Journal of managed care & specialty pharmacy最新文献

Background: Quality initiatives such as the Medicare Part D Star Ratings program rely on medication adherence measurements. Prior research characterized the longitudinal patterns of adherence to medications for chronic conditions such as hypertension, dyslipidemia, and diabetes. However, the association between longitudinal trajectories of medication adherence and disease-specific clinical outcomes has not been explored, hindering the evaluation of incentive programs like the Medicare Part D Star Ratings.

Objective: To examine the association between longitudinal trajectories of adherence to medication for hypertension, dyslipidemia, and diabetes and clinical outcomes, including myocardial infarction (MI), stroke, and diabetes-specific clinical outcomes (diabetic neuropathy, nephropathy, peripheral angiopathy, and ophthalmic complications).

Methods: Administrative claims data linked to the Health and Retirement Study between 2008 and 2016 (N = 11,068) were used to calculate the monthly proportion of days covered and estimate longitudinal medication adherence trajectories of antihypertensives, statins, and oral diabetes medications. Clinical events were identified by the first respective medical diagnosis codes. The association between longitudinal medication adherence trajectories and clinical outcomes was examined by logistic regression models.

Results: Trajectory groups showing suboptimal adherence for patients taking hypertension or statin medications were found to exhibit higher risk for MI and stroke than high or very high adherence trajectories. For diabetes medications, declining adherence trajectories were found to have higher risk for MI, nephropathy, and peripheral angiopathy complications but not stroke, neuropathy, or ophthalmic complications. This study showed an inconsistent association between trajectory groups exhibiting suboptimal adherence and adverse clinical outcomes across different chronic medications. Trajectory groups with steeper declines in adherence were generally associated with worse outcomes.

Conclusions: The results described the nuanced association between levels of adherence and risk of experiencing certain disease-specific clinical outcomes. Although improving medication adherence is a valuable method to achieve optimal outcomes, quality metrics based on medication adherence could be adjusted to help providers further personalize care and structure value-based care programs tied to pharmacy interventions aimed at improving medication adherence.

Background: Comprehensive medication reviews (CMRs) are a cornerstone of medication therapy management (MTM) for millions of Medicare Part D beneficiaries, designed to optimize medication use and health outcomes. However, uptake is inconsistent, with known disparities affecting groups such as Asian, Black, and Hispanic patients.

Objective: To evaluate CMR trends from 2013 to 2021, analyzing changes in provider types, delivery methods, and recipients, with a particular focus on variations across Asian, Black, Hispanic, and White beneficiaries.

Methods: Employing a serial cross-sectional design, we analyzed Part D MTM program data submitted to the Centers for Medicare & Medicaid Services (CMS) from 2013 through 2021, covering all MTM-eligible Medicare beneficiaries. To explore differences based on race and ethnicity, this dataset was linked with a 5% random sample of Medicare fee-for-service beneficiaries. Descriptive statistics were used to evaluate year-over-year trends in CMR provider categories, the methods of service delivery, and the individuals who received the CMR.

Results: The volume of completed CMRs expanded more than 4-fold, increasing from 526,150 encounters in 2013 to more than 2 million by 2020, before a slight decrease in 2021. The proportion of CMRs delivered by plan or pharmacy benefit manager pharmacists declined from 40% in 2013 to 29% in 2021, and the share of reviews provided by MTM vendors and other pharmacist categories generally increased over the same period. Telephone consultations, already the primary mode of delivery, increased their share from 86% to 96% of all CMRs, whereas face-to-face services correspondingly decreased from 14% to 4% across all racial groups. The decline in face-to-face services was steepest for Asian (from 18% in 2013 to 7% by 2021) and Hispanic patients (from 18% in 2013 to 3% by 2021). Black individuals consistently had the highest rates of direct beneficiary involvement (88% in 2021) and the lowest caregiver use.

Conclusions: The substantial growth in CMR services represents a positive development in patient care. Nevertheless, the marked shifts toward telephonic delivery and changes in the types of providers and recipients engaged highlight a critical need for ongoing assessment.

Background: Although immune checkpoint inhibitors (ICIs) have significantly improved overall survival (OS) for patients with metastatic non-small cell lung cancer (mNSCLC), there is a paucity of comparative effectiveness evidence to inform optimal first-line treatment selection.

