Overuse and over pricing of stents in cardiac care procedures has been a hot topic for discussion lately. An analysis delving into the factors driving these issues and measures to mitigate them By Raelene Kambli
In the last five years, the coronary stent market in India has been growing at an impressive rate due to rise in coronary angioplasties which have resulted from a surge in cardiovascular diseases (CVDs). According to the National Interventional Council (NIC), coronary interventions in India have increased from 117420 since the year 2010 to 248152 in the year 2014. The NIC report discloses that India is one of the few countries where percutaneous coronary intervention (PCI) are growing at 14.5 per cent rate over 2013 (Check table on NIC statistics on CVDs, PCI and Stents implants). The total number of stents implanted last year was 3,10,190, out of which approximately 60 per cent of the market is shared by multinational companies such as Abbott, Medtronics, Meril Lifesciences, Boston Scientific etc. As per a report published by Ace Business and Market Research Group (ABMRG), a research and consulting company, the coronary stent market in India, which comprises drug eluting stents (DES), bare metal stents (BMS) and bio-absorbable stents (BVS), was valued above $400 million in 2012. The report further states that the stent market in India would triple in numbers by 2021.
However, in the last few months, the success of the stent market in India has been constantly under the scanner by various government agencies and the media. The industry is presently battling against two major accusations- over pricing and over use. Express Healthcare chose to dig deep and examine this situation.
Beginning of the story
Dr Hasmukh Ravat, Cardiologist, Fortis Healthcare, Mumbai remembers the way angioplasties were performed earlier and says, “In the evolution of angioplasty as a procedure, two factors (and limitation) have always remained matters of concern. First, the acute closure happening within a few hours to the day of stenting and the other concern is restenosis (or reocclusion), the recurrence of abnormal narrowing of an artery or valve after corrective surgery. The percentage/ incidence of closure/ restenosis was very high in balloon angioplasty, depending on the lesion length and size – sometimes as high as 30-40 per cent. This meant the failure of the procedure. A number of factors (methods/ procedures?) such as i.e. drilling, laser, cutting, radiation were tried as a solution of this problem, but nothing was so successful between 1988 and 1996.”
Stents entered the Indian market during the 90s in the form of bare metal stents which proved to be one of the most useful and beneficial devices for patient of coronary artery blockage undergoing angioplasty at that time. “Early stents solved the main problem of acute closure markedly and also the restenosis problem to a certain extent, which resulted in the percentage of closure/ restenosis coming down from 30-40 per cent to around 15-20 per cent. Subsequently, the drug-eluting stents, which became available in 2005-06, addressed the problem of restenosis successfully with the percentage of restenosis coming down sharply from 40 per cent to less than 10 per cent and in some cases, no restenosis at all, depending on the size and length of lesion,” informs Dr Ravat.
Talking about the initial prices of stents in India, Dr Praveen Chandra, Chairman- Division of Interventional Cardiology Heart Institute-Division of Cardiology, Medanta-The Medicity mentions, “Initially, (in 1992-1993), none of the stents were manufactured in India. Since these bare metal stents were imported to India the cost of these stents were around Rs 80,000-95,000 in those days. At that time there were around 25-30 cath labs in India. Soon, with the upsurge in CVDs, the demand for stents and cath labs increased. In 2004, drug eluting stents entered the Indian market whose costs ranged between Rs 80,000-127,000 . Today, there are around 10,000 cath labs in India that performed around three lakh stent implants last year”.
Facts provided by the NIC, a data registry for the cardiologist and people associated with cardiac care), proves that there is a growing demand for cardiac interventions, especially in terms of stent implants. But, does this mean that all these CVD patients require stents? Why is the industry being accused of overuse of stents?
Let’s understand this aspect first.
US stent market vs India
If we take a look at the global scenario, the increasing numbers of PCIs has been questioned worldwide by several research agencies. Take the example of the US, where in the last 10 years several studies published by association such as American Medical Association, the Joint Commission and reputed publications such as New York Times, Reuters etc., show that there is a constant misuse and overuse of stents. In January 2006, an article published in the journal Circulation observed that although there has been a dramatic increase in artery-opening procedures to prevent heart attacks, over the last 10 to 15 years, the rate of heart attacks stayed relatively constant.
