“A superiority study will need at least a sample size of 15,000 patients and a follow-up period of five years,” a senior official from Boston Scientific said.
Probir Das, India head of Terumo, a Japanese device maker, said that by the time a company can prove superiority of one stent over another, the technology will become redundant.
Multinational device makers agree that the difference between stents is marginal. Studies have also noted that non-inferiority does not necessarily mean superiority. A study by TCTMD, an online resource platform on cardiovascular issues, conducted on fully dissolvable stents has stressed this point.
The study reads, “Absorb did not prove superior to standard of care. There were no differences in any components of one-year Target Lesion Failure or cardiac death between the stents, nor were there any differences in device thrombosis in terms of early or late, or definite or probable.”
The India head of a multinational stent manufacturing company said, “If the new stent is only slightly better than the older stent, the price should only be marginally high. But it must be priced higher than a stent of the previous generation.”
Medical Technology Association of India (MTAI) has been critical of the National List of Essential Medicines (NLEM) committee that brought stents under the list of essential medicines. MTAI states that the NLEM committee has not considered many important parameters to measure efficacy of stents.
Apart from Boston Scientific, Abbott wanted to withdraw its novel product Absorb fully dissolvable stent and applied to the NPPA. The NPPA rejected Boston Scientific’s and Abbott’s requests for withdrawal. The pharmaceutical pricing regulator asked the companies to prove superiority of these stents if they wished for a better price.
 "Industry opposes move to control stent prices")
