What is Leqvio (inclisiran)?
Leqvio, with the generic name inclisiran, is an injectable prescription medicine used to lower low-density lipoprotein cholesterol (LDL-C), often called "bad cholesterol" [1.5.1]. It is approved for adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), which are conditions that cause high cholesterol [1.5.5]. Leqvio is typically used in conjunction with a low-cholesterol diet and a maximally tolerated statin therapy [1.5.5]. One of its distinguishing features is its dosing schedule. After an initial dose and a second dose three months later, it is administered by a healthcare provider just twice a year (every six months) [1.5.1].
Leqvio works differently than other cholesterol medications like statins or even other PCSK9-targeting drugs. It uses a novel mechanism called RNA interference (siRNA) [1.5.4]. It specifically targets and prevents the production of the PCSK9 protein in the liver [1.5.2]. The PCSK9 protein normally degrades LDL receptors, which are responsible for removing bad cholesterol from the blood. By inhibiting PCSK9 production, Leqvio increases the number of available LDL receptors on liver cells, enhancing the clearance of LDL-C from the bloodstream [1.5.4]. Clinical trials have shown that this can lead to a significant and sustained reduction in LDL-C levels, with studies reporting around a 50% decrease compared to a placebo [1.8.3].
How Much is a Shot of Leqvio?
The list price, also known as the wholesale acquisition cost (WAC), for a single shot of Leqvio is approximately $3,250 to $3,588 [1.2.2, 1.2.7]. Because the initial year of treatment requires three doses (an initial shot, one at 3 months, and one at 9 months), the first-year cost can be around $9,750 [1.2.5]. Subsequent years require two doses, making the annual list price about $6,500 [1.2.5].
It is crucial to understand that the list price is not what most patients pay. The final out-of-pocket cost depends heavily on insurance coverage, deductibles, and co-insurance. Leqvio is typically covered under a patient's medical benefit, not the pharmacy benefit, because it is administered by a healthcare professional in a clinical setting [1.2.1].
Financial Assistance and Insurance Coverage
Recognizing the high list price, the manufacturer, Novartis, offers several support programs. The LEQVIO Co-pay Program is available for commercially insured patients and can reduce the out-of-pocket cost significantly. According to the manufacturer, 86% of commercially insured patients who used the co-pay program paid $0 for their treatment [1.2.1]. This program has eligibility requirements and annual benefit caps [1.4.2]. Patients with government-sponsored insurance plans like Medicare, Medicaid, or TRICARE are not eligible for this specific co-pay program [1.2.1].
For patients with Medicare, Leqvio is generally covered under Part B as a physician-administered drug [1.2.5]. Patients may still be responsible for a percentage of the cost (co-insurance). Organizations like Simplefill also offer services to connect patients with various patient assistance programs that can help manage the cost of treatment [1.4.7]. Before starting treatment, it is common for insurance companies to require a prior authorization to confirm the medical necessity of the drug [1.2.7].
Leqvio vs. Other PCSK9 Inhibitors
Leqvio is often compared to other drugs that target the PCSK9 pathway, namely Repatha (evolocumab) and Praluent (alirocumab). While they all aim to lower LDL-C by targeting PCSK9, their mechanisms and administration differ.
| Feature | Leqvio (inclisiran) | Repatha (evolocumab) | Praluent (alirocumab) |
|---|---|---|---|
| Mechanism | siRNA; prevents PCSK9 protein production in the liver [1.5.2]. | Monoclonal antibody; binds to existing PCSK9 protein in the blood [1.5.2]. | Monoclonal antibody; binds to existing PCSK9 protein in the blood [1.7.2]. |
| Administration | Subcutaneous injection by a healthcare provider [1.5.1]. | Self-administered subcutaneous injection [1.7.2]. | Self-administered subcutaneous injection [1.7.2]. |
| Frequency | 2 times per year (after initial doses) [1.5.2]. | Once every 2 weeks or once a month [1.7.2]. | Once every 2 weeks or once a month [1.7.2]. |
| Annual List Price | ~$6,500 (after first year) [1.3.2]. | ~$5,850 [1.3.2]. | ~$5,400 - $5,850 [1.3.2]. |
| CV Outcome Data | Awaiting data from ongoing trials [1.7.3]. | Proven to reduce risk of heart attack and stroke [1.7.3]. | Proven to reduce risk of cardiovascular events. |
Common Side Effects
The most common side effects associated with Leqvio are generally mild. The most frequently reported adverse event in clinical trials was an injection site reaction, which can include pain, redness, or a rash [1.6.2]. Other reported side effects include joint pain, urinary tract infections (UTIs), diarrhea, and bronchitis [1.6.1]. Serious side effects are not common, but can include shortness of breath or a severe allergic reaction [1.6.1]. Patients should always discuss their full medical history with their doctor before starting any new medication.
Conclusion
While the answer to "How much is a shot of Leqvio?" starts with a high list price of over $3,000, the reality for most patients is far different [1.2.2]. Thanks to its coverage under medical benefits and robust patient assistance programs, many commercially insured individuals may pay little to nothing out-of-pocket [1.2.1]. Its unique twice-yearly dosing schedule offers a significant convenience advantage over other PCSK9 inhibitors that require more frequent self-injections [1.7.2]. As a powerful tool for lowering bad cholesterol, Leqvio represents a significant advancement in cardiovascular care, and understanding the pathways to access and affordability is key for eligible patients.
For more information from the manufacturer, you can visit the official LEQVIO® website.
