NPPA wants govt to consider new category of premium stents
NEW DELHI: The national drug price regulator, which slashed the price of cardiac stents by up to 80% nearly a year ago, has asked the heath ministry to consider creating a new category of highend stents. The demand for such a category originated from the stent-makers themselves, who withdrew their top-end stents after the price cut. Firms hope such a category will help them launch new premium stents.
In a January 9 letter, the National Pharmaceutical Pricing Authority (NPPA) chairman Bhupendra Singh asked Union health secretary Preeti Sudan to call an urgent meeting of the cardiacs tent score committee for the National List of Essential Medicines (NLEM) to“re-consider” the issue and review if all drug-eluting stents (DES) are equal, or if a new category is required. Mint has seen a copy of the letter.
“NP PA received several representations from th es tent importers (MNCs) urging the need for a new sub-category of st en ts within DES to include ‘new generation’ st en ts with added features. In this context, I would request you that ministry of health and family welfare may like to convene an urgent meeting of NLEM core committee on cardiac stents to re-consider the issue and if necessary, whether all DES stents in the market are equal or there is a need for adding a sub category under DES to take care of new generations of stents.”
Following the recommendations of the core committee, the health ministry on July 19, 2016 included coronary stents in N LE M. Th es tents were classified into two categories: Bare Metal stents (BMS) and Drug Eluting Stents (DES). According to the core committee, it did not find it necessary to create a separate category for certain categories of stents as it found that there was no “scientific and statistically, proven data to validate the therapeutic superiority of these stents”. On December 21, 2016, stents were included under Schedule 1 drugs. Subsequently, the NP PA capped prices of st en ts on February 13, 2017 which is valid for one year.
In its letter, the NPPA asked the health ministry to communicate its decision by January 31, following which the authority will revisit the issue. Last year’s price cap is valid for one year ending February 13, meaning NP PA has to settle price revision discussions before February 2018.
In November, following representations from multinational st en t-makers, NP PA sought their views. In November, US-based Abbott Laboratories said it would not introduce its latest stent Xi en ce Sierra in India. In September, it had received permission to withdraw its premium Xience Alpine metallic stents as well as its dissolving stents.
“To preserve access of Indian patients and doctors, it will be ideal if they made a superior category either out of price control, or covered by margin rationalisation, or at the very least a higher price point,” said Probir Das, chairman ofFi cc i’ s medical devices forum and the Healthcare Federation of India’s Medical Technology Forum.
“We agree that any stent produced with a claimed superior technology backed by clinical evidence of proven superiority would be worthy of differential pricing,” said Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry.