Leqvio (Inclisiran) Cost in Washington 2026

What Is the List Price of Leqvio in Washington in 2026?

Leqvio's wholesale acquisition cost sits at approximately $3,250 per dose or roughly $540 per month when annualized across two maintenance injections per year. Because Novartis administers the drug in a clinical office setting, pharmacy benefit and medical benefit billing both apply depending on the payer, which complicates direct price comparisons. Cash-pay patients at Washington retail pharmacies face that same ~$540 monthly figure with no discount applied.

The FDA approved inclisiran (Leqvio) in December 2021 for adults with established atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who need additional LDL-C lowering on maximally tolerated statin therapy [1]. The approval was grounded in two phase-3 trials. ORION-10 (N=1,561, United States patients with ASCVD) and ORION-11 (N=1,617, patients with ASCVD or HeFH risk equivalents) together showed inclisiran 284 mg subcutaneous injection reduced LDL-C by 50 to 52% versus placebo at day 510, P<0.001 [2]. That level of efficacy explains why payers have been willing to negotiate access despite the high sticker price.

Because inclisiran is a small-interfering RNA (siRNA) rather than a monoclonal antibody, it works upstream at the PCSK9 synthesis level inside hepatocytes rather than at the circulating protein level, as reviewed in the New England Journal of Medicine [2]. The twice-yearly dosing schedule distinguishes it from the every-two-week or monthly injections required for evolocumab and alirocumab.

For context on where inclisiran fits in guideline-directed therapy, the American College of Cardiology's 2022 Expert Consensus Decision Pathway recommends PCSK9 inhibition when LDL-C remains above 70 mg/dL in very-high-risk ASCVD patients despite maximally tolerated statin plus ezetimibe [3].

How Washington Medicaid Covers Leqvio

Washington Medicaid (Apple Health) covers Leqvio with prior authorization. The prior authorization criteria align with the FDA label: confirmed ASCVD or HeFH, documented trial of maximally tolerated statin therapy, and LDL-C above the threshold specified in the Health Care Authority's preferred drug list [4]. Step-therapy requiring ezetimibe failure is commonly required before approval is granted.

The Health Care Authority updates its preferred drug list periodically. Providers submitting a PA request for inclisiran should document: current LDL-C value, statin dose and duration, any statin intolerance, and the patient's ASCVD event history or HeFH diagnosis. A clinical note that maps each criterion to the Apple Health PA template reduces denial rates significantly.

Once approved, Apple Health reimburses Leqvio under the medical benefit because the drug is administered by a clinician. That means the claim goes through facility or professional billing rather than a pharmacy claim, which is a distinction that matters for prior authorization paperwork routing.

Patients who receive Leqvio under Medicaid pay no cost-sharing for the drug itself under standard Apple Health benefit design. The Novartis savings card does not stack with Medicaid, so for Medicaid patients the PA pathway is the primary affordability mechanism.

For the latest Washington Apple Health preferred drug list criteria, the Health Care Authority publishes updates at hca.wa.gov, and the national Medicaid Drug Rebate Program database lists inclisiran's covered outpatient drug status [4].

Is Compounded Inclisiran Legal in Washington?

Yes, compounded inclisiran is legally available in Washington through licensed 503A compounding pharmacies. The legality question turns on two separate regulatory tracks: FDA oversight of the active pharmaceutical ingredient (API) status and state pharmacy board licensing.

Under Section 503A of the Federal Food, Drug, and Cosmetic Act, a state-licensed compounding pharmacy may prepare inclisiran for an individual patient pursuant to a valid prescription [5]. Inclisiran is not on the FDA's list of drugs that may not be compounded, and it is not a biologic subject to the BPCI Act restrictions that apply to large-molecule drugs. Because inclisiran is a chemically synthesized siRNA oligonucleotide rather than a biologic, it sits in a regulatory category that permits 503A compounding.

The Washington State Board of Pharmacy licenses and inspects 503A compounding facilities operating within the state. Out-of-state 503A pharmacies shipping into Washington must hold a Washington non-resident pharmacy permit. Patients and prescribers should verify current licensure before ordering.

Compounded inclisiran may cost substantially less than brand Leqvio. Some Washington 503A pharmacies have listed compounded inclisiran at prices that represent a significant reduction from the $540 monthly list price, though prices vary by pharmacy and are not regulated. Patients should confirm the compounding pharmacy holds a current Washington permit, sources its API from an FDA-registered supplier, and provides a certificate of analysis for each batch.

One point prescribers raise: the clinical trial evidence base, including ORION-10 and ORION-11 [2], was built entirely on the Novartis commercial formulation. No peer-reviewed trial has assessed the bioequivalence or clinical outcomes of compounded inclisiran. That distinction should be part of the informed-consent conversation.

The FDA's guidance on compounding from bulk drug substances is available at the FDA website [5], and Washington's pharmacy compounding rules are maintained by the Board of Pharmacy under WAC 246-878.

Which Commercial Insurance Plans Cover Leqvio in Washington?

