GVS assessment - extension of further conditions for nintedanib (Ofev®)

Zorginstituut Nederland has completed its assessment of the possible extension of the further conditions for nintedanib (Ofev®) in the Medication Reimbursement System (GVS), to include the treatment of adults with progressive fibrosing interstitial lung diseases (PF-ILD) other than idiopathic pulmonary fibrosis (IPF). The Zorginstituut recommends the Minister of Medical Care to modify the List 2 condition for nintedanib, by adding patients with PF-ILD.

Current situation

Nintedanib (Ofev®) has been registered for the treatment of IPF since 2015 and for systemic sclerosis-related (Ssc) ILD and PF-ILD since 2020. The progressive form of Ssc-ILD is also categorised as PF-ILD. The market authorisation holder is not claiming reimbursement for the non-progressive form of Ssc-ILD. At the present time, the Dutch basic healthcare insurance package only reimburses the use of Ofev® for the treatment of IPF. The condition set out in List 2 of the GVS reads as follows: “For the treatment of idiopathic pulmonary fibrosis (IPF) in adults only”.

Therapeutic value

Zorginstituut Nederland has concluded that the treatment of adults with progressive fibrosing interstitial lung diseases (PF-ILD, including the progressive form of Ssc-ILD), other than idiopathic pulmonary fibrosis (IPF), with nintedanib has added value compared to placebo.

Zorginstituut's advice

Nintedanib (Ofev®) has already been included on List 1A, cluster 0L04AXBO, together with further conditions limiting reimbursement to IPF. The Zorginstituut recommends the Minister of Medical Care to modify the List 2 condition for nintedanib, by adding patients with PF-ILD.

New condition for nintedanib (Ofev®)

For the treatment of progressive fibrosing interstitial lung diseases (PF-ILD, including the progressive form of Ssc-ILD) and idiopathic pulmonary fibrosis (IPF) in adults only.