What is stent? how stent pricing has been in india?

1. STENT PRICING IN INDIA

2. What is Stent?
 In medicine, a stent is a metal or plastic tube inserted
into the lumen of an anatomic vessel or duct to keep the
passageway open, and stenting is the placement of a
stent. There is a wide variety of stents used for different
purposes, from
expandable coronary, vascular and biliary stents, to
simple plastic stents used to allow the flow
of urine between kidney and bladder. Stent is also used as
a verb to describe the placement of such a device,
particularly when a disease such
as atherosclerosis has pathologically narrowed a structure
such as an artery.

4. QUALITIES OF A GOOD STENT
 Low crossing profile
 High flexibility
 High host bio compatibility
 High radial strength
 Low metallic surface area
 Favorable radiographic properties
 Easy to deploy

5. TYPES OF STENT
 Coronary stents
 Vascular stents
 Stent graft or covered stent
 Ureteral stents
 Prostatic stents
 Esophageal stents
 Biliary stents

6.  Coronary stents are placed during a coronary angioplasty.
The most common use for coronary stents is in
the coronary arteries, into which a bare-metal stent,
a drug-eluting stent, a bio absorbable stent, a dual-
therapy stent (combination of both drug and
bioengineered stent), or occasionally a covered stent is
inserted.
 Vascular stents are commonly placed as part of peripheral
artery angioplasty. Common sites treated with peripheral
artery stents include the carotid, iliac,
and femoral arteries. Because of the external compression
and mechanical forces subjected to these locations,
flexible stent materials such as nitinol are used in a
majority of peripheral stent placements

7.  A stent graft or covered stent is type of vascular stent
with a fabric coating that creates a contained tube but is
expandable like a bare metal stent. Covered stents are
used in endovascular surgical procedures such
as endovascular repair. Stent grafts are also used to
treat stenoses in vascular grafts and fistulas used
for hemodialysis.
 Ureteral stents are used to ensure the patency of a ureter,
which may be compromised, for example, by a kidney
stone. This method is sometimes used as a temporary
measure to prevent damage to a blocked kidney until a
procedure to remove the stone can be performed.

8.  Prostatic stents are places from the bladder through
the prostatic and penile urethra to allow drainage of the
bladder through the penis. This is sometimes required
in benign prostatic hypertrophy.
 Esophageal stents are a palliative treatment for
advanced esophageal cancer.
 Biliary stents provide bile drainage from
the gallbladder, pancreas and bile ducts to
the duodenum in conditions such as ascending
cholangitis due to obstructing gallstones.

9. STATISTICS: STENT PLACEMENT
 The coronary stent market is expected to reach USD 10.31
Billion by 2021 from USD 7.16 Billion in 2016, at a CAGR of
7.6% from 2016 to 2021.
 Patients spend about Rs. 2,500 crore on cardiac stents alone
every year in India.
 An estimated four lakh stents were implanted in India in 2014
as per survey conducted by Indian Council of Medical
Research.
 While Prime Minister Modi talks of 'Make in India', when it
comes to stents, more than 60% of the market is with just
three US-based multinational firms - Abbot, Medtronics and
Boston Scientific, which import the stents.

10. CARDIOVASCULAR DISEASES






11. DOMESTIC COMPANIES
 Surat has emerged to be the biggest manufacturer of cardiac
stents in India. Nine of the 11 Indian companies manufacturing
stents — tiny tubes that make blood flow through choked
arteries — are based in Surat and neighbouring Vapi.
Example –
a) Vascular concepts ltd.
b) Nanotherapeutics private ltd.
c) Shahajanand medical technologies
d) Opto Circuits ltd.

12. INTERNATIONAL COMPANIES

13. PRICE SLABS PRIOR TO CAPPING
Five lakh stents were implanted in 2015, according to the
National Interventional Council (NIC) registry 2015.
Prices of drug eluting stents, used in 95% cases, range
between Rs 23,625 to Rs 1,50,000 in private hospitals.
In government establishments, the same stent costs only up
to Rs 60,000 .
There has been a lot of criticism about hospitals making huge
profits on stents, which in some cases was as high as 650%
according to NPPA.

