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Tips, trends, and best practices shared by our team of life insurance underwriters and technologists

Underwriting Off-Label Drug Use

RGAX Life Underwriting Hub - Off-Label Drug Use

The medications we take control our ailments and make us feel better, but what many patients don’t know is that the pills they take may not be approved for their condition. After all, in the US, Canada, and the UK once a medication is approved to treat a condition, a physician can legally prescribe it for any other purpose. This medical practice of writing prescriptions for non-approved medication is called off-label prescribing or off-label drug use. Off-label prescribing is widespread in medicine: some estimates place the rate of all off-label prescriptions as high as 20%, with psychiatric drugs alone at 31%.

Off-label drug use has been around as long as modern medicine

Aspirin, for instance, was used for years to prevent or reduce the impact of myocardial infarctions - or heart attacks - before its 1998 approval for that purpose. Despite this practice’s long history and subsequent acceptance, a 2016 systematic review by Eguale et al. of 46,021 Canadian patients to identify the risk of adverse drug events associated with off-label uses showed some alarming findings. 81% of off-label drug use wasn’t backed by strong scientific evidence, and the risk of adverse events increased by 44% with off-label use.

Life Underwriting Expert Series: Off-Label Drug Use

Do off-label drug uses outweigh the drawbacks?

While such staggering statistics may make it sound like physicians are experimenting on their patients, most physicians believe the benefits off-label uses outweigh the drawbacks. In fact, many off-label uses have at least some scientific backing or are only approved for certain age groups or populations. Additionally, a good number of off-label uses are the second or third choice of therapy for patients who don’t tolerate first line therapy.

Still, it’s important to consider the impact off-label prescribing, not to mention whether it’s ethical or even legal in the first place. More pertinent here though is the question of how the insurance industry should handle it.

Why is off-label drug use important to life underwriters?

Challenges for the insurance industry mostly concern underwriting off-label uses. Underwriters have the critical responsibility of confirming why medications are taken, especially since many clients can’t do so themselves. This confirmation process is challenging for underwriters because a number of medications have additional indications. Further complicating an already difficult task is that not only medications but also vitamins, naturopathic, and homeopathic therapies need confirmation.

Examples of off-label drug use

To understand the confirmation process better, consider the following example. When a client indicates they’re taking Wellbutrin, which only indicated use is for treating major depressive disorders, the underwriter might consider examining the case more closely. If the client does not disclose a history of depression but indicates he or she has recently quit smoking, the underwriter can maintain a lower degree of suspicion. The reason for this change of approach is that Wellbutrin is widely used to aid smoking cessation even though it’s not approved by the FDA for that purpose. Another form of bupropion, Zyban, is indicated for smoking cessation, but physicians often prescribe Wellbutrin off-label for smoking cessation due to brand familiarity.

Bupropion represents a less common off-label use: prescribing a medication for its side effects. The drug has risen in popularity as one of the few anti-depressants causing patients to lose weight consistently. As a result, it’s often prescribed in conjunction with diet and exercise as a form of weight loss therapy. Likewise, levothyroxine and stimulants including amphetamines have seen an uptick in use for weight loss although most physicians do not recommend them for that purpose.

Awareness of off-label drug use is an important skill for proficient underwriters

It serves as a reminder that remaining critical of any information provided can help reduce underwriting errors as well as operational and reputational risk. That said, not every abnormality requires a referral to the medical director. Sound judgment here is a key tool for the expert underwriter. 

While the popular physicians’ idiom “when you hear hoofbeats, think of horses not zebras” also pertains to underwriting, the occasional possibility of a “zebra” should remain in the back of every conscientious underwriter’s mind.

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Eguale T, Buckeridge DL, Verma A, et al. Association of Off-label Drug Use and Adverse Drug Events in an Adult Population. JAMA Intern Med. 2016;176(1):55–63. doi:10.1001/jamainternmed.2015.6058

Jeffreys D. Aspirin: The Remarkable Story of a Wonder Drug. New York: Bloomsbury; 2004.

Radley DC, Finkelstein SN, & Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med. 2006 May 8;166(9):1021-6. PubMed PMID: 16682577.


Written by: Al Thai

Al is an Underwriter at RGAX. He supports the RGAX Underwriting Solution Services team in providing comprehensive life insurance underwriting solutions to help carriers optimize risk management outcomes and better compete now and into the future. A subject matter expert, Al holds a medical doctorate and Master of Science degree, and has extensive experience in medicine, teaching, and risk management, bringing a new perspective to a rapidly changing and growing industry.