The National Pharmaceutical Pricing Authority (NPPA), on Monday, brought down the prices of cardiac stents by about Rs 2,000 – the price of drug eluting stents has now been capped at Rs 27,890. Bare metal stents have been capped at Rs 7,600.
The revised prices will be considered from February 13 and will be in effect till March 31, 2019, when it will be reviewed once again. The existing trade margin of 8% for hospitals and distributors remains unaltered, according to the new announcement.
The NPPA has also warned stern action against anyone billing stents to the patients higher than the capped prices. “Trade margin in excess of 8% specified above, in whatsoever form, shall be construed as 'violation' by the person/institutions/manufacturers/importers/distributors/hospitals involved in the transactions, jointly and severally, and shall be liable to appropriate action including prosecution, for violation of the provisions of the DPCO, 2013 under the Essential Commodities Act, 1955,” the notification reads.
The authority has mandated that essential accessories used during stenting procedure also be billed individually so as to ensure more transparency. “Since cardiac catheters are necessarily used during angioplasties and are integrated part of the angioplasty package by healthcare institutions which are performing angioplasty and billing the patients shall also mention cost of cardiac catheters, balloon catheter and guide wire separately along with their respective brand name, if any, name of the company, batch number and specifications in order to bring in greater transparency in the billing and monitoring of compliance with the MRPs by the NPPA under Para 20 of DPCO, 2013,” reads the notification.
President of the Heartcare Foundation of India, DR KK Aggarwal said, “It’s good that the government did not succumb to international pressure. The prices have been capped and nothing has been moved out of the National List of Essential Medicines. The price of accessories, like catheters and balloons, will need to be displayed separately on the bill with their brand names. Patients will have the option of buying the stent and accessories from outside the establishment.”
Meanwhile, NPPA also ruled out the possibility of having sub categories under drug eluting cardiac stents for price capping as was sought after by the manufacturers and medical representatives. The NPPA maintained its stand that there was little evidence to show that one drug eluting stent was better than another and, hence, denied any further classification.
The NPPA, at present has stents capped under two categories – bare metal stents (the low-end ones) and drug eluting stents (high-end ones).
Manufacturers and dealers had expressed that by having just two categories there would be little room for them to import high-end stents.
They had also expressed their reservations that other countries may not supply stents that emerge from the latest studies to India due to the price cap.
Manufacturers have expressed their dissatisfaction over the decision.
“AdvaMed and its members are deeply disappointed with the NPPA’s notification on the ceiling price for coronary stents. This notification disregards stakeholder representations and goes against patient interest by failing to reward innovative technologies, thereby limiting patient choice for current and future medical device innovations.
“A recent study by IQVIA, commissioned by AdvaMed, clearly shows that price controls have not led to lower procedure costs – where patients need relief the most. Furthermore, patients have not gained greater access as indicated by the fact that angioplasty treatments have not increased in any meaningful way as a result of this policy. To achieve real, on-the-ground impact, we hoped that the government would consider alternate approaches such as Trade Margin Rationalization and differential pricing that have the dual effect of benefiting patients while preserving the environment for innovation and investment in India,” they said in a statement.