Government Panel refuses to exempt Next Gen DES from price cap
New Delhi: Various domestic and multinational stent makers failed to convince the Government to allow the manufacture and sale of drug-eluting stents with features advanced enough to be exempted from price cap.
The Government-led committee observed that there are no grounds for creating a separate category for keeping the Next-Generation DES outside the purview of price control. Moreover, the stent makers could not furnish adequate data to validate therapeutic superiority, thereby, failing to convince the committee for the said proposal.
In 2017, the prices of cardiac stents were capped by 85%, which came as a major setback to several global stent makers and many expensive stents were retracted from the market. Since then the stakeholders have been pressing the government to create a new category of stents with advanced features.
Over the past few months, various stent makers including Boston Scientific Corp., Medtronic, and Abbott Laboratories represented their case before the committee.
Stent makers claimed that the newly developed stents are the thinnest with a high-performance delivery system. Stressing on the same, Meril Life insisted that the product should be dealt distinctly and exempted from the price cap. The stent makers were of the opinion that quality and creativity should be recognized and the high-end segment should be kept feasible.
The Government considered the proposal and constituted a committee on the National List of Essential Medicines led by Indian Council of Medical Research (ICMR) director Dr Balram Bhargava, a cardiologist himself. The committee was reviewing whether all DES are the same or there is a need to add a new category. However, the stent makers failed to convince the Committee to decide in their favour.
As per a recent media report by Live Mint, “Committee members found ‘no grounds’ for a new category."
“While in the 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," sources told the daily.
Prior to this, NPPA had approached a sub-committee of experts to include a ‘new generation’ of stents with added features as a category within the DES category.
However, the panel dismissed the same stating that there were “no grounds” to create a new category. The firms did not “present adequate clinical evidence of superiority in terms of safety and benefit of their stents over currently available DES,” stated the panel report.