欧盟《患者跨境医疗权利指令》实施及其借鉴

提升欧盟成员国卫生体系的协同效应,解决共同面临的健康挑战,是欧盟卫生体系一体化发展的重要目标。2013年10月,欧盟所有成员国通过了《患者跨境医疗权利指令》的法律,并在全欧盟范围内正式生效并实施。该指令针对患者的权利做了一些调整,扩大了医疗服务范围,提出了报销原则、成员国职责和创新性措施,如,建立国家联系点,改善各国电子医疗系统,促进各国卫生技术评估,促进各国医疗产品使用和处方的互认,以及促进开发和建立欧洲参考网络等。该指令旨在通过促进成员国合作组织和提供医疗服务,为欧盟公民提供安全、高质的跨境医疗服务。中国与欧盟社会管理体系虽然不同,但该法令在立法过程、实施原则和具体措施等方面,对我国正在实施的医药卫生体制改革有所借鉴。     

Healthcare utilization changes in relation to treatment intensification with insulin aspart in patients with type 2 diabetes. Data from a large US managed-care organization

ABSTRACT

Objective: Most patients with type 2 diabetes eventually require exogenous insulin therapy to achieve good glycemic control due to the progressive nature of the disease. Insulin aspart is a rapid-acting insulin analog developed for prandial use. This study aimed to illustrate the implications on healthcare costs of adding insulin aspart to basal therapy in a real-world setting.

Methods: Patients with type 2 diabetes who intensified previous basal therapy with insulin aspart were identified from a large commercial US healthcare data source between April 2007 and September 2008. Patients were required to have received basal insulin treatment with or without concomitant oral antidiabetic (OAD) therapy for at least 90 days pre- and post-initiation of insulin aspart. Wilcoxon signed-rank test and McNemar's test were used for continuous and categorical variables, respectively, to analyze the difference of self-comparison between pre- and post insulin aspart add-on.

Results: In total, 1,739 patients with an average age of 56 years were identified, of whom 55% were male. After initiation of insulin aspart, a significant improvement in glycemic control was observed (change in HbA_1c: –0.5%, p=0.0013). Similarly, a reduction of 0.4% in HbA_1c was observed for the subpopulation of 151 patients, who had both pre-and post-index HbA_1c data (p=0.0085). Also, significantly fewer patients used OADs after insulin aspart initiation (56 vs. 64%, p< 0.0001). Overall and diabetes-related healthcare costs also significantly decreased by $2,283 and $2,028, respectively (p≤0.0001). Diabetes-related inpatient visits appear to be the main contributor to total cost (46%); however, after initiation of insulin aspart the number of inpatient visits decreased by 0.50 visits/patient/year (p< 0.05). This decrease was reflected in a large reduction in cost related to inpatient visits ($3,019/patient).

Limitations: A regression to the mean effect may be associated with this pre-post comparison. The ability to make conclusions regarding cause and effect may be limited due to the retrospective design of this study.

Conclusions: Patients with type 2 diabetes achieved better glycemic control and needed less OAD treatment after adding insulin aspart to previous basal therapy. Furthermore, patients experienced on average reduced healthcare utilization after initiation of insulin aspart, which resulted in significant cost savings.     

Cost of fractures commonly associated with osteoporosis in a managed-care population

Objective: To examine direct costs of hip, vertebral, and non-hip non-vertebral (NHNV) fractures, and to estimate the rate of osteoporosis (OA) diagnosis and treatment in the fracture population.

Methods: Subjects ≥ 45 years with a new hip, vertebral, or NHNV fragility (closed) fracture between June 30, 2002 and June 30, 2006 were studied retrospectively. All-cause and fracture-specific medical costs were calculated from medical claims in the 12-month baseline and follow-up periods. Total healthcare costs included pharmacy and medical costs. Diagnosis for OA and OA treatment were identified in both the baseline and follow-up period from diagnosis codes on medical claims for OA, and from pharmacy claims for treatment. Analyses were performed separately for commercial (COM) and Medicare Advantage (MA) populations and stratified by fracture type. Generalized linear models were estimated for total follow-up healthcare cost.

Results: The study sample included 36,521 COM and 10,160 MA subjects. Hip fracture subjects had the highest follow-up medical costs in unadjusted and adjusted analyses (COM: mean $35,898; median $22,945; MA: mean $32,919; median $26,047). Follow-up costs were much higher than baseline costs. Fracture-related costs accounted for a large proportion of follow-up medical costs. Although rates of osteoporosis diagnosis and treatment increased from baseline to follow-up, the majority of both COM and MA subjects had no evidence of osteoporosis diagnosis or treatment in either period.

