Why is Leqvio so expensive? Unpacking the Cost of Inclisiran

October 11, 2025 •

4 min read

According to Novartis, the manufacturer of Leqvio, the wholesale acquisition cost for uninsured patients is over $3,500 per dose, creating significant sticker shock for many. This high price tag leaves many patients and healthcare providers asking: why is Leqvio so expensive? The answer lies in a complex interplay of research costs, novel technology, patent protection, and market dynamics.

Quick Summary

This article explores the multiple factors contributing to the high price of Leqvio, including research and development costs, its unique RNAi technology, patent exclusivity, and strategic market positioning. It also discusses patient affordability programs and comparisons with other cholesterol-lowering medications.

Key Points

Novel RNAi Technology: Leqvio is based on a novel RNA interference technology, which requires significant research, development, and complex manufacturing, contributing to its high cost.
Strong Patent Protection: Active patents grant market exclusivity to Novartis for Leqvio, preventing generic competition and allowing them to maintain a premium price point.
High R&D Investment: The extensive R&D required for a new drug, including clinical trials and potential failures, is a major factor in the final price, which Novartis also recouped via the initial acquisition cost.
Strategic Pricing and Value: Novartis prices Leqvio based on its perceived value in preventing costly cardiovascular events, even though its initial cost-effectiveness has been questioned by external reviewers.
Convenient Dosing Schedule: Leqvio's twice-yearly dosing offers a significant convenience advantage over other PCSK9 inhibitors, reinforcing its premium market position.
Complex Reimbursement: The "buy-and-bill" model for Leqvio means it is often covered under the medical benefit, leading to different reimbursement and out-of-pocket cost dynamics compared to standard pharmacy-filled prescriptions.

The Innovation Factor: RNAi Technology

Leqvio is not a traditional small-molecule drug or a monoclonal antibody like other PCSK9 inhibitors; it uses a novel technology called RNA interference (RNAi). This represents a significant investment in research and development (R&D).

Extensive R&D: The journey from a promising molecular compound to an FDA-approved drug is long, expensive, and fraught with failures. Developers of RNAi therapeutics like Leqvio must invest billions of dollars to identify the right molecular target, ensure safety, and conduct extensive clinical trials.
Complex Manufacturing: The manufacturing process for an RNAi therapeutic is significantly more complex and costly than for conventional drugs. It involves synthesizing delicate nucleic acid molecules and ensuring their stable delivery within the body, which requires specialized facilities and expertise.
Novel Mechanism of Action: Leqvio works by silencing the PCSK9 gene in the liver, which prevents the production of the PCSK9 protein. This is a fundamentally different approach compared to PCSK9 monoclonal antibodies (mAbs) like Repatha and Praluent, which work by binding to the PCSK9 protein in circulation.

Market Exclusivity and Patents

To recoup their substantial investment and reward innovation, pharmaceutical companies are granted a period of market exclusivity, protected by patents.

Patent Protection: Novartis holds multiple active patents protecting Leqvio's technology and method of use. These patents prevent other manufacturers from creating generic versions, ensuring the company has a monopoly on the drug for a set period. Leqvio is not expected to face generic competition until at least the mid-2030s, according to some analyses.
Limited Competition: While other PCSK9 inhibitors exist, Leqvio's unique twice-yearly dosing schedule offers a significant convenience advantage for patients, allowing Novartis to set a premium price. This limited direct competition, especially with its specific dosing and mechanism, contributes to the high price.
Strategic Acquisition: Novartis did not develop Leqvio in-house but acquired it when purchasing The Medicines Company for nearly $10 billion in 2020. This acquisition cost is another factor baked into the final price of the drug.

Pharmacoeconomics and Pricing Strategy

Drug pricing is also heavily influenced by pharmacoeconomics—the economic analysis of pharmaceutical products. Pharmaceutical companies determine pricing based on perceived value to the healthcare system and patient population, rather than simply R&D costs.

