Medical devices

Regulator to reexamine cardiac stent prices as manufacturers threaten to withdraw from India

Benefits of price cap still not available to all as some hospitals have raised the prices of treatment packages involving stents.

With the National Pharmaceutical Pricing Authority or NPPA set to revise the cardiac stent prices caps in January 2018, multinational companies are already signalling that they might withdraw existing stents from the market.

In February 2017, the NPPA had capped the prices of the stents by invoking Para 19 of the Drug Price Control Order, which allows the authority to regulate the prices of drugs and medical devices that are not under the National List of Essential Medicines under extraordinary circumstances in public interest.

Cardiac stents are small scaffolds that are inserted into blood vessels during procedures called angioplasties to unblock the vessels, restore normal blood flow and thereby prevent heart attacks.

Before stent prices were capped, they were sold at exorbitant prices. The most commonly used type of stent called drug-eluting stent could cost as much as Rs 2.5 lakh. The NPPA fixed the ceiling price for this variety of stent at Rs 29,600. However, the NPPA price order is time bound. “The order was valid for one year,” said Bhupendra Singh, chairman of NPPA. “We have invited suggestions from all stakeholders and by January we will have meetings to decide on the capping.”

Amid speculation the price cap will not continue after the first year, Singh clarified that the government is considering extending the order capping stent prices for a longer period of time.

In the past few months, several companies have asked the authority to reconsider the pricing of some stents, which they claim are technologically more advanced than the older stents, and therefore should be priced higher.

In November, the NPPA invited suggestions from Indian drug manufacturers and importers. “The companies will have to come up with clinical data to explain if there is any new development that differentiates these stents,” said Singh.

The NPPA will be advised by a committee constituted by the government on the matter of revising the ceiling rates. “The decision of NPPA will be final,” said Singh. “The committee will have a advisory role only,”

However, the authority is under enormous pressure from industry to remove any sort of price cap. United States Trade Representative and Ambassador Robert B Lighthizer asserted in a letter to the Indian government that US stent manufacturers have been discouraged from introducing the latest technology in the Indian market.

Patients vs hospitals vs stent manufacturers

The aim of capping the prices of cardiac stents was to make angioplasties affordable to all patients. “Yes, there is no doubt that the number of people undergoing angioplasties, for whom cost was a factor, has gone up,” said Dr Vijay Surase, cardiologist at Jupiter Hospital in Thane.

At the same time, benefits of the price cap have not been passed on to many patients because several hospitals have found ways around the price cap. “Some hospitals have raised the packages of the total angioplasty procedures,” said Surase.

Although the NPPA can take action against hospitals for overcharging patients for stents, it cannot regulate other charges levied on the patients. Since February, the NPPA has registered about 40 complaints for overcharging of stents.

Medical device manufacturing companies said that hospitals making super profits off stents resulted in the NPPA’s stringent crackdown. “Globally, the prices had reduced over the last few years but hospitals in India refused to reduce the maximum retail price even when the cost to the company had drastically reduced,” said a person working in the medical device industry.

Medical device manufacturers and doctors claim the price cap will limit the introduction of the latest technology cardiac stents in India. “First there was balloon angioplasty which had high restenosis rates, following which came the cardiac stents and latest are the drug eluting stents to further reduce the risk of restenosis,” said a senior executive from an international medical device company. Restenosis is to the narrowing of a blood vessel, that has already been treated for blockage.

“Now, the latest stents have innovations with respect to the designs which gives benefits that only clinicians can appreciate.”

A company representative working for an international medical device company in western India said that if the price are not corrected to suit the industry, more companies will apply to withdraw their stent products.

But, activists working for price control in the medical device industry feel that only claims of stent innovation are not enough. Malini Aisola, convenor of the All India Drugs Action Network who monitors the medical device industry closely said that a doctor’s perception about the efficacy of the cardiac stent is not enough. “Companies need to conduct research and prove the benefits in terms of treatment outcome to claim superiority,” she said.

In fact, NPPA’s chairman Singh has asked companies to come up with clinical data to prove the difference (in efficacy) between the stents.

Surase said that amid the discussion about stent pricing, he is witnessing a drop in patients who come to Indian hospitals from outside India. “I have seen a drop in patients coming from Middle East as people perceive that quality stents are not available in India.”

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