Journal of managed care & specialty pharmacy最新文献

{"title":"Artificial intelligence in prior authorization and coverage decisions: A systematic review of methods, evidence gaps, and future implications for patient access.","authors":"Taraneh Mousavi, Fadia Tohme Shaya, Catherine E Cooke","doi":"10.18553/jmcp.2026.32.9.1135","DOIUrl":"10.18553/jmcp.2026.32.9.1135","url":null,"abstract":"<p><strong>Background: </strong>Prior authorization (PA) is intended to support appropriate use and spending of services and medications, yet 1 in 6 insured adults report PA-related problems linked to delayed care, worse access, and higher financial burden. As artificial intelligence (AI) expands in utilization management and other pharmacy benefit operations, evidence guiding responsible AI use in PA remains fragmented.</p><p><strong>Objective: </strong>To systematically map AI applications across PA workflow and evaluate model development, validation, equity, and implementation outcomes relevant to managed care pharmacy and patient access, while identifying AI adoption priorities.</p><p><strong>Methods: </strong>A systematic review was conducted in Embase, PubMed, Scopus, and Google Scholar from October 1, 1988, to January 27, 2026. Eligible studies applied AI (rule-based systems, classical machine learning, deep learning, large language models, or hybrid approaches) to real-world PA workflows. Data were extracted on workflow stage (initiation, submission, payer review, appeals, patient engagement), model type, dataset characteristics, outcomes, and bias assessment. Risk of bias for prediction models was evaluated using PROBAST-AI.</p><p><strong>Results: </strong>Of 3,417 records, 16 studies met eligibility criteria. AI use was concentrated in payer review/decision-making (62.5%), followed by post-denial appeals (18.8%), initial PA submission (12.5%), and early PA initiation (6.3%), with limited focus on patient engagement. Supervised classical machine learning predominated (37.5%), followed by hybrid multimodal models (31.3%) and deep learning (25.0%). Administrative PA datasets (25.0%) and synthetic datasets (18.8%) were the most common training data. Most studies reported technical metrics (F1, precision, accuracy, recall, area under the receiver operating characteristic curve), while few demonstrated operational gains, including faster decisions, lower denial rates, and reduced cost. Most studies had high analysis bias, limited generalizability, inadequate validation, and limited subgroup reporting. Only 1 study assessed demographic bias and found significant disparities. Patient- and provider-centered outcomes and long-term system impact were rarely evaluated.</p><p><strong>Conclusions: </strong>This systematic review synthesized AI literature into a PA workflow-based map and identified critical gaps in equity, stakeholder engagement, and validated real-world outcomes. Although AI demonstrates acceptable technical performance and some operational gains, its impact on medication access, financial burden, and trust remains uncertain. Managed care pharmacy should adopt a risk-tiered hybrid AI-human model spanning workforce augmentation, workflow automation, and business process innovation, with human oversight for complex decisions. This should be guided by governance, vendor accountability, transparency, subgroup monitoring, external validat","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"32 9","pages":"1135-1153"},"PeriodicalIF":3.3,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13505359/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148813132","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Payer coverage principles for precision medicine biomarker testing in oncology.","authors":"Steven S Kheloussi, Tianyi Wang, Kimberly Tsai, Dana McCormick, Pamala A Pawloski","doi":"10.18553/jmcp.2026.32.9-b.s3","DOIUrl":"10.18553/jmcp.2026.32.9-b.s3","url":null,"abstract":"<p><p>In 2025, the Academy of Managed Care Pharmacy (AMCP) held a 2-day partnership forum on the topic of advancing precision medicine access in oncology. Precision medicine, in this context, focuses on biomarker testing required to create personalized treatment plans and procedures. The forum brought together patients; payers, including health insurers and employer groups; pharmacy benefit managers; providers; pathologists; laboratory benefit managers; and leaders from patient advocacy organizations, coalitions, and professional associations. In response to fundamental coverage challenges impacting patient access to biomarker testing, the overarching goal of the forum was to collaboratively ideate deliverables to drive a standardized approach to assessing and determining coverage. A critical deliverable from this initiative included 8 guiding principles for managed care stakeholders as it relates to the coverage of biomarker testing. This article provides detail on each guiding principle, which are considerations intended to guide managed care decision-makers on determining and monitoring coverage for biomarker-driven testing used to inform treatment decisions in oncologic indications.