Demand for products that combined “fen” (fenfluramine), an appetite depressant, with “phen” (phentermine), an amphetamine, soared after a small study published in 1992 showed how the combined therapy curbed appetite and reduced weight. In a craze that predated social media, millions of people took fen-phen. Then, in 1997, fenfluramine and a similar molecule, dexfenfluramine, were withdrawn from the market following reports that these drugs led to heart valve damage and pulmonary hypertension.
Byetta and Victoza, older GLP-1s indicated for diabetes, have demonstrated a weight-loss effect. Larger weight-loss effects were observed with two newer GLP-1s approved for weight loss, Saxenda and Wegovy. Given its cost, Saxenda’s value proposition did not resonate with payers and an ICER report concluded that Wegovy’s wholesale acquisition cost required a 44%–57% discount to reach the health-benefit price benchmark range (the price range that would achieve incremental cost-effectiveness ratios between $100,000 and $150,000 per QALY gained) compared with lifestyle modification alone.
Over the past year or so, demand has surged for Ozempic and Mounjaro. These GLP-1s are indicated for adults with type 2 diabetes but not indicated for weight loss. For some payers, spend on Ozempic eclipsed spend on Humira! This feeding frenzy is due, in part, to off-label use promoted by celebrities and influencers on social media.
Payers did not sit back and weigh the pros and cons of action. In response to rapid gains in GLP-1 utilization and costs, they are pushing back and are exploring other ways to push back harder.
How they’re pushing back
Many self-insured employers have made weight-loss medications benefit exclusions. That’s not a surprise. These plan sponsors have made weight-loss surgeries a benefit exclusion and consider them to be cosmetic and not medically necessary. When drugs become a benefit exclusion, they are not covered and ineligible for medical exceptions and appeals. When a drug has only a weight-loss indication, it is easy for payers to block. However, for products that do not have a weight-loss indication, off-label use is blocked through prior authorization (PA).
Some payers may choose to exclude products with only weight-loss indications. However, unlike benefit exclusions, these formulary exclusions may be vulnerable to medical exception and appeals processes. A reviewer’s determination that a weight-loss product is medically necessary can tip the scale in favor of the member. So, an excluded weight-loss product may be covered.
Payers use PAs and PA criteria to impact GLP-1 spend and trend. Some payers require that patients have a diabetes diagnosis before being prescribed a product with the potential for off-label use. And some payers further clarify that patients with prediabetes do not qualify for these medications. Some have added clinical trial inclusion and exclusion criteria to further manage utilization and costs.
Some payers that cover weight-loss drugs require that patients first try and fail formal lifestyle modification programs under provider supervision, and only then step through other, less-costly drugs that reduce hunger and cravings, such as Contrave and Qsymia. These payers assume that some patients will have sufficient success with less costly first-line products and not feel compelled to then try a second-line GLP-1.
Rather than simply relying on provider attestations, some payers require the submission of medical records to substantiate diagnosis of obesity and other comorbidities or trial and failure of lifestyle modifications and other weight-loss therapies. Prescribers do not take the submission of medical records lightly, and these requirements can help to reduce inappropriate and unnecessary prescribing.
How they may push back
Some payers are exploring the viability of requiring specialists to prescribe weight-loss drugs. The American Board of Obesity Medicine certifies physicians who specialize in obesity management. There are more than 6,000 board-certified obesity specialists, most of whom are internal or family medicine physicians. In the short term, payers whose provider networks do not include sufficient obesity specialists may find it challenging to disintermediate primary care providers who are not obesity specialists. Therefore, payers may require that only obesity specialists to write prescriptions for patients whose need is less clear cut (e.g., those with a lower BMI and/or less-severe comorbidity).
Down the road, some payers may develop reauthorization criteria that are contingent on measurable success. For example, if sufficient weight is not lost within a specified period or if the weight loss is not maintained, the treatment and/or lifestyle modifications may be viewed as a failure and, as a result, the weight-loss drug may not be reauthorized. Alternatively, if sufficient weight is lost and there is evidence that lifestyle modifications and/or less-costly drugs may help the patient maintain the lower weight, then a payer might not reauthorize the GLP-1. Currently, weight-loss products do not specify duration limits, and payers may conclude that lifelong therapy is not financially sustainable and potentially risky. Payers are looking for an offramp.
Managing obesity or adiposity-based chronic disease (ABCD) across the benefits is yet another potential approach. Self-insured employers commonly make weight-loss surgery or bariatric surgery an excluded benefit and insurers typically offer coverage through an optional rider when coverage is not mandated. In their early years, these procedures carried safety concerns and were viewed as costly. That said, payers have lowered risks and costs of bariatric surgery by requiring coverage through centers of excellence. If a GLP-1 costs approximately $1,000 per month, then the drug cost would likely exceed the cost of surgery in under one or two years (depending upon the procedure). Payers covering weight-loss surgery may start to promote surgical options to patients who request or are at high risk for starting a GLP-1 for weight loss. Alternatively, payers not currently covering weight-loss surgery may now revisit that decision, given GLP-1 utilization and costs.
If at some point the GLP-1s that are indicated only for diabetes but not weight loss become less costly than those indicated for weight loss, and if there are no concerns about GLP-1 shortages for patients with diabetes, then payers may subtly encourage off-label use by applying less-restrictive PA criteria for preferred products — much the same way a preferred product may be placed on a lower tier.
Weighty decisions
When payers add restrictions, they must evaluate what, if any, impact such actions would have on rebates and ensure that policy changes will likely lower costs. Unintentionally, some restrictions can backfire and result in higher costs.
Payers have been restricting access to GLP-1s used for weight loss and are actively exploring other ways to do so, but another complexity is looming on the horizon. GLP-1s have been shown to also reduce the risk of heart attack, stroke, and other major adverse cardiovascular events (MACE) in patients with type 2 diabetes who have or are at high risk for atherosclerosis. We’ll surely see new products and expanded labels for some GLP-1s with and without weight loss indications. For payers, these new indications will require yet another round of weighty decisions — depending upon the cost, an ounce of prevention may be worth more than a pound of cure.
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