Authors:

T Sente¹ , R Van Landuyt² , M Vanlierde² , S Vancayzeele¹ , ¹Novartis Pharma, Medical Affairs - Vilvoorde - Belgium , ²Novartis Pharma, Market Access - Vilvoorde - Belgium ,

Citation:

Background: The angiotensin receptor neprilysin inhibitor sacubitril/valsartan (s/v) was granted reimbursed market access in Belgium on November 1, 2016 for the treatment of adult patients (=18 years) with symptomatic heart failure with reduced ejection fraction (HFrEF; LVEF=35% and optimally treated with an ACEi or ARB). In Belgium, s/v can only be initiated by cardiologists and internists. However, information on its real world use is scarce. Purpose: To provide data on real world clinical practice of all HFrEF patients treated with s/v in Belgium. Methods: A nationwide, retrospective cohort study was performed based on patient level linkage of integrated electronic healthcare datasets including administrative payer claims, national health registries, pharmacy claims and medical records. All HFrEF patients receiving reimbursement for s/v in Belgium between November 2016 and December 2018 will be included, regardless of prior history or length of follow-up. Results: An interim functional analysis was performed covering data from 2200 HFrEF patients treated with s/v, being 69.3% men. S/v was prescribed in 97.7% (n=2149) by cardiologists and 2.1% (n=46) by internists. 515 different physicians prescribed s/v and the average number of prescriptions per physician was 4.3. 48.3% were in NYHA II, 46.4% in NYHA III and the remaining in NYHA IV patients (5.2%). 28.7% of patients were between 60-70 years and 32.1% between 70-80 years. 16.8% of patients were over 80 years of age. The number of s/v packs delivered steadily increases over time for all dosages. Most patients were initiated s/v at the lowest dose of 24/26mg twice a day (BID), and only 24.1% achieved the target dose of 97/103mg BID after one year of treatment. Conclusion: The majority of the HFrEF patients treated with s/v in Belgium are male with NYHA II and =60 years. Almost all applications for s/v reimbursement came from physician specialists in cardiology. Real life data shows that most patients were initiated at the lowest dose of s/v. Final analysis is expected in March 2019 and will consist of a full real life profile of every single Belgian HFrEF patient treated with s/v providing the first insights on s/v utilization, outcomes and patient profiles in Belgium.