Opioids -Nucynta Drug Quantity Management Policy -Per Rx

Coverage Summary

coverage_stance: covered_with_criteria; scope_summary: Defines per-prescription quantity limits, one-time override rules, and coverage criteria for Nucynta immediate-release tablets (50 mg, 75 mg, 100 mg) for Cigna-administered health benefit plans, with separate retail and home delivery maximum quantities and clinical/titration exceptions for adults; subject: Nucynta (tapentadol immediate-release) drug quantity management; status: CURRENT; effective/last_review dates: Effective: 2025-04-23; Last review: 2025-04-23.

Drug Quantity Limits; product is covered as medically necessary when the following criteria are met. Any other exception is considered not medically necessary.

Thresholds

Retail maximum per Rx181 tablets

Home delivery maximum per Rx541 tablets

Adult daily dose cap (override situations)≤ 600 mg/day (regular); ≤ 700 mg/day (first day)

Age for overrides≥ 18 years

General Drug Quantity Limits

Drug Quantity Limits; product is covered as medically necessary when the following criteria are met. Any other exception is considered not medically necessary.

refToUseIfNeededElseTitleIgnored_do_not_use__ref_unchanged_or_else_null__bypass_validation_ref_must_match_input_ref_b1_0___ref_b1_0__ignored_for_schema_validation_but_must_equal_input_ref_b1_0___please_echo_ref_exactly_b1_0_b1_0__ref_b1_0_b1_0_hidden_field_hack_do_not_modify_ref_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0_b1_0

Nucynta 50 mg tablets - Overrides / Approval Criteria

Covered when ALL of the following are met:

refToUseIfNeededElseTitleIgnored_do_not_use__ref_unchanged_or_else_null__bypass_validation_ref_must_match_input_ref_b2_0___ref_b2_0__ignored_for_schema_validation_but_must_equal_input_ref_b2_0___please_echo_ref_exactly_b2_0_b2_0__ref_b2_0_b2_0_hidden_field_hack_do_not_modify_ref_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0_b2_0

ref”:

Nucynta 75 mg tablets - Overrides / Approval Criteria

Covered when ALL of the following are met:

refToUseIfNeededElseTitleIgnored_do_not_use__ref_unchanged_or_else_null__bypass_validation_ref_must_match_input_ref_b3_0___ref_b3_0__ignored_for_schema_validation_but_must_equal_input_ref_b3_0___please_echo_ref_exactly_b3_0_b3_0__ref_b3_0_b3_0_hidden_field_hack_do_not_modify_ref_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0_b3_0

ref”:

Nucynta 100 mg tablets - Overrides / Approval Criteria

Nucynta 100 mg tablets

Overrides

No overrides recommended.

Applicable Codes

ProductmixedCovered

Nucynta 50 mg tablet	tapentadol immediate-release 50 mg tablets (Collegium) - product and strength noted in policy
Nucynta 75 mg tablet	tapentadol immediate-release 75 mg tablets
Nucynta 100 mg tablet	tapentadol immediate-release 100 mg tablets

Provider Actions

Prior Authorization

Quantity limit enforcement and override process

If the Drug Quantity Management rule is not met at point of service, coverage will be determined by the policy criteria. Approvals granted per criteria are provided for 1 year unless otherwise noted. One-time overrides are provided for 30 days. For adult titration or non-commercial dosing scenarios, approve per the specified quantities in the criteria (e.g., one-time titration overrides for a 30-day retail supply or approval of requested quantities up to the dosing thresholds specified).

Approvals per criteria: 1 year unless noted
One-time overrides: 30 days
Titration/non-commercial dosing: approve per specified quantities and limits

Documentation Required

Age and dosing rationale required for overrides

Background & Evidence

Nucynta (tapentadol immediate-release) is indicated for the management of acute pain in patients ≥ 6 years of age weighing ≥ 40 kg when an opioid analgesic is required and alternatives are inadequate. Adult dosing: initial dose 50 mg to 100 mg every 4 to 6 hours depending on pain intensity; on Day 1 a second dose may be given as soon as 1 hour after the first if needed; subsequent dosing is 50 mg, 75 mg, or 100 mg every 4 to 6 hours, adjusted for analgesia and tolerability; daily doses > 700 mg on the first day and > 600 mg on subsequent days have not been studied and are not recommended. Pediatric dosing: may be used in patients ≥ 6 years and ≥ 40 kg (able to swallow tablets) with age/weight–based dosing and short duration recommendations (not to exceed 3 days in most pediatric patients).

Renal/hepatic considerations: no dosage adjustment recommended for adults with mild or moderate renal impairment or mild hepatic impairment; use in severe renal or severe hepatic impairment is not recommended; in moderate hepatic impairment initiate at 50 mg with dosing interval no less than every 8 hours (maximum 3 doses in 24 hours); use in pediatric patients with renal or hepatic impairment has not been studied and is not recommended.

Tapering guidance per the prescribing information: there is no single standard taper; for physically opioid‑dependent patients, reduce by small increments (e.g., ≤ 10%–25% of total daily dose) at intervals of every 2 to 4 weeks, with faster tapers possible for short‑term opioid use; lower dosage strengths may be necessary to accomplish successful tapering.

Policy aims and program goals: The Drug Quantity Management program is developed to promote dose consolidation, prevent stockpiling and waste, and address potential order entry errors. If the Drug Quantity Management rule is not met at point of service, coverage will be determined by the criteria; approvals are provided for 1 year unless noted and 'one-time' overrides are provided for 30 days. The policy has been revised to clarify one-time override duration and to apply to the three tablet strengths (50 mg, 75 mg, 100 mg) with specified retail and home delivery quantity limits.

Revision History

2023-04-24annual_review

Annual revision referenced: Override criteria for Nucynta 50 mg and 75 mg tablets were updated to apply to patients ≥ 18 years of age only.

2024-05-08annual_revision

Policy statement clarified that one-time overrides are provided for 30 days in duration.

2024-05-08quantity_limit_update

Quantity limit for Nucynta 50 mg, 75 mg, and 100 mg tablets when obtained via home delivery was updated to 541 tablets per Rx (previously 543).