NPPA Panel Suggests Retail Price of Atorvastatin,Bempedoic Acid FDC Marketed By Zydus Healthcare
New Delhi: The National Pharmaceutical Pricing Authority (NPPA) Committee has suggested the retail price of each film coated tablet containing Atorvastatin Calcium equivalent, Atorvastatin 80mg and Bempedoic Acid 180mg marketed by Zydus Healthcare Limited at Rs. 50.71 per tablet excluding GST.
This recommendation came during the 48th meeting of the Multidisciplinary Committee of Experts, held on October 19, 2022, under the convenorship of Shri Manmohan Sachdeva , Advisor(cost), through video conferencing, where the issue of retail price fixation of Atorvastatin Calcium equivalent Atorvastatin 80mg and Bempedoic Acid 180mg manufactured by Exemed Pharmaceutical and marketed by Zydus Healthcare Limited under Para 5 DPCO, 2013 was analysed.
Atorvastatin is an HMG-CoA reductase inhibitor used to lower lipid levels and reduce the risk of cardiovascular disease, including myocardial infarction and stroke. Atorvastatin acts primarily in the liver, where decreased hepatic cholesterol concentrations stimulate the upregulation of hepatic low-density lipoprotein (LDL) receptors, which increases hepatic uptake of LDL. Atorvastatin also reduces Very-Low-Density Lipoprotein-Cholesterol (VLDL-C), serum triglycerides (TG), and Intermediate Density Lipoproteins (IDL), as well as the number of apolipoprotein B (apo B) containing particles, but increases High-Density Lipoprotein Cholesterol (HDL-C).
Bempedoic acid is a drug used in conjunction with lifestyle modification and/or other agents for the treatment of refractory hypercholesterolemia. Bempedoic acid is indicated as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia or existing atherosclerotic cardiovascular disease that warrants additional lowering of LDL-C.
Regarding the fixed dose combination of Atorvastatin and Bempedoic Acid, in the latest Multidisciplinary Committee meeting, the committee noted that the therapeutic category and use of the formulation claimed by the applicant " for short-term treatment of moderate pain" is incorrect.
Furthermore, it is also observed that cardiovascular medicine is stated in the size of packs. Therefore, the committee noted that the therapeutic category of the formulation is "lipid lowering agent."
Accordingly, the committee recommended the retail price of each film coated tablet containing Atorvastatin 80mg and Bempedoic Acid 180mg,manufactured by Exemed Pharmaceutical and marketed by Zydus Healthcare , at Rs. 50.71 per excluding GST as detailed below.
S.No | Particular | Source/Method | Amount (Rs.) |
Each film coated tablet containig Atorvasatin Calcium IP eq. to Atorvastatin 80mg and Bempedoic Acid 180mg | |||
(a) | Derived retail price of Atorvastatin 80mg tablet | Retail price (as per the formula of Pranob Sen Committee)_Note 1 | 34.81 |
(b) | Derived retail price of Bempedoic Acid 180mg tablet | Retail Price [as per Pharmatrac data for the period from June,2021 toMay,2022 as no datanis available in Pharmatrac database for the months prior to 6 months before the date of application and Pharmatrac database used is for the month of September,2022] | 19.88 |
(c) | Total (a)+(b) | 54.69 | |
(d) | Less 20% of the lower of (a) or (b) as recommended in the Pronab Sen Committee re report | 3.98 | |
(e) | Worked out Retail Price (c)-(d) | 50.71 | |
(f) | Claimed Retail Price | 53.57 | |
(g) | Recommended Retail Price | 50.71 |
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