The Food and Drug Administration plans to soon release two new draft guidance documents aimed at expanding the options for medication-assisted treatments, or MATs, for people addicted to opioids, Health and Human Services Secretary Alex Azar told state governors.
MATs are intended to relieve the withdrawal symptoms of opioids and psychological cravings that cause chemical imbalances in the body, according to the U.S. Substance Abuse and Mental Health Services Administration.
The FDA has approved three types of MATs: buprenorphine, methadone and naltrexone.
One of the FDA's pending guidance documents is intended to correct a misconception that patients must achieve total abstinence for a MAT to be considered effective, Azar said Feb. 24 during a speech at the 2018 National Governors Association annual meeting in Washington.
The guidance would encourage more flexible and creative designs of MAT studies, he said.
Researchers will be invited to develop new measures for evaluating the effects of MAT formulations, like looking at emergency-room visits or overdoses, rather than just patterns of drug use, Azar explained.
The other guidance is meant to clarify what kind of evidence is needed to gain approval for new "depot," or slow-release, slow-acting, forms of buprenorphine, he said.
The FDA has already approved one depot version of buprenorphine — Indivior PLC's once-monthly product Sublocade.
The FDA's new draft guidance documents may make a material difference in accelerating efforts to develop new forms of medication-assisted treatments and are intended to complement work elsewhere in the federal government to deepen the understanding of how the products work and how access to MATs can be expanded, Azar said.
He noted that the use of MATs has often been surrounded by stigma.
"Someone on MAT, even one who requires long-term treatment, is not an addict," Azar said. "They need medicine to return to work, re-engage with their families and regain the dignity that comes with being in control of their lives. These outcomes are literally the opposite of how we define addiction."
The new health chief said he chose to speak about MATs because the drugs are an aspect of the opioid epidemic that demanded "leadership that is willing to work to overcome any stigma associated with addiction and addiction treatment," which were not moral failings.
"Our fellow citizens who commit to treatment should not be treated as pariahs. They are role models," Azar insisted.
His remarks mirrored those made during an Oct. 25, 2017, hearing by FDA Commissioner Scott Gottlieb, who said people often wrongly assume that because someone is using MAT they continue to experience addiction, even when they are in full recovery.
"This attitude reveals a flawed interpretation of science," he said. Such wrong thinking stems from a misunderstanding about the difference between a physical dependence and an addiction, Gottlieb told lawmakers last fall.
Gottlieb had declared his intention in January to advance policies aimed at enabling the development of improved MATs as part of his strategic roadmap.
Other efforts to address the opioid crisis
Meanwhile, lawmakers are also considering a number of legislative solutions to address the epidemic — several of which are slated to be discussed at a Feb. 28 House Energy and Commerce Health Subcommittee hearing.
The Senate Health, Education, Labor and Pensions Committee is also meeting Feb. 27 to examine the role technology and data play in preventing and treating addiction.
In a letter to Senate Finance Committee leaders, the American Medical Association, or AMA, called on Capitol Hill to implement a number of measures to address the opioid epidemic, including making MATs a protected class of medicines under the Medicare Part D prescription drug program.
The Centers for Medicare and Medicaid Services, or CMS, currently requires that Part D plan sponsors cover all drugs in the classes of anticonvulsants, antidepressants, antineoplastic, antipsychotics, antiretrovirals and immunosuppressants.
The AMA said FDA-approved MATs should be the seventh protected class to ensure beneficiaries have access to the products for opioid addiction.
The medical group also asked lawmakers to support alternative payment models for MATs, noting that one reason the drugs are underused is because traditional physician payment systems "provide little or no support" for non-face-to-face services, such as phone calls and email consultations with patients, or collaborations between addiction specialists and other physicians or those with outpatient treatment programs and emergency departments.
The U.S. Chamber of Commerce is also seeking to highlight the work the business community, public sector and local communities are undertaking to combat the opioid epidemic by convening a March 1 all-day forum with various members of Congress, including Rep. Greg Walden, R-Ore., chairman of the House Energy and Commerce Committee.
Anne Schuchat, acting director of the Centers for Disease Control and Prevention, or CDC, and U.S. Surgeon General Jerome Adams are also slated to speak.
In addition, Thomas Moriarty, general counsel at CVS Health Corp., and Hal Paz, chief medical officer at Aetna Inc., are expected to address the forum.
Chamber President and CEO Thomas Donohue first announced plans to convene the opioid crisis forum during his Jan. 10 annual State of American Business address in Washington.
"Governments at every level, community organizations and businesses all have a role to play in addressing the epidemic," Donohue said.
Azar meets with Idaho governor
While at the National Governors Association meeting, Azar also had one-to-one chats about other healthcare issues with state governors, including Idaho's Gov. Butch Otter, who ordered his insurance commissioner last month to find a way to let insurers sell plans that escape meeting all of the requirements of the Affordable Care Act, or ACA, like its essential health benefits.
Blue Cross of Idaho said Feb. 14 that it planned to be the first to offer such plans.
Azar was grilled during three Capitol Hill hearings on Feb. 14 and Feb. 15 over what his agency was doing to prevent Idaho from allowing those policies, often called "skimpy" or "junk" plans by opponents.
At that time, Azar said he was only aware of media reports about Idaho and said that as far as he knew, the state had not sought a CMS waiver.
Fewer flu doctor visits, but virus still raging, CDC says
Fewer Americans sought medical attention from doctors outside of hospitals for the flu in the past week, the CDC reported Feb. 23, though hospitalizations due to the virus continued to climb.
The proportion of outpatient visits for influenza-like illness dropped from 7.5% to 6.4%, which "looks encouraging," CDC spokeswoman Kristen Nordlund told S&P Global Market Intelligence.
Still, influenza activity remained high in more than half of the U.S., with 39 states, plus the District of Columbia, Puerto Rico and New York City experiencing increased levels of flu-like illnesses.
The U.S. has been struggling with a particularly difficult flu season. On Feb. 15, the CDC reported that the vaccine was only 36% effective overall, though the product showed higher efficacy in young children — of up to 59% against the influenza A and B strains and 51% for the H3N2 strain.
The cumulative rate of flu-related hospitalizations rose to 74.5 per 100,000 people from about 68 out of 100,000 reported a week earlier, the CDC said in its latest report.
The agency also reported that 13 more children had died of the flu, bringing the total number of pediatric deaths to 97 for the 2017-2018 influenza season.