ModifiedColorado Rocky Mountain Health PlansPolicy 2025 P 2045-18

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

Defines prior authorization/notification criteria and coverage rules for Nicotrol Inhaler (nicotine inhalation system) and Nicotrol NS (nicotine nasal spray) under UnitedHealthcare Pharmacy Clinical Pharmacy Programs to meet Health Care Reform tobacco cessation coverage requirements (zero dollar cost share).

Policy Summary

PayerColorado Rocky Mountain Health Plans

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

Policy CodePolicy 2025 P 2045-18

Change TypeMODIFIED

Effective DateNov 1, 2025

Next Review Date

Key ActionPrior authorization/notification required for Nicotrol Inhaler and Nicotrol NS per program; document prior failure/contraindication to at least one OTC NRT and to bupropion and follow cycle limits (max 2 three-month cycles per 12 months).

SourceLink

POLICY UPDATE CHANGES

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

Added treatment cycle limit: treatment duration not to exceed 2 (3 month) cycles per 12 month period (added 3/2021).

Removed varenicline from prior authorization requirements (9/2025).

Added states for bypass of prior authorization (California, Colorado, Illinois, New York, West Virginia; earlier additions included Colorado and New York).

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2Maximum 3-month cycles per 12 months

3 monthsAuthorization duration per approval

18Minimum age (general)

15Minimum age (Oregon plans)

Coverage Summary

This policy defines prior authorization and coverage rules for Nicotrol Inhaler (nicotine inhalation system) and Nicotrol NS (nicotine nasal spray) to meet Health Care Reform tobacco cessation requirements. The program provides tobacco cessation therapies at zero dollar cost share when criteria are met. Authorizations are issued for 3 months and coverage is limited to a maximum of 2 (3-month) cycles per 12-month period. Pharmacist review is required for treatment beyond these cycles.

Key thresholds and stats

Maximum treatment cycles<= 2 (3 month) cycles per 12 month period

Authorization duration3 months per authorization

Minimum age (general)>= 18 years

Minimum age (Oregon plans)>= 15 years

Medical Necessity Criteria

Initial Approval Criteria

Nicotrol NS or Nicotrol Inhaler will be approved when ALL of the following are met:

ALL of the following

Minimum age: Patient is 18 years of age or older
Age is 15 years or older for plans sitused in the state of Oregon
Indication: Treatment is being requested for tobacco cessation
History of failure, contraindication, or intolerance to ONE of the following OTC nicotine replacement therapies:
- Nicotine replacement patches OTC (e.g. Nicoderm CQ-OTC)
- Nicotine gum OTC (eg Nicorette gum- OTC)

Actions for Providers

Prior Authorization

Prior authorization required (except specific states)

Prior authorization or notification is required for Nicotrol Inhaler and Nicotrol NS under this program. Review is not required (the PA/notification may be bypassed) for plans sitused in California, Colorado, Illinois, New York, or West Virginia; historical notes indicate these states were added over time.

Documentation Required

Document prior therapy or contraindication

Document the patient’s history showing failure, contraindication, or intolerance to at least one OTC nicotine replacement therapy (patch, gum, or lozenge) and to bupropion to meet the approval criteria.

Coding

No procedure/drug codes provided in policy textmixed

No codes listed

Background & Evidence

Tobacco cessation therapies are more likely to succeed when patients are motivated to quit and receive additional advice and support. Patients should be provided with appropriate educational materials, counseling, and set a quit date to support the quit attempt. This program is designed to meet Health Care Reform requirements by providing coverage for tobacco cessation therapies with a zero dollar cost share when criteria are satisfied. Counseling and supportive services are recommended alongside pharmacologic therapy to improve success rates.

Source	Reference
Package inserts	Nicotrol NS (June 2024); Nicotrol Inhaler (July 2024)
Guideline	US DHHS Clinical practice guideline for treating tobacco use and dependence: 2008 Update

Cycle: One cycle is defined as more than 1 month of medication; if only one month is filled, 2 additional cycles may be authorized in the 12 month period.

Revision History

10/2014p&t_approval

P&T approval and historical updates begin (program established).

11/2018policy_update

Added West Virginia and California to bypass of prior authorization requirements.

12/2019policy_update

Added Colorado and New York to bypass of prior authorization requirements.

Policy Summary

PayerColorado Rocky Mountain Health Plans

Policy CodePolicy 2025 P 2045-18

Change TypeMODIFIED

Effective DateNov 1, 2025

Next Review Date

SourceLink

On This Page

Nicotine lozenge or mini-lozenge OTC (e.g. Nicorette lozenge-OTC)

History of failure, contraindication, or intolerance to bupropion

Treatment duration / cycle limit: Treatment duration has not exceeded a total of 2 (3 month) cycles of Tobacco Cessation Therapy per 12 month period<= 2 (3 month) cycles per 12 month period

Authorization will be issued for zero copay with deductible bypass for 3 months per 12 month period. Pharmacist review is required for more than 2 cycles per 12 month period. One cycle is defined as more than 1 month of medication. If only one month of medication is filled, 2 additional cycles of medication may be authorized in the 12 month period.

Limits on treatment cycles

Treatment duration is limited to a maximum of 2 cycles (each cycle = a 3‑month authorization) per 12‑month period. Pharmacist review is required for more than 2 cycles per 12 months, and claims may be denied if the limits are exceeded.

Billing Rule

Zero cost-share authorization

When criteria are met, an authorization will be issued for zero copay with deductible bypass for a 3‑month period per authorization (maximum coverage is 2 such 3‑month cycles per 12 months).

Documentation Required

Automated approval allowance

UnitedHealthcare may approve initial requests and reauthorizations based solely on prior claim or medication history, diagnosis (ICD‑10) codes, and/or claim logic; the use of automated approval processes varies by program.

3/2021material_change

Added treatment cycle limit: treatment duration not to exceed 2 (3 month) cycles per 12 month period; pharmacist review required for more than 2 cycles per 12 month period.

3/2025policy_update

Removed reference to Zyban due to product becoming obsolete; updated references.

9/2025revisedLatest

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

11/1/2025effective_dateLatest

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