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Introduction: Secondary prevention of cardiovascular events among patients with diagnosed cardiovascular disease and high ischemic risk poses a significant challenge in clinical practice. The combinations of aspirin with low dose (LD) Ticagrelor or LD-Rivaroxaban have shown superiority in preventing major adverse cardiovascular events (MACE) than aspirin treatment alone. The comparative value for money of these two regimens remains unexplored.Methods: We analyzed each regimen's annual cost needed to treat (CNT) by multiplying the annualized number needed to treat (aNNT) by the annual cost of each drug. The aNNTs were based on outcome data from PEGASUS TIMI-54 and COMPASS trials. Scenario analyses were performed to overcome variances in terms of population risk. Costs were based on 2021 US prices. The primary outcome was defined as CNT to prevent one MACE across the two regimens. Secondary value analysis was performed for myocardial infarction (MI), stroke, and CV death as separate outcomes. Results: The aNNTs to prevent MACE with LD-Ticagrelor and with LD-Rivaroxaban were 229 [95% confidence interval (CI):141-734] and 147 (95%CI:104-252), respectively. At an annual cost of 3,618$ versus 4,308$, the corresponding CNTs were 828,478$ (95%CI:510,111$-2,655,471$) with LD-Ticagrelor and 633,270$ (95%CI:448,028$-1,085,607$) with LD-Rivaroxaban. LD-Rivaroxaban.Conclusion: Combining aspirin with LD-Rivaroxaban provides better value for money than with LD-Ticagrelor for secondary prevention of MACE.

Empagliflozin and oral semaglutide reduce the incidence of cardiovascular mortality (CVM) in patients with type 2 diabetes mellitus. However, these therapies impose a significant financial burden on healthcare systems. Therefore, we compared the value for money of empagliflozin versus oral semaglutide to prevent CVM. We calculated the cost needed to treat to prevent 1 case of CVM using either drug by multiplying the annualized number needed to treat to prevent 1 event by the annual cost of the therapy. Efficacy estimates were extracted from published randomized controlled trials data. We performed a scenario analysis to mitigate the primary differences between the populations of randomized controlled trials. Drug costs were calculated as 75% of the United States National Average Drug Acquisition Cost listing. The annualized number needed to treat for empagliflozin in EMPA-REG-OUTCOME was 141 (95% confidence interval [CI] 104 to 230) and 141 (95% CI 96 to 879) for oral semaglutide in PIONEER 6. The annual treatment costs are $4,797 for empagliflozin versus $7,133 for oral semaglutide. Therefore, the corresponding costs needed to treat are $676,385 ($498,894-$1,101,039) and $1,005,855 (95% CI $684,837-$6,270,544) respectively. In conclusion, our findings suggest that empagliflozin provides better value for money than oral semaglutide to prevent CVM in patients with type 2 diabetes mellitus at the current United States prices of the interventions.

Higher doses of the glucagon-like peptide-1 agonist (GLP-1RA) semaglutide and, more recently, tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1RA demonstrated a significant reduction in body weight in patients with Type 2 Diabetes Mellitus (T2DM). However, their comparative value for money for this indication is unclear. Therefore, we aimed to establish which provides better value for money.We calculated the cost needed to treat (CNT) to achieve a one percent reduction in body weight using high-dose tirzepatide (15mg) versus semaglutide (2.4mg). The body weight reductions were extracted from published results of SURMOUNT-1 and STEP 1 trials, respectively. In addition, we performed a scenario analysis to mitigate the primary differences between the two studies' populations. Drug costs were based on US GoodRx prices as of October 2022.Using tirzepatide resulted in a weight loss of 17.8% (95% CI: 16.3%-19.3%) compared to 12.4% (95% CI: 11.5%-13.4%) for semaglutide. The total cost of 72 weeks of tirzepatide was estimated at $17,527 compared with $22,878 for 68 weeks of semaglutide. Accordingly, the CNT per one percent of body weight reduction with tirzepatide is estimated at $985 (95% CI:$908-$1,075) compared to $1,845 (95% CI: $1,707-$1,989) with semaglutide. Scenario analysis confirmed these findings.Tirzepatide provides better value for money than semaglutide for weight reduction. This article is protected by copyright. All rights reserved.

