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OFEV (nintedanib) - Pulmonary fibrosis
Reason for request
Reassessment.
Key points
Favourable opinion for maintenance of reimbursement in the idiopathic pulmonary fibrosis indication.
Clinical Benefit
| Moderate |
The clinical benefit of OFEV (nintedanib) remains moderate in patients with a confirmed clinical, radiological and/or histopathological diagnosis of idiopathic pulmonary fibrosis, with the following respiratory function criteria: FVCp ≥ 50% and DLCO ≥ 30%. |
Clinical Added Value
| minor |
The Committee considers that the data from the RaDiCo-FPI post-registration study is not of a nature to modify its assessment of the clinical benefit formulated in its previous opinion of 20 May 2015: CAV IV, in patients with a confirmed clinical, radiological and/or histopathological diagnosis of idiopathic pulmonary fibrosis, with the following respiratory function criteria: FVCp ≥ 50% and DLCO ≥ 30%. |
