New Delhi: Multinational stent makers pressed for differential pricing of advanced coronary stents before the national drug pricing watchdog on Monday, after a government panel rejected the demand last week.
Last year’s price control on stents—mesh tubes placed in arteries to improve blood flow —led to a price cut of up to 85% and prompted many multinational companies to withdraw their premium products from India. They have since pushed for creating a new category of high-end stents, which can be kept out of price control.
On Monday, Mint reported the sub-committee’s rejection of the proposal.The National Pharmaceuticals Pricing Authority (NPPA) met representatives of MNCs, along with other industry stakeholders on Monday.
“Innovative medical device companies are driven by research and quality. Therefore, in the interest of preserving the environment for innovation and ensuring that the patients in India have access to high-quality stent technologies, we continue to urge the government to consider differential pricing for Drug Eluting Stents (DES)," the Advanced Medical Technology Association (AdvaMed), an international lobby group representing medical device companies said in a press release.
AdvaMed has suggested considering alternatives to price control such as trade margin rationalization and more scientific approaches that facilitate differential pricing for innovative medical technologies.
Probir Das, chairman of industry lobby Ficci’s Medical Devices Forum and the Healthcare Federation of India’s Medical Technology Forum called the sub-committee’s decision “disappointing", adding, “Given the current committee is too invested in their previous decision against stent categorisation, their latest decision is not surprising." The industry wants the expert committee reconstituted to include private sector specialists, Das added.
NPPA has to settle price revision discussions before 13 February. Discussions started last Tuesday with NPPA meeting cardiologists.
Before it reaches a conclusion, NPPA will meet stakeholders again on 8 February. “After day-long hearing of the views of all the stakeholders, Authority to meet again on Feb 8, as an extended meeting, to deliberate on new stent prices with the concerns of all on board," NPPA tweeted late on Monday.
In its report, the eight-member sub-committee that met on 25 January and considered stent makers’ arguments said there were “no grounds" to create a new category. The companies did not “present adequate clinical evidence of superiority in terms of safety and benefit of their stents over currently available DES," it said in a report.
Indian stent makers, meanwhile, continue to oppose differential pricing. “The risk management and product specifications and similarly regulations for consumer protection are based on sound principles which will understandably not keep it differential unless the specifications are linked to cleared clinical differentiation," said Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMed).
Ganesh Sabat, president of Indian Stent Manufacturing Association and CEO, Sahajanand Medical Technologies Pvt. Ltd said the market has grown for both Indian and global stent makers. “The market still remains attractive. We stand by no-categorisation right now because there is no data that indicate or prove that high-end stents are to be treated differently and should be priced better."
Malini Aisola of All India Drugs Association Network recommended further reduction in stent prices, saying more regulation is needed to relieve patients of overcharging in medical devices and procedures. “Our view is that there is potential for a downward price revision of stents. We support innovation that is backed by scientific evidence of superiority".