Even as healthcare major Abbott's bio-absorable stent ‘Absorb' battles price control challenges in India, another storm seems to be blowing in from Europe.
The healthcare multinational has sent a letter to doctors in Europe informing them that the product will now be restricted only to clinical registries, involving post-marketing surveillance on the product, according to reports.
The development followed recent safety concerns that had emerged from three year data on the cardiac stent.
Abbott has since informed the Indian Drug Controller General of India that post-marketing registries are being initiated in Europe “to monitor implantation technique for Absorb.”
Allaying fears that the product had been pulled out of the European market, an Abbott spokesperson told BusinessLine , “Absorb continues to be commercially available in Europe through the registries. Absorb is not being withdrawn from Europe and nothing has changed with the product’s regulatory status.
The vast majority of hospitals that currently use Absorb in Europe will continue to have access to Absorb through the registries.”
Pricing issueCardiac stents are in the eye of a price storm in India after the National Pharmaceutical Pricing Authority brought it under a price control regime.
As prices on stents were slashed, hospital and medical circles have been rife with speculation that Absorb will be out of the local market as it was unviable for the company to market what is referred to as a next-generation stent at reduced prices.
The price of Absorb has come down from close to ₹2 lakh to ₹30,000-odd now.
Abbott, however, maintains that it continues to market its full range of coronary stents in India.
“We have also advised trade partners and hospital partners to abide by the ceiling prices determined by the NPPA order.”
About 18,000 Absorb stents have been deployed in India since its was approved more than four years ago.
Presently, it is said to account for about one per cent of Abbott's total number of stents sold here.
“The current advisory is specific to countries in the EU. Abbott has emphasised implant techniques for Absorb in a training program for physicians globally, including India,” it added.
European shadowExplaining the developments in Europe, Abbott said, “Post-marketing registries are being initiated in Europe to monitor implantation technique for the Absorb dissolving stent.
Analyses of Absorb trials from 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 it dissolves.”
The objective of the EU registries is similar to post-approval observational studies and training being conducted in other parts of the world to confirm the effect of current implantation technique on clinical outcomes.