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January 22, 2024
India is on the brink of introducing a groundbreaking medicine, Inclisiran, approved by the Drug Controller General of India (DCGI) and the US FDA, designed to significantly lower cholesterol with just two doses a year. Manufactured by the Swiss multinational pharmaceutical company Novartis and priced at approximately Rs 1.2 lakh, Inclisiran has garnered attention for its potential to revolutionize cholesterol management. However, healthcare experts emphasize the importance of evaluating its cost-effectiveness compared to existing alternatives.
Inclisiran, the first and only small interfering RNA (siRNA) therapy for lowering low-density lipoprotein cholesterol (LDL-C or bad cholesterol), involves two doses annually, administered initially and then at three months. While lauded as an innovative solution to cholesterol control, its high cost has led experts to stress the need for optimizing the use of more affordable cholesterol-lowering medications already available in the market.
Dr. Vivek Chaturvedi, Head of the Department of Cardiology at Amrita Hospital, Faridabad, underscores the significance of addressing the pricing of such injectable treatments. He suggests that, at present, the focus should be on maximizing the utilization of cost-effective statins, which are readily available in generic form in India. Statins, although underused in the country, remain an effective and economical option for controlling cholesterol.
“Inclisiran is a new cholesterol-lowering drug administered subcutaneously twice yearly. Being both very expensive and a very potent drug, its use will initially be restricted to those patients with severely raised blood cholesterol levels that don’t respond to current orally administered pills,” notes Dr. Atul Mathur, Executive Director of Interventional Cardiology & Chief of Cath Lab at Fortis Escorts Hospital, New Delhi.
While acknowledging the potency of Inclisiran, experts highlight the pivotal role of well-established and affordable drugs like statins in cholesterol management. Dr. Chaturvedi stresses that other oral medications, including histamine and bampidoic acid, are also available in India. However, their high cost limits their widespread use, making them less accessible for the average Indian household.
India, grappling with a considerable burden of dyslipidemia affecting around 24% of the population, according to a study by the Indian Council and Medical Research and Madras Diabetes Research Foundation, faces challenges in optimizing lipid-lowering therapies. Experts believe that while Inclisiran presents an innovative approach, it’s essential to consider the economic viability and the existing availability of effective alternatives.
Dr. Ashwani Mehta, Senior Cardiologist at Sir Ganga Ram Hospital, highlights the potential of Inclisiran to overcome adherence issues associated with daily pills. However, the focus should remain on addressing concerns about side effects and misconceptions about benefits related to statins, which are essential in preventing cardiovascular events.
As India prepares to embrace Inclisiran, the medical community advocates a comprehensive evaluation of its cost-effectiveness and a concerted effort to enhance the utilization of more affordable cholesterol-lowering medications already at our disposal.
