BERLIN, Feb 19 (APM) - Pierre Fabre’s infantile hemangioma treatment Hemangiol (propranolol oral solution) has become the first drug ever to receive the highest added benefit rating, Germany's superior health technology (HTA) assessment body, the G-BA, said on Thursday.
Hemangiol shows 'major added benefit' for patients at risk of permanent scarring or disfigurement through hemangioma compared to placebo, the G-BA said in line with an earlier ruling by the country’s lower HTA body, IQWiG. (APMMA 40643)
While added benefit could not be proven for some of the end points such as mortality because data did not exist, could not be assessed or there was no statistically significant differences between the Hemangiol and the placebo arm, the G-BA said the drug “achieved a previously unreached improvement” in treatment.
According to the G-BA, the French pharma submitted a “very informative comparative study for assessment” which was “particularly noteworthy in light of the known difficulties of carrying out clinical studies with children”.
The G-BA said the drug showed added benefit for those whose hemangioma are life-threatening, ulcerated or painful but it could not quantify whether it was minor, considerable or major on the basis of supplied data.
The G-BA’s decision will now provide the basis for pricing negotiations between Pierre Fabre and the payer for the drug.
Hemangioma are benign tumours that form due to an abnormal collection of blood vessels, which appear as a birthmark and can currently only be treated with an operation or cortisone - both of which are connected to considerable side-effects, said the G-BA in its statement.
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