CurrentCentenePolicy CP.PMN.95

Fluticasone Propionate (Xhance) (PDF)

Defines medical necessity criteria, prior authorization requirements, dosing limits, approval durations, continuation criteria, exclusions, and therapeutic alternatives for Xhance (fluticasone propionate Exhalation Delivery System) for members (HIM, Medicaid).

Policy Summary

PayerCentene

PolicyFluticasone Propionate (Xhance) (PDF)

Policy CodePolicy CP.PMN.95

Change TypeMultiple updates (indication added, step therapy edits, approval duration revised)

Effective DateMar 1, 2018

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added indication for chronic rhinosinusitis without nasal polyps (CRSsNP).

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

Added step therapy bypass for Illinois HIM per IL HB 5395.

Revised initial approval duration from 6 to 12 months.

Clarified diagnosis terminology from 'nasal polyps' to 'CRSwNP' per FDA language updates.

2Required intranasal steroid trials for CRSsNP

1Required intranasal steroid trial for CRSwNP

744 mcg/dayMaximum daily dose

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2Devices per 30 days maximum

12 monthsApproval duration (initial and continued)

Coverage Summary

Coverage stance: covered_with_criteria. Scope summary: Defines medical necessity criteria, prior authorization requirements, dosing limits, approval durations, continuation criteria, exclusions, and therapeutic alternatives for Xhance (fluticasone propionate Exhalation Delivery System) for members (HIM, Medicaid). FDA-approved indications (per PI March 2024): CRSwNP and CRSsNP in adults. Minimum age: ≥ 18 years.

Initial Therapy Criteria — CRSwNP

Initial Approval Criteria

Xhance is medically necessary when ALL criteria in the relevant subsection are met.

ALL of the following

Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP)
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
For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 per IL HB 5395
Dose limits (both must be met)
- Dose does not exceed 744 mcg per day744 mcg/day
- No more than 2 devices per 30 days2 devices/30 days

Step Therapy

Step therapy requirement

For initial approval, CRSwNP requires trial/failure of one formulary intranasal steroid; CRSsNP requires trial/failure of two formulary intranasal steroids plus failure of one intranasal saline agent. Exceptions: clinically significant adverse effects or contraindications to required agents waive the step requirement. For Illinois HIM requests, step therapy requirements do not apply as of 2026-01-01 per IL HB 5395.

CRSwNP: failure of one formulary intranasal steroid required
CRSsNP: failure of two formulary intranasal steroids AND one intranasal saline agent required
Exceptions allowed for clinically significant adverse effects or contraindications
Illinois HIM step therapy bypass effective 2026-01-01 (IL HB 5395)

Prior Authorization

Documentation required for prior authorization

Provider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria when requesting prior authorization.

Office chart notes
Lab results
Other clinical information

Initial Therapy Criteria — CRSsNP

Initial Approval Criteria - CRSsNP

For chronic rhinosinusitis without nasal polyps (CRSsNP): must meet ALL below.

ALL of the following

Diagnosis of chronic rhinosinusitis without nasal polyps (CRSsNP)
Age ≥ 18 years
Failure of two formulary intranasal steroids (e.g., fluticasone propionate, mometasone, budesonide), unless clinically significant adverse effects are experienced or all are contraindicated
For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 per IL HB 5395
Failure of one intranasal saline agent, unless clinically significant adverse effects are experienced or all are contraindicated (see Appendix B)

Continuation Therapy Criteria

Continued Therapy

All indications in Section I: must meet ALL of the following.

ALL 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 CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively to therapy (e.g., improvement in nasal congestion or obstruction, reduction of bilateral polyp grade)
Dose increase limits (if request is for dose increase)
- New dose does not exceed 744 mcg per day

Unproven / Not Authorized Indications

Other indications / Diagnoses/Indications Not Authorized

If requested use does not match sections I or III, follow one of the policies below.

ANY of the following

If drug had a label change within the last 6 months not reflected in this policy, refer to no coverage criteria policy (HIM.PA.33 or CP.PMN.255) or non-formulary policy (HIM.PA.103 or CP.PMN.16) as applicable
If requested use is not listed under section III and criterion 1 above does not apply, refer to off-label use policy (HIM.PA.154 or CP.PMN.53) as applicable

Non-FDA approved indications that are not addressed in this policy are not authorized unless sufficient documentation per off-label use policies (HIM.PA.154 or CP.PMN.53) or evidence of coverage documents is provided

Provider Actions & Prior Authorization

Prior Authorization

Documentation required for prior authorization

Provider must submit documentation to support that the member meets all approval criteria when requesting prior authorization. Acceptable documentation examples include office chart notes, laboratory results, and other clinical information.

Office chart notes
Lab results
Other clinical information

Prior Authorization

Illinois HIM step therapy bypass

Effective 2026-01-01, Illinois HIM requests are exempt from the policy's step therapy requirements per IL HB 5395. Do not apply the intranasal steroid/saline step requirements for Illinois HIM prior authorization requests submitted on or after that date.

