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Background: Limited published information exists that compares the costs of metastatic prostate cancer with nonmetastatic prostate cancer. Although most research has focused on the costs of metastatic prostate cancer, delaying metastases in patients with nonmetastatic prostate cancer can reduce or delay healthcare resource utilization and any associated expenditures.

Objective: To compare the costs and healthcare resource utilization of patients with metastatic or nonmetastatic prostate cancer who were receiving care in an inpatient or an outpatient hospital setting.

Methods: Claims from between June 2010 and September 2016 of patients with metastatic or nonmetastatic prostate cancer were retrospectively identified from the Premier Healthcare Database. Patients with a primary diagnosis of malignant neoplasm of the prostate in the inpatient or outpatient setting during the study period were included. Admissions were categorized as metastatic or nonmetastatic prostate cancer based on the presence or absence of an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) and/or ICD-10-CM code for metastatic prostate cancer on discharge. Patients with a secondary diagnosis of distant skeletal, lymph node, or visceral metastasis or who received ≥1 treatments indicative of bone metastasis on the same admission were considered to have metastatic prostate cancer.

Results: The study included prostate cancer admissions totaling 78,667 inpatient (4576 with metastatic disease) and 874,366 outpatient (71,545 with metastatic disease) admissions. Among the metastatic prostate cancer inpatient admissions, 72.6% of the patients were aged ≥65 years (mean age, 72 years for metastatic disease vs 63 years for nonmetastatic disease) and approximately 77.5% of these patients had bone metastases. The mean total cost per inpatient admission was $12,324 (standard deviation [SD], $13,506) for metastatic prostate cancer versus $10,987 (SD, $6912) for nonmetastatic disease. The mean total cost per outpatient admission was $1627 (SD, $6182) for metastatic versus $909 (SD, $3458) for nonmetastatic prostate cancer.

Conclusions: The results of this study demonstrate the increased economic burden associated with hospital admissions, particularly inpatient admissions, for patients with metastases compared with patients without metastases. In addition to the clinical burden on patients, these findings further highlight the importance of implementing treatment strategies that can delay progression to metastatic prostate cancer and subsequent increases in healthcare resource utilization and cost.

Background: Primary immune-deficiency disease (PIDD) is a rare, debilitating disease of the immune system that predisposes the affected individual to infection, autoimmune conditions, and neoplasm. A major component of the cost of treating PIDD is the high price of immunoglobulin drugs, which can be administered via an intravenous (IV) or subcutaneous (SC) route.

Objective: To compare real-world costs for patients with PIDD who are receiving IV immunoglobulin (IVIG) or SC immunoglobulin (SCIG) treatment, from a US payer perspective, using a large claims database.

Methods: Based on 2011 to 2013 data from the PharMetrics Plus database, a large national healthcare claims database, patients who were newly diagnosed with PIDD were included in the study if they had ≥2 claims for PIDD that were ≥90 days apart, and if they were treatment-naïve for a minimum of 1 year before the study period. Patients who switched the route of immunoglobulin administration were excluded, with the exception of patients who received SCIG who could initially receive ≤2 IV-loading infusions, as directed by treatment guidelines. We used propensity score analysis to match the patients in the SCIG cohort to patients in the IVIG cohort based on age, sex, and all Elixhauser comorbidities. We compared the patient characteristics and direct medical costs (all-cause, PIDD-related, and pharmacy-related) before and after matching, using t-tests for continuous variables, chi-square test for categorical variables, and Wilcoxon rank-sum test for differences in medians.

Results: A total of 1639 patients with PIDD (986 who received IVIG and 653 who received SCIG) met all the study inclusion criteria. Compared with the patients who received IVIG, the patients who received SCIG were predominantly female (58% vs 63%, respectively) and significantly younger (mean age, 49.1 vs 40.3 years, respectively). Significantly fewer patients who received SCIG than those receiving IVIG had claims with International Classification of Diseases, Ninth Revision codes for Elixhauser comorbidities, including cardiovascular and pulmonary conditions, diabetes, renal failure, liver disease, cancers, weight loss, fluid and electrolyte disorders, and psychoses (P <.05 for all), and their Charlson Comorbidity Index scores were lower than those receiving IVIG (1.74 vs 3.01, respectively; P ≤.05 for all). After matching the 2 cohorts (N = 553 in each), the 1-year postindex median total PIDD-related costs were significantly lower in the IVIG group than in the SCIG group ($38,064 vs $43,266, respectively; P = .002).

Conclusions: In matched analyses, PIDD-related treatment costs were higher for patients who received SCIG than for those who received IVIG. Furthermore, patients who received SCIG were significantly younger and had significantly less comorbidities than their counter

Background: Screening for colorectal cancer (CRC) is effective at reducing mortality, but nearly 35% of eligible patients do not get screened. New noninvasive screening methods may help increase CRC screening participation. Current CRC screening methods include blood-based screening with methylated Septin 9 (SEPT9) DNA (Epi proColon), stool-based screening with fecal immunochemical testing (FIT), and the multianalyte fecal test combining FIT and stool DNA (Cologuard).

