Real-world evidence of Entresto adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction

Description

Novartis and RIZIV-INAMI agreed upon an article 81 procedure for which real world evidence of Entresto needs to be collected in order to evaluate the product for future reimbursement. Reimbursement criteria for Entresto are defined by the Royal Decree of Dec. 21 2001 §8410000. Entresto is reimbursed starting from Nov. 1 2016.

All the objectives of the Entresto registration will be limited to adult patients treated with Entresto for Heart Failure with Reduced Ejection Fraction (HFrEF) in Belgium for the reference period of Nov. 1 2016 up to and including Dec. 31 2017. The primary objectives are: a) To describe the population characteristics; b) To estimate the hospitalization rates (all causes); c) To estimate the mortality (all causes) rates. The secondary objectives are: a) To estimate the cardiovascular hospitalization rates; b) To estimate the cardiovascular mortality; c) Data analysis (main & secondary objectives) specific to age group > 75 years; d) Data analysis (main & secondary objectives) specific to NYHA class III and IV

The reporting will facilitate evaluation of the effectiveness and safety of Entresto, and as such contribute to knowledge about the added value of Entresto on the study population in the cardiovascular domain.

Resources

Name Format Description Link
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HD Data Collection Definition of project HDBP0085 ENTRESTO v1 20171107 xlsx Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Data User JSON JSON Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Data User CSV CSV Open resource
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e9430a2e-4fb1-4a86-aec3-86e288a573ac SCRA JSON JSON Open resource
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SCRA_ENTRESTO_2020_01.pdf: e9430a2e-4fb1-4a86-aec3-86e288a573ac SCRA PDF Document PDF Open resource
HD Data Collection Definition of project HDBP0085 ENTRESTO v1 20171107 xlsx Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac SCRA JSON JSON Open resource
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HD Data Collection Definition of project HDBP0085 ENTRESTO v1 20171107 xlsx Open resource
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e9430a2e-4fb1-4a86-aec3-86e288a573ac Stakeholders CSV CSV Open resource
HD Data Collection Definition of project HDBP0085 ENTRESTO v1 20171107 xlsx Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Stakeholders CSV CSV Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Data User CSV CSV Open resource
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HD Data Collection Definition of project HDBP0085 ENTRESTO v1 20171107 xlsx Open resource
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HD Data Collection Definition of project HDBP0085 ENTRESTO v1 20171107 xlsx Open resource
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HD Data Collection Definition of project HDBP0085 ENTRESTO v1 20171107 xlsx Open resource
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HD Data Collection Definition of project HDBP0085 ENTRESTO v1 20171107 xlsx Open resource
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e9430a2e-4fb1-4a86-aec3-86e288a573ac Stakeholders JSON JSON Open resource
SCRA_ENTRESTO_2020_01.pdf SCRA PDF document PDF Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Stakeholders CSV CSV Open resource
HD Data Collection Definition of project HDBP0085 ENTRESTO v1 20171107 xlsx Open resource
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HD Data Collection Definition of project HDBP0085 ENTRESTO v1 20171107 xlsx Open resource
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HD Data Collection Definition of project HDBP0085 ENTRESTO v1 20171107 xlsx Open resource
SCRA_ENTRESTO_2020_01.pdf: e9430a2e-4fb1-4a86-aec3-86e288a573ac SCRA PDF Document PDF Open resource
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SCRA_ENTRESTO_2020_01.pdf SCRA PDF document PDF Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Stakeholders JSON JSON Open resource
HD Data Collection Definition of project HDBP0085 ENTRESTO v1 20171107 xlsx Open resource
SCRA_ENTRESTO_2020_01.pdf: e9430a2e-4fb1-4a86-aec3-86e288a573ac SCRA PDF Document PDF Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Data User CSV CSV Open resource
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e9430a2e-4fb1-4a86-aec3-86e288a573ac Data User JSON JSON Open resource
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HD Data Collection Definition of project HDBP0085 ENTRESTO v1 20171107 xlsx Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac SCRA JSON JSON Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Stakeholders JSON JSON Open resource