Objective: To compare OS among older patients with mNSCLC who received first-line atezolizumab, nivolumab, or pembrolizumab.

Methods: This retrospective cohort study used the 2014-2020 Surveillance, Epidemiology, and End Results-Medicare data and included patients aged 66 years or older, diagnosed with mNSCLC, and treated with first-line atezolizumab, nivolumab, or pembrolizumab. OS was compared using unadjusted, multivariable-adjusted, and propensity score matching (PSM) Cox proportional hazards models. Sensitivity and subgroup analyses by patient histology (squamous and nonsquamous) were also conducted.

Results: The study cohort included 4,635 patients, 112 treated with atezolizumab, 251 with nivolumab, and 4,272 with pembrolizumab. Pembrolizumab was associated with a significant survival advantage compared with atezolizumab (multivariable-adjusted hazard ratio [HR], 0.67; 95% CI, 0.53-0.84; PSM HR, 0.69; 95% CI, 0.54-0.87) and nivolumab (multivariable-adjusted HR, 0.83; 95% CI, 0.69-0.99) in both main analyses and sensitivity analyses. The OS difference between nivolumab and atezolizumab was inconclusive (multivariable-adjusted HR, 0.73; 95% CI, 0.46-1.16; PSM HR, 0.65; 95% CI, 0.41-1.04). In subgroup analyses, differences in OS between pembrolizumab and nivolumab were not observed among patients with squamous histology (multivariable-adjusted HR, 0.85; 95% CI, 0.65-1.11; PSM HR, 1.15; 95% CI, 0.89-1.49).

Conclusions: In this population-based study, first-line pembrolizumab was associated with a significant OS benefit compared with atezolizumab and nivolumab among older adults with mNSCLC. For patients with squamous histology, OS differences between pembrolizumab and nivolumab were not observed. These findings support pembrolizumab as the preferred first-line treatment for older patients with mNSCLC, while highlighting the need for further investigation into the effectiveness of nivolumab specifically within squamous histology subgroups.

Background: Hepatitis C is a viral infection that can lead to severe liver damage, liver cancer, and death. However, it has remained a major public health concern, affecting millions worldwide, including over 2.4 million people in the United States. Although the advent of direct-acting antiviral (DAA) therapy has significantly improved treatment outcomes, the high cost of these drugs poses challenges for health care systems. Most economic evaluations of DAA therapy rely on simulation models, which often overlook individual, geographic, and health system variations, limiting their relevance for policy decisions.

Objective: To synthesize evidence from retrospective observational studies on health care utilization and cost of care among patients with hepatitis C treated with DAA therapy, compared with those receiving pre-DAA treatments, a combination of pre-DAA, and no treatment. The goal is to understand real-world health care costs and utilization patterns, which simulation-based approaches cannot capture.

Methods: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, US-based retrospective observational studies published between 2010 and 2024 were considered. A comprehensive search was conducted across multiple databases: MEDLINE, Embase, Web of Science Core Collection, ProQuest, EconLit, and Health Technology Assessment. Data, methods, and results information were extracted and synthesized.

Results: A total of 1,981 records were identified across databases. Most were excluded due to irrelevant comparisons, non-US populations, or outcomes unrelated to utilization and cost (eg, mortality or hospitalization rates). Ultimately, 6 studies met the inclusion criteria. The most common reasons for exclusion were methodological limitations, such as reliance on cost-effectiveness simulation models or a primary focus on access barriers.

Conclusions: This systematic review reveals significant gaps in the real-world economic evaluation of DAA therapy. In particular, longitudinal data, geographic granularity, and state-specific analyses are lacking. Future research should address these limitations and further explore the long-term impacts of DAA therapy and variations in access and costs across different populations and insurance programs.

Background: Rheumatoid arthritis (RA) is the most common inflammatory joint disease worldwide. T-cell inhibitors, tumor necrosis factor inhibitors, interleukin inhibitors (ILIs), Janus kinase inhibitors, and B-cell depletion therapy are indicated as second-line therapy and are prescribed for other inflammatory autoimmune conditions (ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn disease, ulcerative colitis) co-occurring in an estimated 7% to 20% of patients with RA but are routinely excluded from RA studies. There is a lack of real-world evidence documenting treatment patterns in the large segment of patients with RA with inflammatory autoimmune comorbidities.

