It’s ironic that at the same time India is separating out medical device regulations from pharmaceutical regulations for the first time, it will now place coronary stents on its national drug list.
The move will mean the stents will likely also fall under price controls.
After numerous meetings with stent manufacturers, cardiologists and NGOs, a government committee created in 2011 concluded that the stents are essential, and thus should appear on the National List of Essential Medicines.
The decision to put the stents on the national list was not made lightly.
Experts overwhelmingly concurred that coronary stents are reliant on constant research and development, and as such, the move to place them under price controls should be carefully considered.
Committee members also questioned whether the quality of domestic stents could be reasonably assured. It also considered the prevalence of cardiovascular disease in the country and the percentage of patients receiving coronary stents. In making its decision, the committee considered evidence for efficacy among different types of coronary stents.
Experts stressed that a proper infrastructure needed to be in place for stents, such as a catheter lab and interventional cardiologists, and more investment would be required for manufacturing, distribution, follow up and training. Overwhelmingly, they agreed that the same regulatory approach given for drugs was not appropriate for the devices.
However, at the time the committee was considering the move, devices were regulated as drugs. Since that time, the government released a new framework that will see devices regulated separately. It remains to be seen if devices would have a separate essential list in the country ().
The committee reported that in India, the coronary stent itself represents roughly 25 percent to 40 percent of the total cost of percutaneous interventions and implantations. It stressed that patients would not benefit unless the cost of the procedure is also reduced.
Accessability and affordability remains a key concern, with patients paying out of pocket for roughly 41.38 percent of the stent procedures. The government picks up 42.8 percent, and private insurance only accounts for 17.75 percent of the cost.
Cardiovascular disease is the leading cause of morbidity and mortality in India and accounts for one-fourth of deaths.
In 2015, roughly 473,000 coronary stents were implanted in patients, and 95 percent of those were drug-eluting stents.
The committee concluded that drug-eluting stents have better efficacy, safety and performance compared to bare metal stents. “However, there is no definite superiority among currently available metallic drug-eluting stents in terms of their clinical outcomes of mortality and myocardial infarction,” the report said.
It recommended that authorities differentiate between bare metal stents and drug eluting stents on the NLEM for pricing purposes. Drug-eluting stents should be classified according to the “quality of traits,” the committee said.
To read the committee report, visit: www.fdanews.com/07-21-16-Indiastents.pdf. — Tamra Sami