Journal of managed care & specialty pharmacy最新文献

Background: Influenza causes approximately 3-5 million severe cases and 290,000-650,000 deaths annually, and oseltamivir is considered the first-line pharmacotherapy. Recent reports on neuropsychiatric events (NPEs) associated with the use of oseltamivir necessitated a systematic safety profile review.

Objective: To systematically review and meta-synthesize the evidence on the associations of oseltamivir with adverse NPEs and behavioral events.

Methods: We conducted a systematic review and meta-analysis following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines using the PubMed/Medline, Embase, and Cochrane Library databases from inception through October 31, 2024. Studies comparing oseltamivir with other control groups for NPEs were analyzed. Outcomes were categorized into (1) affective disorders, (2) neuropsychiatric symptoms, (3) anxiety disorders, (4) schizophrenic/psychotic disorders, and (5) suicide-related behaviors.

Results: 9 studies with 1,139-3,352,015 patients were identified. Oseltamivir significantly associated with a lower overall NPE incidence (risk ratio [RR] = 0.83; 95% CI = 0.72-0.97), except in patients younger than 20 years. Subgroup analyses showed significant association with a lower incidence risk in suicide attempts across all ages (RR = 0.60; 95% CI = 0.46-0.77) and in schizophrenia/psychotic disorders for patients younger than 20 years (RR = 0.75; 95% CI = 0.61-0.93).

Conclusions: This is the first comprehensive meta-analysis examining the associations of oseltamivir with various NPEs and behavioral adverse events, and we found no evidence supporting increased risks of these adverse events with oseltamivir use.

Background: Albuminuria, indicated by an elevated urine albumin-to-creatinine ratio (UACR) at baseline, is consistently associated with poor clinical outcomes and increased economic burden. The effect of a change in albuminuria over time on health care resource utilization is not well understood.

Objective: To assess the association between changes in UACR and economic outcomes in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).

Methods: The Optum electronic health records database (January 2007 to September 2021) was used to identify adult patients with albuminuria, measured by UACR of 30 mg/g or more (initial test) after diagnosis of T2D and CKD. UACR change was categorized as increased (>30% change), stable (30% increase to 30% decrease), or decreased (>30% change) based on the percentage of change between the initial test and the follow-up test (the last test within 0.5 to 2 years after the initial test). All-cause inpatient (IP) admissions, emergency department (ED) visits, outpatient (OP) visits, and total medical costs were evaluated during the year after the follow-up test. The association of UACR change with health care resource utilization (HRU) was evaluated using Poisson regression, adjusting for key baseline characteristics. Medical costs (2022 US dollars) were estimated using a unit costing approach based on HRU frequencies.

Results: Among 144,814 eligible patients included in the study, 81,084 (56%) had decreased, 31,766 (22%) had stable, and 31,964 (22%) had increased UACR. Patients with increased UACR had higher HRU (IP admissions: 0.24 per-person per-year [PPPY]; ED visits: 0.35 PPPY; OP visits: 21.20 PPPY) and annual medical costs ($15,013 PPPY) than patients with stable UACR (IP: 0.18 PPPY; ED: 0.31 PPPY; OP: 19.13 PPPY; costs: $12,521 PPPY) and decreased UACR (IP: 0.17 PPPY, ED: 0.31 PPPY, OP: 19.90 PPPY; costs: $12,329 PPPY). Compared with patients with increased UACR, those with decreased UACR had adjusted incidence rate ratios of 0.79 (95% CI = 0.76-0.82) for IP, 0.88 (0.85-0.92) for ED, and 0.96 (0.95-0.97) for OP, and patients with stable UACR had adjusted incidence rate ratios of 0.82 (0.78-0.86) for IP, 0.91 (0.87-0.95) for ED, and 0.94 (0.92-0.95) for OP (all P values of <0.001).

Conclusions: Among patients with CKD and T2D who had albuminuria, an increase in UACR over time was associated with significantly higher HRU and costs compared with patients with stable or decreased UACR. Managed care organizations and other health care decision-makers should consider strategies that enhance monitoring and management of UACR in patients with CKD and T2D to potentially reduce HRU and associated costs.

Background: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) offer cardiorenal benefits in diabetes management. Since 2020, public awareness of GLP-1 RAs for diabetes, weight loss, and the prevention of cardiovascular disease has led to a surge in their utilization. However, the high cost of GLP-1 RAs and limitations in insurance coverage have been considered significant barriers to access. Current knowledge regarding how GLP-1 RA use affects total health care costs in diabetes care after 2020 in the United States remains limited. Consequently, further research is needed to examine the financial burden of GLP-1 RA use on patients and payers, as well as its overall impact on total health care costs at the national level.

Objective: To examine GLP-1 RA utilization and association with health care costs among US adults with type 2 diabetes.

