Even as National Pharmaceutical Pricing Authority (NPPA) has sent notices to medical device companies for submission of pricing data on cardiac stents, manufacturers suggest that NPPA should come out with a pricing regime that is based on performance and features associated with the cardiac stents after evaluating the data sought from the concerned companies.
Based on the meetings with the drug regulator recently, some manufacturers have also shared sentiments that pricing data sought on cardiac stents will help NPPA to frame a pricing mechanism for its better regulation and monitoring in the larger interest of the patients and industry.
In the wake of the issue of overpricing of cardiac stents, the government is considering to evaluate the pricing data to define medical devices separately from drugs and regulate their prices with a different mechanism. Expressing concern over suppliers of various pharmaceutical products raising prices manifold, the drug regulator's assessment, however, have shown that the prices multiply by four to five times by the time it reaches the patients.
A Maharashtra Food and Drug Administration (FDA) report to the government has also revealed that drug eluting stents (DES) in one such case was imported at Rs.40,710 and sold to distributor at Rs.73,440, while the company listed MRP was Rs.1.5 lakh, a mark-up of over 250 per cent. According to industry sources, It has been observed that the distributor or wholesaler charges hospitals generally a mark-up of 15 per cent to 20 per cent on the device, which is then sold by hospitals to patients at a price which may be nearly double or triple at which it was imported.
Manufacturers are optimistic that now with NPPA evaluating these details, the pricing structure will become transparent. The government should also look at ways to regulate the hospitals which seem to be over charging patients. Since prices of these devices are not controlled by the government, the annual increase allowed to them is 10 per cent. But there is not enough information available on what the increases have been year-on-year.
Director General of Central Government Health Scheme recently negotiated prices of certain drug eluting stents (DES) at 75 per cent discount. "This shows how the maximum retail price is substantially hiked," NPPA Chairman Injeti Srinivas points out.
As DES fall under the category of cardiac stents. NPPA has sought data on 22 categories of which cardiac stent is one category. Industry sources inform that this may take some time as pricing of cardiac stents might be evaluated first in the current scheme of things followed with other devices.
According to a manufacturer, three lakh drug eluting stents (DES) were being sold in India in the year 2014 of which one lakh DES were being sold as a part of government healthcare schemes. DES was launched in India in 2006 and has evolved as a technology to give better patient health outcomes in terms of clearing heart blockages as compared to bare metal stents. The MRP of a DES ranges anywhere between Rs.75,000 to Rs.2 Lakh+ while bare metal stent costs two to three times less or more if delivered through government healthcare schemes.
Asking medical device companies to submit prices at which they import and sell the devices to distributors, and also their maximum retail prices in Form V is based on the premise that patients are charged almost three to four times of the landed cost (price at which these are imported) in terms of certain devices.
In a communication dated February 9 this year, drug pricing regulator NPPA first directed all medical device companies including Abbott, Johnson and Johnson and Medtronic to submit pricing data . This was immediately followed up by a show-cause issued on February 16 to those in the industry who had not submitted these details. Sources said the government is keen to monitor prices of cardiac stents in order to prevent patients from being over-charged.