1Universitätsklinikum Würzburg Deutsches Zentrum für Herzinsuffizienz Würzburg, Deutschland; 2Novartis Pharma GmbH Medical Affairs Nürnberg, Deutschland; 3Universitätsklinikum Leipzig Klinik und Poliklinik für Kardiologie Leipzig, Deutschland; 4Universitätsmedizin Göttingen Herzzentrum, Klinik für Kardiologie und Pneumologie Göttingen, Deutschland; 5Universitätsklinikum des Saarlandes Innere Medizin III - Kardiologie, Angiologie und internistische Intensivmedizin Homburg/Saar, Deutschland; 6ABDA-Bundesvereinigung Deutscher Apothekerverbände e. V. GB Arzneimittel Berlin, Deutschland
Background Guideline-directed medical therapy (GDMT) is the cornerstone in the treatment of patients with heart failure and reduced ejection fraction (HFrEF). Besides established pharmacotherapy, novel substances such as sacubitril/valsartan (S/V) and sodium-glucose co-transporter-2 inhibitors (SGLT2i) have demonstrated marked clinical benefits. However, their implementation into clinical practice is challenging and previous studies reported altered drug and healthcare utilization during the COVID-19 pandemic. Therefore, we investigated the implementation of novel GDMT into real-world HF care in Germany before, during, and after the COVID-19 pandemic period.
Methods This was a descriptive, retrospective analysis of patients from the IQVIA longitudinal prescription (LRx) database including all adult patients with a prescription of S/V between Q1/2016 and Q2/2023. The IQVIA LRx data set is based on ~80% of 73 million people covered by the German statutory health insurance. Prescriptions of sacubitril/valsartan (S/V) were used as a proxy for HFrEF. Time trends were analysed for prevalent and incident prescriptions for S/V alone and in combination therapy with sodium-glucose co-transporter-2 inhibitors (SGLT2i).
Results The number of prevalent patients treated with S/V increased from 5,260 in Q1/2016 to 351,262 in Q2/2023. The share of patients with combination therapy grew from 0.6% to 14.2% in Q2/2021, and then showed a steep surge up to 54.8% in Q2/2023, coinciding with the release of the European Society of Cardiology (ESC) guidelines for HF in Q3/2021. Women and patients aged >80 years were treated less often with combined therapy than men and younger patients.
As shown in the figure, the number of incident patients with S/V continuously increased from Q1/2016 to Q2/2023. With the implementation of nation-wide restrictions due to the COVID-19 pandemic in Germany, the number of patients with new S/V prescriptions dropped by 17.5% within one quarter, i.e., from 26,855 in Q1/2020 to 22,145 in Q2/2020, and returned to pre-pandemic levels only in Q1/2021. Before the approval of the first SGLT2i for HFrEF in Q4/2020, the increase of new S/V prescriptions was driven by prescribing S/V without concomitant SGLT2i. Thereafter, the simultaneous initiation of S/V and SGLT2i or the addition of S/V to pre-existing SGLT2i became the favoured approach. This trend was further accelerated after the release of the new ESC HF guidelines in Q3/2021.
Conclusion The COVID-19 pandemic notably compromised the initiation of disease modifying drug therapy resulting in a 12-month period of delayed treatment initiation of S/V. After the release of the ESC HF guidelines, prescribing behaviours markedly changed from isolated S/V therapy to combined therapy with S/V and SGLT2i. Further efforts are needed to fully implement GDMT, including both S/V and SGLT2i, and to strengthen the resilience of healthcare systems during public health crises.