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The Price

of Saving a Life
How Price Gouging of Naloxone
has put New Yorkers at Risk

Senator David Carlucci

NOVEMBER 2016

The Heroin & Opioid Problem


Heroin and prescription opioid abuse continue to be a life-threatening problem across the state of
New York. The addiction and substance abuse, particularly among teenagers and children, has
devastated families and their communities. Although prescription opioids are used to treat pain,
their abuse can lead to fatal consequences. They also serve as a gateway drug to heroin, which is
cheaper and does not require a prescription to obtain.
In the state of New York, 1,833 people died in 2014 due to heroin and prescription opioid
overdoses. Of those 1,833 New Yorkers, 825 died of heroin-related overdoses and 1,008 died
where opioids were a contributing cause. That represents a 23% increase from heroin deaths in
2013, in which 637 people died related to heroin use and 952 people died involving prescription
opioids. According to the Centers for Disease Control, 28,647 people died nationwide from
heroin and opioid related overdoses in 2014.

Heroin & Opioid Related Deaths


in New York 2013-2014
1,900
1,833

1,850
1,800
1,750
1,700

Number of Deaths

1,650
1,600

1,589

1,550
1,500
1,450
2013

2014

The Life-Saving Power of Naloxone


Naloxone was first approved by the Food and Drug Administration (FDA) in 1971 under the
brand name Narcan as an injectable medication. Naloxone is part of a family of drugs called
opioid antagonists, and acts in the human body by out-competing opioids in their ability to
connect with receptors in the central nervous system. Administration of a proper dose of
Naloxone has the effect of rapidly blocking opioid receptors and consequently placing the
recipient into a state of withdrawal from any opioids in their system. For recipients in a state of
opioid overdose, this rapid onset can have the effect of very rapidly bringing them back from the
brink of an overdose.
Currently, Naloxone is commonly found as a nasal injectable device with the use of an injectable
Naloxone form being assembled with a nasal atomizer device called a Mucosal Atomization
Device.1 This atomizer allows the Naloxone to be sprayed into the nasal cavity. Although this
nasal delivery method of Naloxone has been widely used for several years, the FDA did not
formally approve of a nasal spray delivery until November 18, 2015. On this date, the FDA
approved the product Narcan, manufactured by Adapt Pharma, which does not require
assembly. Prior to November 2015, Amphastar Pharmaceuticals was the only company to
manufacture Naloxone in a form that can be coupled with an atomizer to be used as a nasal
spray.2 The shelf life of Naloxone products is 18 to 24 months and should be replaced before the
expiration date of the product.

Naloxone Kit

Daniel Wermiling, A Response to the Opioid Overdose Epidemic: Naloxone Nasal Spray, US National Library of
Medicine: National Institutes of Health, Aug. 1., 2012,
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3668569/#R17
2
NPR, Price Soars for Key Weapon Against Heroin Overdoses, Sept. 10, 2015.

According to the State Health Department, Naloxone was administered during 11,992 emergency
medical service (EMS) calls in 2014, and administered during 7,649 EMS calls in 2013,
representing a 57% increase.3

EMS Calls Involving Naloxone


2013-2014 in New York
14,000
11,992
12,000
10,000
8,000

7,649
Number of Times Naloxone Was
Administered

6,000
4,000
2,000
0
2013

2014

The heroin and opioid epidemic in New York, while ravaging our communities, has also led to
reports of unscrupulous pharmaceutical manufacturers capitalizing on the success of Naloxone.
This life saving antidote blocks opioid receptors in the brain and can reverse the effects of an
opioid overdose.
In 2014, the New York State Senate created a bi-partisan task force to tackle the heroin and
opioid epidemic head on. As Co-chair of the 2014 task force, Senator Carlucci traveled across
the state, hearing from experts and New Yorkers affected by this epidemic. Since 2014, Senator
Carlucci has hosted Naloxone trainings and town halls with residents of the Hudson Valley, in
which more than 400 people have been trained in the use of Naloxone in workshops he has
hosted.
Recently, in June 2016, Senator Carlucci successfully negotiated the passage of his bill,
S.6346B, which was subsequently signed into law. The bill requires chain pharmacies with at
least twenty locations to register with the Department of Healths overdose prevention program
and to dispense opioid antagonists such as Naloxone, enhancing the publics access to the drug at
pharmacies across the state. Further, to combat the rise of heroin overdoses and addiction,
Senator Carlucci advocated for comprehensive legislation that was signed into law to increase
access to treatment, break down barriers from insurance carriers, and permit doctors to
administer naloxone.
3

