Medicare Advantage Prescription Drug Plan Research Articles

Real-World Incidence and Management of Immune-Related Adverse Events from Immune Checkpoint Inhibitors: Retrospective Claims-Based Analysis

Purpose We assessed real-world spectrum and patterns of irAEs for patients treated with anti-PD(L)1 ICIs. Methods irAEs were defined using medical and pharmacy claims for patients enrolled in a Medicare Advantage Prescription Drug plan who initiated treatment with anti-PD(L)-1 and received ≥ 1 dose of therapy between 1 September 2014 and 28 February 2018. Results Treatment was discontinued for 46.6% of patients, and withheld and subsequently restarted for 10.3%. While toxicity profiles did not differ by age, RiskRx-V co-morbidity index was higher in patients with irAEs. Conclusion These data underscore the needs for tailored irAE diagnostic and management pathways.

The Impact of Opioid Safety Edits on Opioid Utilization.

Objective To evaluate the impact of opioid safety edits on opioid utilization. Design Retrospective review. Setting Senior Care Action Network (SCAN) Health Plan, a Medicare Advantage Prescription Drug Plan. Patients, Participants The opioid safety edits reviewed included edits for the following: initial opioid fill more than 7 days' supply (DS), cumulative opioid doses 90 or greater and 240 or greater morphine milligram equivalent (MME), concurrent opioid and benzodiazepine (COB) use. Members with prescription drug claims meeting these criteria pre- and postedit implementation and those with prescription drug claim rejections resulting from the edits were included in the review. Results 15,232 members experienced claim rejections resulting from the edits. Comparison of utilization pre and postedit implementation revealed the following results (P < 0.001): 41% decrease in the proportion of members with an initial opioid fill for more than 7 DS; 18% decrease in the proportion of members on opioid doses 90 MME or more; 26% decrease in the proportion of members on opioid doses 240 MME or more; 18% decrease in the proportion of members with COB. Conclusion Opioid safety edits are an effective way to combat overuse and misuse. They serve as a means for increasing collaboration between plans, prescribers, pharmacists, and members which improves care coordination, reduces adverse risks, and helps keep members safe.

Real-world treatment, clinical outcomes and healthcare resource utilization among persons with hemophilia A by age.

Aim: Examine real-world characteristics, treatment patterns, and outcomes among treated persons with hemophilia A (PwHA) stratified by age. Patients & methods: This study utilized US claims data from 1 January 2007-31 July2018 from the Humana Research Database. Unadjusted comparisons were conducted across PwHA (<18, 18-55, 56-89years) enrolled in commercial or Medicare Advantage Prescription Drug plans. Results: A total of 294 PwHA were identified; 21.1% experienced ≥1 bleeding event, and 41.2and 53.1% had evidence of arthropathy or related disorders, and pain, respectively. Along with all-cause and hemophilia-related healthcare resource utilization (HCRU), these were highest among PwHA aged 56-89years. Conclusion: Insights into treatment, outcomesand HCRUmay identify opportunities for enhanced disease management, particularly in older PwHA.

Association of low-income subsidy, medicaid dual eligibility, and disability status with high-risk medication use among Medicare Part D beneficiaries.

Low-income subsidy/dual eligibility (LIS/DE) status and disability status may be associated with high-risk medication (HRM) use but are not usually accounted for in medication-use quality measures. To examine the association of: 1) LIS/DE status and HRM use; and 2) disability status and HRM use, while controlling for both health plan level effects and patient characteristics for Medicare beneficiaries enrolled in Medicare Advantage Prescription Drug Plans (MA-PD) and stand-alone Prescription Drug Plans (PDP). This retrospective cross-sectional study used 2013 Medicare data to determine if LIS/DE status and disability status were independently associated with HRM use (using the Pharmacy Quality Alliance HRM measure) in MA-PDs and PDPs. Multivariable generalized linear mixed models assessed the association of LIS/DE and HRM use, and disability and HRM use, after adjusting for health plan effect and patient-level confounders for MA-PD and PDP beneficiaries. Of 520,019MA-PD beneficiaries, 88,693 (17.1%) were LIS/DE and 48,997 (9.4%) were disabled. Of 881,264 PDP beneficiaries, 213,096 (24.2%) were LIS/DE, and 83,593 (9.5%) were disabled. LIS/DE beneficiaries had a higher percent of HRM users compared to non-LIS/DE MA-PD (13.3% vs. 9.7%, p<0.001) and PDP (17.1% vs. 13.2%, p<0.001) beneficiaries. Disabled beneficiaries had a higher percent of HRM users compared to non-disabled MA-PD (17.0% vs. 9.6%, p<0.001) and PDP (22.9% vs. 13.2%, p<0.001) beneficiaries. Multivariable analyses showed LIS/DE (adjusted odds ratio [AOR]=1.07; 95% CI=1.04, 1.10) and disability (AOR=1.38; 95% CI=1.34, 1.42) were associated with HRM use among MA-PD and PDP beneficiaries (LIS/DE AOR=1.14; 95% CI=1.12, 1.16; disability AOR=1.37; 95% CI=1.34, 1.40). The association of LIS/DE and disability with higher HRM use in both MA-PD and PDP beneficiaries, when controlling for health plan effects and patient characteristics, suggests these factors should be considered when comparing health plan performance on HRM measures.

