Against the backdrop of National Pharmaceutical Pricing Authority (NPPA) seeking pricing details from medical device companies, official sources inform that the pricing regulator is keen on evaluating the pricing of cardiac stents and drug eluting stents (DES) on a priority basis followed by other 20 medical device categories.
Drug pricing regulator NPPA has directed all medical device companies including Abbott, Johnson and Johnson, Medtronic, Edward Lifesciences and Boston Scientific to submit pricing data on cardiac stents for effective monitoring of prices. Official sources said the government is keen to monitor prices of cardiac stents in order to prevent patients from being over-charged.
In a recent communication, drug pricing regulator NPPA directed medical device companies to submit pricing data on cardiac stents followed by a show-cause notice who had not submitted these details. A meeting to this effect was held recently with the manufacturers. Based on the meetings with the drug regulator a manufacturer said that a uniform pricing policy on cardiac stents and DES is required 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 also 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.
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. They advocate that 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.
Around three lakh drug eluting stents 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. As per conservative estimates, the MRP of a DES ranges anywhere between Rs.75,000 and Rs.2 lakh+ while bare metal stent costs two to three times less or even more lesser 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.
NPPA has sought data on 22 categories of which cardiac stent and DES are other two categories. Other categories include disposable hypodermic syringes, disposable hypodermic needles, disposable perfusion sets, in -vitro diagnostic devices for HIV, HBsAg and HCV, catheters, intra ocular lenses, IV cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants, internal prosthetic implants, blood grouping sera, ligatures, sutures and staplers, intra-uterine devices, condoms, tubal rings, surgical dressings, umbilical tapes, blood/blood component bags.