Thread: LETTING FIRST RESPONDERS USE HIGHER DOSES OF NARCAN TO FIGHT OPIATE OVERDOSES

We know the primary source of Heroin and fentanyl..it is an epidemic coming across our borders and it looks like one PHARMACEUTICAL company is cashing in on the crisis drugs. imo


LETTING FIRST RESPONDERS USE HIGHER DOSES OF NARCAN TO FIGHT OPIATE OVERDOSES

LILO H. STAINTON | DECEMBER 15, 2017

Bipartisan move to give paramedics, firefighters more flexibility in type and dosage of opioid antidotes



New Jersey is considering updates to a law designed to protect emergency responders who administer life-saving opioid antidotes in order to address a growing and painful truth: preventing overdoses with today’s more powerful drugs requires increasingly robust strategies.

The Senate health committee unanimously approved a bipartisan bill Thursday that would give paramedics, firefighters, and other first responders more flexibility in the type and number of doses they can use when administering naloxone, which can reverse an opioid overdose. The measure, which cleared the Assembly in March, awaits final passage in the full Senate.

The vote followed graphic testimony from emergency responders who said that current Garden State regulations do not enable an individual to administer multiple doses of naloxone without approval from a medical director. They said a single dose is sometimes not enough to save a patient overcome by the more powerful, and increasingly common, blends of heroin and the cheaper, synthetic opiate fentanyl.

“The game has changed. These are not the opioids of the 20th century,” warned Steve Spurr, a firefighter who heads the EMS committee for the New Jersey Firefighters Mutual Benefit Association.

John Armato, a committeeman and longtime firefighter in Buena Vista Township — who will be sworn in as a state Assemblyman in January — recalled a recent incident in which responders struggled in pouring rain to revive a drug user lying in the street outside his home, while the man’s family surrounded them screaming for his life. The first 2mg dose failed to rouse him, and it took several long minutes until a state trooper arrived and was able to administer a second naloxone dose.

Naloxone combats overdoses

“Fentanyl makes the drug Narcan (a leading brand of naloxone) work so much harder,” explained Armato, who approached Assemblyman Vincent Mazzeo (D-Atlantic) and worked with him to sponsor the proposed change. “This bill will go far in saving lives,” Armato said.

Naloxone is becoming an increasingly common weapon in combating overdose deaths, which killed more than 2,100 New Jersey residents last year; according to a task force report, 800 of those deaths involved fentanyl. Under Gov. Chris Christie, the state has ramped up programs to support the use of these products — formulated as shots and now a nasal spray; it has helped to distribute the antidote to first responders, starting in 2014, and has hosted training for citizens to ensure they can use it safely.

In addition, citizens can purchase naloxone at drugstores around the state. While it was already on sale at hundreds of chain stores, like CVS, Christie signed a law in June that makes it easier for independent pharmacies to sell it. Overall, the treatment has been administered more than 12,000 times in New Jersey in the past three years.
The Overdose Prevention Act, which Christie approved in 2013, was also designed to increase public access to naloxone and to protect those who prescribe and administer the antidote from criminal or civil penalties, or disciplinary action.

Under protocols issued by the state Department of Health — which apply to emergency medical technicians, but not firefighters, and were updated this fall — responders can administer one 2mg dose via a muscle shot or nasal spray, or opt for a new 4mg nasal spray. But they must wait several minutes to assess the patient’s response, to be sure they are not dealing with seizures or other complications, and get permission from a medical director to provide a second dose.

Many patients need a second dose of antidote

After minor amendments in the Senate, the proposed reform, led by Mazzeo and Assembly health committee chairman Herb Conaway (D-Burlington), a physician, would enable responders to use any naloxone brand and administer up to three shots or nasal spray doses without consulting outside professionals. The amended version would also give the DOH 45 days to update emergency medical services statewide.

Tommy Begres, a firefighter in Michigan and clinical director at Adapt Pharma, which makes Narcan, called the bill a “common sense” approach to solving what has become a widespread problem nationwide, now that nearly one-third of all opioids are laced with fentanyl. While research shows one in four overdose patients may need a second dose of the 2mg antidote, Begres said that has only happened with 6 percent of the patients who receive the 4mg version.

Sen. Colin Bell (D-Atlantic), a lead sponsor of the measure (S-3083) with Sen. Steven Oroho (R-Sussex), said that even with state permission to use a full 4mg of naloxone, one dose is not always enough. “Fentanyl is so potent, it may require several doses of naloxone to bring someone out of a fentanyl overdose,” he said.

