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A little over four years after Abbott introduced its bio-absorbable cardiac stent in India, the healthcare major has decided to pull the product out of India along with another stent Alpine.
Confirming the development, an Abbott spokesperson said: “Following the NPPA (National Pharmaceutical Pricing Authority) price ceiling decision, we have examined and re-examined whether there is a sustainable way to make available in India two of Abbott's latest stent technologies, the Alpine drug eluting stent and the Absorb dissolving stent, considering their higher manufacturing costs and other associated costs. We have determined it is not sustainable, and we have applied to the NPPA to withdraw these two stents.”
Cardiac stents have been in the eye of a price storm after the NPPA brought them under price control to make it more affordable to patients. Pointing out that they were aligned with the government's intent for broad access to care, Abbott said, “we’re disappointed that the NPPA concluded there is no differentiation in coronary stent technology.”
Stents are wire-like meshes that are used to remove blocks, largely in the heart. Absorb was priced at close to ₹2 lakh, while Alpine’s MRP was about ₹1.5 lakh.
The price on these drug eluting or drug-coated stents were slashed by the NPPA to about ₹30,000.
The NPPA officials could not be reached for comment on the development at the time of filing this story.
Europe action Earlier this month, the United States-based company had sent a letter to doctors in Europe informing them that the product would now be restricted only to clinical registries, involving post-marketing surveillance on the product.
This development followed recent safety concerns that had emerged from three year data on the cardiac stent.
On whether the India development was linked to the Europe action, Abbott said: “We have taken this step because of commercial unsustainability of Alpine and Absorb. The CDSCO medical device alert of April 7 does not restrict the use of Absorb in India.
“Data presented at major cardiology medical meetings from Absorb trials around the world have demonstrated that optimal implantation technique results in outcomes comparable to the best-in-class metallic drug eluting stent, with the added feature of leaving no metal behind once Absorb dissolves. When Absorb is implanted according to training and instructions for use, results are comparable to Xience.”
India supplies Responding to whether Indian patients will face a shortage, Abbott said, “Presently, only a very small percentage of patients in India receive Alpine and Absorb.
Abbott will continue to make available all other Xience coronary stent products, which are considered the worldwide gold standard in stent technology.
“There is no shortage of Xience stents and they continue to remain available within the ceiling price set by the NPPA order of February 13, 2017.”
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