Semaglutide, a glucagon-like peptide-1 receptor agonist (GLP1a), reduces the risk of major adverse cardiovascular events (MACE) in patients with Type 2 diabetes mellitus (T2DM). An oral version of semaglutide is now available, and patients may prefer it over the subcutaneous form. Our objective was to compare the value for money of the two modalities by assessing the cost needed to treat (CNT) to prevent MACE.The CNT to prevent MACE was figured by multiplying the one-year number needed to treat (NNT) with either oral or subcutaneous semaglutide by the annual cost of therapy. Efficacy estimates and the resulting NNT figures were extracted from the published results of the SUSTAIN-6 and the PIONEER-6 trials for the injectable and oral versions of semaglutide, respectively. Drug costs were estimated as 75% of the United States national average drug acquisition cost listing in June 2021. We performed a scenario analysis to mitigate the primary differences between the populations in the two trials. Sensitivity analysis was performed to evaluate the effect of price changes of the interventions.The CNT to prevent one MACE with subcutaneous semaglutide in SUSTAIN-6 was $966,693 ($594,888-$5,035,302) compared to $948,689 ($463,465-∞) with oral semaglutide in PIONEER-6. The scenario analysis demonstrated a 17% lower CNT for oral semaglutide. The difference between CNTs was sensitive to price fluctuations of the two interventions.Oral and subcutaneous semaglutide prescribed to prevent MACE in patients with T2DM provide similar value for money. The choice between both therapies should be guided mainly by patient preferences.

Aims The Angiotensin Receptor-Neprilysin Inhibitor sacubitril-valsartan (ARNI) and dapagliflozin, a sodium-glucose transport protein 2 inhibitor, reduce the risk of heart failure hospitalization (hHF) and cardiovascular (CV) mortality in patients with reduced ejection fraction (HFrEF). Their comparative value for money is undetermined. Therefore, our aim was to compare the cost per outcome implications of utilizing dapagliflozin vs. ARNI for preventing heart failure (HF) events of non-diabetic patients with HFrEF. Methods and results We calculated the cost needed to treat (CNT) to prevent one HF event. The cost needed to treat was estimated by multiplying the annualized number needed to treat (NNT) to prevent one event by each therapy’s annual cost. Efficacy estimates were extracted from published secondary analyses of non-diabetic patients in DAPA-HF and PARADIGM-HF trials. Drug costs were estimated as 75% of the 2020 US National Average Drug Acquisition Cost listing. Sensitivity analysis was performed to mitigate differences between the trial’s populations and drug costs in various countries. The annualized NNT to prevent one HF event for dapagliflozin was 31 (95% CI 21–71) vs. 33 (95% CI 24–62) for ARNI. The CNT of dapagliflozin in the US is $141 112 (95% CI $95 592–$323 192) compared to $158 169 (95% CI $115 032–$297 166) for sacubitril-valsartan. The CNT results were sensitive to drug costs in various countries. Conclusion Dapagliflozin and ARNI provide comparable value for money for preventing HF events in non-diabetic patients with HFrEF. In healthcare settings where dapagliflozin’s price is significantly lower than ARNI, it provides superior value for money.

Introduction: Several innovative medications have recently demonstrated significant efficacy in preventing major adverse cardiovascular events. In many situations, payers need to understand promptly whether the novel interventions provide good value for their resources invested. Cost-effectiveness analysis (CEA) is the gold standard and cornerstone of pharmacoeconomic evaluation but requires significant resources, and is not always available at the period needed for reimbursement decisions. Therefore, we suggest using the "Cost Needed to Treat" (CNT) measure as a preliminary economic figure for comparing novel preventive therapies' value until valid CEA is available. CNT represents the extra cost of therapy needed to prevent one additional adverse event. The CNT is a product of the number needed to treat (NNT) and the cost of the therapy. A lower CNT indicates more value for money. To validate the usefulness of the CNT measure, we aimed to retrospectively compare outcomes of published CNT evaluations and the later published CEAs. Hypothesis: CNT measure and CEA result in comparable recommendations. Methods: We compared the conclusions of all published CNT evaluations with available published CEA results. Results: Seven published CNT figures, based on cardiovascular outcome trial results, were identified. Four CNTs had matched CEAs. The CNT evaluation and the CEA resulted in the same conclusions in all four cases (Figure 1). Conclusions: Outcomes of the published CNT evaluations seem to correlate with published CEA results. CNT seems to be a valuable, prompt tool for comparing novel preventive interventions' economic value.