NY State Dept of Health, OPIOID POISONING, OVERDOSE AND PREVENTION (2015)

The Price of Saving a Life


The growing heroin epidemic and increases in overdoses has led to an increase in Naloxone sales
and new Naloxone products. Sales of Naloxone have quadrupled in the past few years from
$21.3M in 2011 to $81.9M in 2015.4 Today, there are five main pharmaceutical companies
manufacturing Naloxone under either a generic or brand name: Amphastar Pharmaceuticals,
Adapt Pharma, Pfizer, Mylan, and Kaleo Inc. Naloxone can be bought as a nasal spray,
injection, or auto-injector. Injectable versions are cheaper to manufacturer than the nasal spray
and auto-injector.
Amphastar manufactures pre-filled injectable syringes of Naloxone in which an atomizer can be
attached. It is commonly used by EMT workers, fire department personnel and most recently,
police officers. Amphastars version was first approved in 2001, starting at $12 per dose and
increased to $41 in January 2015. Naloxone kits provided to the New York City Police
Department by funding from the New York Attorney Generals Office cost $60 each, with each
kit containing two pre-filled syringes, two atomizers, sterile gloves, and an instructional booklet.
Amphastars President, Jason Shandell, explained the reason for the price increase: "Like other
companies in the industry, manufacturing costs for our entire portfolio of products, including
Naloxone, have been steadily increasing due to the continued rise in costs for raw materials,
energy, and labor over the recent several years." However, the compensation of its CEO also
increased from $4.5 million in 2014 to $5.8 million in 2015.5

Amphastars injectable naloxone with atomizer for nasal spray

James T. Mulder, Cost of Nalaxone, the Life-saving Drug in Heroin Battle, Soars as Epidemic Grows, SYRACUSE
POST-STANDARD, Oct 20, 2016.
5
Brian Albright, Navigate the Nalaxone Economy, Behavioral Healthcare, Aug. 2, 2016,
http://www.behavioral.net/article/prescription-drug-abuse/navigate-naloxone-economy?page=2

In 2014, Attorney General Schneiderman wrote a letter to Amphastar, criticizing its increase in
Naloxone pricing and asking for further information about the price increase. In the resulting
settlement in 2015, the company agreed to provide a $6 rebate per dose for customers, with an
additional rebate to be offered to offset any future wholesale price increase of the drug.6 That
agreement was extended in 2016 for an additional year and covers purchases of Naloxone by the
State Department of Health, the City of New York, all counties in the state, 479 CVS stores
across the state, and drug treatment centers.7 On November 3, 2016, the Attorney General
announced another one-year extension of the agreement, through January 2018. Schneidermans
settlement is one of many lawsuits that Amphastar is settling with attorney generals across the
country, by providing each state with a $6 rebate per dose.

Amphastar's Price Increase of Naloxone


$45

$41

$40
$33

$35
$30
$25
$19

$20
$15

$12

$10
$5
$0
October 2011

June 2014

October 2014

June 2015

Naloxone Price

NY Attorney General, Final Naloxone Agreement Executive,


http://www.ag.ny.gov/pdfs/Final_Naloxone_Agreement_Executed.pdf
7
NY Attorney General, Extension of Naloxone Payment Agreement, January 18, 2016,
http://www.ag.ny.gov/pdfs/Amphastar-NYAG_Agreement_to_Extend_Program.pdf

