CurrentCignaPolicy N/A

Opioids - Nucynta Drug Quantity Management Policy - Per Rx

Defines per-prescription quantity limits and override criteria for immediate-release Nucynta (50 mg, 75 mg, 100 mg tablets) for Cigna-administered health benefit plans. Applies to providers and pharmacists submitting quantity requests for members covered under applicable Cigna plans.

Policy Summary

PayerCigna

PolicyOpioids - Nucynta Drug Quantity Management Policy - Per Rx

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApr 23, 2025

Next Review DateApr 24, 2023

Key ActionSubmit documentation to support requested quantity overrides; one-time overrides allowed for titration (30 days retail / 90 days home delivery).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

181Retail max per Rx

541Home delivery max per Rx

600 mg/dayStd max daily dose

700 mg (day 1)First-day max

30d/90dOverride durations

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Nucynta (tapentadol) — Coverage Criteria

Nucynta 50 mg tablets

Covered when the following criteria are met:

50 mg tablet overrides: Patient is ≥ 18 years of age and is titrating the dose of Nucynta using 50 mg immediate‑release tablets; approve a one‑time override for a quantity sufficient for a 30‑day supply at retail or a 90‑day supply at home delivery.age >= 18

one‑time override duration: 30 days (retail) / 90 days (home delivery)

Non‑standard dosing for 50 mg: Patient is ≥ 18 years of age and is taking a dose that does not correspond to a commercially available dosage form (e.g., requires multiple same‑strength tablets or two or more strengths); approve the quantity requested not to exceed 600 mg per day (plus 700 mg for the first day of therapy) for a 30‑day supply per dispensing at retail or a 90‑day supply per dispensing at home delivery.<=600 mg/day (standard); <=700 mg day 1

approvals per dispensing: 30‑day retail / 90‑day home delivery

Nucynta 75 mg tablets

Covered when the following criteria are met:

75 mg tablet overrides: Patient is ≥ 18 years of age and is titrating the dose of Nucynta using 75 mg immediate‑release tablets; approve a one‑time override for a quantity sufficient for a 30‑day supply at retail or a 90‑day supply at home delivery.age >= 18

one‑time override duration: 30 days (retail) / 90 days (home delivery)

Non‑standard dosing for 75 mg: Patient is ≥ 18 years of age and is taking a dose that does not correspond to a commercially available dosage form (e.g., requires multiple same‑strength tablets or two or more strengths); approve the quantity requested not to exceed 600 mg per day (plus 700 mg for the first day of therapy) for a 30‑day supply per dispensing at retail or a 90‑day supply per dispensing at home delivery.<=600 mg/day (standard); <=700 mg day 1

approvals per dispensing: 30‑day retail / 90‑day home delivery

Nucynta 100 mg tablets

Covered when the following criteria are met:

100 mg tablet overrides: No overrides recommended for 100 mg tablets.none

Requests for quantities beyond standard limits are not supported by this policy.

Any exception that does not meet the specified Drug Quantity Management criteria for Nucynta (tapentadol immediate‑release) is considered not medically necessary. This includes requests outside the per‑prescription quantity limits defined for each strength and any requests that fail to meet the documented override criteria for titration, non‑standard dosing, age, or other stated conditions.

Requests that exceed the stated per‑prescription quantity limits (retail > 181 tablets per Rx; home delivery > 541 tablets per Rx) will be reviewed against the specific override criteria. If the request does not meet those documented override conditions — for example, the patient does not meet the age or titration requirements or the requested dosing exceeds the allowed mg/day thresholds — the request is considered not medically necessary and may be denied.

Dosing and Coding Considerations

Maximum daily dose

Maximum daily dose (adults)> 600 mg per day is not studied and is not recommended

First-day maximum dose> 700 mg on the first day has not been studied and is not recommended

Policy numeric threshold> 600 mg/day (standard); >700 mg day 1 (not studied/recommended)

Pediatric age/weight threshold

Age thresholdPatients must be ≥ 6 years of age

Weight thresholdPatients must weigh ≥ 40 kg

Pediatric dosing notePediatric dosing applies only to those ≥6 years and ≥40 kg; duration should not exceed 3 days unless supported

