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Background: Immunotherapies and targeted therapies have drastically improved survival in metastatic melanoma, but they can cause a range of adverse events (AEs). Understanding the costs of these events would facilitate an accurate comparison of melanoma treatments.

Objective: To compare the costs and frequency of AEs associated with immunotherapy and with targeted therapy in elderly patients with metastatic melanoma.

Methods: We conducted a retrospective cohort study using Medicare claims data from 2011 to 2014. Patients included had to have ≥1 diagnoses of metastatic melanoma and ≥1 claims for an immunotherapy or targeted therapy. We compared the 30-day expenditures of patients with and without each AE using a generalized linear model to determine the incremental cost per AE in patients who received immunotherapy or targeted therapy. The baseline demographic and clinical differences were adjusted for using propensity score with inverse probability of treatment. We also compared the mean costs of AEs associated with immunotherapy and targeted therapy.

Results: A total of 844 patients were included in the study (mean age, 75 years; standard deviation, 14 years). The mean baseline Charlson Comorbidity Index score was 8.4, and 65% of the patients were male. The mean cost for AEs was highest for respiratory events (ie, $24,150). Gastrointestinal, respiratory, and hematologic AEs were more common in patients who received immunotherapy, whereas general and administration-site AEs and other AEs (eg, fatigue, infections, muscular weakness) were more frequent in patients who received targeted therapy. AE-related costs with immunotherapy were highest for gastrointestinal, respiratory, and pain-related AEs; AEs with targeted therapy were highest for cardiovascular and general and administration-site events.

Conclusion: These findings suggest that incremental costs associated with treatment-related AEs among elderly patients with metastatic melanoma were substantial, but the risks for and costs of the various types of AEs differed by therapy. Understanding the risks for and costs of AEs associated with the various therapeutic options can inform treatment decision-making in elderly patients with metastatic melanoma.

Background: Alternative payment models (APMs) in healthcare are emerging that reward quality of care over quantity of services. Most bundled payment programs that are described in published studies are related to episodes for a surgical inpatient hospital stay. With outpatient services, monthly capitated payments are an alternative to bundled payments for specialty services.

Objective: To assess the association of a capitated contractual arrangement between a primary care physician group and an oncology clinic group with the quality of care received.

Methods: We evaluated the effect of an oncology group's transition from a fee-for-service (FFS) arrangement to a partial-capitated-payment model with a primary care group. We compared outcomes for patients who received treatment after implementation of the new arrangement (ie, postcontract capitated group) with outcomes of patients receiving treatment before the change (ie, precontract capitated group). In addition, we conducted a parallel analysis of patients from a population that was not affected by the contract to assess temporal effects (ie, postcontract FFS group vs precontract FFS group). All patients were enrolled in Medicare Advantage plans of a single health plan (ie, Humana), and outcomes were measured using claims data provided by that company. Patients in the 2 precontract groups received treatment between July 1, 2010, and June 30, 2011; patients in the 2 postcontract groups received treatment between January 1, 2013, and December 31, 2013. Age- and sex-adjusted all-cause hospitalization, complications from cancer treatment, and ambulance transfers during 6 months of follow-up were evaluated.

Results: In the population subject to the partial-capitated-payment model, the postcontract group (N = 305) was younger than the precontract group (N = 165). In a subset of patients in the 2 capitated groups who had Deyo-Charlson Comorbidity Index (CCI) RxRisk scores, the postcontract capitated group had significantly higher CCI scores. Adjusted odds ratios for the postcontract capitated group versus the precontract capitated group showed no difference in the likelihood that any of the outcomes would occur. However, the mean number of chemotherapy-related complications and ambulance transports were greater postcontract. In the parallel analysis of the population not affected by the new payment arrangement, no differences were found between the pre- and postcontract groups. This suggests that temporal changes potentially affecting patients in the capitated and FFS populations would not have influenced postcontract outcomes.

