Stents: price capping hampers innovation

A sedentary lifestyle coupled with stress and irregular eating habits are worsening the health of our heart. Adding to the woes are several co-morbidities commonly observed in patients with heart failure, such as diabetes, hypertension, dyslipidaemia and obesity. They can be inciting events for the development of heart failure which can complicate the diagnosis and management of heart diseases.

Coronary artery disease (CAD) has become an epidemic in India, responsible for 20% of all cardiovascular related mortalities. The growing burden of CAD requires superior quality medical care including cardiac stents to combat the varying disease profiles. Used to facilitate reopening of arteries, a cardiac stent is one of the most reliable solutions to treat patients with artery blockages.

In 2016 alone, 4,78,770 cardiac stents were used for coronary interventions. This number is expected to grow as the Indian coronary stents market will expand at CAGR of 14.0% over the forecast period (2016–2026). The burgeoning number of heart patients reflecting diverse symptoms make innovation in interventional cardiology a priority. With so many options in the stents market (bare metal stents, drug-eluting stents, biodegradable stents etc), choosing the “right stent” for the “right patient” is imperative.

In a contrast of sorts, the National Pharmaceutical Pricing Authority (NPPA) fixed prices of bare metal stents (BMS) at Rs 7,260, whereas the market price of both drug-eluting stents (DES) and biodegradable stents were fixed at Rs 29,600. Price capping in the wake of making affordable healthcare a reality is limiting a patient’s choice to seek the treatment best suited for their condition. Initiatives such as these, while with the right intentions, promote an empirically baseless argument — “one-size-fits-all” principle.

If no two lesions are similar, how can one kind of stent solve different versions of a problem? To be fair, price-capping did bring down procedural costs to a certain level, and hence, the government hoped to witness a rise in accessibility of medical help for the patients. But did the numbers rise significantly?

According to a study by IQVIA, there was no significant increase in patient numbers. The study revealed, “Amongst government hospitals surveyed, ~80% hospitals cited no significant increase in the number of angioplasty procedures performed, and even in the remaining 20%, the increase was marginal (2-5% only).”

Though the intent of the government to make healthcare affordable must be acknowledged, the question remains: is affordability presenting a patient with a difficult choice to choose between trusted brands and cheaper alternatives? While the world is riding on the innovation curve, India is not reaping the fruits of advancements in medical technology.

Right stent, right patient

A cardiac stent is adjudged for its material, thickness, design and clinical relevance. Investments by major global players in R&D have led to developing safer, better and efficient variants of stents. For instance, DES highlights the coming of age of “first-generation stents technology” which were initially developed as BMS.

The DES marks a breakthrough in interventional cardiology reducing angiographic restenosis and targeting vessel revascularisation. DES is coated with specific drugs to treat diabetic patients who can show signs of re-clogging of the arteries. Each patient reflects a different medical condition. Hence, whether the same stent has to be re-configured or an entirely different stent is to be placed in a patient, should be a prerogative of the doctor.

With price capping, the freedom to choose from superior quality cardiac stents is no longer available. It has not only disincentivised innovation but also limited a patient’s freedom to choose from the list of available options. We must not forget that positive clinical outcomes depend on the placement of the “right stent” in the “right patient” and not the most “affordable stent” in a patient. Hence, the concept of “one-size-fits-all principle does not hold ground”.

With an increase in diverse heart problems, the need to foster innovation is now more crucial. Collaboration between all stakeholders (doctors, medical device manufacturers etc) is a must before reaching a consensus on affordability and accessibility. An unprecedented price-capping of cardiac stents, however, can jeopardise a patient’s access to innovation, quality and safety. Price capping can’t substitute for innovation.

Healthcare policies such as price capping of medical devices need to be reviewed regularly keeping in mind the changing dynamics and diverse patient profiles. It is critical to evaluate these policies in terms of their impact on the intended beneficiaries. While we wait for the long-term impacts of price capping, we must retain superior quality cardiac stents to ensure quality healthcare to all.

(The writer is Director, Sri Jayadeva Institute of Cardiovascular Sciences and Research)