There has been much discussion recently about capping the price of stents in India. This decision has been welcomed by some, but many are unhappy about this.
Recently the National Pharmaceutical Pricing Authority (NPPA) capped the prices of specialised cardiac stents between Rs 7260 to Rs 29,600. This has led to a number of different companies withdrawing their stents from the Indian Market.
Is this going to do our patients good or harm?
Here, I will take a practical look at both sides of the coin of stent price capping.
Cardiac Stents – Evolution and Research
Before we dive into the price of stents, let us first understand how cardiac stents have evolved.
The basic premise of using cardiac stents is to ensure that an artery that is narrowed (from fat deposition) remains open and patent. Stents are like springs that you see in ball point (clicky top) pens.
Insertion of stents require precision, skill and a great deal of training. Passing wires through delicate arteries and inflating balloons and stents is a procedure that requires accuracy and focus. Of course, it is not without it’s problems, but then what isn’t?
The world of cardiology owes a big debt to Dr Andreas Gruntzig, who in September of 1977 performed the first stent implantation into heart arteries in humans. While it appeared as a great success on the outside, the stents used subsequently had a high rate of blocking off, either partly or completely.
But why did these stents get blocked?
It all boils down to a process called ‘neo-intimal proliferation’. In simple terms, this means that the vessel wall to which the stent is abutting grows over the stent.
In other words, if a stent is put in and left in place, the blood vessel wall will begin to grow over it. If this occurs in a very extensive manner, then it can lead to blockage of the stents.
The blocking off of stents is also related to how thick the blood is. In order to prevent blood clots from forming along with the neo-intimal proliferation, blood thinners such as aspirin and clopidogrel (or ticagrelor or prasugrel) are given.
Bare Metal Stents – Initial Promise
The first stents that were introduced in the mid 1990’s were called ‘bare metal’ stents. These were just plain metal meshes that when inserted using a balloon kept a narrowed artery wide open.
The initial results that were obtained with bare metal stents were significantly better than simple ‘ballooning’ of the vessel. The arteries remained patent for longer, and the patient had better long term results.
However, as time passed, more and more research conducted found that around the bare metal stents would get occluded a few months later. This was called ‘late re-occlusion’ or ‘delayed re-stenosis’.
There are a number of factors that determine blockage rates of bare metal stents. Clinical research has shown that around 20 to 25% of cases of bare metal stents get blocked. That’s almost 1 in 4 cases! Some experts believe that the rates may range between 10 – 50%!
So what did the scientists and doctors do to counter this?
After much research, newer stents that are coated with certain medication were introduced. These were called drug coated stents or ‘drug eluting’ stents.
These drugs prevent the vessel wall from growing over the stent, thus ensuring they remain patent for a long time. The rate of neo-intimal proliferation is low.
In fact, the reduction in re-stenosis rate is between 50 – 60%. This makes drug eluting stents a much better option than bare metal stents.
I would like to pause for a minute here and explain 2 terms for you – angiographic re-stenosis and clinical re-stenosis.
Angiographic re-stenosis refers to narrowing of the artery within the stent that is seen when an angiogram is performed. Having angiographic re-stenosis does not necessarily mean the treatment has failed.
Clinical re-stenosis is where the narrowing within the artery starts to cause symptoms or is significant enough to reduce the amount of blood the heart receives.
Clinical re-stenosis is more relevant as it what prompts repeat angiography and additional treatment in most cases.
When inserting stents, cardiologists look at the risk of development of both, more so the clinical re-stenosis. After all, it is clinical re-stenosis that prompts further investigation.
A routine angiogram to check the patency of the stent in someone who is otherwise very well (no chest pain etc) is not only unnecessary; it is unethical.
Drug Eluting Stents – The Advent Of Better Cardiac Care
Drug eluting stents, sometimes called drug coated stents are a higher quality stent that has a lower rate of occlusion compared to bare metal stents.
Each of the metal stents are coated with a drug that is slowly released from it’s skeleton. This drug has the property of preventing smooth muscle cells from proliferating.
In other words, it reduces neo-intimal thickening, thus reducing re-stenosis.
Drug eluting stents have emerged over the years following a large amount of research. Only selected stents have been approved by the US FDA (United States Federal Drug Authority) and these are available to the public once sufficient amount of clinical research has proven their benefit.
In India, cardiologists use US FDA approved stents because of the scientific backing it has behind it. If there is clinical evidence that it works, then they can be rest assured that their patients are getting the right treatment.
The issue with drug coated stents is that they are more expensive compared to bare metal stents.
Bio-Absorbable stents
This is a relatively new technology that has emerged in the world of cardiac stents.
These stents get absorbed and eventually disappear completely. However, they still maintain the patency and flexibility of the blood vessel.
Bioabsorbable stents are not cheap. They can cost quite a lot and not everyone can afford them.
Is Price Capping On Stents Going To Be Good For Patients?
Now that you have an understanding of the stents, let’s take a look at how practical price capping on stents actually is.
Technology has advanced tremendously over the years. Healthcare is no exception. As you have seen above, cardiac stents have evolved over the last 40 years into ones that have quick action, are safe to use and are extremely effective and lifesaving.
Price is always an issue as technology advances. Take mobile phones for example. If you want a phone that is packed with features, you would have to shell out a lot more cash compared to feature-poor phones.
Take restaurants for example. A paneer butter masala at a local food joint may taste just as good as one in a five star restaurant, but the cost may be 10 folds higher at the latter.
Why would that be? Why this difference in price? After all, the ingredients are the same? Why pay more?
It all boils down to initial investment. Five star hotels spend a lot more on their infrastructure, so have to make the money back or the business will be a loss.
