In a major relief to cardiac patients, the country's drug pricing regulator - the National Pharmaceutical Pricing Authority (NPPA) – on Tuesday issued a notification capping coronary stent prices much below the existing prices.
A stent is a tiny expandable metal scaffold to open up narrowed or weakened arteries to ensure blood flow preventing heart attacks. A bare metal stent on average costs about Rs 10,000-Rs.20,000, while a drug eluting stent (DES) ranges between Rs.25,000-Rs.80,000.
NPPA has now capped the prices of bare metal stent at Rs.7260 and drug eluting stent (DES) and biodegradable stents at Rs.29,600. Both the prices are exclusive of value added tax. DES constitutes 95 percent of the market.
NPPA has asked all the manufacturers selling stents at prices higher than the ceiling price to cut the price in compliance with the notification.
NPPA also asked hospitals utilizing coronary stents to separately mention the cost of the coronary stent along with its brand name, name of the manufacturer and other details, in their billing to the patients.
NPPA in its notification said the government's intervention had become necessary to check unethical profiteering and exploitive pricing, and also to ensure fair, reasonable and affordable price for Coronary Stents.
“It has found that huge unethical markups are charged at each stage in the supply chain of Coronary Stents resulting in irrational, restrictive and exorbitant prices in a failed market system driven by information asymmetry between the patient and doctors pushing patients to financial misery; and whereas under such extraordinary circumstances, there is an urgent necessity, in public interest, to fix ceiling price of Coronary Stents to bring respite to patients,” NPPA said.
NPPA data has put the role of distributors, hospitals and doctors under scanner for high stent prices. The data shows that the trade margin of distributors for sale to hospital is in the range of 13 to 196 percent, while the margin of hospital to patient is as high as 11 percent to 650 percent.
The government based its decision on a sub-committee report that recommended putting all types of stents, including the latest biodegradable stents, onto the National List of Essential Medicines (NLEM) list in April last year . Medicines and devices listed in the NLEM must be sold at the price fixed by NPPA.
According to the sub-committee report around 25% of deaths in India is attributed to Cardiovascular disease (CVD) Coronary artery disease (CAD) is the commonest CVD accounting for 90-95% of all CVD cases and deaths.
The sub-committee consisting of cardiologists, policy makers, and public health professional observed that there is very high incidence of coronary artery disease (CAD) in India associated with high morbidity and mortality; and that CAD has become a major public health problem; and that Percutaneous Coronary Intervention (PCI) procedure requiring coronary stent implantation is an important treatment
In India, only about 3 out of 1000 coronary heart disease needy patients are treated with angioplasty compared to 32 in the US. As per the National Interventional Council (NIC) Registry data in 2015 a total of 3,53,346 angioplasties were performed and 4,73,000 stents were implanted in India. Angioplasty is the procedure of placing stent in an artery. India’s coronary stents market was valued at $481 million in 2015, and is expected to reach USD 531 million in revenues by 2016-end.
About 60% of the market for stents is shared by multinational companies such as Abbott, Medtronics, Meril Lifesciences and Boston Scientific.
The medical devices industry which is opposing contolling of stent prices said the decision will stifle access of innovative and advanced therapies for patients.