Close to a year after the National Pharmaceutical Pricing Authority capped the price on cardiac stents, an industry body says the move has not improved access or affordability for patients.

The price cut has not led to “significant increase in total number of angioplasties performed per month; across different hospital segments or the corresponding decrease in angioplasty costs for patients paying out of pocket expense,” said a study conducted by IQVIA for AdvaMed, a platform largely representing foreign medical technology companies. IQVIA is the combined entity of erstwhile data-cruncher IMS and Quintiles.

The study has, however, stirred the pot with local medical device companies claiming that their experience has been quite the opposite. Last February, the NPPA capped the price of cardiac stents by about 80 per cent. The move slashed prices to ₹30,000 on all drug-eluting stents, from over ₹1 lakh, and in some cases, close to ₹2 lakh per product.

The AdvaMed study set out to assess the impact of this move on the overall angioplasty procedure cost and the total number of angioplasties performed across hospital segments.

“The initial findings from the study indicate that benefits to patients and growth in procedure volumes have not indicated significant change in the overall angioplasty numbers and the overall procedure costs,” AdvaMed said.

The number of angioplasties saw a three per cent increase in corporate hospital chains, a five per cent increase in large private hospitals and a seven per cent increase in medium private hospitals, largely in smaller cities, the note said. Ganesh Sabat, Chief Executive with domestic stentmaker SMT (Sahajanand Medical Technologies), said they had seen volume growth especially in tier II and III cities. The overall procedure cost too, has come down, he added.

Responding to AdvaMed's findings, Rajiv Nath of AiMed (Association of Indian Medical Device Industry) said if angioplasty numbers had come down it was because irrational stenting had been curbed.

The government should crack down on hospitals making up for reduced stent prices with increase in other procedural costs, he said.

Infrastructure not affordability Citing doctor observations, the AdvaMEd study further points to infrastructure as the inhibitor to better patient access rather than angioplasty procedure cost. “Inadequate number of cath labs in government hospitals to meet the demand and low availability of skilled interventional cardiologists to perform the procedure were the barriers,” the study said.

Reduction in stent price resulted in a minimal 8-18 per cent reduction in overall angioplasty procedure cost for patients undergoing single vessel procedure (70 per cent of the total angioplasty patients), AdvaMed said.

“In majority of the private hospitals surveyed, reduction in angioplasty cost post stent price control is in the range of 10-25 per cent. A reduction of greater than 25 per cent in angioplasty procedure cost post stent price control is observed in only 15 per cent of the hospitals surveyed,” it noted.

And patients treated in government hospitals did not benefit, the study says, as stents there were already available at less than ₹30,000, even before the price caps.

Rationalise margins Medical devices account for 40 percent of the total procedure cost to the patient, the study said, pointing to doctor fees, room rent, drugs and consumables, diagnostic costs, hospital charges and so on, that also needed regulatory attention.

“Singular focus on controlling price of devices without attempting to address the larger picture will not improve patient access. We need to consider alternatives to price control such as trade margin rationalisation and more scientific approaches that facilitate differential pricing for innovative medical technologies,” said AdvaMed's Abby Pratt.

The vision of Universal Health Care can be addressed through policies benefiting patients and providers, she said, echoing the government's draft report that recommended a margin cap at the price to distributor level in the range of 35-50 per cent.

Nath agreed with trade margins caps of 50 or 75 per cent, but when a product leaves the factory or lands in the country, if imported.

Curbing the price to distributor will not help “Make in India”, he said, as people will resort to importing. Local competition is necessary to keep prices affordable, he added.

In February, the stent price cut decision comes up for its annual review when industry expects to take a price increase. All attention now shifts to the NPPA and the course it will chart this time.