By IRA PORTER, who is a freelance writer in Philadelphia.
A much-anticipated regulatory decision scored a small win for workers' compensation risk managers recently when the Federal Drug Administration approved the ban of generic brands of the popular pain medication, OxyContin. The drug, an opium-based narcotic, is commonly used by workers' compensation beneficiaries but can be habit forming and lead to poor performance or delayed returns to work.
Banning the generic version, which was originally introduced in 1995 for cancer patients, was good timing for the FDA because Purdue Pharma L.P., the privately owned company's patent on OxyContin expired the same day.
General consensus is that without the ban, the flood gates for generic competitors, who would have sold the late 90s version of OxyContin, which was easily crushed to a powder for making it more susceptible to abuse, would have opened. Applications were pending to sell generic forms of the drugs, according to reports.
The decision was praised by risk management industry professionals.
"We were in favor of it because it will benefit patients who are at risk for abusing opioids. We do see it as a way to help efforts to prevent abuse of opioids," said Kate O'Lenic, a clinical pharmacist and manager of clinical services for pharmacy benefit manager Healthesystems.
"It's very positive. It demonstrates that the FDA is concerned about patient safety. Everyone anticipated a surge in abuse and overdoses if the FDA didn't do this. So the FDA took this step, which was a difficult step to take."
An important detail about brand name OxyContin is the fact that all pills manufactured have a built-in abuse deterrent, which prevents the drug from being crushed into a powder. For the past two-and-a-half years, Purdue has produced a version that when crushed turns into a jelly-like substance, which won't stop abuse but may curtail it.
While curtailing the growth of abuse is one thing, dealing with current abuse and the side effects from long-term use is another. The goal of the workers' compensation system is always to get patients back to a healthy quality of life. But what those in the industry have complained about for years is the baggage that comes along with prolonged opioid use.
"The reality is, the insurance industry is struggling with the population that has been on opioid therapy for a long time," said Todd Pisciotti, vice president of sales and marketing for Healthesystems. "It's costing them a lot of money. There is the cost of the drug and many other costs as well. Long-term opioid users are often on a number of other drugs that help them combat the side effects of opioid therapy. We have to get that population under control and return them to functional restoration."
What's more, insurers want to limit how doctors prescribe opioids. Several states have already banned doctors from prescribing and supplying opioids themselves, to stop doctors from marking up prices.
Many hopes exist in light of the new ban, but so do concerns, questions and suggestions. Experts will tell you OxyContin is one drug, but schedule II opioids are not short in brand or supply. A popular drug like Opana has an abuse-resistant component, but the generic version of it doesn't. The same is true for many other opioids. Doctors also seem to prescribe opioid use far longer than the two or three-month period guidelines suggest.
"We look at the big picture of cost. The cost isn't just the price of each drug. We have many costs associated with detox, rehab and the other drugs that address the side effects of opioid therapy. We're looking for a paradigm shift," O'Lenic said.
O'Lenic said alternative treatment programs can help patients in need that don't include prescription medications. The U.S. Army is trying a pilot program for treating injuries without opioids, instead using yoga, physical therapy and nutrition.
Longtime workers' compensation pharmacy benefit manager Phil Walls of myMatrixx, seconded that opinion.
"I think alternative therapy is underutilized. I don't really have a good explanation for why that is," Walls said. "It's probably difficult to get authorization for payment for these types of therapies. It's easier writing a prescription and having the insurance companies pay for it."
In addition to increasing physical therapy treatment, Walls forecast that after the FDA ruled as it did with OxyContin, that more impactful decisions are to come. He said we are bound to see more companies on both sides seeking to block or create opportunities for generic drugs. Walls also suggested that the United States Drug Enforcement Agency update 40-year-old classifications of drugs and bump opioids to schedule I narcotics. He also hoped that the American Medical Association will address physician oversubscribing of such medications.
April 30, 2013
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