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In workers' compensation care, the use of off-label drugs has been creeping up in recent years, as powerful pain killers meant for cancer patients and others suffering severe pain are being prescribed for pain treatment in work-related cases. While that's not necessarily a bad thing, it is still important for payors and their pharmacy benefit manager (PBM) to pay close attention to this growing trend, says Craig Crager, director of clinical services for Progressive Medical, Inc., the Westerville, Ohio-based workers' compensation PBM.

According to Crager, U.S. Food and Drug Administration regulations allow physicians and other healthcare practitioners to prescribe FDA-approved medications for other than their approved indications (but pharmaceutical companies can't promote a drug for any other purpose without formal FDA approval). Once a drug has been approved for sale for one purpose, however, physicians can prescribe it for any other purpose that in their professional judgment is both safe and effective.

As noted, workers' compensation-based medical care is becoming a prime environment for off-label medication use. Crager says that should come as no surprise, considering medications including antipsychotics, anticonvulsants and antidepressants are among the most well-known categories of off-label drugs.

Crager explains that while antipsychotics are traditionally used for schizophrenic disorders and bipolar aggressive disorders, in the recent past antipsychotics have been found useful in treating depression in patients for whom standard antidepressant medications have not worked.

"The mechanism through which these medications treat depression is unknown," Crager says. "However, the increasing success in this use has lead to depression being added as an approved indication for some of these medications." Plus, antipsychotics may also have utility in treating depression and anxiety related to bipolar disorders. Finally, some antipsychotics may be beneficial in the treatment of insomnia, particularly if insomnia co-exists with psychological conditions.

Anticonvulsants have shown utility in the treatment of neuropathic pain and in migraine headaches, and antidepressant medications are used in anxiety conditions, neuropathic pain conditions, migraine prevention and insomnia.

Crager says Gabapentin and Lyrica (pregabalin) have FDA approved indications for post-herpetic neuralgia, and pregabalin carries additional FDA indications for diabetic peripheral neuropathy and fibromyalgia. In addition to these approved uses, however, these two medications are also used successfully in non-herpetic and non-diabetic neuropathic conditions. Also, Topamax (topiramate) and gabapentin, have been found especially useful in the prevention of migraine headaches at much lower doses than those needed to prevent seizures or treat neuropathic pain. Anticonvulsants that may have utility in neuropathic pain and migraine headaches, gabapentin, pregabalin and topiramate are among those with the most supporting evidence.

As for antidepressants, Crager explains that due to their nature, antidepressants are often utilized in patients with multiple conditions. Selective serotonin reuptake inhibitors (SSRIs, examples include paroxetine, sertraline, and fluoxetine) and serotonin norepinephrine reuptake inhibitors (SNRIs, examples are duloxetine (Cymbalta) and venlafaxine (Effexor XR) are often used in anxiety conditions. SSRIs also have some utility in insomnia. The SNRIs and the tricyclic antidepressants (TCAs) are used to treat neuropathic pain conditions and are considered first line therapy in the treatment of neuropathic pain.

"As many disease states and disorders become more understood, many existing medications may be put to use in treating conditions previously thought to be unrelated," explains Tron Emptage, a pharmacist and chief clinical and compliance officer at Progressive Medical.

Emptage says there are many reasons why the growth of off-label medication is taking place, and why it makes sense in some cases. He notes that to bring a drug to market is an expensive process that can drag on for longer than a decade. So it's easy to understand how drug companies seek more than a single use that can extend beyond original, and narrowly focused, initial clinical trials.

"As we have seen, many times those drugs can treat other conditions," he says. "The pharma companies understandably are trying to maximize their investment. And while the drugs are not initially FDA-approved for those conditions, we have seen that they can make a difference."

Emptage says that in order to ensure that off-label medications are medically appropriate and not driving higher (and sometimes hidden) costs, workers' compensation payors should seek a pharmacy benefit manager specifically designed to provide very close scrutiny to off-label prescriptions.

"PBMs should offer an injury-specific formulary, with guidelines in place that allow off-label medications through prior authorization or letters of necessity," he says. "There also needs to be a process by which claims professionals can ask questions of the physicians, so that off-label medications make sense for a particular case."

The critical aspect is to get safety nets and guides in place that go over and above the standard medication review process, Emptage adds, ones that involve pharmacists and nurses looking for medications that don't make sense in a specific workers' compensation claim. The next step is to do intensive reviews on any claim above the broader processes, where the PBM can hone in and get specific about off-label medications.

"One problem with off-label is medications is that the issue comes and goes, and is very drug specific," Emptage says. "If a particular drug gets in the spotlight, it can become very expensive and may not be appropriate for a specific claim."

Emptage sites Actiq and Fentora, two powerful pain killers originally FDA-approved for cancer patients, as an example. In both cases, the drugs, highly dangerous and expensive, are used at a disproportionate in the non-malignant and non-terminal pain arenas.

"As you look at some of those issues, you need to consider if these types of medications are approved for these indications, especially if a medication is potentially dangerous for the patient," he says.

Adds Crager, "For doctors, it's a science in trying to decide how to most effectively treat patients. They have a lot of literature and if off-label has been proven a success, they may want to try it with their patients."

Both Crager and Emptage say if a payor is using a PBM, when it comes to off-label medications, it's critical to make sure the PBM has the right clinical services in place to find the potential for inappropriate use of medications, overuse of narcotics, non-workers' compensation formulary medications, etc. Also, having experienced pharmacists and nurses on staff to help and assist is a critical success factor. In addition, there is always a chance that a treating physicians is not a pain management specialist, so they may not have the expertise a PBM can provide to ensure that they are using the right off-label medications for the right type of pain.

"Of course, not every off-label use is inappropriate," Emptage says. "The PBM's main job is more about helping a potentially less clinically astute adjustor, one who might not be trained to manage cases of off-label drug use, by delivering the data and processes to help them make better decisions. They need to know what orders to follow, what questions to ask."

The critical end result is to determine if the off-label medication is safe and if it's effective based on clinical evidence.

"The goal is to get people back to work as quickly and safely as possible," Emptage says. "We're trying to do the right thing for the patient, decide what gives them the right quality of care. If an off-label medication can help them do it, then it's worth it."

For more information, call Progressive Medical toll-free number at 866.742.7676, or visit us at http://www.progressive-medical.com

(The above piece is part of our continuing Insights series designed to highlight key products and services to our readers. This paid-for Insights was written and edited by Risk & Insurance® on behalf of our marketing partner. Additional Insights can be found on our Web site at www.riskandinsurance.com/.)

April 6, 2011

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