Similarly, certain mobile phone companies have invested millions of dollars into research and development, and hence the greater cost of better phones.
The same is true for cardiac stents. A lot of money and work has gone into developing advanced stents, so it should come as no surprise that the cost of better stents is going to be higher.
Furthermore, these stents form a part of what we call ‘life-saving’ treatment. You would want the best stent if you wish to have the best outcome.
Yes, the price of stents is no doubt high, but it is important to recognise the amount of work and money that has gone into developing it.
I am a big believer that every person who seeks medical attention should get the best care there is. But the harsh truth in India is that the best care costs money.
Not only that – the cheaper stents can only help around 50 – 70% of patients due to the nature of their clinical condition. What about the rest?
Price caps on stents are a boon to many patients. Those who are not very well off can now look forward to receiving the same care that those who are better off financially receive.
But here lie the problems.
#1 – Lower Profit Margins For Imported Stents
Many companies do not see price capping as a good thing.
Profit margins drop remarkably once prices are cut. Pumping money into research and development does not make financial sense anymore.
It is no surprise that companies who create these advanced stents are pulling out of the Indian market. After all, it is a business that could come crashing down.
#2 – Research And Development Will Take A Back Seat
Putting a cap on the price of stents hinders research. Research requires money; money that has to come back to the company that invests it.
If the research itself, along with the cost of manufacturing exceeds the price of the stent, which company in the right state of mind would continue developing new stents? Alternatively, no company would want to import their stents to India.
10 years down the line, when the western world has seen tremendous advances in cardiac treatments, will we lag behind due to price cuts?
#3 – No Incentive For Indian Companies To Create New Stents
My dear friend and esteemed cardiologist Dr S Venkatesh brought up a very valid point when I was discussing price capping with him.
When taking into account profit margins of stents that are imported, one must bear in mind additional costs that are incurred such as licensing, import duties etc. This is what makes the stents more expensive (to an extent).
With Indian manufactured stents, these additional costs come down significantly.
With price cap, the profit that is made by Indian stent companies will be significantly greater for the same type of stent as compared to foreign stents.
As time passes, Indian stents will begin to dominate the market. With higher profit margins, is there any real need to keep innovating and creating new stents?
After all, even if you did create a new stent after putting in crores of rupees into research, patients will still pay the same price as capped by the government.
In other words, as long as the relatively higher profits come in, there is theoretically no need to develop new stents.
There are many Indian stents currently available, but there is very limited clinical data on how effective they are. Head to head studies that compare Indian stents to US FDA approved stents are necessary to ensure what each patient is receiving are scientifically proven to help.
If more and more companies withdraw their stents, there is another problem. People who are willing to pay more for the latest stents will not be able to avail it.
This makes price caps a double edged sword.
What is the solution to this problem? I really do not know. I (and many doctors I know) only hope that patient care does not get compromised in any way as a result of this.
While it all looks great on paper, time will tell if price caps and fewer advanced stents along with hindered research will have a negative impact on patient outcomes in the long run.
Closing Remarks
Stent price capping is a boon to the patients from a financial perspective; there is no doubt about that. With respect to getting the best treatments, it is debatable.
It is a matter of time before we know if the right decision has been made. Clinical studies could be conducted assessing this change and I have no doubt the data will be eye-opening.
As a patient or a family member of a patient, which type of stent would you like to have inserted? One that is cheaper and has limited clinical data supporting its efficiency or one that has backing by the US FDA, more expensive and is proven to work?
Please reply in the comments section below!
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Dear Vivek,
Top notch article. Firstly, thanks for speaking the detail on the evolution of stents. I also agree with you that price capping comes with its own advantages and disadvantages. But here are my arguments and lot of this is linked to just two broad points government and administration rather than life saver doctors. Doctors are made to treat patients and they should not actually worry on pricing.
#1 – Government should utilize the money paid by tax payers and allot the significant percentage to R&D. Which will further aid the research in most needed areas.
#2 – The management in health care companies should think the break even and profit margin are two different things. Planning the break even plays significant part in pricing. e.g. If I have invested Rs 100 and I plan my break even in 2 yrs, I will price the product such that my investment of 100 comes back in 2 yrs.
So, health care stakeholders should take into consideration the feasibility (company perspective), affordability (public) and act evenly with public administration (government) to provide the quality healthcare to all levels of the society.
My father (Janardhanaiah CM) is a cardiac patient and he is being treated from you and your father from past 10 years. That’s how I know you and Dr. Ganesh Baliga.
Regards
Manjunath
Sir, thank you for your comment. I agree that stent prices and roi strategies need to be changed. There are many times that we have advised stents for patients but affordability is a real issue. We do our best to negotiate rates for our patients but not always does it work. I personally think it is great for patients and as such we are enthralled about it. The idea about governments keeping aside money for research is a brilliant one, as long as the money goes to the right hands.
Excellent article that brings out the implications of price capping.
I have read the NPPA Order dt 13th Feb 2017. All have to comply with the Order. It leaves no leeway for working any way out. Looks like the Order was inevitable. Govt had to intervene with price capping to rein in the imperfect practices prevailing in the market to protect public interest and also as coronary stents are essential for public health.
In the short run, it would cause ripples in the market with withdrawal of high cost (and perhaps high quality) stents and dilution in the quality of stents supplied at the capped prices. India is too large a market for any company – domestic or MNC – to ignore. In the long run, sanity would prevail with suppliers restoring quality and perhaps Govt also bringing in flexibility in the policy.
While, prices could continue to be capped in general, patients could also be given the option to select a higher cost stent. Or else, the affluent would go abroad for better quality.
Self-regulation is the first order but when it is absent forced regulation comes in.