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New HTA Decisions in France
December 2019
Drug name
DELTYBA® (delamanid)
Company
Otsuka Pharmaceutical France SAS
Decision date
06/11/2019
Therapeutic area
Respiratory conditions
Therapeutic sub area
Tuberculosis
Official notice date
27/11/2019
Reimbursement %
Decision (SMR)
Important
Decision (ASMR)
Moderate improvement (III)
Indication
DELTYBA® is indicated for the treatment of multidrug-resistant tuberculosis, sensitive to delamanid, when the use of another effective regimen is impossible for reasons of resistance or intolerance and the prescription of a WHO Group C drug is indicated.
Decision Type
New review following the filing of new data
Summary
The committee considered the actual benefit of DELTYBA® to be 'important' in patients with multidrug-resistant tuberculosis susceptible to delamanid and when the prescription of a WHO Group C drug is indicated. Taking into account: - the important medical need in multidrug-resistant tuberculosis; - the bactericidal activity of delamanid and the preliminary data (phase II studies) having shown its effectiveness in terms of increasing the frequency of negativation of bacteriological cultures; - the new clinical data (phase III study) did not show any benefit from the systematic addition of delamanid to a multi-antibiotic anti-tuberculosis treatment consisting of at least 4 effective drugs; - the fact that delamanid retains its place as a last resort in accordance with the WMA and the updated WHO recommendations; it was concluded that DELTYBA® provides a moderate improvement in the medical service rendered (ASMR III) in the management strategy for multidrug-resistant tuberculosis, sensitive to delamanid, when the use of another effective regimen is impossible for reasons of resistance or intolerance and the prescription of a WHO Group C drug is indicated.