NPPA panel fixes price of Human Coagulation Factor IX,Details

The recommendation was made by the Multidisciplinary Committee of Experts at its 33rd meeting held on 21.06.2021. The issue of the retail price fixation of Human Coagulation Factor IX Freeze dried IP 1200 IU for Baxalta Bioscience India Pvt. Ltd. (manufacturer/importer and marketer) under Para 5 of DPCO, 2013 was analyzed at the meeting.

Coagulation Factor IX Human is a coagulation factor, used in the treatment of hemophilia B or factor IX hemophilia.

Coagulation Factor IX is an important protein in the process of hemostasis and normal blood clotting as it plays a key role within the coagulation cascade. Factor IX (or Christmas factor) is one of the serine proteases of the coagulation system; it belongs to peptidase family S1. Deficiency of this protein causes hemophilia B.

Hemophilia B is a rare genetic bleeding disorder in which affected individuals have insufficient levels of a blood protein called factor IX, which is a clotting factor, needed for blood clotting, the process by which blood seals a wound to stop bleeding and promote healing.

In the latest Multidisciplinary Committee meeting, the committee noted that the present applicable ceiling price for Coagulation Factor IX Powder for Injection 600 IU is 12350.88 per pack excluding GST.

Further, as per the recommendation of the Pronab Sen committee, the formula for calculating derived retail price is:

P(s) = P*.[1+a.{(s-s*)/s*}]

where : P(s) = Price ceiling of the strength s,

P* = price ceiling for reference strength s* s = strength in terms of API content

s* = reference strength

a= 0.8 for pack/ capsule and 0.7 for injectibles.

In respect to the above mentioned formula, derived Retail price for Human Coagulation Factor IX 1200 IU

= 12350.88 [1+0.7{1200-600)/600}]

= Rs. 20996.50 per pack

In view of the above, the Multidisciplinary Committee of Experts at its 33rd meeting approved a retail price of Rs. 20996.50 per pack excluding GST for each Human Coagulation Factor IX Freeze dried IP 1200 IU manufactured and marketed by Baxalta Bioscience India.