Curb on stent prices: putting lives before profit

Drug eluting stents (DES) are used by cardiologists whenever a block is detected in the coronary arteries. These blocks are not sudden but occur over a period of time as cholesterol-ridden material slowly settles down – known in the field of medicine as atherosclerosis. The patients often present themselves with severe chest pain and sweating.

These arteries supply blood to the heart and a block can be life threatening. The bare metal stents (BMS) are not much in use and constitute only 5% of the market. The DES, as the name rightly suggests, are coated with an anti-proliferative or an immunosuppressive drug to prevent re-blocking.

Stents are actually small wire metal mesh tubes placed inside the blocked arteries with the help of a catheter and the procedure is called Percutaneous Transluminal Coronary Angioplasty (PCTA) or simply angioplasty. The procedure takes between one and three hours and is done without anaesthesia. Hence, this procedure is preferred to the bypass surgery, which is more invasive and also costly.

The patient is awake while the procedure is carried out by an interventional cardiologist. Often angioplasty is also referred to as “Dottering” after D Charles Dotter who first described it in 1964. The Percutaneous Coronary Intervention (PCI) done on coronary arteries diseases reduces chest pain but in no way influences the risk of death or heart attack or other major problems.

The cost of stents has been in news recently and the media, along with a few civil society members, have unearthed the clandestine dealing that makes its cost exorbitant. The stent manufacturing companies include the Indian ones like Sahajanand Technologies, Translumina and others, while the foreign companies include Abbott (USA), Medtronic (Ireland) and others.

These stent manufacturing companies supply them to the main distributors. The distributors then strike a deal with hospitals and cardiologists and finally the stent reaches the customer. But the process is not so simple because a cardiologist is known to get a cut. If no cuts are given, then the stents may remain unused and the companies will not take back those beyond the expiry date.

So it is obvious that the companies will try to keep the cardiologist in a good mood, thus increasing the cost of the stent. But this is not the only reason for the high cost. The companies also produce stents under different “brands”, thus playing to the advertising segment and investing a big chunk on promotion. This further escalates the cost unnecessarily.

But the major reason behind high cost is the hospitals themselves as they also form a part of the distributors’ chain. By rough estimates, the hospitals themselves account for anywhere from 11% to 654% towards the cost of a stent. All this increases the cost on an average to around 50%.

But there are a few paradoxes in this issue. For example, Abbott imports its stents to India under the brand name Xience Xpedition which costs between Rs 17,000 and Rs 23,000, while a patient is charged anywhere between Rs 65,000 and Rs 1.5 lakh.
The same holds good for Indian companies as well, and the real contradiction is that the same stent costs differently in two hospitals. For example, Indian company Meril Lifesciences manufactures stent under the trade name Bionime Aura which is available for Rs 50,000 in Sir Ganga Ram Hospital and for Rs 1 lakh at Max Hospital, both in New Delhi.

According to the National Interventional Council (NIC) registry, close to 1.5 lakh stents were used for angioplasty in 2010, and the number has tripled in 2015. The growing numbers indicate that coronary heart diseases are a major public health problem in India. Coronary stents account for 25% to 40% of the total cost in private hospitals and 70% to 90% in government hospitals during angioplasty. So, it is obvious that the cost of a stent is a major contributing factor to the high cost of this life saving procedure.

Regulating the price
As many people in India need stent intervention, the government decided to intervene and rightly included stents (DES and BMS) in the National List of Essential Medicines. The National Pharmaceutical Pricing Authority (NPPA) – the highest body in India that continuously monitors and regulates price of drugs – also decided to include stents under price regulation.

This move by the government in 2015 was opposed by the Federation of Multinational Stent Manufacturing Companies on the ground that innovations will be stifled, while the same was welcomed by Indian companies, hoping that this will give a better chance to establish themselves in the Indian market.

No wonder, big drug companies spend huge money by giving freebies to medical professionals which at times include tours abroad. This has to be shunned and laws have to be put in place. At present, there is a code that prohibits doctors from accepting any gift from drug companies but this does not apply to the doctors’ associations.

The code of conduct for drug companies is voluntary so far and needs to be made mandatory. The NPPA has taken on a big challenge to make angioplasty affordable.
The people have great expectations from the NPPA and it is for the concerned and socially conscious citizens to raise their voice to seek justice. The NPPA also needs to get into action by exerting pressure on the industry over the huge difference between the actual cost of manufacturing a drug and the maximum retail price. Will the NPPA take up the task?

(The writer is president, Drug Action Forum – Karnataka)