Also
Proposes Classification Of Life-Saving Tubes
Moving a
step closer to capping stent prices, the drug price regulator has proposed
classifying the life-saving tubes which keep blood vessels open under two
categories and could offer up to 50% reduction in the cost of drug eluting
cardiac stents. If accepted, the National Pharmaceutical Pricing Authority's
(NPPA) proposals will become effective from February . The stents have been
primarily placed under two categories -drug eluting stents (DES) and bare metal
stents (BMS) with NPPA setting out an option to fix prices.
The
options include fixed percentage margins over average price to distributor,
hospital, on production cost and on landed cost for imported products. For
instance, while most proposed DES ceiling prices are in the range of Rs
20,000-Rs 40,000, the highest at Rs 67,272 has been calculated using the
average price of the stent to the hospital topped with a 16% margin. Similarly
, another suggestion to fix price of DES at Rs 39,978 is based on average price
to the distributor plus a 16% margin.
The
pricing decision is now in its final stages with NPPA asking all stakeholders
to submit suggestions on the proposed options by January 26.The regulator has
also asked companies to submit documents and relevant data to support their
representations.
Besides
these options, the regulator has also suggested using the current CGHS
pricing.Companies provide high quality stents at best prices under the central
government health scheme. The maximum retail prices of DES in the market can go
up to around Rs 2 lakh, whereas the reimbursement rate for DES under CGHS is Rs
22,500.
NPPA, in
its notification dated January 13, has also suggested fixing prices with an
annual hike on CGHS price for both DES and BMS categories.
The
regulator has proposed that ceiling prices of drug elut ing stents, which also
include biodegradable stents, be fixed at rates ranging between Rs 10,699 to Rs
67,272. For bare metal stents, the price ranges between Rs 8,422 to Rs 15,211.
In case of bare metal stents, NPPA has differentiated between stainless steel
and cobalt stents and accordingly suggested price caps.
The
regulator, however, has not accepted suggestions from medical device makers,
mainly multinational companies, to further differentiate ceiling prices of drug
eluting stents based on a matrix that includes criteria like complexity of the
stent design or how innovative it is.
Manufacturers
have also strongly opposed CGHS as well as distributor price-based mechanisms
which set prices at a lower range. “NPPA is open to considering additional
options, if any , which may be suggested by any of the stakeholders,“ an
official said.
Source: TIMES OF INDIA-16th January,2017