In the year 2010, a stent scandal broke out after the arrest of Dr Mark Midei, a star cardiologist at St Joseph Medical Center in Townson, Maryland. The New York Times published a head-turning tale about this well-acclaimed cardiac surgeon who was found to be taking illegal kickbacks from a leading multinational stent making company that operates in India as well. After this incident, leading cardiologists in the US confessed that some doctors were overusing heart stents in an effort to make up for lost revenue due to health revenue cutbacks and also because of kickbacks received from multinational stent makers.
The multinational stent maker who was involved in the scandal is still freely doing and growing its business worldwide and enjoys a huge market share in India’s thriving stent market.
Episodes similar to what happened in the US have been reported in other parts of the world as well. So, what’s the scenario in India?
Over use of stents in India: Decoding the issue
Looking at the alarming rise of CVDs in India, it won’t be hard to believe that the increasing number of stent implants can be justified. Still, how many of these stenting procedures are medically advisable and how many doctors put patients at unnecessary risk and make them bear unnecessary procedure costs?
A well-read daily recently published a study by interventional cardiologists in the country which revealed that 50 per cent of patients who have been advised stents to remove heart blockages do not require it! The study further states that every heart block does not need a stent and can be managed with medical treatment. And again, every block does not need a drug eluting stent or the latest technology of absorbable stents (costing between Rs 1.5 to Rs 2 lakhs).
Renowned cardiologists also fear overuse of stents in India. “In India, there is no audit for the medical procedure, so claiming misuse of stents can neither be validated nor dismissed,” says Dr Praveen Kulkarni, Consultant- Cardiologist, Global Hospitals Mumbai. Adding to this, Dr Ravat, says, “There have been instances of misuse of stents in India. Stents can be misused in some cases where they are not required, i.e. in case of a small vessel or not-significant size of vessel or less severe or significant lesion, there is a possibility that instead of one long stent, a number of small stents are used. There is no evidence that lesion will be of any benefit in case of total damaged heart wall muscle.”
“With no standardised regulations, misuse or overuse is ought to happen. At my hospital I get around 30 per cent patients who have been advised stent implants or bypass procedures by their doctors and who actually do not require these surgeries. I treat them with just medication,” reveals Dr Ramakant Panda, Vice Chairman and MD, Asian Heart Institute.
Dr Prafulla Kerkar, HOD -Cardiology Department, KEM Hospital, and Consultant Interventional Cadiologist, Asian Heart Institute explains how this overuse or misuse happens. He says, “Stents are most useful in saving lives while dealing with acute problems of the heart, like heart attack or pre-heart attack symptoms. Implanting a stent in a 100 per cent blocked artery after 24 hours of a heart attack in a stable patient is useless. It should be implanted before the golden hours. So when cardiologists do not test the viability of the heart muscle before implanting the stent in this scenario, the actual misuse happens.”
While there are a few cardiologists who agree that there is overuse to certain extent, there are a few who spurn this allegation.
Dr Lekha Pathak, Executive President, Heart Foundation of India is one of them who denies this accusation. She says, that this issue is overhyped and people should remember that stents are used to save lives of patients and that there is no misuse or overuse.
“There is a misconception about this problem,” Dr Chandra asserts. But, he agrees that there are some grey zones within the industry as well.
Giving the view of a multinational stent maker, Milind Shah, MD and VP-South Asia, India, Medtronic points out, “India has a very low usage of stents. The recently published NIC registry data suggested that only 0.02 per cent of the coronary artery disease (CAD) patients in India go through angioplasty whereas in the US, 3.24 per cent of the population undergoes angioplasty every year. Interestingly, NIC registry data also reflected a trend contrary to the claims of overuse, with the rate of growth of angioplasties going down from 22 per cent in 2013 to 14 per cent in 2014. The reduction of growth rate in procedure points towards reducing treatment adoption of angioplasty. These data points may not suggest an overuse.”
