The impact of an interprofessional care transitions clinic on readmission rates and costs.

The objective of this study was to assess the effectiveness of the Interprofessional Care Transitions Clinic (ICTC) in reducing preventable readmissions and their associated costs among Medicare/Medicaid patients. A prospective cohort study was conducted among adults who were discharged from the University of Maryland Prince George's Hospital Center to assess the comparative effectiveness of a clinic-based intervention in terms of readmission events, potentially avoidable utilization, length of stay, and hospital charges. Outcomes were evaluated at 1 month, 3 months, and 6 months post-discharge. There were statistically significant differences in the following outcomes (follow-up period): proportion of readmissions (3 months), potentially avoidable utilization (1 month), and mean medical charges for ICTC patients compared to non-ICTC patients (1 month). This program was aimed at testing the impact of having an interprofessional team focused on providing holistic patient-centered care.

Continuity of Care and Mental Health Service Use Among Medicaid-enrolled Youths.

BACKGROUND: Recent reports of increased national estimates of pediatric psychiatric emergency department (ED) visits and psychiatric hospitalizations emphasize the need to research these utilization patterns. OBJECTIVES: To assess the patient-provider continuity of care (CoC) and compare the risk of psychiatric ED visits or hospitalization according to the CoC level. RESEARCH DESIGN: A cohort design was applied to Medicaid administrative claims data (2007-2014) for 3-16-year olds with a first psychiatric diagnosis between 2009 and 2013 (n=38,825). SUBJECTS: Continuously enrolled youths with (1) ≥1 outpatient psychiatric visits and (2) ≥4 pediatric outpatient visits in the prior 24 months. MEASURES: The authors assessed CoC in the 24 months before the first psychiatric outpatient visit and quantified CoC using the Alpha Index. The authors assessed patient-provider CoC before first psychiatric diagnosis and the odds of psychiatric ED visits or psychiatric hospitalizations in the year after diagnosis. RESULTS: Of the 38,825 youths, 88.9% received a first psychiatric diagnosis by age 14. The odds of ED visits were significantly higher among youths with low CoC [6.63%, adjusted odds ratio (AOR), 1.27; 95% confidence interval (CI), 1.13-1.41] or moderate CoC (5.76%; AOR, 1.14; 95% CI, 1.02-1.27) compared with those with high CoC (4.96%). Greater odds of psychiatric hospitalization related to low (7.53%; AOR, 1.17; 95% CI, 1.06-1.29) or moderate CoC (7.01%; AOR, 1.15; 95% CI, 1.03-1.27) compared with high CoC (6.06%). CONCLUSIONS: The odds of potentially disruptive clinical management and costly psychiatric ED visits or hospitalizations were lower for youths with high CoC. The findings support the need to research the impact of CoC on long-term pediatric mental health service use.

Exploring the Use of State Medical Cannabis Legislation as a Proxy for Medical Cannabis Use Among Patients Receiving Chemotherapy.

OPINION STATEMENT: The use of medical cannabis is expanding in the USA. Due to conflicting, low-quality evidence, many oncologists may not feel confident to recommend it to patients. Given the potential for legal and financial risks when conducting clinical trials with medical cannabis, the use of observational data should be explored. Observational data that directly capture medical cannabis use in relation to prescription medications and track the prevalence and patterns of cannabis use is sparse. To gain insights into the role medical cannabis plays in the pharmaceutical landscape, proxies such as cannabis legislation need to be explored. In the context of recommendation-nonadherent antiemetic prescribing among patients experiencing chemotherapy-induced nausea and vomiting, medical cannabis may be a suitable alternative to an antiemetic in states that allow medical cannabis. Findings suggest that legislation may impact the use of certain antiemetics in states with cannabis legislation in place. The presence or absence of legislation regarding medical cannabis use may serve as an early, observable surrogate marker of medical cannabis use in the community. In light of the paucity of clinical trials and observational datasets that capture cannabis use, there remains a tremendous need for the development of methodologies or standardized datasets that appropriately and reliably capture the use of medical cannabis to facilitate research into its clinical application and effect on prescription medication use. Standardizing the reporting and destigmatizing use could eliminate the dependence upon proxy measures as a substitute for more extensive data and go a long way in improving data capture, thus allowing us to generate knowledge and hypotheses from observational data until research conditions improve and allow for expanded clinical trials involving medical cannabis.

