The national drug price regulator will hold meetings with stent-makersboth local and multinationaland lobby groups representing them next Monday
New Delhi: Global stent makers seeking higher prices or an exemption from a price cap for their high-end stents may heave a sigh of relief. The national drug price regulator, which slashed the price of cardiac stents by up to 80% in February last year, will hold discussions on their requests next Monday (5 February), following which the National Pharmaceutical Pricing Authority (NPPA) will revisit the issue.
Last year’s price cap is valid for a year ending 13 February, meaning NPPA has to settle price revision discussions before then.
The NPPA will hold meetings with stent-makers—both local and multinational—and lobby groups representing them. It will meet representatives of Advanced Medical Technology Association (AdvaMed) representing multinationals, and the Association of Indian Medical Device Industry (AiMeD). Top industry bodies like the Confederation of Indian Industry (CII) and the Federation of Indian Chambers of Commerce and Industry (Ficci) will attend the discussions besides the All India Drugs Action network (AIDAN), a group of healthcare-focused NGOs and the Public Health Foundation of India (PHFI).
“We thank NPPA for consulting with manufacturers and other stakeholders at the anniversary of the stent price cap. We are opposed to the suggestion by overseas manufacturers to have differential pricing for US FDA-approved stents," said Rajiv Nath, forum coordinator, AiMed. FDA is short for the Food and Drug Administration, the US drug regulator.
According to Nishith Chandra, director and interventional cardiologist at Fortis Escorts Heart Institute, a middle ground should be adopted on FDA-approved stents.
“With the one-year anniversary of stent price capping by NPPA arriving in February, all eyes are on government regarding the continuation of the scheme in its present format or with some modifications," Chandra said. “As an interventional cardiologist we welcomed the government’s decision on stent price capping, but we would appreciate a middle ground for FDA-approved stents with latest technology. These latest generation stents should be placed in a separate higher price bracket, enabling Indian patients access to the latest cutting edge technology. For those who want cheaper options, that too is available in the Indian market."
Significantly, the national drug price regulator has also asked the heath ministry to consider creating a new category of high-end stents. In a 9 January letter, NPPA chairman Bhupendra Singh asked Union health secretary Preeti Sudan to call an urgent meeting of the cardiac stents core committee for the National List of Essential Medicines (NLEM) to “re-consider" the issue and review if all drug-eluting stents (DES) are equal, or if a new category is required. Mint reported this on 24 January.
The cardiac stent core committee met on 25 January but is yet to take a decision. “The multinational companies asking for better pricing gave their representations before the committee but a decision is yet to be taken," a person with direct knowledge of the matter said on condition of anonymity.
The process of discussions on stent pricing started on Tuesday with NPPA meeting eminent cardiologists from both government and private sector. The cardiologists briefed the NPPA how price capping has resulted in Increase in no of angioplasties, reduction in by pass surgeries. The doctors expressed the need for “more transparency in billing, law for compulsory national registry & legal reuse of sterilised catheters/ballons for cost saving" NPPA chairman tweeted late on Tuesday.
Following the recommendations of the core committee, the health ministry had on 19 July 2016 included coronary stents in the NLEM.
The stents were classified into two categories: Bare Metal stents (BMS) and Drug Eluting Stents (DES). According to the core committee, it did not find it necessary to create a separate category for certain categories of stents as it found that there was no “scientific and statistically, proven data to validate the therapeutic superiority of these stents". On 21 December 2016, stents were included under Schedule 1 drugs. Subsequently, the NPPA capped prices of both categories of stents on 13 February, 2017 which is valid for one year.
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