Stents as Essential Medicine: India’s Cap on Stent Prices Could Have Ripples Around the Globe

In a move that many hope will increase the dismally low numbers of patients undergoing primary angioplasty in India, lawmakers have declared that coronary stents are “essential medicines.” Prices for both bare-metal and drug-eluting stents there have now been capped at roughly 25% of their previous cost.

The National Pharmaceutical Pricing Authority (NPPA)’s action is being hailed by interventional cardiologists who, for years, have seen the majority of their patients (and patients’ families) turning down the option of PCI and stenting due to its sheer unaffordability.

“This had to happen,” Upendra Kaul, MD (Fortis Escorts Heart Institute, New Delhi, India), told TCTMD. Even without taking into account the lower incomes and living standards of the vast majority of Indians, most of whom have no medical insurance whatsoever, prices of coronary stents in India were in many cases higher than what Americans pay in the United States. “This was really exorbitant,” Kaul said.

The NPPA’s ruling, passed in February, capped the price of bare-metal stents at 7,260 INR and drug-eluting stents at 29,600 INR (approximately $110 and $450 USD, respectively). Drug-eluting bioresorbable scaffolds also fall under this cap. Prior to the decision, the average price of a bare-metal or drug-eluting stent on a patient’s medical bill would be in the range of 45,000 INR for a BMS and 121,000 INR, almost $1,900 USD, for a DES. By contrast, the price of a DES in the United States hovers at around $1,200.

“There have been mixed feelings in the Indian medical fraternity about the price capping of stents in India, but I think that this decision of the government has been well received by the common people at large,” Shantanu P. Sengupta, MD (Sengupta Hospital & Research Institute, Nagpur, India), told TCTMD. “It has made the cardiology healthcare system more affordable, so the common man can afford cardiac stents.”

[Now] the common man can afford cardiac stents. Shantanu P. Sengupta

Multinational companies, however, say they cannot feasibly sell their latest-generation stents at the new prices. Late last month, Abbott petitioned to remove its Alpine and Absorb stents from the market, while Medtronic asked to withdraw its Onyx stent. Indian authorities have rejected the requests, invoking emergency measures to mandate manufacturers, distributors, and supplies to keep products on the market for a 6-month period. Just this week, the NPPA followed this up with a memorandum asking hospitals, physicians, and patients to report back to authorities if they experience any shortages of stents supplied by international manufacturers.

Contacted by TCTMD, an Abbott spokesperson said the company is “aligned to the government's vision of broader access to care, and [we] have always maintained that we will ensure availability of our world-leading gold standard Xience stents, which account for the vast majority of all Abbott stents used by patients in India.” The decision to ask to withdraw the Alpine and Absorb stents was based on the fact that the ceiling price “makes it unsustainable for us to continue to sell them,” she said.

Skyrocketing Prices, Desperate Need

The scope of cardiovascular disease in India—and the lack of access to care—puts the government’s action in perspective. Cardiovascular disease has now surpassed infectious diseases as the country’s number one cause of death, with ischemic heart disease and stroke accounting for more than 80% of CVD deaths.

“Cardiovascular disease is a growing menace, and it is increasing in epidemic proportions,” Sundeep Mishra, MD (All India Institute of Medical Sciences, New Delhi), told TCTMD. “Two interesting things about India is that CVD hits patients earlier, about a decade earlier than in the West, and the outcomes for this disease even with best of treatments are not equal to what they are in the West. . . . It is really a big problem, and that was why the government included stents in this essential category.”

Compounding the problem is that only 22-24% of Indians have any form of health insurance, Sengupta estimated. “So if they have to undergo any kind of procedure, they have to shell out money from their own pockets.”

Brahmajee Nallamothu, MD (University of Michigan Medical School, Ann Arbor), co-authored a Perspective published in Circulation online this week addressing India’s stent prices. Speaking with TCTMD, he too called out the country’s rapidly shifting demographics. Indian health authorities, he said, must come to terms with the fact that while infectious diseases and malnutrition remain important issues for much of the country, these are coupled with soaring rates of noncommunicable disease in the burgeoning middle class.

“This growing middle class is starting to develop problems around diabetes, hypertension, and dyslipidemia, and the manifestation of those is coronary disease,” he said. “The way [the health system] is currently set up is complicated and leaves a lot of people unfortunately not equally treated by these therapies, just because of access issues.”

The number of cath labs nationwide has, in fact, been rising—from 251 in 2010 to 630 in 2015, according to a report by India’s Observer Research Foundation. In 2016, Kaul said, that number has spiked to 950. Still, the proportion of STEMI patients undergoing primary PCI hovers around 6%.

“The facilities and infrastructure for coronary interventions in our country are grossly inadequate if we take as our standard Western Europe and the United States,” Kaul said. Yet given the sheer size of India’s population, the number of patients at risk, and the number of new cath labs sprouting up each year, Kaul believes international stent manufacturers—who make up 60% of the Indian market—will want to stay at the negotiating table.

