Pharma companies want you to pay more for 'risky' bioresorbable stents

Bioresorbable scaffolds showed that the device might perform as well as a metallic stent clinically , but it also meant an “increased risk“ of stent thrombosis.

Would you pay a higher price for a 'technological advancement' that might be worse for you? That may sound bizarre, but it is what stent manufacturers are demanding.

In the ongoing tussle over fixing a ceiling price for stents, companies want the National Pharmaceutical Pricing Authority (NPPA) to fix a higher price for bioresorbable stents or stents that get absorbed by the body after they finish the job of propping open a clogged artery. But the latest study on them published in the premier medical journal Lancet has shown that the risk of restenosis -the artery narrowing again after stenting -might be higher with bioresorbable stents.

According to the study, published in the November 2016 issue of Lancet, a three year comparison of drug eluting metallic stents (DES) and bioresorbable scaffolds (stents) showed that the device might perform as well as a metallic stent clinically , but it also meant an “increased risk“ of stent thrombosis (blockage). Bioresorbable stents were introduced into the Indian market and in Europe by Abbott in 2012. However, it did not receive US FDA approval till March last year.

According to a market study, India accounted for a third of the Abbott's global revenues of $132 million in 2014 from CE marked (European approval) bioresorbable stents. The National Intervention Council regis try maintained by the Cardiology Society of India showed that in 2013, about 8,500 bioresorbable stents were used. This despite the very high cost, over Rs 2 lakh, when it was introduced.

Cardiologists, who have repeatedly claimed that they prefer foreign-manufactured stents only because they are FDA approved and have more clinical data to back their efficacy and safety than Indian made stents, appear to have had no problem in using the bioresorbable stents, which had neither FDA approval nor enough clinical data to back claims of superiority .

The import price of Abbott's bioresorbable stent is Rs 42,000. For the distributors, the price is Rs 65,000 70,000 and it's sold to patients for Rs 1.75 lakh or Rs 1.9 lakh on the claim that it is the most technologically advanced.

“Obviously , no cardiologist recommending bioresorbable stents will tell patients that it is not proven to be better than DES. The price tells you how hefty a cut doctors and hospitals are getting for this stent and that is the incentive to push the stent for a patient who can bear the cost,“ explained a cardiologist, adding that there was no justification for demanding such a high price when it was not proven.

The leading players in the bioresorbable scaffold market include Abbott in the US, Kyoto Medical Co in Japan, Arterial Remodelling Technologies in France, and Meril Life Sciences and Sahajanand in India. With Indian companies also fighting for a share of this market, both Indian and foreign manufacturers are lobbying for higher prices for bioresorbable or biodegradable stents. However, the government notification on price control for stents has clubbed DES and bioresorbable as a single category . But intense lobbying continues.




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