Govt Likely To Review Differential Pricing With MNC Stent Makers

New Delhi, 1 Aug 2019: 

Multinational stent makers will meet government officials later this month in a renewed push for differential pricing, two people aware of the matter said, a demand that was rejected a year and a half ago.
 
In September 2017, the government had slashed prices of cardiac stents by up to 80%. MNC stent makers soon pulled out their products from India, and their request to create a separate category of drug-eluting stents (DES) with superior features outside price control did not find favour with the government.
 
Balram Bhargava, chairman of the committee on essential medicines, will separately meet local as well as MNC stent makers, the people cited above said to “re-consider" the issue and review if all DES were equal, or if a new category is required. Manufacturers hope a new category outside price control will help them launch premium stents.
 
Government has invited the stent makers to represent their case.
 
“Multinational stent makers have been asking to represent their cases once again, which will be further reviewed by a panel of experts including cardiologists. The committee has invited the stent makers to represent their case," said the first person, requesting anonymity.
 
MNC stent makers, such as Boston Scientific Corp., Medtronic, Abbott Laboratories and Translumina, used to sell premium stents in India. Vapi-based Indian stent maker Meril Life Sciences Pvt. Ltd also makes advanced stents.
 
According to the people cited above, the National Pharmaceutical Pricing Authority (NPPA) has received several representations from MNC stent makers who sought a new sub-category of stents within DES to include ‘new generation’ stents with added features.
 
In January 2018, the then NPPA chairman Bhupendra Singh had asked Union health secretary Preeti Sudan to call an urgent meeting of the cardiac stents core committee to reconsider and review the issue. However, a government committee decided against creating such a category in February 2018.
 
In its report, the committee said the companies did not “present adequate clinical evidence of superiority in terms of safety and benefit of their stents over currently available DES".
 
According to the people quoted above, the companies have now communicated that they have sufficient data to show the superiority of their products, which they want to share with the core committee.
 
Meril Life Sciences has held back the launch of its locally-made biodegradable cardiac scaffold (naturally dissolving stents). The company is likely to meet the committee on 7 August to share additional data on their stents. “Likewise, other companies like Boston Scientific Corp. and Medtronic India Pvt. Ltd will also represent their case," said the second person, also requesting anonymity.
 
In November 2017, two months after the price cap was announced, US-based Abbott Laboratories had said that it would not introduce its latest stent, Xience Sierra, in India. It had also received permission to withdraw its premium, Xience Alpine, metallic stents, as well as its dissolving stents. Boston Scientific also withdrew its high-end Synergy stents from the market.
 
Nishith Chandra, director and interventional cardiologist, Fortis Escorts Heart Institute, said a separate category for stents must be created. “In the absence of latest technology and devices in India, international patients have the choice to go to other destinations like Singapore or Thailand, where there is no such price capping. One possible solution for the government is to introduce differential pricing. One lower price category for normal products and higher price for latest state-of-the-art technology products. Alternatively, instead of blanket capping of price of a particular product, they should cap the profit percentage, over the landing cost. That way, a company has incentive to introduce newer technologies," he added.
 
Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AiMeD) said the subject needs a careful evaluation. “While the NPPA and IMA have always maintained that differential pricing can be considered for innovation in medical devices on proven clinical superiority, no such claim has been settled till date. AiMeD welcomes innovation in products that can enhance patient safety and longevity. It will be prudent to not disturb the capped prices for stents at this early stage when the market is still stabilising, consumers are getting access to more affordable cardiac care via reasonably priced stents. We hope that while evaluating marketing claims of superiority by overseas manufacturers, the committee does take into account what’s critically beneficial to patient and not superficial claims by the companies."
 
“The technology of merils stent requires close scrutiny. Given the higher risk associated with a similar stent by Abbott that was globally withdrawn, there ought to been stringent evaluation of its performance prior to marketing approval and close monitoring since. To our knowledge, we do not believe Meril has data to support greater clinical benefits over existing stents. On the other hand, data for its risk profile should be sought by the regulator," said Malini Aisola of non-government organisation All India Drugs Action Network (AIDAN). Livemint