American healthcare major Abbott will book its last sale on the Xience Alpine premium brand of drug-eluting stent on Thursday, following which the product will be discontinued. The development follows the National Pharmaceutical Pricing Authority's cap on cardiac stent prices, early last year.

“Abbott has fulfilled all the requirements to discontinue its Xience Alpine drug-eluting stent in India as of April 26. Abbott began notifying hospitals and healthcare providers of the planned discontinuation last year. And, there is ample supply of our other Xience stents,” a company spokesperson said confirming the development.

In fact, an NPPA communication giving the minutes of a meeting chaired by its recently appointed Chairman Dr Rakesh Kumar Vats on April 23, said the authority had approved “the change in date of withdrawal” of the Xience Alpine stents. Industry estimates that Alpine accounts for about 13 per cent of Abbott's stent sales.

This is Abbott’s second stent that is being withdrawn from India. Last September, the company had pulled the plug globally on its reabsorbable stent “Absorb”due to various factors, including safety concerns . A stent is a wire-like mesh inserted into blood vessels to remove blockages and it finds extensive use in opening up heart blocks.

Addressing product shortage concerns raised earlier by the NPPA, Abbott said it would ensure that Indian patients had access to “other products in its Xience line of drug eluting stents, which were among the most widely used stents in the world with a proven track record of quality and safety.”

Margin crackdown

The NPPA’s initial crackdown on the exorbitant trade margins that inflated the price of cardiac stents had brought much relief to patients. Prices on drug eluting stents were slashed from ₹1.5 lakh or close to ₹2 lakh to about ₹30,000 and bare metal stents were pegged a little over ₹7,000, down from between ₹30,000 and ₹75,000. Xience Alpine, for instance, sold at about ₹1.6 lakh before the price cap.

But the medical devices industry continues to be divided along the lines of domestic and foreign device makers on the NPPA’s view to categorise all stents as drug-eluting stents or bare metal stents. Foreign device makers had called for differential pricing or sub-categories on products that showed greater features on counts of safety, efficacy etc. But that view did not find favour with the NPPA.

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Commercially unviable

On withdrawing Xience Alpine, Abbott said, “While we are aligned with the government's intent for broader access to healthcare, we’re disappointed that the NPPA has determined that there is no differentiation for advances among stent generations, which could restrict future investment and innovation that benefit patients. The ceiling price that has been set unfortunately makes it an unsustainable business to continue to supply Alpine given our cost of importation and other associated costs.”

Between the NPPA and the Department of Pharmaceuticals, the Centre too has sent mixed signals on cardiac stents. Initially, the NPPA said that all stents were made equal, indicating there was enough supply in the country. However, subsequent directives expressed concerns on possible shortages if companies pulled out their premium products.

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Maintaining that price caps were not a solution, Abbott said that such initiatives would have a negative effect on the industry’s ability to bring innovations to patients in India. “We will look at future opportunities to bring back Alpine if it becomes commercially viable,” the company added.

jyothi.datta@thehindu.co.in

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