Conclusions: After the implementation of partial-capitated payments for medical oncology services in the oncology practice, the likelihood of a patient experiencing at least 1 event of a specific adverse outcome did not change; however, the average number of some advers

Background: Diabetes is associated with substantial clinical and economic burdens on patients and on the US healthcare system. Treatment options for patients with type 1 or type 2 diabetes have increased significantly, from only 3 drug classes in 1995 to more than 12 distinct classes today. Although several of the newer treatments are reported to have improved efficacy and safety profiles, they are often substantially more costly than older medications. Consequently, as drug options increase, the cost of diabetes management continues to grow.

Objectives: To estimate the annual real-world costs of type 1 and 2 diabetes, as well as diabetes prevalence, treatment patterns, care quality, and resource utilization during 8 years.

Methods: In this cross-sectional study, we examined 8 annual cohorts of patients with type 1 or type 2 diabetes, on a biennial basis, using claims data from the HealthCore Integrated Research Database between 2006 and 2014. Patients were matched with controls by age, sex, residency, and health plan type. We assessed the prevalence of diabetes, treatment patterns, care quality measures, and all-cause and diabetes-related healthcare costs using 2 methods. Method 1 calculated the annual costs as the difference in all-cause costs between patients with diabetes and matched controls. Method 2 calculated the costs for healthcare encounters based on specific codes for a diabetes diagnosis or for antidiabetes medications.

Results: Between 346,486 and 410,234 patients with type 2 diabetes and between 21,176 and 26,228 patients with type 1 diabetes were included in each study year cohort. Between 2007 and 2014, the prevalence of type 2 diabetes increased from 4.9% to 6.3%. The costs associated with using Method 1 were almost double the cost estimates in Method 2 during most of the study period. For patients with type 1 diabetes, the associated costs were twice greater with Method 1 than with Method 2. Projections to the entire US population in 2014 indicated a total of 19.3 million individuals with diabetes and associated direct costs of $314.8 billion that year.

Conclusion: Cost estimates can guide the prioritization of healthcare expenditures. The results of this study showed that costs attributable to diabetes differed by approximately 2-fold, depending on the estimation method. The management of the escalating expenses for diabetes management in the United States requires judicious selection of the methods for estimating costs.

Background: Fibromyalgia is a chronic condition characterized by widespread pain, fatigue, and sleep disturbances that affects approximately 2% to 4% of the adult population in the United States, with minimal real-world data related to the use of medications and associated dosages for this condition.

Objective: To analyze the real-world dosing patterns of the 3 medications approved by the US Food and Drug Administration for fibromyalgia-pregabalin, duloxetine, and milnacipran.

Methods: Using QuintilesIMS' (now IQVIA) electronic medical record data linked to administrative claims, we identified adults with fibromyalgia who were newly prescribed pregabalin, duloxetine, or milnacipran between January 1, 2006, and December 31, 2014. We summarized and compared the starting and maximum doses with United States prescribing information (USPI) dosing recommendations.

Results: In all, 1043 patients who were receiving pregabalin, 1281 receiving duloxetine, and 326 patients receiving milnacipran with similar age and comorbidity profiles were included in the study. The mean starting dose was 176 mg daily, 56 mg daily, and 95 mg daily for pregabalin, duloxetine, and milnacipran, respectively. More patients receiving pregabalin (35%) had a starting dose lower than recommended compared with patients receiving duloxetine (7%) or milnacipran (17%; P <.0001). Of the patients who received pregabalin, 27% had USPI-recommended maintenance dosing versus 91% of patients who received duloxetine and 80% who received milnacipran (P <.0001). The mean duration of treatment was longer for duloxetine (205 days; P <.0001) than for pregabalin (167 days) and milnacipran (167 days). The duration of using the maximum dose of each medication as a percentage of the total time of medication use was 77% for pregabalin, 84% for duloxetine, and 90% for milnacipran (P <.0001).

Conclusions: Patients using pregabalin were the most likely of the 3 cohorts to receive lower than label-recommended starting doses and the least likely to receive the recommended maintenance doses during follow-up compared with those receiving duloxetine or milnacipran. Real-world prescribing patterns indicate that factors other than label recommendations may be influencing prescribed dosing.

