In a move that may pave way for differential pricing of cardiac stents, a medical device under price cap, the country's drug and medical devices pricing regulator allowed to exempt Gujarat-based Meril Lifesciences' bioresorbable stent from price control. The company had been seeking differential pricing for its stents on the grounds that it met specific unmet clinical needs and was distinct from the rest of the cardiac stents available in the market.
The National Pharmaceutical Pricing Authority (NPPA) invoked the para 32 (ii) of the Drug Price Control Order, 2013 to grant the exemption to the indigenously developed stent. Experts felt that this may pave the way for other companies including multinationals to seek differential pricing for their products that are under price control by citing innovation in the product.
Meril's application was long pending and has been reviewed by several multi-disciplinary committees in the recent years. Meril's MeRes 100 is a bioabsorbable cardiac stent that dissolves in the blood vessel after its work is done. This is different from the other coronary stents available in the market and currently under price cap that are bare metal stents, drug eluting stents. The Bioresorbable Vascular Scaffold (BVS) or simply put biodegradable stents are currently also under price control.
Stent prices are capped at around Rs 30,000 or so for a single device.
Patient advocacy group AIDAN said, “We do not know the basis for the experts to be satisfied by the (safety & efficacy) data of the stent. It has been our concern that the only data submitted by Meril are limited to a small, non-randomised, single-arm trial which was inadequate to prove safety. While close monitoring has been recommended, we are concerned that no specific plan has been drawn up for post-marketing evaluation of safety and efficacy, against the current standard of care - a DES stent, as far as we are aware."
AIDAN has also challenged the exemption provisions of the DPCO 2013 in the Delhi High Court.