Novel Approach Using Administrative Claims to Evaluate Trends in Oncology Multigene Panel Testing for Patients Enrolled in Medicare Advantage Health Plans.

PURPOSETo develop an approach to identify and evaluate recent use of multigene panel testing over time.METHODSWe conducted a retrospective database analysis using medical and pharmacy claims data. Medicare Advantage Prescription Drug Plan members diagnosed with select malignant solid tumors were identified. The pattern of somatic genetic testing for each patient was evaluated from January 2016 through December 2018. Tests were classified by the number of genes tested in the panel: < 50 (small or medium) and ≥ 50 (large).RESULTSAn initial feasibility study using our novel approach for identifying panel tests resulted in 2.4 and 1.2 times more large and medium panels, respectively, identified compared with using procedure codes alone. A total of 121,675 eligible patients were identified, with 131,915 unique cancer cases. Overall, 5,457 (4.5%) patients received any panel test from 2016 to 2018. We found the number of tests performed each quarter increased from 238 in Q1 of 2016 to 755 in Q4 of 2018. The highest number of cases were genitourinary cancers; however, the highest proportion of cancer-related genetic testing was among patients with respiratory cancer. Across all tumor types, the proportion of large-panel tests performed as a function of all multigene panel tests increased from 20.7% of tests in Q1 of 2016 to 46.4% of tests in Q4 of 2018. The three cancer categories with the highest count of cancer-related panel tests, respiratory cancer, GI cancer, and female reproductive cancer, had a consistently greater proportion receiving a panel test at any point postindex.CONCLUSIONAcross a variety of cancers, use of somatic, large-panel cancer-related genetic testing, as a proportion of all somatic cancer-related genetic testing, increased from 2016 to 2018, although testing overall was low.

Variability of COPD inhaler coverage in Medicare Part D

Stand-alone prescription drug plans (S-PDPs) and Medicare Advantage prescription drug (MA-PD) plans are incentivized to cover outpatient medications differently. This could affect the coverage of inhalers that prevent costly exacerbations of chronic obstructive pulmonary disease (COPD), with impacts for the Medicare program and its beneficiaries. This study compared the coverage of guideline-recommended COPD inhalers between S-PDPs and MA-PD plans. A cross-sectional analysis of the formularies for all 689 S-PDPs and 2578 MA-PD plans offered in 2017. We assessed each prescription drug plan's coverage of inhalers in 6 therapeutic categories recommended by the 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) report and compared the use of prior authorization, step therapy, and coinsurance between S-PDPs and MA-PD plans. In 2017, all S-PDPs and MA-PD plans covered at least 1 inhaler from each GOLD therapeutic category, except for long-acting β agonist/long-acting muscarinic antagonist combination inhalers. S-PDPs were more likely to require coinsurance for inhalers across all therapeutic categories, whereas MA-PD plans required prior authorization more frequently for 3 of the 6 therapeutic categories. S-PDPs required coinsurance more frequently than MA-PD plans for inhalers that treat mild (20.8% vs 11.4%; P < .001), moderate (40.0 vs 13.2%; P < .001), and severe (45.4% vs 11.0%; P < .001) disease. Medicare Part D S-PDPs are more likely than MA-PD plans to require coinsurance for outpatient COPD inhalers, especially for severe disease. This likely reflects their different financial incentives and is an important consideration for providers and policy makers aiming to improve outpatient COPD management.

Treatment patterns for patients with advanced/metastatic cancers by site of care.