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"32 9-b Suppl","pages":"S17-S24"},"PeriodicalIF":3.3,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13452050/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148697621","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Economic burden of immune-mediated and psychiatric comorbidities in patients with newly diagnosed vitiligo.","authors":"David Rosmarin, Ahmed M Soliman, Kent A Hanson, Bang Truong, Sylvester Uwumarogie, Nguyen Le, Nada Elbuluk","doi":"10.18553/jmcp.2026.26157","DOIUrl":"https://doi.org/10.18553/jmcp.2026.26157","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Vitiligo is a chronic autoimmune skin disorder characterized by loss of melanocytes, resulting in patches of skin depigmentation across the body. Vitiligo can have a substantial negative impact on patients' health-related quality of life, is associated with increased health care costs, and has no known cure.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To evaluate the prevalence and economic burden of immune-mediated and psychiatric comorbidities in patients with newly diagnosed vitiligo.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This retrospective cohort study used data from the Merative MarketScan Commercial Database. Eligible patients were aged 12 to 64 years with a new diagnosis of vitiligo (&lt;i&gt;International Classification of Diseases, Tenth Revision&lt;/i&gt;; codes L80.x, H02.73-, or N90.89); index date recorded on a nondiagnostic medical claim between January 1, 2019, and September 30, 2024, together with 12 months of pre-index continuous medical/pharmacy enrollment. Outcomes included prevalence of immune-mediated or psychiatric comorbidities at diagnosis (evaluated using up to 3 years of pre-index data) and associated per-patient per-month (PPPM) all-cause and vitiligo-related mean health care costs and health care resource utilization, both unadjusted and adjusted for age, sex, US region, and Charlson Comorbidity Index score. Comorbidities were summarized descriptively; health care costs were compared using γ log-link models.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Among the 14,059 patients with vitiligo, 52.8% (n = 7,430) were female and the mean (SD) age was 43 (15) years. Overall, 23.8% of patients had at least 1 immune-mediated comorbidity, most commonly atopic dermatitis (8.0%), psoriasis (5.4%), Hashimoto thyroiditis (3.8%), and alopecia areata (2.0%). At least 1 psychiatric diagnosis was present in 39.4% of patients, most commonly anxiety (20.9%), sleep disturbance (15.2%), and depression (12.7%). PPPM all-cause mean total health care costs among patients with vitiligo and at least 1 immune-mediated comorbidity were significantly higher than those among patients without an immune-mediated comorbidity ($2,112 vs $957, respectively; &lt;i&gt;P&lt;/i&gt; &lt; 0.001), as were costs for those with vs without at least 1 psychiatric comorbidity ($1,751 vs $896, respectively; &lt;i&gt;P&lt;/i&gt; &lt; 0.001). Among patients with at least 1 Janus kinase-related comorbidity, PPPM costs were $2,105, compared with $1,041 for those without such comorbidities at baseline.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study highlights the substantial economic burden that patients with preexisting immune-mediated and psychiatric conditions face following vitiligo diagnosis. Approximately 1 in 4 patients had a prior diagnosis of at least 1 immune-mediated condition, reflecting the immunological pathogenesis of vitiligo and that it is not a cosmetic disease. Patients with immune-mediated and psychiatric comorbidities incurred significantly higher health care costs relative to those wit","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":" ","pages":"1-9"},"PeriodicalIF":3.3,"publicationDate":"2026-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148794151","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical harm from failure to deploy personalized medicine for patients with metastatic non-small cell