NEW DELHI :
Premium coronary stents may remain out of reach for Indian patients, with stent manufacturers failing to convince an expert panel that their products are special enough to be kept out of price control.
Domestic and multinational manufacturers have failed to impress the government-led committee for a second time about the therapeutical superiority of their stents, two people aware of the matter said, requesting anonymity. Two years ago advanced stent manufacturers had withdrawn their products after India capped prices to benefit patients.
The committee, which met stent makers several times this month to re-examine if all drug-eluting stents (DES) were equal, or if a new category is required, could not be persuaded, the people said.
“Committee members found ‘no grounds’ for a new category," the first person said, adding that the firms did not “present adequate clinical evidence of superiority in terms of safety and benefit of their stents over currently available DES".
The second person confirmed the development. “While in case of drugs, efficacy can be ascertained easily, in stents, the same formula is not applicable. Also, manufacturers have failed to present enough data to validate therapeutic superiority. Hence, their request to create a separate category of DES with superior features outside price control is unlikely to find favour with the committee," he added.
On 21 December 2016, stents were included under Schedule 1 drugs. Subsequently, the National Pharmaceutical Pricing Authority (NPPA) capped prices of bare metal stents and DES on 13 February, 2017. Stent prices were slashed by up to 80%, pushing MNC stent makers to withdraw their products from the Indian market.
In November 2017, two months after the price cap was announced, US-based Abbott Laboratories said it would not introduce its latest stent, Xience Sierra, in India. It also received permission to withdraw its premium Xience Alpine metallic stents, as well as its dissolving stents. Boston Scientific also withdrew its high-end Synergy stents from the market.
According to the people cited above, since then, NPPA has been receiving representations from MNC stent makers seeking a new sub-category of stents within DES to include ‘new generation’ stents with added features.
Hence, in August, the committee of experts headed by Balram Bhargava, director general of Indian Council of Medical Research (ICMR), invited stent makers to represent their case, which was further reviewed by a panel of experts, including cardiologists.
Multinational stent makers such as Boston Scientific Corp., Medtronic, and Abbott Laboratories represented their case before the committee.
Vapi-based Indian stent maker Meril Life Sciences Pvt. Ltd, which claims to make advanced stents, also met the committee. Meril Life Sciences has held back the launch of its naturally dissolving stents.
In January 2018, the then NPPA chairman Bhupendra Singh had also asked Union health secretary Preeti Sudan to call an urgent meeting of the cardiac stents core committee to reconsider and review the issue. However, a government committee had decided against creating such a category in February 2018.