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Weighing In on the Battle of the Bulge: Underwriting Insights on Off-label Weight Loss Drugs

For life insurance underwriters, evaluating the purpose and use of prescription drugs is not new, but it gets a bit more complicated when those drugs are being used for reasons other than what the drug was intended, or “off-label.” When newer drugs enter the market, their limited history can pose questions for underwriters as to the long-term impact and effects, which can make it a challenge to properly classify the risk that an insurance applicant poses. This is especially true with the new class of drugs being used for weight loss.

In this Quick Read, Prajakt Mahajan, Head of Underwriting Services & Solutions, US Life, shares his insights from “The Battle of the Bulge” industry panel at the annual conference of the Metropolitan Underwriting Discussion Group.

What is important to know when we talk about weight loss and underwriting?

Obesity has long been associated with additional mortality. A higher Body Mass Index (BMI) prevents applicants from qualifying for best underwriting rates and leads to further health complications, including hypertension, diabetes, hypercholesterolemia and sleep apnea, among others, which can further impact an applicant’s risk profile.

Society has traditionally emphasized weight loss through exercise, improved diets, surgical intervention and prescription drugs. Recent developments in weight loss medications have shown increased effectiveness with less frequent administration and fewer side effects. This challenges the more common view of obesity, posing the question of whether obesity is an issue of chemistry or will-power.

What were some key takeaways from the panel discussion?

When it comes to life insurance underwriting, assessing cases involving these new drugs entails many considerations and uncertainties. During the panel discussion, we focused on several key points related to the rise in popularity of weight loss drugs including:

  • Safety
  • Effectiveness
  • Durability and affordability
  • Underwriting approach

What specific drugs were discussed during the panel?

Since the mid-1990s, several different drugs have been available for treating weight loss. The older drugs were found to be less effective for treating obesity and came with significant safety issues. The table below provides a brief overview of their mechanisms and limitations.

  Drug (trade name) Approval FDA / EMA (year) Mechanism  Adverse events a Contraindications b
  Orlistat (Xenical, Alli) FDA 1999
EMA 1998
Gastric and pancreatic lipase inhibitor Oily rectal leakage, abdominal distress, abdominal pain, flatulence with discharge, fecal urgency, steatorrhea, fecal incontinence, increased defecation Patients with chronic malabsorption syndrome or cholestasis, pregnancy
  Phentermine/ Topiramate (Qsymia) FDA 2012 NE agonist/GABA agonist, glutamate antagonist Elevation in heartrate, mood and sleep disorders, cognitive impairment, metabolic acidosis, paresthesia, dry mouth Glaucoma, hyperthyroidism, during or within 14 days following the administration of monoamine oxidase inhibitors, hypersensitivity to sympathomimetic amines, pregnancy
  Naltrexone/ Bupropion (Contrave/ Mysimba) FDA 2014
EMA 2015
Opioid receptor antagonist/DA and NE reuptake inhibitor Nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, diarrhea, sleep disorder Chronic opioid use, acute opioid withdrawal, uncontrolled hypertension, seizure disorder, bulimia or anorexia nervosa, abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiseizure drugs; concomitant use of MAOIs, patient receiving linezolid or IV methylene blue, pregnancy
  Liraglutide (Saxenda) FDA 2014
EMA 2015
GLP-1 analogue Increased heart rate, hypoglycemia, constipation, diarrhea, nausea, vomiting, headache Persona lor family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type2, pregnancy
  Semaglutide (Wegovy) FDA 2021
EMA 2021
GLP-1 analogue Nausea, vomiting, diarrhea, abdominal pain, constipation, headache Personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type2,  pregnancy
  Setmelanotide (Imcivree) FDA 2020
EMA 2021
MC4R agonist Injection site reactions, hyperpigmentation, nausea, headache, diarrhea, vomiting, abdominal pain None
  Tirzepatidecc Under consideration by FDA  GIP/GLP-1 dual agonist Nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type2, known serious hypersensitivity to tirzepatide or any of the excipients

 

Table 1: Anti-obesity medications: approval, mechanism of action, adverse events, and contraindications.Abbreviations: DA, dopamine; EMA, European Medicines Agency; FDA, Food and Drug Administration; GABA, gamma-aminobutyric acid; GI, gastrointestinal; GIP, gastric inhibitory polypeptide; GLP-1, glucagon-likepeptide1; IV, intravenous; MAOIs, monoamine oxidase inhibitors; MC4R: melanocortin-4receptor; NE, norepinephrine. Adverse events presented here are those that are present in more than 10% of the population, based on the FDA approval leaflet. Contraindications are based on the FDA approval leaflet. Under expedited consideration for FDA approval. 

 

In recent years, it was found that GLP-1 agonist drugs (Glucagon-like peptide-1), historically used for treating diabetes, showed significant benefits for weight loss, with fewer safety concerns. Drugs like Ozempic and Mounjaro, originally prescribed for diabetes, were found to also increase satiety leading to decreased food intake and overall weight loss.

