OBJECTIVES:

Nintedanib (Ofev^Ò) is used to treat adults with Idiopathic Pulmonary Fibrosis (IPF). IPF is a rare disease characterized by the formation of hard fibrous tissue in the lungs, causing persistent cough and severe shortness of breath. Despite treatment, IPF is typically progressive and median survival is 3 years from the time of diagnosis. Since its registration in 2015, nintedanib gained reimbursement in several countries. The aim is this study is to evaluate reimbursement restrictions of nintedanib across several EU Member States.

METHODS:

A comparative analysis of the reimbursement restrictions of nintedanib was performed across eight EU Member States: Belgium, Denmark, Finland, Greece, Luxembourg, the Netherlands, Portugal and Sweden. Information was gathered on the reimbursement restrictions, the existence of an HTA and the delay between registration and reimbursement.

RESULTS:

In five countries (DE, GR, LU, PO and SW), nintedanib is reimbursed for all adults with IPF (according to the label), i.e. without further reimbursement restrictions. In Finland, the reimbursement of nintedanib is restricted to patients with a Forced Vital Capacity (FVC) between 50% and 90%. In Belgium and the Netherlands there are strict and specific reimbursement criteria. For example, in Belgium, nintedanib is only reimbursed for non-smoking patients with an FVC above 50% and a DLco above 30%. Furthermore, only a very limited number of experts can prescribe nintedanib. The average delay between the EU registration and the approval for reimbursement amounted to 316 days (min: 127 days – max: 781 days).

CONCLUSIONS:

Access to nintedanib varies across EU Member States and significant delays in the reimbursement procedure prevent early access for patients. Some national authorities, such as Belgium, impose very strict access conditions. In light of the life-threatening nature of IPF, access restrictions need to be evidence based and should not exclude patients that could potentially benefit from treatment.