“First responders who encounter overdose victims should only need to worry about saving lives and not about potential liability,” Bell said, adding, “I am proud to sponsor this legislation in memory of Senator Whelan's tireless struggle for the most vulnerable and for those he has represented. Senator Whelan wanted to provide first responders with the necessary resources to save lives, and that is what this bill does."

Despite the lifesaving nature of these drugs, escalating prices have become a concern and Sen. Joe Vitale (D-Middlesex), the health committee chairman, drilled Begres on the cost of these products.

Price of antidote: $37.50 to $4,700

Berges said Adapt charges the public $125 for two doses of the 4mg spray when purchased at a drug store; insurance generally covers naloxone, often without any co-pay.

Emergency responders and other public officials can get the same two-pack of 4mg spray for $37.50, he said. But Adapt’s competition, Evzio Pharmaceuticals, charges $4,700 for a pair of 2mg injections, he added.

Ensuring that responders are armed with naloxone is critically important, Sen. Fred Madden (D-Burlington), agreed, noting that some 140 people have died this year in his district because of overdoses. Naloxone alone isn’t treatment, he warned, but a chance to escape death. “We’re saving lives, but we’re not curing anything with this. In some cases, we’re just passing it on to the next episode,” he said.

http://www.njspotlight.com/stories/1...ate-overdoses/

Business
The $4,500 injection to stop heroin overdoses

Evzio is used to deliver naloxone, a life-saving antidote to overdoses of opioids. As demand for the product has grown, Kaleo has raised its twin-pack price to $4,500, from $690 in 2014. (Cam Contrill /For The Washington Post)

By Shefali Luthra | Kaiser Health NewsJanuary 27, 2017

First came Martin Shkreli, the brash young pharmaceutical entrepreneur who raised the price for an AIDS treatment by 5,000 percent. Then, Heather Bresch, the CEO of Mylan, who oversaw the price hike for its signature EpiPen to more than $600 for a twin-pack, though its active ingredient costs pennies by comparison.

Now a small company in Richmond called Kaleo Pharma is joining their ranks. It makes an injector device that is suddenly in demand because of the nation’s epidemic use of opioids, a class of drugs that includes heavy painkillers and heroin.

Called Evzio, it is used to deliver naloxone, a life-saving antidote to overdoses of opioids. More than 33,000 people are said to have died from such overdoses in 2015. And as demand for Kaleo’s product has grown, the privately held firm has raised its twin-pack price to $4,500, from $690 in 2014.

Founded by twin brothers Eric and Evan Edwards, 36, the company first sought to develop an EpiPen competitor, thanks to their own food allergies. Now, they’ve taken that model and marketed it for a major public health crisis. It’s another auto-injector that delivers an inexpensive medicine.

One difference, though, is that Evzio talks users through the process as they inject naloxone. The company says the talking device is worth the price because it can guide anyone to jab an overdose victim correctly, leave the needle in for the right amount of time and potentially save his or her life.

According to Food and Drug Administration estimates, the Kaleo product, which won federal approval in 2014, accounted for nearly 20 percent of the naloxone dispensed through retail outlets between 2015 and 2016, and for nearly half of all naloxone products prescribed to patients between ages 40 and 64 — the group that comprises the bulk of naloxone users.

And the cost of generic, injectable naloxone — which has been on the market since 1971 — has been climbing. A 10-milliliter vial sold by one of the dominant vendors costs close to $150, more than double its price from even a few years ago, and far beyond the production costs of the naloxone chemical, researchers say. The other common injectable, which comes in a smaller but more potent dose, costs closer to $40, still about double its 2009 cost.

Still, experts say the device’s price surge is way out of step with production costs and a needless drain on health-care resources.

“There’s absolutely nothing that warrants them charging what they’re charging,” said Leo Beletsky, an associate professor of law and health sciences at Northeastern University in Boston.

Kaleo, which is trying to blunt the pricing backlash and turn Evzio into the trusted brand, is dispensing its device for free — to cities, first responders and drug-treatment programs. Such donations were also essential to the EpiPen’s business strategy.

The device has been invaluable to patients, said Eliza Wheeler of San Francisco’s Harm Reduction Coalition, a nonprofit organization that works to combat overdoses and has received donations of Evzio. But at $4,500 a package?

“I might have $10,000 to spend on naloxone for a year to supply a whole city,” Wheeler said. “If I have 10 grand to spend, I certainly can’t buy two Evzios.”

Mark Herzog, Kaleo’s vice president of corporate affairs, said in an email that most earlier naloxone devices were “developed, designed and intended” for use in medically supervised settings.

Prior kits contained a pre-filled syringe. The Evzio was the first to help nonprofessionals dispense the drug. And competition is limited: One of the few consumer-friendly alternatives to Evzio is a nasal-spray device for naloxone which costs $125 for two doses.

