India rejects pleas for liberalization of stent price cap policy

The NPPA’s ruling likely means the two-tier pricing model will persist for at least another year. (Yann Forget/CC-BY-SA-3.0)(Yann Forget / Wikimedia Commons / CC-BY-SA-3.0)

India has resisted industry pressure to raise the price cap on premium cardiac stents. Manufacturers including Abbott, Boston Scientific and Medtronic have argued that the ceiling makes their high-end products commercially unviable, but India’s cost watchdog declined to create a new category for such stents.

Officials in India introduced the cap on the price of cardiac stents 12 months ago. The action set two price ceilings—one for drug-eluting stents, another for bare-metal products—and stopped companies from withdrawing from the market. That forced companies to sell new, purportedly better stents such as Resolute Onyx and Xience Alpine for the same price as older drug-eluting products. 

With the National Pharmaceutical Pricing Authority (NPPA) rejecting industry requests to pull stents from the market, manufacturers looked to a review of the cap to secure a premium price for their top-end stents. Now, having completed its review, the NPPA has quashed those hopes.

“There is no case for subclassification of [drug-eluting stents] in the light of lack of enough clinical evidence to support superiority of one [product] or other. As a result, there has been no change in classification of coronary stents,” the NPPA wrote in its explanation (PDF) of the revised price ceilings. The argument echoes that made by the NPPA when it first created the stent categories. The NPPA’s ruling likely means the two-tier pricing model will persist for another year and suggests the regime could continue for a lot longer if manufacturers are unable to meet its bar for evidence of clinical superiority. 

In a move likely to further annoy some manufacturers, the NPPA also lowered the maximum amount companies can charge for cardiac stents. The new ceiling for drug-eluting stents is around $434, as compared to $460 before the revision. The NPPA raised the cap on the price of cheaper bare-metal stents by a small amount.

The revision of the stent ceilings is unlikely to be the last time the NPPA butts heads with the industry this year. A cap on the prices of cardiac guidewire, catheters and balloons looks to be in its sights. In a move reminiscent of the buildup to earlier device price caps, the NPPA posted a breakdown (PDF) of the trade margins on the cardiac products this week.