CurrentCentenePolicy CP PMN.95

Fluticasone Propionate (Xhance)

Defines medical necessity criteria, prior authorization and continuation requirements for Xhance (fluticasone propionate exhalation delivery system) for treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) and without nasal polyps (CRSsNP) for Centene-affiliated health plans (HIM, Medicaid). Includes dosing limits, step therapy requirements, approval durations, and excluded indications.

Policy Summary

PayerCentene

PolicyFluticasone Propionate (Xhance)

Policy CodePolicy CP PMN.95

Change TypeAdded CRSsNP; revised CRSwNP trial requirement; IL HIM step therapy bypass

Effective DateMar 1, 2018

Next Review Date

Key ActionProvider must submit documentation (office chart notes, labs or other clinical information) supporting that member meets all approval criteria for initial or continued therapy.

POLICY UPDATE CHANGES

Added new indication for CRSsNP.

Modified requirement for CRSwNP from two formulary intranasal steroids to one formulary intranasal steroid.

Added step therapy bypass for Illinois HIM per IL HB 5395 effective 2026-01-01.

Clarified diagnosis terminology from 'nasal polyps' to 'CRSwNP'.

2Covered Indications

744 mcg/dayMaximum Dose

2 devices/30 daysQuantity Limit

6 months

Initial Approval Duration

12 monthsContinued Approval Duration

Coverage Summary

Policy number CP PMN.95 covers fluticasone propionate (Xhance) for chronic rhinosinusitis. The policy applies to Xhance (an exhalation delivery system for fluticasone propionate) for treatment of CRSwNP and CRSsNP in adults and is classified as covered_with_criteria when the specified prior authorization and documentation requirements are met.

Key approval thresholds include a maximum daily dose of 744 mcg per day, a device quantity limit of 2 devices per 30 days, and a minimum age of ≥ 18 years for CRSwNP. Providers must submit supporting documentation (e.g., office chart notes, labs) demonstrating that members meet the specific criteria for the indicated diagnosis. Initial approvals are limited to the criteria specified for CRSwNP or CRSsNP and continued therapy must show clinical response while adhering to the same dosing and quantity limits.

Approval Durations and Numeric Thresholds

Initial Approval Duration6 months

Continued Approval Duration12 months

Maximum daily dose744 mcg per day

Device quantity limit2 devices per 30 days

Minimum age for CRSwNP≥ 18 years

Medical Necessity Criteria

Initial Approval Criteria

Xhance is medically necessary when ALL of the following for the relevant diagnosis are met and documentation is provided:

Diagnosis (ONE of)

Diagnosis of CRSwNP (chronic rhinosinusitis with nasal polyps)
Diagnosis of CRSsNP (chronic rhinosinusitis without nasal polyps)

CRSwNP specific (must meet all)

Age ≥ 18 years
Failure of one formulary intranasal steroid (e.g., fluticasone propionate, mometasone, budesonide), unless clinically significant adverse effects are experienced or all are contraindicated

Other Diagnoses, Off-Formulary Uses and Exclusions

Other Diagnoses / Off-Formulary / Non-Formulary Uses

If the requested use is not covered above, follow formulary/off-label/non-formulary policies:

Other diagnoses/indications (must meet 1 or 2)

If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to the specified policies for formulary or non-formulary agents as listed
For formulary drugs: For drugs on formulary: follow no coverage criteria policies HIM.PA.33 (commercial/marketplace) or CP.PMN.255 (Medicaid) as applicable
For non-formulary drugs: For drugs NOT on formulary: follow non-formulary policies HIMPA.103 (commercial/marketplace) or CP.PMN.16 (Medicaid) as applicable

Coding

No specific procedure or diagnosis codes listedmixed

No codes listed

Provider Actions

Prior Authorization

Prior authorization required with documentation

Provider must submit documentation (office chart notes, labs or other clinical information) supporting that the member meets all approval criteria for initial or continued therapy. Documentation such as office chart notes and laboratory results must be included with the prior authorization request.

Documentation Required

Document trial of intranasal therapies

For CRSwNP: document failure of one formulary intranasal steroid (e.g., fluticasone propionate, mometasone, budesonide) unless clinically significant adverse effects or contraindications exist. For CRSsNP: document failure of two formulary intranasal steroids and failure of one intranasal saline agent unless clinically significant adverse effects or contraindications exist.

Background and Evidence

Xhance is an exhalation delivery system that administers fluticasone propionate via a unique nasal delivery device for treatment of chronic rhinosinusitis. The policy references the Xhance Prescribing Information (OptiNose, March 2024) and cites randomized trials (NAVIGATE I & II) and other peer-reviewed studies supporting efficacy in CRSwNP and related CRS literature.