A growing market

The opioid crisis has led more experts to call for expanded access to naloxone — for people navigating addiction and for those around them. The idea is that if someone nearby could overdose, dispensing the drug should be as easy as pulling the fire alarm.

Federal and state governments have spent millions of dollars equipping police officers and other first responders with naloxone. In communities particularly hard-hit by drug overdoses, places such as schools, libraries and coffee shops are keeping the antidote on hand. Physicians are prescribing it to patients who are taking prescription painkillers in an effort to make sure they — and their families and friends — are prepared.

The Evzio could be ideal, especially when medical professionals are not nearby, noted Traci Green, an associate professor at Boston University’s School of Medicine. But the price limits access.
“It’s a really good product,” she said. “It’s elegant. People do like it — but they can’t afford it.”

“There’s a lot of value to this formulation,” said Ravi Gupta, a medical student and lead author of a December op-ed on the pricing issue, published in the New England Journal of Medicine. “But it’s not justified. This pricing is not justified.”

But consumers may not yet be pinched. In another Mylan parallel, Kaleo offers coupons to patients with private insurance, so they don’t have any co-pay when they pick up the device.

So Kaleo would say the price hikes are essentially moot. Herzog said they are necessary to subsidize programs that do not offer co-payments. In a follow-up email, he added that the list price is “not a true gauge,” because insurance companies can sometimes negotiate rebates and discounts. And, he said, since the price increase, more patients have gotten Evzio prescriptions filled — so the cost doesn’t seem to be stopping them.

Mylan provides a similar EpiPen discount — a move that’s helped cement it as the dominant epinephrine provider. But even if consumers don’t directly pay for the price increases, they’re affected, analysts cautioned.

“When you have these kinds of programs, the cost is still borne by patients, because insurance premiums go up,” Beletsky said.

That, analysts say, undermines Kaleo’s argument that they’re somehow increasing access. After all, while some government agencies and private organizations get the drug for free or at a deep discount, that isn’t true across the board. For those who don’t get that deal, the list price matters.

Take Vermont. The state’s been particularly hard-hit by the epidemic — more than 70 people died of opioid overdose in 2015, and it’s been dubbed America’s “heroin capital.”

Its health department is trying to get naloxone into the hands of people using opioids, setting up distribution sites around the state. But because of its high cost, Evzio isn’t an option, said Chris Bell, who runs the state health department’s emergency preparedness and injury prevention division. So it is opting for the nasal spray that costs a fraction of the price.

That’s not true everywhere, though. The Veterans Health Administration, known for its especially high rate of patients taking opioid-based prescription painkillers, covers the auto-injector. It can do so, though, because of its bargaining power — the agency is legally authorized to negotiate with pharmaceutical companies.

As a result, Veterans Affairs is paying “far, far less” than the Evzio list price, said Joseph Canzolino, deputy chief consultant for pharmaceutical benefits management at VA. (He would not release the precise figure.)

The agency’s buying power is such, he added, that even when companies drive up prices, what VA pays will stay more or less stable — far below a figure he called “pretty exorbitant.”

Thanks to an infusion of public funding to combat opioid overdoses, other institutional buyers may also be able to afford Evzios. Their budgets are larger right now, so they’re less price sensitive, said Nicholson Price, an assistant professor at the University of Michigan Law School.

But that money comes from somewhere — most probably taxpayers. And it’s hardly sustainable, Price noted, saying “at some point in time, the rubber’s got to hit the road.”

Kaleo has given away more than 180,000 devices, Herzog said, distributed in 34 states among about 250 organizations such as police departments and nonprofit groups that distribute naloxone to people at risk of overdose.

Advocates and pharmacy groups have made videos touting the product. In neighborhoods where overdose is common, businesses — such as fast-food restaurants, grocery stores and other retail establishments — are interested in keeping readily dispensable naloxone on hand.

But those who’ve accepted free Evzio devices and have come to rely on it may soon face withdrawal. Last year, Kaleo’s donation supply was exhausted by July. Herzog said the company has added to its donation supply and is taking applications from groups hoping for free devices.

Barring a meaningful expansion, the free device program could run out of supplies even sooner if the opioid crisis keeps up.

The problem, Price noted, is that policymakers haven’t found a solution to get people needed medication and keep pricing in line with value.

“EpiPen happened, and everyone was like, ‘Wow, this is terrible, we shouldn’t allow this to happen,’ ” he said. “And we haven’t done anything about that, and it’s not clear what the solution is. Now, shocker, it’s happening again.”

