Stents: balancing price with quality

It’s been over a year since India’s National Pharmaceutical Pricing Authority (NPPA) fixed prices of stents. Following which, media reports pointed to an increase in the volume market share of domestic stent manufacturers as they ostensibly occupy ground vacated by relatively pricey imported stents. However, do those products have the same profile, use, benefit, safety and efficacy as the ones they are purportedly replacing?

Price control policies are expected to lower prices to the end consumer and increase affordability without compromising on either quality or availability of appropriate technology that yield the desired outcomes. I’m concerned if this has occurred.

The NPPA’s price cuts included all manners of stents — imported and locally manufactured, bare-metal and drug-coated ones. Among this heterogeneous lot, there are products approved by the world’s most demanding regulators after rigorous testing and those that are not.

However, for fixing prices, products were categorised into two buckets — bare-metal stents and drug-eluting stents (DESs). They’ve been given one price ceiling each. For many imported products in the DESs category, this ceiling is too low, forcing their makers to rethink if India is the market for them anymore.

Each of these products has been developed for a specific purpose — usability, cost or operational efficiency or the relevance of the stent to a growing subset of patients with co-morbidities such as diabetes.

Apart from the stent, a DES contains several parts; a drug preventing repeat narrowing of an operated artery or restenosis; a polymer binding the drug to the stent which controls its release into arteries; the delivery system used to insert the stent. Since the inception of DESs, there have been advances in all these aspects. Barring the changes in the thickness and flex of a stent, it also includes radio-opacity or visibility during implantation, the drug used, etc.

Superior outcome

Patient outcomes of current generation DESs are superior to the earlier versions using scientific end-points such as restenosis. However, the pricing policy does not allow generational advances. Also, one of the preoccupations of stent innovation is improved outcomes of stenting in diabetes. While diabetics are at higher risk of blockages, the complex nature of the disease and the way plaque forms in the arteries make successful stenting challenging.

Despite advances in stenting, doctors often recommend open surgery in the form of a bypass. Whereas DES, a less invasive procedure than open surgery with quicker recovery, can improve outcomes. Imagine, if a DES were invented wherein outcomes of stenting in diabetics was on a par with — or close to — the general population. This would not be possible without substantial time and monetary investments the developer will need to recoup.

Going by the current policy, such a product would be awarded the same price level as less effective predecessors as it will still be a DES. Ergo, it might be unavailable in India, the diabetes capital of the world. But till the headline numbers on the total volumes of all DESs sold in the country continues to grow, the disservice to those patients who would have benefited immensely from such a product will not be immediately obvious.

Healthcare decision-making must be more discerning and nuanced. Indeed, the government had been advised by a sub-committee that even incremental innovations in stent technology do lend themselves to sub-categorisation from a pricing perspective. The extent of evidence required sets the bar unreasonably high. Unless a DES is proved to be ‘superior,’ in a measurable way, to available technology, it is deemed to be no different.

In medical technology, clinical trials are not designed to show ‘superiority’ but to understand its ‘non-inferiority’ from a safety and efficacy perspective. This is also the standard for regulatory approval. Establishing superiority takes decades of actual use in the clinic/surgery requiring evidence. The need for ‘superiority’ data has resulted in sub-categorisation for tiered pricing becoming a non-starter.

An approach with the necessary distinction between drugs and devices is welcomed as fair and reasonable than the current one. Device companies incur additional costs in the training of doctors and assistants to use rapidly advancing technology, which drug companies do not have to. Devices are also rendered obsolete faster than medicines, and cost more to distribute.

To ensure that Indian patients can continue to access advances in medical technology, such a major flaw in the current device pricing policy must be corrected.

(The writer is Director, Cath Lab and Senior Interventional Cardiologist, Ruby Hall Clinic, Pune)