Prior Authorization, Copayments, and Utilization of Sacubitril/Valsartan in Medicare and Commercial Plans in Patients With Heart Failure With Reduced Ejection Fraction

Author(s):  
Aya F. Ozaki ◽  
Harlan M. Krumholz ◽  
Freny Vaghaiwalla Mody ◽  
Tien T. Tran ◽  
Quan T. Le ◽  
...  

Background: Slow uptake of sacubitril/valsartan in patients with heart failure with reduced ejection fraction has been reported, which may negatively impact clinical outcomes. We characterized prior authorization (PA) burden, prescription copayment, and utilization of sacubitril/valsartan by insurance plan type to identify potential barriers to its use. Methods: We conducted a national population-level, cross-sectional study using PA data from an insurance coverage website accessed in March 2019 and IQVIA National Prescription Audit data from August 2018 to July 2019. Primary outcomes were proportion of plans requiring PA, frequency of specific PA criteria, number of sacubitril/valsartan prescriptions, and copayments per insurance plan type. Results: Overall, 48.1% (1394/2896) of insurance plans required PA for sacubitril/valsartan. Fewer Medicare (27.7%) than commercial (57.2%) plans required PA ( P <0.001). For both plan types, the most frequently required PA criteria were ejection fraction (71.6%, 90.9%) and New York Heart Association class (60.4%, 90.8%) for Medicare and commercial plans, respectively. Copayment amounts varied by plan type, with more sacubitril/valsartan prescriptions for commercial plans not requiring a patient copayment (32.4%) compared with Medicare plans (19.3%; P <0.001). There were 814 437 sacubitril/valsartan prescriptions for Medicare and 822 292 for commercial plans dispensed from August 2018 to July 2019. Based on estimated heart failure with reduced ejection fraction populations for each plan type, 4-fold more sacubitril/valsartan prescriptions were dispensed in commercial than in Medicare plans (820 versus 215 prescriptions/1000 individuals in the heart failure with reduced ejection fraction population). The estimated proportion of heart failure with reduced ejection fraction patients prescribed sacubitril/valsartan was 3.6% (1.5%–6.8%) for Medicare and 13.7% (4.9%–31.8%) for commercial plan populations. Conclusions: Despite commercial plans having greater PA requirements than Medicare, population-adjusted use of sacubitril/valsartan was higher in commercial plans. Given that commercial plans had more prescriptions with low copayments than Medicare, copayment policies may be more influential on sacubitril/valsartan use than its PA policies. Low sacubitril/valsartan use in both plan types highlights the multifactorial nature of medication underutilization that includes factors beyond the drug policies that we evaluated.

2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Aya Ozaki ◽  
Harlan M Krumholz ◽  
Tien Tran ◽  
Quan Le ◽  
Mai Yokota ◽  
...  

Background: Sacubitril/valsartan (Entresto ® ) reduces mortality and heart failure (HF) admissions in NYHA Class II/III HF with reduced ejection fraction (HFrEF). However, uptake in practice has been lower than expected. Prior authorization (PA) is a common barrier that may reduce drug access, which may impact clinical outcomes. Our study characterizes PA requirement burden and use of sacubitril/valsartan by insurance plan type. Methods: We conducted a cross-sectional study using insurance plan information directly from a managed care organization-approved insurance coverage website accessed in Mar/2019 to characterize sacubitril/valsartan PA criteria in Medicare and commercial plans. We also used IQVIA National Prescription Audit data from Aug/2018 to Jul/2019 to estimate the number of prescriptions (Rx) dispensed and patient copayment for sacubitril/valsartan. Primary outcomes were proportion of plans requiring PA, frequency of specific PA criteria, number of sacubitril/valsartan Rx, and copayments. Data analysis was descriptive or used Chi-square. Results: For Medicare, 27.7% of plans required PA for sacubitril/valsartan, a significantly lower rate than 57.2% for commercial plans (p<0.001). For both plans, most frequently required PA criteria were ejection fraction (71.6%, 90.9%) and NYHA class (60.4%, 90.8% for Medicare and commercial plans, respectively). There were 814,437 sacubitril/valsartan Rx dispensed over the year for Medicare and 822,292 for commercial plans. Based on estimated HFrEF populations for each plan type, 4-fold more sacubitril/valsartan Rx were dispensed in commercial than in Medicare plans (820 Rx vs. 215 Rx/1,000 HFrEF population). Copay amounts varied by plan type, with significantly more sacubitril/valsartan Rx having no patient copayment required in commercial (32.4%) than Medicare plans (19.3%) (p<0.001). Conclusions: Despite commercial plans having greater PA requirements than Medicare, use of sacubitril/valsartan was higher in commercial plans. Thus, PA policies may not represent a major barrier to sacubitril/valsartan use. Given that commercial plans had more Rx with no or low copays than Medicare, copay amounts may be more influential on sacubitril/valsartan use.


