Reason for request

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Minor improvement in the treatment of idiopathic pulmonary fibrosis only in patients with FVC ≥ 50% and DLCO ≥ 30%

 

  • ESBRIET has Marketing Authorisation in the treatment of mild to moderate idiopathic pulmonary fibrosis.
  • The efficacy of ESBRIET versus placebo has been demonstrated in an improvement in predicted forced vital capacity: the level of the effect is moderate and its efficacy as regards mortality must be viewed with caution given the numerous methodological limitations.
  • It represents only a minor improvement in patients with a forced vital capacity (FVC) ≥ 50% and diffusing capacity for carbon monoxide (DLCO) ≥ 30%.
  • Use of ESBRIET necessitates regular monitoring of tolerability and liver enzymes, as well as stopping smoking.

Clinical Benefit

Moderate

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Clinical Added Value

minor

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Therapeutic use

-

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