Abbott India stops importing Xience Alpine stents

NEW DELHI: Some of Abbott’s highend stents will no longer be available in India, with the company halting imports of the products from Thursday because of price limits set on them, ET has learnt.

By discontinuing its Xience Alpine brand, Abbott becomes the first company to officially stop imports of the drug-eluting cardiac stents on account of the price curbs. It is also the only company to state that it will not introduce any new stent brands in India, adding to concerns that heart patients in the country won’t have access to the latest products.

However, patient-activists and domestic stent makers have said Alpine and other new Xience stents launched by Abbott are not clinically superior to the company’s previous stents in this line of products.

The National Pharmaceutical Pricing Authority (NPPA) approved a “change in date of withdrawal” of Xience Alpine stents proposed by Abbott India, according to the minutes of the drug pricing regulator’s meeting held on April 23.

“Abbott has fulfilled all the requirements to discontinue selling its Xience Alpine drug-eluting stent in India as of April 26,” a company spokesperson confirmed. This does not account for stock previously with hospitals and distributors, the spokesperson said.

The move is not expected to create a shortage in drug-eluting stents in India as Alpine’s share in the market was low due to its premium pricing. Its share is estimated between 2% and 6% of the Rs 1,200-crore Indian stent market, industry officials told ET on condition of anonymity.

Alpine was launched in 2016 and priced at Rs 1.6 lakh before the NPPA slashed prices of drug-eluting stents by over 75%, industry sources had told ET earlier. The stent can now be sold at as much as Rs 27,890, excluding taxes, according to NPPA.

“While we are aligned with the government’s intent for broader access to healthcare, we’re disappointed that NPPA has determined that there is no differentiation for advances among stent generations, which could restrict future investment and innovation that benefit patients.

The price ceiling that has been set unfortunately makes it an unsustainable business to continue to supply Alpine given our cost of importing and other associated costs,” Abbott’s spokesperson said.

The company began notifying hospitals and healthcare providers of the planned discontinuation last year, the spokesperson said, adding that patients here would still have access to other products in the Xience line of drug-eluting stents.

The spokesperson said the company could bring Alpine back to the Indian market “if it becomes commercially viable”.

The company has also decided not to launch Xience Sierra, the latest stent in this line, which has approvals in Europe and is also to be launched in the US. “In the current environment, it is unsustainable for us to sell Xience Sierra in India,” the spokesperson told ET.

“This is a good strategy to put pressure on the Indian government,” said a domestic stent maker on condition of anonymity, adding that NPPA had a provision for companies to claim higher prices for stents that they could prove were clinically superior.

“Alpine and Sierra are essentially repackaged versions of the earlier Xience stents. Abbott has relied on the exact same safety and efficacy data of its early stents for the approval of these newer stents and therefore there are no claimed clinical improvements,” alleged Malini Aisola, a member of patient-activist group All Indian Drug Action Network.