Biotech Values

[turtlepower]

ITMN - pirfenidone
Order of 15 March 2012
Entered into force on:
Federal Gazette [] No [..], dd.mm.yyyy, p [..]
Approved Application:
Esbriet is used in adults for the treatment of mild to
moderate idiopathic pulmonary fibrosis (IPF).
First Extent of the additional benefits of the drug
Pirfenidone has been approved as drugs for treatment of a rare
Suffering under Regulation (EC) No 141/2000 of the European Parliament
and of the Council of 16 December 1999 on orphan medicinal products.
According to § 35a paragraph 1, sentence 10 of the additional medical benefits is through the
Admission as evidence.
The Federal Joint Committee (G-BA) determined according to 5 Section § 12
Paragraph 1 sentence 1 No. 2 of the Rules of the G-BA (Rules of Procedure) the extent
value-added to the number of patients and patient groups, for
a therapeutically significant additional benefit. this quantification
the value added is the measure of in 5th Section § 5, paragraph 7, Nos. 1 to 4
Rules of Procedure established criteria.
Extent of the additional benefits:
not quantifiable
http://www.g-ba.de/downloads/39-261-1456/2012-03-15_AM-RL-XII_Pirfenidon.pdf