lung cancer.","authors":"Kristen Migliaccio-Walle, Scott J Spencer, David L Veenstra, Robert H Dumanois, Jason S White, Lucy Langer, Daryl Pritchard, John Fox, Scott D Ramsey","doi":"10.18553/jmcp.2026.32.8.1029","DOIUrl":"10.18553/jmcp.2026.32.8.1029","url":null,"abstract":"<p><strong>Background: </strong>Among the estimated 234,580 patients diagnosed with lung or bronchus cancer in 2024, an estimated 66%, or 154,823 patients, were diagnosed with advanced or metastatic non-small cell lung cancer (mNSCLC). More than half of patients have a genomic variant that can be treated with targeted therapy. Despite widespread evidence supporting the survival benefits of biomarker-driven management of patients with mNSCLC, real-world implementation of precision oncology has not kept pace with recommendations.</p><p><strong>Objective: </strong>To quantify the potential survival deficit from underutilization of precision oncology (genomic testing and matched therapy) for patients with newly diagnosed mNSCLC in the United States.</p><p><strong>Methods: </strong>We developed a simulation model comparing Observed Practice with Optimal Practice in which all eligible patients receive biomarker testing and appropriate treatment. We assessed a mix of 3 testing pathways assessed: (1) guideline-concordant biomarker testing consistent with National Comprehensive Cancer Network (NCCN) Guideline recommendations, (2) nonguideline biomarker testing, and (3) no biomarker testing. Input values and probabilities for each pathway were obtained from published data. Survival deficit was estimated as life-years lost in Observed Practice vs Optimal Practice.</p><p><strong>Results: </strong>Among the estimated 92,401 patients with new metastatic adenocarcinoma or large cell carcinoma histology, 49,427 patients were projected to have at least 1 of the 10 NCCN-recommended mutations with a known targeted first-line therapy. Among those harboring actionable mutations, 46,757 were assumed to be identified and treated with precision-matched targeted therapy (PMTT) in Optimal Practice vs 28,177 in Observed Practice. The 46,757 patients receiving PMTT in Optimal Practice realized a total of 113,417 life-years, a gain of 20,901 over the patients treated in Observed Practice.</p><p><strong>Conclusions: </strong>Among patients with mNSCLC in the United States, suboptimal use of recommended panel testing and implementation of precision medicine for newly diagnosed mNSCLC is associated with life-years lost. Investments in effective programs that improve adherence to NCCN guideline recommendations and test-concordant therapy would result in increased life expectancy for up to 20,000 patients annually.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"32 8","pages":"1029-1040"},"PeriodicalIF":3.3,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13403261/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148592205","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Health care use and costs associated with clinically impactful immune-related adverse events during immune checkpoint inhibitor therapy for non-small cell lung cancer.","authors":"Olajumoke A Olateju, Meera Patel, Rajender R Aparasu, Chan Shen, Tyler J Varisco, E James Essien, Meghana Trivedi, J Douglas Thornton","doi":"10.18553/jmcp.2026.32.8.979","DOIUrl":"10.18553/jmcp.2026.32.8.979","url":null,"abstract":"<p><strong>Background: </strong>Immune checkpoint inhibitors (ICIs) are widely used in advanced non-small cell lung cancer (NSCLC) but can lead to immune-related adverse events (irAEs) that may disrupt care. Although irAEs are well described clinically, there is limited evidence quantifying their downstream health care use and costs in Medicare beneficiaries with advanced NSCLC.</p><p><strong>Objective: </strong>To evaluate health care use and costs associated with clinically impactful irAEs among older adults receiving ICI therapy.</p><p><strong>Methods: </strong>Using Surveillance, Epidemiology, and End Results-Medicare data, we identified patients (fee-for-service beneficiaries) aged 66 to 85 years with advanced NSCLC and who initiated nivolumab, pembrolizumab, or atezolizumab, alone or in combination with each other or chemotherapy, between 2015 and 2017 (patient identification window), with follow-up through 2019. These agents represent ICIs approved for advanced NSCLC during the identification period. Clinically impactful irAEs were defined using irAE diagnosis codes accompanied by evidence of systemic immunosuppressant use and treatment interruption and were modeled as a time-varying exposure. Health care use and costs were assessed using weighted longitudinal models accounting for time-varying confounding (marginal structural models with stabilized inverse probability weights). Two-part generalized estimating equations estimated per-patient-per-month (PPPM) and cumulative outcomes over 6, 12, and 24 months, with sensitivity analyses including models incorporating ICI drug costs and alternative approaches to account for censoring.