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New HTA Decisions in Germany
December 2021
Drug name
VERQUVO® (vericiguat)
Company
Bayer Vital GmbH
Decision date
15/12/2021
Therapeutic area
Cardiovascular conditions
Therapeutic sub area
Heart failure
G-BA decision date
01/03/2022
Orphan Drug?
No
Decision
Additional benefit not quantifiable
Indication
Adults <75 years with symptomatic, chronic heart failure with reduced ejection fraction, who have experienced a recent decompensation event that required IV therapy and have been stabilised. Appropriate comparator therapy: Optimised standard therapy for the treatment of symptomatic, chronic heart failure and the underlying medical conditions, such as hypertension, cardiac arrhythmias, coronary artery disease, diabetes mellitus, hypercholesterolemia; as well as associated symptoms.
Decision
No additional benefit
Indication
Adults ≥75 years with symptomatic, chronic heart failure with reduced ejection fraction, who have experienced a recent decompensation event that required IV therapy and have been stabilised. Appropriate comparator therapy: Optimised standard therapy for the treatment of symptomatic, chronic heart failure and the underlying medical conditions, such as hypertension, cardiac arrhythmias, coronary artery disease, diabetes mellitus, hypercholesterolemia; as well as associated symptoms.
Decision Detail
Main study: VICTORIA Main drivers of decision: Based on the data presented for the benefit assessment, the indication was split based on population age. A non-quantifiable added benefit of vericuguat for the endpoint hospitalisation for heart failure was evidenced only in indication 1 (patients <75 years). In the total population, a significant difference to the advantage of vericiguat was reported for the outcome atrial fibrillation, however, it was questioned whether the outcome belonged to the endpoint category side effects, or depicts the symptoms of the disease. A clear delimitation was not possible on the basis of the available information. Overall, there were no data to evidence the added benefit of treatment for patients ≥ 75 years (indication 2).
Summary
IQWIG concluded that there was an unquantifiable added benefit for indication 1 and no added benefit for indication 2.