Tirzepatide for PCOS: Evidence, Eligibility, Coverage
Tirzepatide is not FDA approved for polycystic ovary syndrome (PCOS). It is approved for type 2 diabetes and heart risk. Some doctors prescribe it when one of those uses also applies. In SURMOUNT-1, people on Zepbound lost 20.9% of body weight on average, vs 3.1% on placebo.
- Brands
- Mounjaro and Zepbound
- Best result (SURMOUNT-1)
- 20.9% weight loss
Zepbound key facts
Its half-life runs 5 to 6 days: after 5.5 d half is gone, and after five half-lives (27.5 d) about 3% is left.
SURMOUNT-1 over 72 weeks: 20.9% of body weight, compared with 3.1% on placebo.
Monthly prices in US dollars, both list price and self-pay offers, taken from the maker's price page.
Sources: FDA label (DailyMed), Eli Lilly 1 2, cnbc.com.
Who qualifies?
| Who sets the rule | Who qualifies |
|---|---|
| For people aged 10 and older with type 2 diabetes, it lowers blood sugar alongside diet and exercise. | |
| For high-risk adults with type 2 diabetes, it lowers the risk of heart attack, stroke, or heart-related death. | |
| It helps adults with obesity, and those who are overweight and have a weight-related condition, lose weight and hold onto that loss for the long term, when used with diet and activity. | |
| Moderate to severe obstructive sleep apnea in adults with obesity is treated by this drug. | |
| Medicare GLP-1 Bridge | BMI 35 or higher, no condition needed |
| Medicare GLP-1 Bridge | You must have BMI 30 or above, plus heart failure, uncontrolled blood pressure, or CKD 3a+ |
| Medicare GLP-1 Bridge | Prediabetes, a past heart attack or stroke, or PAD must also be present, along with a BMI of 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) | first, a program for diet and activity lasting 6 months |
Sources: FDA label (DailyMed) 1 2, medicare.gov 1 2, aetna.com.
Trial results for PCOS
Not one of these trials enrolled people with only polycystic ovary syndrome (PCOS). Two adult groups were studied: those with obesity or overweight and no diabetes, and those with obesity but not type 2 diabetes.
| Trial | Medicine | Who took part | Length | People | Main result | Comparison |
|---|---|---|---|---|---|---|
| SURMOUNT-1 | Adults with obesity or overweight, without diabetes | 72 weeks | 2,539 | 20.9% weight loss | 3.1% on placebo | |
| SURMOUNT-5 | Adults with obesity, without type 2 diabetes | 72 weeks | 751 | 20.2% weight loss | Not listed |
Trial sources: SURMOUNT-1 (FDA label (DailyMed)), SURMOUNT-5 (PubMed).
What is different for PCOS?
| What changes | What the label says | Labels |
|---|---|---|
| Hypoglycemia When Combined With Insulin Secretagogues or Insulin | Taking it with insulin or a sulfonylurea raises the chance of low blood sugar, and those doses may need lowering. | All of them |
| Taken with birth control pills | For a while, this medicine can reduce how well birth control pills work. Once you start, and again after every dose increase, choose a method that is not oral, or add a barrier method. | All of them |
These details come from the FDA labels: FDA label on DailyMed.
These warnings come from the label: FDA label (DailyMed).
Coverage for PCOS
A GLP-1 used only for weight loss is not covered by Medicare Part D.
Under Medicare GLP-1 Bridge, Zepbound is listed at $50 per month for people who meet its rules.
In places where Medicaid covers weight-loss GLP-1s, prior authorization is the norm.
Sources: humana.com, CMS, KFF.
- Tirzepatide Coupon and Savings Card
- Tirzepatide Cost With Insurance
- Tirzepatide Cost Without Insurance
- Tirzepatide Insurance Coverage
- Does Medicare Cover Tirzepatide? Criteria, Copay, How to Appeal
- Does Kaiser Permanente Cover Tirzepatide? Criteria, Copay, How
- Does Medicaid Cover Tirzepatide? Criteria, Copay, How to Appeal
- Does Blue Cross Blue Shield Cover Tirzepatide? Criteria, Copay
- Does Cigna Cover Tirzepatide? Criteria, Copay, How to Appeal
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 | 20.9% weight loss | |
| 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 | 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).
What to ask your prescriber
- Will this affect my birth control?
- When should I stop taking it ahead of trying to get pregnant?
- If PCOS is the main reason, is my plan likely to cover it?