HIRA (Health Insurance Review & Assessment Service), Revealing new status in June...Cumulative Total 169 cases
Truxima Inj. of Celltrion, a biosimilar in the Mabthera Inj., andJanssen, a multidrug-resistant tuberculosis treatment, have been added to thecase of non-approval of the use of surferous non-wage.
The Health Insurance Review and Assessment Service on Tuesday unveiledtwo more "unapproval cases for the use of non-payments for over-licenseddrugs." As of June this year, the number of non-approval cases increasedto 169.
According to the disclosure, Celltrion's application for approval ofnon-payment use of Truxima Inj. (Rituximab) is 'steroid, immunoglobulin,cyclopophamide-uncondensable acute-splastic encephalopathy'
It said that patients should be given 375 mg/m2 Weekly × 4 weeks oftreatment until they have a reaction and stopped if the disease worsens.
In response, the Health Insurance Review and Assessment Service rejectedthe application, saying that the medical basis for the requested item isinsufficient among the data submitted as an equivalent biomedical drug.
For Janssen's Sirturo Tab. (Bedaquiline Fumarate), the ‘NTM(Mycobacterium Avium complex, Mycobacterium abscessus, etc.) disease’ is"1st – 2nd week: 1day 1 time 200 mg (100 mg 2 tablets) / 3rd week: This isa total of 24 weeks of administration with a three times a week, 200 mg pertime(100 mg 2 tablets) (more than 48 hours for administration period).
The Health Insurance Review and Assessment Service also disapproved thesubmission, saying the medical evidence were insufficient.