Follicular lymphoma treatment patterns between 2000 and 2014: a SEER-Medicare analysis of elderly patients.

Aim: Characterize follicular lymphoma (FL) treatment patterns among elderly patients using a dataset with longer follow-up time. Materials & methods: Using the linked Surveillance, Epidemiology and End Results-Medicare data, we identified patients diagnosed with FL between 2000 and 2013 with claims data until 2014. We investigated the treatments received and assigned them to lines of treatment. Results: We identified 10,238 elderly patients. Over a 4.7-year median follow-up, 78% of the patients received at least first-line treatment. Fewer individuals received second-line (47%) and third-line (30%) treatments. RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone), RCVP (rituximab, cyclophosphamide, vincristine and prednisolone) and rituximab monotherapy were the most common treatment regimens. Conclusion: One in five elderly patients did not receive FL-directed therapy. The most common treatment regimens were limited to RCHOP, RCVP and rituximab monotherapy.

Initiation of Transdermal Fentanyl Among US Commercially Insured Patients Between 2007 and 2015.

INTRODUCTION: This study examined patterns of initial transdermal fentanyl (TDF) claims among US commercially insured patients and explored the risk of 30-day hospitalization among patients with and without prior opioid exposure necessary to produce tolerance. DESIGN: A retrospective cohort study of initial outpatient TDF prescriptions. SETTING: A 10% random sample of commercially insured enrollees within the IQVIA Health Plan Claims Database (formerly known as PharMetrics Plus). SUBJECTS: Individuals with a claim for TDF between 2007 and 2015. METHODS: The primary exposure was a new transdermal fentanyl claim, and the primary outcome was guideline concordance based on time and dose exposure. RESULTS: Among the 24,770 patients in the cohort, 4,848 (20%) patients had sufficient time exposure to opioids before TDF. Among those with sufficient time exposure, 3,971 (82%) had adequate opioid exposure based on the US Food and Drug Administration (FDA) package insert dosing guidance. Overall, 3,971 of the 24,770 (16%) patients received guideline-consistent TDF. An exploratory analysis of 30-day hospitalization after a TDF claim did not detect a difference in odds between guideline-consistent or -inconsistent groups when adjusted for variables known to influence the risk of opioid-induced respiratory depression. CONCLUSIONS: A majority of patients met FDA opioid dose thresholds for TDF but had insufficient time exposure based on package insert recommendations for tolerance. Exploratory analysis did not detect a difference in odds for all-cause hospitalization or respiratory-related 30-day hospitalization between guideline-consistent or -inconsistent TDF claims. Prescribers should continue to adhere to FDA TDF labeling, although certain aspects of the labeling should be reevaluated or clarified.

PEER-REVIEWED JOURNAL EDITORS' VIEWS ON REAL-WORLD EVIDENCE.

