CurrentCignaPolicy N/A

Cardiology - Lodoco Prior Authorization Policy

Cigna prior authorization policy for Lodoco (colchicine 0.5 mg tablets, Agepha) describing coverage criteria for adults with atherosclerotic disease for secondary prevention of cardiovascular events, exclusions (not covered uses), and duration of approval.

Policy Summary

PayerCigna

PolicyCardiology - Lodoco Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNew policy

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended for prescription benefit coverage of Lodoco; approvals are provided for 1 year when criteria are met.

POLICY UPDATE CHANGES

New Policy created with review date 08/30/2023

1Covered Indication (atherosclerotic disease)

>=50Renal function threshold

18+Age requirement (years)

1 yrApproval duration

Coverage Summary

Coverage stance: covered with criteria for Lodoco (colchicine 0.5 mg) for adults with atherosclerotic disease. Scope: Cigna prior authorization policy for Lodoco describing coverage criteria for adults with atherosclerotic disease for secondary prevention of cardiovascular events. Approval duration: 1 year. Age requirement: ≥18 years.

FDA-Approved Indication - Atherosclerotic Disease (Approve for 1 year)

Approve for 1 year if ALL of the following are met:

ALL of the following

Patient is ≥ 18 years of age
Patient has had one of the following conditions or diagnoses
- A previous myocardial infarction or a history of an acute coronary syndrome
- Angina (stable or unstable)
- A past history of stroke or transient ischemic attack
- Coronary artery disease
- Peripheral arterial disease
- Patient has undergone a coronary or other arterial revascularization procedure in the past (examples: coronary artery bypass graft surgery, percutaneous coronary intervention, angioplasty, and coronary stent procedures)
Lodoco is being added onto other background regimens of other atherosclerotic disease medications according to the prescriber
Examples: aspirin, antiplatelet agents (e.g., clopidogrel, ticagrelor), anticoagulants, lipid-lowering agents (e.g., statins), beta blockers, ACE inhibitors, or ARBs
Patient does not have severe hepatic impairment according to the prescriber
Patient has a creatinine clearance ≥ 50 mL/min>= 50 mL/min

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Prior Authorization is recommended for prescription benefit coverage of Lodoco; approvals are provided for 1 year when criteria are met.

Documentation Required

Documentation of diagnosis and prior events

Provider must document patient age, qualifying diagnosis (e.g., prior MI, ACS, angina, stroke/TIA, CAD, PAD, or prior coronary/arterial revascularization), background cardiovascular medications, hepatic function status, and creatinine clearance (>=50 mL/min).

Patient age (≥ 18 years)
Qualifying diagnosis (examples: prior myocardial infarction, acute coronary syndrome, angina [stable or unstable], stroke or transient ischemic attack, coronary artery disease, peripheral arterial disease, prior coronary/arterial revascularization)
Background cardiovascular medications (examples: aspirin, antiplatelet agents such as clopidogrel or ticagrelor, anticoagulants, lipid-lowering agents such as statins, beta blockers, ACE inhibitors or ARBs)
Hepatic function status (no severe hepatic impairment per prescriber)
Creatinine clearance ≥ 50 mL/min

Clinical Evidence

6.8% vs 9.6%, HR 0.69, P < 0.001LoDoCo2 primary endpoint: composite of CV death, MI, ischemic stroke, or ischemia-driven coronary revascularization

2023 AHA/ACC Class 2bGuideline: colchicine for secondary prevention may be considered (randomized evidence)

The pivotal LoDoCo2 trial enrolled adults with chronic stable coronary disease and demonstrated a reduction in the composite primary endpoint; the study population and results support use in adults with chronic coronary disease. Clinical guidance (2023 AHA/ACC) states colchicine for secondary prevention in chronic coronary disease patients may be considered (Class 2b, randomized evidence). The safety and effectiveness of Lodoco have not been established in pediatric patients.

Background & Definitions

Lodoco (colchicine 0.5 mg) is indicated to reduce the risk of myocardial infarction, stroke, coronary revascularization, and cardiovascular death in adults with established atherosclerotic disease or multiple cardiovascular risk factors. Efficacy was demonstrated in the LoDoCo2 randomized trial of adults with chronic stable coronary disease. The safety and effectiveness have not been established in pediatric patients.

Key definitions and thresholds

DefinitionLodoco — Colchicine 0.5 mg tablets (Agepha)

Age requirementAdults 18 years and older (patient is ≥ 18 years of age)

Renal function thresholdCreatinine clearance ≥ 50 mL/min

Approval durationApprove for 1 year when criteria are met

Unproven Uses / Exclusions

Exclusions/unproven uses: Lodoco is limited to secondary prevention in adults with atherosclerotic disease per the policy criteria and is considered experimental, investigational, or unproven for any other use. The safety and effectiveness have not been established in pediatric patients. Primary prevention of cardiovascular events is specifically listed as not covered.

Revision History

2023-08-30policy_createdLatest

Policy established coverage criteria for Lodoco including age, qualifying atherosclerotic conditions, background therapy, hepatic and renal function thresholds; approval duration 1 year. New Policy created with review date 08/30/2023