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GLP-1 Decoder

Semaglutide for PCOS: Evidence, Eligibility, Coverage

Semaglutide is not FDA approved for polycystic ovary syndrome (PCOS). 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

Wegovy, in short

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

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

Amount of weight lost in its main trial
Wegovy (STEP 1)14.9%Placebo2.4%

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

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

Prices each month in US dollars cover the list price and self-pay offers, with values taken from the maker's price page.

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

Who qualifies?

Semaglutide: who qualifies
Who sets the ruleWho qualifies
OzempicIt lowers blood sugar in adults with type 2 diabetes when used with diet and exercise.
OzempicAdults who have heart disease and also type 2 diabetes see a lower risk of a heart attack, of a stroke, or of heart-related death with this medicine.
OzempicIt reduces the risk that kidney disease gets worse, and lowers the risk of kidney failure and of heart-related death, among adults with chronic kidney disease and type 2 diabetes.
WegovyAdults with heart disease plus obesity or overweight see a lower risk of a heart attack or stroke, and of heart-related death (injection and tablets).
WegovyIt supports weight loss and maintaining it long term when you pair it with diet and activity. This applies to adults and children 12 and older with obesity, and to adults who have overweight together with a weight-related condition.
WegovyFor adults, it treats MASH liver disease when scarring is moderate to advanced and cirrhosis is not present.
WegovyFor adults, these tablets are approved for weight loss and heart risk.
RybelsusIt lowers blood sugar in adults with type 2 diabetes when used with diet and exercise.
RybelsusAdults with type 2 diabetes who are at high risk face a smaller 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, CKD 3a+, or heart failure, together with BMI 30 or higher
Medicare GLP-1 BridgeA previous heart attack or stroke, Prediabetes, or PAD, with BMI 27 or higher
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)you start with a diet and activity program for 6 months

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

Trial results for PCOS

These trials did not enroll only people with polycystic ovary syndrome (PCOS). Everyone studied was an adult with obesity or overweight, without diabetes.

Semaglutide and polycystic ovary syndrome (PCOS) trials
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 for the trial: STEP 1 (FDA label (DailyMed)).

What is different for PCOS?

What the semaglutide label says about polycystic ovary syndrome (PCOS)
What changesWhat the label saysLabels
Hypoglycemia When Combined With Insulin Secretagogues or InsulinUsing it with insulin or a sulfonylurea raises the chance of low blood sugar, and those doses may need lowering.All of them

Source: the FDA labels, FDA label (DailyMed).

These label warnings come from: FDA label (DailyMed).

Coverage for PCOS

GLP-1 medicines prescribed for weight loss alone are not covered by Medicare Part D.

People who meet the rules can find Wegovy listed at $50 per month in the Medicare GLP-1 Bridge.

Where Medicaid covers weight-loss GLP-1s, prior authorization is normally required.

Sources: humana.com, CMS, KFF.

Alternatives for PCOS

GLP-1 medicines and polycystic ovary syndrome (PCOS)
MedicineFor PCOSHow 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

Sources: FDA label (DailyMed).

Questions to ask your prescriber