Background: Smoking remains the single largest preventable cause of death and disease. Smoking-cessation medications provide patients a multitude of benefits and can prevent certain diseases, including some cancers. Because of the limited amount of studies on smoking-cessation medications, we wanted to find general trends about the use of these medications.

Objective: To examine trends in the utilization, pharmacy reimbursement, and prices of smoking-cessation medications and nicotine replacement therapy in the US Medicaid-covered population.

Methods: Using national summary files for outpatient drug utilization and expenditure, we extracted data on smoking-cessation medications from the Centers for Medicare & Medicaid Services in the 25 years from January 1991 through June 2015. We conducted a retrospective drug utilization study to examine the annual (or quarterly) trends of the number of prescriptions, reimbursement expenditures, and the prices of smoking-cessation medications. The study drugs included varenicline (Chantix), bupropion (Zyban), and nicotine. We calculated per-prescription pharmacy reimbursement, which was used as a proxy for drug price, as the total quarterly expenditure for the drug, divided by the total number of prescriptions. All expenditures were inflated to 2015 US dollars using the medical services component of the Consumer Price Index.

Results: The total number of prescriptions for smoking-cessation medications increased rapidly from 46,396 in 1991 to 942,562 in 2014, an increase of more than 1931%. During the same period, the total pharmacy reimbursement for smoking-cessation medications in Medicaid increased by 3562%, from approximately $2.8 million in 1991 to approximately $101 million in 2014. The use of the nonnicotine prescription drugs varenicline and bupropion also increased rapidly, with a high cost expenditure. The price per nonnicotine prescription drug increased over time, ranging from approximately $169 for bupropion to approximately $251 for varenicline in 2015.

Conclusions: The substantial increase in nonnicotine prescription drugs and nicotine replacement therapy between 2007 and 2015 may be attributed to smoking-cessation participants nationwide. Cost-containment policies might have inadvertently prevented Medicaid-covered smokers from obtaining appropriate pharmacotherapy.

Background: Hemodialysis is a procedure that requires efficient removal and return of blood to a patient's body. Despite being a life-sustaining process, hemodialysis is associated with morbidity, mortality, and high societal costs. A significant part of the financial costs to patients and society at large can be attributed to vascular access dysfunction. The cornerstone to efficient hemodialysis is a well-functioning vascular access that simultaneously allows efficient blood flow for dialysis and easy cannulation. It is hypothesized that the poor health outcomes associated with vascular access dysfunction can be improved by paying closer attention to patient-specific factors in clinical guidelines for hemodialysis vascular access. This may require a shift to a more patient-centered approach to vascular access management.

Objective: To assess the presence of patient-specific treatment recommendations in the current clinical practice guidelines for hemodialysis vascular access.

Methods: We conducted a systematic search of PubMed and professional nephrology organization websites for full-text clinical practice guidelines with treatment recommendations regarding hemodialysis vascular access. We developed a coding sheet to document the number of patient-specific treatment recommendations and other quality attributes found in the extracted clinical practice guidelines.

Results: Our search resulted in the extraction of 5 clinical practice guidelines for final review. Only 1 of the 5 extracted guidelines was found to contain patient-specific treatment recommendations, but the treatment recommendations were limited to juvenile patients. Of the 5 clinical practice guidelines, 4 were published within the past decade (ie, after 2006).

Conclusion: Our findings show that current clinical practice guidelines for hemodialysis vascular access lack patient-specific recommendations. Future clinical guidelines must consider patient-specific treatment recommendations with the goal of improving hemodialysis vascular access outcomes for patients, a goal that is supported in the recommendations of the National Kidney Foundation.

Background: Vedolizumab is a biologic drug approved by the US Food and Drug Administration (FDA) for the treatment of adults with moderately to severely active Crohn's disease (CD) or ulcerative colitis (UC) who have had inadequate response to, lost response to, or were intolerant of immunomodulators or tumor necrosis factor (TNF) blocker therapy, or who had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroid therapy. The biologics approved by the FDA for CD and/or UC include adalimumab, infliximab, golimumab, certolizumab, and ustekinumab.