Over time, the benefits of these drugs led to newer and advanced products, Wegovy and Zepbound, to be introduced to market specifically targeting obesity. With more convenient dosing intervals and effectiveness for weight loss, we have seen a significant rise in the use of GLP-1 agonists. See Figure 1.

Figure 1: Incidence Rate of all GLP-1 Agonists. Source: Milliman IntelliScript, 2023.

What were the most important insights from the discussion?

We are in the early stages of gaining information and insight related to these drugs. With their surge in popularity, we can make some considerations when it comes to how we have traditionally been looking at obesity. Have we overcomplicated obesity management considering the variety of exercise and diet fads we have seen?

Although the GLP-1 agonists have been shown to contribute to significant weight loss, several questions still remain as to long-term impacts and accessibility. It remains unclear as to what type of weight loss is occurring and how durable that weight loss will be. Is it fat mass or lean mass patients are losing?  How long will they need to be on the drug? Recent studies have shown that when people stop using these drugs, 70% of the weight they lost within the past year is put back on.2

Unlike the incumbent weight loss drugs on the market, GLP-1 agonists are priced higher, and anti-obesity medications are not routinely covered by insurance. Some view them as “cosmetic” while the Medicare program is prohibited by law to cover these drugs.

As these drugs are more readily available, questions also arise about whether more focus is needed on de-prescribing and if they should be viewed as a cure or more as prevention, and if the use of these over complicates the weight loss process.

How does this information impact the approach of life insurers to underwriting and coverage?

Understanding Bias

It’s important to check biases and perceptions as handling of underwriting can differ. It is not uncommon for underwriters, even within the same carrier, to take different approaches when learning that an applicant is using these medications. When considering these drugs can be used for weight loss, the spread of bias increases. Underwriters need to understand the key factors related to the use and risks of these drugs and the purpose of the treatment – whether it addresses diabetes, obesity or cosmetic weight loss.

Additionally, if these drugs are found to be used for weight loss, evaluating potential side effects is vital, including any history of thyroid issues, cancer or suicide ideation as well as an increased risk of pancreatitis. Identifying the advantages and benefits that the medication may offer is essential for a comprehensive assessment.

Underwriting Considerations

Think about what the risk and complicating issues arise is if obesity is untreated, and perhaps ask the question of where the applicant would fall in terms of risk classification had it not been for the medication along with potential benefits of using the medication.

Underwriters need to understand if the motivation for weight loss is a true lifestyle change or simply a quick fix.

What if the applicant’s health insurance does not cover the weight loss drugs? Underwriters need to understand if the motivation for weight loss is a true lifestyle change or simply a quick fix. The cost may not be sustainable without health insurance, and what happens if the applicant stops using the medication and the weight comes back? Do the underwriting rules remain the same in these instances?

We can also look at the role of health and wellness programs and how these drugs fit into broader initiatives by life insurance companies in terms of preventative health measures or incentives for positive health choices.

Maintaining Accelerated Underwriting

Accelerated underwriting faces challenges in distinguishing between diabetics using these drugs for their condition and individuals using them for weight loss, often due to insufficient application details to discern the purpose of the medication. This leads to applicants being removed from accelerated underwriting processes and referred for manual underwriting.

Misrepresentation of BMI complicates accelerated underwriting by affecting mortality slippage. This underscores the importance of holistic weight management approaches, considering long-term health and behavioral factors.

Accelerated underwriting programs can also benefit from incorporating new data sources like labs, medical claims data and electronic health records. Not only do they provide insight into applicant’s history but can be structured into new rules to ensure program continuity.

Conclusion

When considering weight loss drugs from an underwriting perspective, we need to continue to take a comprehensive approach and to think critically about the broader implications of these drugs in the context of obesity management and overall health strategies.

As we navigate the ever-changing field of medical treatments, it is crucial to approach these discussions with a balanced perspective, prioritizing patient safety and informed decision-making. With the increasing popularity of this topic, and the use of these drugs, we will continue to stay informed to ensure we are providing the best services to our clients.

Find out more about Medical Underwriting solutions at PartnerRe.

Contributor

Prajakt Mahajan, Head of Underwriting Services & Solutions, US Life

Opinions expressed are solely those of the author. This article is for general information, education and discussion purposes only. It does not constitute legal or professional advice and does not necessarily reflect, in whole or in part, any corporate position, opinion or view of PartnerRe or its affiliates.

[1] “Pharmacotherapy of obesity: an update on the available medications and drugs under investigation”, Marlene Chakhtoura, Rachelle Haber, Malak Ghezzawi, Caline Rhaydem, Raya Tcheroyan and Christos Mantzoros, available at: https://www.thelancet.com/action/showPdf?pii=S2589-5370%2823%2900059-7. ©2023 TheAuthors.PublishedbyElsevierLtd.  

[2] https://jamanetwork.com/journals/jama/fullarticle/2812936?resultClick=1

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