Retrospective real-world comparison of clinical and economic burden between first-generation and second-generation tyrosine kinase inhibitors (TKIs) in chronic myeloid leukemia (CML).

e19030 Background: TKIs are the standard of care for the treatment of chronic phase CML under National Comprehensive Cancer Network (NCCN) guidelines. Imatinib is recommended as a first-generation TKI (1GTKI), and bosutinib, dasatinib, nilotinib, and ponatinib are recommended as second-generation TKIs (2GTKIs). TKIs are associated with high healthcare resource utilization (HRU) and costs, although literature is limited comparing 1GTKI and 2GTKIs in a U.S. population. Methods: Using the Veteran’s Health Administration (VHA) database between April 1, 2013 and March 31, 2018, the study included patients aged ≥18 years with ≥1 medical claim for CML and ≥1 prescription claim for a TKI on or after the initial CML diagnosis date during the identification period (October 1, 2014 to September 30, 2017); the first TKI prescription claim was defined as the index date. Inverse probability of treatment weighting (IPTW) minimized potential confounding; included variables were age, race, Quan-Charlson Comorbidity Index (CCI) score, and CHA2DS2-VASc Score. Medication possession ratio (MPR) assessed adherence to index TKI; optimal adherence was defined as MPR ≥80%. Results: 944 patients were included: 78.9% on 1GTKI and 21.1% on 2GTKI. Mean age was 62.21 years (SD:18.8); 77.2% were white. At baselinetients on 1GTKI had a higher comorbidity burden than 2GTKIs: COPD (19.7% vs. 8%; p < 0.01), anemia (17.7% vs. 11.1%; p = 0.02), GI symptoms (28.5% vs. 18.6%; p < 0.01), cardiac dysrhythmias (15.6% vs. 7.5%; p < 0.01), coronary artery disease (26.3% vs. 13.6%; p < 0.01), hypertension (55.7% vs. 43.2%; p < 0.01) and CHA2DS2-VASc Score (2.2 vs 1.6; p < 0.01). Optimal adherence was higher with 1GTKI (69.6% vs. 62.2%; p = 0.04), although this was not statistically significant when mean MPR was compared. During follow-up, no difference between 1GTKI and 2GTKIs patients occurred with cardiac-related risk factors or CHA2DS2-VASc Score. Compared to 1GTKI, 2GTKIs had lower medical (inpatient and outpatient) costs ($3,162 vs. $3,906; p = 0.04) but higher all-cause pharmacy cost ($7,214 vs. $3,895; p < 0.01) due to imatinib becoming a generic drug during the study period. CML-related ($2,260 vs. $1,640, p < 0.01) and cardiac-related medical costs ($1,365 vs. $665, p < 0.01) were significantly higher in 1GTKI vs. 2GTKIs patients. Conclusions: Adherence to TKI therapy was suboptimal for both 1GTKI and 2GTKIs. 2GTKIs incurred lower medical cost in comparison to 1GTKI. Differences in total all-cause cost was primarily driven by pharmacy cost of TKIs. These results show that, beyond the cost of the TKI, using a 2GTKIs in the first-line can lead to cost offsets when compared to imatinib.

Clinical Burden and Practice Patterns in Patients With Chronic Hypoparathyroidism in the United States (US): A Claims Data Analysis Using Diagnosis-Based Criteria

Objectives: Significant knowledge gaps exist regarding the comorbidities, treatment and lab testing patterns of patients with chronic hypoparathyroidism (cHP). This study describes a large cohort of patients with cHP identified using a diagnosis-based criteria from a claims database. Methods: This retrospective cohort study was conducted using a large (130 million individuals) claims database (HealthVerity Closed Payer Claim Medical and Pharmacy databases: Private Source 20) from Oct 2014 to Dec 2019. Eligible patients had ≥2 diagnosis claims of HP (ICD9/10 codes: E20.0, E20.8, E20.9, 252.1) that were 6–15 months apart, a prescription claim for either active vitamin D, calcium, PTH or thyroid replacement therapy between the first qualifying HP claim and within 30 days of the second HP claim, and continuous enrollment for one year before the index date (the date of the first of two qualifying HP diagnosis claims) and ≥16 months after. Patients were followed up to two years after the index date. Patient characteristics, comorbidities, lab testing and treatment patterns were descriptively analyzed. Results: Out of 43,640 patients with a diagnosis claim for HP, 4,118 patients met the eligibility criteria. The mean age of the cohort was 56.5 years + 18.6 (SD), and 76.4% were females, similar to data from other large cohort studies. The most common comorbidities during the 1-year follow-up were hypertension (56.0%), hypocalcemia (38.7%), cancer (30.5%, of which 24% were thyroid cancers), diabetes (29.4%), chronic pulmonary disease (24.1%), cardiac arrhythmias (17.4%), CKD stage 3–5 (17.0%), osteoporosis (9.6%) and neuropsychiatric disorders, including depressive disorders (22.0%), anxiety (21.6%), and sleep-wake disorders (18.4%). During the 1-year follow up, commonly monitored lab tests included serum calcium (89.9%), eGFR/creatinine (85.7%), 25-hydroxy vitamin D (61.1%), and intact PTH (43.9%). Remarkably, serum phosphorous (36.3%), serum magnesium (35.4%), and 24h-urine calcium (10.5%) were much less often monitored. In addition, BMD was measured in 10.9% patients. Also during the 1-year follow-up, 67.1% of patients had a prescription claim for thyroid replacement therapy, 60.5% for calcitriol, 15.7% for ergocalciferol, and 3.4 % for PTH. Conclusion: Findings from this study highlight the high comorbidity burden in cHP patients which aligns with the monitoring patterns. Kidney function appears to be a key concern and may be important when considering therapeutic intervention. The comorbidities and practice patterns observed in this study are consistent with the results obtained using a surgery-based approach to identify cHP patients in the same claims database. Future studies will also examine the economic burden of cHP.

