NPPA signals rethink on price caps for stents

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New Delhi: Nine months after its order capping cardiovascular stent prices prompted companies to withdraw products and sparked interventions by the US government, India’s drug price regulator has written to stent makers for their views on pricing, indicating a rethink on the issue.

In February, the National Pharmaceuticals Pricing Authority (NPPA) cut average stent prices by as much as 80% and set price caps for all drug-eluting stents and bio-resorbable vascular scaffolds. The order was valid for a year, meaning NPPA has to settle price revision discussions before February 2018.

In a memorandum dated 9 November, NPPA asked domestic and foreign stent makers to submit their suggestions and representations on stent pricing by 31 December. The authority said on its website on Friday that it has already received some representations regarding pricing and other related issues.

Earlier this month, US-based Abbott Laboratories said it would not introduce its latest stent Xience Sierra in India. In September, it had received permission to withdraw its premium Xience Alpine metallic stents as well as its dissolving stents. Boston Scientific Corp. is also considering withdrawing its high-end stents, Mint reported on 20 September.

The stent price cap was also discussed at the 26 October US India Trade Policy Forum in Washington DC.

In September, US trade representative (USTR) Robert E. Lighthizer wrote to commerce minister Suresh Prabhu and the prime minister’s principal secretary Nripendra Misra that the policy had created serious problems for US stent makers in India. He also urged India not to extend caps to other devices. The matter had also been discussed during Prime Minister Narendra Modi’s visit to Washington in June.

Earlier in September, American medical device makers had asked the USTR to suspend or withdraw India’s benefits under the Generalized System of Preferences (GSP) to counter India’s decision to fix retail prices of various medical devices. Under the GSP, Indian exports to the US enjoy lower import tariffs compared to those imposed on non-GSP exporters.

“Any initiative from NPPA to resolve the issues on stent pricing that addresses the differentiation between generations of stents, and factors in the appropriate and genuine needs of a consignment-based supply chain, will go a long way to both drive Indian patients’ access to latest technology and long-term survival of medtech in India. These will be very welcome by the industry and the industry stands committed to work with the government through the process,” said Probir Das, chairman of industry lobby Ficci’s Medical Devices Forum and the Healthcare Federation of India’s Medical Technology Forum.

Malini Aisola, an activist of the All India Drugs Action Network (AIDAN), said NPPA should not succumb to pressure from the imported device industry.

“Any price revisions should take into account the state of competition in the market and placing access as paramount. A downward revision may be warranted where there is data showing the stents are being sold at much lower prices in developed country markets,” said Aisola. “Demands from foreign companies for price differentiation and unsupported by clinical evidence should not be entertained.”

Rajiv Nath, forum coordinator of the Association of Indian medical devices industry, said he appreciated NPPA being “proactively communicative” on the issue.

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