Total (N=66)Occurrence of VTE01.6%0.7%2.5%01.5%PE, n011000DVT, n000000PE + DVT, n000101All cause mortality (3 months), n(%)02 (3.2)2 (1.5)000Table 2Safety outcomesEnoxaparinRivaroxabanOutcomeTKRA (N=67)THRA (N=62)Total (N=129)TKRA (N=39)THRA (N=27)Total (N=66)major bleeding following thromboprophylaxis -no. (%)0002 (5.1)02 (3.0)Clinically overt surgical site bleeding, leading to a decreased Hb — no. (%)0001 (2.5)01 (1.5)Clinically overt extra-surgical site bleeding, leading to a decreased Hb — no. (%)0001 (2.5)01 (1.5)Cardiovascular adverse event ≤1 day after last dose of study medication — no. (%)Ischemic stroke0001 (2.5)01 (1.5) Disclosures:No relevant conflicts of interest to declare.

PHP70 A 3-Year Follow-Up Study on National Health Insurance Reimbursements Among Atrial Fibrillation Patients With/Without Stroke in Taiwan: A Population-Based Study

PHP70 A 3-Year Follow-Up Study on National Health Insurance Reimbursements Among Atrial Fibrillation Patients With/Without Stroke in Taiwan: A Population-Based Study

Economic burden of acute pesticide poisoning in South Korea

To investigate the magnitude and characteristics of the economic burden resulting from acute pesticide poisoning (APP) in South Korea. The total costs of APP from a societal perspective were estimated by summing the direct medical and non-medical costs together with the indirect costs. Direct medical costs for patients assigned a disease code of pesticide poisoning were extracted from the Korean National Health Insurance Reimbursement Data. Direct non-medical costs were estimated using the average transportation and caregiving costs from the Korea Health Panel Survey. Indirect costs, incurred by pre-mature deaths and work loss, were obtained using 2009 Life Tables for Korea and other relevant literature. In 2009, a total of 11,453 patients were treated for APP and 1311 died, corresponding to an incidence of 23.1 per 100,000 population and a mortality rate of 2.6 per 100,000 population in South Korea. The total costs of APP were estimated at approximately US$ 150 million, 0.3% of the costs of total diseases. Costs due to pre-mature mortality accounted for 90.6% of the total costs, whereas the contribution of direct medical costs was relatively small. Costs from APP demonstrate a unique characteristic of a large proportion of the indirect costs originating from pre-mature mortality. This finding suggests policy implications for restrictions on lethal pesticides and safe storage to reduce fatality and cost due to APP.

Cost-Effectiveness of Sertindole among Atypical Antipsychotics in the Treatment of Schizophrenia in South Korea

ObjectivesThis study assessed the cost-effectiveness of sertindole compared with existing atypical antipsychotics in the treatment of patients with schizophrenia in the South Korean setting. MethodsA Markov model was developed to estimate the cost-effectiveness of sertindole compared with risperidone, olanzapine, and quetiapine with a cycle of 6 months on a 5-year time horizon. Effectiveness was defined as the length of time without relapse and quality-adjusted life-years. Parameter estimates including drug-induced adverse events, compliance rate, and relapse rate were based on published literature and clinical trial data. Resource utilization data were obtained from the 2010 National Health Insurance reimbursement data, and costs were estimated from the health care system's perspective. A discount rate of 5% was applied to both cost and effectiveness. One-way sensitivity analyses and probabilistic sensitivity analysis were carried out to check the robustness of the base-case analysis. ResultsThe length of time without relapse was 1.90 years for all study drugs. The estimated quality-adjusted life-years were 1.27 for sertindole, followed by quetiapine, risperidone, and olanzapine. Total costs were 10.51 million Korean won (KRW) for sertindole, 12.86 million KRW for olanzapine, 8.38 million KRW for risperidone, and 8.91 million KRW for quetiapine. The incremental cost-effectiveness ratios showed that sertindole was dominant only over olanzapine and was not cost-effective compared with risperidone and quetiapine. Various sensitivity analyses confirmed the results from the base-case analysis. ConclusionsSertindole may be considered a valuable treatment option for South Korean patients who have failed the therapy with other atypical antipsychotic agents.

