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WHITE PAPER ON MEDICAL DEVICES

1. Differential pricing pattern of stents worldwide especially in developed and


developing countries.
The price of medical technologies, such as stents, is often considered as one driver of the
increasing costs of healthcare. In the developed countries, earlier the doctors would solely
make the decisions which are now made by the regulators, hospital administrators and
other non-clinicians. They have different objectives in mind, like prioritization of cost
effectiveness. This has resulted in diversion of the focus from the individual to
population-level effectiveness, such as the general, overall improvement in the public
health, within a given level of spending. The emerging markets of the developing
countries, which earlier acted as a safe haven for the premium products, are now
introducing various regulatory reforms and price control mechanisms. This is done to
address the increasing demands of the growing middle class population and investment in
the healthcare sector. At the same time, the medical devices industry has become more
competitive. Growing use of tenders in Europe and the United States has brought a
greater price transparency.
In developing countries like India, most patients are forced to shell out an amount
between Rs 60,000 and Rs 1 lakh or more for cardiac drug eluting stents (DES) whereas
the very same stents cost Rs 28,000-Rs 48,000 even in rich European countries and the
UK, where there is price control or a fair pricing mechanism for medical devices.1
The Maharashtra FDA report cites the example of drug eluting stents manufactured by
Abbotts Vascular Devices Holland BV, a Holland-based firm. These stents were imported
into India by Abbotts Healthcare Pvt Ltd at Rs 40,710 and sold to the distributor Sinocare
at Rs 73,440 against a marked MRP of Rs 1.5 lakh. The distributor then sold it at Rs 1.1
lakh to Hinduja hospital, which in turn charged the patient Rs 1.2 lakh, a near three-fold
jump over the import price.2 This high price of stents, as well as the absence of

1http://timesofindia.indiatimes.com/india/Patients-pay-three-times-import-price-forstents/articleshow/42483945.cms
2http://timesofindia.indiatimes.com/india/Patients-pay-three-times-import-price-forstents/articleshow/42483945.cms

incremental reimbursement in most countries, has been an obstacle to more widespread


utilization of drug-eluting stents.3
The high cost of these stents are inclusive of the costs relating to developmental and
research, acquisition of exclusive and expensive licenses from pharmaceutical companies,
building of new manufacturing facilities, and low production yield in the early stages of
the new product.4 In developed countries, like the US, there is an insurance and
reimbursement-based healthcare system and patients do not have to pay the entire
expense from their pocket. In fact, there is a decline US stunt market. This is due to
overall decrease in stenting procedures due to over-stenting and a preference for drugbased therapy in order to prevent heart attacks and death in patients with stable heart
disease.5 Bare-metal and drug-eluting stents have decreased in price due to the increasing
number of stent brands available, and the pricing pressures arising from increased
competition.6 Also, due to the evolution in technology, for example, introduction of the
SYNERGY Stent, a bioabsorbable Polymer Drug-Eluting Stent System (BP-DES) which
is designed to improve patient outcomes, there is ultimately a reduction in health care
costs associated with the treatment of coronary artery disease. 7 This is supported by a
strong regulatory framework (U.S. regulatory approval stent trial to check the
performance and safety of the SYNERGRY stent) and a robust clinical program, which is
mostly absent or in-making in the developing countries.
In India, steps are being taken to cap the exorbitantly high prices of the cardiac stents.
National Health Systems Resource Centre (NHSRC), a technical support institution under
the ministry of health and family welfare, has submitted its final report to the National
Pharmaceutical Pricing Authority (NPPA) in relation to capping of prices. Going by the
3 http://circ.ahajournals.org/content/107/24/3003.full
4 http://circ.ahajournals.org/content/107/24/3003.full
5https://globenewswire.com/news-release/2015/05/12/735066/10133998/en/U-S-Coronary-StentMarket-in-Decline-due-to-Over-Stenting-Procedures-Market-Led-by-Boston-Scientific.html
6 Id.
7http://news.bostonscientific.com/2015-10-05-Boston-Scientific-Receives-FDA-Approval-ForSYNERGY-Bioabsorbable-Polymer-Drug-Eluting-Stent-System

report, the prices of bare metal stents could be capped at 19,000 and the maximum price
for drug eluting stents may be fixed at 28,000. 8 In comparison to the US, this range is
seen as equal to or slightly higher, given that the US has an insurance and reimbursementbased healthcare system and patients do not pay the entire expense. Industry estimates
suggest stent prices in China, Singapore and Malaysia are roughly one and half times
higher as compared to India.9 Absence of the price regulation led to a huge exploitation of
consumers due to extreme overpricing of stents, especially imported brands, as stated by
the NHSRC report. This report faced opposition from the Medical Devices industry,
which is split up into domestic and multinational players.
According to the global players, attention should be paid to the quality of the imported
products and overall hospitalization charges before imposing a price control. On the other
hand, the domestic stent makers emphasize on the steep information symmetry and
aggressive promotions of big companies as reasons for Indias import dependency.
In order to regulate the Medical Devices industry, a Draft National Medical Policy was
introduced, which recommended for the creation of an autonomous body called the
National Medical Devices Authority (NDMA) which aims at controlling the price of the
Medical Devices by including them under the Essential Commodities Act. It also aims at
introducing separate pricing division in the drug pricing regulator, NPPA.
As per the Draft, government may announce a separate policy enunciating the principles
for regulating the prices of identified medical devices and implement the same by
notifying a separate Medical Devices Prices Control Order (MDPCO). In a patientfriendly measure, the draft mentions adopting policies on efficacy and safety testing, and
quality control through a 'Made in India' marking (BIS) specific to medical devices in line
with global standards.10

8 http://health.economictimes.indiatimes.com/news/medical-devices/capping-cardiac-stent-prices-infinal-lap/48445997
9 http://health.economictimes.indiatimes.com/news/medical-devices/capping-cardiac-stent-prices-infinal-lap/48445997
10 http://pharmaceuticals.gov.in/sites/default/files/Draft%20National%20Medical%20Device
%20Policy%20-%202015.pdf