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New HTA Decisions in France
June 2020
Drug name
FLEBOGAMMA® DIF (normal human immunoglobulin)
Company
Grifols France
Decision date
23/10/2019
Therapeutic area
Neurological conditions
Therapeutic sub area
Neurological conditions: general and other
Official notice date
18/11/2019
Reimbursement %
Decision (SMR)
Important
Decision (ASMR)
No improvement (V)
Indication
FLEBOGAMMA® DIF is indicated as immunomodulatory treatment in adults, children and adolescents (2 to 18 years old) with: - chronic inflammatory demyelinating polyneuropathy (CIDP); - multifocal motor neuropathy (MMN).
Decision Type
Extension of indication
Summary
The committee considered the actual benefit of FLEBOGAMMA® DIF to be 'important' in the indications of CIDP and MMN. It was concluded that FLEBOGAMMA® DIF does not provide any improvement in the medical service rendered (ASMR V) in the management of CIDP or MMN compared to other normal human immunoglobulins administered subcutaneously or intravenously and with the same indications.