To compare treatments, overall survival (OS), and total costs among patients receiving anticancer therapy in hospital outpatient vs physician office settings. This retrospective observational study utilized claims data from a large national health plan to identify patients with advanced/metastatic non-small cell lung cancer (aNSCLC), metastatic colorectal cancer (mCRC), or metastatic breast cancer (mBC) treated in hospital outpatient or physician office settings. Patients enrolled in Medicare Advantage Prescription Drug or commercial plans for at least 180 days prior to and at least 30 days after start of first-line (1L) therapy were included. Treatments by lines of therapy, OS, and total costs were evaluated by site of care. Eligible patients included 4618 with aNSCLC, 2304 with mCRC, and 1411 with mBC. There were no major differences in 1L, second-line, or third-line therapy by site of care. Patients with aNSCLC in physician office had longer 1L duration (hospital outpatient, 96 days vs physician office, 102 days; P < .01), but there were no differences in duration of therapy by site of care for mBC or mCRC. Costs were higher in the hospital outpatient setting for mCRC and mBC, but there were no differences in OS for any of the cancers. Although patients received similar care in hospital outpatient and physician office settings, the differences in duration of treatment and costs warrant further evaluation.

Projected 30-day out-of-pocket and total spending on pancreatic enzyme replacement therapy under Medicare Part D.

401 Background: Pancreatic enzyme replacement therapy (PERT) can reduce symptoms of indigestion and improve nutrition in patients with exocrine pancreatic insufficiency. PERT is under-prescribed, and this may be related to actual costs and prescriber sensitivity to these costs. Thus, we aimed to assess PERT costs. Methods: We used Medicare Part D formulary and pricing files for the first quarter of 2020 to conduct a patient-level modeling study to describe point-of-sale and out-of-pocket costs for each PERT formulation among Part D stand-alone and Medicare Advantage prescription drug plans. We calculated costs across nationwide plans under three scenarios: (1) standard benefit design ($435 deductible and 25% coinsurance after the deductible is met); (2) 25% coinsurance (for fills after the deductible and in the coverage gap until the patient spends $6,350 out-of-pocket); and (3) 5% coinsurance (once catastrophic coverage is reached). PERT doses are identified by the lipase content per capsule (in United States Pharmacopeia, USP, units). We calculated the number of units for each PERT formulation/ dose form that would provide optimally dosed PERT for the average US adult (250,000 USP units of lipase per day), based on guidelines and consensus. We first calculated costs for a single unit of PERT. Next, we calculated the number of units needed daily for each formulation/ dose form to provide optimally dosed PERT, and multiplied it by 30 to generate 30-day requirements and costs. Results: Across 3,974 plans nationwide, five PERT formulations in seventeen different doses were covered by Medicare plans in 2020. The range of lipase content in a single unit ranged from 3,000 to 40,000 USP units, and the per-unit list price ranged from $1.44 to $13.89. The point-of-sale price for a 30-day supply of optimally dosed PERT ranged from $2,109 to $4,840. For patients, the expected out-of-pocket costs for a 30-day supply of optimally dosed PERT averaged $999 across formulations (range, $853 to $1536) for those paying a deductible and coinsurance, $673 (range, $527 to $1210) for fills made after meeting the deductible until reaching catastrophic coverage, and $135 (range, $105 to $242) after reaching catastrophic coverage. Conclusions: In this analysis of 2020 Medicare Part D plans, the estimated out-of-pocket cost for just a 30-day supply of optimally dosed PERT was high— at least $100 in the catastrophic phase and approximately $1,000 in the initial phase. In the setting of pancreas cancer, already associated with heavy symptom burden and distress, the financial burden from a supportive care intervention (such as PERT) has been underappreciated. These costs may serve as a barrier to Medicare beneficiary drug access and contribute to financial toxicity.

Characteristics of Parkinson's Disease in Patients with and without Cognitive Impairment.

Background:Characterizing patients with Parkinson’s disease (PD) and cognitive impairment is important toward understanding their natural history.Objective:Understand clinical, treatment, and cost characteristics of patients with PD pre- and post-cognitive impairment (memory loss/mild cognitive impairment/dementia or dementia treatment) recognition.Methods:2,711 patients with PD newly diagnosed with cognitive impairment (index) were identified using administrative claims data. They were matched (1:1) on age and gender to patients with PD and no cognitive impairment (controls). These two cohorts were compared on patient characteristics, healthcare resource utilization, and total median costs for 3 years pre- and post-index using Chi-square tests, t-tests, and Wilcoxon rank-sum tests. Logistic regression was used to identify factors predicting cognitive impairment.Results:Comorbidity indices for patients with cognitive impairment increased during the 6-year study period, especially after the index. Enrollment in Medicare Advantage Prescription Drug plans vs. commercial (OR = 1.60), dual Medicare/Medicaid eligibility (OR = 1.36), cerebrovascular disease (OR = 1.24), and PD medication use (OR = 1.46) were associated with a new cognitive impairment diagnosis (all p < 0.05). A greater proportion of patients with cognitive impairment had hospitalizations and emergency department visits and higher median total healthcare costs than controls for each year pre- and post-index.Conclusion:In patients with PD newly diagnosed with cognitive impairment, comorbidity burden, hospitalizations, emergency department visits, and total costs peaked 1-year pre- and post-identification. These data coupled with recommendations for annual screening for cognitive impairment in PD support the early diagnosis and management of cognitive impairment in order to optimize care for patients and their caregivers.