Abstract 9: Alirocumab Prior Authorization Approval and Prescription Fill Rates Among Medicare Advantage Patients in a Large US Managed Care Plan

Introduction: Alirocumab is a proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibitor approved as an adjunct to diet and maximally tolerated statin therapy for treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL-cholesterol. Barriers to possession, including therapy cost and cost-sharing implications, may contribute to low utilization of this therapy. Objective: To explore differences in demographic and clinical characteristics between patients with prior authorization (PA) approvals or denials for alirocumab as evidenced through filled alirocumab prescription claims. Methods: A retrospective claims-based database analysis of patients with a Medicare Advantage Prescription Drug (MAPD) plan was conducted to identify patients with evidence of a PA approval for alirocumab. Among the group of patients with a PA for alirocumab, the pharmacy claims database was searched for evidence of a corresponding prescription claim within 30 days following the first PA request (index date). The analysis was stratified by evidence of Federal low income subsidy (LIS) support, a program that provides extra assistance with prescription drug costs for eligible individuals whose income and resources are limited, and/ or dual eligibility (DE) status, eligible for Medicare and Medicaid, (LIS/DE) at index. Results: A total of 2,098 MAPD patients meeting study inclusion/exclusion criteria and with a PA for alirocumab were identified between March 1, 2016 and February 28, 2017. Non-LIS/DE patients comprised approximately 82% of the eligible population (n=1,730). There were several notable differences in baseline demographics between the non-LIS/DE vs. the LIS/DE cohorts with an approved PA claim, including Deyo-Charlson Comorbidity Index (2.2 vs. 3.0), prevalence of diabetes mellitus (39.2% vs. 54.7%), and prevalence of HeFH (11.8% vs. 15.6%). While the percentage of patients with an approved PA was similar between the LIS/DE and non-LIS/DE cohorts, 88.9% and 91.2%, respectively, substantially more patients in the LIS/DE cohort had evidence of alirocumab possession based on a paid claim (60.6%) vs. those in the non-LIS/DE cohort (17.3%). Conclusion: Although a high percentage of MAPD patients had evidence of an approved PA, there were notable differences in clinical and demographic characteristics between those with and without LIS/ DE status. Further, the proportion of patients with an approved PA and a paid prescription claim differed markedly amongst MAPD patients with and without LIS/DE status, suggesting further research is needed to understand potential barriers to obtaining PCSK9i therapy.

Estimation of hypertension (HTN) occurrence, severity changes, and patterns of antihypertensive (AH) use in patients (pts) receiving VEGF inhibitors for the treatment of cancer.

e16541 Background: Reports have examined the occurrence and management of HTN in pts receiving VGEF inhibitors, but typically have small samples and represent single institutions. This study used a large claims database to describe how the use of VGEF inhibitors impacted the occurrence, severity and management of HTN. Methods: Claims data (2004-2009) from Medstat’s MarketScan database identified pts with bevacizumab (BEV), sorafeninb (SO) and sunitinib (SU) claims and an approved cancer indication. First prescription claim for a VGEF inhibitor was the index date; treatment period began on this date and ended 30-60 days after the last VEGF inhibitor claim. Pts were followed for 12 months pre and post index date. HTN was defined as at least one ICD-9 (401.xx) or AH prescription claim. Cohort A (A) included pts with no HTN prior to index date; Cohort B (B) included pts with HTN prior to index date. A was divided into cohort A1 (A1): no HTN pre or post index date; and cohort A2 (A2): HTN post index date. HTN severity was defined in accordance with CTCAE v4.0 as: pre-HTN and no AH claims (grade [gr] 1); 1 or 2+ AH claims within 90 days (gr 2, 3); or life threatening complications (gr 4). Cardiac complication ICD-9 codes were collected. Results: 2177 pts received BEV (89.3%), SO (4.9%) and SU (5.8%). A had 1041 pts; 32% (A2) had HTN. B had 1136 pts. Gr 1 HTN incidence increased during the treatment period in A1 (0.1 to 0.7%) and A2 (0.9 to 12.3%), but decreased in B (12 to 7.5%). Gr 2 HTN increased from 1.2 to 48% (A2) and 26.4 to 32.4% (B). Gr 3 HTN increased from 0 to 18.6% (A2) and 33.5 to 41% (B). Gr 4 HTN occurred in 3.4% (A1), 8.4% (A2) and 6.3% (B) of pts within one year post index date. B had higher complication rates (16.7%) than A1 (2.3%) and A2 (9.6%). 286 (85.9%) pts in A2 received AH; median time to AH initiation was 96 days. Pts in A2 required 0.9 AH during the treatment period compared to 1.3 in B. Initial AH class did not affect complication rates in A2. Conclusions: We observed clinically relevant HTN in a significant proportion of pts receiving VEGF inhibitors with real world data. HTN incidence increased in all cohorts, regardless of baseline HTN. Pts should be monitored carefully for HTN.