Tag Archives: naloxone

The price of a life-saving overdose treatment has increased 680% to $4,500 in the last 3 years


An emergency medication often referred to as an “antidote” for opioid overdoses has been skyrocketing in price over the last few years.

The device, the only auto-injector version of naloxone, is called Evzio, and it’s made by Kaleo. 

Naloxone instantly reverses opioid overdoses by blocking the drug from interacting with the brain’s receptors. It has been on the market since 1971.

In 2014, when Evzio was approved in the US, the list price was $575 for a two-pack. Now, it has a list price of $4,500 — an increase of 680%.

Kaleo, a private company based in Richmond, Virginia, also owns Auvi-Q, the emergency epinephrine device that made headlines in October 2016 when the company announced it would come back to the US as competition to the EpiPen after getting recalled a year earlier. The Auvi-Q and Evzio use the same auto-injector technology to deliver their respective emergency medications. 

The list price for a two-pack of the Auvi-Q comes in at $4,500 as well, though the company maintains that the cash price for people without insurance is $360 and that more than 200 million people will be able to get the device with a $0 copay. That list price is roughly 640% higher than the list price of the EpiPen, which was singled out in August 2016 for increasing the price of a two-pack by 500% over the course of seven years.

Now, the list prices of the two drugs is catching the eye of Democratic Senator Amy Klobuchar of Minnesota, who sent a letter Friday to Kaleo asking for more information about the company’s pricing strategy.

List prices don’t often tell the whole story when it comes to a drug’s price. There are other players in the system that each take a piece, which means that what a drugmaker actually receives could be lower even as the list price rises. Kaleo declined to comment on its average net price for Evzio. 

“When setting the ‘list’ price for products, kaléo always starts with the needs of the patient first and then engages with multiple stakeholders in the healthcare system,” Kaleo’s vice president of corporate affairs Mark Herzog said in a statement emailed to Business Insider. “Following these discussions, in order to help ensure our product is available as an option to most patients for $0 out-of-pocket, we set the list price at $4500.”

The rationale of the company’s pricing strategy didn’t seem to satisfy Klobuchar. 

auvi q 

“I understand that Kaleo is trying to mitigate the impact on consumers by providing Evzio for free to cities, first responders, and drug treatment programs, and offering various programs to help ensure that no consumer pays the $4,500 price for Auvi-Q,” Klobuchar wrote. “While these subsidies and programs are noteworthy, I am concerned that they do not address the underlying problem of rising prescription drug costs.”

This isn’t the first time rising naloxone prices have been called out. Until recently, Evzio’s price had been $3,750 per two-pack. And across the board, naloxone prices have been skyrocketing, as Business Insider’s Harrison Jacobs has reported.

However, most other naloxone options — syringes, and a nasal spray — have list prices in the hundreds for sets of 10 vials or two nose sprays. As a proportion of total naloxone market, Evzio made up roughly a third of prescriptions in 2016, according to data from IMS Health.

It remains to be seen how many prescriptions transfer from the EpiPen to the Auvi-Q. Before it was recalled, Auvi-Q only had a small share of the market at a list price of around $500.

But its high list price is already turning off health insurers and pharmacy benefits managers. FiercePharma reports that Cigna, Humana, and the pharmacy benefits manager Express Scripts have come out against the pricing strategy for Auvi-Q, while Aetna is putting it on restricted coverage. The device officially launches in the US on February 14. 

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U.S. Attorney General addresses opioid, heroin addiction during Richmond town hall


BY CRITLEY KING CNHI News Service

Lynch

RICHMOND — U.S. Attorney General Loretta Lynch spoke to a crowded auditorium at a Town Hall meeting in Richmond as part of the Obama Administration’s newly designated National Prescription Opium and Heroin Epidemic Awareness Week.

The audience, mainly consisting of young people, was addressed on the dangers of heroin and opioid addiction, the pathways that lead to destruction, and the redeeming hope that help is available.

“I want to hear your questions, I want to hear your comments, I want to hear your ideas about how we can solve this (crisis), and about how we can prevent this,” said Lynch on Tuesday at Madison Central High School. “It’s not just putting people in jail, its about stopping it before it happens. And making sure people that do have a problem get treated.”

In her opening comments, Lynch asked the nearly 500 students if they had been considering where they would go to college, what careers they had planned for their futures, whether as journalists, doctors, law enforcement, teachers or fashion bloggers.

Then, Lynch told the students to look around at their classmates and friends and asked them to consider that last year, in Kentucky, approximately 12,000 died from opioid and heroin abuse overdoses.

