LESSON 5: Off-Label Prescribing and GLP-1 Drugs

What is the difference between Ozempic and Wegovy?

Ozempic is FDA-approved for blood sugar control (diabetes); Wegovy is FDA-approved for weight loss; both contain the exact same active ingredient (semaglutide).

What is the difference between Mounjaro and Zepbound?

Mounjaro is FDA-approved for diabetes; Zepbound is FDA-approved for obesity; both contain the same active ingredient (tirzepatide) made by Eli Lilly.

Can a doctor prescribe Ozempic for weight loss even though it's not approved for that?

Yes it is NOT illegal to prescribe a drug for an indication that it is NOT approved for; this is called off-label prescribing and it is completely legal.

What is off-label prescribing in simple words?

When a doctor thinks a drug can serve a different purpose than what is written on the label; doctors have the legal ability to prescribe the drug for an off-label indication.

Who is responsible if something goes wrong with off-label prescribing?

If something goes wrong you sue the doctor (in the professor's words: "sue the damn doctor").

Can the drug company promote their drug for off-label uses?

No the drug company (like Novo Nordisk) cannot promote Ozempic for weight loss purposes UNLESS they have tested the drug for safety and efficacy for that specific use.

Why did Novo Nordisk sue Hims and Hers?

Novo Nordisk sued Hims and Hers because they were making copycat versions of Wegovy that were NOT FDA approved; the lawsuit happened in February.

Why doesn't insurance always cover off-label prescriptions?

When a drug is prescribed off-label the healthcare system may not allow insurance coverage; especially Medicaid and Medicare (public insurance) MAY NOT cover these drugs for off-label indication.

Why did Novo Nordisk create a whole new drug (Wegovy) instead of just promoting Ozempic for weight loss?

Because insurance wouldn't cover Ozempic for off-label weight loss; so Novo Nordisk created Wegovy tested it for safety and efficacy for weight loss spent millions of dollars and got official FDA approval for weight loss.

Why did Eli Lilly create Zepbound instead of just using Mounjaro for weight loss?

Because physicians could NO longer prescribe Mounjaro off-label and get it covered by insurance; so Eli Lilly created Zepbound got FDA approval for obesity and now insurance will cover it.

What is serendipity in pharmacy?

Serendipity means accidental discovery; it's when a drug has a positive side effect that was NOT what the drug was initially tested for.

What are some examples of serendipity in pharmacy?

Viagra (was being tested for heart problems but helped with erections); Ozempic (was for diabetes but caused weight loss); Minoxidil (was for blood pressure but grew hair).

What is the problem with off-label use from an insurance perspective?

Most insurers may NOT cover off-label use because there is NO OFFICIAL indication; this is problematic for payers because of liability lack of proof of safety and efficacy and high costs; this is why people need to pay cash for off-label drugs.

What percentage of large employers cover GLP-1 drugs for weight loss?

Only about 43% of payers with 5

What is the BMI threshold for obesity coverage?

Obesity is a formal diagnosis; being overweight is NOT a formal diagnosis. Once the BMI threshold is met insurers will start covering when you are considered clinically obese. You can still take weight loss drugs but you have to pay out of pocket if you are not officially obese.

What is Lilly Direct?

Lilly Direct is Eli Lilly's own DTC (direct-to-consumer) platform; you can order the exact same drugs directly from Eli Lilly but you still need a prescription.

What is off-label promotion?

Off-label promotion is when a drug company advertises a drug for a use that the FDA has NOT approved; this is ILLEGAL. For example you can't advertise Ozempic for weight loss because that use is NOT FDA-approved.