Biosimilar formulary placement in Medicare Part D prescription drug plans: A case study of infliximab.

Biosimilars can generate competition and provide cost savings over reference biologics for the Medicare program and beneficiaries. The extent to which these benefits can be realized in the Medicare Part D program depends on how biosimilars and biologics are placed in the formulary. We conducted a study to examine Medicare formulary placement of the first biologic to have 2 biosimilars on the market-infliximab and its biosimilars infliximab-dyyb and infliximab-abda. All standalone and Medicare Advantage (MA) prescription drug plans (PDPs) offered in Medicare Part D were examined between September 2016 (ie, at the end of the last quarter before the launch of the first infliximab biosimilar) and September 2018, at which time a second biosimilar had been on the market for about 14 months. When PDPs covered both the reference biologic and a biosimilar, we compared the cost-sharing tier and the frequency of prior authorization and step therapy requirements for each drug. Nearly all PDPs covered infliximab throughout the study period. By September 2018, 31.7% of MA plans and 14.9% of standalone PDPs were covering a biosimilar on the market. Nearly all plans that covered a biosimilar also covered the reference product. Most plans (98% of standalone PDPs and 89% of MA plans) had placed prior authorization restrictions on both the biologic and the biosimilar. All plans covering both products placed them in the same cost-sharing tier. No plan required step therapy for either product. Formulary placement of infliximab biologic and biosimilars in Medicare Part D is not optimized to generate cost savings for the Medicare program and beneficiaries, whose cost sharing is often based on the drug's list price. The Medicare program should provide incentives for PDPs to expand biosimilar coverage.

Geographic Variation in the Prevalence of High-Risk Medication Use Among Medicare Part D Beneficiaries by Hospital Referral Region.

Understanding geographic patterns of high-risk medication (HRM) prescribed and dispensed among older adults may help the Centers for Medicare & Medicaid Services and their partners develop and tailor prevention strategies. To compare the geographic variation in the prevalence of HRM use among Medicare Part D beneficiaries from 2011 to 2013, for Medicare Advantage Prescription Drug (MA-PD) plans and stand-alone Prescription Drug Plans (PDPs). This retrospective study used the data of a 5% national Medicare sample (2011-2013). Beneficiaries were included in the study if they were aged ≥ 65 years, continuously enrolled in MA-PDs or PDPs (~1.3 million each year), and had ≥ 2 prescriptions for the same HRM (e.g., amitriptyline) prescribed and dispensed during the year based on the Pharmacy Quality Alliance's (PQA) quality measures for HRM use. Multivariable logistic regression was used to estimate adjusted annual HRM use rates (i.e., adjusted predictions, average marginal predictions, or model-adjusted risk) across 306 Dartmouth Atlas of Health Care hospital referral regions (HRRs), controlling for sociodemographic, health-status, and access-to-care factors. Among eligible beneficiaries each year (1,161,076 in 2011, 1,237,653 in 2012, and 1,402,861 in 2013), nearly 40% were enrolled in MA-PD plans, whereas the remaining 60% were in PDP plans. The adjusted prevalence of HRM use significantly decreased among Medicare beneficiaries enrolled in MA-PD (13.1%-8.4%, P < 0.001) and PDP (16.2%-12.2%, P < 0.001) plans from 2011 to 2013. For MA-PD and PDP beneficiaries, HRM users were more likely to be (all P < 0.001) the following: female (MA-PD: 70.4% vs. 59.9%; PDP: 72.8% vs. 62.5%); White (MA-PD: 84.6% vs. 81.4%; PDP: 86.6% vs. 85.3%); with low-income subsidy or dual eligibility for Medicaid (MA-PD: 22.3% vs. 16.6%; PDP: 29.2% vs. 23.3%); and disabled (MA-PD: 15.6% vs. 8.7%; PDP: 15.4% vs. 8.5%) compared with non-HRM users in 2013. In 2013, significant geographic variation existed, with the ratios of 75th-25th percentiles of HRM use rates across HRRs as 1.42 for MA-PDs and 1.31 for PDPs. For MA-PDs, the top 5 HRRs with the highest HRM use rates in 2013 were Casper, WY (20.4%), Waco, TX (16.7%), Lubbock, TX (15.7%), Santa Barbara, CA (15.2%), and Temple, TX (15.1%); for PDPs, they were Lawton, OK (18.8%), Alexandria, LA (18.8%), Lake Charles, LA (18.6%), Oklahoma City, OK (18.0%), and Slidell, LA (18.0%). Substantial geographic variation exists in the prevalence of HRM use among older adults in Medicare, regardless of prescription drug plan. Areas with high prevalence of HRM use may benefit from targeted interventions (e.g., medication therapy management monitoring or alternative medication substitutions) to prevent potential adverse consequences. No outside funding supported this study. The authors have nothing to disclose. This study was presented as a poster at the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) Asia Pacific Meeting; September 8-11, 2018; Tokyo, Japan.