OBJECTIVES: Peer-review publication is a critical step to the translation and dissemination of research results into clinical practice guidelines, health technology assessment (HTA) and payment policies, and clinical care. The objective of this study was to examine current views of journal editors regarding: (i) The value of real-world evidence (RWE) and how it compares with other types of studies; (ii) Education and/or resources journal editors provide to their peer reviewers or perceive as needed for authors, reviewers, and editors related to RWE. METHODS: Journal editors' views on the value of RWE and editorial procedures for RWE manuscripts were obtained through telephone interviews, a survey, and in-person, roundtable discussion. RESULTS: In total, seventy-nine journals were approached, resulting in fifteen telephone interviews, seventeen survey responses and eight roundtable participants. RWE was considered valuable by all interviewed editors (n = 15). Characteristics of high-quality RWE manuscripts included: novelty/relevance, rigorous methodology, and alignment of data to research question. Editors experience challenges finding peer reviewers; however, these challenges persist across all study designs. Journals generally do not provide guidance, assistance, or training for reviewers, including for RWE studies. Health policy/health services research (HSR) editors were more likely than specialty or general medicine editors to participate in this study, potentially indicating that HSR researchers are more comfortable/interested in RWE. CONCLUSIONS: Editors report favorable views of RWE studies provided studies examine important questions and are methodologically rigorous. Improving peer-review processes across all study designs, has the potential to improve the evidence base for decision making, including HTA.

Impact of Coordinated Behavioral Health Management on Quality Measures of Antipsychotic Use.

A state Care Management Entity (CME) using the wraparound practice model provided intensive care coordination for youth with severe mental illness, those most likely to receive antipsychotics. The model has led to improved clinical/functional outcomes, but little is known about the impact on antipsychotic prescribing and safety monitoring. A pre-post study was conducted to evaluate antipsychotic dosing, concomitant antipsychotic use, and metabolic monitoring among CME-enrolled and non-CME-enrolled comparison groups. CME-enrolled youth had greater decrease in concomitant antipsychotic use than non-CME-enrolled youth, but no difference in dosing or metabolic monitoring. More education of prescribing antipsychotics and team-based engagement in care coordination are needed.

Examining patient-provider relationship (PPR) quality and patient activation in the Medicare population.

BACKGROUND: Patient activation describes an individual's willingness and ability to take actions to independently manage health. Additional qualities of the relationship between a patient and provider may play a role in patient decision-making and motivation. AIMS: (1) To describe patient characteristics for groups who perceive different quality levels of PPR. (2) To examine the association and determine the effect of PPR on patient activation. METHODS: The Medicare Current Beneficiary Surveys was used to gather information on patient confidence, information seeking behaviors, and PPR. Scores for each variable set were categorized and described. Odds ratios were calculated using multinomial logistic regression models adjusting for sociodemographic variables. RESULTS: The study included 15,185 beneficiaries, 4198 (27.6 %) were categorized as low PPR, 6752 (44.5 %) were moderate PPR, and 4235 (27.9 %) high PPR. Adjusting for covariates, patients with moderate PPR and high PPR were more likely to have higher confidence when making healthcare decisions and exhibit information seeking behaviors compared to low PPR beneficiaries. DISCUSSION: This study supports the notion that patients with stronger relationships with their providers are also more active in healthcare decisions. After adjusting for gender, race, age, education, and income, high-quality PPR was still found to be associated with increased levels of activation in the Medicare population. CONCLUSIONS: High-quality patient-provider relationships are associated with improved patient confidence and information seeking behaviors. Provider-centered strategies to improve patients' connections to their physicians may motivate patients to engage in the healthcare process.

Foreword: Big Data and Its Application in Health Disparities Research.

The articles presented in this special issue advance the conversation by describing the current efforts, findings and concerns related to Big Data and health disparities. They offer important recommendations and perspectives to consider when designing systems that can usefully leverage Big Data to reduce health disparities. We hope that ongoing Big Data efforts can build on these contributions to advance the conversation, address our embedded assumptions, and identify levers for action to reduce health care disparities.

The Impact of Coverage Restrictions on Antipsychotic Utilization Among Low-Income Medicare Part D Enrollees.

Prior research demonstrates substantial access problems associated with utilization management and formulary exclusions for antipsychotics in Medicaid, but the use and impact of coverage restrictions for these medications in Medicare Part D remains unknown. We assess the effect of coverage restrictions on antipsychotic utilization in Part D by exploiting a unique natural experiment in which low-income beneficiaries are randomly assigned to prescription drug plans with varying levels of formulary generosity. Despite considerable variation in use of coverage restrictions across Part D plans, we find no evidence that these restrictions significantly deter utilization or reduce access to antipsychotics for low-income beneficiaries.

