Formulary Placement Led to Delays, Disruptions in Receiving Sacubitril/Valsartan for CHF

Despite being recommended as the preferred renin-angiotensin-aldosterone system (RAAS) inhibitor in chronic heart failure (CHF), uptake of sacubitril/valsartan (Entresto) among eligible patients has been slow. In a session at the annual meeting of the Academy of Managed Care Pharmacy (AMCP), Chi-Chang Chen, MsPharm, PhD, principal, IQVIA, presented results of a poster identifying the role of prescription abandonment and rejection.

The poster was 1 of 4 posters at AMCP to be awarded the platinum medal based on 5 criteria: relevance, originality, quality, bias, and clarity.

The study was a retrospective cohort analysis using IQVIA Longitudinal Access and Adjudication Data between January 1, 2016 and February 29, 2020.

“Despite an established efficacy and safety profile, uptake of [sacubitril/valsartan] in eligible [patients] has been slow, partially due to access barriers,” the authors wrote in the poster.

Patients included had an initial prescription request for sacubitril/valsartan between January 1, 2017, and November 30, 2019. Chen and his fellow researchers examined whether the prescriptions were approved (approved by the payer and filled by the patient), abandoned (approved by the payer but not filled), or rejected (not approved by the payer), and then the proportion of patients who later received sacubitril/valsartan.

A total of 205,040 patients were identified, of which 75,441 were in 12 commercial plans and 129,599 were in 9 Medicare national plans.

Among the patients with abandoned or rejected prescriptions, the researchers found:

• 33.4% were in commercial plans vs 25.8% in Medicare plans
• Formularies with the treatment on a non-preferred tier had the highest rejection rates
  • 41.9% in commercial plans and 42.4% in Medicare with the therapy non-preferred that also had prior authorization (PA)
  • 41.7% in commercial plans with non-preferred formularies without PA
• The lowest rates of abandonment or rejection were in plans in which the therapy was on the preferred tier and there was no PA (29.5% in commercial plans and 19.0% in Medicare plans)

A total of 107,225 patients had their initial sacubitril/valsartan prescription abandoned or rejected, but 56% of them did have it filled in the first 3 months. A total of 46,791 sacubitril/valsartan prescriptions still had the treatment abandoned or rejected after 3 days with 12 months of follow up.

Among these patients, 19% ended up receiving sacubitril/valsartan during a 12-month follow up, 15% received angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACEi/ARB), and 10% received neither sacubitril/valsartan nor ACEi/ARB.

The patients who eventually received sacubitril/valsartan or ACEi/ARB experienced delays. The median (SD) time in delay to starting sacubitril/valsartan was 97 (87) days and to starting ACEi/ARB was 62 (74) days.

A third (32%) of the patients with sacubitril/valsartan abandoned/rejected after the first 3 months had pre-index RAAS inhibitor use and 19% had RAAS inhibitor use at the index date. As a result, 8% of the patients experienced treatment disruption of at least 90 days when their prescription was abandoned/rejected.

“We did observe a very high proportion of abandonment/rejection rate and that appeared to lead to some unintended consequences,” Chen said.

He and his fellow researchers noted that additional research is needed to evaluate the impact of sacubitril/valsartan prescription abandonment or rejection on the downstream clinical and economic outcomes.

Reference

Chen CC, Yasuda M, Sun Ki. Impact of formulary coverage of Entresto (sacubitril/valsartan) on prescription abandonment/rejection and subsequent treatment patterns in chronic heart failure patients in the United States. Presented at: AMCP 2022; March 29-April 1; Chicago, Illinois. Poster I5.