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Kexin Type 9 Inhibitors in a Medicare Population
832 P50.091); 3) higher postprandial insulin (303+159 U vs. 93+134 U, P50.014); and 4) higher postprandial C-peptide (32.5+12.4 vs. 20.2+6.3 U, P,0.0001). There was no significant difference in acute pancreatitis history between nonLPL and LPL FCS groups (75.0% vs. 78.7%, respectively). Conclusions: These results show that LPL:-FCS and non-LPL-FCS are largely phenotypically similar, but that LPL-FCS has lower post-heparin LPL activity, somewhat higher triglycerides, while indices of glucose metabolism and insulin resistance are higher in non-LPL-FCS.
PCSK9i 197 Characteristics Associated with Prior Authorization Approvals for Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors in a Medicare Population Richard Sheer, BA, David Harrison, PhD, Stefan DiMario, PharmD, Jeetvan Patel, PhD, Lavanya Sudharshan, MS, Daniel Cornett, PharmD, Margaret Pasquale, PhD, (Louisville, KY)
Lead Author’s Financial Disclosures: mployee of Comprehensive Health Insights, Inc., a wholly-owned subsidiary of Humana Inc.; CHI received payment from Amgen for the study. Owns stock in Humana Study Funding: Amgen Background/Synopsis: Proprotein Convertase Subtilisin/Kexin Type 9 inhibitors (PCSK9is) are indicated as an adjunct to diet and maximally tolerated statin therapy in adults with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH) who need additional lowering of low density lipoprotein cholesterol (LDL-C). PCSK9is often require prior authorization (PA) approval before payers reimburse for these agents. Objective/Purpose: This study evaluated characteristics associated with PA approvals in patients enrolled in Medicare Advantage and Prescription Drug (MAPD) plans. Methods: Patients with $1 PA request for PCSK9i from 3/1/2016 to 6/30/2016 were identified in the Humana Research Database, which includes administrative claims and lab data. The index date was the first PA request date. Patients without prior PCSK9i use, age 1889 years, and continuously enrolled with medical and pharmacy benefits 1-year pre- and 90 days post-index (to allow for PA resubmissions and adjudications) were included. Demographic and clinical characteristics were assessed. Risk of cardiovascular events was evaluated using a modified REACH score. RxRisk-V score and Deyo-Charlson Comorbidity Index (DCCI) were used to assess comorbidity burden. Age, gender, race, geographic region, RxRisk-V, REACH, diabetes, myositis/myalgia/rhabdomyolysis, ASCVD, prescriber specialty, statin intensity, ezetimibe use, and baseline
Journal of Clinical Lipidology, Vol 11, No 3, June 2017 LDL-C were evaluated in a multivariate stepwise logistic regression with backward elimination to model PA approval (p-value,0.1 for retention). Results: A total of 982 patients were included; 76% approved, 48.2% male, average age 69.8 years. Demographic characteristics were similar among patients approved versus denied. Mean RxRisk-V score was significantly higher among those approved (7.3 vs 6.5, P50.002). DCCI and REACH scores were similar. ASCVD was more common in approved patients (73.3% vs 53.6%, P,0.01). Type of ASCVD event, prescriber specialty, prior statin or ezetimibe use, and baseline LDL-C levels (in patients with LDL-C recorded) were not significantly different. RxRisk-V score (odds ratio [OR] 5 1.07, 95% CI 1.02–1.12, P50.0067) and ASCVD (OR 5 2.26, 95% CI 1.66–3.06, P,0.0001) were retained in the final model. Conclusions: As expected, ASCVD and RxRisk-V were associated with PA approval; however, prior statin/ezetimibe use and LDL-C were not. A key limitation is that this study used claims to assess approvals whereas plans rely on data from PA request forms. Additional research is needed to examine clinical factors associated with approval using data from PA forms including statin intolerance, maximally tolerated statin dose, LDL-C goal attainment, and FH. These data can supplement and be compared to the claims data to provide a more complete assessment.
Pharmacological Control of Lipids and Lipoproteins 198 Development of Small Molecule Screening Assay for Modulation of Lipoprotein Lipase activity Using Hepatocyte Secretome Sahana Venkatesh, Prabodh Sadana, PhD, Li Lin, (Rootstown, OH)
Lead Author’s Financial Disclosures: None Study Funding: None Background/Synopsis: Lipoprotein lipase (LPL) hydrolyses core triglycerides (TGs) of chylomicrons and very-low density lipoproteins (VLDL) in the circulation. Hepatocytes secrete LPL regulatory proteins with either LPL stimulatory [Apolipoprotein C2 (APOC2) and APOA5] or LPL inhibitory [APOC1, APOC3, angiopoietin-like 3 (ANGPTL3), ANGPTL 4, and ANGPTL 8] properties. Objective/Purpose: We hypothesize that pharmacological modification of the secretion of LPL regulatory proteins from hepatocytes is a strategy to activate LPL and lower lipids. Thus, we established a screening assay for identifying small molecule activators of LPL via modulation of the hepatocyte secretome and consequently conducted a pilot screen of 26 compounds to assess for such activity.