Objectives: To estimate the cost and clinical implications to health plans, including the clinical and fiscal implications of the use of blood-based screening with SEPT9 DNA, FIT, and FIT/stool DNA, for patients who are unwilling or unable to undergo other recommended screening methods, and to quantify the clinical and fiscal impacts on health plans of expanding CRC screening participation from today's level of 65% up to 80%.

Methods: We designed a simulation model to estimate the 3-year clinical and economic impacts for noninvasive screening scenarios and for no screening in the screening-nonadherent population. Clinical inputs were derived from SEPT9, FIT, and FIT/stool DNA validation studies in the peer-reviewed literature, the US census, and other sources in the peer-reviewed literature. We modeled a population of 1 million covered lives (aged 0-64 years) in a hypothetical health plan to estimate CRC, advanced adenoma, and nonadvanced adenoma diagnoses for different screening scenarios. We also modeled the expenditures related to screening, diagnostic follow-up, and treatment costs for CRC for a 15% increase (34,800 members) to 80% screening over the course of 3 years.

Results: In the health plan population, 232,000 members aged 50 to 64 years were eligible for screening, of whom 81,200 (35%) were unscreened. The number of cases of CRC that were detected was similar for each screening scenario, including 221 for SEPT9, 216 for FIT, and 193 for FIT/stool DNA versus 49 for no screening. The 3-year per-member per-month (PMPM) cost impact for screening versus no screening and the evaluation of positive tests for the scenarios was $0.67 for SEPT9, $0.33 for FIT, and $0.69 for FIT/stool DNA. Including the treatment costs for CRC, the PMPM costs increased to $1.08, $0.71, and $0.98, respectively.

Conclusions: Our simulation model suggests that similar clinical detection rates are achievable with the 3 noninvasive blood- and stool-based screening methods. These results support a role for blood- and stool-based screening to increase participation in CRC screening.

Background: In 2006, the Centers for Medicare & Medicaid Services (CMS) implemented the newly established Medicare Part D program that required plan sponsors to offer a medication therapy management (MTM) program. The MTM program requirements have become more prescriptive over the past decade in the attempt to address low beneficiary enrollment rates, improve the quality of services provided, and address gaps in meeting the needs of enrollees.

Objective: To describe changes to the requirements for the Medicare Part D MTM program since its inception in 2006 and the impact of these changes to inform future program enhancements.

Methods: We obtained publicly available information extracted from the Medicare Part D MTM program fact sheets for the years 2008 through 2018, in addition to searching indexed literature through PubMed and additional literature through Internet searches. We then categorized the program's requirement changes annually, and described the Part D MTM program characteristics and reported statistics.

Discussion: Significant changes to the Part D MTM program requirements occurred in 2010, 2013, and 2016 regarding eligibility criteria, MTM services, and reporting requirements. Thresholds to determine beneficiary eligibility have been lowered. Specific MTM services now include an annual comprehensive medication review, followed by a written summary using the Standardized Format. Quarterly targeted medication reviews are also required. Reporting requirements now include comprehensive medication review completion rates and the number of prescriber interventions, among others. Despite more prescriptive MTM program requirements, the low utilization of the MTM program continues.

Conclusion: Low beneficiary enrollment rates in the Medicare Part D MTM program led CMS to lower thresholds required for eligibility to expand the beneficiary pool. More prescriptive MTM service requirements enhanced service standardization. Despite these changes, MTM enrollment and comprehensive medication review rates remain low, likely, in part, from a lack of financial incentives. The Enhanced MTM program is a 5-year test model that is providing participating Part D plans regulatory flexibility and financial incentives to design their own MTM programs, to evaluate the impact of different program designs on beneficiary engagement and outcomes.

Background: In recent years, dipeptidyl peptidase (DPP)-4 inhibitors have been added to the diabetes treatment algorithm. Few published studies have shown that the use of DPP-4 inhibitors is associated with joint pain. To our knowledge, no population-based studies in the United States have studied this association.

Objective: To evaluate the association between a new prescription of DPP-4 inhibitors and joint pain within 1 year among older veterans with diabetes.

Methods: This was a retrospective cohort study of older veterans (aged ≥66 years) who were dually enrolled in Medicare and the Veterans Health Administration (VHA; N = 134,488). Data were derived from linked Medicare claims and VHA electronic health records from 2008 to 2010. Diabetes during the baseline and joint pain during the follow-up period were identified with International Classification of Diseases, Ninth Revision codes. Filled prescriptions for DPP-4 inhibitors during the baseline period were identified from Medicare Part D and VHA pharmacy records. The adjusted associations between DPP-4 inhibitors and joint pain were examined with logistic regressions.

Results: Approximately 8.4% of the 134,488 study patients received at least 1 prescription for DPP-4 inhibitors and 11.7% were diagnosed with joint pain during the follow-up period. An unadjusted analysis showed significant differences in joint pain by DPP-4 inhibitor status (12.9% among users vs 11.6% among nonusers; P <.0001). In a fully adjusted model, having a DPP-4 inhibitor prescription had higher odds of joint pain (adjusted odds ratio, 1.17; 95% confidence interval, 1.10-1.24) compared with no prescription for a DPP-4 inhibitor.

Conclusion: In a cohort of older veterans who did not have documented joint pain at baseline, a prescription for DPP-4 inhibitors was significantly associated with a newly documented joint pain.