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e9430a2e-4fb1-4a86-aec3-86e288a573ac SCRA JSON JSON Open resource
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SCRA_ENTRESTO_2020_01.pdf SCRA PDF document PDF Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Data User CSV CSV Open resource
HD Data Collection Definition of project HDBP0085 ENTRESTO v1 20171107 xlsx Open resource
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e9430a2e-4fb1-4a86-aec3-86e288a573ac Data User JSON JSON Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Data User JSON JSON Open resource
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HD Data Collection Definition of project HDBP0085 ENTRESTO v1 20171107 xlsx Open resource
HD Data Collection Definition of project HDBP0085 ENTRESTO v1 20171107 xlsx Open resource
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SCRA_ENTRESTO_2020_01.pdf SCRA PDF document PDF Open resource
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HD Data Collection Definition of project HDBP0085 ENTRESTO v1 20171107 xlsx Open resource
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e9430a2e-4fb1-4a86-aec3-86e288a573ac Legal JSON JSON Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Legal JSON JSON Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Legal JSON JSON Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Legal JSON JSON Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Stakeholders JSON JSON Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Stakeholders CSV CSV Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Legal JSON JSON Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Legal JSON JSON Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Legal CSV CSV Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Stakeholders CSV CSV Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Data User JSON JSON Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac SCRA CSV CSV Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Data User CSV CSV Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Legal JSON JSON Open resource
SCRA_ENTRESTO_2020_01.pdf SCRA PDF document PDF Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Stakeholders CSV CSV Open resource
SCRA_ENTRESTO_2020_01.pdf: e9430a2e-4fb1-4a86-aec3-86e288a573ac SCRA PDF Document PDF Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac SCRA JSON JSON Open resource
SCRA_ENTRESTO_2020_01.pdf: e9430a2e-4fb1-4a86-aec3-86e288a573ac SCRA PDF Document PDF Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Data User CSV CSV Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac SCRA CSV CSV Open resource
HD Data Collection Definition of project HDBP0085 ENTRESTO v1 20171107 xlsx Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Stakeholders JSON JSON Open resource
SCRA_ENTRESTO_2020_01.pdf: e9430a2e-4fb1-4a86-aec3-86e288a573ac SCRA PDF Document PDF Open resource
HD Data Collection Definition of project HDBP0085 ENTRESTO v1 20171107 xlsx Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Stakeholders JSON JSON Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Legal JSON JSON Open resource
SCRA_ENTRESTO_2020_01.pdf SCRA PDF document PDF Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Stakeholders CSV CSV Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac SCRA CSV CSV Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac SCRA CSV CSV Open resource
SCRA_ENTRESTO_2020_01.pdf SCRA PDF document PDF Open resource
SCRA_ENTRESTO_2020_01.pdf: e9430a2e-4fb1-4a86-aec3-86e288a573ac SCRA PDF Document PDF Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Stakeholders CSV CSV Open resource
SCRA_ENTRESTO_2020_01.pdf: e9430a2e-4fb1-4a86-aec3-86e288a573ac SCRA PDF Document PDF Open resource
HD Data Collection Definition of project HDBP0085 ENTRESTO v1 20171107 xlsx Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Data User JSON JSON Open resource
SCRA_ENTRESTO_2020_01.pdf: e9430a2e-4fb1-4a86-aec3-86e288a573ac SCRA PDF Document PDF Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Stakeholders CSV CSV Open resource
SCRA_ENTRESTO_2020_01.pdf: e9430a2e-4fb1-4a86-aec3-86e288a573ac SCRA PDF Document PDF Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac SCRA JSON JSON Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac Legal CSV CSV Open resource
SCRA_ENTRESTO_2020_01.pdf: e9430a2e-4fb1-4a86-aec3-86e288a573ac SCRA PDF Document PDF Open resource
e9430a2e-4fb1-4a86-aec3-86e288a573ac SCRA CSV CSV Open resource

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