Reason for request
Favourable opinion for reimbursement in the indication extension to “treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB) in adults, adolescents and children with a body weight of at least 30 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
What therapeutic improvement?
Therapeutic improvement in the care pathway for multi-drug resistant tuberculosis.
Role in the care pathway?
The management of tuberculosis is well standardised and is the subject of national (HCSP) and international guidelines (WHO).
Role of the medicinal product in the care pathway
DELTYBA (delamanid) is a reference treatment option for the treatment of patients with pulmonary multi-drug resistant tuberculosis sensitive to delamanid, when the use of a WHO group C anti-tuberculosis drug is indicated and following the opinion of the mycobacteria reference centre.
The prescription of DELTYBA (delamanid) in adolescents and children must take into account a potential risk of increased occurrence of adverse effects (in particular, QT interval prolongation and increased transaminases) due to overexposure to drugs.
The Summary of Product Characteristics (SPC) and the Risk Management Plan (RMP) must be complied with.
In accordance with its previous opinion, the Committee recommends restricting the prescription of DELTYBA (delamanid) to physicians experienced in the management of patients with multi-drug resistant tuberculosis. In addition, the decision to initiate treatment with this drug should be based on a written recommendation issued at a meeting of a multidisciplinary team (MDT) with an expert group for the choice of treatment regimen (e.g. CNR-MyRMA).
The Committee deems that the clinical benefit of DELTYBA (delamanid) is substantial in the MA indication.
Clinical Added Value
the Committee deems that, as in adults, DELTYBA (delamanid), as part of an appropriate combination regimen, provides a moderate clinical added value (CAV III) in adolescents and children with a body weight of at least 30 kg with multi-drug resistant tuberculosis sensitive to delamanid, when the use of a WHO group C anti-tuberculosis drug is indicated and following the opinion of the mycobacteria reference centre.