The government has shown its willingness to make NLEM effective and rational by incorporating the recommendations of various stakeholders including medical technology and provider sectors.
In recent meetings with the sector representatives, senior officials of the Department of Pharmaceuticals (DoP) and the National Pharmaceutical Pricing Authority (NPPA) deliberated in detail all aspects and issues related to pricing mechanism for stents.
It is expected that the government would soon come out with a robust policy which would be effective, relevant and acceptable to all, which will create a balance between quality patient care and the sector’s healthy growth.
Appreciating the government’s move and the positive, balanced approach, President-NATHEALTH, Rahul Khosla said, “We welcome DOP/NPPA’s consultative and inclusive approach by involving providers/eminent clinicians.
NATHEALTH, as a unique collaborative multi segment platform, is aligned with the government’s approach. It also stresses on the fact that all Drug Eluting Stents (DES) cannot be considered the same.
During the consultation meeting, the clinicians and experts recommended to the Government that a DES classification norm via 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 / Track-ability etc.
It was also suggested that the classifications should be based on published safety and efficacy outcome data and global regulatory approvals need to be taken into consideration.
“There seemed to be a consensus amongst 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 Secretary General NATHEALTH, Anjan Bose.
MedTech and Provider 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.
According to them, this is imperative to keep the innovation momentum going. Hence having different pricing (or percent reduction in proposed pricing) slabs categorized by different stent types, is recommended.
It is widely agreed that rising Non-Communicable Disease (NCD) burden may have prompted the government to bring in Stents in the National List.
Additionally, the Committee of experts constituted by the Union Ministry of Health and Family Welfare (MoHFW), in its report, has indicated its desire to bring other cardiology products under NLEM as well.
The reason cited for this action is the Government’s desire to improve the number of Percutaneous Cardiac Interventions (Angioplasty).
There is sufficient evidence that generational improvements in DES through incremental innovation has resulted in improved patient outcomes (Thrombosis and Re-stenosis reduction for example).
“NATHEALTH feels that there is a great collaborative opportunity here for Healthcare Providers and MedTech Industry to work together providing the Government with the required support and input which should result in improved healthcare accessibility and affordability without compromising on the genuine needs of the industry considering the differences between Drugs and Devices,” added Bose.
“Coronary Stent is an essential device for ensuring optimal outcomes for coronary/ cardiac procedures. Selecting the appropriate stent for each procedure should be the choice of patients and medical practitioners in order to ensure such optimal outcomes. Bringing stents under the ambit of a totally pharmaceutical-style pricing control regime will restrict their inflow and usage into India, and thus, negatively impact patient choice and outcomes,” added Khosla.
NATHEALTH, which is a unique collaborative forum comprising of both healthcare providers and medical technology companies as well as Diagnostic, Health Insurance, Health IT, Health Education, Health innovators/start-up companies has been constantly engaging with several Government Agencies to explain that due to their uniqueness, medical devices cannot be treated through policies and framework made completely for pharmaceutical products.
In this context, NATHEALTH sincerely appreciates Government’s desire to seek and integrate various stakeholders’ input in the final policy decisions.