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OFEV - PID (nintedanib)
Reason for request
Key points
Favourable opinion for reimbursement in the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.
What therapeutic improvement?
Therapeutic improvement in the management of the disease.
Role in the care pathway?
There are no international guidelines concerning the diagnosis of chronic fibrosing interstitial lung diseases with a progressive phenotype (PF-ILD), except for idiopathic pulmonary fibrosis (IPF). On the basis of what is done for IPF, the diagnosis of PF-ILD should be based on a combination of clinical, radiological and sometimes histological criteria.
The differential diagnosis should be discussed during multidisciplinary team meetings by specialists in the field concerned by the underlying disease.
Diagnosis of PF-ILD includes a clinical assessment and an analysis of the medical history, smoking status, evolution of lung function, results of serological, genetic and imaging tests and, if applicable, lung biopsies.
Analysis of the chest high resolution computed tomography (HRCT) scan plays a crucial role in the diagnostic strategy. In almost all cases, it is the first diagnostic tool.
Taking into account the clinical context, serological tests can determine whether any underlying autoimmune disease or autoreactive component exists. Via measurements conducted at regular intervals, lung function tests (such as forced vital capacity [FVC]) make it possible to monitor progression of the disease.
The international guidelines concerning the diagnosis of IPF enable HRCT observations to be divided into four distinct categories (definite usual interstitial pneumonia [UIP], probable UIP, indeterminate for UIP and alternate diagnosis).
The terminology of fibrosing ILD with a progressive phenotype, means that the disease is progressing despite standard-of-care therapy depending on the underlying disease. Currently, there is no consensus with respect to definition of the progressive fibrosing phenotype within ILDs.
No international or French guidelines specify the specific management of patients with ILD, with the exception of French guidelines for the management of IPF and the recommendations of the French national diagnostic and care protocol (PNDS) on the management of systemic sclerosis associated interstitial lung disease (SSc-ILD).
Role of the medicinal product in the care pathway:
OFEV (nintedanib) can be used in adult patients with PF-ILD, progressing despite standard-of-care therapy adapted to each of the aetiologies of PF-ILD.
It should be highlighted that the efficacy and safety data were only obtained in patients with the following respiratory function criteria: FVC ≥ 45% and DLCO ≥ 30%.
Special recommendations
Due to the complexity of diagnosing and managing these diseases, the Committee recommends that the decision to initiate OFEV (nintedanib) treatment be discussed during a multidisciplinary team (MDT) meeting and that the decision be tracked, then submitted and explained to the patient.
Clinical Benefit
| Moderate |
The Committee deems that the clinical benefit of OFEV (nintedanib) is moderate in the treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype.
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Clinical Added Value
| minor |
Considering:
but the absence of:
the Committee considers that OFEV (nintedanib) provides a minor clinical added value (CAV IV) in the current care pathway for the treatment of patients with chronic fibrosing interstitial lung diseases with a progressive phenotype.
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