Talks with Centre on price regulation of stents positive: NATHEALTH

Stakeholders moot steps to classify drug-eluting stent through a scoring matrix

Discussions with the central government on price regulation of coronary stents, used in treating certain cardiac conditions, have been positive and a consensus has been arrived at with the government on implementing a scoring matrix for drug-eluting stents (DES), said Healthcare Federation of India (NATHEALTH).

The industry body, which represents the top Indian and international healthcare companies, medical technology, health insurance, health IT and start up companies in the country, has been arguing against the recent decision of the Ministry of Health and Family Welfare to add coronary Stents to the National List of Essential Medicines 2015 (NLEM 2015), bringing the product under price control, as medical devices cannot be treated through policies and framework made completely for pharmaceutical products. Besides, the a report of the ministry has indicated its desire to bring other cardiology products under NLEM as well.

In a meeting held last week between the senior officials of Department of Pharmaceuticals, National Pharmaceutical Pricing Authority (NPPA) and other stake holders, has discussed all aspects related to the pricing of the stents. NATHEALTH officials, following the meeting, said that the government is soon expected to come out with a policy related to this.

During the meeting, the clinicians and experts recommended to the Government that a DES classification norm through a matrix be prepared through a detailed workshop deliberating on all the relevant criteria like type of drug, type of alloy, strut thickness, polymer profile, deliverability and trackability, among others.

"There seems to be a consensus among clinicians, government and industry that a scoring matrix, with above parameters, should be designed to determine the DES classification and NATHEALTH sincerely requests the Government to follow up through a multi-stakeholder workshop to design the matrix," said Anjan Bose, secretary general, NATHEALTH.

He earlier said that the decision to include stents under the NLEM has created apprehension among the foreign medical devices companies on investing in India. The industry has been concerned about the policy approach, rather than the size of the stent market in the country.

Medical Technology and other healthcare sectors also recommended that the government allows differential pricing for discrete generation stents as the new generation stents are believed to have better long-term patient-centric outcomes like low thrombosis and low re-stenosis rates.

It may be noted that the medical devices industry has raised concerns almost a decade back when the the centre took steps to include cardiac stents and DES notified as 'drugs' under section 3, clause (b) (iv), of the Drugs and Cosmetics Act & the Rules.