NPPA panel fixes price of Intas Pharma oncology drug, Details

New Delhi: The National Pharmaceutical Pricing Authority (NPPA) Committee has suggested the retail price of an oncology drug combination pack of Trastuzumab lyophilized powder for concentrate for solution for infusion vial 375 mg and Bacteriostatic Water for Injection USP 20 ml Vial, manufactured and marketed by lntas Pharmaceuticals, at Rs.17500.00 per vial excluding GST.

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 the combipack of (a) Trastuzumab lyophilized powder for concentrate for solution for infusion vial 375 mg and (b) Bacteriostatic Water for Injection USP 20 ml Vial for lntas Pharmaceuticals was addressed during the meeting.

Trastuzumab is a monoclonal anti-human epidermal growth factor receptor 2 protein antibody used to treat HER2-positive breast, gastroesophageal, and gastric cancers. Trastuzumab binds to HER2 and suppresses cancer cells growth, proliferation, and survival directly and indirectly.

In the latest Multidisciplinary Committee meeting, the committee noted that the retail price claimed by  lntas Pharmaceuticals for Combipack of (a) Trastuzumab lyophilized powder for concentrate for solution for infusion vial 375 mg and (b) Bacteriostatic Water for Injection USP 20 ml Vial at Rs. 17500 per vial.

After detailed deliberation, the committee recommended the retail price of each Combipack of (a) Trastuzumab lyophilized powder for concentrate for solution for infusion vial 375 mg and (b) Bacteriostatic Water for Injection USP 20 ml Vial for M/s lntas Pharmaceuticals Ltd. (manufacturer and marketer) at Rs. 17500 per vial excluding GST as detailed below:

a. Worked out Price

Retail price provided for Trastuzumab 150 mg vial at Rs: 15526.97 per vial excluding GST vide SO. 2334(E) dated 15.06.2021.

Derived retail price as per recommendation of Pronab Sen committee: 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.

Derived Retail price for Trastuzumab 375 mg/50 ml Pack= 15526.97[1+0.70{375- 150)/150}] = Rs. 31830.29 per pack

b. Retail price claimed by lntas Pharmaceuticals Ltd Rs. 17500.00 per vial

c. Recommended retail price =Rs. 17500.00 per vial excluding GST