After the latest revision - the ceiling price of drug eluting stent (DES) that constitutes 95 percent of the market was cut 5.8 percent to Rs 27,890, excluding GST.
The National Pharmaceutical Pricing Authority (NPPA) on Monday further cut the ceiling prices of the most commonly used drug-eluting stent (DES) by 5.8 percent as it pursues the policy of price controls on coronary stents citing “larger public interest”.
After the latest revision, the price of DES that constitutes 95 percent of the market is now capped at Rs 27,890.
The government raised ceiling price of bare metal stents (BMS) by 5.5 percent to Rs 7,660.
Both the prices were excluding GST. The government charges 5 percent GST on stents.
The ceiling price fixed is applicable till March, 31, 2019 unless revised by another notification by NPPA.
The ceiling prices are inclusive of 8 percent maximum permissible trade margin.
NPPA warned that trade margin in excess of 8 percent shall be construed as ‘violation’ of the provisions of the DPCO, 2013 under the Essential Commodities Act, 1955.
The government also declined to sub-classify stents, a demand made by multinational stent makers and a section of private hospitals and doctors.
“There is no case for sub classification of DES in the light of lack of enough clinical evidence to support superiority of one DES or other; and as a result there has been no change in classification of coronary stents,” NPPA said.
NPPA, which met on Monday, followed by extensive deliberations in the preceding week with the stakeholders decided to continue with the policy of price regulation of stents in “larger public interest till the country is under acute and emergent threat of cardiovascular diseases requiring PTC interventions and to prevent the cardiac stents.”
NPPA also held its view that if stents are not kept under price check – the market may fall back to its “old archaic state characterized by exorbitant margins leading to exploitative pricing, unethical profiteering and an extraordinary failed market system causing unwarranted and unreasonable economic burden on out of pocket expenses of hapless patients and their families.”
A stent is a tiny expandable metal scaffold to open up narrowed or weakened arteries to ensure blood flow preventing heart attacks.
The price revision became imminent after the last year’s price cap order lapsed today.
NPPA last year’s February – has imposed pricing caps to bring down the prices of stents by as much as 85 percent under Schedule I of the DPCO, 2013 - citing to check unethical profiteering and exploitive pricing, and also to ensure fair, reasonable and affordable price for coronary stents.
NPPA found out that the trade margin enjoyed by distributors for sale to hospital ranged anywhere between 13 percent and 196 percent, while the margin of hospital to patient was as high as 11 percent and 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 percent of deaths in India is attributed to Cardiovascular disease (CVD) Coronary artery disease (CAD) is the commonest CVD accounting for 90-95 percent 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.
The All India Drug Action Network (AIDAN) a national network of several non-governmental organisations (NGOs) that advocates a rational drug policy welcomed the development.
“Stents are priced much lower in abroad, with growing volumes - the prices of stents should come down,” said Malini Aisola of AIDAN.
Aisola also asked government to also look into the high prices of auxiliary devices used in angioplasties.
Despite government’s best of intention – the reduction in stent prices haven’t been full passed on to the patient as many private hospitals following the price cap have pushed the package costs upwards to protect their margins.
This has been done mainly through hiking the cost of other consumables, doctors' charges, cath lab charges and the cost of angiography.
Multinational companies such as Abbott, Medtronics, Meril Lifesciences and Boston Scientific were opposing control of stent prices on grounds that it will stifle access of innovative and advanced therapies for patients.
The Medical Technology Association of India (MTaI) - the lobby group of multinational or research-based medical devices companies have expressed disappointment over the government's decision.
"The decision is disappointing," said Pavan Choudary, Director General of MTaI reacting to NPPA's notification on stents prices."It will limit patient choice and the availability of innovative technologies in the market. The only saving grace in the order is NPPA's expression that it is open to receiving stakeholder views. Taking that in earnest, we will stay engaged," Choudary said.