Medical device companies Abbott, Boston Scientific, Johnson & Johnson, and Medtronic are trying to come to grips with Indian regulators’ decision to set a price cap on cardiac stents by refiling applications to withdraw certain products, as well as lobbying against such regulation, which they contend increases the risk of introducing new products into the country and places such products out of patients’ reach.
Citing the need to uphold public interest against unconscionable prices, India's National Pharmaceutical Pricing Authority (NPPA) in February slashed prices of coronary stents by nearly 400 percent in some cases, capping them at Rs 7,260 for bare metal stents, and at Rs 29,600 for drug-eluting stents and bioresorbable vascular scaffold (BVS)/biodegradable stents. NPPA is considering setting similar price controls on nearly two dozen other medical device types, as well.
In response to NPPA’s ceiling price order, Abbott and Medtronic applied to withdraw their respective stents off the Indian domestic market, but NPPA last week rejected their bids because no such requests are permitted under current law, which also requires stent makers to maintain supply for up to six months to prevent a shortage.
Now, representatives from coronary stent manufacturers Abbott, Medtronic and Boston Scientific, along with Johnson & Johnson, a maker of knee, hip and joint implants, are reportedly planning "to approach India's health and trade ministries in May to convey that "price control is not the way forward," according to an Indian executive at a multinational medtech company aware of the executives’ plans, reported Business Standard.
The industry source reportedly said the companies will make known to Indian officials their view that the government's price control measures will jeopardize future investments and make them "less likely to introduce new products" into India.
Abbott and Medtronic are likely to refile their applications to withdraw certain high-end coronary stents from the Indian market, according to Live Mint. In the meantime, an Abbott spokesperson says the company is committed to maintaining supplies of its Alpine drug-eluting stent and Absorb dissolving stent. Medtronic, on the other hand, says it will re-file the incomplete paperwork that caused the earlier denial by NPPA, but that it "will continue to supply the Resolute Onyx stent in India."
Boston Scientific requested that NPPA let it sell some stents in India at “special prices” higher than the mandated price caps, reported Live Mint.
NPPA says its order has a provision whereby companies can apply to revise stent prices if they can prove that their products are superior to other stents. The government body had ruled that newer drug-eluting stents showed little difference from older models, and essentially lumped them together under the ordered price ceiling for products deemed “essential” to public health.