Understanding Treatment of Severe Anemia due to CKD: A Descriptive Study in Non-Dialysis Medicare Advantage Prescription Drug Plan Patients

Understanding Treatment of Severe Anemia due to CKD: A Descriptive Study in Non-Dialysis Medicare Advantage Prescription Drug Plan Patients

Phenotypic clustering of heart failure with preserved ejection fraction reveals different rates of hospitalization.

Approximately 50% of patients with heart failure have preserved (≥50%) ejection fraction (HFpEF). Improved understanding of the phenotypic heterogeneity of HFpEF might facilitate development of targeted therapies and interventions. This retrospective study characterized a cohort of patients with HFpEF based on similar clinical profiles and evaluated 1-year heart failure related hospitalization. Enrolment, medical and pharmacy data were used to identify patients newly diagnosed with heart failure enrolled in a Medicare Advantage Prescription Drug or commercial healthcare plan. To identify only those patients with HFpEF, we used natural language processing techniques of ejection fraction values abstracted from a linked free-text clinical notes data source. The study population comprised 1515 patients newly identified with HFpEF between 1 January 2011 and 31 December 2015. Using unsupervised machine learning, we identified three distinguishable patient clusters representing different phenotypes: cluster-1 patients had the lowest prevalence of heart failure comorbidities and highest mean age; cluster-2 patients had higher prevalence of metabolic syndrome and pulmonary disease, despite younger mean age; and cluster-3 patients had higher prevalence of cardiac arrhythmia and renal disease. Cluster-3 had the highest 1-year heart failure related hospitalization rates. Within-cluster analysis, prior use of diuretics (cluster-1 and cluster-2) and age (cluster-2 and cluster-3) was associated with 1-year heart failure related hospitalization. Combination therapy was associated with decreased 1-year heart failure related hospitalization in cluster-1. This study demonstrated that clustering can be used to characterize subgroups of patients with newly identified HFpEF, assess differences in heart failure related hospitalization rates at 1 year and suggest patient subtypes may respond differently to treatments or interventions.

Comparing patient OOP spending for specialty drugs in Medicare Part D and employer-sponsored insurance.

Per capita spending on specialty drugs increased 55% between 2014 and 2018. Individuals aged 55 to 75 years using specialty drugs make the transition from employer-sponsored insurance (ESI) to Medicare Part D coverage. We compared out-of-pocket (OOP) spending across ESI, Medicare fee-for-service (FFS), and Medicare Advantage (MA) prescription drug plans to examine the impact of benefit design on OOP spending. Analyses consisted of Truven MarketScan and Medicare Part D prescription drug claims from 2013 to 2017 for individuals enrolled in ESI, FFS, and MA drug plans taking at least 1 drug among the top 4 specialty drug classes: rheumatoid arthritis (RA), multiple sclerosis (MS), cancer, and hepatitis C. Multivariate regression analyses with fixed effects were used to assess whether there are differences in OOP spending by insurance type and the impact of benefit design differences. A secondary outcome was drug choice within a therapeutic class. There were small differences in drug choice between Medicare and ESI but significant differences in OOP spending. Monthly OOP spending for ESI relative to FFS was $108 less for RA drugs, $288 less for MS drugs, $504 less for cancer drugs, and $1437 less for hepatitis C drugs. Spending was slightly greater for beneficiaries in MA plans compared with FFS. Higher Medicare spending was driven by gaps in coverage in the Part D benefit phases because beneficiaries pay a percentage of list price. OOP spending was substantially higher for Medicare enrollees compared with ESI enrollees as a result of the Part D benefit structure.