Patterns of Biologics Use Across Treatment Lines in Elderly (Age >65) Medicare Patients With Metastatic Colon Cancer.

BACKGROUND: We explored biologics receipt in metastatic colon cancer. METHODS: We used Surveillance, Epidemiology, and End Results-Medicare data of 4,545 elderly patients diagnosed with incident metastatic colon cancer from 2003 to 2009, treated with chemotherapy and/or biologics, and followed up through 2010. RESULTS: A total of 2,504 (55%) patients received a biologics-containing regimen. Treatment with biologics fluctuated between 46% and 63% of first-line regimens and 67% and 73% of second-line regimens. Bevacizumab accounted for 95% of first-line and 68% of second-line biologics use. Cetuximab accounted for 33% of second-line and 48% of third-line use. Panitumumab accounted for 5% of second-line and 27% of third-line use. The adjusted odds of biologics receipt decreased rapidly with age, resulting in a threefold difference between the youngest and the oldest study participants in the sample (odds ratio [OR] 0.35, p < .01). African Americans (OR 0.77, p = .03) and patients with Charlson Comorbidity Index of 1 (OR 0.83, p = .02) or >1 (OR 0.75, p < .01) were considerably less likely to receive biologics therapy. Medicare state buy-in was associated with 2% lower odds of receiving biologics (OR 0.98, p = .04). CONCLUSION: After controlling for sociodemographic and clinical differences, age, race, comorbidities, and low income had a statistically significantly negative effect on the likelihood of receiving biologics among treated patients. Use of biologics varied over time, across the treatment continuum, and by chemotherapy regimen. Bevacizumab was most frequently used in both first- and second-line treatment. Cetuximab was the second most prescribed biologic. Panitumumab use was mostly limited to third-line treatment. IMPLICATIONS FOR PRACTICE: It is well-known that patients in the "real world" receive cancer treatments that do not reflect the strict treatment protocols of clinical trials. This is particularly true for complex and elderly patients with metastatic disease, who are frequently underrepresented in clinical trials. Although this article does not provide any additional evidence about the effectiveness of one treatment regimen or treatment sequence over another, it enhances our understanding of oncology practice outside of the clinical trial setting and provides useful information for future health services and health economics research in metastatic colon cancer.

Algorithm for identifying chemotherapy/biological regimens for metastatic colon cancer in SEER-Medicare.

BACKGROUND: Metastatic colon cancer (mCC) patients often receive multiple lines of chemotherapy/biological treatment (TX), yet subsequent TX lines have not been sufficiently examined using SEER-Medicare data. We developed an algorithm that identifies the number and type of TX lines received by mCC patients. METHODS: The algorithm rules for detecting TX lines were developed a priori and applied to SEER-Medicare data for 7951 elderly mCC patients, diagnosed in 2003-2007 and followed through 2009. Statistical analysis estimated the relationship between the number of treatments received and patient characteristics. Sensitivity analyses examined how results changed when different algorithm rules were used. RESULTS: Only 41% (3266) of mCC patients received any chemotherapy/biologics treatment; 1440 (18% of all, 44% of treated) and 274 (3% of all, 8% of treated) received second-line and third-line treatment, respectively. Initial and subsequent treatment regimens varied widely. Results were robust to alterations in the algorithm. CONCLUSIONS: The number of drugs used to treat cancer patients has increased during the past decade. Patients may have several TX lines with complex regimens. More guidance is needed with regard to identifying and studying these interventions using SEER-Medicare data. By proposing 1 approach to categorizing TX lines for mCC patients, we hope to empower the scientific community and to advance the use of SEER-Medicare data for health outcomes research.

