Pcv31 Comparison of Cost-Effectiveness Between Sacubitril/Valsartan and Valsartan With Enalapril in Heart Failure

Abstract

Objectives: The Kansas City Cardiomyopathy Questionnaire (KCCQ) has been widely used to measure heart failure (HF) patients' perception of their health status, symptoms, physical and social function and quality of life. However, as a disease specific measure, the KCCQ is not designed to estimate health-state utilities, precluding its use in cost-effectiveness research. This study used data from the COAPT trial to map KCCQ scores to the SF-6D utility index. Methods: Data were obtained from the COAPT trial-a prospective, randomized controlled trial of transcatheter mitral valve repair vs. standard care in 614 patients with HF and secondary mitral regurgitation. Patients completed the SF-36 and the KCCQ at baseline and at 1, 6, 12, and 24 months. We calculated SF-6D utility scores and KCCQ overall summary (KCCQ-OS) scores for both the full and short form (KCCQ-12) for each subject. Using mixed linear models with random effects for subjects, we regressed SF-6D utility scores on the KCCQ-OS and the KCCQ-12, testing for age and sex effects. Model fit was evaluated using conditional AIC, R 2 and correlation. Results: Both the KCCQ-OS and the KCCQ-12 score were closely correlated with SF-6D derived health utility (correlation of 0.76 and 0.77 for the KCCQ-OS and KCCQ-12). Model testing revealed a conditional R 2 of 0.71 for the model using the KCCQ-OS and 0.73 for the KCCQ-12. The addition of age and gender to the models had negligible impact on the results. Based on these data, the final mapping equations were 0.44 + 0.0035*(KCCQ-OS) and 0.45 + 0.0034*(KCCQ-12). Conclusions: The KCCQ-OS and the KCCQ-12 are excellent predictors of health state utility in patients with HF, as compared with the SF-6D utility estimates. Further studies are needed to validate these predictive models in other heart failure populations.

Model parameters influencing the cost-effectiveness of sacubitril/valsartan in heart failure: evidence from a systematic literature review

“…A total of 22 full-text publications, 15 conference abstracts, and 5 HTA reports (1 each from the NICE [ 17 ], US ICER [ 61 ], CADTH [ 58 ], PBAC [ 60 ] and SMC [ 59 ]) were included. Of these, seven were from the US [ 18 , 20 , 30 , 33 , 35 , 52 , 61 ], three from Canada [ 51 , 55 , 58 ], three from Australia [ 27 , 56 , 60 ], and two each from the UK [ 17 , 41 ], Germany [ 32 , 48 ], Italy [ 29 , 50 ], the Netherlands [ 21 , 43 ], Russia [ 53 , 57 ], and Singapore [ 19 , 40 ]. Seventeen of the included studies were published by academic research institutions.…”

“…The model results were commonly reported as total costs, ICERs, life-years gained, QALYs gained, and willingness-to-pay (WTP) thresholds. Despite using different model structures, health states, and parameters, the authors concluded sacubitril/valsartan to be a cost-effective therapy compared with an ACEi, ARB or placebo in the base-case results of all except four models (two from the US [ 30 , 52 ], one from Singapore [ 19 ], and one from Thailand [ 36 ]), with ICERs per QALY gained being below the country-specific WTP thresholds (US, US$50,000; Canada, CA$50,000; UK, ₤20,000; Germany/Spain, €30,000; Italy, €40,000; Switzerland, CHF50,000). CE models that showed sacubitril/valsartan not to be a cost-effective treatment option generally had different assumptions from those indicating CE, particularly relating to time horizon.…”

“…Time horizon was explored in the SAs of 14 studies (Table 2 ) [ 17 , 19 , 25 , 29 , 38 , 42 , 43 , 49 , 50 , 52 , 55 , 56 , 59 , 62 ]. Three of the four model analyses [ 19 , 30 , 36 , 52 ] which concluded that sacubitril/valsartan is not a cost-effective therapy modeled shorter time horizons (5 [ 52 ], 10 [ 19 ], and 15 years [ 30 ]) than lifetime in the base-case analysis while other studies with a lifetime horizon typically reported sacubitril/valsartan as cost-effective. A study from the US by Zueger et al [ 52 ] using 5 years’ time horizon in the base-case reported an ICER of US$143,891/QALY.…”

“…Despite the wide variations adopted in the structural assumptions and parameters selected in the model, sacubitril/valsartan was reported as a cost-effective therapy for the treatment of patients with HFrEF in all studies except four (two US [ 30 , 52 ], one Singapore [ 19 ], and one Thailand [ 36 ]). A study from the US by Zueger et al [ 52 ] using enalapril as a comparator and 5 years’ time horizon reported an ICER value of $143,891/QALY gained.…”

“…A total of 22 full-text publications, 15 conference abstracts, and 5 HTA reports (1 each from the NICE [17], US ICER [61], CADTH [58], PBAC [60] and SMC [59]) were included. Of these, seven were from the US [18,20,30,33,35,52,61], three from Canada [51,55,58], three from Australia [27,56,60], and two each from the UK [17,41], Germany [32,48], Italy [29,50], the Netherlands [21,43], Russia [53,57], and Singapore [19,40] From additional bibliography (n = 1) chronic HFrEF in the outpatient setting, three studies modeled patients stabilized in hospital after an acute decompensation for HF [33,56,57] (Supplementary Table S4).…”