Though the growth rate of PCIs may have gone down as per the NIC, the fact that the issue of over use of stents in India can only be dealt with effectively and curbed if the government brings in stringent regulations for such high risk procedures.
The cost issue…
The other and the most talked about issue around the use of stents in India is the problem of high costs associated with these procedures.
Once again, if we compare the Indian cost with the rest of the world, we are far more affordable. Our healthcare costs are lower compared to that of our neighbouring countries, Europe and the US. Dr Chandra informs that nearly 30- 35 per cent of patients from the US, Europe, Africa and some Asian neighbours seek cardiac treatment in India. Dr Panda also reveals that India’s healthcare costs are cheaper than those of even Pakistan and Bangladesh. However, coming back to the costs of stents in the US, in 2010 the price of a stent was less than $1000 but the cost of procedure for implant would range anywhere from $30,000 to more than $100,000. Today, the cost would vary only by a small margin. However, in India there is an assumption that the cost of stent implants is high due to the high cost of the device and also because cardiologists still choose imported stents over local ones.
To understand the real cost difference between imported stents and local ones. We further spoke to some cardiologists and some distributors of stent both local and imported stents after which we derived at the average prices of stents sold in India.
But before this it is important to note that, the Union health ministry has fixed Rs 23,625 as the price of a DES under various government schemes. (See the table above)
While speaking to Dr Panda, he admits that there is no huge difference between imported and local stents. He says, “In fact we expect that local stents should be around 50 per cent cheaper than imported ones. But that’s not the case.”
Dr Chandra also complies with the fact that there is no huge difference. He says there is a difference of around Rs 10-15 thousand only.
Now the question that arises is why do cardiologists prefer imported stents?
Dr Panda explains, “The simple reason is that Indian stents are not clinically proven to the extent that we can recommend it to patients.” On the same lines, Dr Chandra explains, “Imported stents become an obvious choice because these FDA-approved stents have gone through several clinical trials. For any stent to get an FDA approval, manufacturers will not only have to conduct many clinical trials but they also will have to conduct two to three compound studies on the device before undergoing certification. So, since these stents have gone through so many trials and are acclaimed worldover, we prefer these stents.”
Giving the stent manufacturers the benefit of doubt, Dr Praveen Kulkarni, Consultant- Cardiologist, Global Hospitals Mumbai, speaks about the rationale behind the high cost of stents and the reason why patients pay so much for such procedures in India. “Speaking economically, actual production price of any product is always dramatically different from the cost of the product to the end users. Stents costs are expensive because the research and development costs are very high. The companies who invest heavily into R&D have to recover their costs and hence the cost is high. These expenses are always borne by the end users that are patients. Also, India has one of the highest ‘out-of-pocket’ expenditure on healthcare. This directly burdens the common man, especially in high-end procedures,” he accounts.
We acknowledge that more investment in R&D will increase the overall cost of the product. That does not mean we can ignore the affordability part of these procedures for Indian patients.
Studying the US market on this aspect we derive that even if the price of stents and the procedures in this part of the world are higher than that of India yet insurance and government funding does relieve maximum burden of their medical expenses.
Nonetheless in India, we have approximately 15 per cent people having medical insurance and our government funding in this area is around 37 per cent, as per NIC reports. So, still a large amount of CVD patients who undergo PCIs have to pay out of pocket.
Well, the good news is that the government has taken initiatives in this regard to bring prices under control by capping the amount of DES stents under various government schemes. And, taking this as opportunity, stent makers are leaving no stone unturned to grab a share of the pie by bringing down the cost of their products. Informs, Dr Nilesh Gautam, Senior Interventional Cardiologist, Asian Heart Institute, “As new players are entering the angio-device industry, the competition to grab the maximum market share is increasing. Hence, every player is trying to provide the best quality equipment at the lowest possible price, leading to an overall reduction in the device prices. For example, the price of bare metal stents and drug eluting stents has been slashed by approximately 15 per cent. The price of angioplasty balloons, catheters, and wires has fallen by almost 40 per cent.” Dr (Prof) Harsh Wardhan, Head of Department of Cardiology, Primus Hospital, New Delhi, opines, “The prices of stents have been coming down in India over the years. With the availability of stents manufactured in India and regulatory bodies keeping a close watch on stent prices, they are expected to come down further, making it more affordable for patients. Some state governments have taken the initiative to provide free PCI procedures and stents to poor patients. Clinical research and trials of indigenously manufactured stents will go a long way in developing the confidence in these indigenously produced devices and reducing the cost of procedures.” However, if stent prices are dropping, why is the patient paying a huge price for angioplasty procedures?