Methods: Using data from the 2021-2022 Medical Expenditure Panel Survey, the study sample included individuals (aged ≥18 years) with a diagnosis of type 2 diabetes. Outcomes included GLP-1 RA use and all-cause and diabetes-related health care costs, including medical and prescription drug costs paid by patients and insurers. Generalized linear regression with a log link and gamma distribution was used to assess the effect of GLP-1 RA use on health care costs, adjusting for sociodemographic and health-related characteristics.

Results: Among 3,587 eligible adults with type 2 diabetes, 637 (18.8%) used GLP-1 RAs, representing an estimated 3.66 million US adults-a marked increase compared with pre-2020 estimates of less than 10%. Fewer older adults (aged ≥65 years) used GLP-1 RAs (35.1%) compared with adults aged 45-64 years (50.6%). The average annual per-person cost of GLP-1 RA was $6,947. Although insurance covered more than 95% of GLP-1 RA cost, these medications represented a substantial proportion of diabetes care costs: 63.3% of antidiabetic drug costs and 55.7% of total diabetes-related costs among GLP-1 RA users. After adjustment, GLP-1 RA use was associated with a 219% increase in diabetes-related costs and a 55.3% increase in total all-cause health care costs.

Conclusions: GLP-1 RA utilization among US adults with type 2 diabetes has substantially increased, with use in 2021-2022 nearly double that of the period prior to 2020. The higher health care costs associated with taking GLP-1 RAs were largely attributable to high drug costs, of which over 95% were covered by insurance.

Background: Stereotactic body radiotherapy (SBRT) is the recommended treatment for inoperable, early-stage non-small cell lung cancer (NSCLC). Although prior research has assessed overall survival (OS) and recurrence rates post-SBRT, limited data exist on the clinical and economic impact of recurrence and the association between event-free survival (EFS) and OS in this patient population.

Objective: To compare OS, health care resource utilization (HRU), and costs between patients with early-stage NSCLC receiving primary SBRT, with and without recurrence, and assess the association between real-world EFS (rwEFS) and OS.

Methods: The SEER-Medicare database (2007-2020) was used to identify patients with stage I-IIB (N0) NSCLC receiving primary SBRT. Patients were categorized into recurrence and nonrecurrence cohorts based on disease recurrence status post-SBRT. OS, all-cause and NSCLC-related HRU, and health care costs were compared between patients with and without recurrence. The correlation between OS and rwEFS was assessed using the normal scores rank correlation and landmark analyses.

Results: A total of 3,014 patients met the inclusion criteria, with 1,455 (48.3%) experiencing disease recurrence. Median OS was significantly shorter for the recurrence cohort (18.9 months) compared with the nonrecurrence cohort (51.4 months; log-rank P < 0.001). Patients with recurrence had a 2.16-fold higher risk of death (95% CI = 1.94-2.42; P < 0.001). HRU and health care costs were significantly higher in the recurrence cohort, with adjusted monthly all-cause and NSCLC-related costs per patient exceeding those of nonrecurrence patients by $5,458 and $3,838, respectively (both P < 0.001). A significant correlation was observed between rwEFS and OS (ρ = 0.74; P < 0.0001).

Conclusions: Recurrence after SBRT in unresected, early-stage NSCLC was associated with worse survival and substantial economic burden. The strong correlation between rwEFS and OS suggests that EFS may serve as a good predictor for OS and be a clinically relevant trial endpoint. These findings highlight the need for novel strategies to prevent/delay recurrence.

Amblyopia is the most common cause of vision impairment in children and presents as reduced visual acuity caused by suppression of neurologic signals from an eye. Traditional treatments include penalizing the better-seeing eye by occlusion, most commonly with patching. This does not address the binocular vision deficits of amblyopia and leaves most patients with unresolved disease and permanent vision loss. Digital, dual-acting therapy (Luminopia, Luminopia, Inc) was cleared in October 2021 via US Food and Drug Administration de novo market authorization for the treatment of amblyopia associated with anisometropia and/or with mild strabismus in children aged 4-7 years. Binocular digital therapy is now included in the American Academy of Ophthalmology's amblyopia treatment guidelines, the Amblyopia Preferred Practice Pattern (PPP). The pivotal randomized, controlled phase 3 trial evaluating Luminopia was recognized in the PPP as Level I+ evidence. Pediatric ophthalmologists and national and regional health plan leaders formed a roundtable panel to evaluate disease impact, the current treatment landscape, and guideline-based treatment principles. At the conclusion of this discussion, the panel developed a unanimous recommendation for the appropriate clinical and value-driven use of Luminopia and payer coverage recommendations. Luminopia is recommended for use to treat amblyopia and should be covered by payer policies. Duration of therapy should be based on patient needs as determined by prescribing physician expertise. Luminopia may be covered under either medical or pharmacy benefit. Step-edits may be used, and documentation of inadequate response to other therapies may be necessary to obtain coverage. Clinical documentation and medical letters of exception may also be needed for off-label use of Luminopia. The recommendations achieved in this roundtable based on the clinical evidence available provide a justification for broad payer coverage and improved patient access to a full range of evidence-based amblyopia treatments.