Introduction: Patients with HF and reduced ejection fraction (HFrEF) are at high risk for CV mortality and HF-related hospitalizations (HHF). The Sodium-Glucose Transport protein 2 inhibitors (SGLT2i) dapagliflozin and empagliflozin improve the outcomes of non-diabetic patients with HFrEF. We aimed to compare their value for money for this indication. Hypothesis: Empagliflozin and dapagliflozin have comparable value for money for improving the HF outcomes of non-diabetic patients with HFrEF. Methods: SGLT2i data was extracted from published results of empagliflozin and dapagliflozin in the subgroups of patients without diabetes. The primary clinical outcome measure was a composite of HHF or CV mortality events. The economic measure was the cost needed to treat (CNT) to prevent one event, calculated by multiplying the one-year number needed to treat (NNT) to prevent one event by the annual cost of each therapy. Drug costs were based on the 2021 US National Average Drug Acquisition Cost prices. Secondary outcomes were the CNT to prevent one event of HHF and CV mortality as separate clinical outcomes. Sensitivity analysis was performed to mitigate differences between the trial’s populations Results: Treatment with empagliflozin in EMPEROR-REDUCED has resulted in an NNT of 29 (95% CI: 18-212) compared to 32 (95% CI: 21-72) with dapagliflozin in DAPA-HF. Accordingly the CNT to prevent one event of CVM or HHF was $139,115 (95% CI: $86,347-$1,016,976) and $144,751 (95% CI: $94,993-$325,690), respectively. The sensitivity analysis confirmed the primary results, but the CNT to prevent CV mortality is significantly lower with dapagliflozin (Fig. 1) Conclusions: Empagliflozin and dapagliflozin have comparable value for money for improving HF outcomes of non-diabetic patients with HFrEF, with an advantage for dapagliflozin in CV mortality.

Introduction: Secondary prevention of cardiovascular events among patients with diagnosed cardiovascular disease and high ischemic risk poses a significant challenge in clinical practice. Both Ticagrelor and low-dose (LD) Rivaroxaban have shown superiority in preventing major adverse cardiovascular events (MACE) than aspirin treatment alone. The comparative value for money of these two regimens remains unexplored. Hypothesis: Ticagrelor and LD-Rivaroxaban are comparable in their clinical efficacy and cost-effectiveness. Methods: We analyzed the annualized cost needed to treat (CNT) of each regimen by multiplying the annualized number needed to treat (aNNT) by the annual cost of each drug. The aNNTs were based on outcome data from PEGASUS TIMI-54 and COMPASS trials. Scenario analyses were performed to overcome variances in terms of population risk. Costs were based on 2021 US prices. Secondary outcomes analysis was performed for myocardial infarction (MI), stroke, and CV death as separate outcomes. Results: The aNNTs to prevent MACE with Ticagrelor and with LD-Rivaroxaban were 207 [95% confidence interval (CI):138-553] and 147 (95%CI:104-252), respectively. At an annual cost of $3,541 versus $4,308, the corresponding CNTs were 734,429$ (95%CI:489,619$-1,958,478$) with ticagrelor and 633,003$ (95%CI:446,826$-1,085,149$) with LD-Rivaroxaban. Results of the scenario and secondary outcomes analysis are presented in Figure 1 . Conclusions: LD-Rivaroxaban provides better value for money than Ticagrelor for secondary prevention of MACE. Ticagrelor offers an advantage over LD-Rivaroxaban specifically to prevent MI and should be considered in cases where MI is the primary concern.