Objective: To describe RA medication utilization patterns among biologic-naive patients, with and without similarly treated comorbidities.

Methods: This retrospective cohort study uses administrative health claims from a large national health insurer between 2016 and 2022. Persistence, medication possession ratio (MPR), and utilization patterns were measured for patients with and without similarly treated comorbidities. Differences in means were calculated using a t-test, and Cox proportional hazards regression modeling was used to estimate persistence and hazard ratio (HR).

Results: A total of 22,946 patients with RA persisted on the index therapy for an average of 368.2 days (SD, 436). MPR varied across drug classes, with ILIs having the highest MPR at 0.95 (SD, 0.10) and B-cell depletion class having the lowest at 0.82 (SD, 0.19). Patients with RA with psoriatic arthritis were more likely to end the episode with therapy gap restart (HR, 1.1; CI, 1.02-1.22), yet patients with RA with psoriasis were less likely to experience a therapy gap restart (HR, 0.91; CI, 0.83-0.99). Among patients with RA initiated on ILIs, those with psoriasis are more likely to stop or switch compared with those without psoriasis (HR, 1.19; CI, 1.02-1.39). Among patients with RA initiated on Janus kinase inhibitors, those with psoriatic arthritis were more likely to stop or switch therapy compared with patients with RA without psoriatic arthritis (HR, 1.27; CI, 1.02-1.59).

Conclusions: RA medication utilization varied significantly and may be influenced by comorbidities differently across RA drug classes. More research is needed to understand why therapies like tumor necrosis factor inhibitors persist longer in patients with RA with ulcerative colitis yet are discontinued earlier in patients with psoriatic arthritis.

The Inflation Reduction Act empowered Medicare to negotiate drug prices for certain drugs, but the initial program guidance treated fixed-dose combination drugs separately, which would allow manufacturers of biologics to launch subcutaneous versions coformulated with hyaluronidase to defer negotiation eligibility, which we call "hyaluronidase hopping." In May 2025, the Centers for Medicare & Medicaid Services issued draft guidance requesting comments on a policy that could partially address hyaluronidase hopping by selecting and negotiating fixed-dosed combination products that contain therapeutically inactive ingredients (eg, hyaluronidase) alongside the original noncombination product. This proposed change was not adopted in the final guidance released in September 2025, although it will still be under consideration in future years. Adopting the proposed change is one of several policies needed to safeguard negotiation from hyaluronidase hopping to protect savings and patient access.

Background: During the pandemic, the US government loosened restrictions on telemedicine prescribing for controlled substance refills. Parent requests for attention-deficit/hyperactivity disorder (ADHD) medication refills have increased electronic inbox workload for physicians. Pharmacists can now fulfill these requests via collaborative practice agreements, but scant information exists on the effectiveness of this approach.

Objective: To compare pharmacist with pediatrician management of ADHD medication refill requests regarding quality, timeliness, and parent ratings.

Methods: This cluster randomized clinical trial assigned electronic ADHD medication refill requests from 63 medical facilities in a regional health care system to either Pharmacist Care by a regional team (32 facilities) or local Pediatrician Care (31 facilities) from May 14, 2024, to June 21, 2024. The primary outcome was prespecified in the study protocol as a quality measure to be evaluated among patients without weight and height recorded within 180 days before the refill request. This measure was based on national clinical guideline recommendations to monitor weight and height in children taking ADHD medications, which can be associated with reduced weight gain. It was met if the prescribing clinician collected a weight and height by parent report or initiated an in-person appointment.

Results: Among 2,442 eligible refill requests among study patients (mean age = 11.6 [SD = 3.1] years, 28.6% female), 512 received Pharmacist Care and 1,930 received Pediatrician Care; the latter group included 706 patients with unintended crossover from the group assigned to Pharmacist Care. Of the 793 refill requests eligible for evaluation of the primary outcome, 88.6% (132/149) with Pharmacist Care and 66.1% (426/644) with Pediatrician Care met the quality measure (adjusted rate ratio = 1.26; 95% CI = 1.13-1.40). Compared with pediatricians, pharmacists had slightly longer times to prescription ordering (median = 2.15 vs 1.78 hours, difference = 22 minutes) but similar times to medication filling and similar parent ratings of quality.

