Mumbai: Abbott Healthcare Pvt. Ltd and Medtronic India Pvt. Ltd are likely to refile their applications with the National Pharmaceutical Pricing Authority (NPPA) to withdraw certain high-end coronary stents from the Indian market which they claim have become commercially unviable after government slashed prices by up to 85% in February.
In February, the NPPA capped the price of bare metal stents at Rs7,260 and that of all drug-eluting stents at Rs29,600. In April, the regulator said price of stents can be increased by around 2% after taking into account the wholesale price index.
Last week, Abbott had sought permission to withdraw its Alpine drug-eluting stent and Absorb dissolving stent, while Medtronic had sought to withdraw its Onyx Zotarolimus eluting stents but the NPPA rejected both the applications.
“The NPPA has concluded that all generations of drug-eluting stents are the same and on that basis, we had submitted withdrawal applications for Alpine and Absorb because they are no longer commercially viable for us in India. We have committed to maintaining supplies of Alpine and Absorb until the government advises us to do so, as part of the application review process. We continue to engage with relevant stakeholders on the right time to file the requisite applications, per due process,” an Abbott spokesperson said.
“Medtronic’s application for the withdrawal of Resolute Onyx was not accepted by the NPPA on the basis of incomplete paperwork. We intend to resubmit the application, and until it is re-submitted and approved we will continue to supply the Resolute Onyx stent in India. All decisions to withdraw or introduce products to the market are made only after taking into consideration all guidelines and norms set by the government and applicable legal and regulatory requirements,” Medtronic said in an email statement.
On 21 February, the government had invoked an emergency clause under the Drug Price Control Order, citing public interest, and asked stent makers to maintain supplies of their products for six months. In a notification on Wednesday, the NPPA said during this period no such request from the companies to withdraw their products could be entertained.
In a press conference here on Thursday, NPPA chairman Bhupendra Singh eased concerns over any shortages saying that all stents which were there in the Indian market before the price cap are there in the market even now.
While rejecting pleas of Abbott and Medtronic for withdrawing high-end stents from the market, the NPPA has provided an escape clause that the companies can seek regulatory approval to revise prices as per the provisions of the Drug Price Control Order if they can prove superiority of these stents over others.
Another major multinational stent maker Boston Scientific has already filed an application with NPPA to let it sell some stents in India at “special prices” higher than the mandated ceiling prices.
Singh said, “This application is being examined in consultation with the health ministry with an open mind.”
However, proving the superiority of these high-end stents over others is a challenging task for the companies.
“The differences in the new generations of stents are difficult to explain as these improvements were not in the ambit of the non-inferiority trials, which are commonplace in medical device approvals. Superiority trials are relatively difficult to do and need a lot more trial data, as also time,” said Shirish Hiremath, president of the Cardiologist Society of India.
“Having said that, deliverability, trackability, strut thickness and design, flexibility, dissolution and disappearance of a stent over a period of time are all scientific, clinically objective ways in which a new stent can be differentiated from the older generations. These factors affect a physician’s performance in the cath-lab and the well-being of a patient,” he said.
Meanwhile, NPPA has maintained its stance that there is not much difference in latest and older generation of stents.
“The issue of generation of stents was debated for 7 months (before the price cap) by 18 eminent cardiologists in the country and they finally reached a conclusion that all the drug-eluting stents available in the country at that time and also as of now is same. This verdict of expert cardiologists was incorporated in the drugs price control order. NPPA, legally and otherwise, also had no option but to put all the DES (drug-eluting stents) together,” Singh said.
“The issues that companies are raising now were the same issues they were raising before the price capping and they also knew that once the prices are fixed they have the window to seek price revision based on certain conditions. So that window is still open. There is a legal provision under which there is a method of examining a case and we will do it on case to case basis if it comes to us,” he said.