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An opioid medication being developed by several companies could nearly double the daily dosage of hydrocodone available by prescription, and workers compensation experts are tracking the drug's progress.
San Diego-based pharmaceutical firm Zogenix Inc. said in a recent statement that it plans to submit a drug application this year to the U.S. Food and Drug Administration for Zohydro.
The drug, being tested in extended-release capsules ranging from 10 to 50 milligrams, could be the first pain medication on the market to contain hydrocodone without other non-narcotic drugs mixed in, such as acetaminophen, the company said.
Insurers, third-party administrators and pharmacy benefit managers say they are readying safeguards to help avoid addiction issues if the pending drug receives FDA approval and hits the market.
“We absolutely anticipate seeing this within comp,” said Brian Carpenter, Tucson, Ariz.-based vp of pharmacy product development for managed care company Coventry Workers' Comp Services, which operates a workers comp PBM called First Script.
Aside from Zogenix, similar medications are being tested by pharmaceutical companies such as Frazer, Pa.-based Cephalon Inc. and Stamford, Conn.-based Purdue Pharma L.P., according to the National Institutes of Health.
Current hydrocodone pain-killers, such as Vicodin, contain up to 10 milligrams of hydrocodone. Those pills typically are taken every four to six hours, leading to a daily maximum dosage of 60 milligrams, said Jim Andrews, senior vp of pharmacy services at Healthcare Solutions, a Duluth, Ga.-based PBM specializing in workers comp.
Drugs such as Zohydro, which likely would be taken twice a day, could result in a daily dosage of up to 100 milligrams if the strongest pill is approved by the FDA, Mr. Andrews said.
That potential increase in hydrocodone usage is cause for concern, said Dr. Robert Bonner, Hartford, Conn.-based vp of medical practices and medical director for The Hartford Financial Services Group Inc.
“That's going to put another very potent drug in the marketplace,” Dr. Bonner said.
In a statement, Zogenix said Zohydro would be safer than hydrocodone/acetaminophen pills because acetaminophen is “known to cause significant liver toxicity when taken in large doses over time.”
Full hydrocodone pills aren't expected to reach the market until next year, sources say. But workers comp experts are planning now to prevent potential health hazards, including addiction and overdoses.
Much of that will mean placing the new medications on specialized drug formularies that would require workers comp patients to receive approval before being issued some potent opioid prescriptions.
Sedgwick Claims Management Services Inc. began discussing such a strategy for Zohydro and other full hydrocodone drugs last month, said Kimberly George, Chicago-based senior vp of the managed care practice and client services.
The TPA uses a formulary that allows some medications to be approved based the severity of a patient's injury.
If a claimant is prescribed opioids for an injury that doesn't typically warrant such powerful medications, Sedgwick's claims examiners or nurse case managers may intervene and help the patient receive less potent drugs or medical treatments that could relieve their pain, Ms. George said. She said the company likely would use the same protocol for full hydrocodone pills.
Sedgwick's plan was developed several years ago with the introduction of drugs such as Actiq, a painkiller lollypop that contains the potent narcotic fentanyl.
“I think that really opened the eyes of Sedgwick, and certainly our pharmacy partners and clients, to track and identify medications like this,” Ms. George said.
Monitoring and intervention also are done by companies such as Atlanta-based TPA Broadspire Services Inc., Hartford, Coventry and Healthcare Solutions.
“The true solution lies in an integrated approach across all medical practices, and one of our best allies in trying to create better solutions is case management,” said Coventry's Mr. Carpenter.
Hartford's Dr. Bonner said some workers comp patients could receive Zohydro or similar prescriptions if the drug is deemed appropriate for an injured worker.
“Although there are concerns about this very potent drug, the Hartford would not automatically deny payment for it,” Dr. Bonner said. “However, we would put it through a review process to make sure that it made sense for that patient.”
Sources say they track the development of multiple drugs that could be used in workers comp, but Mr. Andrews said such medications may not always be as problematic as anticipated.
For instance, Healthcare Solutions was concerned whether last year's release of Lazanda, a fentanyl nasal spray, could create problems for injured workers. However, Mr. Andrews said that medication has not been prescribed much in workers comp.
Dr. Jacob Lazarovic, Broadspire's chief medical officer in Sunrise, Fla., said claim monitoring and patient intervention are the top tools that the workers comp industry has to stem abuse of hydrocodone and other medications.
“Whether it's a new or old drug, I think the industry is trying to deal with addiction issues and abuse issues, and I think it's fair to say that (the process) hasn't been perfected and hasn't been done as aggressively as it should have been in the past,” Dr. Lazarovic said. “But I think more and more so, we are dealing with it in a more aggressive and successful way.”
In a separate statement, Zogenix said Zohydro would be more difficult for patients to receive than drugs currently on the market. The medication would be classified as a Schedule II controlled substance by the U.S. Drug Enforcement Administration, which would prevent patients from receiving refills without a new prescription.
The DEA ranks controlled substances from Schedule I, which include illegal drugs, to Schedule V, which include drugs with “low potential for abuse.” Hydrocodone pills on the market today have a Schedule III classification.
Since only clinical data is available right now for Zohydro, only time will tell if the full hydrocodone pills are approved and if their benefits outweigh the potential risks for such drugs, Mr. Andrews said.
“The question now is: Is the cost and benefit worth (it),” Mr. Andrews said.