Five patients at the opioid treatment program (OTP) where Jana Burson, MD, serves as medical director have rescued people—not patients—with naloxone they obtained from her OTP. “That’s a powerful agent of change for the person who does the reviving,” said Dr. Burson, because the rescuer is an OTP patient – and maybe the person rescued will see addiction treatment as an option, too. It’s very cool. Here’s a person who was once an addict, and is now in methadone treatment, and all of a sudden, he’s a hero.”
Wilkesboro Comprehensive Treatment Center, the Acadia OTP in North Wilkesboro, North Carolina where Dr. Burson works, was one of the pioneers in distributing naloxone to patients (see http://atforum.com/2014/06/project-lazarus-brings-opioid-treatment-program-to-wilkes-county).
The naloxone nasal spray is “easy to use,” said Dr. Burson. It consists of a vial containing the naloxone, which reverses the effects of opioids and can bring someone back from an overdose. The spray comes in a kit with a syringe and an adaptor that squirts the liquid naloxone into the nose.
A patient can get the naloxone kit from an OTP, but it’s important for a family member to have it available and know how to use it, because if a patient overdoses, he or she will be incapacitated and unable to use the kit. The first two weeks of methadone treatment in an OTP are the most dangerous for patients, said Dr. Burson.
Laws about prescribing naloxone vary among states. In some states, a physician writing a prescription for a patient has to actually see that patient. But other states, including North Carolina, allow “third-party prescribing,” so physicians can prescribe for family members of someone who is addicted. That’s what Dr. Burson does, sometimes even for parents whose children are not in treatment. “If a parent comes to me and asks for a prescription for her son, who is addicted, I write it,” she said. “I do not have to meet the actual patient.”
The problem is how to work out the reimbursement details. The cost of naloxone increased about a year ago, with kits containing two doses now costing more than $100.
Medicaid pays for naloxone—at least in North Carolina—but it’s unclear whether OTPs themselves can get reimbursed for it. “We are just starting to bill Medicaid, and we haven’t tried yet,” said Dr. Burson. So the OTP calls in a prescription, and the patient
goes to the pharmacy to pick it up. This isn’t ideal, because the patient might not go to the pharmacy right away, said Dr. Burson. However, Project Lazarus has given her clinic many Evzio kits recently. “We have handed out all that they gave us to patients, but that didn’t go through Medicaid,” she noted.
“We’re one of the few OTPs in the state that dispense or prescribe naloxone,” said Dr. Burson. “Right now we’re just prescribing. We’ve been talking about this at our OTP medical directors’ meetings in North Carolina—we’re trying to figure out who will pay for the kits.” As it is, Dr. Burson’s OTP just started accepting Medicaid patients within the last few months. “We’re still trying to figure out how to bill Medicaid for regular OTP services.”
Project Lazarus, in Moravian Falls, North Carolina, had a grant to give out free naloxone kits, and many kits went to OTPs. Dr. Burson’s OTP used to receive free naloxone kits for all new admissions.
New Nasal Spray Formulation
On November 18 the FDA approved the first intranasal form of naloxone. The Narcan nasal spray comes in a kit that includes a dose-measured syringe, and does not require assembly. Kits commonly used by OTPs and first responders are not approved by the FDA, so it’s possible Medicaid will now require use of the FDA-approved version.
A second intranasal naloxone product is up for FDA review. Both products were given fast-track designation and priority review. “Combating the opioid abuse epidemic is a top priority for the FDA,” said Stephen Ostroff, MD, acting commissioner of the FDA, in approving the first intranasal Narcan product.
“This easy-to-use intranasal formulation will no doubt save many lives,” said Nora Volkow, MD, director of the National Institute on Drug Abuse (NIDA), in a statement. Her agency helped provide the data the FDA used in its approval to show that intranasal administration is equivalent in efficacy to intramuscular administration. “While prevention is the ultimate goal, the drug’s successful development illustrates how public/private scientific partnerships can play an important role in responding to a national crisis, right now,” said Dr. Volkow.
Narcan nasal spray is distributed by Adapt Pharma, Inc., headquartered in Ireland, with U.S. headquarters in Radnor, Pennsylvania. Reportedly, group purchasers, such as people in law enforcement, fire fighters, and certain health care workers, will be able to purchase one four-milligram dose for a discounted public interest price of $37.50.
Indivior is the other company that has submitted an application to the FDA for an intranasal naloxone spray. Indivor is a spinoff of Reckitt Benckiser, the company that manufactures and markets Suboxone.
The only other FDA-approved formulations of naloxone are two injectable products. One is mainly for medical use; it comes as a kit containing a vial of naloxone (the type of vial used in the makeshift kits) and a syringe and needle. This product is typically used in hospitals to reverse opioid sedation after surgery. Sometimes emergency responders use it to treat opioid overdoses. The other product is the Evzio auto-injector, made by Kaleo and approved by the FDA last year.
The big problem for Evzio is the product cost: about $600, says Ed Higgins, director of JSAS Healthcare, an Asbury Park, New Jersey-based OTP. Mr. Higgins, the naloxone purchasing coordinator for OTPs and other buyers in New Jersey, has been focusing on the naloxone kits instead. “We know a lot about it, but we’re not going to buy it,” said Mr. Higgins of Evzio, noting that this auto-injector may be too expensive for OTPs and insurance companies, in light of the effectiveness of the intranasal spray.
Combining a $1 million grant from the state’s Governor’s Council on Alcoholism and Drug Abuse with some federal prevention block grant money, Mr. Higgins has been able to lower the cost of the naloxone kit, usually more than $100, to $85. He also uses treatment vouchers to help pay for the initial costs of OTP treatment. “Get them inside and we have a chance,” he said.
The Harm Reduction Coalition of North Carolina, if asked, will go to any OTP in the state to provide naloxone kits to patients, said Dr. Burson. This group distributes vials of naloxone with a large-gauge needle and syringe. “Some people voice concern about those kits, saying the needle and syringe could be used to inject drugs,” she said. “However, the large size of both needle and syringe would prevent most addicts from using them.” The kits from the Harm Reduction Coalition are not intranasal, however; they do require the person administering the drug to draw it up in a syringe and inject it into a muscular area, so some people may not be as comfortable using them, said Dr. Burson. “However, those kits are very effective, and the cheapest naloxone kits available.”
Some pain specialists who prescribe opioids to their patients in pain don’t like the idea of also prescribing naloxone. That would be tantamount to admitting that opioids could kill them, said Dr. Burson. “But that’s a reality, and we have to accept it. Bad things can happen to our patients, even after they enter treatment.”