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NO SUB-CATEGORY FOR STENTS

Ramesh Shankar
Wednesday, February 21, 2018, 08:00 Hrs  [IST]

After a series of deliberations with key stakeholders, the National Pharmaceutical Pricing Authority has revised the price cap on coronary stents on February 12. While the price of drug-eluting stents has been capped at Rs 27, 890, the price for bare metal stents has been fixed at Rs 7,660. What was noteworthy in the entire exercise of price revision this year was the refusal of the price regulator to bow to the pressures of a section of stakeholders to provide a separate sub-category and higher ceiling price for latest-generation biodegradable stents. Now, these biodegradable stents will have the ceiling price of DES only. Ever since the prices of stents were capped for the first time in the country by the NPPA on February 13, 2017, a section of the stakeholders including the multinational coronary stent manufacturers and importers, some of the eminent intervention cardiologists and some industry associations has been not in favour of treating all DES in one bracket and favoured a sub-categorization and differential pricing for different categories in order to ensure future innovation and growth in this sector. They argued that if differential prices in DES is not adopted, they may be forced to withdraw their latest generation stents from the market and may not introduce the new generation stents. They also emphasized that some of their brands deserve to be treated differently and be given higher prices to make all the choices available for patients who should not be deprived of new generation stents if they are willing to pay for it. They also favoured a matrix of classification based on several features for a corresponding price preference. They further mentioned that proving 'superiority' of their new generation stents as per the requirements of the government is a long process where adequate clinical data is to be made available which may take years. They insisted on 'generational incremental improvements' within DES and strongly favoured differential pricing based on these incremental innovations for the sake of rewarding investment in R&D and innovation.

Meanwhile, the Indian coronary stent manufacturers and some civil society groups were opposed to the idea of sub-categorization within the DES and claimed that the India made stents are not inferior in any manner to imported stents and these are also being exported to different countries. They emphasized the fact that the so-called new generation DES of MNCs do not have adequate clinical evidence to support their claim of 'superiority' and should not be given preferential price. They brought to the notice of the government that because of price cap, a level playing field has been created after decades and because of that they have been able to compete with the foreign stent manufacturers and been able to capture a larger share of stent market. They also argued that all DES are same and multinational importers are just changing brand names in order to charge higher prices in the name of ill-defined and unverified innovations. Whatever be the merit and otherwise of these arguments, a final call on this issue in future will be taken with due diligence after taking all the stakeholders into confidence. The delicate issue of differential pricing to reward 'incremental innovations', in the name of ensuring availability of imported stents to those who are ready to pay for it, should be dealt carefully and with utmost transparency. Otherwise, the very purpose for which the capping of prices of stents was introduced in the country will get defeated.

 

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Pradeep Awasthi Feb 26, 2018 6:52 AM
In last two years our union government has taken lead for Protecting poir patients from high price leveraged by some big corporate hospitals,during the critical procedures of implanting coronary stents and knee joints replacement whixh is know becoming much more affordable,due to price restrictions kept by NPPA and union government.This is helped poor patients in availing quality treatment at affordable prices from big corporate hospitals.

The recent longstanding debate,which had strongly opposed sub categorization with in stents,is more deliberated,decision of NPPA in order to review the justification of differntiaal price component in stents.This is infact more rationalised approach to verify the various aspects and features of stents manufactured by multinationals, who claims of incremental innovation and special categories,due to so called superiority for leveraging high price on stents.If the clinical benefits does not differentiate Indian stents and MNC's stents t
 
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