Richard Meyer Focus on patients, in the news, Product Launches

Novo’s obesity drug has serious warnings and barriers to overcome

SUMMARY: The media headlines promise weight loss for diabetes patients, but Norvo’s new drug is in the same class as other drugs and carries many warnings. Can diabetes patients really stay adherent to a drug for 63 weeks in which 85% of patients report GI side effects and will insurance cover the cost?

The headlines read “FDA approves obesity drug that helped people cut weight 15%”. But buyer beware.

Wegovy’s most common side effects were gastrointestinal problems, including nausea, diarrhea, and vomiting which was reported by 80% of patients according to USA Today. The drug carries a potential risk for a type of thyroid tumor and has a box warning. Interesting enough Wegovy is in the same class as some other diabetes drugs.

 Wegovy’s class of drug is commonly called glucagon-like peptide 1 (GLP-1) agonists. There are other class of medications associated with weight loss and improved blood sugar control as well. The drug already exists at a lower dose as an anti-diabetic medication under the brand names Ozempic and Rybelsus made by the same pharmaceutical company, Novo Nordisk.

Diabetes drugs in the GLP-1 agonists class include:

  • Dulaglutide (Trulicity), taken by injection weekly
  • Exenatide extended-release (Bydureon), taken by injection weekly
  • Exenatide (Byetta), taken by injection twice daily
  • Semaglutide (Ozempic), taken by injection weekly
  • Semaglutide (Rybelsus), taken by mouth once daily
  • Liraglutide (Victoza), taken by injection daily
  • Lixisenatide (Adlyxin), taken by injection daily

The downside to GLP-1 drugs is that all but one has to be taken by injection. And, like any medication, there is a risk of side effects, some serious. More common side effects usually improve after you’ve taken the medication for a while. Wegovy also contains warnings for pancreatitis, gallbladder problems including gallstones, low blood sugar, acute kidney injury, eye retina damage, increased heart rate, and suicidal behavior or thinking.

Some of the more common side effects include:

  • Nausea
  • Vomiting
  • Diarrhea

Still study trials show Wegovy is more effective than any other weight loss management drug currently on the market. More than 50% of the participants lost more than 15% of their body weight over 68 weeks. Nearly 85% of trial participants reported adverse events, more than 70% affecting the gastrointestinal tract. Side effects were mostly mild to moderate and included nausea, vomiting, and diarrhea. Constipation was another side effect, which in some participants lasted as long as 27 days.

Medicare currently doesn’t cover treatments for obesity because it categorizes medications for weight loss as cosmetic, like medications for hair loss. A bill in Congress, called the “Treat and Reduce Obesity Act of 2021,” aims to include obesity medication as a covered treatment under Medicare.

Medicaid coverage also is dependent on states with broad federal guidelines, many of whichemphasize programs that address prevention instead of treatment. Meanwhile, a 2020 study found Medicaid beneficiaries were 27% more likely to have obesity than those who had commercial insurance.

The key issues will be two-fold: will insurance cover the product, and two, will patients stay compliant if they start to experience GI side effects? Even if a small population uses the drug to lose weight, it’s helpful. There are many causes for obesity, and having another option can help, but potential patients will need to balance the benefit with the risks.

My guess is Norvo will heavily discount the product via coupons or cards, but ultimately patients working with their doctor will determine if it’s successful.