CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

varenicline

Policy governing coverage of the smoking cessation drug varenicline, including step-therapy requirements (trial/failure of nicotine replacement or bupropion products), coverage duration, coding logic for prior medication claims, and exclusion for investigational uses.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policyvarenicline

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain and submit evidence of at least one paid claim for a ≥10-day supply of bupropion (IR/SR/XL) or nicotine replacement (patch/gum/lozenge) within the prior 365 days to qualify for varenicline coverage.

POLICY UPDATE CHANGES

No material clinical/coverage changes.

1Required prior agent class(es)

12 monthsCoverage Duration

>=10 daysMinimum prior supply claim

Coverage Summary

Initial Coverage Criteria

Covered when ALL of the following are met:

Initial Therapy Criteria

Initial Coverage Criteria

Covered when ALL of the following are met:

Initial Coverage Criteria (Operational)

Prior trial or intolerance: The member has trialed and experienced an inadequate treatment response or intolerance to bupropion immediate-release, bupropion sustained-release, bupropion extended-release, nicotine patch, nicotine gum, OR nicotine lozenge

Operational documentation: Obtain and submit evidence of at least one paid claim for a ≥10-day supply of bupropion (IR/SR/XL) or nicotine replacement (patch/gum/lozenge) within the prior 365 days to qualify for varenicline coverage.>= 10 days supply within prior 365 days

Operational Coding Logic for Step Therapy

Coding Logic for Step Therapy (Operational Acceptance)

Operational Acceptance (Coding Logic): Varenicline will be approved if there is at least one paid claim for at least a 10-day supply within the last 365 days for one of the following: bupropion immediate-release, bupropion sustained-release, bupropion extended-release, nicotine patch, nicotine gum, OR nicotine lozenge>= 10 days supply within prior 365 days

Operational interpretation: at least one claim of ≥10 days' supply in prior 365 days

Step Therapy

Step therapy / prior medication evidence required

Obtain and submit evidence of at least one paid claim for a ≥10-day supply of a qualifying prior agent (bupropion immediate‑release, bupropion sustained‑release, bupropion extended‑release, nicotine patch, nicotine gum, or nicotine lozenge) within the prior 365 days to meet step‑therapy requirements for varenicline coverage.

Documentation Required

Document inadequate response or intolerance

Document in the medical record that the member experienced an inadequate treatment response or intolerance to one of the listed prior agents (bupropion IR, SR, or XL, nicotine patch, nicotine gum, or nicotine lozenge).

Unproven Uses / Exclusions

Exclusions

Exclusions: Use of varenicline for investigational purposes is not covered

Investigational = doses or indications not recognized as medically accepted per AHFS-DI, Micromedex DrugDex, Clinical Pharmacology, Lexi-Drugs, or peer-reviewed literature

Investigational = Use at a dose or for a condition other than medically accepted indications as defined by AHFS-DI, Micromedex DrugDex, Clinical Pharmacology, Lexi-Drugs, or peer-reviewed literature.

Applicable Codes

Relevant prior medication products for step therapy verificationmixed

	bupropion immediate-release (product)
	bupropion sustained-release (product)
	bupropion extended-release (product)
	nicotine patch (product)
	nicotine gum (product)
	nicotine lozenge (product)

Background

Varenicline is a prescription medication for smoking cessation. The policy requires trial and inadequate response or intolerance to one of the specified prior agents (bupropion immediate-release, bupropion sustained-release, bupropion extended-release, nicotine patch, nicotine gum, or nicotine lozenge) before coverage. Coverage duration is 12 months, and operational coding accepts at least one paid claim for a ≥10-day supply of one of the listed prior agents within the prior 365 days. Use of varenicline for investigational purposes is not covered.

Key Thresholds and Parameters

Prior medication and coverage thresholds

Required prior agent class(es)Bupropion (IR, SR, ER) or nicotine replacement (patch, gum, lozenge)

Coverage Duration12 months

Minimum prior supply claim>= 10 days supply within prior 365 days