Conclusions: Despite limitations of this study, including conventional generalizability issues, and sensitivity and specificity of claims-based diagnoses, results are consistent with other research and provide compelling results of substantial cost burden of fractures related to osteoporosis. Low rates of osteoporosis diagnosis and treatment among patients with costly fragility fractures underscore the opportunity for managed care organizations to initiate comprehensive disease management programs in osteoporosis.     

Antiepileptic drug treatment patterns and economic burden of commercially-insured patients with refractory epilepsy with partial onset seizures in the United States

Abstract

Objective:

To assess the economic burden in direct healthcare utilization and costs for refractory epileptic patients with partial onset seizures (POS) and assess the antiepileptic drug (AED) treatment patterns among these patients.     

An organizational culture for all seasons? How cultural type dominance and strength influence different performance goals

Organizational culture might influence results, especially in public healthcare organizations characterized by strong professional control. This study investigates whether a specific culture type is most effective in fostering performances. We assess organizational culture through Competing Values Framework and use multivariate regression analysis to test the relationship between dominant culture and competitiveness and financial results. Based on 529 responses from senior managers of 59 organizations, we found that dominant rational and hierarchical culture types are associated, respectively, with higher competitiveness and better financial results. Enhancing a specific performance dimension might require cultural changes aimed to align values with targeted results.     

Medical costs in patients with heart failure after acute heart failure events: one-year follow-up study

Aims: This study investigated annual medical costs using real-world data focusing on acute heart failure.

Methods: The data were retrospectively collected from six tertiary hospitals in South Korea. Overall, 330 patients who were hospitalized for acute heart failure between January 2011 and July 2012 were selected. Data were collected on their follow-up medical visits for 1 year, including medical costs incurred toward treatment. Those who died within the observational period or who had no records of follow-up visits were excluded. Annual per patient medical costs were estimated according to the type of medical services, and factors contributing to the costs using Gamma Generalized Linear Models (GLM) with log link were analyzed.

Results: On average, total annual medical costs for each patient were USD 6,199 (±9,675), with hospitalization accounting for 95% of the total expenses. Hospitalization cost USD 5,904 (±9,666) per patient. Those who are re-admitted have 88.5% higher medical expenditure than those who have not been re-admitted in 1 year, and patients using intensive care units have 19.6% higher expenditure than those who do not. When the number of hospital days increased by 1?day, medical expenses increased by 6.7%.

Limitations: Outpatient drug costs were not included. There is a possibility that medical expenses for AHF may have been under-estimated.

Conclusion: It was found that hospitalization resulted in substantial costs for treatment of heart failure in South Korea, especially in patients with an acute heart failure event. Prevention strategies and appropriate management programs that would reduce both frequency of hospitalization and length of stay for patients with the underlying risk of heart failure are needed.     

Treatment patterns,healthcare resource utilization,and costs in patients with acute myeloid leukemia in commercially insured and Medicare populations

Objective: To describe the setting, duration, and costs of induction and consolidation chemotherapy for adults with newly-diagnosed acute myeloid leukemia (AML), who are candidates for standard induction chemotherapy, in the US.

Methods: Adults newly-diagnosed with AML who received standard induction chemotherapy in an inpatient setting were identified from the Truven Health Analytics MarketScan (2006–2015) and SEER-Medicare (2007–2011) databases. Patients were observed from induction therapy start to the first of hematopoietic stem cell transplant, 180 days after induction discharge, health plan enrollment/data availability end, or death. Induction and consolidation chemotherapy were identified using Diagnosis-Related Group codes (chemotherapy with acute leukemia) or procedure codes for AML chemotherapy administration. AML treatment episode setting (inpatient or outpatient), duration, and costs (2015 USD, payers’ perspective) were described for commercially insured patients and Medicare beneficiaries.

Results: In total, 459 commercially insured patients and 563 Medicare beneficiaries (mean age?=?54 and 66 years; 53% and 54% male; respectively) were identified. For induction therapy, mean costs were $145,189 for commercially insured patients and $85,734 for Medicare beneficiaries, and median inpatient duration was 31 days (both). Following induction, 64% of commercially insured patients and 53% of Medicare beneficiaries had ≥1 consolidation cycle; 75% and 65% of consolidation cycles were in an inpatient setting, respectively. For consolidation cycles, in the inpatient setting, mean costs were $28,137 for commercially insured patients and $28,843 for Medicare beneficiaries, median cycle duration was 6 days (both); in the outpatient setting, mean costs were $11,271 for commercially insured patients and $5,803 Medicare beneficiaries, median duration was 5 days (both).

