Are we facing another Fen-Phen? Off-label GLP-1 use impacts more than the bottom line

Updated on August 21, 2023

Formulary management is the first option for combating off-label prescribing of GLP-1s for diabetic use. Through formulary management, plan sponsors can add or remove restrictions and requirements around coverage of specific classes of medications to incentivize providers’ adherence to FDA guidelines when prescribing those drugs. For example, including the weight-loss medications Wegovy or Saxenda (GLP-1s specifically indicated for weight management) on a drug formulary may deter the improper usage of GLP-1s intended only for diabetics while simultaneously encouraging labeled use of GLP1-s (e.g., Ozempic, Mounjaro) specific to treating diabetes.

Prior authorization is another practical option for dissuading off-label utilization. Prior authorizations require providers to submit additional information supporting their proposed treatment plans before they are allowed to prescribe certain medications. The drugs are then checked against a plan sponsor’s formulary before being reviewed for clinical appropriateness by either a pharmacy benefits manager, pharmacy benefits optimizer, or insurance provider’s clinical team. This evaluation helps to ascertain that less expensive, clinically similar alternatives are not being overlooked as well as confirming that medications are being prescribed appropriately. For example, a plan could require prior authorization for certain high-cost drugs, such as GLP-1s used to treat diabetes or weight management (if covered under formulary management), to affirm access to the appropriate drug once being matched to its appropriate indication while also restricting prescription access when there is an attempted use outside of their FDA-approved purpose.

Lastly, when formulary-covered medications are deemed appropriate through the prior authorization process, quantity limits assist in ensuring that medications are not being procured in quantities beyond their typical daily use. For example, four pens of Ozempic to be dosed once weekly indicates a 28-day supply is appropriate. To allow twelve pens every 28 days would be inappropriate. Quantity limits can prevent this. A progressive method for controlling quantity dispensed over a period of time is the use of refill too soon edits. These edits allow a prescription to process only after a certain amount of time has lapsed since the previous prescription was processed. The tactic ensures that individuals who are appropriately receiving medications do not receive medications beyond a set schedule. This ensures the individual cannot stockpile expensive medications and pay more than necessary.  

Though plan sponsors’ insights into members’ benefit utilization patterns is limited, they can still implement member engagement strategies that may provide visibility into members’ behavior. Offering a two-way communication platform to gather feedback or conducting a survey to gauge members’ satisfaction can identify what steps may be needed to eliminate the demand for off-label prescribing, such as offering coverage of other drugs known to effectively treat conditions that members report could lead to coverage expansion as in our referenced formulary management example using Wegovy or Saxenda. Equipped with solid knowledge, plan sponsors can make more informed decisions, adjust their strategies accordingly and take action if necessary. 

What’s next for weight loss coverage decisions? 

There are early reports that weight loss medications are showing a positive impact in the reduction of cardiovascular events. However, the study was funded by the manufacturer and targeted specific populations. There’s still an unknown impact to the overall health of the larger population – including the likelihood of reducing cardiovascular events. As healthcare experts, we should all continue to monitor the space and review clinical trial information as it becomes available. 

Plan sponsors can prioritize their members’ health and safety, ensure medication is available for those who depend on it, and avoid unnecessary financial burden when it comes to their pharmacy spend. In doing so, they’ll create a downstream impact that helps to keep treatments affordable for members – a critical consideration given the uncertain future of drug pricing.

J. Bradley Nelson
Bradley Nelson

Bradley Nelson is an expert pharmacoeconomics strategist, with more than 15 years of experience in the pharmacy industry. At RxBenefits, he blends his retail pharmacy and managed care background to help clients address their pharmacy concerns and focus on strategies to manage drug costs.