CareCost Prior authorization
Required
Check what the payer requires before you schedule Leqvio.
Prior authorization · statin and PCSK9 history · clinical criteria · dosing
28 of 30 payer policy sets hold an inclisiran policy · source-linked · reviewed August 2026
Aetna + primary hypercholesterolemia is shown as a live example until you choose a payer.
This payer requires an approval on file before Leqvio is purchased or administered for this member.
Precertification of inclisiran (Leqvio) is required of all Aetna participating providers and members in applicable plan designs.
Covered under ICD-10 E78.00, E78.5.
Hypercholesterolemia in adult members, when either of the following criteria is met:
What opens in CareCost
Aetna · Leqvio · Hypercholesterolemia
For every requirement: the exact payer criteria, the source citation, a check-off, and a save to the patient’s chart.
In CareCost: check off each requirement · save to the patient · print for the chart
Aetna · Leqvio · Hypercholesterolemia
You have already checked the policy, indication and covered dose. Open the remaining requirements and work them as a patient checklist.
CareCost tracks Leqvio coverage requirements across 28 payer policy sets.
Aetna · Anthem / Elevance · Cigna · UnitedHealthcare · Regence · Premera · BCBS plans + more
Coverage clearance is only the first step.
CareCost carries the same patient through the entire workflow.
Finish this patient’s estimate →22 of 28 commercial payers with an inclisiran policy require prior authorization. Statin history, PCSK9-inhibitor history and dosing rules vary by plan. Two payer policy sets CareCost tracks, BCBS Mississippi and Kaiser Permanente WA, have no inclisiran policy on file.
22 require PA · 27 have clinical criteria · 9 have a site-of-care rule · 25 ask for statin or PCSK9-inhibitor history first
Most commercial payers require approval before inclisiran is purchased or administered.
Coverage depends on the diagnosis in the payer’s inclisiran policy: primary hypercholesterolemia (E78.00) or heterozygous familial hypercholesterolemia, HeFH (E78.011).
20 of the 28 policies quote a statin requirement, most often a trial of high-intensity statin therapy lasting 8 weeks to 3 months before Leqvio. Aetna and CareFirst accept a moderate-intensity statin when high-intensity is not tolerated.
15 of the 28 policies ask for a documented trial, failure, intolerance or contraindication to a PCSK9 inhibitor before Leqvio is authorized. Five name Repatha alone: BCBS Massachusetts, Blue Shield of California, Cigna (Individual and Family Plans), Excellus and Premera.
Some payers will not cover Leqvio at the same time as a PCSK9 inhibitor once therapy has started, even where a PCSK9 trial was the qualifying step.
The billed dose is 284 mg at day 0, again at 3 months, then every 6 months: the whole prefilled syringe, 284 units with JZ, on each claim.
9 of the 28 policies carry a site-of-care rule. BCBS Massachusetts states, "This medication is covered ONLY under the pharmacy benefit." BCBS Michigan flags J1306 "PPO-SOC HMO-SOC" on its drug list, and Highmark calls Leqvio "typically an outpatient procedure" with inpatient coverage only in special circumstances. Arkansas BCBS, Blue Shield of California, Excellus, Premera, Regence and UnitedHealthcare list Leqvio under a separate site-of-care or site-of-service review.
Leqvio has no J-coded biosimilar or same-class alternative in CareCost’s corpus. What payers gate on instead is prior therapy: 25 of 28 inclisiran policies CareCost has read ask for statin history, PCSK9-inhibitor history, or both before Leqvio is authorized. Six payers also carry a separate combination rule against using Leqvio with a PCSK9 inhibitor, and nine more write that bar into their clinical criteria.