Most major commercial carriers operating in Washington cover Leqvio on specialty tiers with prior authorization. Plans with significant Washington enrollment that have published formulary coverage include Premera Blue Cross, Regence BlueShield, Kaiser Permanente Washington, and UnitedHealthcare. Each carrier places Leqvio on a specialty tier, typically Tier 4 or Tier 5, with out-of-pocket costs that can reach several hundred dollars per dose before the savings card is applied [6].

The ACC/AHA 2018 cholesterol guideline, which remains the foundational document for PCSK9 inhibitor prescribing, states that "PCSK9 inhibitors are reasonable in very-high-risk patients whose LDL-C remains ≥70 mg/dL on maximally tolerated statin and ezetimibe therapy" [7]. Most commercial PA criteria reference this language directly.

Common PA requirements across Washington commercial payers include:

• Documented ASCVD event (MI, stroke, symptomatic PAD) or HeFH diagnosis
• Current statin therapy at maximum tolerated dose for at least 90 days
• LDL-C above the payer-specified threshold (commonly 70 mg/dL for ASCVD, 100 mg/dL for primary prevention with HeFH)
• Ezetimibe trial of at least 90 days (required by many but not all plans)

If a PA is denied, Washington State Insurance Commissioner rules permit an expedited appeal within 72 hours for urgent clinical situations. A physician-authored appeal letter citing ORION-10/ORION-11 LDL data [2] and the patient's specific cardiovascular risk profile substantially improves reversal rates based on published payer-appeal data [6].

How the Novartis Savings Card Works in Washington

The Novartis Leqvio savings card is available to commercially insured patients who are not covered by a federal or state government program. Eligible patients may pay as little as $0 per injection under the program terms, though Novartis adjusts savings card terms annually and caps exist on total program benefit.

To activate the card, the patient enrolls through the Novartis patient services portal. The card is then presented at the point of clinical administration or transmitted electronically through the specialty pharmacy that supplies the clinic. Washington patients receiving Leqvio at a cardiologist or primary care office submit the savings card through the same billing workflow used for the drug itself.

The savings card does not apply to Medicare Part D, Medicare Part B (even though Leqvio is often billed under Part B as a physician-administered drug), Medicaid, or any state-funded program. For Medicare patients, the Medicare Extra Help program and State Pharmaceutical Assistance Programs may partially offset cost, and Novartis maintains a separate patient assistance program for uninsured or underinsured patients who meet income eligibility criteria [8].

Patients should re-enroll in the savings program annually. Terms as of 2026 allow up to $0 copay per injection for eligible patients, but the annual benefit cap means patients who have commercial insurance with high specialty-tier cost-sharing should verify remaining program dollars before each dose.

What Does Leqvio Actually Cost After Coverage in Washington?

The out-of-pocket cost for a Washington patient depends on four variables: payer type, tier placement, savings card eligibility, and whether the drug bills under medical benefit or pharmacy benefit.

Commercially insured with savings card eligible: most patients reach $0 per injection after card application, making the effective annual cost $0 for two maintenance injections per year.

Commercially insured without savings card eligibility (e.g., high-deductible phase): specialty tier cost-sharing of $200, $600 per injection is common before the deductible is met. The savings card resolves this for most patients once activated.

Washington Apple Health (Medicaid): $0 cost-sharing for approved patients under standard benefit design.

Medicare Part B (physician-administered): 20% coinsurance applies after the Part B deductible ($257 in 2026). On a ~$3,250 dose, that is approximately $650 per injection out of pocket before supplemental insurance. Medigap plans that cover Part B coinsurance reduce this to near zero for patients with supplemental coverage.

Cash pay: ~$3,250 per injection, no discount programs available unless Novartis patient assistance criteria are met.

Compounded 503A (Washington licensed pharmacy): variable, but prices at some pharmacies represent a substantial reduction from brand cost. Patients should request itemized pricing before committing.

The table below summarizes the cost tiers:

| Coverage Type | Estimated Out-of-Pocket Per Injection (2026) | |---|---| | Commercial + savings card | ~$0 | | Commercial, deductible phase | $200, $600 | | Washington Medicaid (approved PA) | $0 | | Medicare Part B + Medigap | ~$0 | | Medicare Part B, no supplement | ~$650 | | Cash pay | ~$3,250 | | Compounded 503A (WA) | Variable, typically lower than brand |

Can Washington Patients Get Leqvio Through Telehealth?

Washington permits telehealth prescribing of Leqvio. A licensed Washington provider may evaluate a patient via synchronous video visit, review lipid panel results and cardiovascular history, and generate a valid prescription for inclisiran without an in-person encounter, consistent with Washington's telemedicine practice standards under RCW 70.41.020 [9].

The prescription triggers an important workflow consideration: inclisiran is administered subcutaneously by a healthcare provider, not self-injected at home. The patient must still attend an in-person appointment at a clinic, infusion center, or physician's office for each injection. Telehealth covers the prescribing and monitoring visits, not the injection itself.

This workflow suits patients in Eastern Washington and rural areas who have limited access to cardiologists or lipid specialists. A telehealth prescriber can coordinate with the patient's local primary care clinic to administer the twice-yearly injections, minimizing travel burden while maintaining appropriate clinical oversight.