Do physician incentives increase patient medication adherence?

To test the effectiveness of physician incentives for increasing patient medication adherence in three drug classes: diabetes medication, antihypertensives, and statins. Pharmacy and medical claims from a large Medicare Advantage Prescription Drug Plan from January 2011 to December 2012. We conducted a randomized experiment (911 primary care practices and 8,935 nonadherent patients) to test the effect of paying physicians for increasing patient medication adherence in three drug classes: diabetes medication, antihypertensives, and statins. We measured patients' medication adherence for 18 (6) months before (after) the intervention. We obtained data directly from the health insurer. We found no evidence that physician incentives increased adherence in any drug class. Our results rule out increases in the proportion of days covered by medication larger than 4.2 percentage points. Physician incentives of $50 per patient per drug class are not effective for increasing patient medication adherence among the drug classes and primary care practices studied. Such incentives may be more likely to improve measures under physicians' direct control rather than those that predominantly reflect patient behaviors. Additional research is warranted to disentangle whether physician effort is not responsive to these types of incentives, or medication adherence is not responsive to physician effort. Our results suggest that significant changes in the incentive amount or program design may be necessary to produce responses from physicians or patients.

Treatment Patterns and Characteristics of Individuals Initiating High-Dose Insulin for Type 2 Diabetes Mellitus.

Few studies have examined patient characteristics and treatment patterns of high-dose insulin therapy (> 200 units/day) among patients with type 2 diabetes mellitus (T2DM). To understand patient characteristics, dosing, adherence, and persistence related to high-dose insulin therapy. This was a retrospective observational study that used administrative claims from a large national health plan. Patients were identified who had been diagnosed with T2DM and who were aged 18-89 years, enrolled in a commercial or Medicare Advantage Prescription Drug plan, newly initiated on a total daily dose (TDD) > 200 units of insulin between January 2011 and August 2015. Patients were required to be enrolled 6 months before and 12 months after the index date. Patients were categorized to Regimen-100 if treated with U-100 insulin only or Regimen-500 if treated with U-500R with or without U-100. Baseline demographic and clinical characteristics were evaluated. An adjustment factor for the days supply was calculated as the ratio of median time between insulin claims, and median pharmacy reported days supply for each insulin prescription. Adjusted days supply, quantity, and concentration were used to calculate TDD for each quarter after the index date. Adherence was measured as the proportion of days covered (PDC) for each regimen. Persistence was measured in 2 ways: the percentage of patients remaining on index medications in each quarter and the proportion of patients who maintained TDD > 200 units during all 4 quarters of the 12-month post-index period. We identified 2,339 patients newly titrated up to TDD > 200 units on either Regimen-100 (2,062, 88.2%) or Regimen-500 (277, 11.8%). Patients on Regimen-500 were slightly younger with higher prevalence of comorbidities. The mean TDD (SD) for Regimen-100 decreased from 228.6 (36.0) units during the first quarter to 194.2 (181.4) units during the last quarter. The mean TDD (SD) for Regimen-500 increased from 294.2 (102.2) units in the first quarter to 304.8 (281.6) units in last quarter. The average adherence to the high-dose insulin regimen was 68.2% (30.7; median 72.6%) for the Regimen-100 cohort and 75.5% (27.0; median 85.2%) for the Regimen-500 cohort. In the Regimen-100 and Regimen-500 cohorts, 45.3% and 55.2% had a PDC ≥ 80%, respectively. Only 23.0% and 51.6% of patients maintained TDD > 200 units for the Regimen-100 and Regimen-500 cohorts, respectively, throughout the 4 quarters after the index date. We observed that many patients did not maintain high-dose insulin use over time, especially those on standard U-100 insulin only. This dosing pattern appears to reflect the differences in patient characteristics, insulin needs, and adherence/persistence behavior between those on Regimen-100 and those on Regimen-500. This study was supported by funding from Eli Lilly and Company to Humana as a collaborative research project involving employees of both companies. Chen, Brown, Fan, Taylor, and He are employees of Eli Lilly and Company. Nair and Meah are employees of Humana, which received funding to complete this research. Siadaty was an employee of Humana at the time of this study.

