FDA Commissioner-designate Scott Gottlieb testifies during a Senate Health, Education, Labor and Pensions Committee

FDA Head Wants Insurers, Pharmacy Benefit Managers To Help Curb Opioid Prescriptions

WASHINGTON, D.C. (July 27, 2017) – Commissioner of the Food and Drug Administration Scott Gottlieb, M.D. tells Bloomberg that insurers and pharmacy benefit managers could help control massive opioid dispensing, which could mean a change advocates have been hoping for: changing labels and mandatory training for doctors.

“I think it makes perfect sense for insurance companies to take a role in the prevention of overuse of opioid medications,” says The Bluffs Ohio and Pennsylvania Market Director Krista Sweet. “They are the ones who are seeing the huge cost increases in opioid addiction treatment authorizations as a direct result of opioids being overprescribed and misused.”

Sweet says having an extra step of accountability when dealing with these highly addictive medications is truly the responsible thing to do.

“I’m looking at different models that could potentially be less burdensome but be more effective at achieving the goal of making sure that prescribing conforms more closely with clinical guidelines,” said Gottlieb. “They’re not in there right now. There’s no information in the drug label about what the appropriate dispensing should be.”

Insurers could help in a number of ways, but this is a start – and it could save money for them in the long run by keeping them from having to provide addiction treatment. Researcher Andrew Kolody, M.D. says pharmacy benefit managers could require prior authorization for opioid prescriptions.

“Pharmacy benefit managers should provide ‘flags’ or warnings to alert the pharmacist to possible opioid overuse and abuse,” says The Treehouse Texas Market Director Micah Petty. “There are many safety precautions that can be put in place to cut down on misuse and it’s about time.”

The Centers for Disease Control and Prevention found the number of prescriptions for opioids has tripled since 1999. Gottlieb plans to meet with benefit payers and insurance administrators in September, both groups the FDA hasn’t typically worked with in its role.

“Most people who become addicted to opioids are medically addicted,” Gottlieb said. “The way to reduce the rate of new addiction is to reduce the rate of exposure, and the way to reduce the rate of exposure is to make sure people are receiving prescriptions when it’s only medically appropriate.”

The sessions with insurers and pharmacy managers will be his first official meetings with healthcare companies, although insurance companies are overseen by other departments – a proactive step on Gottlieb’s part to tackle the crisis.

More than 240 million opioid prescriptions were dispensed in the U.S. in 2014. Deaths from opioid pain pill overdoses in 2015 totaled almost 23,000 in the U.S., double the number a decade ago. Gottlieb says he plans to examine whether insurers and pharmacy benefit managers can reduce the number of pills dispensed.

“There shouldn’t be 30-day prescriptions for a tooth extraction or 30-day prescriptions for a hernia repair,” says Gottlieb.

Gottlieb in the past has worked as an adviser to investment firms and conservative think tanks. He says policy regarding opioid prescriptions has been his largest focus since he was confirmed as commissioner.

“Coming out of the confirmation process, I had a mandate to try to steer the agency in a little bit of a different philosophical direction,” says Gottlieb. “I talked to 65 senators who all wanted to see the agency act differently.”

And he’s been proactive. The FDA just asked Endo International to pull Opana ER and the company agreed to stop sales after abuse lead to an outbreak of HIV and Hepatitis C linked to IV use of the drug.

“We’re constantly looking retrospectively to what’s on the market and making sure that it still makes sense relative to today’s marketplace and what’s available,” says Gottlieb.

Healthcare spending among private insurers for opioid-related diagnoses increased more than 1,000% between 2011-2015. The per-member average annual cost burden among patients with opioid abuse disorders amounted to $63,356 compared to $11,404 for all patients.

Vertava Health Vice President of Compliance Maeve O’Neill agrees with Gottlieb on how critical it is to educate all physicians who prescribe opioids on the dangers of addiction and potential for relapse, and thinks payers should take more responsibility.

“We would also support any and all options being provided to folks seeking recovery,” says O’Neill. “Any initiative must include providing clients the full continuum of care they need and deserve, including residential treatment when needed and continuing care after residential treatment for at least 12 months, such as Vertava Health’ A Balanced Life.”

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