| Payer | PA? | Prior therapy required | Rule type | Notes |
|---|---|---|---|---|
| Aetna Commercial · CPB 1004 |
Yes | High-intensity statin, 3 months (moderate-intensity if not tolerated) | Clinical prerequisite | No PCSK9-inhibitor trial named for the hypercholesterolemia or HeFH pathway |
| Blue Shield of California Commercial |
Yes | Inadequate response, intolerable side effect or contraindication to Repatha (evolocumab) | Clinical prerequisite | Mandatory cross-benefit PCSK9 step, plus a separate 8-week statin trial |
| Cigna Commercial · IP0380 |
Yes | Tried Repatha, with inadequate efficacy or significant intolerance | Clinical prerequisite | Individual and Family Plans only; also excludes concurrent PCSK9 use (combination rule) |
| Regence Commercial · dru697 |
Yes | Praluent (alirocumab) or Repatha (evolocumab), as part of the maximally-tolerated regimen | Step (external) | Also excludes concurrent use with another PCSK9 inhibitor or Juxtapid |
| UnitedHealthcare Commercial · 2026D0101L |
Yes | Documented failure, contraindication or intolerance to PCSK9 therapy (Praluent or Repatha) | Clinical prerequisite | Also a combination rule: will not cover Leqvio with a PCSK9 inhibitor or Juxtapid at the same time |
| Independence Blue Cross Commercial · 08.01.91a |
No (criteria-based) | LDL-C threshold after 3 months of high-intensity statin (≥70 mg/dL hypercholesterolemia, ≥100 mg/dL HeFH) | Clinical prerequisite | No PCSK9-inhibitor step and no prior authorization requirement in this policy |
The governing local coverage determinations are published in the CMS Medicare Coverage Database, and a MAC can differ from its neighbour on the same drug. CareCost has not read a Leqvio-specific local coverage determination for this corpus; the statin and PCSK9-inhibitor history below is commercial payer medical policy, not Medicare LCD criteria.
This is the Original Medicare answer. A Medicare Advantage plan administers the same Part B benefit but can layer its own prior-authorization and prior-therapy rules on top. Check the plan’s own policy rather than assuming the Original Medicare rules below carry over.
E78.01 (familial hypercholesterolemia) is a category header, not a billable code, yet 23 of the 28 payer policies CareCost has read still cite it; the unspecified familial code is E78.019. E78.5 (hyperlipidemia, unspecified) appears in the coverage lists of 23 of the 28 payers alongside E78.00; CareCost reports that the corpus lists it and takes no position on whether it independently qualifies a claim. 16 corpus payers also carry a homozygous familial hypercholesterolemia (HoFH) coverage key. Unlike the codes above, E78.010 is fully billable — it is a third labeled indication, for children 12 and older, not an unbilled header or an ambiguous code. The payer-and-diagnosis checker above currently covers primary hypercholesterolemia and HeFH; HoFH is not yet one of its two picker options.
These prior-therapy requirements are not Medicare LCD criteria in this corpus: they come from commercial payer medical policy, and they vary by plan.
Payer citation language above is drawn from CareCost’s own inclisiran policy corpus (28 payers). Check the specific payer’s language →
It depends on the payer and plan. 22 of the 28 commercial inclisiran policies CareCost has read require prior authorization before Leqvio is covered. Check this patient’s payer →
Yes, for adults with primary hypercholesterolemia (E78.00) and for adults and children 12 and older with heterozygous familial hypercholesterolemia, HeFH (E78.011). A statin history, clinical criteria and the dosing schedule still apply on top of the diagnosis. Check coverage →
Mostly the corpus does not say. Of the 28 payer policies CareCost has read, only BCBS Massachusetts states a benefit rule outright: this medication is covered only under the pharmacy benefit. Eight others carry a site-of-care rule, which governs where the injection is given, not which benefit pays the claim. Check this patient’s payer →
CareCost turns the applicable payer policy for Leqvio (J1306) into a patient-level checklist showing each requirement, what to confirm, and the source language supporting it. Open patient clearance →
Data current: payer policies Aug 2026 · reviewed dates come from each payer
Payer medical and specialty-drug policies · prior-authorization criteria · statin and PCSK9-inhibitor step-therapy rules · clinical coverage criteria. Medicare coverage from the CMS Medicare Coverage Database. Every CareCost requirement links back to its source policy.