Perceived Value: Leqvio is indicated for patients who have already had a cardiovascular event or have a high genetic risk, and for whom standard statin therapy is insufficient. By effectively lowering 'bad' LDL-C cholesterol, the drug can prevent future, much more expensive cardiovascular events like heart attacks and strokes. The company can justify a high price based on the long-term cost savings to the healthcare system, though this is often debated by health technology assessment bodies.
Buy-and-Bill Model: Unlike many drugs picked up at a pharmacy, Leqvio is administered by a healthcare professional and is often covered under the medical benefit of an insurance plan. This "buy-and-bill" model can create a revenue opportunity for hospitals and clinics that stock and administer the drug, which may influence prescribing habits despite the high sticker price.

Understanding the Costs of Leqvio vs. Other Treatments


Feature	Leqvio (Inclisiran)	Repatha (Evolocumab) / Praluent (Alirocumab)	Statins (e.g., Atorvastatin)
Mechanism	RNAi; directly silences PCSK9 gene in liver.	Monoclonal Antibody; binds to PCSK9 protein in blood.	HMG-CoA reductase inhibitor; blocks cholesterol synthesis.
Administration	Subcutaneous injection, twice yearly after initial two doses.	Subcutaneous injection, biweekly or monthly.	Oral tablet, daily.
Cost	Wholesale cost of ~$6,500 annually (after initial year), varies by insurance.	List prices around $5,850 annually after price cuts.	Generic statins are very low cost.
Technology	Novel RNAi technology, complex manufacturing.	Biologic protein, complex manufacturing.	Small-molecule compound, straightforward manufacturing.
Patent Protection	Strong patent protection, generic entry not expected until mid-2030s.	Patents on brand name drugs have expired or are expiring. Biosimilars are available or in development.	Generics widely available for decades.

The Role of Patient Assistance and Insurance Coverage

While the list price is high, many patients do not pay this amount due to insurance coverage and manufacturer assistance programs.

Insurance Coverage: For patients with commercial insurance, many plans cover Leqvio, and co-pay programs can significantly reduce out-of-pocket costs, sometimes to as little as $0. However, this often requires prior authorization or other hurdles.
Medical vs. Pharmacy Benefit: Since Leqvio is administered in a healthcare setting, it is often billed under the medical benefit rather than the pharmacy benefit, which can alter coverage and patient costs.
Patient Assistance Programs: The manufacturer, Novartis, offers programs to assist commercially insured patients with high co-pays. Independent foundations also exist to help patients access the medication.

Conclusion

The high cost of Leqvio is the result of a combination of factors including the massive investment in novel RNAi technology, the expensive and complex manufacturing process, and a market exclusivity period protected by patents. While the potential long-term benefits in preventing cardiovascular events add to its perceived value, health technology bodies often debate whether the price is cost-effective at launch. Patient assistance programs and insurance coverage play a crucial role in mitigating the burden of the high list price, but access remains a complex issue influenced by regulatory decisions and pricing strategies.

Visit the Novartis Leqvio savings and support page for more information on assistance programs.

Frequently Asked Questions

No, Leqvio is not a statin. It is a PCSK9 inhibitor that works via RNA interference to silence a specific gene in the liver. It is often used in addition to statin therapy for high-risk patients who need additional LDL-C lowering.

The annual cost for Leqvio can vary, but based on the list price, it is approximately $6,500 per year after the initial loading dose year, which is more expensive. However, patient out-of-pocket costs can be much lower depending on insurance coverage and assistance programs.

Yes, many insurance plans cover Leqvio, but coverage is often dependent on specific criteria and may require prior authorization. Since it's administered by a healthcare provider, it is typically covered under the medical benefit of a plan.

No, there is currently no generic version of Leqvio. The brand-name drug is protected by several patents that grant market exclusivity to the manufacturer, Novartis, for a specified period.

Yes, Novartis offers patient assistance programs for eligible, commercially insured patients to help with the cost of Leqvio, including co-pay cards that can reduce out-of-pocket expenses.

Leqvio's annual list price of around $6,500 is generally comparable to the reduced list prices of other PCSK9 monoclonal antibody inhibitors like Repatha and Praluent, which are now closer to $5,850 per year.

The "buy-and-bill" model, where providers purchase and bill for the drug, can influence pricing and reimbursement. It can provide a revenue stream for healthcare systems but also makes the drug's true cost less transparent to the patient compared to a standard prescription fill.