CurrentCignaPolicy IP0595

Cardiology - Lodoco

This Cigna coverage policy governs prior authorization and medical necessity criteria for Lodoco (colchicine 0.5 mg) when used to reduce risk of cardiovascular events in adults with established atherosclerotic disease or multiple CV risk factors; it applies to members covered under Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyCardiology - Lodoco

Policy CodePolicy IP0595

Change TypeMaterial change — criteria revised

Effective Date

Next Review Date

Key ActionObtain prior authorization; approvals are provided for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Removed the creatinine clearance requirement (previously ≥ 50 mL/min) from the atherosclerotic disease criteria.

Removed Brilinta from the note of example background regimens because generic ticagrelor tablets are now available.

Removed documentation requirements in the Atherosclerotic Disease criteria and preferred product table.

Updated policy title to 'Cardiology - Lodoco'.

≥18minimum patient age for coverage

1 yearinitial approval duration

0.5 mgLodoco dose evaluated/indicated

5,522LoDoCo2 trial patients

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4,745COLCOT trial patients

Coverage and Medical Necessity Criteria

Atherosclerotic Disease (Initial approval)

Lodoco is considered medically necessary when ALL of the following are met:

A: Patient is ≥ 18 years of age>= 18 years

B: Patient has one of the following diagnoses: previous myocardial infarction or history of an acute coronary syndrome; OR angina (stable or unstable); OR past history of stroke or transient ischemic attack; OR coronary artery disease; OR peripheral arterial disease; OR prior coronary or other arterial revascularization procedure

Examples include coronary artery bypass graft surgery (CABG), percutaneous coronary intervention (PCI), angioplasty, and coronary stent procedures

C: Lodoco is being added to other background regimens of atherosclerotic disease medications per the prescriber

Examples include aspirin, antiplatelet agents (e.g., clopidogrel, ticagrelor), anticoagulants, lipid-lowering agents (e.g., statins such as atorvastatin and rosuvastatin), beta blockers, ACE inhibitors, and/or ARBs

D: Patient does not have severe hepatic impairment according to the prescriber

E: Preferred product criteria is met (trial of colchicine 0.6 mg tablets or capsules as specified for plan type)

See Employer and Individual/Family plan tables for preferred product/prior therapy requirements

Use of Lodoco for primary prevention of cardiovascular events is considered not medically necessary and not covered. The policy specifies that Lodoco for primary prevention is excluded because most patients in pivotal trials had prior cardiovascular events or prior arterial revascularization, and current primary prevention guidelines do not address Lodoco.

Lodoco for any use other than the specified atherosclerotic disease indication (including primary prevention) is considered not medically necessary. The Conditions Not Covered section clarifies that uses outside the described atherosclerotic disease indications are excluded from coverage and that the list may be updated as new data become available.

Prior Authorization, Step Therapy, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required — Prior authorization is required for coverage of Lodoco. Approvals are provided for 1 year when criteria are met.

All approvals are provided for 1 year when criteria are met.
Claims for Lodoco will be denied if billed without a covered diagnosis or procedure code per the policy.
Receipt of sample product does not satisfy any criteria requirements for coverage.

Step Therapy

Step Therapy — Try Generic Colchicine First

Step therapy — trial of generic colchicine 0.6 mg tablets or capsules is required prior to approving Lodoco for covered plans (may require prior authorization). This applies to Employer and Individual/Family plans.

Employer Plans: patient must have tried colchicine 0.6 mg tablets or capsules (may require prior authorization).

Background and Rationale

Lodoco (colchicine 0.5 mg) is the brand formulation of colchicine evaluated and indicated for secondary prevention of atherosclerotic cardiovascular events in adults with established disease or multiple cardiovascular risk factors. Efficacy was demonstrated in large randomized trials (for example, LoDoCo2 in stable coronary disease and COLCOT in post‑MI patients) where Lodoco was added to guideline‑directed secondary prevention therapies to reduce the risk of myocardial infarction, stroke, coronary revascularization, and cardiovascular death.

Per the policy, coverage for Lodoco is limited to patients meeting the atherosclerotic disease criteria and requires prior authorization; approvals are provided for 1 year when criteria are met. The product evaluated and indicated is 0.5 mg once daily Lodoco, and generic colchicine formulations at different strengths are considered non‑interchangeable by the policy.

Product Definitions and Interchangeability

Lodoco

DrugLodoco (brand formulation of colchicine 0.5 mg)

IndicationReduce risk of myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adults with established atherosclerotic disease or multiple CV risk factors

Evaluated dose0.5 mg once daily

Key supportive trialsLoDoCo2 (5,522 patients) and COLCOT (4,745 patients)

Pediatric useSafety and effectiveness not established in pediatric patients

Not interchangeable

Generic alternative and strength

Policy Summary

PayerCigna

PolicyCardiology - Lodoco

Policy CodePolicy IP0595

Change TypeMaterial change — criteria revised

Effective Date

Next Review Date

Key ActionObtain prior authorization; approvals are provided for 1 year when criteria are met.

SourceLink

On This Page

Individual and Family Plans: patient must have tried colchicine 0.6 mg tablets or capsules (may require prior authorization).

Note

Preferred Product / Prior Therapy Requirement

Preferred product/prior therapy requirement — For Employer and Individual/Family plans, the preferred product criteria require that the patient has tried colchicine 0.6 mg tablets or capsules (may require prior authorization) before Lodoco will be approved.

Denial Risk

Denial Triggers

Denial triggers — Claims for Lodoco will be denied if services are billed without covered diagnosis or procedure codes per the policy, or if Lodoco is used for uses considered not medically necessary (e.g., primary prevention of cardiovascular events).

Not medically necessary uses include Lodoco for primary prevention of cardiovascular events.
Claims lacking covered diagnosis/procedure codes will be denied as not covered.

Documentation Required

Documentation Expectations

Documentation expectations — Documentation requirements referenced previously were removed from the Atherosclerotic Disease criteria and preferred product table per the update; however clinical documentation supporting prior therapy with generic colchicine and eligibility for atherosclerotic disease indications should be maintained.

Documentation that the patient trialed colchicine 0.6 mg tablets or capsules if required for the plan.
Documentation of the atherosclerotic disease diagnosis (e.g., prior MI, ACS, angina, stroke/TIA, coronary artery disease, peripheral arterial disease, or prior arterial revascularization).

Colchicine is available generically in a 0.6 mg strength (tablets)

InterchangeabilityPolicy states products are not interchangeable

Preferred product requirementFor Employer and Individual/Family plans, trial of colchicine 0.6 mg tablets or capsules is required prior to Lodoco (may require PA)