Measurement of skeletal related events in SEER-Medicare: a comparison of claims-based methods.

BACKGROUND: Skeletal related events (SREs) are common in men with metastatic prostate cancer (mPC). Various methods have been used to identify SREs from claims data. The objective of this study was to provide a framework for measuring SREs from claims and compare SRE prevalence and cumulative incidence estimates based on alternative approaches in men with mPC. METHODS: Several claims-based approaches for identifying SREs were developed and applied to data for men aged [greater than or equal to] 66 years newly diagnosed with mPC between 2000 and 2009 in the SEER-Medicare datasets and followed through 2010 or until censoring. Post-diagnosis SREs were identified using claims that indicated spinal cord compression (SCC), pathologic fracture (PF), surgery to bone (BS), or radiation (suggestive of bone palliative radiation, RAD). To measure SRE prevalence, two SRE definitions were created: 'base case' (most commonly used in the literature) and 'alternative' in which different claims were used to identify each type of SRE. To measure cumulative incidence, we used the 'base case' definition and applied three periods in which claims were clustered to episodes: 14-, 21-, and 28-day windows. RESULTS: Among 8997 mPC patients, 46 % experienced an SRE according to the 'base case' definition and 43 % patients experienced an SRE according to the 'alternative' definition. Varying the code definition from 'base case' to 'alternative' resulted in an 8 % increase in the overall SRE prevalence. Using the 21-day window, a total of 12,930 SRE episodes were observed during follow up. Varying the window length from 21 to 28 days resulted in an 8 % decrease in SRE cumulative incidence (RAD: 10 %, PF: 8 %, SCC: 6 %, BS: 0.2 %). CONCLUSIONS: SRE prevalence was affected by the codes used, with PF being most impacted. The overall SRE cumulative incidence was affected by the window length used, with RAD being most affected. These results underscore the importance of the baseline definitions used to study claims data when attempting to understand relevant clinical events such as SREs in the real world setting.

Racial disparities in urologist visits among elderly men with prostate cancer: a cohort analysis of patient-related and county of residence-related factors.

BACKGROUND: Factors contributing to the lower likelihood of urologist follow-up among African American (AA) men diagnosed with prostate cancer may not be strictly related to patient factors. The authors investigated the relationship between crime, poverty, and poor housing, among others, and postdiagnosis urologist visits among AA and white men. METHODS: The authors used linked cancer registry and Medicare claims data from 1999 through 2007 for men diagnosed with American Joint Committee on Cancer stage I to III prostate cancer. The USA Counties and County Business Patterns data sets provided county-level data. Variance components models reported the percentage of variation attributed to county of residence. Postdiagnosis urologist visits for AA and white men were investigated using logistic and modified Poisson regression models. RESULTS: A total of 65,635 patients were identified; 87% of whom were non-Hispanic white and 9.3% of whom were non-Hispanic AA. Approximately 16% of men diagnosed with stage I to III prostate cancer did not visit a urologist within 1 year after diagnosis (22% of AA men and 15% of white men). County of residence accounted for 10% of the variation in the visit outcome (13% for AA men and 10% for white men). AA men were more likely to live in counties ranked highest in terms of poverty, occupied housing units with no telephone, and crime. AA men were less likely to see a urologist (odds ratio, 0.65 [95% confidence interval, 0.6-0.71]; rate ratio, 0.94 [95% confidence interval, 0.92-0.95]). The sign and magnitude of the coefficients for the county-level measures differed across race-specific regression models of urologist visits. CONCLUSIONS: Among older men diagnosed with stage I to III prostate cancer, the social environment appears to contribute to some of the disparities in postdiagnosis urologist visits between AA and white men.

Hospital center effect for laparoscopic colectomy among elderly stage I-III colon cancer patients.

