Contributor: Nick Hawkes

PARADIGM – HF demonstrated that Sacubitril/Valsartan reduces morbidity and mortality in patients with HFrEF compared to ACE-I/ARB therapy, so why is its adoption in the real world delayed?

Sangaralingham et al. accessed data from OptumLabs Data Warehouse, a large database of de-identified medical and pharmacy claims. Among patients identified based on systolic HF ICD codes, those prescribed sacubitril/valsartan were compared to those who were not. Patient variables included health plan, age, gender, race, region, comorbidities, other prescription medications, and provider specialty. Additionally the costs, out-of-pocket (OOP) and to the health plan, were captured.

Patients treated with sacubitril/valsartan (n=2244) were compared to patients on ACE-i/ARB therapy (n=39,598). Patients taking sacubitril/valsartan were younger (mean age: 67.6 vs 70.3 y/o, p<0.001), more likely male (68.2% vs 58.5%, p<0.001), and had fewer comorbidities (Charlson Comorbidity Index 3.6 vs 4.0, p<0.001). The majority of prescribers were cardiologists (82%).

When started on sacubitril/valsartan, the majority of patients were started on the lowest dose 24/26mg (58.6%) as compared to 49/51mg (32%) or 97/103mg (9.4%). Patients who remained on sacubitril/valsartan tended to be on more medications (OR 1.047, p<0.001) and began therapy at the 97/103mg dose (OR 1.320, p<0.001). Although in PARADIGM-HF patients received an ACE-I prior to initiation, among this real world cohort 43.9% of patients were not taking an ACE-I/ARB prior to receiving sacubitril/valsartan. Patients with prior use of ACE-i/ARB were shown to have a higher rate of adherence (OR 1.42, p<0.001).

All-in-all, 1161 (59.1%) of patients initiated on sacubitril/valsartan remained adherent at 180 days. Of those patients that were non-adherent/discontinued sacubitril/valsartan, 160 (20%) switched to ACE-i/ARB therapy.

So, what about cost? The mean 30-day out-of-pocket (OOP) cost for ACE-i/ARB therapy was $3.07 vs $71.16 for sacubitril/valsartan (p<0.001). Interestingly, OOP cost was not associated with adherence.

No study is perfect. First, the data includes patients enrolled in private and Medicare Advantage health plans with pharmacy benefits, so this may not represent all populations. Second, the HFrEF cohort was based on billing codes for systolic HF and may overestimate the patients truly eligible for sacubitril/valsartan.

In a heartbeat… Sacubitril/valsartan has been shown to reduce morbidity and mortality in patients with HFrEF, however the rate of use remains small. Furthermore, less than 60% of patients remained on the drug at 180 days. Although in this analysis cost was not associated with adherence, sacubitril/valsartan was 20x more expensive that ACE-i/ARB therapy.

Study Link: Adoption of Sacubitril/Valsartan for the Management of Patients With Heart Failure