CurrentUnitedHealthcarePolicy 2025 P 2045-18

Tobacco Cessation - Nicotrol Inhaler® (nicotine inhalation system), and Nicotrol NS® (nicotine nasal spray) - Prior Authorization/Notification - Healthcare Reform - UnitedHealthcare Commercial Plansop

Defines prior authorization/notification requirements and clinical criteria for coverage of Nicotrol Inhaler (nicotine inhalation system) and Nicotrol NS (nicotine nasal spray) under UnitedHealthcare commercial plans to meet Health Care Reform zero dollar cost-share requirements.

Policy Summary

PayerUnitedHealthcare

PolicyTobacco Cessation - Nicotrol Inhaler® (nicotine inhalation system), and Nicotrol NS® (nicotine nasal spray) - Prior Authorization/Notification - Healthcare Reform - UnitedHealthcare Commercial Plansop

Policy CodePolicy 2025 P 2045-18

Change TypeRevised (administrative and clinical updates)

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionRequest for Nicotrol NS or Nicotrol Inhaler must document patient age, indication for tobacco cessation, history of failure/contraindication/intolerance to an OTC nicotine replacement product and to bupropion, and confirm treatment duration does not exceed policy limits; authorization issued for zero copay with deductible bypass for 3 months.

SourceLink

POLICY UPDATE CHANGES

Effective Date 11/1/2025 and program number set to 2025 P 2045-18.

3/2025 removed reference to Zyban; updated references.

9/2025 removed varenicline from PA requirements; treatment cycle duration remains in place.

2Maximum 3-month cycles allowed per 12 months

0Copay required at point of sale

Coverage Summary

Overview: This policy defines prior authorization and clinical criteria for coverage of Nicotrol Inhaler (nicotine inhalation system) and Nicotrol NS (nicotine nasal spray) to meet Health Care Reform requirements. Coverage stance: covered_with_criteria. Effective date: 11/01/2025; last review: 09/2025. The program requires a $0 patient cost-share (zero-dollar copay with deductible bypass) when authorization criteria are met. High-level limits: authorization is issued for up to 3 months per cycle, with a maximum of 2 three-month cycles per 12-month period (pharmacist review required for more than 2 cycles).

Key policy facts

Policy number2025 P 2045-18

Effective date2025-11-01

Last review2025-09

Coverage stancecovered_with_criteria

Scope summaryDefines prior authorization and clinical criteria for coverage of Nicotrol Inhaler and Nicotrol NS under UnitedHealthcare commercial plans to meet Health Care Reform zero dollar cost-share requirements; includes counseling, educational materials, and quit date documentation.

Approval Criteria for Nicotrol NS or Nicotrol Inhaler

Thresholds

Treatment duration cyclesMaximum 2 cycles per 12 month period; one cycle = 3 months (authorization issued for 3 months). Pharmacist review required for more than 2 cycles per 12 month period; one cycle defined as more than 1 month of medication.

Provider Actions & Requirements

Prior Authorization

Prior authorization required with documentation of criteria

Request for Nicotrol NS or Nicotrol Inhaler must document patient age, indication for tobacco cessation, history of failure/contraindication/intolerance to an OTC nicotine replacement product and to bupropion, and confirm treatment duration does not exceed policy limits. Authorization will be issued for zero copay with deductible bypass for 3 months.

Zero copay authorization for 3 months (deductible bypass)

Documentation Required

Counseling and quit support

Provide appropriate educational materials and counseling to support the quit attempt and document a quit date as part of the quit attempt. This program meets Health Care Reform requirements for tobacco cessation coverage at zero dollar cost share.

Coding

No specific billing or drug codes listedmixed

No codes listed

Background & Evidence

Background: The program meets Health Care Reform requirements for tobacco cessation coverage at zero dollar cost share. Tobacco cessation therapies are more effective when patients are motivated and receive support; patients should be provided appropriate educational materials and counseling and should set a quit date. This policy applies to Nicotrol Inhaler and Nicotrol NS and specifies prior authorization and documentation requirements to ensure coverage under the HCR program.

Evidence/references: Nicotrol NS and Nicotrol Inhaler package inserts (June and July 2024) and the US Department of Health and Human Services Clinical Practice Guideline for Treating Tobacco Use and Dependence: 2008 Update are cited as supporting references.

Definitions

CycleOne cycle is defined as more than 1 month of medication; authorization is issued for 3 months per cycle.

Revision History

2025-11-01revisedLatest

Effective Date set to 11/1/2025 and program number set to 2025 P 2045-18.

2025-03revised

Removed reference to Zyban; updated references.

2025-09revised

Removed varenicline from prior authorization requirements; treatment cycle duration remains in place.