Drug pricing authority warns stent manufacturers against creating 'artificial' shortage

For the past week, since the National Pharmaceutical Pricing Authority or NPPA capped prices of cardiac stents, there have been reports of pharmaceutical companies withdrawing stents – especially the latest generation ones – from the market.

Cardiac stents are used to unblock the clogged arteries in the heart. The NPPA had fixed the ceiling price of the most commonly used drug-eluting stents at Rs 29,600. These stents were being sold to cardiac patients for as much as Rs 2.5 lakh earlier.

While alarm over the availability of this life-saving medical device while shifting to a new pricing system is inevitable, some of the panic over the past week has been “artificial,” said NPPA chief Bhupendra Singh.“The vested interests (of these stent-manufacturing companies) have been hurt,” he said. “They will try to malign the government’s move which is in public interest.”

Probir Das, chairman of the Medical Devices Forum of the Federation of Indian Chambers of Commerce that represents foreign companies manufacturing stents, told Scroll.in on Tuesday when the order was formally announced, that angioplasties would cease to be performed for a few days. He said that stent manufacturers would have to remove stent stocks that have already been sold at higher prices to hospitals and stick new price labels on them before sending them back to the hospitals.

Many of the stent withdrawals, doctors say, is for this repricing and resale of stents to hospitals.

On Thursday, reports of high-end stents being withdrawn were reported. Cardiologists confirmed that the last generation drug-eluting stents and bioresorbable stents were taken from their hospital stocks.

The question is whether the move has endangered the lives of people who need cardiac stents and, experts say, capping stent prices has not stopped doctors from performing procedures using stents. Neither have the stents available in the market after the NPPA’s order been of inferior quality.

A drug-eluting stent consists of a wire-mesh scaffolding but is coated with medicine that is released periodically to prevents further arterial blockage. Each new generation of stents has design modifications that allow doctors to insert stents into clogged arteries more easily.
Bioresorbable stent dissolve in the arteries and are absorbed by the body after a period of time, and are the most expensive forms of stents.

“The premium stents have been taken off the shelves because the companies are not in a position to supply (at the price-controlled rate),” said Dr Dev Pahalajani, a cardiologist with Breach Candy Hospital, Mumbai. “The NPPA move is good for 80% of the patients. But for the remaining 20% of the patients, the government should not have impinged on the rights of these patients to buy a stent of their choice.”

Meanwhile, the NPPA said that there is no evidence of withdrawal of these stents from the market so far. “We need tangible evidence to proceed against anyone,” said Singh.

The NPPA has in fact tried to pre-empt stents being taken off hospital shelves. On Thursday and Friday, the authority issued a clarification that stent manufacturers do not need to re-label their products and can submit the revised price list online both to the NPPA and to hospitals. In case an artificial stent shortage is created, state governments had been asked to proceed against the manufacturers and seize their stent stocks as per provisions of the Drug Price Control Order, 2013

Singh observed that he had never seen such rumours of shortages when it came to drugs and medical devices as there have been about stents in the past week. “We have 600 drugs under price control,” he pointed out. “This normally does not happen because the trade channels partners know about the process of price change. They get enough time to manage stocks and inventories. It is not a sudden blow like demonetisation.”

Even with the case of cardiac stents, the NPPA has been in talks with various stakeholders for more than a month and manufacturers have known about imminent price control even if they were hoping for none.

After NPPA’s notification on penalties in case of artificial stent shortages, the associations of stent manufacturers quickly issued press releases stating that they were complying with the NPPA’s order.

“Given that stent manufacturers have always prioritised well-being and safety of the patients in India, we refute the claims that medical device companies are trying to create an artificial shortage of stents,” said a statement from the Advanced Medical Technology Association.

Standard operating procedure

Meanwhile, doctors have not stopped performing angioplasties and using stents.

“I did not find today different from any other day in the cathlab,” said Dr Sundeep Mishra, a cardiologist with All India Institute of Medical Sciences in Delhi. A cathlab is where stent insertions are usually carried out. Public hospitals were not expected to be affected by the price change since they have been getting drug-eluting stents at subsidised rates of about Rs 23,000 per piece.

But the change in stent prices has not had a major impact in the private sector either. This is because fewer cardiologists have been using or recommending the use of bioresorbable stents – one of the kinds that has reportedly been withdrawn.

While some cardiologists claim that the bioresorbable stents worked better with young patients, studies related to bioresorbable stents are not encouraging, said others. More than 8,000 bioresorbable stents are used in India annually, a report said.

“The latest data is not very encouraging,” said Dr Mishra, who feels that bioresorbable stents might actually be inferior to drug-eluting stents.

“Many of us have not used these stents enthusiastically anyway,” said Dr Akshay Mehta, who practices at Nanavati Hospital, Mumbai. “I was anyway not using bioresorbable stents. It had a higher rate of thrombosis, or blood clotting. I suppose some features will be corrected by the companies. But till that happens, I will not use them.”

The other type of stent that has been pulled off the market is the latest generation drug-eluting stents, which, doctors say, had the only advantage of being easily deployable in an artery and do not make any tangible difference in patients’ disease outcomes.

“Among the latest generations there are very small differences, mostly related to deliverability and deployability,” said Dr Mishra.

He explained that an experienced cardiologist will be able to deploy a slightly older generation stent with ease, whereas an inexperienced cardiologist might find using the newer generation stent easier.

“Bute,” Dr Mishra added,“how much cost can a patient bear for such small differences?”