Pharmacy Prior Authorization Criteria

Lodoco (colchicine)

For diagnosis of Cardiovascular Disease
Indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

AND

Used for the secondary prevention of cardiovascular (CV) disease events (e.g., very high-risk patients) [A, 3]

AND

Patient is on maximally tolerated therapy with at least two agents for coronary disease [e.g., antiplatelet (aspirin), lipid-lowering agent (statin [atorvastatin], ezetimibe, PCSK9 inhibitors [evolocumab]), beta-blocker (atenolol) or renin-angiotensin-aldosterone system blockers (lisinopril)] [A-B, 3]

AND

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

AND

2024-11-06, 2024-06-07, 2023-12-15, 2023-11-20

Lodoco Prescribing Information. Agepha Pharma USA, LLC. Parsippany, NJ. Auguat 2024.
LoDoCo2 Clinical Trials. "The LoDoCo2 Trial":Low Dose Colchicine for secondary prevention of cardiovascular disease. Available at: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363771&isReview=true. Accessed October 14, 2024.
Virani, S., Newby, L., et al. The 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Available at: https://www.jacc.org/guidelines/chronic-coronary-disease. Accessed October 14, 2024.
Nidorf, S., Fiolet, A., et al. Colchicine in Patients with Chronic Coronary Disease. Available at: https://www.nejm.org/doi/full/10.1056/nejmoa2021372. Accessed October 14, 2024.
Mukherjee, Debabrata. 2023 Multisociety Guideline for Managing Chronic Coronary Disease: Key Perspectives. July 2023. Available at: https://www.acc.org/Latest-in-Cardiology/ten-points-to-remember/2023/07/17/19/06/2023-guideline-for-chronic-coronary-disease-gl-ccd. Accessed October 12, 2023.
Robinson, P., Terkeltaub, R., et al. Consensus Statement Regarding the Efficacy and Safety of Long-Term Low-Dose Colchicine in Gout and Cardiovascular Disease. Available at: https://www.amjmed.com/article/S0002-9343(21)00510-6/fulltext#seccesectitle0008. Accessed October 14, 2024.

Colchicine is considered a drug with narrow therapeutic index, meaning there is a small difference in the dose that is effective and what can lead to serious or toxic adverse effects. Additionally, colchicine is metabolized by cytochrome P450 3A4 and p-glycoprotein, making it prone to drug-drug interactions. Therefore, monitoring for adverse effects is of paramount importance. Given this, there is a need for a highly individualized approach, limiting the use of colchicine to those patients who remain at very high risk despite maximum tolerated GDMT until further data become available. [3]
Comprehensive risk factor control should include lifestyle modifications (e.g., weight management, nutrition, physical activity) and Guideline Directed Management and Therapy (GDMT) to optimize dyslipidemia, hypertension, and hyperglycemia. [3]
Clinical evaluations were scheduled at 6 month intervals until completion of the trial. Median duration of follow up 28.6 months [2]
In each trial group, 10.5% of the patients permanently discontinued colchicine (e.g., side effects) [4]