On March 28, the Department of Industrial Policy and Promotion (DIPP) had informed the Prime Minister’s Office (PMO) that “price control of cardiac stents has led to cheaper Chinese stents entering the Indian market”. Thereafter, PMO asked the health ministry’s expert panel to examine if stents with ‘futuristic innovations’, such as biodegradable ones, can be excluded from the “current two categories of stents” that were under price cap. However, the panel, which met on June 29, found “no evidence or data” for such exclusion. Consequently, multinational medical device companies have now started requesting the pricing regulator to let them withdraw their latest-generation stents from India.
On February 13, the National Pharmaceutical Pricing Authority (NPPA) capped the prices of coronary stents. The ceiling price of bare metal stents (BMS) has been fixed at Rs 7,400 per piece and that of drug eluting stents (DES) and biodegradable stents has been fixed at Rs 30,180 apiece. The NPPA did not put a separate price cap for biodegradable stents as requested by multinational companies such as India Medtronic, Abbott Healthcare and Boston Scientific India.
The PMO meeting, which was called on March 28 to review pharma issues, was chaired by Nripendra Misra, principal secretary to PM, and attended by senior officials of the government, including Ramesh Abhishek, secretary, DIPP. Abhishek gave a presentation wherein he stated that the “price control of cardiac stents has led to cheaper Chinese stents entering the Indian market” and this may “adversely affect efficacy of treatment in India”. He also said that prices have been fixed “on certain medical devices without taking into account the quality, complexity or technological advancement of such devices”.
He added: “(The) NPPA’s contention that higher price may be provided if the applicant can prove clinically that the innovative product (like bio-resorbable stents) is ‘superior over the rest DES’, may be examined by leading cardiologists.” According to the minutes of this meeting, the PMO directed the ministry that “the issue of excluding futuristic innovations from the current two categories of stents under price control may be examined by the existing committee of experts under the Ministry of Health and Family Welfare”.
The expert sub-committee was formed by the Union health ministry on October 15, 2015, to “deliberate on the essentiality of coronary stents”. After the PMO’s direction, the ministry asked the Central Drugs Standard Control Organisation (CDSCO) for comments, as the sub-committee was working under the latter.
The CDSCO replied to the ministry: “The issue was last deliberated by the sub-committee in its meeting held on June 29, 2017. However, the sub-committee has opined that no information/evidence/data has been generated which changes the opinion and, therefore, the sub-committee reiterated its earlier recommendation and did not agree to exclude bioabsorbable vascular scaffold/biodegradable stents from the two categories of stents currently under price control.”
Consequently, companies such as Boston Scientific India and Abbott Healthcare have requested the NPPA to let them withdraw their latest-generation stents, which include biodegradable stents, from the Indian market. Multinational companies have a share of more than 50 per cent in India’s stent market, according to industry sources. Boston Scientific India has put in the request with the NPPA to withdraw two of its latest stents: Promus Premier Everolimus Eluting Coronary Stent and Synergy Monorail Everolimus Eluting PtCr Coronary Stent System with Biodegradable Polymer.
The NPPA considered Boston Scientific India’s request on September 19. The minutes of meeting state: “The Authority deliberated and decided that the NPPA, in any case, shall revisit the pricing of cardiac stents before February 13, 2018. It further noted that the company has submitted two applications: one for withdrawal and the other for price revision; both cannot be considered simultaneously. The company may be directed to forward one request by withdrawing the other request and till then, both the requests may be kept in abeyance.” The company did not respond to the queries sent by The Indian Express about its plans to withdraw any of the two applications.
On September 8, 2017, Abbott Healthcare requested the NPPA to let it withdraw Absorb and Absorb GT1 brands of Bioresorbable Vascular Scaffold (BVS) stents from the Indian market. On September 19, this request of Abbott was accepted. On September 25, the NPPA stated: “The Authority took note of the company’s (Abbott’s) assertion that it is stopping the manufacturing and global withdrawal of these brands based on low commercial uptake. This was being reflected in sale figures of these brands in India.” However, the pricing regulator took a “more specific note” of the issue of “global safety concerns” of “enhanced adverse cardiac activity including increased level of thrombosis” due to these BVS stents, which have been raised by the medical device regulators of the US, the European Union, Australia as well as India.
Abbott Healthcare had also put in its request to withdraw Xience Alpine stents, which the NPPA accepted on September 19. However, as Xience Alpine stents “have a sizeable market share and its withdrawal will create sudden shortage of stents which will not be in the interest of public health safety”, the NPPA asked the company to withdraw it over a period of one year in a staggered manner.
Abbott Healthcare issued a statement on September 25: “While we are aligned with the government’s intent for broad access to healthcare, we’re disappointed that advancements among stent generations have not been recognized, which could restrict future investments and innovations that benefit patients. The NPPA has accepted our application to withdraw our latest drug eluting stent technology Alpine.The ceiling price that has been set unfortunately makes it an unsustainable business to continue to provide Alpine, given our cost of manufacture and other associated costs. We support patient access and will continue to make our Xience stents available, which are the gold standard and account for the vast majority of Abbott stents used every year in India.” Abbott Healthcare did not respond to the queries of The Indian Express.
The company had filed two applications on April 21 to withdraw Absorb and Absorb GT1 brands of BVS stents and Xience Alpine stents, respectively.
On April 3, India Medtronic had filed the application to withdraw “Resolute Onyx Zotarolimus Eluting Coronary Stent System”. Both the companies filed their applications — under Para 21(2) of the DPCO, 2013 — on the ground of “commercial unviability post fixation of ceiling price”. Both the companies’ applications were denied by the NPPA because the “statutory Form IV” attached with their request letters were not “duly signed”.
When The Indian Express asked India Medtronic if it has approached the NPPA again to withdraw stents from the Indian market, the company’s spokesperson stated: “We are in constant contact with NPPA and other relevant departments. We have not revisited our withdrawal request for our latest generation stent, Resolute Onyx, since then.”
The domestic stent firms have stated that they have been gaining market share after the price cap. Rajiv Nath, forum coordinator of the Association of Indian Medical Device Industry (AIMED), which represents domestic manufacturers, said: “All Indian companies have seen growth… Some have reported growth by 40-50 per cent, some by 25 per cent post price cap. Maximum growth in tier 2 and tier 3 (cities). Without price cap, growth would have been maximum 10-15 per cent. We expect market share of Indian stents to cross 50 per cent this year and achieve 60 per cent by next year.”
On being asked if any of the AIMED member-companies are importing stents from China, Nath said: “None that I am aware of”.