Patients' group opposes stent categorisation

In its submission to a committee reviewing the price cap on coronary stents, patients' rights group All India Drug Action Network (AIDAN) asserted that there should be no sub-categorisation of stents as there is currently "no evidence of superiority in terms of safety and clinical benefit of any particular stent over other".
Citing past examples of stents hailed as being innovative turning out to have adverse results for patients in the long run, it also asked for the Indian company Meril Life Sciences' application for price exemption for its new bioabsorbable stents to be put on hold till it proves its safety with more data.

In April 2015 and January 2018, expert committees examining the request for separate categories for 'innovative' stents had decided that there was no case for sub-categorisation due to the lack of clinical evidence of superiority of the 'innovative' stents over other drug eluting stents (DES). Supporting the committees' views, AIDAN pointed out that with no clinical difference, companies were now claiming improvements in deliverability in their new innovative DES.

Improved deliverability is mostly driven by changing delivery catheter rather than any improvements on the stent. This saves costs of animal or clinical studies in most cases thereby significantly reducing development costs, AIDAN pointed out.

Also, deliverability was a subjective parameter which could vary from clinician to clinician. Hence, AIDAN argued, any perceived value in an incremental innovation in a stent should be left to the market to reward by surgeons preferring that stent, allowing it to capture a high market share.

Referring to many MNCs seeking to withdraw their 'innovative' stents from India following the price cap, AIDAN detailed how most turned out to be clinically no better than existing ones except for the claims of improved deliverability of some.

Given how ABSORB (Abbott's bioresorbable stent), which showed promising results up to one-year follow-up, had poor long-term performance, AIDAN sought greater caution in the case of Meril's MeRes100, also a bioresorbable stent, though much thinner. MeRes100 has limited clinical data through a small 108-stable patients study, which itself acknowledges that the results could not be generalised to more complex lesions or higher-risk patients. Also, since it wasn't compared with other stents, "any inference of non-inferior or superior safety against current generation drug eluting stents or scaffolds is not possible".

The study also called for "further randomised study in a larger patient population with longer follow-up". Meril has not started any randomised study. It has also not launched the product in India despite getting approval in 2017.

"Given the global uproar over Abbott's BVS and therefore the absence of a safe predicate device, the regulator should have applied a stringent standard for approval of the MeRes100 which is based on the technology now proven to be risky," stated AIDAN.

As for Meril's CE certification in Europe, AIDAN pointed out that the now withdrawn ABSORB and Johnson and Johnson's faulty ASR hip implants too were approved in India based on CE approvals and that the International Consortium of Investigative Journalists has exposed the flawed system for CE approval of high-risk devices.