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GLP-1 Decoder

Liraglutide for PCOS: Evidence, Eligibility, Coverage

Liraglutide 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 SCALE Obesity and Prediabetes, people on Saxenda lost 7.4% of body weight on average, vs 3% on placebo.

Brands
Victoza and Saxenda
Best result (SCALE Obesity and Prediabetes)
7.4% weight loss

Saxenda basics

How long it remains in your body
100%50%25%0%013 h26 h39 h2.2 d2.7 d50%25%12.5%time after the dose

Its half-life is about 13 hours. Once 13 h pass, half the dose is gone. At 2.7 d, or five half-lives, about 3% is left.

Amount of weight lost in the main trial
Saxenda (SCALE Obesity and Prediabetes)7.4%Placebo3%

SCALE Obesity and Prediabetes, 56-week study: 7.4% of body weight lost, versus 3% on placebo.

Where the warning comes from: FDA label (DailyMed).

Who qualifies?

Which patients qualify for liraglutide?
Who sets the ruleWho qualifies
VictozaIt lowers blood sugar when used with diet and exercise, in adults and children age 10 and up with type 2 diabetes.
VictozaIt lowers the risk of heart attack, stroke, or heart-related death for adults with type 2 diabetes plus heart disease.
SaxendaDiet and activity are used to lose weight and to keep it off over the long term. This applies to children and adults 12 and older (over 60 kg) who have obesity, and to adults with overweight plus a weight-related condition.
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 comes a diet and activity program lasting 6 months

Sources: FDA label (DailyMed) 1, 2, and aetna.com.

Trial results for PCOS

None of these trials enrolled only polycystic ovary syndrome (PCOS); the people studied were adults with obesity or overweight but without type 2 diabetes.

Liraglutide trials: polycystic ovary syndrome (PCOS)
TrialMedicineWho took partLengthPeopleMain resultComparison
SCALE Obesity and Prediabetes SaxendaAdults with obesity or overweight but without type 2 diabetes56 weeks3,7317.4% weight loss3% on placebo

Where the trial data come from: SCALE Obesity and Prediabetes (FDA label (DailyMed)).

What is different for PCOS?

What the label says about liraglutide when you have polycystic ovary syndrome (PCOS)
What changesWhat the label saysLabels
HypoglycemiaCombining liraglutide with insulin or a sulfonylurea makes low blood sugar more likely, so the doses of those medicines may need to be lowered.All of them

According to the FDA labels: FDA DailyMed label.

According to the label warnings: FDA DailyMed label.

Coverage for PCOS

A GLP-1 used only for weight loss is not covered by Medicare Part D.

When Medicaid covers weight-loss GLP-1s, it usually requires prior authorization.

Sources: humana.com, KFF.

Alternatives for PCOS

GLP-1 class medicines and polycystic ovary syndrome (PCOS)
MedicineFor PCOSHow it is takenTrial result
SaxendaNot a listed usedaily injection7.4% weight loss
VictozaNot a listed usedaily injectionNot listed
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
ByettaNot a listed usetwice-daily injectionNot listed

Where the warning comes from: FDA label (DailyMed).

Questions to ask your prescriber