</p><p><strong>Results: </strong>Among 4,867 patients, 1,667 (34.3%) experienced a clinically impactful irAE. Adjusted all-cause health care use was higher among patients with irAEs (mean 15.8 [SE = 0.12] vs 12.0 [SE = 0.12] visits PPPM; difference, 3.9; 95% CI = 2.9-4.8), with more than double the odds of inpatient hospitalization (odds ratio, 2.21; 95% CI = 2.15-2.29). Adjusted all-cause medical costs averaged $16,042 (SE = 14.7) vs $12,721 (SE = 13.1) PPPM (difference, $3,322; 95% CI = $3,283-$3,361), driven primarily by inpatient care ($2,922; 95% CI = $2,903-$2,941). At 24 months, cumulative costs per patients were $846,013 (SE = 12,786) for patients with irAEs compared with $751,606 (SE = 11,358) for those without (difference, $94,407; 95% CI = $91,606-$97,207). Findings were consistent in sensitivity analyses.</p><p><strong>Conclusions: </strong>Clinically impactful irAEs were associated with substantially higher health care use and costs among older adults with advanced NSCLC receiving ICIs, with inpatient care accounting for most excess costs. These findings have implications for managed care strategies focused on toxicity monitoring, hospitalization prevention, and value-based ICI management.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"32 8","pages":"979-993"},"PeriodicalIF":3.3,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13403263/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148592154","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"RAPID3 disease activity trajectory among patients with rheumatoid arthritis new to specialty pharmacy medications.","authors":"Alicia L Zagel, Dana Simonson, R May O'Donnell, Ann Harty, Tori Grier, Ann McNamara","doi":"10.18553/jmcp.2025.25219","DOIUrl":"10.18553/jmcp.2025.25219","url":null,"abstract":"<p><strong>Background: </strong>Understanding disease activity and therapy goals of patients with rheumatoid arthritis (RA) is important to provide patient-centered specialty pharmacy care and achieve positive therapy outcomes. The Routine Assessment of Patient Index Data 3 (RAPID3) is a validated metric to track patient-reported RA disease activity. Consistent and frequent monitoring of RAPID3 scores may provide clinically meaningful insights.</p><p><strong>Objective: </strong>To describe the trajectory of RAPID3 scores over time and factors related to changes in RAPID3 scores among patients new to specialty medications.</p><p><strong>Methods: </strong>Adult patients with RA who initiated specialty medications were included if they filled medications at least 3 times and had at least 2 RAPID3 scores documented in 6 months. Linear mixed effects regression models estimated trends in RAPID3 scores over time with respect to patient identifiers. Logistic regression models adjusted for baseline RAPID3 severity and estimated adjusted odds ratios (aOR) and associated 95% CIs of achieving a minimal clinically important improvement (≥3.8 points) or low severity/near remission (LS/NR) RAPID3 severity score at 6 months, by patient characteristics.</p><p><strong>Results: </strong>Of 312 patients with RA, 195 (63%) had baseline high severity RAPID3 scores. Patients with baseline high severity achieved significant RAPID3 decreases over 6 months (5.9 points; <i>P</i> < 0.0001). Nearly half of patients (N = 147, 47%) had a clinically important improvement and 105 (34%) were LS/NR at follow-up; 67 patients (21%) met both criteria. After adjusting for baseline RAPID3 severity category, medication change (aOR, 0.39; 95% CI, 0.21-0.71) and opting out of full therapy management (aOR, 0.36; 95% CI, 0.19-0.65) were inversely associated with achieving a clinically important improvement. Being LS/NR at follow-up was also inversely associated with medication change (aOR, 0.19; 95% CI, 0.075-0.48) and opting out of full therapy management (aOR, 0.27; 95% CI, 0.12-0.63). Low medication adherence (aOR, 0.28; 95% CI, 0.11-0.72) and Medicaid insurance (aOR, 0.52; 95% CI, 0.29-0.93) were also inversely associated with being LS/NR at follow-up.