Cost of Vyleesi in 2025: Cash Price, Insurance Coverage, and How It Compares to Addyi

What Does Vyleesi Cost Without Insurance?

Without insurance, a single Vyleesi kit containing four 1.75 mg bremelanotide auto-injectors retails for approximately $800 to $1,200 at major U.S. pharmacies. That translates to roughly $200 to $300 per dose. Because Vyleesi is dosed on-demand rather than taken daily, actual monthly spending depends entirely on how often a patient uses it. A woman who uses two doses per month pays far less annually than one who uses the full limit of one dose per day.

The manufacturer, AMAG Pharmaceuticals (now part of the Cosette Pharmaceuticals portfolio), launched a savings card program that brings the per-kit out-of-pocket cost down to $99 for eligible commercially insured patients. Uninsured patients may also qualify depending on income criteria. Patients can activate the card at the official Vyleesi website or ask their pharmacist to apply it at the point of sale.

No generic version of bremelanotide exists as of mid-2025. The FDA granted Vyleesi a New Chemical Entity exclusivity period, and no abbreviated new drug applications (ANDAs) for bremelanotide are listed as pending in the FDA's Orange Book, meaning no generic is imminent. [1][2]

Specialty pharmacy dispensing is common for Vyleesi. Because many large retail chains do not stock it routinely, patients often receive it through mail-order specialty pharmacies, which can add or subtract $10 to $30 in shipping costs depending on the service.

Does Insurance Cover Vyleesi?

Commercial insurance coverage exists but requires prior authorization in nearly every plan that includes the drug on its formulary. Insurers typically require documentation of a formal HSDD diagnosis, confirmation that the patient is premenopausal, and sometimes evidence that a prior treatment or lifestyle intervention was attempted.

The FDA approved bremelanotide specifically for "premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD)," a narrow indication that insurers use to gate access. [3] Postmenopausal use is off-label and almost universally denied by payers.

Medicare Part D does not cover Vyleesi. The Social Security Act excludes drugs used for the "treatment of sexual or erectile dysfunction" unless the condition arose from another covered condition such as diabetes or a spinal cord injury, an exception that rarely applies in practice. Medicaid coverage varies by state but is likewise excluded in most state formularies.

Employer-sponsored plans and ACA marketplace plans vary widely. A 2022 analysis of 50 large U.S. commercial formularies found that roughly 40 percent included Vyleesi at tier 3 or tier 4, meaning co-pays between $75 and $200 per kit after deductibles. The remaining 60 percent excluded it outright or required specialty-tier cost-sharing above $200. [4]

If a plan denies coverage, patients have the right to appeal. A prescriber letter documenting the clinical diagnosis under DSM-5 criteria and the impact on quality of life strengthens the appeal. The American College of Obstetricians and Gynecologists (ACOG) notes in its 2023 guidance that HSDD "is a real medical condition associated with significant psychological distress and reduced quality of life," language useful for insurance appeals. [5]

How Much Does the Vyleesi Savings Card Save?

The Vyleesi Co-Pay Savings Program reduces the cost to $99 per kit for eligible patients. Eligibility rules as of 2025 include:

• The patient must be a U.S. resident.
• Commercial insurance is preferred; uninsured patients may qualify under a separate assistance tier.
• Federal and state government plan beneficiaries (Medicare, Medicaid, TRICARE, VA) are excluded by law from manufacturer co-pay programs.
• The card is not transferable and requires a valid prescription.

Over 12 months, a patient using one kit per month and paying $99 each time would spend $1,188 annually. Without the savings card and without insurance, the same usage costs between $9,600 and $14,400 per year at full retail. The savings are substantial, but patients should confirm each year that the program terms have not changed, as manufacturers revise co-pay card limits periodically.

Patients who do not qualify for the savings card and lack insurance coverage should ask their prescriber about the Cosette patient assistance program, which provides free medication to patients below 400 percent of the federal poverty level. Applications are processed through the manufacturer's patient support line and typically take two to four weeks.

Cost of Addyi: How Does It Compare?

Addyi (flibanserin 100 mg) is the only other FDA-approved drug for HSDD and costs roughly $400 to $800 per month at retail for 30 tablets, depending on the pharmacy. [6] Unlike Vyleesi, Addyi is taken once daily at bedtime rather than on demand, so monthly drug quantity is fixed. This makes cost comparison straightforward: one month of Addyi costs the equivalent of one to two Vyleesi kits.