Prescriptions of Traditional Chinese Medicine Are Specific to Cancer Types and Adjustable to Temperature Changes

Targeted cancer therapies, with specific molecular targets, ameliorate the side effect issue of radiation and chemotherapy and also point to the development of personalized medicine. Combination of drugs targeting multiple pathways of carcinogenesis is potentially more fruitful. Traditional Chinese medicine (TCM) has been tailoring herbal mixtures for individualized healthcare for two thousand years. A systematic study of the patterns of TCM formulas and herbs prescribed to cancers is valuable. We analysed a total of 187,230 TCM prescriptions to 30 types of cancer in Taiwan in 2007, a year's worth of collection from the National Health Insurance reimbursement database (Taiwan). We found that a TCM cancer prescription consists on average of two formulas and four herbs. We show that the percentage weights of TCM formulas and herbs in a TCM prescription follow Zipf's law with an exponent around 0.6. TCM prescriptions to benign neoplasms have a larger Zipf's exponent than those to malignant cancers. Furthermore, we show that TCM prescriptions, via weighted combination of formulas and herbs, are specific to not only the malignancy of neoplasms but also the sites of origins of malignant cancers. From the effects of formulas and natures of herbs that were heavily prescribed to cancers, that cancers are a ‘warm and stagnant’ syndrome in TCM can be proposed, suggesting anti-inflammatory regimens for better prevention and treatment of cancers. We show that TCM incorporated relevant formulas to the prescriptions to cancer patients with a secondary morbidity. We compared TCM prescriptions made in different seasons and identified temperatures as the environmental factor that correlates with changes in TCM prescriptions in Taiwan. Lung cancer patients were among the patients whose prescriptions were adjusted when temperatures drop. The findings of our study provide insight to TCM cancer treatment, helping dialogue between modern western medicine and TCM for better cancer care.

Taux d’hospitalisation des bénéficiaires de la couverture maladie universelle complémentaire (CMUC) pour des pathologies associées aux immigrants en France en 2009

Complementary Universal Health Insurance (CMUC) which provides free access to health care has been available in France since 2000 for people with an annual income less than 60% of the poverty threshold. Hospitalization rates in 2009 for common diseases among immigrants were compared between beneficiaries of the general scheme under the age of 60 years with (4.5 millions) or without CMUC (34.1 millions) in 2008 and still alive at the end of the year. Data were derived from the French national health insurance reimbursements and short-stay hospital discharge databases. Age - and sex-adjusted hospitalization rates and relative risk significantly greater overall hospitalization rates (17.5% vs 13.2%) (males RR= 2.0, female RR 2.3) and each parasitic diseases (RR = 2.1), which include viral diseases and fevers of unknown origin (1.1/1000, RR =1.6), septicaemia (0.4/1000, RR = 2.2), HIV infection (0.7/1000, RR = 3.5), other infectious and parasitic diseases (0.7/1000, RR= 2.5) and, more precisely, measles (2.7/1000, RR = 5.0). Hospitalization for sickle cell disease (3%, RR = 4.5) were also more frequent as also for lead poisoning (0.12/1000, RR = 5.2). In this low-income population with free access to health care, hospitalizations were higher for many diseases that are targets for prevention and screening actions. This is tha case for immigrant with CMUC coverage arriving in France and when they travel to their country of origin.

Comparison Korean National Health Insurance Reimbursement and Other Guidelines for TNF-α Blocker in Rheumatoid Arthritis