</p><p><strong>Conclusions: </strong>RAPID3 is a valuable tool in the specialty pharmacy setting, helping assess patient outcomes beyond traditional metrics. Specialty pharmacies should support their patients in striving to reach clinically important improvement and/or achieving LS/NR as measures of quality pharmacy care during the crucial months after therapy initiation and throughout care. Active collaboration between patients and pharmacists is crucial in reaching positive RA disease activity outcomes. To support this, implementing programs that foster patient engagement with pharmacists may be important for optimizing care delivery.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":" ","pages":"955-967"},"PeriodicalIF":3.3,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13404591/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148302003","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prevalence of renal and bone risk factors and nucleos(t)ide analogue treatment among patients with chronic hepatitis B in the United States.","authors":"Alice E Stead, Mary J Christoph, Amanda W Singer, Wenyi Wang, Alice Hsiao, Sunil Majethia, Sean Byrne, Woodie Zachry","doi":"10.18553/jmcp.2026.26066","DOIUrl":"10.18553/jmcp.2026.26066","url":null,"abstract":"<p><strong>Background: </strong>Chronic hepatitis B (CHB) can lead to serious health complications. Patients with CHB often have a higher burden of extrahepatic comorbidities such as chronic kidney disease (CKD) and osteopenia/osteoporosis (OP) compared with the general population. Understanding the burden of these comorbidities in those with CHB may facilitate the development of strategies to better support patients and guide treatment decisions.</p><p><strong>Objective: </strong>To evaluate demographic characteristics and prevalence of CKD, OP, and established risk factors for CKD and OP in patients with a confirmed diagnosis of CHB and assess prevalence of nucleos(t)ide analogue (NA) use in the United States.</p><p><strong>Methods: </strong>This study evaluated retrospective claims data from Optum's deidentified Clinformatics® Data Mart database between January 1, 2016, and March 31, 2025. Commercially and Medicare-insured adults (aged ≥18 years) with a confirmed diagnosis of CHB (≥1 inpatient or ≥2 outpatient diagnostic codes ≥30 days apart) who met continuous enrollment criteria and had no evidence of HIV infection were included. Descriptive analyses were carried out to estimate the prevalence of CKD, OP, related established risk factors, and NA treatment experience.</p><p><strong>Results: </strong>A total of 19,176 patients with CHB meeting eligibility were identified; 73% were older than 50 years, and 53% were male. Twenty-seven percent received NA treatment during the observation period: tenofovir disoproxil fumarate was most commonly used (14%), followed by entecavir (12%) and tenofovir alafenamide (7%). More than one-quarter (30%) of patients had CKD, including 9% with stage 4 or 5 CKD. Among patients with CHB, renal risk factors were prevalent, with 80% and 27%, respectively, having risk factors for CKD related to a comorbidity or medication use. More than one-quarter (29%) of the patients had a diagnosis of OP. Risk factors for OP were also prevalent, with 72% and 60% of patients, respectively, having a risk factor for OP-driven comorbidities or medication use. The overall prevalence of renal- and bone-related comorbidities and risk factors was similar among patients treated with NAs.</p><p><strong>Conclusions: </strong>This study demonstrates the high burden of comorbidities among patients with CHB, with established risk factors for CKD and OP present among most individuals. Although NAs are the mainstay therapy for CHB, different safety considerations exist for each therapy, and this analysis found that fewer than one-third of patients had a history of NA use. These findings highlight the importance of considering the renal and bone safety profiles of CHB treatment options to help mitigate comorbidities and prevent complications.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":" ","pages":"994-1006"},"PeriodicalIF":3.3,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13403256/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148421697","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Equivalent effectiveness of a prescription binocular treatment for amblyopia in real-world practice.","authors":"Eric D Gaier, Brenda L Bohnsack, Maria I Bodack, Fatema Ghasia, Shelley E Hancock, Euna Koo, Michael X Repka, Gil Binenbaum","doi":"10.18553/jmcp.2026.25336","DOIUrl":"10.18553/jmcp.2026.25336","url":null,"abstract":"<p><strong>Background: </strong>Gaps often exist between a therapy's performance in a controlled research setting and outcomes in routine clinical practice. A prescription binocular treatment delivered via head-mounted display has demonstrated efficacy for improving visual acuity in children with amblyopia in a pivotal randomized controlled trial (RCT). A retrospective patient registry has been established to collect real-world data on the treatment.