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Stent Price Regulation

 2/17/2017  1005

In a major relief to lakhs of cardiac patients, the government has cut prices of life-saving coronary stents by up to 85 percent. The National Pharmaceutical Pricing Authority (NPPA), the Centre's drug pricing wing, has fixed the ceiling price of bare metal stents (BMS) at Rs 7,260 against their previous MRP of Rs 45,000. Drug eluting stents (DES) and biodegradable stents cannot be sold at more than Rs 29,600 as against their previous MRP range of Rs 80,000 to Rs 1,21,000. These caps mark 83.8 per cent price reduction in the BMS category and 75.53 per cent reduction for DES stents which release drugs into arteries long after the implant. DES is preferred over BMS as the latter are known to cause a higher recurrence rate of blocked arteries, thereby raising the risk of heart attacks.
 

NPPA's notification says stent price reduction will apply immediately and will cover stents in trade channels. Stent manufacturers will have to revise prices downward and hospitals billing stents directly to patients will have to reimburse overcharged amounts. The NPPA stent pricing will apply for a year initially. Capped prices are, however, exclusive of VAT and other taxes. Since most states have 5 per cent VAT on stents, BMS stents will cost around Rs 7,623 per unit and DES around Rs 31,080. NPPA’s notification follows the Health Ministry’s 2016 move to include coronary stents in the National List of Essential Medicines which automatically come under drug pricing. The government has also made it mandatory for hospitals to bill stents separately from surgical procedures or package costs.

Coronary heart diseases in India:
There has been an alarming increase over the past two decades in the prevalence of Coronary heart diseases (CHD) and cardiovascular mortality in India and other south Asian countries. India is going through an epidemiologic transition whereby the burden of communicable diseases have declined slowly, but that of non-communicable diseases (NCD) has risen rapidly, thus leading to a dual burden. There has been a 4-fold rise of CHD prevalence in India during the past 40 years. The burgeoning burden of CHD in India can be explained by the alarming rise in the prevalence of coronary risk factors like diabetes, hypertension, atherogenic dyslipidemia, smoking, central obesity and physical inactivity. Rapid urbanization and change in lifestyle that occurred during the past two decades have led to the growing burden of coronary risk factors in India.

Coronary Stent:
A coronary stent is a tube-shaped device placed in the arteries that supply blood to the heart. It keeps the arteries open in the treatment of coronary heart diseases. A coronary stent is used to clear blockages in the arteries and prevent heart attacks.
 

Need for regulation:
It was found that huge unethical mark-ups are charged at each stage in the supply chain of coronary stents resulting in irrational, restrictive and exorbitant prices in a failed market system driven by information asymmetry between patients and doctors, pushing patients to financial misery. Under such extraordinary circumstances, there was an urgent necessity, in public interest, to fix ceiling price of coronary stents to bring respite to the patients.
 

Benefits:

  • Heart patients who require coronary stents stand to get an average benefit of close to `1lakh after the country's drug pricing authority fixed a cap on stent prices.
  • The move would encourage companies to make in India to cut costs.
  • The move has been welcomed favorably by most civil society fighting for price fixation as it could lead to a reduction in medical expenses.

Criticism

  • Stent manufacturers, however, said the move will kill the industry by discouraging companies to innovate and bring in new technologies into this space.
  • Such a regulation might lead to flooding of substandard products from China and Canada.
  • US FDA approved stents will be withdrawn from the market as the government has brought all stents under one category.
  • The NPPA notification completely disregards all stakeholder representations on the need to differentiate stents based on their technological differences. While the intent is to cap prices in the interests of patients, this pricing has the potential to block innovations and limit access to world-class medical care.
  • In the US, 12 lakh stents are implanted annually and there are just three approved manufacturers. In India, four lakh stents are implanted, but there are 60 approved stent makers. Our drug controller lacks the infrastructure to regulate stent firms.
     

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