“Imagine if all of you and others who fill these chairs were suddenly gone,” said Lynch. “And then that each of you had a friend, just one of your friends each, all gone. That’s what happened last year in Kentucky. That’s why this is so important.”

The chief law enforcement officer in the U.S. spoke about not only the problem of substance abuse and how to stop it, but also how to prevent it from even starting.

Lynch also put out a call to action to the students.

“We are talking to young people like you, because you have a role in this effort,” she said. “We want you to understand the issues, we went you to understand how serious it is, and we went to give you the information you need to make good choices in your own life. We also need you to look out for each other.”

During a question and answer session with local high school students, Kayla Greene, who lost her son to overdose, Tonya Snyder, MCHS social worker, Alex Elswick, a recovered addict, and MCHS student Julia Rahimzadeh, joined Lynch onstage.

Later in the day, Lynch traveled to make remarks at the University of Kentucky. Both events were part of the awareness week and the President’s Cabinet and Federal agencies’ focus on work being done/new efforts to address the national prescription opioid and heroin epidemic, according to a release by the Office of the Press Secretary.

The release also noted that Federal agencies are currently taking actions such as:

Expanding substance abuse treatment in the TRICARE system so that it includes intensive outpatient programs and treatment of opioid disorders with medication-assisted treatment.

Working with the Chinese government to combat the supply of fentanyl and its analogues from entering the U.S.

Increasing patient limits from 100 to 275 for practitioners prescribing buprenorphine to treat opioid use disorders.

Support programs that increase access to healthcare, substance abuse treatment, and educational opportunities in rural areas, such as telemedicine and distance learning.

Currently, the President is seeking $1.1 billion in new funding to combat opioid abuse.

During a press conference following the town hall meeting, Lynch told The Register, that one of the ways the Department of Justice funding specifically would assist communities on a local level would be through a grant making process that provides assistance to law enforcement through grants for additional officers, resources to help states improve their prescription drug monitoring programs and provide examples of programs that are working efficiently and consistently.

Lynch reiterated that administration wide, when treatment is spoken of, they are referring to improving and increasing the availability of treatment facilities and also treatment within local hospitals.

Critley King writes for The Richmond Register.

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The Law of Unintended Consequences: Illicit for Licit Narcotic Substitution


Image result for heroin plant

Originally written July 15, 2014 at LINK below

Martin R. Huecker, MD and Hugh W. Shoff, MD, MS

 

The dealers will not use it. Heroin dealers have explicit knowledge of the addictive properties of their product. The heroin addict is no longer the desperate character living under a bridge. She is a 17-year-old high school senior who runs out of her grandmother’s oxycodone. He is the stockbroker who weighs the economics of purchasing one oxymorphone on the street for $100 or ten doses of heroin for $200. Because these people are ingesting and injecting products of unknown composition and unfamiliar potency, they can potentially overdose. If lucky, they end up in the emergency department rather than the morgue.

Kentucky ranks third in the nation in drug overdose mortality rate per 100,000 persons, with opioid pills making up the majority.1 In response to these statistics, the State of Kentucky passed House Bill One (HB1) in April 2012, effective October 2012. Also known as “the pill mill bill,” HB1 contains provisions intended to limit opioid prescriptions by pain management physicians and by other acute care providers such as emergency physicians. To prescribe narcotic pain medications, physicians must perform a full history and physical, prescribe only a short course, educate the patient on risks of controlled substances, and obtain a report from a statewide prescription monitoring program (PMP) (Kentucky All Schedule Prescription Electronic Reporting [KASPER]).2

As a result, the number of registered KASPER users in Kentucky has gone from 7500 to 23,000 from December, 2011 to November, 2012. Reports are up from 3300 to 17000 in the same time frame.3 According to the same press release, Kentucky witnessed a decrease of 10.4% total prescriptions in the first six months since HB1 was enacted.3

Mandating PMP reports, as sixteen states currently do, leads to an increase in reports, but so far no statistical difference in opioid overdose mortality.1,4,5,6 In fact, this legislation may not even lower the rate of opioid consumption, rather may shift which opioids are being prescribed.6

Researchers in Ohio looked at the impact of real time PMP information on opioid prescriptions. With PMP data, providers changed prescriptions in 41% of cases; 61% giving fewer opioids but 39% prescribing more opioids.7

