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The National Pharmaceutical Pricing Authority (NPPA) has given Abbott Healthcare permission to discontinue its second stent, Alpine, from the Indian market. A decision that has sent out disconcerting signals at different levels.
Late on Monday, the NPPA said that it was allowing Abbott to discontinue its drug-eluting stent Alpine in India.
Just last week, the NPPA had made a similar announcement involving Abbott's dissolvable stent “Absorb”. This time though the pricing regulator's statement struck a worrisome note, hinting at dissonance between the Department of Pharmaceuticals and the NPPA, besides raising concerns over a “sudden shortage” that may arise on the withdrawal of this stent.
Explaining its decision, the NPPA said, “The Authority, after examining the legal status of the application and taking into account the fact that Department of Pharmaceuticals has not accepted the request of NPPA to exercise Government powers under Para (3) of the DPCO, 2013 and extend the restriction on the stent manufacturers from withdrawing, NPPA is left with no option but to allow formal withdrawal as per the provisions of Para 21(2) of DPCO, 2013.”
Further, the pricing regulator says on Alpine's withdrawal, “It was also found that these brands have a sizable marketshare and its withdrawal will create sudden shortage of stents which will not be in the interest of public health safety.” Keeping in mind the availability of other brands in the country and to ensure adequate supplies of life-saving cardiac stents, the NPPA decided to “invoke the public interest clause under Para 21(2) to allow the complete withdrawal of Xience Alpine brand by the applicant company in a period of one year from the date of issue of public notice,” the regulator said.
A stent is a wire-like mesh inserted into blood-vessels to remove blockages, largely used in heart procedures. Earlier this year, the NPPA brought cardiac stents under price control, slashing trade margins on the product to make it way more affordable for patients.
The point of rancor though for the industry was that all drug-coated stents were pegged at the same price just shy of Rs 30,000, down from the Rs 1.5 to 1.9 odd lakhs they earlier commanded. And this had industry representatives from large healthcare companies complaining that the controlled prices did not reflect their research and superiority of products. Subsequently, companies including Abbott and Medtronic filed with the NPPA to withdraw some of their top drug-eluting stents from the Indian market.
Abbott's court
Putting the ball in Abbott's court, the NPPA said that the company had not issued a public notice to withdraw the product six months ahead of its intended date of discontinuation. The NPPA directed the company to issue a public notice for at least six months and maintain “uninterrupted supplies” of Xience Alpine for the same period. From the 7th month, it could reduce supplies by 15 per cent every month, withdrawing completely in a year's time, the NPPA said.
Responding to this observation, Abbott said, “a public notice should only be issued by the manufacturer after receipt of intimation from NPPA. Now that we have received communication from NPPA on our submission for withdrawal of Alpine, we will issue the said notification soon.”
Referring to Abbott's earlier statements that the ceiling price on stents had made it unsustainable for the company, the NPPA said it had examined the issue and found that “the import cost of Alpine brand is less than the ceiling price and adequate margins are there, so the reason of unviability of sales in India is not understandable.”
Alpine is a latest-generation drug eluting stent and has higher research, manufacturing and clinical costs than earlier generation Xience stents, Abbott responded. And the ceiling price made it unsustainable to provide Alpine, given the cost of manufacture and other associated costs, it added.
On possible shortages, Abbott clarified, Alpine would continue to be available for the time stipulated by Government. “We will continue to make our other XIENCE stents available, which account for the vast majority of Abbott stents used every year in India. There is no shortage of other XIENCE coronary stent products, the gold standard in stent technology.”
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