Addyi was approved in August 2015 by the FDA for premenopausal women with acquired, generalized HSDD. The FDA required a Risk Evaluation and Mitigation Strategy (REMS) program at launch because of serious hypotension and syncope risk when flibanserin is combined with alcohol, though the REMS was subsequently modified and eventually discontinued in 2019. [7]

Sprout Pharmaceuticals offers a savings card for Addyi that brings monthly cost to approximately $99 for eligible commercially insured patients, mirroring Vyleesi's program structure. No generic flibanserin is available in the U.S. as of mid-2025.

Key cost comparison at a glance:

| Factor | Vyleesi (bremelanotide) | Addyi (flibanserin) | |---|---|---| | Dosing | On-demand | Daily | | Retail price | $800, $1,200 per kit | $400, $800 per month | | Savings card price | $99 per kit | ~$99 per month | | Generic available | No | No | | FDA approval year | 2019 | 2015 |

For a woman who has sex two to four times per month, Vyleesi may cost less than Addyi even at full retail, because she uses two to four doses rather than 30 pills. For daily or near-daily use, Addyi's per-event cost drops considerably. Prescribers and patients should factor actual anticipated use frequency into any cost comparison.

Clinical Effectiveness and What the Trials Show

The cost is most meaningful when weighed against documented clinical outcomes. The phase 3 RECONNECT trial program evaluated bremelanotide in two key studies (Study 1: N=628; Study 2: N=625) in premenopausal women with HSDD over 24 weeks. [8] Patients using bremelanotide reported a statistically significant increase in the number of satisfying sexual events per month compared with placebo (P<0.001 in both studies), and the proportion reporting "distressing low sexual desire" decreased by approximately 25 percentage points versus placebo.

For Addyi, the FDA reviewed five randomized controlled trials enrolling more than 5,000 women. Across these trials, women taking flibanserin 100 mg daily reported 0.5 to 1.0 additional satisfying sexual events per month compared with placebo, a modest but statistically significant effect. [9]

Neither drug produces dramatic response rates. The RECONNECT authors noted, "Bremelanotide produced statistically significant improvements in sexual desire and distress compared with placebo, though the absolute effect sizes were modest." [8] This context matters for cost-effectiveness discussions: paying $800 per month out-of-pocket for a modest effect size may not be acceptable to every patient.

Why Is Vyleesi So Expensive?

Vyleesi's price reflects the economics of specialty drug development for a relatively small patient population, not manufacturing complexity. Bremelanotide is a synthetic heptapeptide melanocortin receptor agonist, meaning it acts on MC3R and MC4R receptors in the central nervous system to increase sexual desire. [10] Peptide synthesis costs more per unit than small-molecule synthesis, and the auto-injector delivery system adds device costs.

HSDD affects an estimated 8 to 10 percent of premenopausal women in the United States, roughly 5 to 6 million women, according to a 2014 epidemiological study published in the Journal of Sexual Medicine. [11] A relatively small prescribing base spreads development and marketing costs across fewer units, pushing list price upward. This is the same mechanism that drives high prices for other sexual health and hormone-related specialty drugs.

The absence of generic competition will keep prices elevated until patent expiration. The Vyleesi compound patent extends through the early 2030s based on current Orange Book listings, meaning at least five to seven more years without generic pressure. [2]

Who Is a Candidate for Vyleesi?

Vyleesi is FDA-approved only for premenopausal women with acquired, generalized HSDD. "Acquired" means the low desire developed after a period of normal desire. "Generalized" means it occurs regardless of partner, situation, or stimulation type. HSDD must also be causing personal distress under DSM-5 criteria for Female Sexual Interest/Arousal Disorder (FSIAD) to meet diagnostic thresholds. [12]

Vyleesi is contraindicated in patients with known hypersensitivity to bremelanotide and should not be used by patients with cardiovascular disease or uncontrolled hypertension, because the drug transiently raises mean blood pressure by approximately 2 to 4 mmHg and reduces heart rate by approximately 1 to 2 bpm for up to 12 hours after injection. [3] Patients with high cardiovascular risk should discuss this profile with their cardiologist before starting treatment.

Nausea is the most common adverse effect, occurring in approximately 40 percent of patients in the RECONNECT trials. [8] About 13 percent of patients discontinued due to nausea. An antiemetic taken 30 minutes before the Vyleesi injection can reduce this risk, and prescribers often recommend starting with the lowest effective dose frequency to assess tolerance before committing to a refill.

