Abuse-deterrent opioids are being pushed by manufacturers as a tool to combat drug use, but on the national level some physicians and scientists have raised new questions about their effectiveness.
In New Jersey, an advisory panel warned that requiring insurance coverage for these formulations could add $200 million to the state’s healthcare costs over the next decade, without providing major public health benefits. And one of the sponsors of legislation to mandate this coverage has suggested it might now be worth revisiting the issue.
Advocates for the drugs, which are designed to thwart certain kinds of abuse, said they aren’t a cure-all but another critical tool in the state’s effort to reduce the epidemic of opiate addiction. Pharmaceutical representatives and their allies have continued to push for legislation that would require state-regulated health plans to cover abuse-deterrent opioid drugs (ADOs), although Gov. Chris Christie pocket vetoed a similar measure in January 2016. Insurance companies and business leaders remain opposed to the plan.
Created in a way that makes it nearly impossible to crush or cook them into a liquid, these drugs are designed to guard against users who want to snort or inject the medicines to get a quicker high then they would if they swallowed the pill. Common brands include newer, long-acting versions of OxyContin, Hysingla, and Opana, although a Food and Drug Administration advisory panel declared in March that Opana does more harm than good.
They ‘are not the panacea’
That same month, New Jersey’s Mandated Health Benefits Advisory Commission — an arm of the state Department of Banking and Insurance that provides technical assistance to the Legislature — issued a report that said mandating coverage of these drugs would add $425 to the cost of an average opioid prescription. Altogether, the legislation would add $111 million in the first year and up to $203 million over a decade to the healthcare costs borne by patients, businesses and taxpayers, who cover the cost of insuring some 700,000 government workers in New Jersey.
“In summary, abuse-deterrent opioids are not the panacea for opioid addiction that their title might suggest, given their increased cost compared to other formulations, the fact that they are not fully abuse-resistant and can be abused orally,” the advisory commission found. But it also warned about the risk of diverting addicts to more deadly drugs like heroin and fentanyl and warned against increased HIV rates and other diseases if these users turn to injecting these substances instead.
“Thus, the single element of expanding the availability of ADOs appears unlikely to be a ‘silver bullet’ or have a decisive impact on the opioid addiction and overdose epidemic in New Jersey. A policy that may have a more significant impact is a multi-faceted program addressing a number of aspects of the opioid crisis,” it said. In 2015, some 1,600 Garden State residents died of addiction-related issues.
Dr. Deni Carise, the chief clinical officer with the Recovery Centers of America, a national treatment provider that operates several programs in South Jersey, largely agreed. “They’re a really nice drop in the bucket, one of 50 things we need to do,” she said. After all, most abuse starts with just taking more pills than are prescribed. “That’s the most common avenue to abuse and nothing’s going to stop that,” she said, underscoring that pharmaceutical companies have made millions in profit off this addiction — and now stand to gain from these new formulations.
But Dan Cohen, a leader with the Abuse Deterrent Coalition, a national advocacy group that includes pharmaceutical companies, technology experts and others, stressed that these drugs are not intended as a silver bullet at all, but as part of a solution to the national crisis. The products are not designed to stop addicts from getting high, but are crafted to make it far more difficult for “early-stage recreational users” to get that powerful high that might get them hooked.
‘It’s about de-risking the system’
“We make no claims that our product is abuse-proof,” Cohen explained, acknowledging that oral abuse remains a challenge. “But it makes it harder for young people to tamper with the products,” he said. “It’s about de-risking the system.”
And when more than 70 percent of prescription opiate abuse involves pills taken by someone who was not prescribed the drugs but got them from the medicine cabinet of a friend, family member or acquaintance, or because of a similar “leakage” to unauthorized users, these added barriers can make a big difference, Cohen added. “We’re not able to solve the problem of drug abuse,” he said, “but we’re able to impede the progress to a quicker high.”
The coalition’s goal, Cohen added, is not to advocate for pharmaceutical companies, but to reduce the impact of addiction. “The ultimate goal of this is to lower the death rate and the rate of use and abuse. Period, full stop,” he said.
Assemblyman Herb Conaway (D-Burlington), a practicing physician who is the lead sponsor of the legislation in New Jersey, has said that policymakers should be doing what they can to encourage the use of ADOs if they can help reduce the epidemic of opioid addiction and death.
“As a doctor, my goal is to reduce those risks and make the patient well. Removing the cost barrier to abuse-deterrent opiates will increase the prescribing and use of these high-tech drugs, which have significant potential to reduce dependency and overdoses,” Conaway, the chair of the Assembly health committee, said in October, when the bill passed a key panel. The measure now awaits a full Assembly vote; the Senate version has yet to have a hearing this year.
Sen. Vitale said further study needed
“We need to approach this problem with a variety of solutions,” added Assemblyman Vincent Mazzeo (D-Atlantic), another sponsor. “This is another option.”
But Sen. Joe Vitale (D-Middlesex), said Monday the concerns raised by the FDA panel and the questions generated by the DOBI commission have led him to believe the matter needs further study. Vitale, the Senate health committee chairman, has led many legislative efforts to combat addiction.
The latest legislation (A-1833/S-1313) would require all health plans regulated by the DOBI — including those covering state, local and school workers — to include abuse-deterrent drugs on their formulary, or approved drug list, without additional insurance review or extra cost to the patient. Christie declined to sign a similar bill that was approved by the Legislature last year, based on concerns about the technology and cost. (Cohen said nine states have adopted legislation to study the efficacy of these drugs or include them on the insurance formularies, but it is too soon to understand the full impact.)
The measure is also backed by BioNJ, an advocacy organization for life science companies in the Garden State, which said it is an important weapon in the ongoing effort to reduce what Christie has declared a public health crisis. “We understand, as does the Food and Drug Administration, that abuse-deterrent opioid analgesics by themselves will not solve this problem, but they are part of a multi-faceted approach that will hopefully provide a solution to this national epidemic,” said Debbie Hart, BioNJ president and CEO.
But insurance providers remain opposed to the plan — as they have been from the start. Wardell Sanders, president and CEO of the New Jersey Association of Health Plans, blamed “relentless lobbying” from big pharma for pushing the mandate bill that will only add to their bottom line. “In the case of opioid drugs with so-called abuse-deterrent properties, experts are increasingly concluding that these drugs are not the panacea for opioid addiction despite their high cost,” he said.