Indications listed in the FDA labeling include treatment of both chronic rhinosinusitis with nasal polyps (CRSwNP) and chronic rhinosinusitis without nasal polyps (CRSsNP) in adults. The policy notes clinical trial evidence (NAVIGATE I & II) and references multidisciplinary consensus guidance and practice parameter publications, aligning the prior authorization requirements with consensus treatment algorithms recommending Xhance after trials of traditional intranasal therapies due to its delivery method and improved deposition.

The policy background documents alignment with guideline-based, stepwise care: requiring trials of intranasal steroids (and intranasal saline for CRSsNP) before Xhance per the algorithm, and it incorporates FDA labeling dosing and device information (744 mcg/day; 93 mcg per spray; 120 sprays per device) into the coverage criteria.

Evidence / Text

Key sources

Revision History

3Q 2024 (06.06.24 / P&T Approval Date 08.24)added

Added CRSsNP indication and required trials: trial of two intranasal corticosteroids and one intranasal saline agent; updated Appendix B with therapeutic alternatives for CRSsNP.

2023 (02.21.23 / P&T Approval Date 05.23)revised

Per SDC/P&T decisions changed requirement for CRSwNP from failure of two formulary intranasal steroids to failure of one formulary intranasal steroid.

RT4 clarification 02.10.23clarified

Clarified diagnosis terminology from 'nasal polyps' to 'CRSwNP'.

Policy Summary

PayerCentene

PolicyFluticasone Propionate (Xhance)

Policy CodePolicy CP PMN.95

Change TypeAdded CRSsNP; revised CRSwNP trial requirement; IL HIM step therapy bypass

Effective DateMar 1, 2018

Next Review Date

Key ActionProvider must submit documentation (office chart notes, labs or other clinical information) supporting that member meets all approval criteria for initial or continued therapy.

On This Page

Per policy, modified to require only one formulary intranasal steroid for CRSwNP

Dose does not exceed 744 mcg per day744 mcg per day

Quantity does not exceed 2 devices per 30 days2 devices per 30 days

CRSsNP specific (must meet all)

Diagnosis of CRSsNP
Failure of two formulary intranasal steroids (e.g., fluticasone propionate, mometasone, budesonide), unless clinically significant adverse effects are experienced or all are contraindicated
Failure of one intranasal saline agent unless clinically significant adverse effects are experienced or all are contraindicated (see Appendix B)
Dose does not exceed 744 mcg per day744 mcg per day
Quantity does not exceed 2 devices per 30 days2 devices per 30 days

Administrative/Documentation: Provider must submit documentation (e.g., office chart notes, lab results or other clinical information) supporting that member has met all approval criteria

Step therapy exceptions: For Illinois HIM requests, the step therapy requirements do not apply as of 2026-01-01 per IL HB 5395

Applies to Illinois HIM line of business

Continued Therapy (Renewal) Criteria

Member must meet ONE of the following and all applicable conditions:

ANY of the following

Member is currently receiving medication via Centene benefit or member has previously met initial approval criteria
Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums)

Response and dosing limits (must meet all)

Member is responding positively to therapy (e.g., improvement in nasal congestion or obstruction, reduction of bilateral polyp grade)
If request is for a dose increase, new dose does not exceed 744 mcg per day744 mcg per day
If request is for a dose increase, quantity does not exceed 2 devices per 30 days2 devices per 30 days

Off-label uses: If requested use not listed and criterion 1 above does not apply, refer to off-label use policies HIM.PA.154 (commercial/marketplace) or CP.PMN.53 (Medicaid) as applicable

Not Authorized / Exclusions

Coverage is not authorized for:

Non-FDA approved indications that are not addressed in this policy unless there is sufficient documentation of efficacy and safety per off-label use policies

Billing Rule

Dosing and quantity limits enforced

Claims will be limited to doses ≤ 744 mcg per day and to no more than 2 devices per 30 days. Requests for dose increases must not exceed these maximums.

Prior Authorization

Step therapy bypass for IL HIM

For Illinois HIM requests, the step therapy requirements do not apply effective 2026-01-01 per Illinois HB 5395; providers should note this exception when submitting requests for Illinois HIM members.

3Q 2025 (04.21.25 / P&T Approval Date 08.25)addedLatest

Added step therapy bypass for Illinois HIM per IL HB 5395 effective 2026-01-01 (step therapy requirements do not apply for Illinois HIM requests as of 1/1/2026).