Introduction: Heart failure with preserved ejection fraction (HFpEF) is associated with frequent hospitalizations and an increased risk of death. There are no therapies with certain benefits for the treatment of HFpEF. Spironolactone and Sacubitril/Valsartan have shown marginal significance benefits in HFpEF and are approved to treat this condition. We aimed to compare the value for money of these treatments. Hypothesis: Spironolactone provides better value for money than Sacubitril/Valsartan for preventing HF events in patients with HFpEF. Methods: We compared the cost needed to treat (CNT) to prevent the composite outcome of HF hospitalization and CV death with Spironolactone or Sacubitril/Valsartan. The CNT was estimated by multiplying the annualized number needed-to-treat (aNNT) by the annual cost of therapy. The aNNTs were calculated based on data from the TOP-CAT and PARAGON trials. Costs were based on 2021 US prices. Scenario analyses were performed to attenuate the differences in the studies’ populations. Subgroup analyses were performed for mildly reduced EF. Results: The aNNT to prevent the composite outcome with Sacubitril/Valsartan in PARAGON was 53 [95% CI:28-∞] versus 107 (95% CI:51-∞), with spironolactone in TOPCAT. At an annual cost of $5,100 versus $1,353, The corresponding CNTs were $270,273 (95% CI:142,786-∞) for Sacubitril/Valsartan and $144,773 (95% CI:69,004-∞) for spironolactone. Figure 1 illustrates the results of the scenario and subgroup analysis. Conclusion: Despite lower clinical efficacy, spironolactone provides better value for money than Sacubitril/Valsartan in preventing HF hospitalizations and cardiovascular death among patients with HFpEF.

Background Comorbid heart failure with reduced ejection fraction (HFrEF) and type 2 diabetes mellitus (DM) is associated with a very high risk of HF events. Sacubitril-valsartan, an angiotensin receptor-neprilysin inhibitor (ARNI), and dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, improve HF outcomes in these patients, but their comparative value for money in this patient population has not yet been determined. Objective We aimed to compare the cost needed to treat (CNT) to avoid an HF event with each drug. Methods CNT was estimated by multiplying the annualized number needed to treat (NNT) to prevent one HF event by the annual cost of each therapy. HF events were defined as the first event of hospitalization for HF or cardiovascular mortality. Drug efficacy data were extracted from published secondary analyses of patients with DM in the DAPA-HF and PARADIGM-HF trials. Drug costs were estimated as 75% of the 2021 US National Average Drug Acquisition Cost listing. Sensitivity analysis was performed on parameters that may have affected the CNT. Results The annualized NNT was 24 (95% confidence interval [CI] 16-54) for dapagliflozin and 57 (95% CI 31-433) for the ARNI. At an annual cost of $US4523 and 5099, respectively, the CNT was $US108,563 (95% CI 72,375-244,267) for dapagliflozin and $US290,671 (95% CI 158,084-2,208,079) for the ARNI. Conclusions Dapagliflozin seems to offer greater value for money than the ARNI for patients with HFrEF and DM. Our results provide support for contemporary guidelines advocating the use of dapagliflozin in these patients.

The sodium-glucose cotransporter 2 inhibitors (SGLT2i) empagliflozin, canagliflozin, and dapagliflozin reduce the risk of heart failure (HF) events in patients with diabetes mellitus (DM) at high risk for HF. Differences in HF outcomes between SGLT2i were demonstrated in a recent-published meta-analysis. Nevertheless, comparative cost-effectiveness analyses of SGLT2i provided for this indication have not been published yet. Therefore, we aimed to provide a preceding economic comparison of the costs required for improving HF outcomes by these three SGLT2i. The primary outcome was the cost needed to treat (CNT) to prevent one event of hospitalization for HF or cardiovascular mortality. CNT is calculated by multiplying the annualized number needed to treat to prevent one event by the annual cost of therapy. Clinical outcome data were extracted from pre-specified cohorts of HF-naive patients in the pivotal randomized controlled trials (RCTs). Costs of interventions were estimated as 75% of the US National Average Drug Acquisition Cost listing. Sensitivity analysis was performed to mitigate differences between the RCT's populations. We figured the CNT for the primary prevention of HF events in DM patients to be $542,328 ($409,044-$905,412) for empagliflozin, $2,347,488 ($1,066,208-∞) for canagliflozin and $2,128,374 ($1,204,740-$48,140,518) for dapagliflozin. Sensitivity analysis confirmed the cost benefit of empagliflozin. Our findings suggest that between the available SGLT2i, the cost of primary prevention of HF in patients with DM at high risk for HF is lowest with empagliflozin. These findings may help choose an SGLT2i until head-to-head RCTs, and comprehensive cost-effective analyses for this indication are available.

