The expert panel of the National Pharmaceutical Pricing Authority (NPPA) has recommended retail price fixation for lipid-lowering combination drugs comprising atorvastatin and bempedoic acid for Zydus Healthcare and Sun Pharma Laboratories.

A multidisciplinary Committee (MDC) of experts in a recent meeting opined that the claim by Zydus Healthcare that the therapeutic use of the formulation is “for short-term treatment of moderate pain” is not correct.

Cardiovascular medicines are stated in the size of packs and the therapeutic category of the formulation is like a lowering agent.

The MDC, after detailed deliberation, recommended the retail price of each film-coated tablet containing atorvastatin calcium IP equivalent to atorvastatin 80 mg and bempedoic acid 180 mg, manufactured by Exemed Pharmaceuticals and marketed by Zydus Healthcare Ltd, at Rs. 50.71 per tablet.

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It has recommended the same price for the same formulation manufactured by Exemed Pharmaceuticals and marketed by Sun Pharma Laboratories, during the meeting.

Bempedoic acid, a novel drug that entered the country with the launch of the brand Bendac by Zydus Lifesciences in May, this year, has attracted several companies, including Sun Pharma, Akum Drugs and Pharmaceuticals, and Cadila Pharma, to grab a piece of this market.

The MDC, while deriving the retail price of bempedoic acid 180 mg tablets, said that there was no data available on the drug for the months prior to six months before the date of application, as per the Pharmatrac data for the period from June 2021 to May 2022, the database used is for the month of September 2022.

It has fixed the price of bempedoic acid at Rs. 19.88 per tablet, while Atorvastatin 80 mg retail price is fixed at Rs. 34.81 per tablet, making the recommended retail price of the combination at Rs. 50.71 per tablet.

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Zydus Healthcare claimed a retail price of Rs. 98 per tablet, while Sun Pharma claimed Rs. 53.57 per tablet.

According to a report from randomized placebo-controlled trial results published in the Journal of Clinical Lipidology, in 2019, written by Lalwani ND, Hanselman JC, MacDougall DE, Sterling LR, and Cramer CT, bempedoic acid 180 mg added to stable high-dose atorvastatin therapy can lower low-density lipoprotein cholesterol (LDL-C) in patients with hypercholesterolemia without clinically important increases in atorvastatin exposure.

Bempedoic acid helps lower cardiovascular risk in high or very high-risk atherosclerotic cardiovascular disease (ASCVD) patients as an add-on therapy to maximally tolerated statin and/or ezetimibe. Moreover, it has shown promising results in patients intolerant to statins and patients not responding to statins.

Soon after the launch of the first bempedoic acid drug by Zydus Lifesciences, data analysis firm GlobalData opined that the market of the cholesterol drug will be crowded by Indian players soon.

Prashant Khadayate, the pharma analyst at GlobalData, said, “Indian pharma companies are always looking to grab opportunities created by first-in-class drugs to meet the current unmet needs."

Moreover, irrespective of great progress over the years in lipid-lowering treatments, there remains an unmet need for uncontrolled low-density lipoprotein cholesterol (LDL-C) levels, especially in patients with known ASCVD, familial hypercholesterolemia (FH), and those with multiple risk factors for cardiovascular disease.”

According to GlobalData’s ‘Pharmaceutical Intelligence Center, the number of prevalent cases of dyslipidemia in India is estimated to grow at a CAGR of 1.9% from 691 million in 2021 to 737 million in 2025.

Khadayate added, “Indian players can launch bempedoic acid in India as there is no valid product patent in India. bempedoic acid has a huge potential in India, based on the overall dyslipidemia patient population and the patients with uncontrolled LDL-c levels. Moreover, affordable treatment will make it easy to access the therapy, which is crucial for the Indian market".

The lipid-lowering drug market in India is crowded, with multiple generics available.

For bempedoic acid, Indian pharma companies would be aiming to get the first mover advantage before it also becomes crowded, added the expert.

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