Firms did not present adequate clinical evidence of superiority in terms of safety and benefit of their stents over currently available DES (drug eluting stents), the panel said in a report
New Delhi: Global stent makers’ attempt to skirt price caps in India by introducing advanced stents in a new category has failed, with a government committee deciding against creating such a category.
A year ago, the government capped the price of stents, a mesh tube placed in arteries to improve blood flow, forcing manufacturers to cut prices by up to 85%. Since then, many global stent makers withdrew their high-end devices from India, and have been pressing to create a new category of stents with advanced features.
An eight-member government sub-committee of experts 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 (drug eluting stents)," it said in a report. Mint has reviewed the report.
“The sub-committee noted that though the companies have claimed that their newer generation stents have incremental innovations in technology in terms of design, polymer coating and drug, they could not produce enough data for superiority in terms of safety and efficacy. The superiority in terms of safety and benefits of a newer stent of a company over the other currently available DES has not yet established through adequate clinical data. Hence, for the purpose of NLEM, (National List of Essential Medicines) the subcommittee reiterated its earlier categorization of coronary stents as bare metal stents (BMS) and DES," the report said.
Following last year’s price cap recommended by India’s drug pricing watchdog—National Pharmaceuticals Pricing Authority (NPPA), maximum retail price of bare metal stents and drug eluting stents fell from Rs45,000 and Rs1.21 lakh to Rs7,623 and Rs31,080, respectively.
The sub-committee took up the matter after NPPA apprised the health ministry of representations it received from companies to include ‘new generation’ of stents with added features as a category within the DES category.
Among stent makers and importers who made representations before the committee on 25 January are Boston Scientific India Pvt. Ltd, Abbott Healthcare Pvt. Ltd, India Medtronic Pvt. Ltd, Meril Life Sciences Pvt. Ltd. The companies said with a new category, quality and innovation would be rewarded and the segment kept viable.
Last year’s price cap is valid till 13 February, meaning NPPA has to settle price revision discussions before that date. Discussions started last Tuesday with NPPA meeting eminent cardiologists, who said the price cap has resulted in more angioplasties and fewer bypass surgeries. The NPPA will also meet various stakeholders on 5 February.
“While we are aligned with the government’s intent for broader access to healthcare, we’re disappointed that differences among stent generations have not been recognized, which could restrict future investment and innovation that benefits patients. Abbott will continue to participate in discussions with the government to find solutions, so that accessibility and innovation can co-exist," an Abbott spokesperson said.
“Access to healthcare innovation extends well beyond affordability and pricing, and will require many people working together toward policy changes that address the entire landscape to support physicians and their patients," the spokesperson added.
Emails sent to Boston Scientific and Medtronic India remained unanswered until press time.
Probir Das, chairman of FICCI Medical Devices Forum, said the price cap would limit patients’ choice.
“The industry seeks that Medtech innovation be recognised through an ‘innovation category’ in stents, one that is not based on just a claim, but validated through a matrix that balances global benchmarks, clinical — scientific features and patient benefits, especially for complex cases," Das said.
In its submission before the sub-committee, Abbott said its Xience DES stent has an innovative delivery system. India Medtronic Pvt. Ltd said its new generation Onyx DES stent is superior based on platform and delivery system.
The committee had sought claims and suggestions from the companies to “re-consider" the issue and review if all DES are equal, or if a new category is required. However, it didn’t find adequate data to establish the superiority of newer stents in terms of safety and benefits in support of further categorization of DES.
The committee had earlier said that various incremental innovations in technology of the coronary stents may be considered for sub categorization if enough data and evidence are produced in terms of safety and benefits.
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