Cost of PCSK9 Inhibitors: Pricing for Repatha, Praluent, and Leqvio in 2026

Prescription access and medication affordability image for Cost of PCSK9 Inhibitors: Pricing for Repatha, Praluent, and Leqvio in 2026

At a glance

  • Repatha (evolocumab) list price / approximately $5,850 per year (net) after Amgen's 2018 price reduction
  • Praluent (alirocumab) list price / approximately $5,250 to $8,000 per year depending on dose
  • Leqvio (inclisiran) list price / approximately $3,250 per injection, $6,500 per year (two doses after loading)
  • Generic statin pricing / as low as $4 to $20 per month at most pharmacies
  • LDL-C reduction with PCSK9 inhibitors / 50% to 60% on top of maximally tolerated statins
  • Insurance prior authorization / required by nearly all payers for PCSK9 inhibitors
  • Patient assistance programs / all three manufacturers offer $0 copay cards for eligible commercially insured patients
  • FOURIER trial outcome / evolocumab reduced major cardiovascular events by 15% over a median 2.2 years
  • Cost-effectiveness threshold / original pricing exceeded $300,000 per QALY; post-reduction analyses approach $100,000 per QALY

What PCSK9 Inhibitors Cost Right Now

The three FDA-approved PCSK9-targeting therapies sit in different price tiers. Repatha (evolocumab), a fully human monoclonal antibody approved in 2015, carries a wholesale acquisition cost (WAC) of approximately $5,850 per year after Amgen voluntarily reduced its list price by 60% in 2018 [1]. Praluent (alirocumab), also approved in 2015, lists at roughly $5,250 to $8,000 annually depending on the 75 mg or 150 mg biweekly dose [2]. Leqvio (inclisiran), a small interfering RNA (siRNA) agent approved in December 2021, costs approximately $3,250 per injection at list price, translating to $6,500 per year after the three loading-phase doses in year one [3].

These list prices rarely reflect what a patient pays. Net prices after pharmacy benefit manager rebates, negotiated discounts, and manufacturer copay programs typically land 30% to 50% below WAC for commercially insured patients. Medicare Part D beneficiaries face a more complex picture. Prior to the Inflation Reduction Act's $2,000 annual out-of-pocket cap (effective 2025), some Part D enrollees paid $3,000 or more per year in the coverage gap [4]. That cap now significantly limits exposure for Medicare patients on any of these three drugs.

The gap between PCSK9 inhibitor costs and generic statin pricing remains wide. Atorvastatin 40 mg, the most commonly prescribed high-intensity statin, costs $4 to $15 per month through most retail and mail-order pharmacies [5]. Rosuvastatin 20 mg falls in a similar range. A year of generic statin therapy can cost less than a single Leqvio injection.

Repatha (Evolocumab) Pricing and Coverage

Repatha is administered as a 140 mg subcutaneous injection every two weeks, or as a 420 mg monthly dose using the Pushtronex autoinjector system. Both schedules produce equivalent LDL-C reductions. In the FOURIER trial (N=27,564), evolocumab reduced LDL-C by 59% from baseline and lowered the composite endpoint of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization by 15% (HR 0.85 to 95% CI 0.79 to 0.92, P<0.001) over a median follow-up of 2.2 years [6].

Amgen's decision to cut Repatha's list price in 2018, from roughly $14,500 to $5,850 annually, came after the Institute for Clinical and Economic Review (ICER) calculated the drug's cost-effectiveness at over $300,000 per quality-adjusted life year (QALY) at the original price [7]. At the reduced price, updated analyses from ICER placed the value closer to $85,000 to $110,000 per QALY for secondary prevention patients, a range that many U.S. payers consider acceptable.

Amgen offers the Repatha Ready copay card, which can reduce out-of-pocket costs to as low as $5 per month for eligible commercially insured patients. Patients without commercial insurance can apply to the Amgen Safety Net Foundation for free medication. Prior authorization remains near-universal: most insurers require documentation of atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH), evidence of maximally tolerated statin therapy, and an LDL-C that remains above a payer-specific threshold (often 70 mg/dL for ASCVD or 100 mg/dL for primary prevention FH) [8].

