CurrentCignaPolicy N/A

Colchicine Products Preferred Step Therapy Policy

Defines Cigna's preferred step therapy requirements for oral colchicine products (tablets and capsules) for members covered under Cigna-administered health benefit plans; affects prescribers and pharmacy prior authorization processes.

Policy Summary

PayerCigna

PolicyColchicine Products Preferred Step Therapy Policy

Policy CodePolicy N/A

Change TypeStep therapy revisiontitle clarified

Effective Date

Next Review DateNov 13, 2024

Key ActionObtain prior authorization for Step 2 colchicine products after the patient has tried one Step 1 colchicine tablet (generic).

SourceLink

POLICY UPDATE CHANGES

Mitigare (brand) was moved from Step 1 to Step 2 in the Step Therapy listing.

The word 'Products' was added to the policy title.

A note was added that Gloperba (colchicine oral solution) and Lodoco (colchicine 0.5 mg tablets) are not targeted in this policy.

2Step levels

1 yearApproval duration

1Required Step 1 trials

11/13/2024Review date

Coverage and Targeting

Policy Summary

PayerCigna

PolicyColchicine Products Preferred Step Therapy Policy

Policy CodePolicy N/A

Change TypeStep therapy revisiontitle clarified

Effective Date

Next Review DateNov 13, 2024

Key ActionObtain prior authorization for Step 2 colchicine products after the patient has tried one Step 1 colchicine tablet (generic).

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior Authorization Required: This program requires that members try a Step 1 colchicine product before a Step 2 product will be approved. If the Preferred Step Therapy rule is not met at the point of service, coverage will be determined by the Preferred Step Therapy criteria and the claim may be denied.

Step 1: colchicine tablets (generic)
Step 2: colchicine capsules (generic), Colcrys (brand), Mitigare (brand)
Gloperba® (colchicine oral solution) and Lodoco® (colchicine 0.5 mg tablets) are not targeted by this policy — they are excluded from the step sequence.

Step Therapy

Step Therapy Sequence

Step therapy sequence: Member must have tried ONE Step 1 product prior to approval of a Step 2 product. Note that Colcrys dispensed with DAW 9 (prescriber allows substitution but plan requests brand) counts as a Step 1 trial.

Step 1 = colchicine tablets (generic)
Step 2 = colchicine capsules (generic), Colcrys (brand), Mitigare (brand)
Colcrys with DAW 9 counts as a Step 1 product trial.

Documentation Required

Approval Duration & Documentation

Approval duration and required documentation: All approvals are provided for 1 year. Documented evidence of a Step 1 trial (including pharmacy fill records, prescriber notes, or DAW 9 notation when applicable) should be included with the authorization request to demonstrate the trial or support an exception.

Approval duration: 1 year
Acceptable documentation: pharmacy fill history, prescriber notes, or DAW 9 notation indicating brand request.

Denial Risk

Denial Risk for Failing Step Therapy

Denial Risk: Claims or authorization requests for Step 2 colchicine products may be denied if the required Step 1 trial is not met at the point of service. Exceptions not meeting the preferred step therapy criteria are considered not medically necessary.

Failure to show one Step 1 trial → denial or not medically necessary determination
Exceptions must meet criteria to be approved; otherwise not medically necessary.

Initial Therapy Requirement

Initial therapy requirement

Covered when ALL of the following are met

Step 1 product requirement: Patient must have tried ONE Step 1 product: colchicine tablets (generic)1 trial

Colcrys dispensed with DAW 9 (prescriber allows substitution but requests brand) counts as a Step 1 product

Step 2 products: Requested product is one of the Step 2 products: colchicine capsules (generic), Colcrys (brand), or Mitigare (brand)

Coverage and duration: If the Preferred Step Therapy rule is met, approve the Step 2 product; all approvals are provided for 1 year in duration

Step	Product(s)	Notes
Step 1	Colchicine tablets (generic)	Patient must try ONE Step 1 product prior to approval of a Step 2 product. Gloperba and Lodoco are not targeted in this policy.
Step 2	Colchicine capsules (generic); Colcrys (brand); Mitigare (brand)	A Step 2 product may be approved after one trial of a Step 1 product. Colcrys prescribed with DAW 9 counts as a Step 1 product for the purposes of the requirement. Approvals are provided for 1 year.

Product Indications and Definitions

Colcrys (colchicine tablets) — FDA indications and policy-relevant details

IndicationsProphylaxis of gout flares in adults and adolescents >16; treatment of gout flares in adults; familial Mediterranean fever in adults and children ≥4.

Dosage forms / strengths0.6 mg tablets (Colcrys); recommended dosing >16 years: 0.6 mg QD or BID; maximum recommended dose 1.2 mg/day.

Age limitationsProphylaxis: adults and adolescents >16 years; treatment of gout flares: adults; familial Mediterranean fever: adults and children ≥4 years.

Key policy note (most actionable)Colcrys counts as a Step 1 product when dispensed with DAW 9 (substitution allowed) for the Step Therapy requirement.

Mitigare (colchicine capsules) — FDA indication and limitations

IndicationProphylaxis of gout flares in adults.

Limitations of useSafety and effectiveness for acute treatment of gout flares during prophylaxis have not been studied; Mitigare is not an analgesic and should not be used to treat pain from other causes.

Comparative noteProduct labeling reports comparable safety and pharmacokinetic profiles between Mitigare and Colcrys.

Background

Colchicine is available in multiple oral formulations including generic colchicine tablets and capsules, and brand products such as Colcrys and Mitigare. Colcrys and Mitigare are FDA‑approved for prevention of gout flares, with Colcrys additionally indicated for treatment of gout flares and familial Mediterranean fever; Mitigare’s labeling differs in indications and dosing. This policy implements a two‑step preferred therapy sequence to encourage use of a Step 1 product (colchicine tablets, generic) before authorizing Step 2 products (colchicine capsules, generic; Colcrys; Mitigare). The policy history notes that Mitigare was moved from Step 1 to Step 2 and that Gloperba and Lodoco are not targeted by the policy.

OpenPayer