Empagliflozin will be funded from May for symptomatic heart failure regardless of EF LK value
Empagliflozin entered the market as an antidiabetic drug operating on the principle of reducing glucose reabsorption by the kidneys from the urine and increasing its excretion through urine. Thanks to its very favorable impact on cardiovascular (CV) risks, it has gradually become an important part of treatment in cardiology as well. On May 1st, the long-awaited expansion of its reimbursement from public health insurance (ZP) for symptomatic heart failure with mildly reduced and preserved left ventricular ejection fraction (EF LK) will take place. It will thus be possible to improve the prognosis and quality of life for patients with this diagnosis. However, upon the availability of clinically verified therapy, another challenge arises in the form of underdiagnosis of patients with heart failure with preserved EF LK.
COMMERCIAL ANNOUNCEMENT
New Indication Criteria
From May 1, 2023, public health insurance will cover treatment with the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance) for patients with symptomatic heart failure of NYHA class II–III with EF LK > 40%, i.e., in the so-called mid-range ejection fraction (HFmrEF), and with preserved ejection fraction (HFpEF), with an eGFR > 20 ml/min/1.73 m2 and NT-proBNP value > 300 pg/ml (or > 900 pg/ml in patients with atrial fibrillation) (1). This is an expansion of reimbursement after it had previously gained coverage for heart failure with reduced EF LK (based on the EMPEROR-Reduced clinical trial) (2).
Possibility of Treating a Wide Range of Heart Failures
This expanded indication received approval from the European Medicines Agency (EMA) in March 2022 and was based on results from the EMPEROR-Preserved clinical trial, which demonstrated a significant reduction in the composite risk of heart failure hospitalization or cardiovascular death by a quarter compared to placebo in a cohort of nearly 6,000 patients (3). This made empagliflozin the first clinically verified modality in this indication (4). It is thus possible to prescribe this medicinal product for symptomatic heart failure regardless of the EF LK value (3).
Prescription Conditions
As with the previous indication, reimbursement applies to the 10 mg strength and 28-tablet packaging. Cardiologists and internists will be authorized to prescribe empagliflozin with reimbursement (5).
Additional Expert Information on the Topic
The newly reimbursed treatment in the HFpEF indication was also a topic at several cardiological expert meetings. We have already thoroughly informed you about the most interesting points discussed, for example, at the ESC 2022 congress (6).
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Sources:
1. Summary of the evaluation report. SÚKL, October 26, 2022. Available at: www.sukl.cz/file/100421_1_1
2. Empagliflozin gained reimbursement for heart failure treatment. proLékaře.cz, May 3, 2022. Available at: www.prolekare.cz/tema/srdecni-selhani/detail/empagliflozin-gained-reimbursement-for-heart-failure-treatment-130674
3. Jardiance. CHMP extension of indication variation assessment report. EMA, January 27, 2022. Available at: www.ema.europa.eu/en/documents/variation-report/jardiance-h-c-002677-ii-0060-epar-assessment-report-variation_en.pdf
4. Press release: EMPEROR-Preserved study with empagliflozin delivered breakthrough results, making it the first and so far the only successful study in the HFpEF indication. Available at: www.prolekare.cz/tema/srdecni-selhani/detail/press-release-emperor-preserved-study-with-empagliflozin-delivered-breakthrough-results-making-it-the-first-and-so-far-only-successful-study-in-the-hfpef-indication-127755
5. Jardiance, 10 mg tablets FLM 28×1. Medicinal database. SÚKL, 2023. Available at: www.sukl.cz/modules/medication/detail.php?code=0210022&tab=prices
6. ESC 2022: SGLT2 Inhibitors as a Hope for HFpEF: How to Implement Them in Practice? proLékaře.cz, November 10, 2022. Available at: www.prolekare.cz/tema/srdecni-selhani/detail/esc-2022-sglt2-inhibitors-as-hope-for-hfpef-how-to-implement-them-in-practice-132470
PC-CZ-102703
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