</p><p><strong>Objective: </strong>To evaluate the real-world effectiveness of this treatment by benchmarking outcomes from a patient registry against those from the RCT.</p><p><strong>Methods: </strong>A retrospective analysis of a multicenter US patient registry was completed. The Registry was queried for patients who matched key eligibility criteria of the RCT with respect to age, amblyopia type and severity, and prior treatment exposure. The primary outcome was the change in amblyopic eye best-corrected visual acuity from baseline to the 12-week follow-up visit. These outcomes were compared with the historical intent-to-treat cohort (n = 45) from the RCT using a two one-sided tests procedure for equivalence with an equivalence margin of ±0.75 lines.</p><p><strong>Results: </strong>Among the 40 registry patients meeting query criteria, mean age was 5.7 ± 1.0 years, and 21/40 (53%) had a history of prior treatment. Amblyopic eye best-corrected visual acuity improved a mean 1.7 lines (95% CI = 1.2-2.2), consistent with statistical equivalence within the prespecified ±0.75-line margin compared with RCT participants (1.8 lines; 95% CI = 1.4-2.3; two one-sided tests <i>P</i> = 0.038). No adverse safety events were reported.</p><p><strong>Conclusions: </strong>Patients prescribed this treatment for amblyopia in clinical practice achieved visual acuity improvements consistent with those observed in the RCT, indicating that effectiveness generalizes to real-world settings.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":" ","pages":"923-931"},"PeriodicalIF":3.3,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13403260/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148204940","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Discontinuation of glucagon-like peptide-1 receptor agonists among US adults: A national survey.","authors":"Michael J DiStefano, Juliet Zon, Erik G Olson, Joseph F Levy, Gerard F Anderson, G Caleb Alexander","doi":"10.18553/jmcp.2026.32.8.903","DOIUrl":"10.18553/jmcp.2026.32.8.903","url":null,"abstract":"<p><strong>Background: </strong>Although many people discontinue glucagon-like peptide-1 receptor agonists (GLP-1 RAs), the reasons for discontinuation are unclear.</p><p><strong>Objective: </strong>To identify self-reported reasons for GLP-1 RA discontinuation among US adults.</p><p><strong>Methods: </strong>Cross-sectional survey of US adults fielded in June 2025 using Ipsos Omnibus and incorporating survey weights calibrated to census benchmarks. We included individuals who initiated a GLP-1 RA between January 2022 and June 2025 and subsequently discontinued therapy. Outcomes included duration of use, self-reported reason(s) for discontinuation, medication source, out-of-pocket payment, and insurance coverage. Descriptive statistics and chi-square tests for statistical significance were used.</p><p><strong>Results: </strong>Of 7,035 individuals screened, 440 respondents met eligibility criteria and completed the survey. Of these 440 participants, 51.1% were female, 42.3% were aged between 18 and 34 years, and 23.8% reported having type 2 diabetes. More than half of these discontinuers (54.6%) reported discontinuing a GLP-1 RA within 6 months of initiation, and 79.7% reported discontinuation within 12 months of use. Approximately 1 in 7 (14.4%) reported sourcing GLP-1 RAs from a friend or family member, and more than half reported using a copayment coupon (35.4%) or free sample (22.0%). Many respondents (31.3%) reported first filling a prescription without insurance. Approximately 1 in 5 reported sourcing their medicine from a compounding pharmacy (9.8%) or Internet-based (9.1%) source. The most frequently cited reasons for discontinuation were cost (36.1%), side effects (33.3%), no insurance coverage (28.2%), and achieving a weight-loss goal (26.1%). Compared with those without diabetes, respondents with diabetes were significantly more likely to discontinue because of side effects (50.1% vs 28.1%, <i>P</i> = 0.0008). Respondents who reported sourcing their GLP-1 RA from a compounding pharmacy or Internet-based source were significantly more likely to discontinue because they perceived the medication to be ineffective compared with those who obtained their medication from a retail or mail-order pharmacy (17.5% vs 6.6%, <i>P</i> = 0.009). Neither diabetes status nor GLP-1 RA source was significantly associated with early discontinuation (<6 months).