We are doing 500,000 procedures per year and that number is growing. Upendra Kaul

“In spite of all the shortcomings, we are doing 500,000 procedures per year and that number is growing,” he said, noting that these figures are second only to countries like the United States and Germany. “In those other markets, angioplasty numbers have become stagnant, [but] here the market is growing by about 7% per year.” The multinational device makers “can’t ignore the Indian market,” Kaul said. “They might posture and push back, but finally a balance should be struck.”

Kaul predicts the pricing may be relaxed at a future time point. Alternatively, tiered pricing may be introduced to permit higher prices for stents that hold US Food and Drug Administration approval, followed by stents that hold CE Mark, with locally made stents priced more cheaply.

Potential Impact

Indian cardiologists who spoke with TCTMD were generally positive, predicting that the caps will lead to more patients undergoing primary PCI. Sengupta said that he personally has already had patients choosing to undergo angioplasty after learning that the stent had become more affordable. Kaul, likewise, predicted that patients with multivessel disease who might have opted for coronary bypass surgery in the past will now choose PCI. Prior to the stent price cap, bypass surgery in India was actually cheaper than PCI if more than two stents were likely to be needed, he said.

Mishra, however, injected a note of caution. “As far as patients are concerned, hopefully more of them can afford the stent prices, and we could see an increase in the volumes of this particular procedure if this benefit is passed onto the patient,” he said. “But as you might understand, the price of the stent is just a brick in the wall, just one part of the procedure cost.”

The price of the stent is just a brick in the wall, just one part of the procedure cost. Sundeep Mishra

In recent weeks, government agencies have been cracking down on hundreds of hospitals for listing the stent price on patient’s billing according to the caps set by the NPPA but inflating other procedural, physician, or hospital costs. “Unless the regulation is very strong, and unless the government bodies are really very careful, ultimately the patient will not benefit at all,” Mishra noted. “So that is the concern the government has, and that is why they are investigating these cases to be sure that this benefit is truly passed along to consumers.”

To that end, said Kaul, all hospitals are now required to specify the type of stent used and record the lot number on the patient’s medical bill, with a sticker added to his or her chart “to show that they did not allow any hanky-panky.”

Kaul, however, predicted that there may be other ripple effects of forcing international medical device giants to supply product at affordable prices. He expects to see less investment by multinational companies in sponsorship of meetings and training events in India as well as fewer payments to physicians for international meeting travel—something he acknowledges is already in the crosshairs of the Medical Council of India, which regulates medical practice qualifications and education.

Kaul also worries that if some agreement is not reached, multinational companies will not bring their latest technologies to India in the future. Not only would patients not get access to the best care, potentially affecting outcomes, but also operators would not get the chance to use the more deliverable technology, he said.

On the flip side, Indian manufacturers are poised to benefit. “For them, this price cap is not bad because actually the manufacturing costs for these stents is very little,” Kaul observed.

Everyone who spoke with TCTMD acknowledged that Indian-made stents have not, in most cases, been subject to the same level of testing as the world-renowned brands. But Kaul, for one, believes this may be another potential positive to emerge from the government’s interference. Implanting cardiologists may be more likely to use different devices if they are all the same price, and Indian manufacturers may take the step of testing their products against foreign-made devices. “I know one of the studies comparing an Indian stent to an Abbott stent has recruited 50% of patients and is being done in Rotterdam, by the Cardialysis group, and it will be a credible study,” he said. “I think these kinds of studies are going to be very, very important.”

Focusing not just on medicines but more broadly on therapies and accessibility—this is a very important and different step [for the Indian government]. Brahmajee Nallamothu

“I think this is a game-changer,” Nallamothu said, noting that the only other device designated as essential by Indian regulators, to date, is the intrauterine device, or IUD.  At least two dozen other medical devices, including a number of other cardiac devices, are rumored to be under consideration. “Moving away from that national list of essential medications and focusing not just on medicines but more broadly on therapies and accessibility—this is a very important and different step than what has historically been taken by the Indian government,” he commented.

This story is just beginning, he added. “At the end of the day, what is going to happen in 3 to 6 months is going to be important to report. The companies have some legitimate points as well, but I think we just have to come to some middle ground.”

Of course, whether this government action will translate into any improvements in the health of a nation with one of the world’s fastest growing cardiovascular disease pandemics remains to be seen.

“Whether you put in the best stent or the lower-cost stent, it is not only the stent that defines the patient’s outcome,” Sengupta said. “There are other comorbid conditions—the atherosclerotic burden, the family history, the diabetes: a lot of things. So even if I put in the best, most expensive stent, if the patient keeps using tobacco and stops taking his medication, he’s going to come back.”