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But just as challenging is keeping track of what new, potentially costly pain medications are emerging from the pharmaceutical company pipelines, says Daryl Corr, President, at Healthesystems, a Tampa, Fla.-based specialty provider of medical cost management solutions for the workers' compensation industry.

According to Corr, American consumers get a strong dose of advertising on national television for drugs that purport to control cholesterol or help them sleep better, but they don't often hear about the "next big thing" when it comes to managing pain, especially the more powerful opioids.

"When it comes to long-term drug treatments, there's never really a silver bullet that fixes everything," Corr says.

Corr explains that while drug treatments have a path that easily can change based upon influences beyond what the injury is, the introduction of new drugs into the market sometimes can start out slow and then turn into the next major prescription trend regardless of whether it is the most appropriate for treating the injured worker.

"Knowing what is coming is crucial," Corr says. "Keeping a close watch on the drug manufacturers' pipelines and what is in R&D to potentially impact our portion of the medical space is critical."

Of course, the most important aspect of this situation is if these new prescription pain medications hit the market without any forethought or plan for what the potential impact is going to be on your current claimant population or new patients, it may well become part of the next big drug trend that a payer really didn't want to get swept up in.

"This potential for high costs can be minimized as long as you have a targeted clinical program focused not only on the patients being treated, but also what is happening in the pharmaceutical marketplace," Corr says.

Oxycontin is a perfect example of how this can happen. For quite some time there has been a tremendous amount of press about the abuse of Oxycontin (and Oxycodone, the generic form). Yet, despite all the media coverage, it continues on this very problematic track and unfortunately it isn't likely to get any easier, says Dr. Ralph Kendall, Vice President of Clinical Services for Healthesystems.

In this case, the manufacturer is close to introducing a new "abuse deterrent" formulation of the drug to the market. For many people, on the surface this may sound great in that you have a pain treatment drug that is very popular, albeit very dangerous, and it is being reformulated so that it will control abuse. But the solution may not be as simple as that.

Of course, there is little doubt that alternatives are needed. Treating chronic pain conditions often places healthcare professionals in a dilemma as they navigate between the appropriate use of opioids and the misuse, abuse and diversion. And while the incidence and prevalence of opioid misuse and/or abuse in patients treated for chronic pain has not been fully studied or validated, one small study from BMC Health Services Research reported that 32 percent of chronic pain patients committed opioid misuse. Another study, from the Journal of Pain Symptom Management, reported abuse and dependence rates of 4.9% for patients receiving products containing hydrocodone. According to the 2007 report from the National Household Survey on Drug Use and Health, pain relievers used for nonmedical reasons was 2.1 percent or 5.2 million persons in the U.S. aged 12 and older in 2007 versus 1.8% in 2004.

Yet, while it is ideal to deter opioid abuse with new drugs, Dr. Kendall says, it is nearly impossible to develop a tamper-proof opioid. For example, a prescription opioid that is developed to deter crushing and injecting may not be a deterrent for overdosing when an intact product is consumed. Other forms of abuse include crushing for oral ingestion, dissolving for injection, nasal inhalation and smoking.

Healthesystems is keeping a close eye on several new abuse-deterrent opioid medications that may have an impact in the workers' compensation industry for 2010, including:

-- Acurox (by King Pharmaceuticals): an abuse deterrent formulation of immediate release oxycodone with niacin.

--Embeda (by King Pharmaceuticals): a recently released abuse deterrent formulation of morphine sulfate.

--Onsolis (by Meda-BioDelivery Sciences): a buccal, soluble film formulation of fentanyl.

--OROS (by Neuromed): an abuse-deterrent controlled release hydromorphone; it may become available in 2010.

--Remoxy (by King Pharmaceuticals): an abuse deterrent formulation of oxycodone.

In addition, Elite Pharmaceuticals, IntelliPharmaCeutics, and Collegium Pharmaceuticals also have abuse deterrent oxycodone formulations in various stages of development.

