Ill-considered price control will block newer, advanced stents

We have all experienced the ‘same pinch’ phenomenon in our childhood, when a friend or cousin pinched us for wearing the same clothes or having the same toy. This phenomenon has also been creeping across our medical field, if one considers the arguments made about medical devices, especially coronary stents.

Many have called for price control thro-ugh uniform stent pricing, which means that all (drug eluting) stents should be priced equally, because the assumption is that they all ‘are the same’. As an interventional card-iologist and director of a very successful and specialised heart treatment institute, one finds these arguments unscientific and fallacious. What is troubling is that we do not realise that this over-simplification and generalisation of technology, procedures and care for a patient will hurt us more than any ‘same pinch’, in the long run. Here’s why.

Even as we are built from the same building blocks, we are all different.  Morphology, genetics, environment, lifestyle, all conspire to create thousands of variations in how we react, cope and adapt. So while every human heart has four chambers, a diabetic patient undergoing a procedure may need a different stent as compared to a person who has had a bypass surgery and has come back for re-narrowing of arteries, or someone else who may have a block in a small, torturously winding blood vessel. 

Different clinical scenarios require different types of stents. As cardiologists, we learn and build our capabilities around understanding which stent is needed where. To someone who does not have a good idea of the complexity involved, a stent may just seem like a tiny, medicine-coated tube that is used to open a blocked vessel. But to clinicians who use them every day, no two stents are the same, in terms of their application and their outcomes.  

Public opinion about stent prices being exorbitantly high is not misplaced. The government, however, has led the way in a gradual reduction in stent prices through its reimbursement schemes. Stent prices have dropped from Rs 95,000 to less than Rs 25,000 in a span of two years, and these are high-quality, US FDA-approved stents we are talking about. The National Interventional Council (NIC maintains a registry of cardiac procedures in India) also indicates that government funding of cardiac procedures increased in 2015, over 2014. 

So if the price of a standard, US FDA-approved stent has dropped to Rs 25,000, why is there a clamour for price control on stents? The issue is that some hospitals continue to charge multiples of the procurement price, in turn giving the impression that stents, overall, are exorbitant.  Even in a state government institution such as ours, we use high quality, USFDA and CE-marked stents, and we procure these at a reasonable price, passing on the benefit to patients.

Even as the industry has reduced prices of good quality USFDA and CE-marked stents, India, an out-of-pocket market, is among the few countries where stents belonging to advanced generations are available at several price points. This has brought in a new element of dispute, with claims that all the drug eluting stents are the same and, therefore, they must be capped at one price. This is where the government’s intervention is critical, because this is not a scientifically backed argument.

Stent differentiation matrix
The government and the medical community are working on a differentiation matrix to classify stents based on various factors. This will eventually be helpful in differentiating stents and, thereby, pricing them appropriately. But this process is seeing its share of naysayers, the argument being that the latest generation of a coronary stent is not proven superior to the earlier generation in clinical trials. What one needs to understand is that superiority trials in medical devices (such as drug eluting stents) are not very common as the complexities and scale involved are significant.

Non-inferiority trials, where a new product is proven to be at least as good as the earlier generation, are commonly done. Such a trial does not limit the parameters of performance in a product – there are other non-trial measures, for example, deliverability of a stent in torturous anatomies, flexibility, even scientific publications, that can be used to profile and classify a stent better. This is what the intent of the stent differentiation matrix is. Done well, this matrix will be a pioneering effort and other countries could possibly learn from our experience.

Once stents are differentiated per the matrix, differential pricing can be applied more scientifically. Given that there are many variables at play, there could be a review mechanism, say every couple of years, to adjust to the changes in the external environment. Custom duties and taxation keep changing periodically, so a review will keep things real. It is also of utmost importance to ensure that the system is regulated in such a way that the price benefits arising from stent differentiation are passed on to the patient.

This is a complex process, no doubt, and an iterative one. But not applying one’s mind and taking the simpler route of capping prices haphazardly will set us back at least a few years. In our enthusiasm to ‘punish’ manufacturers for exorbitant pricing, we should not lose sight of innovation and responsiveness to patients’ needs. Unfair pricing must be called out, but we need to better understand where the price hikes are happening.

Ill-considered price control will end up blocking the option of using newer, more advanced stents that come in every few years. We will be stuck with using older stents as there will be no incentive for inventors to bring breakthroughs into India. 

As doctors, we want to use the best quality products and contemporary technology for our patients. We also need to achieve a balance of pricing these reasonably for our patients, which is what a good differentiation matrix will achieve. So, rather than oversimplify by ‘same pinching’ stents, let’s try and differentiate, based on scientific evidence. After all, a heart attack is no child’s play.

(The writer is a Cardiologist and Director, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bengaluru)