14. PRICE CAPPING
 Prices of life-saving coronary stents -- a spring-like metal
device used to prop open blocked arteries -- have been
capped at Rs 30,000 by National Pharmaceutical Pricing
Authority (NPPA) which is a cost drop of about 85% from
what is commercially available.
 There are massive margins charged at each step in the
distribution and supply of stents, and by the time the
patient gets it, the increase from the original cost of the
stent is often in the range of 1,000-2,000%.
 There has been a lot of criticism about hospitals making
huge profits on stents, which in some cases was as high as
650%.

15. AFTER PRICE CAPPING RESULTS
BOOST IN DOMESTIC MARKET
Indian, Chinese and other non-US manufacturers seem to have benefitted from the
price control on cardiac stents, as they increased their share at the expense of
American companies in the Indian market for the device used to unblock coronary
arteries.
US stent firms posted a 14% reduction in the stents they distributed in 2017
compared with 2016, the data showed. These firms together distributed around 3 lakh
stents that year, compared with 3.5 lakh in the year before, even as their market share
fell to 33% from 39%.
At the same time, Indian firms upped their share of the market to 61% in 2017 from
57% in 2016. They distributed 5.4 lakh devices in the past year, up from 5.1 lakh in
2016.

16. NLEM (National List of Essential
Medicines)
 It is that the drugs included in it are adequate to meet the common
contemporary health needs of the general population of the country.
 It is one of the key instruments in balanced healthcare delivery system of a
country.
 It is the general obligation of the health administrators to ensure abundant
availability of these drugs in the country.
 The primary purpose of NLEM is to promote rational use of medicines
considering the three important aspects i.e. cost, safety and efficacy.
 The first NLEM was prepared and released in 1996.

17. PROCEDURE FOR DECLARING NLEM
 The Core-Committee was constituted by the Ministry of Health & Family
Welfare (MOHFW), Government of India, under the chairmanship of Dr VM
Katoch, the then Secretary, Department of Health Research (DHR) and
Director General, Indian Council of Medical Research (ICMR), and Dr YK Gupta,
Professor and Head, Department of Pharmacology, All India Institute of
Medical Sciences (AIIMS) as the Vice Chairman.
 The Core-Committee in its initial meetings deliberated and decided on the
criteria for inclusion and deletion of medicines in National List of Essential
Medicines (NLEM).

18. Continued…
 The criteria for inclusion of a medicine in NLEM are as follows: –
 The medicine should be approved/licensed in India.
 The medicine should be useful in disease which is a public health problem in
India.
 The medicine should have proven efficacy and safety profile based on valid
scientific evidence.
 The medicine should be aligned with the current treatment guidelines for the
disease.
 The medicine should be stable under the storage conditions in India.

19. Price Control
 Drug Price Control Orders (DPCO) are issued by the Government, in
exercise of the powers conferred under section 3 of the Essential
Commodities Act, 1955, for enabling the Government to declare a ceiling
price for essential and life saving medicines (as per a prescribed formula)
so as to ensure that these medicines are available at a reasonable price to
the general public.
 Price controls are applicable to what is generally known as “Scheduled
drugs” or “Scheduled formulations” that is, those medicines which are
listed out in the Schedule I of Drug Price Control Order (DPCO), issued by
the Government of India from time to time.
 NLEM forms the basis of deciding which medicines should come under
price control via DPCO.
 Since 2013, all essential medicines (as defined under NLEM) are treated as
scheduled formulations (under DPCO-2013)`

20. TIMELINE

21. TIMELINE -

22. Arguments for Price
Capping
1. Quality healthcare to masses at affordable prices.
2. Cardiac related diseases on rise, capping made
healthcare accessible.
3. Successive generation stents represent small
improvements but price increases exponentially.
4. Boost to indigenous players.
5. Transparency and better governmental control.

23. Arguments against Price Capping
1. Foreign companies withdrawing from market. Latest
generation stents not available at low prices.
2. Indian stents do not meet quality standards.
3. Disincentive for indigenous R&D as international
competition is reduced.
4. Benefit not passed on to patients.
5. Stents of lower price also introduced at ceiling price
and low prices leading to overuse.

24. Conclusion
1. Encourage and support Indian manufacturers to
improve quality.
2. Fund indigenous R&D to make indigenous products
globally competitive.
3. Aspects involving medical device development should
be fast-tracked and made transparent.

25. THEENKS …