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GLP-1 Decoder

Semaglutide for Prediabetes: Evidence, Eligibility, Coverage

Semaglutide is not FDA approved for prediabetes. It is approved for type 2 diabetes, heart risk and kidney disease in type 2 diabetes. Some doctors prescribe it when one of those uses also applies. In STEP 1, people on Wegovy lost 14.9% of body weight on average, vs 2.4% on placebo.

Brands
Ozempic, Wegovy and Rybelsus
Best result (STEP 1)
14.9% weight loss

A quick look at Wegovy

How long it remains in the body
100%50%25%0%07 d14 d21 d28 d35 d50%25%12.5%time after the dose

Its half-life is about 1 week: after 7 d, half is gone, and about 3% remains after five half-lives (35 d).

Weight loss in its main trial
Wegovy (STEP 1)14.9%Placebo2.4%

In STEP 1 over 68 weeks, weight loss was 14.9% of body weight, compared with 2.4% on placebo.

Costs over time
202520262027$1,349.02$0List priceSelf-pay

The maker's price page lists monthly prices in US dollars, including the list price and self-pay offers.

Sources: FDA label (DailyMed), healthsystemtracker.org, prnewswire.com 1 2.

Who qualifies?

Which people qualify for semaglutide
Who sets the ruleWho qualifies
OzempicIt lowers blood sugar in adults with type 2 diabetes when used with diet and exercise.
OzempicIn adults with heart disease and type 2 diabetes, the risk of a stroke, heart attack or heart-related death is lower.
OzempicFor adults with chronic kidney disease and type 2 diabetes, this medicine reduces the chance of worsening kidney disease, kidney failure and heart-related death.
WegovyWhen adults have heart disease and obesity or overweight, stroke, heart attack and heart-related death become less likely with injection and tablets.
WegovyIt helps adults and children 12 and older with obesity, and adults with overweight and a weight-related condition, lose weight and keep it off long term when used with diet and activity.
WegovyFor adults, the injection treats MASH liver disease with scarring that is moderate to advanced and no cirrhosis.
WegovyIn adults, the tablets are approved to support weight loss and reduce heart risk.
RybelsusIt lowers blood sugar in adults with type 2 diabetes when used with diet and exercise.
RybelsusFor high-risk adults with type 2 diabetes, it reduces the chance of a heart attack, a stroke or a heart-related death.
Medicare GLP-1 BridgeBMI 35 or higher, no condition needed
Medicare GLP-1 BridgeUncontrolled blood pressure, heart failure or CKD 3a+, plus a BMI of 30 or above
Medicare GLP-1 BridgePrediabetes, PAD, or a previous heart attack or stroke, with a BMI of 27 or above
Typical commercial plan (Aetna policy)BMI 30 or higher
Typical commercial plan (Aetna policy)BMI 27 or higher with a weight-related condition
Typical commercial plan (Aetna policy)a diet and activity program lasting 6 months comes first

Sources: FDA label (DailyMed) 1 2 3, medicare.gov 1 2, aetna.com.

Trial results for prediabetes

These studies included participants beyond people with prediabetes. The adults enrolled had obesity or overweight and did not have diabetes.

Semaglutide trials: Prediabetes
TrialMedicineWho took partLengthPeopleMain resultComparison
STEP 1 WegovyAdults with obesity or overweight, without diabetes68 weeks1,96114.9% weight loss2.4% on placebo
OASIS 4 WegovyAdults with obesity or overweight, without diabetes64 weeks30713.6% weight loss2.4% on placebo

Source of the trial: STEP 1 (FDA label (DailyMed)).

What is different for prediabetes?

Semaglutide: label points for prediabetes
What changesWhat the label saysLabels
Low Blood Sugar When You Also Use Insulin Secretagogues or InsulinWhen used with insulin or a sulfonylurea, it makes low blood sugar more likely, so those doses may need lowering.All of them
Taken with insulin or sulfonylureasWhen combined with insulin or a sulfonylurea such as glipizide or glimepiride, this medicine increases the risk of low blood sugar.All of them

These details come from the FDA labels: FDA label (DailyMed).

Label warnings: FDA label (DailyMed).

Coverage for prediabetes

Medicare Part D does not pay for a GLP-1 when it is used only for weight loss.

The Medicare GLP-1 Bridge lists Wegovy at $50 per month for people who meet its rules.

The standard is prior authorization when Medicaid covers weight-loss GLP-1s.

Sources: humana.com, CMS, KFF.

Alternatives for prediabetes

GLP-1 medicines and prediabetes
MedicineFor prediabetesHow it is takenTrial result
OzempicNot a listed useweekly injectionNot listed
WegovyNot a listed useweekly injection or daily tablet14.9% weight loss
RybelsusNot a listed usedaily tabletNot listed
MounjaroNot a listed useweekly injectionNot listed
ZepboundNot a listed useweekly injection20.9% weight loss
FoundayoNot a listed usedaily tablet11.1% weight loss
TrulicityNot a listed useweekly injectionNot listed
SaxendaNot a listed usedaily injection7.4% weight loss
VictozaNot a listed usedaily injectionNot listed
ByettaNot a listed usetwice-daily injectionNot listed

Warning source: FDA DailyMed label.

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