Adapt Pharma received approval from the FDA on November 18, 2015, for an all-in-one nasal
spray device, which does not need an atomizer attached. This nasal spray device was
trademarked as Narcan.8 Each Narcan package contains two single-use nasal sprays, with each
single-use spray containing 4 milligrams of Naloxone. Narcan began selling at the end of 2015
for $125 for its two-dose package with nearly a half-price cost to first responders and customers
without insurance, at $75.9 Narcan has not increased in price since it began sales in 2016. 10

A demonstration of how to administer Narcan

Kaleos Price Increase of Naloxone


Kaleo, Inc., which produces a hand-held pre-filled Naloxone auto-injector called Evzio, has
drastically increased the price of its Naloxone product since it first went to market. Evzio was
approved in 2014 and works like an EpiPen. A person can easily administer it without needing
medical training. Each Evzio package contains two auto-injectors, each with 0.4 milligrams of
Naloxone, and one trainer container for practice.
Evzio was approved by the FDA on April 3, 2014 and began sales at $575 for its two-dose
injector. Prices soared to $3,750 by 2016.11 Evzios shelf life is two years. Kaleo sells Evzio to
EMS personnel at $250 when financed by federal grants. 12
8

US House of Representatives, Judiciary Subcommittee on Regulatory Reform, Commercial and Anti-trust Law,
Treating the Opioid Epidemic: The State of Competition in the Markets for Addiction Medicine, Testimony of Mark
Merritt, Sept, 22, 2016, https://judiciary.house.gov/wp-content/uploads/2016/09/Merritt-Testimony.pdf
9
David Armstrong, FDA Approves Nasal Spray that Reverses Opioid Overdose, Stat,
https://www.statnews.com/2015/11/18/fda-nasal-spray-overdose/
10
Krystal Alexander, Before the EpiPen and Daraprim there was Nalaxone- Generic Price Gouging Has a History,
AMERICAN COUNCIL ON SCIENCE & HEALTH, Sept. 2, 2016. http://acsh.org/news/2016/09/02/epipen-and-daraprimthere-was-naloxone-%E2%80%94-generic-price-gouging-has-history-9940
11
Sarah Karlin-Smith, Price Spikes for Life Saving Drug, Politico, http://www.politico.com/story/2016/05/drugprices-addiction-223192

Evzio Price 2014-16 for 2-Dose Package


$5,000.00
$4,500.00

$4,500

$4,000.00

$3,750

$3,500.00
$3,000.00
$2,500.00
$2,000.00
$1,500.00
$1,000.00
$500.00

$750

$690.00

$0.00
Nov-14

Nov-15

Feb-16

Sep-16

Pfizers Price Increase of Naloxone


Pfizer, which owns Hospira, sells an injectable Naloxone. Wholesale Prices started in 2005 at
$1.10 per dose and are currently $15.80 per dose. Mylan also entered the market in 2014 with
an injectable form of nalaxone and it sells for $23.70 per vial, the same price in which it entered
the market in 2014. Each vial has 0.4 mg/ml.
Comparison of Naloxone Price Increases by Company
Manufacturer

Delivery Type

Starting Price

Current Price

Price % Increase

Pfizer

Injection

$1.10 per dose


(2005)

$15.80 per dose

1717%

Kaleo (Evzio)

Auto-injection

$690 for 2-doses

$4500 for 2doses

652%

Amphaster

Injection (plus atomizer)

$12 per dose


(2001)

$41 per dose


(with $6 rebate)

342%

Adapt (Narcan)

Nasal Spray

$125 for 2-doses


(Nov 2015)

$125 for 2-doses

0%

Mylan

Injection

$23.70 per dose


(2014)

$23.70 per dose

0%

12

US House of Representatives, Judiciary Subcommittee on Regulatory Reform, Commercial and Anti-trust Law,
Treating the Opioid Epidemic: The State of Competition in the Markets for Addiction Medicine, Testimony of Dr.
Eric Kretchem https://judiciary.house.gov/wp-content/uploads/2016/09/Ketcham-Testimony-.pdf