Objective: To assess the budget impact of including vedolizumab in a health plan formulary among current options as a preferred first-line biologic therapy for UC and CD rather than only for patients who failed anti-TNF therapy.

Methods: We developed a 3-year budget impact model for a 1-million-member health plan. Comparators included all currently approved brand-name biologic and biosimilar agents for the treatment of UC (ie, adalimumab, infliximab, and golimumab) and CD (ie, adalimumab, certolizumab, infliximab, and ustekinumab). Clinical inputs included therapy response probabilities, disease remission, and surgery risk. Given the lack of head-to-head clinical trials, we estimated indirect comparisons of treatment efficacy based on clinical trial data using the Bucher method. The drug and medical costs were obtained from published literature. The model compared hypothetical health plan costs for 2 scenarios-(1) a market mix with vedolizumab included on the formulary with currently existing first- and second-line preferred treatments, and (2) vedolizumab included only with existing preferred second-line treatments on the hypothetical formulary. These scenarios were compared in the context of 3 hypothetical health plan formulary cases.

Results: Including vedolizumab in a hypothetical formulary with currently preferred first-line biologic treatment options (Scenario 1) resulted in cost-savings compared with vedolizumab as a preferred second-line biologic option (Scenario 2). The total cost-savings were from $0.13 million to $1.63 million in year 1, and from $0.38 million to $4.68 million in year 3. The per-member per-month cost-savings were from $0.01 to $0.14 in year 1 and from $0.03 to $0.39 in year 3.

Conclusion: Based on our model's results, including vedolizumab among the current health plan formulary biologic options as a preferred first-line treatment for UC and CD can result in substantial cost-savings compared with including vedolizumab as a preferred second-line treatment only.

Background: Concern over amniotic fluid leakage is common among pregnant women. Uncertainty about prelabor rupture of amniotic membranes (PROM) can lead women to present to emergency departments or to labor and delivery units for medical evaluation. Many of such visits do not result in delivery, yet they carry significant, and potentially unnecessary, healthcare expenditures.

Objective: To estimate the prevalence and payer cost of potentially avoidable visits by pregnant women to an emergent care facility (including emergency departments, labor and delivery units, or observation units) for suspected PROM.

Methods: This study included 2 processes-an electronic medical records chart review and a commercial health insurance claims data analysis. The medical chart review included 843 scheduled and 1250 unscheduled pregnancy-related visits at Robert Wood Johnson University Hospital between January 4 and June 30, 2017, which was conducted to determine the rates of visits by pregnant women with suspected PROM and their results (ie, hospital admission or discharge). In addition, we performed a retrospective analysis of medical claims data from the Truven Health MarketScan Commercial Database to measure population-level incidence rates and the costs of pregnancy-related emergent care visits for suspected PROM.

Results: Of the 1250 unscheduled visits reviewed, 663 did not result in delivery; of these, 68 had a primary complaint of suspected PROM, and 55 (81%) of them were discharged with PROM ruled out. Of all scheduled and unscheduled nondelivery visits (N = 1069), 5.1% (N = 55) were associated with suspected PROM but were discharged home with PROM ruled out. In the commercial claims analysis, the average rate of emergent care visits by pregnant women was 436.69 per 1000 deliveries, with an estimated average cost of $1428 per visit (in 2018 dollars), or $0.58 per member per month. Applying the rates from our chart review to the claims data, we estimated that commercial insurers pay, on average, for approximately 22.47 facility visits per 1000 deliveries for suspected and ruled-out PROM.

Conclusions: Our findings suggest that for most PROM cases that do not result in delivery, PROM is ruled out and patients are sent home. Reducing the number of PROM-related visits to emergent care facilities that result in ruled-out PROM could reduce healthcare costs and help patients and providers avoid these inconvenient visits.