Updated to include extra information on company plans for the market.
Medtronic (NYSE:MDT) and Abbott (NYSE:ABT) could take another run at taking their high-end stents off the Indian market, after the Indian National Pharmaceutical Pricing Authority this week rejected their applications to withdraw.
Abbott, Boston Scientific and Johnson & Johnson (NYSE:JNJ) have said they plan to tell Indian officials next month that any further price control measures would risk future investments and make them less likely to introduce new products to the region, according to a source familiar with the matter.
The companies said that price controls could extend to other devices, such as implants and valves, and could make the market less viable for their newer products.
Earlier this month, Medtronic and Abbott said they would look to withdraw select high-value coronary stents from the Indian market in light of cost caps imposed by the NPPA. Medtronic filed to remove its Resolute Onyx stent from the market, while Abbott filed to remove both its Absorb and Alpine stents.
But the NPPA rejected the applications, requesting that the companies consider other options, including permission to raise prices for their later-generation devices, before withdrawing their stents. The rejection was based on restrictions enacted Feb. 21 requiring stent makers, distributors and suppliers to maintain 6 months worth of inventory.
“The NPPA has concluded that all generations of drug-eluting stents are the same and on that basis, we had submitted withdrawal applications for Alpine and Absorb because they are no longer commercially viable for us in India. We have committed to maintaining supplies of Alpine and Absorb until the government advises us to do so, as part of the application review process. We continue to engage with relevant stakeholders on the right time to file the requisite applications, per due process,” an Abbott spokesman told Live Mint.
“Medtronic’s application for the withdrawal of Resolute Onyx was not accepted by the NPPA on the basis of incomplete paperwork. We intend to resubmit the application, and until it is re-submitted and approved we will continue to supply the Resolute Onyx stent in India. All decisions to withdraw or introduce products to the market are made only after taking into consideration all guidelines and norms set by the government and applicable legal and regulatory requirements,” Medtronic told the site via email.
Boston Scientific (NYSE:BSX), also said to be mulling an exit from the high-end Indian stent market, has asked the NPPA to allow it to sell some stents at prices that would exceed the agency’s caps, according to Live Mint. To win that argument the company must prove that its high-end products are superior to older stents.
Executives from Medtronic, Abbott, Boston Scientific and J&J said they plan to approach India’s health and trade ministries in May to communicate their concerns over price control issues, according to an India executive at a multinational medtech company who is aware of the plans.
“There is a lot of nervousness,” the executive said.
Boston Scientific said it is engaging with the government and would abide by regulations, while Medtronic said it intends to file yet again to withdraw its stents. Abbott said it is also seeking to withdraw 2 stents, but that it would look at introducing them if they became “commercially viable.”
Johnson & Johnson did not comment on their position.
Last year, Indian NPPA imposed price restrictions which set limits on the costs of metal, drug-eluting and bioresorbable stents. The price of bare-metal stents at about $113 (Rs 7,260) and drug-eluting stents at roughly$460 (Rs29,600).
The move led to rumors that larger players in medtech would pull their high-cost stents from the market, with Abbott denying claims that it would withdraw from the region in February.
Material from Reuters was used in this report ($1 = Rs 64.3)