</p><p><strong>Conclusions: </strong>In this national survey, most US adults who stopped GLP-1 RAs did so within 6 months because of cost, adverse effects, lack of coverage, or having achieved a weight loss goal. Differences in coverage, costs, and sourcing are modifiable targets that may decrease high rates of GLP-1 RA discontinuation.</p>","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"32 8","pages":"903-910"},"PeriodicalIF":3.3,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13403254/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148592190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Piloting a specialty pharmacy turnaround time quality measure: Findings and lessons learned.","authors":"Heather Gibson, Benjamin Shirley, Kim Nguyen, Noel Hunt, Carlyn Vogel, Lynn Pezzullo","doi":"10.18553/jmcp.2026.32.8.1007","DOIUrl":"10.18553/jmcp.2026.32.8.1007","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Interested parties have recognized the need for quality measurement focused on pharmacy services. As the use of specialty medications continues to grow, quality measurement is increasingly critical. One key area of quality is prescription turnaround time (TAT) given that prompt treatment initiation is important for optimal management of a variety of complex conditions. However, pharmacy data availability remains highly variable and may impact consistent measurement of TAT.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;To investigate potential inconsistencies in TAT calculation with the Pharmacy Quality Alliance-endorsed &lt;i&gt;Specialty Pharmacy Turnaround Time [Pharmacy]&lt;/i&gt; (SP-TAT-PH) measure. Further, the pilot sought to elicit participant feedback and lessons learned to support accurate calculation of TAT and to add to previously identified promising practices to optimize TAT. An exploratory objective was to evaluate mean TAT by medication category.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Five specialty pharmacy organizations used the SP-TAT-PH measure specifications to calculate baseline, midpoint, and endpoint TAT rates at the pharmacy National Provider Identifier level for each organization's participating pharmacies. At each time point, organizations provided their TAT rates and raw data to the authors for validation, who then developed and shared a report of calculation discrepancies. Each organization then recalculated their measure rates and resubmitted to the authors for further comparison and resolution. Surveys and online debrief meetings were used to capture feedback and lessons learned on calculating and improving TAT. Sensitivity analyses were conducted to explore mean TAT by specialty medication category.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Mean TAT (in days) across all participating National Provider Identifiers was 2.42 (range: 1.17, 11.09), 2.42 (range: 1.12, 10.03), and 2.52 (range: 1.11, 10.20) for baseline, midpoint, and endpoint measurement, respectively. Baseline validation activities resulted in a negligible impact on TAT rates for 3 organizations, moderate impact for 1 organization, and substantial impact (close to 1 full day of TAT) for 1 organization. As anticipated, resolving discrepancies between organization- and author-calculated rates during baseline validation resulted in fewer discrepancies at midpoint and endpoint and therefore had negligible impact on these subsequent TAT rates for all 5 organizations. In the debrief meetings, participants highlighted areas in the SP-TAT-PH measure specifications with opportunity for clarification to support accurate and consistent implementation. Full staffing levels, technology improvements, and process improvements were cited as main facilitators to optimizing TAT, whereas prior authorizations and processes that required coordination between patients and providers were identified as barriers. Participants also noted that variations in data availability posed challeng","PeriodicalId":16170,"journal":{"name":"Journal of managed care & specialty pharmacy","volume":"32 8","pages":"1007-1017"},"PeriodicalIF":3.3,"publicationDate":"2026-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13403253/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148592140","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}