RALEIGH, NC (WBTV) - Guidelines established by the North Carolina Department of Health and Human Services restrict the medication doctors can prescribe to patients using Medicaid who are addicted to opioids, a WBTV investigation has found.
A combination drug known generically as buprenorphine-naloxone is used to treat patients who are attempting to stop using opioids.
"If they're using heroin or Percocet and they come off of that drug that they're using, they're going to go into withdrawal," Doctor Heather Manos, who is the medical director of McLeod Addictive Disease Center, explained.
"If you replace with buprenorphine, then they're not going to experience the withdrawal, sometimes," Manos continued. "Buprenorphine, rather than a medication like methadone, per se, has fewer side effects, which is why it's considered by some professionals superior."
The most commonly-known brand of buprenorphine-naloxone is a drug called Suboxone.
Currently, Suboxone is available as a sub-lingual strip that dissolves on someone's tongue.
More recently, the maker of Suboxone, a company called Indivior, gained federal approval to also sell an injectable form of the drug, known as Sublocade.
In North Carolina, doctors must prescribe either Suboxone or Sublocade to treat opioid addiction in new patients who are using Medicaid insurance.
The requirements are listed on the state's Medicaid formulary, which sets out preferred drugs and non-preferred drugs. Under the formulary for drugs to treat opioid addiction, doctors must first prescribe Suboxone or Sublocade before trying any other generic or pill form of the drug.
But, doctors like Manos say there is no medical difference between the name brand drugs and the generic alternatives.
"If you have the active ingredient of buprenorphine in a product and it's FDA regulated, then the generic is the equivalent to the name brand," Manos explained.
The only real difference in the name brand and generic versions is price.
Manos said the generic alternatives to Suboxone and Sublocation could be one-third to one-fourth of the cost of the name brand drug without rebates.
"Does that tie your hands as a physician?" a WBTV reporter asked Manos of the requirement to prescribe only the name brand sublingual strip or injectable.
"Well, of course, if they're saying that you must use what's on the formulary," Manos said. "It's just the way of medicine today."
But the head of North Carolina's Medicaid takes a different view.
Dave Richard, Deputy Secretary for North Carolina Department of Health and Human Services, said the limits imposed by the state's formulary is the best for patients and for taxpayers who fund the Medicaid program.
Specifically, Richard told WBTV, the state uses a preferred drug list that is administered by the federal government that gives the state rebates on certain drugs. In the case of drugs that treat opioid addiction, the state gets a rebate on name brand drugs manufactured by Indivior.
"Through the rebate process, we try to get the best deal for North Carolina for those drugs, which are appropriate for the use of the individuals," Richard said.
But Richard said he couldn't provide any data to support his assertion that North Carolina's rebate is so large that the state pays less for name brand Suboxone or Sublocade than the generic alternatives that cost three or four times less.
"It is a significant cost savings to the taxpayers because of the preferred nature of the drug, yeah," Richard said.
"Would you be willing to give us documentation supporting that?" a WBTV reporter asked.
"We can't release the rebates that we receive," Richard said. "That's a federal law that we can't do that, nor can we do that for the supplement rebates that we have."
"So we're supposed to take your word for it?" WBTV asked.
"I, uh... yes," Richard said.
As North Carolina mandates physicians prescribe the name brand drugs made by Indivior, the state is suing the drug manufacturer as part of a coalition of 42 states that allege the company has engaged in anti-competitive practice in manufacturing and marketing Suboxone.
Richard said the allegations made by one branch of North Carolina's government in court have no sway over the decisions made by his office.
"We don't take into account any of that litigation, certainly until things are finalized in that effort," Richard said.
Separately, North Carolina is also a plaintiff, along with the United States Department of Justice and 34 other states and major cities, in a federal whistleblower lawsuit unsealed in August 2018.
The lawsuit, originally filed by a manager who worked for a parent company of Indivior, accuses the company of making misleading claims to the US Food and Drug Administration to obtain approval for the sublingual film and alleges that the film version of Suboxone could be more easily smuggled onto the black market and into prisons than the pill form.
Indivior and the other plaintiffs named in the whistleblower lawsuit had not yet filed a formal response in court.
That allegation is borne out by a survey of media reports across the country. WBTV found stories in which law enforcement arrested people for smuggling Suboxone sublingual strips into prisons in jails across the United States.
The problem was enough for Maryland to remove the sublingual film from its formulary.
Despite that, Richard, North Carolina's Medicaid leader, said one reason the state doesn't include a pill form on its formulary because it was easier to divert.
"We believe that the pill form is much easier to have a redistribution on instead of the strips," Richard said of the Suboxone strip, which is smaller than a stamp and can easily be affixed to other things to smuggle into secure facilities.
"A body of facts and evidence suggests that what you're saying is not accurate," a WBTV reporter told Richard in response to his claim.
"What I'm suggesting to you is that there are multiple studies and there will be studies that exist on both sides. You presented one group of studies," Richard responded.
"I'm presenting a group of facts and experts who say that," the reporter said.
"I don't disagree that those are facts," Richard said. "Certainly, it is easy—well, I don't want to say it's easier but it's certainly possible to smuggle those into prisons. We've heard that, we know that."
The board that NCDHHS established to determine which drugs are included on the Medicaid formulary is scheduled to meet again in September to consider changes, if any, to the formulary for opioid medications.