This article is more than 5 years old. Information may no longer be current.

Unrestricted coverage of many opioids persists

Although daily allowable dosing of prescription opioids was increasingly restricted between 2006 and 2015 under Medicare Part D formularies, unrestricted coverage of many opioids, especially at high doses, persisted, according to research published in Annals of Internal Medicine.

“Over the past 2 decades, prescription opioid sales and overdose deaths have quadrupled,” Elizabeth A. Samuels, MD, MPH, from Yale University, New Haven, Conn., and colleagues wrote.

“Restricting formulary coverage for prescription drugs is one strategy to decrease opioid prescribing. ... The extent to which opioids are covered and/or restricted among formularies serving Medicare beneficiaries is unknown,” they added.

Samuels and colleagues sought to determine how access to prescription opioids among Medicare Part D formularies was restricted due to the use of management strategies during a 10-year interval. The researchers compared the coverage for all available doses of short- and long-acting opioids except for methadone in 2006, 2011 and 2015 using the CMS prescription drug plan formulary files. They calculated the median proportion of drug-dosage combinations that formularies did not cover, covered but did not restrict or restricted through prior authorization, step therapy or quantity limits.

In addition, researchers determined if prescribed dosages were restricted to less than 50 morphine milligram equivalents (MME) per day or to 50 to 90 MME per day and if dosages greater than 90 MME per day were permitted.

A total of 324, 244 and 389 formularies from 2006, 2011 and 2015 were studied.

The researchers found no opioid prescribing restrictions for more than two-thirds of drug-dosage combinations in 2006 and 2011 and no restrictions for about one-third in 2015. Step therapy was not often required. Prior authorization requirements increased from 0% in 2006 and 2011 to 4.4% in 2015.

Over time, there was an increase in the median proportion of drug-dosage combinations with quantity limits: 2006, 8.9%; 2011, 22.2%; and 2015, 71.1%. There was also an increase in dose restrictions less than 50 MME per day from a median of 2.2% of drug-dose combinations in 2006 to 4.4% in 2011 and 13.3% in 2015.

During the study period, hydrocodone-acetaminophen was increasingly covered at all dosages. Formularies did not require prior authorization or step therapy for hydrocodone-acetaminophen, but there was an increase in restrictions for its daily dosage of 5-mg/325-mg and 7.5-mg/325-mg formulations, and a greater proportion of formularies limited prescriptions to less than 90 MME per day.

Between 2011 and 2015, there was a slight increase in restrictions on MME per day for the 10-mg/325-mg formulation. In 2015, prescribing greater than 90 MME per day of 10 mg/325 mg was permitted by about 80%.

“Given that higher doses are associated with higher overdose rates, limiting prescribed MME per day or requiring prior authorization or step therapy for high-dose opioids may facilitate better adherence to [CDC] prescribing recommendations,” Samuels and colleagues concluded. “Because formulary coverage directly affects prescribing, our study suggests that formularies present an underused opportunity to restrict opioid prescribing.” – by Alaina Tedesco

Disclosures: Samuels reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.