WASHINGTON — The White House’s national strategy to combat the opioid crisis, unveiled last week, would expand a particular kind of addiction treatment in federal criminal justice settings: a single drug, manufactured by a single company, with mixed views on the evidence regarding its use.

Federal prisons should “facilitate naltrexone treatment and access to treatment” to inmates as they transition out of incarceration, according to a fact sheet circulated by the administration. A White House spokesman later confirmed to STAT that the document referred specifically to naltrexone in its injectable form.

Only one manufacturer makes a drug fitting that description: Alkermes, a Massachusetts pharmaceutical company that makes Vivitrol, a monthly injectable drug that blocks the effects of opioids and reduces cravings. The company has been criticized for aggressive tactics in pitching its product — which can cost over $1,000 per dose — to criminal justice systems. In November, Sen. Kamala Harris (D-Calif.) opened an investigation into the company’s marketing practices.

The federal prison system oversees roughly 185,000 inmates, and some estimates indicate that nearly half meet criteria for a substance use disorder. The plan, according to the White House spokesman, was to use Vivitrol to provide a month of reduced risk for relapse before transitioning individuals into longer-term recovery. The spokesman later added that the policy objective was to save lives and not to punish the pharmaceutical industry.

But addiction experts say that, though ensuring access to medication-assisted treatment (MAT) is an improvement on status quo, multiple MAT drugs should be made available and chosen according to physician judgment and patient need.

Criminal justice systems have often favored naltrexone since it is not opioid-based and not a potential drug of abuse, as are true of methadone and buprenorphine. Alkermes CEO Richard Pops, when testifying before a White House commission on the opioid crisis in September, stressed the importance of increasing insurance coverage for Vivitrol, but added that patients should be made aware of all available treatment options.

When asked about the plan, administration health officials themselves expressed doubts about the approach.

“We don’t per se favor one drug over the other, because some patients respond better to one or the other,” said Nora Volkow, the director of the National Institute on Drug Abuse, at a press event on Tuesday. “It is clear that treatment in the prison system significantly improves outcomes, whether it’s [with naltrexone or buprenorphine].”

Health secretary Alex Azar was unfamiliar with the proposal to provide Vivitrol exclusively, saying in response to a STAT question: “I have a feeling that was an inadvertent reference. I think the key thing was the prison population, as opposed to any one product.”

Azar, who was sworn in as health secretary in late January, walked back his remark 15 minutes later, citing “staff-level discussions” and a directive from the Substance Abuse and Mental Health Services Administration that anyone “coming out of prison or a detox program should in fact be put on naltrexone, but that doesn’t mean it’s the best form [of MAT] for all populations.”

Limited options

Vivitrol’s favored position may be thanks to a distinction in its chemistry — the drug isn’t itself an opioid. The predominant other forms of medication-assisted treatment on the market, methadone and buprenorphine, are opioids. Many in public health and policy spheres have expressed doubts regarding those drugs’ use, including former health secretary Tom Price, who said in May that they may amount to “substituting one opioid for another.”

Vivitrol, by contrast, blocks drug users’ high from opioids.

“Methadone and buprenorphine have been shown on a variety of metrics to be far superior to Vivitrol — that includes safety, effectiveness, and cost,” said Leo Beletsky, a professor of law and public health at Northeastern University who focuses on drug policy. “The reason Vivitrol is preferred is that it’s a medical version of forced abstinence. That is why it’s been the darling of those who rhetorically support medication assisted treatment.”

A Vivitrol-only policy is unlikely to yield the best possible outcomes, Beletsky and other experts said, because it limits patient options in a situation where multiple medications are available. A better system, they said, would involve offering Vivitrol alongside either buprenorphine or methadone, and preferably both.

It’s a model being pioneered by the corrections system in Rhode Island, the results of which were recently praised by Chris Jones, who directs the National Mental Health and Substance Use Policy Laboratory, in an interview with STAT.

Rhode Island offers methadone, buprenorphine, and naltrexone to inmates with opioid use disorder based on which medication is deemed to be most appropriate. The state’s approach is increasingly seen as a nationwide model for administering MAT within prisons.

Connecticut similarly strives to ensure multiple options for patients seeking treatment.

“We favor an approach to patients with [substance use disorders] that offers the full range of medicines, including no medicine, as well as behavioral treatment like psychosocial counseling, and to provide patients with a full accounting of the risks and benefits of the treatment option,” Kathleen Maurer, who oversees health services for Connecticut’s corrections department, told STAT. “If we start someone on a medicine in our system, we have to make sure they have access to that medicine when they go home.”

Evidence and marketing

The White House’s plan is consistent with a number of efforts Alkermes has made around the country to market its drug at the state level. In California, for instance, Alkermes employs Kathryn Jett as a consultant in criminal justice and substance use disorders. Previously, she spent four years overseeing drug and alcohol treatment programs in California’s department of corrections.

Alkermes hired Jett, a company spokeswoman said in a statement to STAT, because “it is important for us to understand how we can best support access to our medicine for all patient populations, including those involved in the criminal justice system.”

Vivitrol has also marketed its product directly to judges in drug court systems. Many judges, NPR reported last year, were willing to order a Vivitrol prescription because it had no potential for abuse.

“Alkermes believes that all FDA-approved medicines have an important role to play in our national response to this epidemic,” the spokeswoman said. “This is something that we have communicated consistently in testimony, press releases, earnings updates and interactions with addiction-related stakeholders.”

Evidence of Vivitrol’s efficacy became much stronger in November, when a study funded by NIDA found the drug to be as effective as buprenorphine, another common form of MAT, in patients who adhered to treatment for an extended period. However, Vivitrol was found to be at a disadvantage for immediate treatment, given that patients need to detox for seven to 10 days prior to the drug’s use. A White House spokesman said Vivitrol was most appropriate for addiction treatment in federal prisons in part because inmates who had been incarcerated for long periods would already have detoxed.

Another recent paper — co-authored by Andrew Saxon, a researcher at the University of Washington, and a number of other researchers who had been employed or otherwise compensated by Alkermes — used data from 2011 to 2013 to show some positive results for Vivitrol users. Their data, however, also showed that 49 percent of participants, for a variety of reasons, never received more than two injections.

Low adherence rates are an obstacle in delivering addiction treatment regardless of the drug in question. For that reason and others, multiple experts in addiction treatment including Saxon said doctors and patients should have options in choosing a medication.

“I would not want to treat people in the criminal justice system any differently than I would want to treat any other patient,” Saxon said.

By LEV FACHER @levfacher

MARCH 26, 2018

https://www.statnews.com/2018/03/26/trump-opioid-plan-alkermes-vivitrol/