Objective. The aim of this study was to examine how many Korean rheumatoid arthritis (RA) patients fulfilling the 2008 American College of Rheumatology (ACR) recommendation, 2007 British Society for Rheumatology (BSR) guideline and 2010 Japan College of Rheumatology (JCR) guideline for TNF-α blocker, meet the Korean National Health Insurance reimbursement criteria and to evaluate the reasons for failing the Korean National Health Insurance reimbursement criteria. Methods. Data were obtained from a registry of RA patients who visited rheumatology clinics of Hallym university affiliated hospitals. Patients who were previously prescribed with methotrexate or leflunomide for more than 3 months and had at least one DAS28 examination were included in the present study. Results. Of 642 patients included, 118 episodes meeting ACR guideline for using TNF-α blocker were identified in 88 patients (13.7%). In addition, 19 episodes meeting BSR guideline in 17 patients (2.6%) and 21 episodes meeting JCR guideline in 21 patients (6.2%) were identified. Four episodes (4.8%) meeting ACR recommendation, 0 episodes meeting BSR criteria and 5 episodes (12%) meeting JCR criteria, respectively, were eligible for TNF-α blocker according to the Korean National Health Insurance reimbursement guideline. The most common reason for failing the Korean National Health Insurance reimbursement criteria was the number of active joint counts (92.6%). Conclusion. Our results show that the majority of RA patients satisfying the ACR guideline, BSR and JCR guideline for use of the TNF-α blocker did not meet the Korean National Health Insurance reimbursement criteria. Patients most often failed due to active joint count criteria.

An investigation of the use of traditional chinese medicine in stroke patients in taiwan.

Background. The use of complementary and alternative medicine in critical illness is increasing worldwide. This study investigates how traditional Chinese medicine (TCM) is used in stroke patients. Methods. Using Taiwan National Health Insurance reimbursement claims, we compared the annual use of TCM between stroke patients and general population, identifying 15,330 patients with a new onset of stroke in 2000–2009. The sociodemographic status and medical comorbidities between stroke patients receiving TCM services and those without using the service were compared. Results. The use of TCM was higher in stroke patients than in the general population, 27.9% versus 25.4% in 2000 and 32.7% versus 27.8% in 2009, respectively, and grew consistently from 2000 to 2009. Among stroke patients, women, younger patients, white-collar employees, higher-income residents, and those living in areas with more TCM physicians were more likely to use TCM. Stroke patients using rehabilitation services were more likely to have more TCM visits (OR = 2.28, 95% CI = 1.96–2.66) and higher expenditure on TCM (OR = 2.67, 95% CI = 2.29–3.12) compared with stroke patients without rehabilitation. Conclusion. TCM is popular and well accepted in Taiwan. Patients with stroke have a higher TCM utilization rate than people without stroke.

Use of chinese medicine and subsequent surgery in women with uterine fibroid: a retrospective cohort study.

Background. Chinese medicine (CM) has been used to relieve symptoms relevant to uterine fibroids. Objective. This study investigated the association between the use of CM and the incidence of uterine surgery in women with uterine fibroids. Subjects and Methods. This retrospective cohort study extracted records for 16,690 subjects diagnosed with a uterine fibroid between 2000 and 2003 from the National Health Insurance reimbursement database. The risk factors for surgery were examined via Cox proportional hazard analysis, and the difference in incidence of surgery between CM users and nonusers was compared using incidence rate ratios (IRRs) derived from Poisson's models. Results. After an average follow-up period of 4.5 years, the cumulative incidence of uterine surgery was significantly lower in CM users than CM nonusers (P < 0.0001). Compared to CM nonusers, CM users were more unlikely to undergo uterine surgery (adjusted hazard ratio = 0.18, 95% confidence interval (CI) = 0.17, 0.19). The incidence of surgery in CM users was dramatically different from that for CM nonusers (IRR = 0.17, 95% CI = 0.16, 0.18). Conclusion. The risk of uterine surgery among fibroid patients who used CM was significantly decreased, implying an effective treatment of fibroid-related symptoms provided by CM.