Conclusions: Pharmacist management yielded more consistent quality of care and similar timeliness and parent ratings as pediatrician management of electronic ADHD medication refill requests.Study registration number: ClinicalTrials.gov NCT06388694.

Background: Overprescribing of opioids has led to hundreds of thousands of overdose deaths and substantial health care costs. In response, the US Food and Drug Administration (FDA) implemented a revised Risk Evaluation and Mitigation Strategy (REMS) for opioids in 2018.

Objective: To evaluate trends in opioid prescribing by oncologists for Medicare Part D beneficiaries from 2014 to 2022.

Methods: This cross-sectional study used data from the 2014-2022 Medicare Part D Prescriber Public Use Files. Opioid claims and prescribing trends were assessed by opioid types, oncologist subspecialty, geographic region, and rurality status. An interrupted time series analysis was conducted to assess the changes in oncologists' prescribing patterns before and after the 2018 REMS modifications.

Results: The analysis included 25,371 unique oncologists, with the majority being male (66%) and specializing in hematology-oncology (47%). Over the study period, oncologists issued more than 9.4 million opioid prescriptions, with long-acting opioids accounting for 18% of these claims. Hematology-oncology specialists were responsible for the largest share of the prescriptions (67%). Oncologists practicing in the South and rural areas exhibited higher prescribing rates and longer average supply durations than those in other regions. A national sustainable decline in opioid prescribing was observed among oncologists between 2014 and 2022, with a significant immediate decline following 2018 in which the REMS changes were implemented.

Conclusions: The 2018 FDA REMS update coincided with significant declines in opioid prescribing by oncologists treating Medicare beneficiaries. Although other factors, such as the COVID-19 pandemic, may have also contributed to this decline, the sustained downward trend over time highlights the need for targeted policies and tailored provider education to ensure effective cancer pain management and to address persistent regional and rural-urban disparities in prescribing practices.

Background: Insurers increasingly use copay maximizer programs to control costs. Although these programs shield patients from out-of-pocket (OOP) exposure for drugs, the impact on OOP costs for other health care services is unknown.

Objective: To examine the impact of copay maximizer programs on overall patient liability for all health care services.

Methods: This retrospective analysis of pharmacy and medical claims from the IQVIA PharMetrics Plus database included patients who were required to have 3 or more prescriptions (for autoimmune, multiple sclerosis, or oral oncolytic drugs) in a calendar year between 2018 and 2022 and have been continuously enrolled in a commercial plan during that year. An algorithm was applied to identify patients with presumed exposure to a copay maximizer program within each calendar year. Patients with presumed exposure to a maximizer program in a given year and no exposure to a maximizer program in prior years were eligible for the maximizer cohort. Patients without presumed exposure to a maximizer program were eligible for the nonmaximizer cohort. Eligible patients were matched 1:1 for the study cohorts. The outcome of interest was the effect of copay maximizer programs on patient liability for other health care services (via a difference-in-difference [DiD]) approach using a generalized linear mixed-effects model).

Results: In total, 5,976 patients were included in the analysis. Assuming no change in total costs from baseline to follow-up, copay maximizer programs were associated with increased patient liability for other health care services. When patient liabilities for the maximizer drug in the baseline period were $125, there was no effect on patient liabilities for other health care services (DiD [95% CI] = 0.98 [0.71-1.37]), whereas at $4,000, there was a 51% increase in patient liabilities for other health care services (1.51 [1.17-1.95]). In scenario analyses for which total costs changed from baseline to follow-up, results were similar to the base case. In the patient subgroup with no other health care patient liability at baseline ($0), a greater proportion of those who participated in a copay maximizer program had some (>$0) patient liability for other health care services in the follow-up period, compared with patients who did not participate (94.3% vs 63.2%).

Conclusions: Our results indicated that copay maximizer programs are associated with an increase in patient liability for other health care services, especially for patients who relied heavily on the maximizer drug to meet deductible requirements or OOP maximums. These findings should be factored into decisions and policies on implementing and regulating these programs.