Even with those new medications entering or about to enter the workers' compensation pain management landscape, are these new drugs necessarily the best strategy for all patients? Most likely not, says Dr. Kendall.

"You really want to treat patients with the most appropriate drug, and in many cases it may require doing more work up front by using tools such as pain management contracts, urinalysis and other monitoring programs, including a new process from the Food and Drug Administration possibly being introduced, called REMS," he says. REMs, or Risk Evaluation and Mitigation Strategies, require the manufacturers of opioid pain medications to ensure that the benefits of these drugs outweigh the risks.

New drugs aside, Dr. Kendall says that the following steps may be more effective in preventing or intercepting problems than the use of these dosage forms:

--Appropriate patient screening to anticipate those who may be prone to abuse

--The use of the Screener and Opioid Assessment for Patients with Pain (SOAPP); used to predict future drug-related aberrant behaviors 6 months after screening.

--The Current Opioid Misuse Measure (COMM), which evaluates the degree of abuse-related behaviors in patients currently on opioids for pain.

--Regular confirmation of pain cause and use of opioid-sparing strategies

--Implementation of a patient pain management agreement for chronic therapy

--Pill counts and urine testing

--Confirmatory assessment of improved performance capacity to justify therapy

--Beginning opioid treatment with a planned exit strategy

To Dr. Kendall, while it does seem appropriate to make available abuse-deterrent opioid formulations for patients at high-risk for abuse, the smarter path could be that a cost-versus-benefit study be conducted prior to a shift from traditional opioids to a more costly opioid abuse-deterrent formulation.

"The idea is to evaluate if the shift in treatment would decrease the burden seen with prescription opioid abuse," Dr. Kendall says. "If managed using the above suggestions, the current pain medications can satisfactorily address most of the concerns observed in current trends."

At Healthesystems, the company's clinical services program, called VigilentRx, stays ahead of the new drug therapy curve by going beyond the traditional management process of writing letters and providing other informational programs for doctors.

"We do a lot to work directly with our clients to determine on a patient level where pain contracts or other external reviews are required," Dr. Kendall says. "We also closely monitor the drug manufacturers' pipeline and R&D process."

One example of how it can be more effective and less costly to use existing medications is urinalysis. Healthesystems can work with clients using periodic, random urine drug testing (UDT), but it is most effective when used with patients treated with opioids who have any predisposing factors for abuse/dependence, misuse or diversion (given or sold to another rather than taken).

"Using a urinalysis strategy can be a much more cost-effective way to manage medications for chronic pain than newer, more expensive drugs about to hit the marketplace," Dr. Kendall says. "It's just one strategy, but it has been proven to be effective."

In fact, one study found that of nearly one million UDTs done over a three-year period, 75 percent had abnormal results (patients were taking more than prescribed, none of the prescribed medication, or taking street drugs).

"Of course, an abnormal result should not be the sole determinant in decisions regarding treatment continuation," Dr. Kendall says. "But an unexpected UDT result may be a very good reason to refer the patient to a specialist experienced in treating complex pain patients."

Apart from the urinalysis, other effective ways to manage opioid use for chronic pain in workers' compensation cases should involve a multi-step process for identifying, reviewing and addressing the most appropriate care, especially when it comes to a drug regimen involving narcotics. At the same time, a strong clinical intervention program can accomplish the dual goal of keeping costs down while improving patient safety and better quality of care. Finally, it can keep payers in tune and informed about what is happening within the pharmaceutical industry regarding opioid-based pain medications.

In other words, it's a good idea to consider all the options before being swept into the "next big thing" and an effective clinical intervention program can do that.

"Payers need to manage their overall drug utilization and at the same time minimize one of the most significant cost drivers for prescription drugs," Corr says. "A clinical intervention program needs to be ahead of the curve, and ready to use up-to-date information to help clients make the most informed decisions possible. That way, everybody wins."

(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/.)

November 16, 2009

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