BJGP Open ◽  
2021 ◽  
pp. BJGPO.2021.0094
Author(s):  
Faye Forsyth ◽  
James Brimicombe ◽  
Joseph Cheriyan ◽  
Duncan Edwards ◽  
Richard Hobbs ◽  
...  

BackgroundMany patients with heart failure with preserved ejection fraction (HFpEF) are undiagnosed, and UK general practice registers do not typically record HF sub-type. Improvements in management of HFpEF is dependent on improved identification and characterisation of patients in primary care.AimsTo describe a cohort of patients recruited from primary care with suspected HFpEF and compare patients in whom HFpEF was confirmed and refuted.Design and SettingBaseline data from a longitudinal cohort study of patients with suspected HFpEF recruited from primary care in two areas of England.MethodsA screening algorithm and review were used to find patients on HF registers without a record of reduced ejection fraction. Baseline evaluation included cardiac, mental and physical function, clinical characteristics and patient reported outcomes. Confirmation of HFpEF was clinically adjudicated by a cardiologist.ResultsNinety-three (61%) of 152 patients were confirmed HFpEF. The mean age of patients with HFpEF was 79.3, 46% were female, 80% had hypertension, and 37% took 10 or more medications. Patients with HFpEF were more likely to be obese, pre-frail/frail, report more dyspnoea and fatigue, were more functionally impaired, and less active than patients in whom HFpEF was refuted. Few had attended cardiac rehabilitation.ConclusionsPatients with confirmed HFpEF had frequent multimorbidity, functional impairment, frailty and polypharmacy. Although comorbid conditions were similar between people with and without HFpEF, the former had more obesity, symptoms and worse physical function. These findings highlight the potential to optimise well-being through comorbidity management, medication rationalisation, rehabilitation, and supported self-management.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Shahryar M Chowdhury ◽  
Kimberly E McHugh ◽  
Stephanie S Gaydos ◽  
carolyn taylor ◽  
Eric M Graham ◽  
...  

Introduction: The cardiac mechanics that contribute to the development of heterogenous heart failure phenotypes in Fontan patients have not been investigated. The objective of this study was to investigate the differences in contractility, afterload, and ventriculo-arterial (VA) coupling between patients with heart failure and preserved ejection fraction (HFpEF) versus heart failure with reduced ejection fraction (HFrEF). Methods: Core-lab echocardiograms were obtained from the publically-available Pediatric Heart Network Fontan Cross-sectional Study database. Ejection fraction was considered abnormal if < 50%. Diastolic function was defined as abnormal if the diastolic pressure:volume quotient (lateral E:e’/end-diastolic volume) was > 10 th percentile. Patients were divided into three groups: 1 = normal EF and normal diastolic function, 2 = decreased EF with normal diastolic function, 3 = normal EF with abnormal diastolic function. End-systolic elastance (Ees), a measure of contractility, and arterial elastance (Ea), a measure of afterload, were calculated. VA coupling was defined as Ea/Ees. Results: 238 patients (61% left, 39% right ventricular dominant) were included. Differences between groups are reported in the Table. Conclusion: Both Fontan patients with HFpEF and HFrEF display increased afterload compared to their non-heart failure counterparts. However, HFpEF patients displayed a hypercontractile state to maintain a VA coupling ratio comparable to the non-heart failure group. These measures of cardiac mechanics may be useful in identifying the mechanisms that drive Fontan patients toward HFpEF versus HFrEF phenotypes.


