OBJECTIVES:

Sacubitril/valsartan (Entresto®) has been reimbursed in Ireland since December 2017, for the treatment of symptomatic chronic heart failure with reduced ejection fraction (HF-rEF). It was reimbursed subject to a reimbursement application system (RAS) which requires individual applications for reimbursement approval, which is only supported in patients who meet specific clinical criteria including:

1. Left ventricular ejection fraction of ≤35%
2. Symptomatic with New York Heart Association class II to IV symptoms
3. Receiving optimal medical therapy for heart failure
4. Systolic blood pressure ≥ 100mm Hg.

This study provides an overview of utilisation and expenditure on Entresto® in Ireland, and examines the ability of the RAS to contain expenditure in line with projections.

METHODS:

Data pertaining to individual reimbursement applications was extracted from the online application system. Utilisation and expenditure data were extracted from the national pharmacy claims database, and analysed in R studio. Total annual expenditure was calculated and compared with projections in the health technology assessment (HTA) report. The study time frame was 1 December 2017 to 30 November 2022 inclusive, aligned with the budget impact projections in the HTA report.

RESULTS:

The number of applications for reimbursement received annually has been consistent, with 1,923 applications received in year 1 (2017/2018), and 2,001 applications received in year 5 (2021/2022). The number of patients treated annually with Entresto® has increased from 1,186 in November 2018 (end year 1) to 5,519 in November 2022 (end year 5). The annual cost of Entresto® to the public health service increased from €1,537,383 in year 1, to €8,774,908 in year 5. The cumulative expenditure across the five year period was €25,386,126, compared to projections of up to €50 million in the HTA report.

CONCLUSIONS:

The RAS for Entresto® has enabled patient access to a high-cost medicine for the management of a common condition, HR-rEF, while containing expenditure below projections.