34-OR: SGLT2 Inhibitors: A Comparison of Cardiovascular, Medical, and Cost Outcomes

Since 2016, empagliflozin (EFZ) has been known to reduce cardiovascular (CV) events in patients with type 2 diabetes; however, similar label expansions for dapagliflozin (DFZ) and canagliflozin (CFZ) are quite recent. To date, limited evidence has been published comparing these drugs in real-world practice. This retrospective cohort study address that gap, and used administrative claims data from a nationwide Medicare Advantage Prescription Drug and commercial health plan to compare CFZ, EFZ and DFZ on CV outcomes, treatment persistence, healthcare utilization and costs. Eligible patients naïve to the SGLT2 inhibitor drug class for 6 months from January 2015 to June 2017 were identified. Patients had at least 12 months of continuous enrollment pre- and post-index date (i.e., date of first new prescription). Propensity score method using inverse probability of treatment weighting was used to adjust outcomes. A total of 5,503, 2,052 and 587 patients used CFZ, EFZ and DFZ, respectively. Weighted comparisons showed no difference in the risk of primary composite CV outcome (myocardial infarction, stroke, or mortality) between treatments, but a lower risk of secondary CV outcome (heart failure or death) in the DFZ cohort (hazard ratio 0.82, 95% CI 0.75-0.88) compared to CFZ. Patients indexed to use EFZ were more likely to remain persistent to treatment (odds ratio [OR] 1.09, 95% CI 1.03-1.16), and patients who used DFZ had lower odds of an emergency department visit encounter (OR 0.85, 95% CI 0.79-0.92), relative to the use of CFZ. There were no differences in inpatient hospitalization stays and outpatient services between treatment groups. This population-based study showed minor differences in clinical and cost outcomes between CFZ, EFZ and DFZ, including a post-hoc analysis showing slight variations in use of adjuvant glucose lowering therapies across the SGLT2 inhibitor cohorts. With the ever-evolving landscape of treatment in the care of patients with diabetes, these findings may be helpful to providers. Disclosure P. Schwab: Employee; Self; Humana. Employee; Spouse/Partner; Humana. A. Bowe: Employee; Self; Humana. M. Tindal: None. Y.A. Meah: None. I. Poonawalla: None.

36-OR: Comparative Effectiveness of SGLT2 Inhibitors vs. GLP-1 Agonists

This retrospective cohort study compared sodium-glucose co-transporter-2 (SGLT2) inhibitor and glucagon-like peptide-1 (GLP-1) agonist therapeutic drug classes on cardiovascular (CV) outcomes, treatment persistence/discontinuation, healthcare utilization and costs. Using medical and pharmacy claims data from the Humana Research Database, new users of SGLT2 inhibitors or GLP-1 agonists from January 2015 to June 2017 were identified. Eligible patients were 19-89 years, enrolled in a Medicare Advantage Prescription Drug or fully-insured commercial health plan, with at least 12 months of continuous enrollment pre- and post-index date (i.e., date of first new prescription). Propensity score matching (1:1) was used to balance baseline characteristics. Cox proportional hazards models were used to compare CV outcomes and treatment discontinuation. Healthcare resource utilization and costs were compared using Wilcoxon signed rank test. A total of 5,507 patients were included in each treatment group. Patients indexed to use GLP-1 agonists were more likely to discontinue treatment (hazard ratio 1.15, 95% confidence interval 1.10-1.21) and more likely to encounter an inpatient hospitalization (14.4% vs. 11.9%, P&amp;lt;0.001) or emergency department visit (27.4% vs. 23.5%, P &amp;lt;0.001) compared to patients indexed on SGLT2 inhibitors. The risk of primary composite CV outcome (myocardial infarction or stroke or mortality) and secondary CV outcome (heart failure or death) was similar across cohorts. The average per-person per-month total cost ($1,796 vs. $1,617, P&amp;lt;0.001), medical ($904 vs. $834, P&amp;lt;0.001) and pharmacy costs ($891 vs. $783, P&amp;lt;0.001) were higher for the GLP-1 agonist cohort compared to the SGLT2 inhibitor cohort. Although differences in extra-glycemic CV benefits were not established, these findings may be useful to providers and payers, as this real-world data showed SGLT2 inhibitors were associated with longer treatment persistence and reduced healthcare utilization and costs relative to GLP-1 agonists. Disclosure I. Poonawalla: None. A. Bowe: Employee; Self; Humana. M. Tindal: None. Y.A. Meah: None. P. Schwab: Employee; Self; Humana. Employee; Spouse/Partner; Humana.

