With questions about safety of Meril's Made in India BVS stent, NPPA defers its appeal for price exemption

New Delhi: With an industry association raising health and safety concerns about the flagship Sirolimus-Eluting BioResorbable vascular scaffold system (MeRes100) of Meril Life Sciences, the apex drug price regulator, National Pharmaceutical Pricing Authority (NPPA) has deferred its plea seeking exemption from price control

Under paragraph 32 of the Drug Price Control Order (DPCO), 2013, the NPPA can exempt drugs from price control which are either new or have a new delivery system that is developed through indigenous research. In case the exemption is granted, it will be valid for five years.

The Gujarat-based firm has been striving for the past couple of months to exempt its product from price cap. The product MeRes100 is a bioresorbable vascular scaffold system that resorbs naturally in the artery within a period of 2-3 years thus leaving the vessel in its true form and nature. It was approved by the Drugs Controller General of India (DCGI) in 2017.

Bioresorbable scaffolds (BRS) were designed to overcome the limitations of metallic stents (vessel caging with a lack of coronary vasomotion, preclusion of bypass surgery in stented segments, etc.).

Also Read: Health Ministry nod to MeRes100- India made bioresorbable cardiac Stent

After getting DCGI nod, the firm had forwarded an application to the NPPA to consider exempting MeRes100 from price cap.

NPPA then referred the application to the 'Standing National Committee on Medicines for revision of NLEM' with a request to examine the products from the perspective of any significant therapeutic advantage and increased efficacy that may merit an exemption under para 32 of DPCO, 2013.

"In public health, choice of consumer is impeded by information asymmetry and lack of knowledge regarding quality and efficacy of drugs/ medical devices. Often, high priced items are prescribed/ preferred on the premise of improved quality. It is, therefore, important that pricing policy is not operated in silos. Any decision to exempt drugs from price regulation has to be taken in a holistic perspective," the body had stated

Also Read: Setback to Meril Lifesciences MeRess100: NPPA refuses to give relief of price cap exemption for the biodegradable stent

Recently, in its meeting held on October 30, NPPA decided to postpone a decision on the matter, in view of safety concerns raised by the All India Drugs Action Network (AIDAN), an NGO. AIDAN had raised concerns regarding the marketing approval of the product in India related to the lack of data to establish the product's safety.

Medical Fraternity has been on an alert with respect to BVS scaffolds ever since the USFDA communicated the interim study results through three years from the pivotal clinical trial (ABSORB III) continue to show an increased rate of major adverse cardiac events and BVS scaffold thrombosis in patients receiving the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) when compared to patients treated with the approved metallic XIENCE drug-eluting stent.

While Abbott soon after announced the withdrawal of stent from the market, owing to "low commercial sales", the manufacturer continues to monitor patients currently enrolled in the ABSORB III and ABSORB IV US clinical studies through five years following BVS implantation

With this scenario, in the past, questions have been raised on decision of CDSCO in granting a license to Meril's BVS on the basis of data from the small, single-arm, non-randomised registry which are inadequate to prove safety of the device

Pointing out to patient safety being of paramount importance, critics have pointed out that further studies of the device –a larger, sufficiently powered, randomised trial against the current generation DES - should be a requirement for proving safety of the technology relative to DES and a prior condition for the launching of the product in the Indian market

Taking in consideration the concerns raised by AIDAN, the NPPA held;

The Authority deliberated upon the matter in detail and noted that AIDAN has raised health and safety concerns regarding the usage of MeRes100 stents. The Authority also noted that the matter had been referred to DCGI, DG-ICMR and MoH&FW vide letter dated 21.10.2019 to examine these concerns and that their replies were still awaited. Therefore, the agenda was deferred.