Correction: This story has been changed to correct the price for two doses of a nasal-spray device for naloxone. It is $125 not $150. Contrary to what an earlier version of this story stated, that price has not climbed.
Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

https://www.washingtonpost.com/busin...=.b244e7876d2f

HOW DOES A $575 LIFE-SAVING DRUG JUMP TO $4,500? BLAME A PERVERSE SYSTEM



KALEO

YOUR FRIEND IS on the floor unconscious. The culprit: a heroin overdose. You panic, but then remember a gadget that can save her life. She told you where it would be if this ever happened, didn't she? You run to her bedside table, fling open the drawer, and grab the compact purple and yellow injector. After you pull off the lid, the device speaks, telling you to place the plastic case on your friend's thigh, press down, and dispense the life-saving drug inside. You do what it says, and a few seconds later, your friend's eyes open wide. She's alive.

That's the scenario pharmaceutical company Kaleo envisioned when it developed the Evzio auto-injector. The phone-sized gadget is new, but the drug it administers—naloxone—is an old and inexpensive chemical that works immediately to reverse the effects of opioid overdoses. In 2014, it got FDA approval and hit the market for a list price of $575, an exciting new tool to battle the country's overwhelming opioid epidemic.

But three years after Evzio came out, its cost has exploded to $4,500 per prescription. Like the pharma company Mylan did with Epi-Pen—another simple, life-saving drug—Evzio's maker has raised its price as high as the market will bear.

If you have a friend or loved one who's addicted to painkillers or heroin, they likely won't pay anything for the device. That's not how Kaleo makes money. Insurance holders can get the medication for $0. Same if you make less than $100,000 a year; if you pay cash, it's just $360. Typically, pharma companies set the highest retail price they can get insurance companies to pay and then work out rebates with individual payers. But with Evzio, there's yet another third party to bilk, one with a government mandate to buy the drug in bulk: law enforcement agencies.

In the past few years, state legislatures responded to the growing opioid epidemic by passing laws requiring first responders to carry naloxone. President Obama even signed a law last summer to provide $181 million in funding for naloxone programs. "There was this major push to get cops access," says Leo Beletsky, a professor of public health at Northeastern University who helped the Department of Justice write guidelines for naloxone. "Now thousands of law enforcement agencies have equipped their officers with naloxone." That created an entirely new market for the drug.

To drive awareness of the product, Kaleo has handed out 200,000 Evzio devices free to groups that work with addicts, including to law enforcement, though the company hasn't released information on how many agencies negotiated deals or what they paid. When Beletsky was working with one nonprofit group in New Mexico, people asked for Evzio directly. "They call them talkies. It's a cool, sleek compact gadget," says Beletsky. It's the perfect example of tech taking something clunky but critical and making it sleek and accessible.

Except for the whole price thing. Now that the New Mexico group has run out of talkies, they can't afford to buy any more. That doesn't mean the opioid-addicted people in New Mexico are stuck high and dry; they still have access to the old-school syringe options or the nasal spray Narcan, which just got FDA approval last year and offers bulk deals to harm reduction groups at $37.50 a dose.

But lawmakers want families and first responders to have the easiest-to-use version of naloxone—and when states started passing laws to increase access to naloxone, Kaleo benefited. Florida, Ohio, and Louisiana passed laws in the last three years that required first responders to carry FDA-approved versions of naloxone—which, until last year, only included Evzio. Beletsky says Kaleo actively lobbied to have the laws written that way. (Kaleo did not comment.) Legislators in Florida and Ohio later rewrote the laws so cheaper options are allowed. But other states continue to push for brand names. State Senator Royce West introduced a bill in Texas last year which would limit naloxone options to Evzio and Narcan.

Senator Claire McCaskill, along with 30 other Democratic senators, sent a letter to Kaleo earlier this month demanding an explanation for the price increase. In response, CEO Spencer Williamson pointed out all the outreach programs and rebates the company offers. "To support our enhanced patient access program and to ensure that as many patients as possible have access to Evzio for $0, the list price was increased," he wrote in a letter sent back to lawmakers and the press. In other words, the people who do pay—insurance companies and some government agencies—are footing the bill for people who pay nothing. "It's kind of like a game that pharmaceutical companies play," says Beletsky. "[Kaleo] is trying to make up as much profit as they can before they get scooped."

Which, given that Adapt Pharma's Narcan nasal spray now has FDA approval and costs much less, won't be long. In fact, in Vermont, which has been hard-hit by the opioid epidemic, pharmacies can now sell Narcan over the counter. It may not be as flashy as Evzio—it doesn't talk—but it's nearly as simple to use and it works. And most importantly, it doesn't cost $4,500.
https://www.wired.com/2017/02/575-li...rverse-system/

Taxpayers should not be paying for Narcon!