Completeness and timeliness of tuberculosis notification in Taiwan

Tuberculosis (TB) is a notifiable disease by the Communicable Disease Control Law in Taiwan. Several measures have been undertaken to improve reporting of TB but the completeness and timeliness of TB notification in Taiwan has not yet been systemically evaluated.MethodsTo assess completeness and timeliness of TB notification, potential TB cases diagnosed by health care facilities in the year 2005-2007 were identified using the reimbursement database of national health insurance (NHI), which has 99% population coverage in Taiwan. Potential TB patients required notification were defined as those who have TB-related ICD-9 codes (010-018) in the NHI reimbursement database in 2005-2007, who were not diagnosed with TB in previous year, and who have been prescribed with 2 or more types of anti-TB drugs. Each potential TB case was matched to the national TB registry maintained at Taiwan Centers for Disease Control (CDC) by using national identity number or, if non-citizen, passport number to determine whether the patients had been notified to local public health authorities and Taiwan CDC. The difference in the number of days between date of anti-tuberculosis treatment and date of notification was calculated to determine the timeliness of TB reporting.ResultsOf the 57,405 TB patients who were prescribed with 2 or more anti-tuberculosis drugs, 55,291 (96.3%) were notified to National TB Registry and 2,114 (3.7%) were not. Of the 55,291 notified cases, 45,250 (81.8%) were notified within 7 days of anti-tuberculosis treatment (timely reporting) and 10,041(18.2%) after 7 days (delayed reporting). Factors significantly associated with failure of notification are younger age, previously notified cases, foreigner, those who visited clinics and those who visited health care facilities only once or twice in 6 months.ConclusionA small proportion of TB cases were not notified and a substantial proportion of notified TB cases had delayed reporting, findings with implication for strengthening surveillance of tuberculosis in Taiwan. Countries where the completeness and timeliness of TB notification has not yet been evaluated should take similar action to strengthen surveillance of TB.

Economic benefits of sponsored clinical trials on pharmaceutical expenditures at a medical center in Taiwan

Concerns exist regarding the additional cost of patient care when patients are enrolled in clinical trials at hospitals. To assess the avoidance of drug costs by conducting sponsored clinical trials, a retrospective analysis evaluating drug cost avoidance in all sponsored clinical trials was conducted in 2008 at the most prominent medical center in Taiwan. The National Health Insurance (NHI) reimbursement prices of either the investigated drugs or the standardized drug therapy for each specific disease were used to calculate the cost avoidance. Drug cost avoidance from sponsored clinical trials per year, per trial, per patient, in different therapeutic areas, and in different phases was analyzed. Three quarters of the cost avoidance in drug expenditures from 194 sponsored clinical trials were estimated. All cost values are in US Dollars. Around $11.2 million was avoided at the center in 2008. The average value of cost avoidance was $58,000/trial-year or $3900/participant-year. The early-phase trials and phase III trials accounted for 25% and 56% of all trials, respectively, while they constituted 32% and 49% of the total costs avoided, respectively. The most frequently conducted and highest cost-avoiding trials were those for antineoplastic agents, especially targeted therapy which accounted for 85% of the total cost avoidance of anti-cancer trials. This study demonstrates the profoundly positive economic impact on the healthcare system in Taiwan by sponsored clinical trials. To understand the trend of economic benefits of the trials on pharmaceutical expenditure, it would be important to analyze the cost avoidance of trials regularly in an institution.

Feedback and lessons from the prescription of rimonabant, a drug to be used under strict guidelines, in southeastern France, March 2007 through June 2008

Background To provide feedback on the initial market authorization of rimonabant, a drug to be used under strict guidelines, we conducted a study with information from the National health insurance reimbursements database for southeastern France. The aims of this study were to: (1) describe the characteristics of subjects who have had one rimonabant prescription reimbursed; (2) study the frequency of prescriptions that did not comply with reimbursement criteria; (3) study the frequency of prescriptions for patients simultaneously treated with antidepressants; and (4) analyse the factors associated with both types of prescription (patient and prescriber characteristics). Methods Using the database of drug reimbursements maintained by the southeastern France general health insurance fund, we studied the characteristics of outpatients with at least one reimbursement for rimonabant, compared them to the rest of the population, and analysed compliance with the indications, contraindications, and regulations for rimonabant prescription with multivariate logistic regressions. Results A total of 10,510 beneficiaries (0.28%) had at least one rimonabant reimbursement. Among them, 55.7% were treated for diabetes. For at least 62.4% of rimonabant beneficiaries, the reimbursement regulations were not respected: this was significantly more frequent among women less than 57 years old, subjects with no chronic diseases, and when the prescriber was not an endocrinologist; 11.4% of rimonabant beneficiaries also received an antidepressant treatment. Conclusion Despite the specific status of rimonabant regarding its reimbursement modalities, these results suggest that some prescribers get around reimbursement instructions and that a significant percentage of prescriptions did not respect an important contraindication. Tools to follow up the prescriptions of new drugs with strict guidelines for use should be developed and physicians should be better informed and trained regarding specific prescription regulations.