Stents Regulate(d)

Recently the National Pharmaceutical Pricing Authority slashed prices of stents by up to 85 per cent.

 

What are stents?

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.  The devices save thousands of lives globally, every year. Emergency angioplasty is the treatment of choice during an acute heart attack, wherein the clot is crushed with a balloon and a stent is placed. It improves the chance of the patient surviving by almost 30 per cent when compared to clot dissolving medication (thrombolysis).

Why price control:

In India, emergency angioplasty was carried out in less than 10 per cent of patients mainly because of the cost involved in the procedure and the lack of access to stents.

Bringing the devices under price control will enable more patients to make use of this life-saving procedure.

Effects of price control move:

Capping the prices of stents has had an unexpected outcome-

  • Preference for stenting even in cases when it is not the best treatment.
    With cheaper stents and a fall in procedure costs, many more patients are opting for angioplasty. In patients with multiple blocks in all three vessels, open heart surgery is a better procedure than the use of multiple stents. However, with lower stent prices, ill-informed patients often choose multi-vessel angioplasty as it is cheaper (even with three stents) than open heart surgery. With the increasing use of the tiny metal tubes, the chances of a stent blocking with consequent damage to the heart muscle will only increase.
  • The availability of latest generation stents.
    In April, this year, major international stent companies had filed for withdrawing their latest products from the Indian market. Discussions are still going on between major manufacturers and the government about the withdrawal of already available stents. If the logjam continues, newer and innovative stent technology will never be introduced in India.
  • Research on indigenous stents has been hurt.
    Stent manufacturers typically spend millions of dollars on research before they can make the device and commercialise it. Some of the profit from sales is pumped back into research. Abruptly reducing stent prices will have adverse effects on the development of improved stents.
  • Preference of imported devices over indigenous ones.
    Even before the price control move was instituted, only 40 per cent of the stents used in the country were indigenously manufactured; the rest were imported. With prices of imported stents and Indian stents now being the same, doctors and patients could prefer the imported devices. If the situation continues, the financial viability of Indian stent manufacturers could be hit. This will have a bearing on their capacity to do quality research. Lack of government funding for clinical research in India only aggravates the issue.
  • As future generation stents come into clinical use, multinational companies may choose not to release their latest products in India because of the country’s price control regime. In fact, such an alarming scenario might pertain not only to stent technology but also to research and marketing of other implantable devices. We could end up with a situation where hospitals in the country would have older generation stents. Patients hoping to have advanced stents may have to travel abroad — of course, only a few will manage to do so.
  • Medical tourism also will be hit.
    As it will become apparent that Indian hospitals do not have the latest generation stents.

While the government must ensure that the common man has access to proper healthcare, it also cannot undercut market dynamics entirely. If companies do not have the resources to invest in research and innovation, it is ultimately the public that will suffer.

Suggestions:

  • The best long-term solution is to encourage and support Indian stent manufacturers and medical device research so that we do no need to depend on imported stents.
  • All aspects involving medical device development (clinical research, animal testing, human trials) must be fast-tracked and should be as transparent as possible. There must be a system to make sure that the latest medical devices, including stents, are priced differently.
  • A more comprehensive regulatory framework that looks beyond price caps to ensure quality healthcare coverage for all citizens is required. As policymakers grapple with the issue of supporting public welfare versus medical innovation on limited resources, they must look at other key elements of the healthcare matrix, such as extending the insurance coverage (currently at 25%) and shoring up healthcare infrastructure.
  • At the same time, the manufacturing industry should also reach out to the public and explain how there is more to its pricing strategy than just profits. This year, Johnson & Johnson has led the way with a report detailing its medicines’ price increases, while Allergan, Novo Nordisk and AbbVie have all pledged to limit price increases to a certain percentage. A little bit of transparency can go a long way.

To Conclude:

Price control of stents is a positive step, but more needs to be done. It should be seen as an opportunity to shore up healthcare infrastructure in country. The government needs to see that the domestic stent manufacturing industry is unhurt and rather competes with international market. Once such a level of competency is achieved, India could actually export stents making Prime Minister’s Make in India viable for medical devices


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