404-P: Cardiovascular Risk Scoring and Stratification in Patients with Type 2 Diabetes Enrolled in a Medicare Advantage Plan

Current tools to identify patients at risk for cardiovascular (CV) disease or events are variable, limiting their utility and generalizability. The purpose of this study was to develop a predictive model to identify patients with type 2 diabetes (T2D) who are ≥65 years of age, enrolled in a Medicare Advantage Prescription Drug (MAPD) plan and at risk for future CV events. This retrospective cohort study used administrative claims, laboratory and enrollment data from 1/2011-12/2018. Patients with T2D were identified from 1/2012-12/2013 using diagnosis codes and/or claims for antihyperglycemic medications. The dependent variable was the first composite CV event defined as ≥1 inpatient hospitalization for myocardial infarction, ischemic stroke, unstable angina, or heart failure or any evidence of revascularization. Independent variables for the prediction survival model included baseline demographic and clinical characteristics prognostic for the dependent variable. C-statistic, accuracy, sensitivity, and specificity were used to assess model performance. Risk ranking was conducted, whereby patients were classified as low, medium or at high risk of an event based on probability distribution derived cut-points. A total of 362,791 patients with T2D were identified. The proportion of patients with ≥1 CV event was 18.0% up to 5 years after T2D identification. The final model included 42 demographic and clinical variables. The C-statistic was 0.68, and accuracy, sensitivity and specificity were 0.63. Results were consistent across the training, test and holdout datasets suggesting internal validity. Up to 5 years after identification, 11% of patients classified as low, 27% as medium, and 51% as high risk had a future CV event. A predictive model for composite CV events utilizing administrative claims to identify and risk stratify patients may be used to scale focused interventions to high-risk T2D patients in a MAPD population to prevent future CVD events. Disclosure J.D. Hayden: Employee; Self; Humana. P. Pimple: Employee; Self; Boehringer Ingelheim Pharmaceuticals, Inc. Employee; Spouse/Partner; CVS Caremark. R. Luthra: Employee; Self; Boehringer Ingelheim Pharmaceuticals, Inc. T.G. Prewitt: None. V. Chiguluri: None. M. Kattan: Consultant; Self; GlaxoSmithKline plc. Research Support; Self; Boehringer Ingelheim (Canada) Ltd., Novo Nordisk Inc. R. Harvey: None. A.M. Goss: Employee; Self; Boehringer Ingelheim Pharmaceuticals, Inc. E.O. Caplan: Employee; Self; Humana. Funding Boehringer Ingelheim; Humana

PNS111 HEALTH PLAN PERFORMANCE ON HIGH-RISK MEDICATION USE AMONG MEDICARE PART D BENEFICIARIES: IMPACT OF RISK ADJUSTMENT

Current Medicare health plan performance measures do not consider variations of patient characteristics within health plans, potentially leading to incorrect performance evaluations. This study examined the relationship between patient characteristics and high-risk medication (HRM) use and the impact of risk adjustment on HRM use measures among Medicare Advantage Prescription Drug Plan (MA-PD) and stand-alone Prescription Drug Plan (PDP) beneficiaries. This retrospective cross-sectional study used a 5% national sample of 2013 Medicare claims. Two groups of beneficiaries aged ≥65 years, continuously enrolled in MA-PD or PDP, and with ≥2 prescriptions for the same HRM (defined by Pharmacy Quality Alliance) were identified. First, we calculated unadjusted performance scores as a proportion of HRM users in each health plan. Second, we identified HRM use risk factors using multivariable logistic regression models for MA-PD and PDP. Third, we developed risk-adjustment scores using generalized linear mixed models to adjust for identified risk factors in specific plans within MA-PDs and PDPs. Agreement between unadjusted and adjusted scores was evaluated using Cohen’s kappa to demonstrate the effect of risk adjustment. This study included 520,019 MA-PD and 881,264 PDP beneficiaries (mean age=74.7±7.3 versus 75.6±7.8 years; females=61% versus 64%; white=81.7% versus 85.5%) enrolled in 474 MA-PD and 60 PDP contracts. In adjusted analyses, HRM users in MA-PDs were more likely to be younger (OR=0.981, 95%CI=0.980-0.983); women (OR=1.545, 95%CI=1.514-1.576); eligible for low-income subsidy (OR=1.086, 95%CI=1.057-1.115); disabled (OR=1.380, 95%CI=1.342-1.420); seeing multiple prescribers (OR=1.076, 95%CI=1.072-1.081); using multiple pharmacies (OR=1.092, 95%CI=1.083-1.102); and higher average modified RxRisk-V index (OR=1.176, 95%CI=1.171-1.181) than non-HRM users. PDP results were similar. Unadjusted scores had low levels of agreement (Cohen’s kappa <0.7) with risk-adjusted scores. This study suggests risk adjustment influences health plan performance evaluation. Thus, risk adjustment of HRM performance is recommended to ensure health plans are not penalized due to their beneficiaries’ characteristics.