OBJECTIVE: To investigate hospital-level variation in short-term laparoscopic colectomy outcomes among stage I-III elderly colon cancer patients. BACKGROUND: Surgical outcomes are associated with patient and surgeon characteristics. If outcomes are also impacted by the hospital where the surgery occurs, there is a hospital center effect (HCE). METHODS: Surveillance, Epidemiology, and End Results (SEER)-Medicare data was used to identify stage I-III colon cancer patients treated with laparoscopic colectomies. Multilevel regressions were utilized to study potential HCE for length of stay (LOS), 30-day rehospitalization, and in-hospital mortality, adjusting for patient, surgeon, and hospital-level characteristics. To quantify HCE, we calculated the median instantaneous rate ratio (MIRR) for LOS and median odds ratio (MOR) for in-hospital mortality and 30-day rehospitalization. Sensitivity analyses were conducted for high volume/medical school affiliated hospitals and colorectal surgeons. RESULTS: The multilevel analyses based on 4617 patients from 465 hospitals documented statistically significant HCEs for LOS (MIRR = 1.35; P < 0.001) and in-hospital mortality (MOR = 1.69; P = 0.032), but no HCE for 30-day rehospitalization. Sensitivity analyses confirmed our findings. HCE was significant for LOS in all sensitivity analyses and was significant for in-hospital mortality for high volume/medical school affiliated hospitals. CONCLUSIONS: HCE exists for LOS and in-hospital mortality of laparoscopic colectomy, which suggests that the choice of hospital affects outcomes independently of other confounding variables. Reducing the variation in outcomes associated with HCE may improve the quality of cancer care.

Clinical and economic burden of bone metastasis and skeletal-related events in prostate cancer.

PURPOSE OF REVIEW: We review the clinical trials and observational studies literature regarding the clinical and economic burden of bone metastasis and skeletal-related events (SREs) in prostate cancer, and discuss current gaps in understanding the impact of bone metastasis in this disease. RECENT FINDINGS: Trial data indicate that SREs occur in half of prostate cancer patients with bone metastasis in the absence of treatment, and 30-45% among those who receive bone-modifying agents. In the United States, the cost of SRE ranged from $7553 per radiation episode to $88 838 per bone surgery episode. Prevalence of SRE, time to SRE occurrence, and cost of SRE varied across studies because of differences in study populations, follow-up period, and the algorithm used to measure SRE. There is limited evidence on the clinical and economic impact by SRE subtype. Information regarding patient-reported outcomes and costs from the patient's perspective is lacking. SUMMARY: Bone metastasis and SREs in prostate cancer patients are associated with considerable morbidity, reduced survival, and substantial economic burden. Consistent study methodology, particularly the measurement of SREs, is necessary to allow comparison of estimates across studies. The inclusion of patient-centered clinical and economic outcomes in future research will provide pertinent information regarding the burden of bone metastasis and SREs.

Concordance between administrative claims and registry data for identifying metastasis to the bone: an exploratory analysis in prostate cancer.

BACKGROUND: To assess concordance between Medicare claims and Surveillance, Epidemiology, and End Results (SEER) reports of incident BM among prostate cancer (PCa) patients. The prevalence and consequences of bone metastases (BM) have been examined across tumor sites using healthcare claims data however the reliability of these claims-based BM measures has not been investigated. METHODS: This retrospective cohort study utilized linked registry and claims (SEER-Medicare) data on men diagnosed with incident stage IV M1 PCa between 2005 and 2007. The SEER-based measure of incident BM was cross-tabulated with three separate Medicare claims approaches to assess concordance. Sensitivity, specificity and positive predictive value (PPV) were calculated to assess the concordance between registry- and claims-based measures. RESULTS: Based on 2,708 PCa patients in SEER-Medicare, there is low to moderate concordance between the SEER- and claims-based measures of incident BM. Across the three approaches, sensitivity ranged from 0.48 (0.456 - 0.504) to 0.598 (0.574 - 0.621), specificity ranged from 0.538 (0.507 - 0.569) to 0.620 (0.590 - 0.650) and PPV ranged from 0.679 (0.651 - 0.705) to 0.690 (0.665 - 0.715). A comparison of utilization patterns between SEER-based and claims-based measures suggested avenues for improving sensitivity. CONCLUSION: Claims-based measures using BM ICD 9 coding may be insufficient to identify patients with incident BM diagnosis and should be validated against chart data to maximize their potential for population-based analyses.

