CurrentCignaPolicy N/A

Opioids - Tramadol Extended-Release Products Drug Quantity Management Policy

Defines drug quantity limits and one-time override criteria for tramadol extended-release products (generic tramadol ER tablets and ConZip authorized generic capsules) for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOpioids - Tramadol Extended-Release Products Drug Quantity Management Policy

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review DateJul 17, 2023

Key ActionRequest one-time override only when titrating tramadol ER 100 mg; otherwise follow quantity limits at point of service.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

30Retail max per Rx

90Home delivery max per Rx

300 mg/dayMax daily dose

30 daysOne-time approval duration

Coverage Criteria

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Default quantity limits: Retail maximum quantity per Rx = 30 tablets/capsules; Home delivery maximum quantity per Rx = 90 tablets/capsules

Applies to tramadol ER products (100 mg, 200 mg, 300 mg)

One-time override for 100 mg ER: If the patient's dose is being titrated (to a higher or lower dose), approve a one-time override for the requested quantity not to exceed 90 tablets/capsules at retail or 270 tablets/capsules at home delivery (equivalent to 300 mg/day)<=300 mg/day

One-time approvals are provided for 30 days in duration

200 mg and 300 mg ER: No overrides recommended for 200 mg and 300 mg strengths

Requests outside listed exceptions are considered not medically necessary

Exceptions to the stated quantity limits beyond the specific one-time titration override for 100 mg extended-release tramadol are not medically necessary. The policy explicitly states: “EXCEPTIONS TO THE QUANTITY LIMITS LISTED ABOVE ARE COVERED AS MEDICALLY NECESSARY WHEN THE FOLLOWING CRITERIA ARE MET. ANY OTHER EXCEPTION IS CONSIDERED NOT MEDICALLY NECESSARY.”

Provider Actions and Operational Notes

Documentation Required

Coverage determination documentation

Coverage determinations require review of the applicable benefit plan document, any applicable laws/regulations, relevant collateral materials (including this coverage policy), and the specific facts of the individual case. Each request must be reviewed on its own merits; medical directors should exercise clinical judgment and have discretion in individual determinations. When coverage does not depend on specific circumstances, reimbursement is provided only if the request complies with the criteria in this policy (including covered diagnosis/procedure codes). Claims without covered code(s) will be denied.

Review: benefit plan document in effect on date of service
Consider: applicable laws/regulations
Consult: relevant collateral materials including this coverage policy
Assess: specific facts of the particular situation

Step Therapy

Step therapy — not applicable

This policy addresses Drug Quantity Management limits for tramadol ER; step therapy sequencing is not applicable. Providers should not interpret this policy as imposing step therapy requirements.

Prior Authorization

Quantity limit enforcement and overrides

If the Drug Quantity Management rule is not met at point of service, coverage will be determined based on the policy criteria. One-time overrides are available per the criteria (see overrides for titration of 100 mg products); otherwise the quantity limits apply at point of service.

One-time overrides: 30 days (retail up to 90 tablets/capsules; home delivery up to 270) for titration of 100 mg ER products — not to exceed 300 mg/day
No overrides recommended for 200 mg or 300 mg ER products

Denial Risk

Denial risk for nonconforming quantities

If requests for quantities fall outside the Drug Quantity Management exceptions and one-time override conditions, they may be denied as not medically necessary. Ensure documentation supports any exception claimed.

Exceptions are covered only when criteria are met
Requests outside exceptions may be denied at point of service

Background

Extended-release tramadol is indicated for adults who require daily, around-the-clock, long-term opioid treatment for severe pain when alternatives are inadequate. ER formulations provide continuous release and are intended for once-daily dosing; dosing must be titrated and should not exceed 300 mg per day. For quantity management, the policy sets product-level maximums and permits a single, short-duration titration override for 100 mg ER (one-time approval up to quantities corresponding to 300 mg/day); no overrides are recommended for the 200 mg or 300 mg strengths.

Definitions

Extended‑release tramadol (ER) — formulation and strengths

Formulation descriptionExtended-release tramadol produces a continuous release of tramadol for once-daily (QD) dosing; products should be swallowed whole (not crushed, chewed, or split).

Available dosage strengths - tablets100 mg, 200 mg, 300 mg tablets (generic extended-release tramadol)

Available dosage strengths - ConZip capsulesConZip authorized generic extended-release capsules available in 100 mg, 200 mg, 300 mg strengths

Quantity Limits and Overrides

Quantity limits — tramadol ER products

Retail maximum per Rx30 tablets or capsules per Rx

Home delivery maximum per Rx90 tablets or capsules per Rx

Applies totramadol ER 100 mg, 200 mg, 300 mg tablets and ConZip authorized generic capsules

One-time override — tramadol ER 100 mg (titration)

One-time titration override (retail)Up to 90 tablets or capsules at retail (one-time approval, 30 days)

One-time titration override (home delivery)Up to 270 tablets or capsules at home delivery (one-time approval, 30 days)

Applies toTramadol 100 mg extended-release tablets and 100 mg ConZip capsules when patient dose is being titrated