PCSK9i 197 Characteristics Associated with Prior Authorization Approvals for Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors in a Medicare Population Richard Sheer, BA, David Harrison, PhD, Stefan DiMario, PharmD, Jeetvan Patel, PhD, Lavanya Sudharshan, MS, Daniel Cornett, PharmD, Margaret Pasquale, PhD, (Louisville, KY)
Lead Author’s Financial Disclosures: mployee of Comprehensive Health Insights, Inc., a wholly-owned subsidiary of Humana Inc.; CHI received payment from Amgen for the study. Owns stock in Humana Study Funding: Amgen Background/Synopsis: Proprotein Convertase Subtilisin/Kexin Type 9 inhibitors (PCSK9is) are indicated as an adjunct to diet and maximally tolerated statin therapy in adults with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH) who need additional lowering of low density lipoprotein cholesterol (LDL-C). PCSK9is often require prior authorization (PA) approval before payers reimburse for these agents. Objective/Purpose: This study evaluated characteristics associated with PA approvals in patients enrolled in Medicare Advantage and Prescription Drug (MAPD) plans. Methods: Patients with $1 PA request for PCSK9i from 3/1/2016 to 6/30/2016 were identified in the Humana Research Database, which includes administrative claims and lab data. The index date was the first PA request date. Patients without prior PCSK9i use, age 1889 years, and continuously enrolled with medical and pharmacy benefits 1-year pre- and 90 days post-index (to allow for PA resubmissions and adjudications) were included. Demographic and clinical characteristics were assessed. Risk of cardiovascular events was evaluated using a modified REACH score. RxRisk-V score and Deyo-Charlson Comorbidity Index (DCCI) were used to assess comorbidity burden. Age, gender, race, geographic region, RxRisk-V, REACH, diabetes, myositis/myalgia/rhabdomyolysis, ASCVD, prescriber specialty, statin intensity, ezetimibe use, and baseline
Journal of Clinical Lipidology, Vol 11, No 3, June 2017 LDL-C were evaluated in a multivariate stepwise logistic regression with backward elimination to model PA approval (p-value,0.1 for retention). Results: A total of 982 patients were included; 76% approved, 48.2% male, average age 69.8 years. Demographic characteristics were similar among patients approved versus denied. Mean RxRisk-V score was significantly higher among those approved (7.3 vs 6.5, P50.002). DCCI and REACH scores were similar. ASCVD was more common in approved patients (73.3% vs 53.6%, P,0.01). Type of ASCVD event, prescriber specialty, prior statin or ezetimibe use, and baseline LDL-C levels (in patients with LDL-C recorded) were not significantly different. RxRisk-V score (odds ratio [OR] 5 1.07, 95% CI 1.02–1.12, P50.0067) and ASCVD (OR 5 2.26, 95% CI 1.66–3.06, P,0.0001) were retained in the final model. Conclusions: As expected, ASCVD and RxRisk-V were associated with PA approval; however, prior statin/ezetimibe use and LDL-C were not. A key limitation is that this study used claims to assess approvals whereas plans rely on data from PA request forms. Additional research is needed to examine clinical factors associated with approval using data from PA forms including statin intolerance, maximally tolerated statin dose, LDL-C goal attainment, and FH. These data can supplement and be compared to the claims data to provide a more complete assessment.
Pharmacological Control of Lipids and Lipoproteins 198 Development of Small Molecule Screening Assay for Modulation of Lipoprotein Lipase activity Using Hepatocyte Secretome Sahana Venkatesh, Prabodh Sadana, PhD, Li Lin, (Rootstown, OH)
Lead Author’s Financial Disclosures: None Study Funding: None Background/Synopsis: Lipoprotein lipase (LPL) hydrolyses core triglycerides (TGs) of chylomicrons and very-low density lipoproteins (VLDL) in the circulation. Hepatocytes secrete LPL regulatory proteins with either LPL stimulatory [Apolipoprotein C2 (APOC2) and APOA5] or LPL inhibitory [APOC1, APOC3, angiopoietin-like 3 (ANGPTL3), ANGPTL 4, and ANGPTL 8] properties. Objective/Purpose: We hypothesize that pharmacological modification of the secretion of LPL regulatory proteins from hepatocytes is a strategy to activate LPL and lower lipids. Thus, we established a screening assay for identifying small molecule activators of LPL via modulation of the hepatocyte secretome and consequently conducted a pilot screen of 26 compounds to assess for such activity.