2019 ◽  
Vol 8 (12) ◽  
pp. 2165 ◽  
Author(s):  
Giuseppe Romano ◽  
Giuseppe Vitale ◽  
Laura Ajello ◽  
Valentina Agnese ◽  
Diego Bellavia ◽  
...  

Background: Sacubitril/valsartan has been shown to be superior to enalapril in reducing the risks of death and hospitalization for heart failure (HF). However, knowledge of the impact on cardiac performance remains limited. We sought to evaluate the effects of sacubitril/valsartan on clinical, biochemical and echocardiographic parameters in patients with heart failure and reduced ejection fraction (HFrEF). Methods: Sacubitril/valsartan was administered to 205 HFrEF patients. Results: Among 230 patients (mean age 59 ± 10 years, 46% with ischemic heart disease) 205 (89%) completed the study. After a follow-up of 10.49 (2.93 ± 18.44) months, the percentage of patients in New York Heart Association (NYHA) class III changed from 40% to 17% (p < 0.001). Median N–Type natriuretic peptide (Nt-proBNP) decreased from 1865 ± 2318 to 1514 ± 2205 pg/mL, (p = 0.01). Furosemide dose reduced from 131.3 ± 154.5 to 120 ± 142.5 (p = 0.047). Ejection fraction (from 27± 5.9% to 30 ± 7.7% (p < 0.001) and E/A ratio (from 1.67 ± 1.21 to 1.42 ± 1.12 (p = 0.002)) improved. Moderate to severe mitral regurgitation (from 30.1% to 17.4%; p = 0.002) and tricuspid velocity decreased from 2.8 ± 0.55 m/s to 2.64 ± 0.59 m/s (p < 0.014). Conclusions: Sacubitril/valsartan induce “hemodynamic recovery” and, consistently with reduction in Nt-proBNP concentrations, improve NYHA class despite diuretic dose reduction.


Author(s):  
Rakesh Gopinathannair ◽  
Lin Y. Chen ◽  
Mina K. Chung ◽  
William K. Cornwell ◽  
Karen L. Furie ◽  
...  

Atrial fibrillation and heart failure with reduced ejection fraction are increasing in prevalence worldwide. Atrial fibrillation can precipitate and can be a consequence of heart failure with reduced ejection fraction and cardiomyopathy. Atrial fibrillation and heart failure, when present together, are associated with worse outcomes. Together, these 2 conditions increase the risk of stroke, requiring oral anticoagulation in many or left atrial appendage closure in some. Medical management for rate and rhythm control of atrial fibrillation in heart failure remain hampered by variable success, intolerance, and adverse effects. In multiple randomized clinical trials in recent years, catheter ablation for atrial fibrillation in patients with heart failure and reduced ejection fraction has shown superiority in improving survival, quality of life, and ventricular function and reducing heart failure hospitalizations compared with antiarrhythmic drugs and rate control therapies. This has resulted in a paradigm shift in management toward nonpharmacological rhythm control of atrial fibrillation in heart failure with reduced ejection fraction. The primary objective of this American Heart Association scientific statement is to review the available evidence on the epidemiology and pathophysiology of atrial fibrillation in relation to heart failure and to provide guidance on the latest advances in pharmacological and nonpharmacological management of atrial fibrillation in patients with heart failure and reduced ejection fraction. The writing committee’s consensus on the implications for clinical practice, gaps in knowledge, and directions for future research are highlighted.


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