Lodoco (colchicine)

Lodoco (colchicine)

Self-Administration – oral tablets

Diagnosis considered for coverage:

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

Coverage Criteria:

For diagnosis of Cardiovascular Disease:

• Diagnosis of atherosclerotic disease AND
• Used for the secondary prevention of cardiovascular (CV) disease events (e.g., very high-risk patients) 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)] AND
• Trial of generic colchicine tablet

Dosing: 

For diagnosis of atherosclerotic disease:

• 0.5 mg orally once daily 

Reauthorization Criteria:

For diagnosis of Cardiovascular Disease:

• Patient demonstrates positive clinical response to therapy AND
• Trial of generic colchicine tablet

Coverage Duration: 

• Initial: 1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Lodoco (colchicine 0.5 mg) received FDA approval on June 20, 2023 to reduce the risk of MI, stroke, coronary revascularization, and CV death in adult patients with established atherosclerotic disease or with multiple risk factors for CV disease
• Lodoco was reformulated in a lower dose of 0.5 mg specifically for long-term use in patients with CV disease

Policy Updates:

• 6/1/2024 (policy effective date)- New Sohonos Criteria (P&T 5/21/2024) (P&T meeting May)

References:

1. Lodoco Prescribing Information. Agepha Pharma USA, LLC. Parsippany, NJ. June 2023.

2.  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 12, 2023. 

3. 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 12, 2023. 

4. 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 12, 2023. 

5. 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.

6. 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 12, 2023. 

7. Lodoco. IBM Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Accessed January 25, 2024. http://www.micromedexsolutions.com.