House Bill One was intended to and has reduced opioid prescriptions in Kentucky. Forty-four pain clinics in Kentucky closed overnight.8 Preliminary analysis at a large, metropolitan emergency department has shown a decrease in prescriptions for hydrocodone and oxycodone, along with a decrease in ED administration of these medications. This type of “pill mill” legislation has been passed in Louisiana, Florida, Texas and California with varying results.9

Florida had a sharp decrease in opioid prescriptions after similar legislation. Having 90 of the top 100 physicians on the Drug Enforcement Agency (DEA) 2010 list of top opioid purchasers, Florida saw the number decrease to 13 in 2011, and zero as of April 2013.10 In 2011, Ohio passed a “pill mill bill” to crack down on pain management clinics.11 This legislation led to seizing of 91,000 prescription pills with 38 doctors and 13 pharmacists losing their medical licenses. In the end, 15 medical professionals were convicted on diversion charges.11 With all of this, pill overdose deaths began to decline, but heroin overdoses “skyrocketed.”11

The unintended but foreseeable consequence of such measures has been increase in distribution, abuse, and overdose of heroin. Heroin has gained market share in a similar way in the past. In 2010, Purdue Pharma began manufacturing a reformulated OxyContin after a $600 million fine for misrepresentation.12 Endo Pharmaceuticals Inc. followed in 2011 with an Opana ER reformulation. This resulted in making the pills harder to crush into powder for snorting or injecting.13,14 States such as Florida, Ohio, Minnesota, and Utah have seen patients turn to heroin after crackdown on prescription opioid availability.11,14

The New England Journal of Medicine warned us of what would be a two-fold increase in heroin use after the reformulation of Oxycontin.15 In the 2010 ODLL report, the United States DEA also attempted to warn health care organizations that Oxycontin users might switch to heroin.16,17 The first paper we know of to report this warning was published 3 years later in 2013.16 This paper, a qualitative study of the transition of opioid pill users to heroin users, provides insight into the economic and convenience factors associated with the switch. The researchers interviewed a small sample of heroin users, forty-one in all. All but one of the 19 heroin users aged 20–29 started with pills and progressed to heroin – “termed pill initiates.”16

Numerous popular news reports directly implicate decreased opioid pill availability in the rise of heroin abuse and overdose.16 However, very little discussion of this phenomenon has entered the emergency medicine literature.

The drug cartels have capitalized on the United States opioid appetite and now decreased supply of pills. The route from Mexico to Detroit, then south through Ohio, ends up in northern and central Kentucky. The Kentucky State Police recovered 433 samples of heroin in 2010. In 2012 the number was 1349.13 In Lexington, KY, the eight total heroin arrests in 2011 exploded into 160 in the first 6 months of 2013.18,19 Undercover narcotics officers in Lexington find it easier to buy heroin than marijuana.

Heroin-related overdoses in Kentucky increased from 22 cases in 2011 to 143 cases in 2012, and 170 in the first 9 months of 2013.8,20,21 Kentucky’s percentage of overdose deaths involving heroin went from 3.2 in 2011 to 19.5 in 2012 and up to 26 in 2013.8.21 This phenomenon has occurred in Florida, California, Massachusetts, New York, Oregon, Washington and Ohio.11,2224

The emergency medicine literature has minimal recent discussion of heroin overdose management in the ED; nor have we discussed secondary prevention. Supportive therapy suffices in the ED, with liberal naloxone use and airway protection. State and federal actions to curb heroin deaths can be effective. Good Samaritan laws, present in only one third of states, protect from prosecution those lay individuals attempting to help themselves or companions in overdose situations.

Also present in only one third of states are laws to expand community access to reversal agents such as naloxone. Twenty-two states have laws requiring or recommending education for opioid prescribers. Medicaid expansion to cover substance abuse treatment has occurred thus far in less than half (24) of states.1

As more states enact measures intended to reduce total opioid prescriptions, legislators and healthcare providers alike must be aware of the predictable and devastating rise in heroin sales, abuse, and overdose. Funding for this legislation should include monies allocated toward substance abuse treatment programs and availability of naloxone. Similarly, pill mill bills could universally be coupled with Good Samaritan laws in anticipation of the increase in parenteral opioid overdoses. Funds could be allocated to lay population education via public service announcements. Stricter punishments for drug traffickers could accompany such legislative changes. Many of these measures have been presented as interventions to combat prescription opioid abuse and can now be applied to the subsequent heroin abuse and overdose dilemma.9

At the first line of medical care, emergency physicians must be involved in efforts to minimize collateral damage in this long-term process of curing America’s addiction to opioid drugs and their horrible consequences.