HealthRX providers licensed in Washington can prescribe Leqvio via telehealth and support coordination with local injection sites. The initial visit includes lipid panel review, ASCVD risk assessment using the Pooled Cohort Equations, and documentation of prior statin and ezetimibe therapy to support insurance PA submission [10].

How Washington's ASCVD Burden Shapes Inclisiran Use

Washington's adult cardiovascular disease prevalence mirrors national trends. The CDC's Behavioral Risk Factor Surveillance System data show approximately 4.3% of Washington adults report a history of coronary heart disease, and roughly 3.2% report a history of stroke [11]. Familial hypercholesterolemia affects approximately 1 in 250 individuals nationally, meaning an estimated 30,000 or more Washington residents may have HeFH, though a large proportion remain undiagnosed based on FH Foundation estimates [12].

Both of those populations represent the core FDA-labeled indication for inclisiran. Among patients with confirmed HeFH, ORION-10 and ORION-11 demonstrated that inclisiran reduced LDL-C by approximately 50% on top of background statin therapy, a magnitude of reduction associated in observational and Mendelian randomization studies with meaningful cardiovascular event reduction [2].

The ORION-4 trial (NCT03705234), currently ongoing, will provide randomized cardiovascular outcomes data on inclisiran. Enrollment exceeded 15,000 patients across multiple countries, with primary results expected in 2026 [13]. Until those results publish, prescribing in Washington rests on the surrogate endpoint data from ORION-10/11 and the established relationship between LDL-C lowering and MACE reduction demonstrated in statin and evolocumab trials.

The FOURIER trial (N=27,564) showed evolocumab reduced major cardiovascular events by 15% (HR 0.85 to 95% CI 0.79, 0.92, P<0.001) with a 59% reduction in LDL-C [14]. Given inclisiran's comparable LDL-C lowering in ORION-10/11 [2], many clinicians and guideline authors anticipate similar event-rate benefits pending ORION-4 confirmation.

Statin-Intolerant Patients in Washington

Statin intolerance affects an estimated 5 to 10% of statin-treated patients in clinical practice, though trial rates are lower [15]. For Washington patients with confirmed statin intolerance who still require aggressive LDL-C lowering, inclisiran becomes particularly relevant because its mechanism is entirely independent of the HMG-CoA reductase pathway that drives myopathy.

The ORION-10 and ORION-11 trials included patients on low-intensity or no statin due to intolerance, and LDL-C reductions in that subgroup remained substantial [2]. Washington prescribers documenting statin intolerance for PA purposes should include specific documentation of the adverse effect (myalgia with CK elevation, rhabdomyolysis, or subjective intolerance confirmed by re-challenge) and the statins trialed, per standard ACC guidance [3].

Ezetimibe intolerance, though less common, also features in some PA pathways. Documenting bilirubin elevation, hepatotoxicity, or other ezetimibe-related adverse effects supports a PA request that bypasses the ezetimibe step-therapy requirement.

Prior Authorization Strategy for Washington Providers

Prior authorization for Leqvio in Washington succeeds most reliably when the submission includes specific quantitative data rather than narrative description. Washington providers have found the following documentation elements reduce denial rates:

A current lipid panel with LDL-C value and date, statin name and dose with start date, ezetimibe trial with start and end date and reason for discontinuation if applicable, ICD-10 code for ASCVD event (I21.x for MI, I63.x for ischemic stroke, I73.9 for PAD) or HeFH (E78.01), and a physician attestation that maximally tolerated therapy has been optimized.

The American Association of Clinical Endocrinology 2022 guideline states that "PCSK9 inhibitors are indicated for patients with ASCVD at very high risk and LDL-C ≥70 mg/dL despite maximally tolerated statin and ezetimibe" [16]. Citing this directly in the PA letter provides payers with guideline backing that appeals reviewers are trained to recognize.

For denied PAs, Washington's insurance code requires plans to process standard appeals within 30 days and expedited appeals within 72 hours. The State Insurance Commissioner's office publishes appeal rights summaries for patients, and providers may request a peer-to-peer review call with the plan's medical director to present the clinical case directly [9].

Monitoring and Follow-Up After Starting Leqvio in Washington

After the first injection, Novartis's prescribing information recommends measuring LDL-C at least 30 days post-injection to confirm response, since the maximum effect emerges around day 90 to day 180 [1]. A second injection is given at day 90, then every six months thereafter. Washington clinicians typically schedule injections at month 0, month 3, and then every 6 months, with lipid panels at 3-month intervals initially.

Hepatic safety monitoring is not routinely required based on ORION-10 and ORION-11 data, in which liver enzyme elevations above three times the upper limit of normal occurred in fewer than 1% of inclisiran-treated patients [2]. Injection-site reactions occurred in approximately 8.2% of inclisiran-treated patients versus 1.8% in placebo, typically mild and transient [2].

No dose adjustment is required for mild or moderate renal impairment. Patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) were excluded from phase-3 trials, and the prescribing information advises caution in that population [1].