Other Drugs
Epinephrine
Mylan is the main manufacturer of EpiPens. The product was sold in 2007 at $93.88 and sold in
2009 at $103.50 for a 2-pack. The price of a set rose to $461 in May 2015 and was sold at
$608.61 in May 2016.13 Mylan also offers a $100 coupon for the product. Epipens may expire
after just a year, requiring customers to get new EpiPens on almost an annual basis. Attorney
General Schneiderman is currently investigating Mylan for antitrust violations. The Attorney
Generals preliminary review revealed that Mylan inserted anti-competitive terms into its sales
contracts with school districts, resulting in the state paying artificially high prices for the
medicine.
EpiPen 2-Pak Price Increase (adjusted for inflation)
Date

EpiPen Price

November 1, 2004

$106.32

February 23, 2005

$106.96

February 23, 2006

$107.76

February 22, 2007

$108.96

January 16, 2008

$110.18

October 12, 2009

$139.42

August 3, 2010

$150.76

May 12, 2011

$176.50

July 27, 2012

$229.52

July 17, 2013

$273.24

May 2, 2014

$354.94

May 1, 2015

$468.06

November 23, 2015

$537.80

May 16, 2016

$608.61

Source: Elsevier Clinical Solutions Gold Standard Drug Database14

13

Tara Parker Pope, EpiPen Price Rise Sparks Concern for Allergy Sufferers, Aug. 22, 2016, NY Times,
http://well.blogs.nytimes.com/2016/08/22/epipen-price-rise-sparks-concern-for-allergy-sufferers/
14
Ike Swetlitz, High Price of EpiPens Spurs Consumers, EMTs to resort to syringes for Allergic Reactions, Stat,
July 6, 2016

Buprenorphine
Buprenorphine was approved by the FDA in 1985 and is used to treat heroin addiction. The
effects of the medication are weaker than methadone and heroin, causing only a limited response
to the central nervous system, and is considered a safer alternative than methadone by the DEA.
In 2012, at least one million people received a subscription for a brand name or generic of
Buprenorphine.
Wholesale prices for 8 miligram generic buprenorphine tablets have increased from $2.37 per
tablet to $5.57 per tablet. A 30-day supply of the generic drug costs $334.20 with patients
needing to take two daily tablets. Buprenorphine is also sold in combination with Naloxone at a
price of $470 for the brand name drug sold by Suboxone, Zubsolv, and Bunavi. Generic
versions of the drug are more expensive than the brand names with generics being sold at $10.42
per tablet and $625.28 for a 30-day supply.15

15

Testimony of Dr. Eric Kretchem, supra note 10.

State Action and Legislative Solutions


The demand for Naloxone has never been higher with first responders, municipalities and states
across the country stocking up on Naloxone to prevent heroin and opioid related deaths. As the
data demonstrates, the price of Naloxone has shot up dramatically from $12 per dose to $41 per
dose by Amphastar; from $5690 to $4500 for a 2-dose package by Kaleo, and from $1.10 to
$15.80 per dose for Pfizers Naloxone. Naloxone must be kept affordable for families and not
conditioned on the amount of money a person has in their pocketbook.
Senator Carlucci has introduced S.8182-B, to provide a civil remedy for the price gouging of
pharmaceutical drugs with enforcement by the Attorney General. If the Attorney General
believes that the pharmaceutical drug price is unconscionable and brings a civil action against the
manufacturer, the court may impose a civil fine of up to $1 million against the pharmaceutical
manufacturer and order restitution to affected consumers of the product. A court would
determine if the price is unconscionable based on any unfair leverage against the consumer,
gross disparity in market price, the price increase over the six-month period, and the factors that
led to the price increase. The legislature must pass this bill when session resumes and the
attorney general should also investigate Naloxone manufacturers for potential price gouging.

Conclusion
The heroin and opioid epidemic continues to ravage our communities at an unprecedented rate.
Although legislative efforts and public awareness events have made a difference in the fight
against this epidemic, more work is needed to protect our communities. Pharmaceutical
companies must be held accountable where suspected price gouging has occurred of vital
prescriptions, including with price increases of Naloxone. Passage of crucial price gouging
legislation will help achieve that goal.

10