Per-prescription Quantity Limits

Nucynta 50 mg — Quantity limits

Retail maximum per Rx181 tablets per Rx

Home delivery maximum per Rx541 tablets per Rx

ProductNucynta (tapentadol) 50 mg tablets

Nucynta 75 mg — Quantity limits

Retail maximum per Rx181 tablets per Rx

Home delivery maximum per Rx541 tablets per Rx

ProductNucynta (tapentadol) 75 mg tablets

Nucynta 100 mg — Quantity limits

Retail maximum per Rx181 tablets per Rx

Home delivery maximum per Rx541 tablets per Rx

ProductNucynta (tapentadol) 100 mg tablets

Provider Requirements and Override Rules

Documentation Required

Plan and documentation considerations

Coverage determinations require review of the applicable benefit plan terms and supporting documentation. In the event of a conflict, the member's benefit plan document governs. Each request should be reviewed on its own merits and medical directors may exercise clinical judgment.

Prior Authorization

Quantity override rules

Quantity overrides are permitted for 50 mg and 75 mg Nucynta immediate‑release tablets per the criteria below. Approvals follow the documented rules: one‑time overrides (30 days) for titration and full approvals (up to 1 year) when criteria for nonstandard dosing are met. No overrides are recommended for 100 mg tablets.

50 mg and 75 mg: one‑time override for titration — quantity sufficient for a 30‑day retail supply or 90‑day home delivery supply.
50 mg and 75 mg: approve requested quantity for nonstandard dosing (multiple same‑strength tablets or multiple strengths) not to exceed 600 mg/day (plus up to 700 mg/day on day 1) for a 30‑day retail or 90‑day home delivery dispensing.
100 mg: no overrides recommended.

Denial Risk

Quantity limit enforcement

Requests exceeding the program limits (retail > 181 tablets per prescription or home delivery > 541 tablets per prescription) will be reviewed and may be denied if appropriate justification and required documentation are not provided.

Retail maximum per Rx: 181 tablets (all strengths).
Home delivery maximum per Rx: 541 tablets (all strengths).
Excess requests require clinical justification and supporting documentation; may be denied without it.

Note

Provider action: use the applicable criteria when requesting an override or exception. For titration, indicate the dose being titrated and duration. For nonstandard dosing, document why commercially available strengths/dosage forms do not meet the patient's needs and provide the calculated daily dose and proposed days' supply. Include the member's age and relevant clinical rationale.

Include patient age (must be ≥ 18 years for criteria above).
For titration overrides, specify the intended titration schedule and request a one‑time 30‑day (retail) or 90‑day (home delivery) supply.
For nonstandard dosing, document the exact dosing regimen, total mg/day (must not exceed 600 mg/day except up to 700 mg on day 1), and requested days' supply.
Attach supporting clinical notes and any prior authorization forms as applicable.

Indications and Dosing Definitions

Indication

IndicationManagement of acute pain in patients ≥ 6 years of age weighing ≥ 40 kg when alternatives are inadequate

Clinical contextFor patients with pain severe enough to require an opioid analgesic

Coverage implicationApplies to patients meeting age/weight criteria per product labeling

Maximum daily dosing

First-day dosingDaily doses >700 mg on the first day have not been studied and are not recommended

Subsequent-day dosingDaily doses >600 mg on subsequent days have not been studied and are not recommended

Pediatric dosing capPediatric maximum is 7.5 mg/kg/day; daily doses >600 mg not studied in pediatrics

Background

Nucynta (tapentadol immediate‑release) is indicated for the management of acute pain in patients aged ≥ 6 years who weigh ≥ 40 kg when pain is severe enough to require an opioid and alternatives are inadequate. Adult dosing is typically 50–100 mg every 4–6 hours. Clinical guidance notes that daily doses > 700 mg on the first day and > 600 mg on subsequent days have not been studied and are not recommended for adults; pediatric dosing limits vary by weight and should not exceed 7.5 mg/kg/day where applicable.

Policy Summary

PayerCigna

PolicyOpioids - Nucynta Drug Quantity Management Policy - Per Rx

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApr 23, 2025

Next Review DateApr 24, 2023

Key ActionSubmit documentation to support requested quantity overrides; one-time overrides allowed for titration (30 days retail / 90 days home delivery).

SourceLink

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