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Kentucky Senate passes bill that could make heroin traffickers face homicide charges


 

 

SB 5 passed 36-0 Thursday with Sen. Perry Clark, D-Louisville, passing.

By Kevin Wheatley, Published: January 17, 2014 10:19AM

The Senate passed a bill Thursday to combat the state’s growing heroin problem, though not without questions during a committee hearing earlier in the day on certain provisions’ constitutionality.

Senate Bill 5 passed 36-0 with Sen. Perry Clark, D-Louisville, passing.

SB 5 would require those convicted of trafficking more than 4 grams of heroin or methamphetamine to serve at least 50 percent of their prison sentence before becoming eligible for probation, parole or early release. Traffickers could be charged with homicide in cases of overdose deaths, and the bill would require coroners to report overdoses caused by Schedule I drugs, such as heroin.

“The bill targets two different groups: the trafficker, who needs to be run out of Kentucky or locked up; and the addict, who has broken the law but has created their own personal prison of addiction that is worse than any jail this state could design and needs treatment,” the bill’s sponsor, Senate President Pro Tem Katie Stine, said.

The legislation would allow the Department of Medicaid Services to expand treatment options and direct a quarter of savings realized through a corrections reform bill passed in 2011 to supplement the Kentucky Agency for Substance Abuse Policy.

SB 5 would also allow police officers and emergency responders to carry and administer naloxone, a drug used to counter opiate overdoses; grant immunity from drug possession charges for those seeking help for someone overdosing; and grant immunity from paraphernalia charges for those who alert law enforcement of any hypodermic needles or sharp objects in their possession before a search. Some could be given leniency for helping prosecute other drug crimes.

Kentucky Office of Drug Control Police Executive Director Van Ingram said the state has had problems with opioid addiction for years, and the heroin trend has evolved from opiate-based painkillers such as OxyContin and Opana. The numbers of heroin overdoses and confiscations have risen dramatically in recent years, he said.

“Senate Bill 5, I think, takes a broad view and it hits on a number of things, all aimed at reducing the availability of heroin, educating our citizens about heroin and some harm reduction things to try to keep people alive,” Ingram said during testimony before the Senate Judiciary Committee.

“We can’t get people into treatment and we can’t get them leading productive lives if they’re gone.”

Supporters of the bill cross party lines with Stine, R-Southgate, Rep. John Tilley, D-Hopkinsville, and Democratic Attorney General Jack Conway backing the measure.

The heroin issue extends beyond northern Kentucky, which supporters of SB 5 spotlight as an area of the state wracked by heroin addiction because of its close proximity to Cincinnati. Clay Mason, public safety commissioner for Lexington-Fayette Urban County Government, said central Kentucky has seen a rise in heroin abuse in recent years.

“This is not a back alley drug situation from the movies of the late ’60s and early ’70s. This is anybody’s problem,” Mason told the committee. “There are many, many people who, as we’ve already heard, have gone from a pill prescription addiction problem and now rolling into heroin for a multitude of reasons — price and availability.”

Ernie Lewis, a lobbyist for the Kentucky Association of Criminal Defense Lawyers, raised concerns about the constitutionality of certain parts of SB 5, specifically in prosecuting dealers of Schedule I substances whose drugs cause overdose deaths.

Offenders convicted of homicide or fetal homicide where the victim dies from such an overdose would not be eligible for release until serving at least half his or her sentence, under SB 5.

Lewis specifically pointed to a provision eliminating the defense that victims contributed to their deaths by willingly ingesting substances, sometimes more than the Schedule I drugs at the center of SB 5.

“Many overdose deaths occur when a person combines drugs; they combine that cocktail, unfortunately,” he said. “They may take cocaine, they may take Xanax, they may take other benzos (benzodiazepine, a psychoactive drug) or opioids. Sometimes the defendant is not even aware of that because that might have occurred earlier, because when you’re sick, you take whatever’s available to you.

“… Foreseeability has to do with the awareness of a risk. The prosecution has to prove awareness of a risk, and this provision says as a matter of law, the risk is there, we’re going to presume it, and they can’t do that under the due process of laws.”

SB 5 is meant to clarify an issue raised in a 2000 Kentucky Supreme Court decision overturning a reckless homicide conviction in which the victim died of an overdose from a mixture of cocaine and heroin, Stine and Tilley said.

“It seems to me that all that provision is doing is eliminating the ‘blame the victim’ defense, and I think we can all agree that’s not a bad thing.”

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