India needs indigenous stents

My friend P called a few days ago, from a fancy private hospital, where his father was undergoing an angioplasty. “They found two blockages in dad’s major arteries and stents are being implanted as we speak,” he said dramatically. When pushed for more information, P admitted to feelings of confusion. “You know, they asked me what kind of stents we wanted, just as they were about to begin, and I had no idea what to say.”

Now P may be a bright guy on the whole, but for the medical establishment to expect him (or any other layperson) to know exactly which kind of stent — metal, drug eluting or biosorbable — he or she wants, is unrealistic. What makes matters worse is that there’s no rule mandating a discussion on the topic before-hand, between the cardiologist and patient; there’s no point at which a group of doctors has to counsel patients and their families about the pros and cons and prices of different stents.

Another friend — an ex-IAS officer covered by the CGHS scheme — also felt duped when the doctor doing his angioplasty implanted the most expensive stent in the hospital. The cost was prohibitive, and our man was denied reimbursement. “At the last minute, the doctor vaguely told me it was the best choice and brought me a sign to form,” he complained.

Indians aren’t exactly known for their health literacy. Most of our information is picked up from well-meaning relatives and Google. We scan the first few lines of health articles, and sit back complacently, confident that we are smarter than our friends. Take the business of stents. We know that these can prevent us from dying from heart attacks.

Some of us have read the news that appeared in July this year, about the Government’s move to include two categories — bare metal, and drug eluting (which includes biodegradable and bioresorbable vascular scaffold) — under the national list of essential medicines, subjecting them to price control regulations. The objectives were to make stents affordable to the neediest, and bridge the gap between demand and supply of angioplasties and stenting procedures.

But only a handful of India’s people will benefit from this move: 70 per cent of the country’s population lives in remote rural areas, with no access to adequate medical facilities, doctors, and life-saving treatments. The absence of extensive public health facilities drives the majority to seek private medical treatment, leading to heavy out-of-pocket expenses on private medical services.

The link between out-of-pocket expenditure and poverty is confirmed in India’s draft National Health Policy 2015, which says that “55 million Indians fell into (a) serious poverty-trap because of their health care spending during (the) 2011-12 period.” The draft NHP also pronounces the country’s out-of-pocket expenditure for health to be one of the highest in the world, at 60 percent.

Unlike pharmaceuticals, critical medical devices such as stents aren’t sold over the counter or purchased directly by the public. The cost of a stent is just a fraction of the total cost paid by a patient for implantation via an angioplasty, in a hospital.

Government hospitals are required to adhere to a fixed cost for angioplasties, which varies based upon the price of medical devices such as stents, but there’s no such rule in private hospitals, no regulation to ensure that the benefits of price reduction are conferred to patients. Though stent prices have dropped steadily over the years, the cost of an angioplasty keeps rising: it averages between ₹2 lakh to ₹2.5 lakh at a private facility depending on the complexity of the case, number and kind of stents used. The cost in a public health facility is less than half of this figure.

At the moment, a variety of stents from many parts of the world are available in India, at prices that range between ₹10,000 and ₹1,80,000. These vary in quality, and cardiologists generally use imported stents with a guaranteed quality for angioplasties.

Though there are a handful of indigenous stents in the market, experts say they haven’t been subjected to enough testing and research. Much fuss is being made about price control of devices, about how this will “limit innovation” and diminish patient choices. How relevant is this concern, however, in a situation where 98 per cent of those in need of an angioplasty can’t get one?

This is a particularly grim statistic, in the context of escalating rates of heart disease. Unlike the West where heart disease is predominantly associated with old age, here in India, coronary artery disease is rampant among the young and middle aged.

About 25 per cent of all deaths among 25-69 years is attributable to Cardiovascular Diseases, says a 2013 study by the Registrar General of India and Indian Council of Medical Research. The number of stent procedures in India has also tripled over the last five years, according to the National Intervention Council (NIC) 2015 registry data, which estimates that 5 lakh stents were implanted last year. But this constitutes just 2 per cent of the need.

India is struggling to provide healthcare to its 1.4 billion people. The challenge has been multiplied by the new wave of non-communicable diseases, of which heart disease heads the list. Smart thinking and long term planning is required to realise the national mission of “health for all” and to breach the huge gap between demand and supply of stents. Equitable access to healthcare, including medical devices and technologies, calls for a broad based strategy that takes the larger picture of public health into account: building the infrastructure of public health facilities, ensuring the presence of skilled doctors with training to implant stents, and making innovative medical reimbursement and insurance schemes available to the majority.

More stringent quality control regulations must be put into place, to protect patients against the risk of receiving poor quality devices. Creating an environment that fosters the development of indigenous stents is also crucial, if we are to provide for the neediest. The Government needs to revise its health expenditure from the current 1 per cent of GDP, and allocate a substantial amount to R&D, to enable the development and testing of innovative, low-cost indigenous devices.

The writer is a microbiologist who writes about health issues