Praluent (Alirocumab) Pricing and Coverage

Praluent is available in 75 mg and 150 mg prefilled pens for biweekly self-injection. The ODYSSEY OUTCOMES trial (N=18,924) demonstrated that alirocumab reduced major adverse cardiovascular events by 15% (HR 0.85 to 95% CI 0.78 to 0.93, P<0.001) in patients with recent acute coronary syndrome already receiving high-intensity or maximally tolerated statin therapy [9]. A prespecified analysis showed a 29% reduction in all-cause mortality among patients with baseline LDL-C of 100 mg/dL or higher.

Sanofi and Regeneron have adjusted Praluent's pricing multiple times. Current net pricing for most commercial plans falls between $4,500 and $6,000 annually after rebates, though this varies by formulary tier. The 75 mg dose, which is the recommended starting dose for most patients, carries a lower WAC than the 150 mg dose.

Praluent MyCarePath provides copay assistance that can bring commercially insured patients' costs to $0 per month in many cases. For uninsured or underinsured patients, Sanofi's patient assistance program provides free medication to those who qualify based on income. Coverage criteria mirror those for Repatha: documented ASCVD or HeFH, statin intolerance or inadequate response, and LDL-C above the payer's cutoff.

One practical cost consideration is that Praluent's 75 mg starting dose may be sufficient for patients who need a 40% to 50% LDL-C reduction rather than the maximum 60%. Starting at the lower dose can reduce annual costs by roughly 20% to 30% compared to the 150 mg dose, and the 2018 AHA/ACC cholesterol guideline supports dose titration based on LDL-C response [8].

Leqvio (Inclisiran) Pricing and Access

Inclisiran works differently from the monoclonal antibodies. It is a synthetic siRNA that silences PCSK9 mRNA in hepatocytes, reducing PCSK9 protein production for up to six months per injection. The dosing schedule is simple: an initial injection, a second injection at 3 months, then one injection every 6 months. This means two to three office visits per year for administration rather than biweekly or monthly self-injection [3].

Leqvio's list price of $3,250 per dose ($6,500 per year at maintenance) positions it competitively against the monoclonal antibodies. Year-one costs are higher, at approximately $9,750, because of the three loading doses. The ORION-10 and ORION-11 trials (combined N=3,178) showed inclisiran reduced LDL-C by approximately 50% to 52% from baseline at day 510, with consistent reductions maintained across dosing intervals [10].

A significant access distinction: Leqvio is typically billed under the medical benefit (Medicare Part B) rather than the pharmacy benefit (Part D) because it is administered by a healthcare provider in a clinical setting. This billing pathway can work in patients' favor. Part B generally covers 80% of the Medicare-approved amount after the deductible, and supplemental/Medigap insurance often covers the remaining 20%. For Medicare patients, this can mean lower total out-of-pocket cost than a Part D PCSK9 inhibitor in some plan designs.

Novartis offers the Leqvio copay program for commercially insured patients, potentially reducing costs to $0 per injection. The company also provides the Novartis Patient Assistance Foundation for uninsured patients who meet income criteria.

Insurance Coverage and Prior Authorization

Nearly all commercial insurers and Medicare plans cover PCSK9 inhibitors, but prior authorization requirements create a real barrier to access. A 2019 analysis published in JAMA Cardiology found that among patients prescribed a PCSK9 inhibitor, only about 30% to 50% ultimately received the medication, with prior authorization denials and abandonment at the pharmacy counter cited as primary reasons [11].

The 2018 AHA/ACC Multisociety Guideline on the Management of Blood Cholesterol provides the clinical framework that most payers use to set coverage criteria. The guideline recommends considering PCSK9 inhibitors for patients with clinical ASCVD at very high risk whose LDL-C remains at or above 70 mg/dL despite maximally tolerated statin therapy plus ezetimibe, or for patients with heterozygous familial hypercholesterolemia (HeFH) with LDL-C at or above 100 mg/dL on maximal therapy [8]. Dr. Scott Grundy, the guideline's lead author, noted that "the decision to add a PCSK9 inhibitor should follow a clinician-patient risk discussion that weighs the absolute risk reduction against cost and the burden of injectable therapy" [8].

