Potentially opening the doors for major U.S. stent manufacturers to discontinue sales of at least some brands in India, the country’s pharmaceutical regulator Feb. 21 said it "has in principle decided not to disallow any applications submitted for withdrawal of stents."
The National Pharmaceutical Pricing Authority did not discuss why it made the statement. However, it comes as the three main importers of stents to the country — Abbott Laboratories, Medtronic plc and Boston Scientific Corp. — have pending applications to stop bringing high-end stents to the country in the wake of a 2017 price cap that reduced the prices of the devices by roughly 85%.
The agency further restricted prices that can be charged to customers amid concerns about the markup of the artery-opening, tube-like devices, particularly by distributors and hospitals. The price limit on popular drug-eluting stents, which release a medicine that helps prevent scarring, was reduced on Feb. 13 from 30,180 rupees to 27,890 rupees. For bare-metal stents that do not release medicine, the agency slightly raised the price cap.
The stent manufacturers, however, did not say whether they will push to withdraw from the market. Boston Scientific spokeswoman Kate Haranis in an email said only that the company continues "to engage in constructive dialogue with the local authorities to determine an appropriate path forward."
Lost market share
The U.S. companies have lost market share in India since the 2017 price caps as manufacturers from other countries and within India stepped up production, according to data recently released by the authority.
The NPPA had told Boston Scientific in September to resubmit its application to withdraw the Promus Premier and Synergy brands, the Economic Times reported Sept. 28, 2017.
Medtronic spokesman Jeff Trauring said the company has not revisited its request to withdraw the Resolute Onyx brand.
NPPA had denied Abbott's requested to withdraw the Xience Alpine medical devices and Absorb BVS Medical device in April 2017, according to an April 26, 2017, report in The Hindu newspaper. According to the Sept. 28 Economic Times report, Abbott got permission to withdraw Absorb over safety concerns and to phase out the supply of Xience Alpine.
Abbott spokespeople did not immediately return emails.
NPPA Chairman Bhupendra Singh said in an email that after the agency’s latest statement, "this issue of U.S. companies has been resolved." He said, though, that Abbott may not withdraw from the country, as the company has increased its market share there since the 2017 price cap went into place.
The Advanced Medical Technology Association, a U.S.-based lobbying group for the medical device industry, had no comment on the NPPA's statement.
The industry group had been protesting the NPPA's decision to tighten its price caps, saying in an emailed statement Feb. 16 that it "goes against patient interest" because it would deter the import of new devices.
India’s authority, however, turned to the price caps in 2017 to grapple with high prices charged to India's patients, largely because of high markups above the imported price by manufacturers.
Singh in the email cited NPPA figures that the imported price of Abbott's drug-eluting stents in 2016 was 15,526 rupees but the manufacturer's retail price was 115,000 rupees. But after the imposition of the 2017 cap, the imported price dropped to 11,452 rupees and the retail price to 24,999 rupees.
According to a Feb. 13, 2017, summary of the proceedings where the authority set the first price cap, hospitals marked up prices by 654% for higher-quality drug-eluting stents. Distributors' markups nearly doubled the price, it said. Imposing the caps would mean the "old system" will be forced to restructure in the public interest, the NPPA summary said.
However, AdvaMed said in a study that the lower prices did not result in more people being able to get stents, as India is still limited by a lack of facilities and trained cardiologists able to insert the stents.
Abby Pratt, AdvaMed's vice president for global strategy and analysis, said in an interview Feb. 21 that she was disappointed that the NPPA decided to lower the price caps further because Indian officials had seemed open to an alternative approach that would limit how much each link the supply chain could mark up prices.
According to NPPA data in a summary of the body's February 2018 meeting, stent imports increased by 1% as new manufacturers from the U.S., Singapore, Spain, China and the U.K. entered the market.
However, the real gains in the stent market came in a 5% increase in stents made by Indian companies, the summary said.
As of Feb. 21, US$1 was equivalent to 64.81 Indian rupees.