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
The half-life is about 1 week: by 7 d half is gone, and after five half-lives (35 d) about 3% is left.
In STEP 1 over 68 weeks, body weight fell 14.9%, compared with 2.4% on placebo.
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?
| Who sets the rule | Who qualifies |
|---|---|
| It lowers blood sugar in adults with type 2 diabetes when used with diet and exercise. | |
| Adults 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. | |
| It 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. | |
| Adults 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). | |
| It 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. | |
| For adults, it treats MASH liver disease when scarring is moderate to advanced and cirrhosis is not present. | |
| For adults, these tablets are approved for weight loss and heart risk. | |
| It lowers blood sugar in adults with type 2 diabetes when used with diet and exercise. | |
| Adults 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 Bridge | BMI 35 or higher, no condition needed |
| Medicare GLP-1 Bridge | Uncontrolled blood pressure, CKD 3a+, or heart failure, together with BMI 30 or higher |
| Medicare GLP-1 Bridge | A 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.
| Trial | Medicine | Who took part | Length | People | Main result | Comparison |
|---|---|---|---|---|---|---|
| STEP 1 | Adults with obesity or overweight, without diabetes | 68 weeks | 1,961 | 14.9% weight loss | 2.4% on placebo | |
| OASIS 4 | Adults with obesity or overweight, without diabetes | 64 weeks | 307 | 13.6% weight loss | 2.4% on placebo |
Source for the trial: STEP 1 (FDA label (DailyMed)).
What is different for PCOS?
| What changes | What the label says | Labels |
|---|---|---|
| Hypoglycemia When Combined With Insulin Secretagogues or Insulin | Using 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.
- Semaglutide Cost Without Insurance
- Semaglutide Coupons
- Semaglutide Insurance Coverage
- Does Medicaid Cover Semaglutide? Wegovy and Ozempic by State
- Does Blue Cross Blue Shield Cover Semaglutide? Criteria, Copay
- Does UnitedHealthcare Cover Semaglutide? Criteria, Copay, Appeals
- Ozempic Coupon
- Ozempic Cost
- Ozempic Cost Without Insurance
Alternatives for PCOS
| Medicine | For PCOS | How it is taken | Trial result |
|---|---|---|---|
| Not a listed use | weekly injection | Not listed | |
| Not a listed use | weekly injection or daily tablet | 14.9% weight loss | |
| Not a listed use | daily tablet | Not listed | |
| Not a listed use | weekly injection | Not listed | |
| Not a listed use | weekly injection | 20.9% weight loss | |
| Not a listed use | daily tablet | 11.1% weight loss | |
| Not a listed use | weekly injection | Not listed | |
| Not a listed use | daily injection | 7.4% weight loss | |
| Not a listed use | daily injection | Not listed | |
| Byetta | Not a listed use | twice-daily injection | Not listed |
Sources: FDA label (DailyMed).
Questions to ask your prescriber
- Will this affect my birth control?
- Before I try to get pregnant, when should I stop?
- If PCOS is the main reason for treatment, is my plan likely to cover it?