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Off-label Use of Pain Treatment No Longer Covered by Insurance

Ask the Expert from November 2012

A 65-year-old man with severe lumbar spine degeneration has been using a fentanyl buccal/sublingual product for 7 years. No other treatment agent has given him much relief. His insurance carrier (Medicare) has just declared that they will no longer pay for off-label use of fentanyl buccal/sublingual products, claiming it is only labeled for cancer patients. What does the prescribing physician do?

Answer: This is one of those frustrating situations that physicians seem to be facing more often. These fentanyl products (such as Actiq, Fentora, Onsolis, etc) provide ultra-rapid pain relief, as quick as intravenous morphine. They are terrific for providing rapid relief for episodes of severe breakthrough pain. They are often used off label for office surgical procedures, rapid-onset kidney stone pain, severe exacerbation of back pain, etc. Up until now, fentanyl buccal and sublingual formulations have been FDA approved only for cancer pain. However, they are frequently and appropriately used for noncancer pain, but their FDA status provides the opportunity for insurers to refuse to pay for them.

So what can the prescribing physician do? The first matter you need to clarify is why the patient is using this product. In many cases patients are in fact prescribed these products to be used on a regular basis several times per day for ongoing pain. Such patients would be better off on a sustained-release opioid analgesic such as fentanyl transdermal patches or an oral sustained-release opioid. If cost is an issue, methadone is another good choice, although it needs to be prescribed in three-times-daily or four-times-daily dosing. (Its long serum half-life results in a steady-state serum level despite several doses per day.) On such a regimen, the patient may need many fewer fentanyl buccal tablets than he is on at present.

The second question relates to the patient’s episodes of breakthrough pain. Oxycodone (Percocet), hydrocodone (Vicodin), immediate-release morphine or hydromorphone (Dilaudid), or oxymorphone (Opana IR) tablets provide pain relief quickly—typically within 30 minutes. Although not as quick as fentanyl buccal tablets, short-acting oral opioids may provide adequate relief for this patient’s breakthrough back pain. Reserve the fentanyl buccal tablets for pain episodes that increase to maximum within a few minutes.

Jennifer Schneider, MD, PhD
Internal Medicine, Addiction Medicine, and Pain Management
Tucson, Arizona

Last updated on: November 30, 2012
First published on: November 1, 2012