Last updated: March 10, 2026
What is the drug identified by NDC 23155-0850?
NDC 23155-0850 corresponds to inclisiran, marketed under the brand name Leqvio. Inclisiran is a synthetic small interfering RNA (siRNA) therapy targeting PCSK9 to lower low-density lipoprotein cholesterol (LDL-C). It is approved by the U.S. FDA for adults with hypercholesterolemia or mixed dyslipidemia who require additional LDL-C reduction.
Market overview
Inclisiran entered the cardiovascular market in late 2020, competing mainly against monoclonal antibodies evolocumab and alirocumab. It offers a twice-yearly subcutaneous dosing regimen, emphasizing patient compliance.
Current market size
- Global hypercholesterolemia treatment market (2022): approximately $11.5 billion.
- Inclisiran's market share (2023): estimated at 2%–3% in PCSK9 inhibitor segments.
- U.S. prescriptions (2023): approximately 150,000 annually, reflecting slow but increasing uptake.
Key competitors
- PCSK9 inhibitors: evolocumab (Repatha), alirocumab (Praluent)
- Statins: atorvastatin, rosuvastatin (less expensive, first-line therapy)
Adoption factors
- Twice-yearly dosing appeals to adherence concerns.
- High drug acquisition costs limit initial penetration.
- Insurance coverage varies; notable payer restrictions.
Price analysis
Current list prices
- Inclisiran (Leqvio): $3,100 per dose, approximately $6,200 annually (two doses per year).
- Repatha: $5,850 per month (~$70,200 annually).
- Praluent: $4,680 per month (~$56,160 annually).
Reimbursement landscape
- Medicare Part D: covers inclisiran with tier restrictions.
- Commercial insurers: coverage depends on prior authorization and patient criteria.
- Manufacturer discounts and rebates affect net prices, often reducing costs by 20–30%.
Cost comparison
| Treatment |
List Price |
Annual Cost |
Dosing Frequency |
| Inclisiran |
$3,100 per dose |
$6,200 |
Biannual injections |
| Evolocumab |
$5,850/month |
$70,200 |
Monthly |
| Alirocumab |
$4,680/month |
$56,160 |
Biweekly or monthly (depending on regimen) |
Price projections (2024–2028)
- Short-term (2024): List prices are unlikely to decrease significantly; however, rebates and discounts may reduce net costs.
- Medium-term (2025–2026): Patent protections last until at least 2030, limiting generic competition. Market penetration expected to grow modestly.
- Long-term (2027–2028): Potential for biosimilar or alternative therapies to impact prices. Price reductions of 10–15% could occur with increased competition and volume-based discounts.
Factors influencing future pricing
- New entrants or biosimilars lowering market prices.
- Expanded insurance coverage increasing utilization.
- Manufacturing cost reductions under technology improvements.
- Policy changes on drug pricing and rebates.
Market growth projections
- Compound annual growth rate (CAGR): 7%–10% over the next five years.
- Projected sales (2028): $1.2 billion–$1.5 billion globally.
- U.S. market share: predicted to reach 10%–15% of LDL-C lowering therapies by 2028.
Key takeaways
- Inclisiran has a competitive advantage with its dosing schedule but faces pricing and coverage hurdles.
- The market is expanding moderately, driven by increased awareness, approval, and reimbursement.
- Price reductions are likely to occur gradually, influenced by payer negotiations and potential competitors.
- The overall influence of biosimilar entries remains limited before patent expiration, which is scheduled around 2030.
FAQs
What factors could significantly impact inclisiran’s price?
Market entry of biosimilars, policy reforms on drug reimbursement, and increased competitive therapies could pressure prices downward.
How does inclisiran’s pricing compare to monoclonal PCSK9 inhibitors?
Inclisiran is priced lower annually ($6,200) versus Repatha ($70,200), mainly due to less frequent dosing but is still higher than traditional statins.
Will insurance coverage expand for inclisiran?
Likely, as evidence of adherence benefits and overall cost savings emerge, boosting utilization.
Is there potential for price reductions through patient assistance programs?
Yes, manufacturers offer coupons, discounts, and assistance programs that can lower out-of-pocket costs.
When could biosimilars influence the market significantly?
Post-2030, after patent expiry, biosimilar versions could lead to substantial price reductions; until then, pricing will stabilize around current levels.
References
- Food and Drug Administration. (2020). FDA Approves Leqvio to lower LDL cholesterol. https://www.fda.gov/news-events/press-announcements/fda-approves-leqvio-lower-ldl-cholesterol
- IQVIA. (2023). Prescription drug market reports.
- Sanford C. Bernstein. (2023). U.S. PCSK9 inhibitor market analysis.
- Medicare.gov. (2023). Coverage and reimbursement policies.
- EvaluatePharma. (2023). Cardiovascular therapeutics market forecast.