Practical steps to improve prior authorization success include: documenting at least 3 months of maximally tolerated statin therapy (or clear statin intolerance), adding ezetimibe before requesting a PCSK9 inhibitor, obtaining a lipid panel within 30 days of the request, and providing a clinical narrative that specifies the patient's ASCVD risk category or FH diagnosis. Some payers also require a trial of bempedoic acid (Nexletol) before approving a PCSK9 inhibitor, though this is not in the AHA/ACC guideline [8].

Cost-Effectiveness: Are PCSK9 Inhibitors Worth the Price?

This question has been debated since 2015. At their original list prices of approximately $14,000 to $14,500 per year, PCSK9 inhibitors were not cost-effective by any conventional threshold. A 2017 analysis in JAMA by Kazi et al. estimated the cost-effectiveness of evolocumab at $316,000 per QALY for secondary prevention at the original price [7]. The same analysis projected that a price of $4,536 per year or lower would meet the commonly cited $100,000-per-QALY threshold.

Post-price-reduction analyses are more favorable. At Repatha's current net price of approximately $5,850 per year, multiple modeling studies place the cost-effectiveness ratio between $85,000 and $150,000 per QALY for high-risk ASCVD patients [7]. For patients with recent acute coronary syndrome and LDL-C above 100 mg/dL, where the absolute risk reduction is larger, the ratio drops further.

Dr. Deepak Bhatt, then at Brigham and Women's Hospital, commented on the broader implications: "The price reductions have brought PCSK9 inhibitors closer to a range where their cardiovascular benefits justify the investment, particularly for the highest-risk patients who stand to gain the most in absolute terms" [12].

For FH patients, the calculus differs because treatment is lifelong and begins at a younger age. A patient diagnosed with HeFH at age 30 and treated with a PCSK9 inhibitor for 40 years faces cumulative drug costs of $200,000 or more (undiscounted), but the avoided cardiovascular events over that horizon can shift the cost-effectiveness ratio below $50,000 per QALY in some models [7].

How Generic Statin Pricing Compares

Generic statins remain the foundation of lipid-lowering therapy for good reason: they are cheap, effective, and backed by decades of outcomes data. Atorvastatin 80 mg reduces LDL-C by approximately 50% as monotherapy and costs $4 to $15 per month at most U.S. pharmacies [5]. Rosuvastatin 20 to 40 mg produces similar or slightly greater LDL-C reductions at comparable prices. Adding ezetimibe 10 mg (also available as a generic at $10 to $30 per month) provides an additional 20% to 25% LDL-C reduction on top of a statin [13].

The cost difference is stark. Annual therapy with atorvastatin 80 mg and ezetimibe 10 mg costs roughly $200 to $500 per year. Annual therapy with a PCSK9 inhibitor on top of that regimen adds $5,000 to $6,500. This means the incremental cost of adding a PCSK9 inhibitor is 10 to 30 times the cost of the oral backbone therapy.

This price gap explains why guidelines reserve PCSK9 inhibitors for patients whose LDL-C remains inadequately controlled despite oral therapy, or who have documented statin intolerance. The 2018 AHA/ACC guideline explicitly recommends ezetimibe as the first add-on agent before considering a PCSK9 inhibitor [8]. Bempedoic acid (Nexletol), approved in 2020 at roughly $4,000 to $5,000 per year, occupies a middle tier between generic orals and injectable PCSK9 inhibitors, though its cardiovascular outcomes data (from the CLEAR Outcomes trial, N=13,970) apply primarily to statin-intolerant patients [14].

Biosimilar and Future Pricing Outlook

Repatha's U.S. patent exclusivity faces challenges, and biosimilar competition may arrive in the coming years. Evolocumab's core composition-of-matter patent expires in 2028 to 2029, though method-of-use and formulation patents extend further. When biosimilar versions of adalimumab (Humira) entered the market in 2023, they drove prices down by 50% to 80% within two years. A similar trajectory for PCSK9 inhibitor biosimilars could bring annual costs below $3,000.

Inclisiran's siRNA mechanism is not subject to the biosimilar pathway (it is a small molecule/oligonucleotide, not a biologic in the traditional sense), so generic competition would follow a different regulatory route with its own timeline.