Introduction: The Glucagon-Like Peptide-1 receptor agonists (GLP-1a) semaglutide, dulaglutide, and liraglutide reduce major adverse cardiovascular events (MACE) in patients with Type 2 diabetes mellitus ( T2DM) and established CVD. The American Diabetes Association currently recommends providing GLP-1a therapy to this patient population independently of glycaemic control. Despite proven clinical benefits, providing GLP-1a to all guideline eligible patients is a significant cost burden on healthcare systems. Therefore, it is imperative to compare the value for money of these agents. Hypothesis: The newly introduced GLP-1a Semaglutide may be cost-saving compared to dulaglutide and liraglutide for preventing MACE in patients with established CVD and T2DM. Methods: We calculated the cost needed to prevent one MACE, by multiplying the annualized number needed to treat to prevent one event, by the annual cost of the therapy. Efficacy estimates were extracted from published RCT data. We performed a sensitivity analysis to mitigate differences between trial populations and other uncertainties. Drug costs were based on published US prices. Results: The cost needed to prevent one MACE with semaglutide is $557,187 ($331,491-$2,194,483) compared to $1,179,360 ($732,888-$2,746,224) with liraglutide and $1,605,904 ($706,044-∞) for dulaglutide. Sensitivity analysis confirmed the advantage of semaglutide. Conclusions: Semaglutide prescribed for secondary prevention of MACE in patients with T2DM and established CVD seems to provide more value for money than dulaglutide and liraglutide for the same purpose.

Introduction: Icosapent ethyl is currently the only drug approved for the prevention of major adverse cardiovascular events (MACE) in patients with hypertriglyceridemia, who are already on statin therapy. The approved use is both for secondary prevention in patients with established cardiovascular disease (CVD) or primary prevention for patients with diabetes and multiple risk factors. Despite its’ proven clinical benefits, the addition of icosapent ethyl to patient’s current treatment regimens may impose a significant cost burden on healthcare systems. Hypothesis: Prioritizing icosapent ethyl therapy for patients with an established CVD may provide significantly more value for money than when prescribed as primary prevention. Methods: We performed an analysis of the cost required for icosapent ethyl per achieved outcome when prescribed either for primary or for secondary prevention of MACE. The cost needed to treat (CNT) to prevent one MACE in the REDUCE-IT trial was estimated by multiplying the annualized number needed to treat to prevent one event, by the annual cost of therapy. The market price of icosapent ethyl in the US was estimated as 75% of the US national average drug acquisition cost listing. Results: In the REDUCE-IT population, the figured CNT of Icosapent ethyl provided as primary prevention was $874,500 (95% CI: $349,800-∞) vs. $206,965 (95% CI: $160,325-$294,415) for secondary prevention; P Conclusions: The CNT for patients receiving the drug for primary prevention of MACE was four-fold higher than when provided as secondary prevention. Our findings suggest that icosapent ethyl therapy for patients with an established CVD provides significantly more value for money.

