Rs 78,400 vs Rs 7,750 medicine: Novartis, Eli Lilly oppose bid to cut breast cancer drug prices in India

Novartis and Eli Lilly have opposed a petition before the Kerala High Court seeking government intervention to make two expensive breast cancer drugs more affordable, even as data placed before the court shows their combined sales in India account for a fraction of their global revenues, according to a report by ToI's Rema Nagarajan.

Novartis made about $12.7 billion from global sales of ribociclib between 2020 and 2025, while sales of the drug in India during the period stood at $55.7 million, or about 0.4% of its global revenue. Lilly's abemaciclib generated $19.6 billion globally during the same period, compared with $31.5 million in India, or about 0.16% of global sales.

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The India sales figures were sourced from market research firm IPSOS, while the global revenue figures were based on disclosures by the drugmakers.

The two companies, which hold patents for the drugs, have argued in their counter-affidavits that they incurred substantial costs in developing them, without providing the court with specific figures for those expenses.

The case has brought the cost of developing the drugs into focus as respondents have presented estimates suggesting that the companies' clinical-trial expenditure was substantially below the global revenues generated by the medicines.

Drug development costs under scrutiny

An affidavit filed by Jamie Love, executive director of US-based Knowledge Ecology International, estimated that Novartis spent $494.5 million on clinical trials for ribociclib, while Lilly spent more than $469 million on trials for abemaciclib.

A separate calculation submitted by two respondents, including advocate Majida MA, who is undergoing treatment for breast cancer, put the estimated clinical-trial costs higher at about $667.5 million for ribociclib and more than $633 million for abemaciclib. The calculation used a more recent estimate of the cost per clinical-trial participant from a 2024 paper published in JAMA Network Open.

The court was also presented with the Tufts Center for the Study of Drug Development estimate that bringing a prescription drug to market costs about $2.6 billion. The centre receives substantial funding from the pharmaceutical industry and bases its estimates on data supplied by drug companies. The figure has also faced criticism over claims that it may overstate development costs and support pharmaceutical companies' justification for high prices.

Even using the $2.6 billion estimate as a broad benchmark, the sales figures cited in the case indicate that the global revenues from both drugs have exceeded that amount by several multiples.

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Manufacturing cost points to price gap

The petition has also brought the manufacturing cost of ribociclib into focus. Yale University drug-costing expert Dr Melissa Barber estimated the cost of producing a 200 mg ribociclib tablet at about $0.85 (Rs 81) when the active pharmaceutical ingredient (API) is manufactured in-house, and roughly $1.29 (Rs 123) when the API is imported.

The prescribed regimen involves three tablets a day for 21 days. Based on the manufacturing-cost estimates, the monthly cost would work out to roughly Rs 5,100-Rs 7,750, compared with Rs 78,400 charged by Novartis in India, according to the data presented before the court.

The case has also cited India's generic-drug industry as an example of how patent-protected medicines can see steep price reductions once generic production begins.

Bayer's patented kidney and liver cancer drug Nexavar, for instance, was priced at about $5,500 a month, while Natco's generic version cost around $175. Similarly, the hepatitis C treatment combination of sofosbuvir and daclatasvir, which cost almost $150,000 in the US, became available for about $200-$350 after generic production in India.

The Kerala High Court is considering the petition against the backdrop of the wide gap between the prices of patented medicines and the costs cited for their manufacture, with the petition seeking government intervention to improve access to the breast cancer treatments.

(With inputs from ToI)