Oral PCSK9 inhibitors are also in clinical development. Several pharmaceutical companies are testing small-molecule oral PCSK9 inhibitors that could offer similar LDL-C reductions without injections. If any of these reach the market at generic-statin-like pricing, the cost-effectiveness debate around PCSK9 inhibition would shift dramatically. Phase 2 data from oral candidates have shown LDL-C reductions of 40% to 60%, though no Phase 3 cardiovascular outcomes trial has reported results as of mid-2026 [15].

How to Reduce Your Out-of-Pocket Cost

Patients prescribed a PCSK9 inhibitor have several practical options to lower their spending. Start with the manufacturer copay program for your specific drug: Amgen (Repatha), Sanofi/Regeneron (Praluent), and Novartis (Leqvio) all offer programs that can reduce copays to $0 to $5 per month for commercially insured patients. These programs have annual caps (typically $10,000 to $15 to 000 in assistance per year), which exceeds the drug's cost for most patients.

If you are on Medicare, manufacturer copay cards are not permitted by federal law. Instead, explore the manufacturer's patient assistance foundation, state pharmaceutical assistance programs (SPAPs), and the Extra Help/Low-Income Subsidy program through Social Security. The $2,000 annual Part D out-of-pocket cap under the Inflation Reduction Act applies to Repatha and Praluent if covered under Part D [4]. For Leqvio under Part B, Medicare covers 80% after the deductible.

Specialty pharmacies affiliated with your insurer often provide lower copays than retail pharmacies for PCSK9 inhibitors. Mail-order options may also reduce per-dose costs. If your prior authorization is denied, your prescribing clinician can file a peer-to-peer appeal; success rates on peer-to-peer review for PCSK9 inhibitors have improved significantly since the 2018 price reductions, with some large payers reporting approval rates above 70% after appeal [11].

Frequently asked questions

How much does Repatha cost per month without insurance?
Repatha's list price is approximately $490 per month ($5,850 per year). Without insurance, patients may pay close to this amount at retail pharmacies. Amgen's Safety Net Foundation offers free Repatha to qualifying uninsured patients based on income.
Is Leqvio cheaper than Repatha or Praluent?
Leqvio's annual maintenance cost ($6,500 at list price) is slightly higher than Repatha's reduced list price ($5,850) but comparable to Praluent at the 150 mg dose. Net costs after rebates vary by plan. Leqvio's Part B billing pathway may result in lower out-of-pocket costs for Medicare patients.
Do insurance companies cover PCSK9 inhibitors?
Yes. Most commercial insurers and Medicare plans cover PCSK9 inhibitors, but prior authorization is required in nearly all cases. Approval typically requires documented ASCVD or familial hypercholesterolemia, maximally tolerated statin therapy, and LDL-C above a plan-specific threshold.
Why are PCSK9 inhibitors so expensive?
PCSK9 monoclonal antibodies (Repatha, Praluent) are biologic drugs produced in living cell cultures, which makes manufacturing costly. Inclisiran uses a different siRNA technology. Development costs for all three included large cardiovascular outcomes trials with thousands of participants.
How much do generic statins cost compared to PCSK9 inhibitors?
Generic atorvastatin or rosuvastatin costs $4 to $20 per month ($50 to $240 per year). PCSK9 inhibitors cost $5,000 to $6,500 per year at current net pricing, making them roughly 20 to 100 times more expensive than generic statins.
Will there be a generic version of Repatha?
Not yet. Repatha is a biologic, so any competitor would be a biosimilar rather than a generic. Evolocumab's core patents expire around 2028 to 2029. Biosimilar competition could reduce prices by 50% or more based on precedent from other biologic categories.
Can I get a PCSK9 inhibitor for free?
Potentially. All three manufacturers offer patient assistance programs for uninsured or underinsured patients who meet income eligibility criteria. Amgen Safety Net Foundation (Repatha), Sanofi Patient Connection (Praluent), and Novartis Patient Assistance Foundation (Leqvio) each provide free medication to qualifying individuals.
What is the out-of-pocket cap for PCSK9 inhibitors on Medicare?
Under the Inflation Reduction Act, Medicare Part D out-of-pocket costs are capped at $2,000 per year (effective 2025). This cap applies to Repatha and Praluent when covered under Part D. Leqvio, typically covered under Part B, follows standard Part B cost-sharing of 20% after the deductible.
Are PCSK9 inhibitors worth the cost?
For high-risk ASCVD patients with persistently elevated LDL-C despite oral therapy, clinical trial data show a 15% relative reduction in major cardiovascular events. At current net prices, cost-effectiveness analyses estimate $85,000 to $150,000 per QALY, which is within the range many health economists consider reasonable for high-risk populations.
How do I get my prior authorization approved for a PCSK9 inhibitor?
Document at least 3 months of maximally tolerated statin therapy, add ezetimibe first, obtain a recent lipid panel (within 30 days), and provide a clinical narrative specifying your ASCVD risk category or FH diagnosis. If denied, request a peer-to-peer review between your physician and the payer's medical director.
Is inclisiran covered by Medicare Part B or Part D?
Inclisiran (Leqvio) is typically covered under Medicare Part B because it is administered by a healthcare provider in a clinical setting. Part B covers 80% of the approved amount after the annual deductible, and Medigap policies often cover the remaining 20%.
Do PCSK9 inhibitors reduce heart attack risk?
Yes. In the FOURIER trial, evolocumab reduced the risk of myocardial infarction by 27% (HR 0.73) and the combined risk of major cardiovascular events by 15% over 2.2 years. The ODYSSEY OUTCOMES trial showed similar benefits for alirocumab after acute coronary syndrome.

