GVS assessment - extension of further conditions for nintedanib (Ofev®)
The National Health Care Institute 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 National Health Care Institute 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
The National Health Care Institute 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.
The National Health Care Institute's advice
Nintedanib (Ofev®) has already been included on List 1A, cluster 0L04AXBO, together with further conditions limiting reimbursement to IPF. The National Health Care Institute 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.