Despite FDA efforts to curb prescription opioid abuse, Medicare Part D plans seem to disfavor abuse-deterrent drugs, according to study from Avalere Health. Although Part D coverage of all opioids declined from 2012 to 2015, coverage of OxyContin® (oxycodone HCl controlled release) with abuse-deterrent labeling declined sharply, from 61 percent of plans in 2012 to 33 percent in 2015. The report’s authors could not pinpoint the reason for the decline, but suggested it could be related to the cost of abuse-deterrent drugs or a lack of data concerning their effectiveness.
Deaths from abuse of prescription opioids, such as oxycodone, hydrocodone, morphine, and codeine, quadrupled from 1999 to more than 16,000 in 2013. The number of seniors “misusing” prescription pain relievers in general nearly tripled from 149,000 in 2003 to 432,000 in 2013. Emergency room visits resulting from use of prescription opioids have also increased. In 2013, the FDA approved labeling for a reformulated version of OxyContin that described physical and chemical properties designed to make the drug more difficult to abuse via injection or snorting (see FDA finds reformulated OxyContin deters abuse, removes original OxyContin from list of safe and effective products, Health Law Daily, April 18, 2013). The FDA rejected similar labeling for Opana® extended release (ER), but approved labeling for Embeda®, Targiniq™ ER, and Hysingla® ER.
Avalere analyzed opioid coverage and utilization management (UM) procedures, such as prior authorization, quantity limits, and step therapy, among Medicare Advantage (MA) prescription drug plans (PDPs) and standalone PDPs between 2012 and 2015. Due to timing of FDA approvals, Avalere could only compare coverage of opioids without abuse-deterrent labeling with OxyContin, and not with Embeda, Targiniq ER, or Hysingla ER. Coverage of all long-acting opioids declined from 46 percent of plans to 36 percent in 2015. Branded drug coverage decreased by a greater percentage, but the decrease in coverage of OxyContin was even greater.
While 33 percent of plans provided coverage for OxyContin in 2015, nearly 100 percent of plans provided coverage for Oxycodone HCl IR, the active ingredient in OxyContin which does not have abuse-deterrent properties. Twenty-five percent of Part D plans require prior authorization for OxyContin in 2015, compared to 0.3 percent or Oxycodone HCl IR. In addition, plans have started placing OxyContin on higher cost-sharing formulary tiers. In 2012, OxyContin appeared in Tier 2 for non-preferred generic drugs in 21 percent of Part D plans; in 2015, it appeared in Tier 2 in only 3 percent of plans.
Although most opioid abuse takes the form of excessive oral doses, there is still an ongoing effort to develop drugs that will deter other forms of abuse, such as use via injection and snorting. However, there has been limited focus on access to drugs with abuse-deterrent properties. Caroline Pearson, Avalere senior vice president, noted, “Policymakers seeking to limit opioid abuse will have to balance the desire for greater access to abuse-deterrent opioids with the increased costs of such medications to public programs and private payers.”