Bioresorbable stents have effectively been pulled from the European market by Abbott and will now be available only in “clinical registry setting at select sites/institutions” in Europe, where they will be monitored till a review in 2018. India has been among the largest markets for these stents in recent years. The development comes in the wake of several studies showing that bioresorbable cardiac stents are not only not superior to existing drug eluting stents (DES), but might even have worse outcomes in some ways. No further BVS (bioresorbable vascular scaffolding) stents will be provided to non-registry sites after 31st march 2017 and these sites have been instructed to cease implants and existing inventory will be removed,” stated an advisory from Abbott, which is “working jointly with the European Regulatory Agencies” to address concerns of increased risk of stent thrombosis and longer duration of use of blood thinners for those implanted with BVS compared to those with DES. These were the risks the studies had highlighted.
This is a new addition to the whole stent controversy which is doing rounds in the healthcare industry since quite a while now. In February 2017, the National Pharmaceuticals Pricing Authority (NPPA) capped prices of stents according to quality: bare metal stents to cost no more than ₹ 7,260, while drug eluting stents and biodegradable stents were capped at ₹ 29,600. The ceiling prices came into effect immediately and were also applicable to all stocks in the trade channel. The government also stipulated that a manufacturer intending to stop production will have to inform the NPPA at least six months in advance.
While many cardiologists thought of this move to be good, it certainly needed more thought. The move sparked panic in the city’s medical circles. The problem being the doctors have no alternative now because Abbott is the only supplier of bioresorbable stents in India. Over 8000 bioresorbable stents are used in India annually, over a thousand of them in Mumbai alone. The decision to use a particular stent involves the life and death of the patient on the angiography table. According to industry officials, four or five types of drug eluting stents are available in the market that are priced based on the innovation and technology. Advanced stents are more expensive than the base products. By no means can we underplay the fact that certain blockages call for good deliverability of the stents and therein the use of appropriate stents. Labeling them all into one category will kill the scope for further newer innovations.
After the government’s decision to slash prices and enforce a single ceiling price for all the different variants of drug-eluting stents, manufactures and distributors started pulling off the high-end stents across the country. This is because manufacturers who took back their stock for re-labeling of prices did not return them. Doctors said the shortage inconvenienced a small group of patients with complex blockages in the artery. Scores of angioplasties in Mumbai were put on hold after Abbott Pharma withdrew bioresorbable stents from all hospitals, claiming it could not afford to sell the stents at prices mandated by the NPPA when they reduced prices of stents by over 75%. Before the cap on prices, Abbott used to sell bioresorbable stents at around Rs 1.9 lakh a piece.
In July 2016, the health ministry included stents in the National List of Essential Medicines (NLEM) after the court demanded action on a public interest petition filed by advocate Birender Sangwan who sought price control on stents. The petitioner alleged that the government and the NPPA are being “insensitive and irresponsible” towards the people by not taking any steps to fix the price of the medical device which is allegedly being sold at high price in the country.
While the maximum retail price (MRP) of a stent manufactured abroad and made in India could be similar, starting anything at over Rs 1 lakh, the cost to the patient could vary by a wide margin. While there is an MRP in the Indian market, at times stents are sold to hospitals at prices much lower, especially in the case of domestically manufactured stents. The Delhi high court had directed the central government to fix the MRP and a ceiling price by March 1, 2017, for coronary stents, used to treat narrowed or weakened arteries in patients.
Additionally, health activists started debating if profit-driven medical institutions will actually pass on the benefit to patients, or find ways to recover the considerable cost difference from them. Despite the NPPA order, activists opined that the benefits being successfully passed on to patients depend on awareness. They believe that unnecessary angioplasties have been common but may increase due to the price control.
As per a rough estimate, about 15% of the patients a cardiologist sees in his OPD would need an angioplasty, but in most corporatized hospitals, doctors are actually given targets of 40% for conversion. It won’t be surprising if hospitals hike costs of other disposables required in angioplasties like the balloon, wire, connectors and special syringes, and increase hospital stay cost. There is also a fear that more stents would be used on a patient. The lack of standard treatment protocols means there is always a risk of un-indicative procedures being performed. Such malpractices are already there due to commercialization of the medical field. The NPPA order is laudable, but when the government regularizes one thing, the industry discovers another way of making profits; and with regulation of stent prices, there could be more push towards even bypass surgeries. The answer to this problem lies in awareness. If something has been brought under price control, it does not mean it will be of bad quality. Consumers need to understand this and question each and every part.
With the entire wrangle over the stent prices and stent shortage in the market eventually de-prioritizing ‘patient care’, one question keeps hovering over us. Whose stent is it anyway??
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