Limitations: Granular information on chemotherapy type administered was unavailable.

Conclusions: This is the first exploratory study providing a complete picture of recent AML treatment patterns and management costs among commercially insured patients and Medicare beneficiaries. There is substantial heterogeneity in the management and costs of AML.     

Cost-effectiveness of Access to Critical Cerebral Emergency Support Services (ACCESS): a neuro-emergent telemedicine consultation program

Aims: Access to Critical Cerebral Emergency Support Services (ACCESS) was developed as a low-cost solution to providing neuro-emergent consultations to rural hospitals in New Mexico that do not offer comprehensive stroke care. ACCESS is a two-way audio-visual program linking remote emergency department physicians and their patients to stroke specialists. ACCESS also has an education component in which hospitals receive training from stroke specialists on the triage and treatment of patients. This study assessed the clinical and economic outcomes of the ACCESS program in providing services to rural New Mexico from a healthcare payer perspective.

Methods: A decision tree model was constructed using findings from the ACCESS program and existing literature, the likelihood that a patient will receive a tissue plasminogen activator (tPA), cost of care, and resulting quality adjusted life years (QALYs). Data from the ACCESS program includes emergency room patients in rural New Mexico from May 2015 to August 2016. Outcomes and costs have been estimated for patients who were taken to a hospital providing neurological telecare and patients who were not.

Results: The use of ACCESS decreased neuro-emergent stroke patient transfers from rural hospitals to urban settings from 85% to 5% (no tPA) and 90% to 23% (tPA), while stroke specialist reading of patient CT/MRI imaging within 3?h of onset of stroke symptoms increased from 2% to 22%. Results indicate that use of ACCESS has the potential to save $4,241 ($3,952–$4,438) per patient and increase QALYs by 0.20 (0.14–0.22). This increase in QALYs equates to ～73 more days of life at full health. The cost savings and QALYs are expected to increase when moving from a 90-day model to a lifetime model.

Conclusion: The analysis demonstrates potential savings and improved quality-of-life associated with the use of ACCESS for patients presenting to rural hospitals with acute ischemic stroke (AIS).     

Healthcare resource utilization with ixazomib or placebo plus lenalidomide-dexamethasone in the randomized,double-blind,phase 3 TOURMALINE-MM1 study in relapsed/refractory multiple myeloma

Aims: The aim of this analysis was to assess healthcare resource utilization in the pivotal phase 3 TOURMALINE-MM1 study of the oral proteasome inhibitor ixazomib or placebo plus lenalidomide and dexamethasone (Rd) in relapsed and/or refractory multiple myeloma (RRMM).

Methods: In this double-blind, placebo-controlled, randomized study (NCT01564537), 722 patients with RRMM following 1–3 prior lines of therapy received Rd plus ixazomib (ixazomib-Rd; n?=?360) or matching placebo (placebo-Rd; n?=?362) until disease progression or unacceptable toxicity. Healthcare resource utilization data were captured on Day 1 of each 28-day cycle, every 4 weeks during follow-up for progression-free survival, and every 12 weeks during subsequent follow-up, and included medical encounters (length of stay, inpatient, outpatient, and reason) and number of missing days from work or other activities for patients and caregivers.

Results: Exposure-adjusted rates of hospitalization were similar between the ixazomib-Rd and placebo-Rd arms, at 0.530 and 0.564 per patient year (ppy), respectively, as were outpatient visit rates (3.305 and 3.355 ppy). Mean length of hospitalization per patient was 10.0 and 10.8 days, respectively. In both arms, hospitalization and outpatient visit rates were higher in patients with two or three prior lines of treatment (ixazomib-Rd: 0.632 and 3.909 ppy; placebo-Rd: 0.774 and 3.539 ppy) compared with patients with one prior line (ixazomib-Rd: 0.460 and 2.888 ppy; placebo-Rd: 0.436 and 3.243 ppy). Patients and their caregivers who missed any work or other activity missed a median of 7 and 5 days in the ixazomib-Rd arm, respectively, vs 8 and 4 days with placebo-Rd.

Limitations: The study was not powered for a statistical comparison of healthcare resource utilization between treatment arms, nor did it capture costs associated with utilization of the identified healthcare resources.

Conclusions: This pre-specified analysis demonstrated that the all-oral triplet regimen of ixazomib added to Rd did not increase healthcare resource utilization compared with placebo-Rd.