The AMCP Poster Abstract Program provides a forum for authors to share their research with the managed care pharmacy community. Authors submit their abstracts to AMCP, and each abstract is reviewed by a team of peer reviewers and editors. All accepted abstracts are presented as posters at AMCP's Annual and Nexus meetings. These abstracts are also available through the AMCP meeting app. This JMCP supplement publishes all abstracts that were peer reviewed and accepted for presentation at AMCP Nexus 2025. Abstracts submitted in the Student and Encore categories did not undergo peer review; therefore, these abstracts are not included in the supplement.

Breast cancer is the most common cancer diagnosed in women in the United States, and its impact on both patients and their caregivers, particularly in advanced or metastatic disease, is substantial. Additionally, for the most common breast cancer subtype (estrogen receptor [ER]+/human endothelial growth factor receptor 2 [HER2]-), the treatment landscape for metastatic disease is continuously evolving, making appropriate therapy sequencing challenging. To discuss navigating the rapidly changing landscape of ER+/HER2- metastatic breast cancer (mBC), AMCP Market Insights virtually convened an expert panel of managed care stakeholders in February 2025. Key insights from the discussion on ER+/HER2- mBC included addressing the patient care journey, maintaining high-quality care, managing the impact to payers, evaluating new and emerging therapies, and looking toward the future. Suggested payer best practices in ER+/HER2- mBC also emerged from the discussion.

Background: Cytomegalovirus (CMV) infection is a common complication in transplant recipients, with refractory or resistant infections making up a subset of this population. Maribavir, indicated for CMV infection that is refractory to first-line treatments, is a high-cost, limited-distribution specialty medication that requires frequent laboratory monitoring to assess efficacy.

Objective: To evaluate outcomes of health system specialty pharmacy (HSSP) management of maribavir including waste and cost avoidance, medication access, and pharmacist interventions during treatment.

Methods: This study was a single-center, retrospective cohort analysis of patients prescribed maribavir from April 1, 2022, to August 1, 2024. Included patients were prescribed maribavir for posttransplant CMV infection/disease that was refractory to treatment with ganciclovir, valganciclovir, cidofovir, or foscarnet. Outcomes included the number of dispenses that were reduced by pharmacist interventions that led to medication waste avoidance and the cost avoidance of these interventions, time to medication access, and the number of pharmacist interventions recommending laboratory tests or medication discontinuation during treatment. Descriptive statistics were used for analysis. To estimate costs avoided by pharmacy and payer, cost avoidance was calculated by multiplying the 14-day supply of maribavir that was not dispensed during the final treatment course because of pharmacist intervention by the average wholesale price (AWP), AWP minus 20% (AWP-20%), and wholesale acquisition cost (WAC).

Results: Included patients (N = 33) were predominately male (64%) with a median age of 62 years (interquartile range [IQR] = 50-66 years). Five patients were required to repeat treatment with maribavir multiple times because of CMV reactivation totaling 41 unique instances of maribavir use. The most common transplant type was kidney (n = 11), and all patients were donor CMV positive (n = 33). 29 patients were able to fill with the institution's HSSP with 36 instances of maribavir use and 113 fills of maribavir. Of these 36 instances, 12 (33%) had the final dispense of the treatment course reduced because of pharmacist intervention, amounting to a cost avoidance range of $143,421 (AWP-20%) to $179,276 (AWP). Maribavir insurance prior approval (PA) was required for 31 (76%) instances of medication use, with median PAs occurring the same day as referral (IQR = 0-2). Of the 41 instances of maribavir use, 8 (20%) required an intervention from the pharmacist recommending CMV laboratory testing be completed.

Conclusions: Pharmacists successfully obtained timely insurance PAs for maribavir. During treatment, pharmacists reduced unnecessary fills, resulting in large cost and waste avoidance. Future research is needed to evaluate the long-term effects of interventions by specialty pharmac

Bispecific antibodies (bsAbs) are an emerging treatment modality particularly in hematologic malignancies such as the non-Hodgkin lymphomas follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). Although bsAbs offer opportunities in the treatment of these conditions, they also present challenges, and additional longer-term data are needed to determine their optimal role. To discuss managed care approaches to bsAbs with a focus on FL and DLBCL, AMCP Market Insights virtually convened an expert panel of managed care stakeholders in April 2025. Key insights from the discussion included that clinical efficacy is a primary consideration when evaluating the role of bsAbs in FL and DLBCL and that ongoing data collection is necessary for increased certainty in long-term outcomes, treatment comparisons, and real-world experience. Other insights related to treatment choice, site-of-care considerations, the evolving place of bsAbs in FL and DLBCL therapy, economic factors, and social determinants of health and equity. Suggested payer best practices for bsAbs in FL and DLBCL also emerged from the discussion.