In view of recent government notification to bring stents under drug price control order and its implications on healthcare technology providers, Healthcare Federation of India (NATHEALTH) has suggested that the government needs to form a Health Technology Assessment Board for standardizing and regulating the stent quality in India.
Medical procedures in India are among the most affordable in the world, which is a combination of cost of devices and services. Any notification should be considered only if it can bring down the overall cost of treatment for the patient without denying them the options to avail the treatment of their choice. Additionally, such notifications significantly impact the ‘Make in India’ attractiveness of the country, said Rahul Khosla, president, NATHEALTH.
With recent government notification to bring stents under the country’s drug price control order, the prices of the life saving device would be regulated and capped by the National Pharmaceutical Pricing Authority (NPPA).
“Recently announced formation of a Medical Technology Assessment Board (MTAB) by the Government would go a long way in standardizing and regulating stent quality in India and usher in the much needed transparency which would also enable pricing standardization in a more rationale manner,”Anjan Bose, Secretary General, NATHEALTH said.
On 21st December 2016, the Ministry of Chemicals and Fertilizers – Department of Pharmaceuticals, notified that the Central Government include Coronary Stents in the Drug Prices Control Order Schedule-1. The notification categorizes Coronary Stents into two: Bare Metal Stents (BMS), and Drug Eluting Stents (DES) which include metallic DES and Bioresorbable Vascular Scaffold (BVS)/ Biodegradable stents.
According to NATHEALTH, almost 80 per cent of the healthcare services in India is provided by private care facilities. As supporters of high quality, safe and reliable patient care, the Federation has expressed its concern that the notification may hamper procedural complexity based choice – both for the treating doctor and the patient.
“We are also concerned that this may disincentivize technology companies from launching newer, safer and more efficacious Drug Eluting Stents in India. Since the latest globally accepted technology will not be available to international patients, they may abandon Indian hospitals. This may also cause the flight of “high quality” seeking Indian patients to overseas hospitals in neighboring countries,” Bose added.
While extending full support to the Government’s direction to drive affordability of medical devices, NATHEALTH sincerely hopes that the Government will take cognizance of quality classification based devices pricing.
“The Government also needs to consider the impact of complex tax structure, and a high inventory cost based consignment supply chain model, which escalates the stent price. We should leverage proposed GST model law to rationalize the pricing and have requested government to consider the same favorably,” emphasized Probir Das, Governing Council Member and Vice Chairman, Medical Technology Forum- NATHEALTH.
“Unlike delivery of medicine, Stent delivery requires hospitals to invest in developing and maintaining quality infrastructure, skilled resources, and operative overheads,” said Bose
“Exact requirement can be ascertained at the time of procedures, which requires hospitals to maintain high inventory (different size, quality and type) and thereby incur holding costs. It takes 60 days for hospitals to recover charges from TPAs and 200+ days from CGHS. This delay adds significant capital costs,” said Anjan Bose, Secretary General, NATHEALTH.
Additionally, NATHEALTH also feels that this will impact India’s Industry friendly image globally.
“We have been constantly engaging with several Government Agencies to explain that due to their uniqueness, medical devices cannot be treated through exactly similar policies and frameworks made for pharmaceutical products. However the notification shows that we still have some work to do…And, we are very thankful that NPPA has invited various healthcare sector representatives for deliberations in early January.” said Milan Rao, Vice President NATHEALTH
The main objective of a welfare state is to provide access to affordable healthcare to all and regulations by the government come with this aim. “The government needs to provide affordable access to drugs and devices, hence regulating prices of medicines and devices is fully justified. However, quality/efficacy of products and clinical outcomes need to be given due priority for patient safety and other critical reasons,” said Mr. Bose.
Hence, NATHEALTH recommends that the government allows for differential pricing for discrete generation stents as the new generation stents are believed to have better long-term outcomes (low thrombosis and low restenosis rates) for patients. This is imperative to keep the innovation momentum going.
NATHEALTH uniquely represents the entire eco-system of healthcare including Healthcare Providers/hospitals/Nursing Homes, Diagnostic Laboratories, Health IT firms, along withMedical Technology enterprises, Homecare, Health Insurance, Health Education and Health Start-up Companies. NATHEALTH recommends separation of medical devices from drugs through a new Act proposed to be tabled in Parliament.