Illinois HIM step therapy bypass effective 1/1/2026 (IL HB 5395)

Applicable Codes

NDC / Drug productNDC

No codes listed

HCPCS / Drug (product) or DeviceHCPCS

No codes listed

ICD-10 Diagnosis Codes (examples)ICD-10

J33.0	Polyp of nasal cavity
J32.9	Chronic sinusitis, unspecified

Administration/Dosingmixed

93 mcg/spray	Strength per spray (Xhance)
1-2 sprays/nostril BID	Typical dosing regimen
744 mcg/day	Maximum daily dose
2 devices/30 days	Maximum devices per 30 days

Clinical Evidence & Basis for Policy

FDA approved indications (per PI March 2024): Xhance is indicated for treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) and chronic rhinosinusitis without nasal polyps (CRSsNP) in adults. Key trials and evidence cited in the policy include the NAVIGATE I and NAVIGATE II randomized trials of the fluticasone exhalation delivery system (EDS-FLU/FLU-EDS) for CRSwNP, as well as other randomized controlled trials and published guidelines referenced to support the policy rationale and stepwise treatment algorithm.

Background

Xhance is an exhalation delivery system (EDS) that administers fluticasone propionate using a unique nasal delivery device. Each metered spray delivers 93 mcg of fluticasone propionate. Recommended dosing regimen for CRSwNP and CRSsNP is 1 to 2 sprays (93 mcg/spray) per nostril twice daily (BID), with a maximum total daily dose of 744 mcg/day.

Maximum daily dose744 mcg per day

Devices per 30 days2 devices per 30 days

Minimum age>= 18 years

Approval duration12 months

Definitions

CRSwNP: chronic rhinosinusitis with nasal polyps (abbreviated CRSwNP). CRSsNP: chronic rhinosinusitis without nasal polyps (abbreviated CRSsNP).

Revision History

2018-03-01Added

Policy effective date (initial policy CP.PMN.95 published).

2021-06-16Revised

Modified requirement from 3 intranasal steroids including fluticasone to any 2 intranasal steroids; removed medical justification requirement based on 2021 consensus panel treatment algorithm.

2023-02-21Revised

Per SDC, modified requirement from two formulary intranasal steroids to require only one for CRSwNP.

Policy Summary

PayerCentene

PolicyFluticasone Propionate (Xhance) (PDF)

Policy CodePolicy CP.PMN.95

Change TypeMultiple updates (indication added, step therapy edits, approval duration revised)

Effective DateMar 1, 2018

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria.

SourceLink

On This Page

For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 per IL HB 5395

Dose limits (both must be met)

Dose does not exceed 744 mcg per day744 mcg/day
No more than 2 devices per 30 days2 devices/30 days

Step Therapy

Step therapy requirement — CRSsNP

For CRSsNP specifically, prior authorization requires documented failure of two formulary intranasal steroids and failure of one intranasal saline agent, unless clinically significant adverse effects or contraindications exist. Note: Illinois HIM requests are exempt from step therapy as of 2026-01-01 per IL HB 5395.

Failure of two formulary intranasal steroids required
Failure of one intranasal saline agent required
Exceptions for adverse effects or contraindications
Illinois HIM step therapy bypass effective 2026-01-01

New dosing does not exceed 2 devices per 30 days2 devices/30 days

Documentation Required

Continuation documentation

For continued therapy, document that the member is responding positively to treatment. Examples of acceptable documentation include improvement in nasal congestion or obstruction and reduction in bilateral polyp grade.

Improvement in nasal congestion or obstruction
Reduction in bilateral polyp grade

Billing Rule

Approval duration and reauthorization

Initial and continued approvals are authorized for 12 months. Reauthorization requests should reflect ongoing response; dose increase requests must still meet the policy's maximum dose and device limits.

Initial approval: 12 months
Continued approval: 12 months
Dose increase requests must meet maximum dose (744 mcg/day) and device limits (2 devices/30 days)

Billing Rule

Approval duration and reauthorization

Initial and continued authorizations are for 12 months. Note that requests for dose increases remain subject to the policy's maximum daily dose and device limits.

Initial authorization length: 12 months
Continued authorization length: 12 months
Dose/device limits still apply for dose increase requests (744 mcg/day; 2 devices/30 days)

Documentation Required

Continuation documentation

For continuation, providers must document that the member is responding positively to therapy. Examples include improvement in nasal congestion/obstruction or reduction in bilateral polyp grade.

Improvement in nasal congestion or obstruction
Reduction in bilateral polyp grade

2023-02-10Clarified

Administrative clarification: diagnosis terminology changed from 'nasal polyps' to 'CRSwNP' per updated FDA language.

2024-03-27Added

Added new FDA indication and policy coverage for chronic rhinosinusitis without nasal polyps (CRSsNP).

2024-06-06Added

Per June SDC and 3Q 2024 annual review: added criteria for CRSsNP requiring trial of two intranasal corticosteroids and one intranasal saline agent; updated Appendix B with therapeutic alternatives for CRSsNP and intranasal saline agents. (Marked material change)

2025-04-21AddedLatest

3Q 2025 annual review: added step therapy bypass for Illinois HIM requests per IL HB 5395 effective 2026-01-01. (Marked material change)

2025-10-21RevisedLatest

Revised initial approval duration from 6 to 12 months; change logged and P&T approval recorded 11.25. (Marked material change)

2024-03 (PI March 2024)Added

FDA approved indications updated to include CRSwNP and CRSsNP in adults per prescribing information.