Affordable coronary care in the offing

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The Government's nod to the inclusion of coronary stents under price control list has evoked mixed reactions. Price and quality must be ensured

After much deliberation and constant pressure from healthcare activists and despite protests from the pharma industry, the department of pharmaceutical under the Ministry of Chemicals and Fertilisers notified the inclusion of coronary stents in the Drug Prices Control Order Schedule-1 on December 21 last year. The notification categorises the life-saving device into two — Bare Metal Stents and Drug Eluting Stents (DES) which includes metallic DES and Bioresorbable Vascular Scaffold (BVS)/ biodegradable stents.

Following the Government's notification to bring coronary stents under the country's drug price control order, the National Pharmaceutical Pricing Authority (NPPA) is working on regulating and capping the prices of life-saving devices. Once this happens, this medical device will be well within the reach of poor patients. At present, the stents are put in the rich and the affluent just for the sake of profit.

However, it is not going to be an easy affair for the NPPA, given the clout of the pharma manufacturers, hospitals and doctors, besides distributors, whose profit margin is at stake when an individual stent is sold. Moreover, quality has to be ensured.

No wonder, the notification and the NPPA's move, to consider capping of prices of coronary stents, has evoked mixed response from stakeholders. For information, stents forms a major cost of the angioplasty and stenting procedure. Various types of coronary stents are available with costs ranging from Rs24,000 to Rs60,000.

But the prices on which these devices are made available to the patients is several times higher than the actual cost. Thus, this was a highly profitable business for those selling this device as well as those advising its implementation — doctors, hospitals, distributors - all were at the receiving end. Since stakes are high, the NPPA may take its own time to decide on settling the selling price of the stents.

In this connection, members of the Alliance of Doctors for Ethical Care (ADEH) met the NPPA recently and urged it to permit sellers a 20 per cent profit margins on the cost price of stents. The ADEH was of the view that the sellers should be given around 20 per cent profit margin on the cost price.

The ADEH which has eminent doctors like Samiran Nundy of Gangaram Hospital, GS Grewal (former president, Punjab Medical Council), Arun Mitra (former chairman, Ethics Committee of Punjab Medical Council) and Sanjay Nagral (gastroenterologist from Mumbai) on its board suggested that the price of each stent should be displayed in the reception counter of the facility putting stents. Additionally, patients should be given the choice of stent with full scientific explanation. Indigenous production should be encouraged and facilitated. Import duty and other taxes should be waived off, suggested.

“The recently announced formation of a Medical Technology Assessment Board (MTAB) by the Government will go a long way in standardising and regulating stent quality in India and usher in the much needed transparency which would also enable pricing standardisation in a more rationale manner”, said Anjan Bose, Secretary General, Healthcare Federation of India. The organisation has expressed its concern that the notification may hamper procedural complexity based choice — both for the treating doctor and the patient.

Bose added that they were also concerned that this decision may disincentivise technology companies from launching newer, safer and more efficacious drug eluting stents in India. Since 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. He also pointed out that the Government will have to look into the impact of complex tax structure and a high inventory cost-based consignment supply chain model which escalates the stent price. “Unlike delivery of medicine, stent delivery requires hospitals to invest in developing and maintaining quality infrastructure, skilled resources, and operative overheads”, said Bose. It has recommended the Government allows for differential pricing for discrete generation stents as the new generation stents are believed to have better long-term outcomes.

However, after intense deleberation with the healthcare sector, the ball now lies in the NPPA court. The Government pricing control body has to ensure that the medical device is within the reach of the poor without compromising the quality.

(The writer is Special Correspondent, The Pioneer)

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