Introduction: Semaglutide, a subcutaneous Glucagon-Like Peptide-1 receptor agonist, reduces the risk of major adverse cardiovascular events (MACE) in patients with Type 2 diabetes mellitus (T2DM). An oral version of semaglutide is now available, and patients may prefer it over a subcutaneous injection. The value for money of the oral version for the prevention of MACE is not clear. Hypothesis: Oral semaglutide provides less value for money than subcutaneous semaglutide for the prevention of MACE, but more value for money for the prevention of the single endpoint of cardiovascular mortality (CVM). Methods: We calculated the cost needed to prevent (CNT) one MACE, by multiplying the one-year number needed to treat to prevent one event, by the annual cost of the therapy. Efficacy estimates were extracted from published RCT data. The CNT to prevent one event of the single endpoint of CVM was analyzed as a secondary outcome. We performed a sensitivity analysis to mitigate primary differences between the RCTs. Drug costs were calculated as 75% of the US National Average Drug Acquisition Cost listing in June 2020. Results: The CNT to prevent one MACE with subcutaneous semaglutide in SUSTAIN-6 is $641,823 ($402,021-$3,533,533) compared to $855,040 (95% CI: $420,840-∞) with oral semaglutide in PIONEER 6. The lower cost of subcutaneous semaglutide was confirmed in a sensitivity analysis simulating the effects of the drugs in both RCTs. The CNT to prevent one CVM with semaglutide is $16,342,560 ($2,020,704.00-∞) compared to $1,315,720 (95% CI: $921,004-$8,392,414) with oral semaglutide. Conclusions: Subcutaneous semaglutide prescribed for the prevention of MACE in patients with T2DM is moderately cost-saving compared to oral semaglutide for the same purpose. However, for the prevention of CVM, the oral version provides significantly better economic value.

Introduction: The AHA 2020 strategic goal of reducing CV mortality by 20% was partially achieved (15% reduction 2011-2019). Empagliflozin, an inhibitor of sodium-glucose cotransporter 2 inhibitor and oral semaglutide, the first oral glucagon-like peptide 1 receptor agonist, both significantly reduce the incidence of cardiovascular mortality (CVM) in patients with type 2 diabetes (DM) and established CVD. However, the addition of either drug to current diabetes treatment regimens may impose a significant burden on healthcare systems. Hypothesis: Empagliflozin provides more value for money than oral semaglutide for the prevention of CVM in patients with DM. Methods: We calculated the cost needed to treat (CNT) to prevent one case of CVM using either drug, by multiplying the annualized number needed to treat (NNT) to prevent one event, by the annual cost of the therapy. Efficacy estimates were extracted from published randomized controlled trials (RCT) data. We performed a sensitivity analysis to mitigate the primary differences between the RCTs and other uncertainties. Drug costs were calculated as 75% of the US National Average Drug Acquisition Cost listing in June 2020. Results: The annualized NNT of empagliflozin in EMPA-REG-OUTCOME was 141 (95% CI: 104-230) versus 140 (95% CI: 98-893) for oral semaglutide in PIONEER 6, while the corresponding annual costs are $4,572 versus $6,680. Therefore, the CNT of empagliflozin was $644,652 ($475,488-$1,051,560) compared to $935,200 (95% CI: $654,640-$5,965,240) with oral semaglutide. The lower CNT of empagliflozin was confirmed in a sensitivity analysis. Conclusions: The annualized NNT of empagliflozin and oral semaglutide prescribed for the prevention of CVM in patients with T2DM and established CVD is similar. Therefore, the lower cost of empagliflozin results in a lower CNT and better value for money.

Background Icosapent ethyl (IPE) is approved for the prevention of major adverse cardiovascular events (MACE) in patients with hypertriglyceridemia. However, due to budget constraints, access to IPE will inevitably be limited to a fraction of eligible patients. To help maximize value for money spent, we estimated the number of preventable MACE when providing IPE for primary versus secondary prevention. Methods The number of preventable MACE was estimated by dividing the available budget by the cost needed to treat (CNT) to prevent one MACE. CNT was calculated as the product of the number needed to treat (NNT) to prevent 1 MACE by therapy cost. NNT values were determined according to the Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (REDUCE-IT) results. The budget limit was set as the United States’ threshold suggested by the Institute for Clinical and Economic Review. Sensitivity analysis was performed regarding the cost of IPE in the United States. Results The NNT to prevent 1 MACE over 4.9 years in the Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial primary prevention cohort was 59 (95% confidence interval [CI]: 24-∞) versus 14 (11-21) for secondary prevention. At an annual IPE cost of $2915, the CNT to prevent 1 MACE was $842,726 (95% CI: $342,804-∞) and $199,969 ($157,118-$299,953) accordingly. A total of $819 million worth of IPE can avoid 4762 MACE (95% CI: 0-11,707) versus 20,069 (13,379-25,541), when provided as primary versus secondary prevention therapy; P Conclusions Prioritizing IPE therapy for patients with an established cardiovascular disease may provide significantly more value for money than primary prevention.