An industry source who prefers to be anonymous informed that in a private set up in New Delhi, the average angioplasty package has moved from 1.5 lakhs in 2001 to Rs 2.25 lakhs in 2015. Which is about Rs 75,000 rise in the last 15 years, notwithstanding inflation. “In the present scenario where the cost of stents to a hospital have dropped by around eight per cent CAGR over last decade, yet the price of a stent to the patient has not seen much reduction,” the source questions. He further says, private hospitals offset the losses on the angioplasty package (which they incur because of higher infrastructure costs, salaries, etc) by cross-subsiding it with what they gain through negotiating a reduction in prices with stent companies.”
We tried to find out from some patients about their experiences.
Arundati Shah, a 56-year old woman has had a stent implant done in 2013. Although she leads a normal life now, she has bitter memories of the time when she suffered a heart attack back then. She recounts, “My family was told by the hospital, which is a leading private healthcare institute in Bandra, that they required to implant a stent when I suffered a massive heart attack in June 2013. However, the price of the procedure was Rs 2.5 lakhs and they had to deposit half of the amount before the operation. Since they could not shFift me to another hospital they went through a tough time arranging the amount.” She further questions why hospitals have this system of first depositing money and then operating on the patients? “Are they institutes to save lives or mint money?,” queries an irate Shah.
On the other hand, Anup Kumar Basu, a 65-year-old resident of Chandannagar, a distant suburb in Kolkata, underwent a stent implant in 2014. The implant took place at a mid-sized hospital in Kolkata. He incurred Rs 75,000 for the implant and Rs 46,000 for hospitalisation, including doctor’s fees and other expenses, the break-up for which was informed to him well before hand. However, Basu also informed that he would had to cough out Rs 2,00,000 for the implant if he would have done the operation at Kolkata’s leading heart care institute as the hospital had quoted them this sum. Despite the price war that Basu faced, he still seems to be visibly happy as he leads a normal life now. “I am leading a normal life after the stent implant and there were no complications after the procedure,” he informs.
It’s a long way to go….
Clarifying why hospitals charge so much for stenting procedures, Dr Ravat says, “Difference in the purchase and sale price of stents by hospitals depends on a number of factors. Corporate hospitals often buy or assure use in bulk, so their actual purchase price is generally less than the listing price of the stents. The companies (stent makers) print liberal MRPs; so the effective price for stent to the patient depends on how much profit margin the hospital wants to maintain on the ‘trading’ of the stents.”
Dr Kerkar, drawing attention to another important issue on this aspect, says, “In Maharashtra, under the RGJAY scheme, cardiac patients who require stent implants are provided with approved well-researched DES however at some private hospitals patients are still implanted with bare metal stents in order to earn profits out of the RGJAY scheme,” he discloses. Moreover, he goes on to say that under such government schemes there should be special packages with immediate sanctions for stenting procedures on heart attack patients so that more lives can be saved.”
Further, pointing out the DCG(I)’s intent to bring stents under essential medicines, he says, “Stents according to me, are not essential medicines. Nowhere in the world are they treated as essential medicines. They need to be put under price control but stents are life saving only in times of acute heart problems.
Otherwise, they only control symptoms and recurrence of blockages. So, they need not be put under essential medicine.”
All said and done, the price war, the over use and the blame game will continue unless the government brings in some stringent norms for use of such life saving devices. The government’s move to bring stents under price control is certainly welcome; however the government also needs to create a cap for prices on performing such
procedures in the best interest of patients.
(With inputs from Sanjiv Das)