Discriminatory power of a 25-item distress screening tool: a cross-sectional survey of 251 cancer survivors.

OBJECTIVE: The objective was to test the discriminatory power of a 25-item distress screening tool for use among cancer survivors. We used a measure of item discrimination to determine which items perform better than others at identifying those at greatest risk of distress. METHODS: A total of 251 members (90 % female, median age 57 years) of a community-based cancer support organization completed a web-based distress screening tool. Participants were asked to rate each of 25 items according to the question "Today, how concerned are you about…?" using a five-point Likert scale (0 not at all to 4 very seriously concerned). An overall distress score was calculated as the sum of items rated at or above two for somewhat concerned. Participants were categorized as high scorers (≥13, n = 59) and low scorers (≤4, n = 60). The item discrimination index (IDI) was calculated for each item as the percentage difference in concerned (somewhat or greater) responses between high and low scorers. RESULTS: Items with the greatest discriminatory power (IDI ≥0.8) were as follows: changes or disruptions in work, school or home life; feeling sad or depressed; feeling too tired to do the things you need or want to do; worrying about the future and what lies ahead; and feeling nervous or afraid. Conversely, items with the lowest IDI included considering taking your own life; eating and nutrition; tobacco or substance use; and transportation to treatment and appointments. CONCLUSION: The results highlight, among 25 items of a community-based distress screening tool, items with the greatest discriminatory power to identify cancer survivors with psychosocial distress. Results suggest targeted screening items to identify those most at risk for distress and priority areas for support services.

Impact of manufacturer-initiated list price reduction on patient out-of-pocket costs for PCSK9 inhibitors.

BACKGROUND: Because of concerns of cost-effectiveness and low utilization, in 2018, manufacturers initiated a 60% price reduction for PCSK9 inhibitors, reducing the list price from more than $14,000 to $5,850. The goal of the reduction was to increase access and lower patient cost sharing for PCSK9 inhibitors. OBJECTIVE: To determine whether list price reductions resulted in a statistically significant decrease in patient cost sharing for PCSK9 inhibitors. The secondary objective is to quantify the change in monthly out-of-pocket (OOP) cost in the years following the price reduction policies. METHODS: This analysis uses a cross-sectional quasi-experimental design, with 2 time periods, to estimate the change in monthly OOP cost. A 2-stage cost model was used to quantify the difference in mean monthly OOP cost between the preprice and postprice reduction periods. This analysis was completed using IQVIA PharMetrics Plus for Academics health plan claims for PSCK9 inhibitors between January 2016 and December 2021 for commercially insured individuals in the United States. The primary exposure of interest is a manufacturer-initiated list price reduction in October 2018. The primary outcome of interest is the difference in the predicted monthly OOP cost between the prereduction and postreduction periods. RESULTS: There was a 50% decrease in the predicted monthly OOP cost, from $235.22 (SD = $241) in the prereduction period to $116.75 (SD = $152) in the postreduction period. CONCLUSIONS: This claims level analysis used robust statistical modeling techniques to quantify the effect of manufacturer-initiated price reductions on monthly OOP cost. This unique manufacturer decision resulted in a statistically significant decrease in the monthly OOP cost for beneficiaries using PCSK9 inhibitors. Manufacturer-initiated price reductions could be a strategy to reduce the cost for other therapies with access and cost concerns. Further research is needed on the downstream patient-level effects of cost reductions, particularly among individuals who experience multiple barriers to care.