March 5, 2014
When Zogenix announced on October 25, 2013 that the U.S. Food and Drug Administration (FDA) had approved ZohydroTM ER (hydrocodone bitartrate) extended-release capsules, an extended-release oral formulation of hydrocodone without acetaminophen, the announcement came with the promise of continuous relief in the management of pain “severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate”.
In fact, according to Dr. Srinivas Nalamachu, M.D., a pain specialist at the International Clinical Research Institute, Overland Park, Kansas and investigator in the clinical trials of Zohydro ER, “Zohydro ER fulfills a critical need among people living with chronic pain who meet the criteria for therapy with extended release opioids. It is the first extended-release hydrocodone medicine that is acetaminophen-free. Also, a significant proportion of patients on existing forms of immediate-release hydrocodone-acetaminophen combination treatments have liver disease or risk factors, and the availability of an acetaminophen-free formulation encompassing a range of hydrocodone doses is an important therapeutic option for these patients.”
Just Say ‘No’ to Zohydro
If Zohydro ER truly is “an important option for patients with chronic pain”, why, then, would 40 experts, in a recent letter entitled “Just Say No to Zohydro”, urge the Food and Drug Administration (FDA) to reconsider its approval? And why did a coalition of Congressional representatives and state Attorney Generals also urge the FDA to listen to is own advisory panel, which voted 11 to 2 against the approval of Zohydro? The major question being posed by the experts who are challenging Zohydro is whether we can justify another potentially addictive opioid when the U.S. has seen deaths from opiate painkillers jump by 415 percent in women and 265 percent in men since 1999. According to the CDC, nearly 60 percent of all drug overdoses occurred from FDA-approved prescription medications (not illegal drugs) with 3 in 4 drug overdose deaths due to an opioid painkiller such as oxycodone, hydrocodone or methadone.
What We Learned From Oxycontin
Looking back, it would seem that our experience with crushed Oxycontin might have taught us that no Class II opioid narcotic should be approved for general release without the existence of an ‘abuse deterrent formulation’. Yet according to Andrew Kolodny, President of the advocacy group, Physicians for Responsible Opioid Prescribing (www.supportprop.org ), “It’s a whopping dose of hydrocodone five times more potent than what we’re dealing with now packed neatly in an easy-to-crush capsule. It will kill people as soon as it’s released.”
Yet the FDA continues to move forward. Zohydro is expected to enter the market later this month already classified as a Schedule II narcotic — one reason both the FDA and the drug’s maker are confident it will not contribute to the broader overdose problem. However, even the less potent formulation of hydrocodone (combined with Tylenol) is of such concern to the DEA that it is recommending it be re-classified from a Schedule III narcotic to Schedule II http://www.deadiversion.usdoj.gov/fed_regs/rules/2014/fr0227.htm. Also, Zohydro’s labeling will feature warnings about abuse, addiction and misuse, and according to a Zogenix spokesperson, the company is now working on an abuse-deterrent version of Zohydro that should become available in three years.
Unfortunately, none of those precautions has assuaged concerns. Those who seek to block Zohydro’s release said that while a small subset of patients may benefit from Zohydro, unleashing such a potent drug in the current environment is unsafe.
Zohydro’s Impact on Claims, Settlement and the MSA
It goes without saying that the release of a new, single source opioid into the current mix of medications prescribed for pain management in a workers’ compensation claim is of significant concern to employers, carriers and TPA’s. So what can be done to prepare for Zohydro’s release?
- Request that your PBM block Zohydro so that prior authorization is required before it can be filled. When requested, verify that other courses of pain management have been tried without success, and if available, send the request through UR.
- If Zohydro is approved, limit the authorization to a maximum of 60 days so that prior authorization will be required for future fills.
- Consider engaging a nurse or practicing physician to dialogue with the treating physician to discuss the long term viability of Zohydro and potential substitutions.
- Implement random UDT’s to insure that the medication is being used as prescribed.
- Monitor for changes in dosage, for the addition of short acting opioids and for increases in MED (morphine equivalent dosage) of > 50mg
To achieve optimum outcomes in care, cost and compliance when settling a workers’ compensation claim, replacement of Zohydro in the drug treatment regimen must be pursued in a proactive and aggressive manner. For more information about strategies to mitigate exposure with Zohydro and other opioids that drive MSA costs to a level that can prohibit settlement, email us at firstname.lastname@example.org.