How to Get Vyleesi at the Lowest Possible Price

Patients wanting to minimize out-of-pocket costs should follow this sequence:

Step 1: Confirm the diagnosis. A formal HSDD diagnosis under DSM-5 criteria is the gating requirement for insurance coverage and for manufacturer assistance programs. A board-certified gynecologist, internist, or sexual medicine specialist can provide this. Telehealth evaluations are valid in most states.

Step 2: Apply for the savings card before filling. The Vyleesi Co-Pay Savings Program must be applied at the point of sale. Retroactive application is not available. Print or download the card from the manufacturer website and bring it to the pharmacy or provide the card number to the specialty pharmacy dispatcher.

Step 3: Use a participating specialty pharmacy. Not all pharmacies stock Vyleesi. The manufacturer's pharmacy locator lists specialty and mail-order pharmacies with confirmed stock. Mail-order pharmacies sometimes offer $0 shipping versus a $15 to $30 charge at non-specialty locations.

Step 4: Request prior authorization for your insurance. Even if the first claim is denied, a PA appeal with supporting clinical notes, a DSM-5 diagnosis, and a physician letter citing ACOG guidance has a meaningful chance of succeeding.

Step 5: If uninsured and the savings card is insufficient, apply for the patient assistance program. The Cosette patient assistance program (formerly AMAG Assist) accepts applications directly or through a prescribing clinician. Approval typically requires income verification and a completed physician attestation form.

Step 6: Compare total annual cost against Addyi. If a patient anticipates needing fewer than 12 doses per year, Vyleesi at the $99 savings card rate costs $99 to $1,188 per year. Addyi at $99/month costs $1,188 regardless of usage frequency. For infrequent use, Vyleesi may be the more cost-efficient option.

Telehealth Prescribing and Vyleesi

Most telehealth platforms that prescribe women's sexual health medications can prescribe Vyleesi after a synchronous or asynchronous clinical evaluation. The evaluation must include a DSM-5-compatible sexual function assessment, current medication review (to screen for drug interactions), and cardiovascular history. Some platforms use validated questionnaires such as the Female Sexual Function Index (FSFI) or the Female Sexual Distress Scale-Revised (FSDS-R) as part of the intake process. [13]

Prescriptions are sent to the patient's preferred pharmacy or to a partnered specialty mail-order pharmacy. Telehealth fees range from $50 to $150 for the initial consultation and $25 to $75 for follow-up visits. These costs are separate from the medication cost and are rarely reimbursed by insurance when the visit is for a non-covered indication.

Patients should verify that the telehealth platform employs licensed providers in their state and that prescribers are comfortable with the full bremelanotide prescribing information, including the cardiovascular precautions and the requirement to assess HSDD duration and distress level. The FDA label specifies that Vyleesi "should not be used more than once within 24 hours." [3]

Practical Considerations Before Starting Vyleesi

Several practical points affect both the cost decision and the clinical decision:

Auto-injector technique matters. Vyleesi is injected subcutaneously into the abdomen or thigh 45 minutes before anticipated sexual activity. Improper injection technique can cause focal hyperpigmentation at injection sites, a known side effect affecting roughly 1 percent of patients with repeated use. [3] Rotating injection sites and following the injection guide included with each kit reduces this risk.

Storage requirements affect mail-order logistics. Vyleesi should be stored at room temperature (68 to 77 degrees Fahrenheit). It does not require refrigeration, which simplifies shipping, but it must not be frozen. Inspect each auto-injector upon receipt; discolored or cloudy solution should not be used and the kit should be returned through the specialty pharmacy's return process.

Duration of effect is three to four hours per injection. This on-demand window is narrower than Addyi's constant steady-state effect from daily dosing. Patients who prefer spontaneous rather than planned sexual activity may find the 45-minute lead time limiting.

Repeat prescriptions and refill timing matter for cost. Because Vyleesi comes in four-dose kits, a patient using two doses per month needs a new prescription or refill every two months. Some insurance plans limit refills to a 30-day supply, which may create administrative friction. Confirming the plan's days-supply rules with the pharmacy before the first fill avoids coverage gaps.

According to the FDA prescribing information, the maximum recommended use is "no more than one dose per 24-hour period," and the prescribing information states the drug has been studied for up to 52 weeks in open-label extension studies without new safety signals emerging beyond those seen in the RECONNECT trials. [3]