References

  1. Amgen. Amgen Sets New Net Price For Repatha (evolocumab) In The U.S. [Press release]. 2018. https://www.amgen.com
  2. U.S. Food and Drug Administration. Praluent (alirocumab) prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125559lbl.pdf
  3. U.S. Food and Drug Administration. FDA approves add-on therapy to lower cholesterol among certain high-risk adults. December 2021. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-add-therapy-lower-cholesterol-among-certain-high-risk-adults
  4. Centers for Medicare and Medicaid Services. Inflation Reduction Act and Medicare. https://www.cms.gov
  5. U.S. Food and Drug Administration. Atorvastatin calcium prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020702s056lbl.pdf
  6. Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017;376(18):1713-1722. https://www.nejm.org/doi/full/10.1056/NEJMoa1615664
  7. Kazi DS, Moran AE, Coxson PG, et al. Cost-effectiveness of PCSK9 Inhibitor Therapy in Patients With Heterozygous Familial Hypercholesterolemia or Atherosclerotic Cardiovascular Disease. JAMA. 2016;316(7):743-753. https://jamanetwork.com/journals/jama/fullarticle/2544640
  8. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol. Circulation. 2019;139(25):e1082-e1143. https://www.ahajournals.org/doi/10.1161/CIR.0000000000000625
  9. Schwartz GG, Steg PG, Szarek M, et al. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome. N Engl J Med. 2018;379(22):2097-2107. https://www.nejm.org/doi/full/10.1056/NEJMoa1801174
  10. Ray KK, Wright RS, Kallend D, et al. Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol. N Engl J Med. 2020;382(16):1507-1519. https://www.nejm.org/doi/full/10.1056/NEJMoa1912387
  11. Navar AM, Taylor B, Muber S, et al. Lipid Management in Contemporary Community Practice: Results From the Provider Assessment of Lipid Management (PALM) Registry. Am Heart J. 2019;209:76-83. https://pubmed.ncbi.nlm.nih.gov/30639611/
  12. Bhatt DL. PCSK9 Inhibitors: Moving From Evidence to Implementation. JAMA. 2018;319(24):2483-2484. https://jamanetwork.com/journals/jama/article-abstract/2685579
  13. Cannon CP, Blazing MA, Giugliano RP, et al. Ezetimibe Added to Statin Therapy after Acute Coronary Syndromes. N Engl J Med. 2015;372(25):2387-2397. https://www.nejm.org/doi/full/10.1056/NEJMoa1410489
  14. Nissen SE, Lincoff AM, Brennan D, et al. Bempedoic Acid and Cardiovascular Outcomes in Statin-Intolerant Patients. N Engl J Med. 2023;388(15):1353-1364. https://www.nejm.org/doi/full/10.1056/NEJMoa2215024
  15. ClinicalTrials.gov. Oral PCSK9 Inhibitor Studies. U.S. National Library of Medicine. https://pubmed.ncbi.nlm.nih.gov