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Xhance Prior Authorization with Quantity Limit Program Summary
Policy Number: PH-1145
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
10-01-2024 |
07-01-2021 |
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Xhance® |
Treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults |
|
1 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Chronic rhinosinusitis |
Chronic rhinosinusitis is an inflammatory condition affecting the paranasal sinuses that is diagnosed by the presence of both subjective and objective evidence of chronic sinonasal inflammation. Hallmarks of the disease consist of at least two out of four cardinal symptoms (i.e., facial pain/pressure, hyposmia/anosmia, nasal drainage, and nasal obstruction) for at least 12 consecutive weeks. The objective evidence of sinonasal inflammation and nasal polyps is needed to confirm the diagnosis may be obtained by physical examination (anterior rhinoscopy, nasal endoscopy) or from sinus computed tomography (CT).(2-4) The exact cause of CRSwNP is unknown, but biopsies of nasal polyps have shown elevated levels of eosinophils.(2) |
Safety |
Xhance is contraindicated in patients with hypersensitivity to any of its ingredients.(1) |
REFERENCES
Number |
Reference |
1 |
Xhance prescribing information. OptiNose US, Inc. March 2024. |
2 |
Stevens WW, Schleimer RP, Kern RC. Chronic Rhinosinusitis with Nasal Polyps. The Journal of Allergy and Clinical Immunology: In Practice. 2016;4(4):565-572. doi:10.1016/j.jaip.2016.04.012 |
3 |
Sedaghat AR. Chronic rhinosinusitis. AAFP. Published October 15, 2017. https://www.aafp.org/pubs/afp/issues/2017/1015/p500.html |
4 |
Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, et al. Clinical Practice Guideline (UPDATE): Adult sinusitis. Otolaryngology and Head and Neck Surgery. 2015;152(S2). doi:10.1177/0194599815572097 |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
Xhance |
fluticasone propionate nasal exhaler susp |
93 MCG/ACT |
M ; N ; O ; Y |
N |
|
|
POLICY AGENT SUMMARY QUANTITY LIMIT
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
QL Amount |
Dose Form |
Day Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
|
|||||||||
Xhance |
Fluticasone Propionate Nasal Exhaler Susp 93 MCG/ACT |
93 MCG/ACT |
2 |
Bottles |
30 |
DAYS |
|
|
|
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Xhance |
fluticasone propionate nasal exhaler susp |
93 MCG/ACT |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
CLIENT SUMMARY – QUANTITY LIMITS
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Xhance |
Fluticasone Propionate Nasal Exhaler Susp 93 MCG/ACT |
93 MCG/ACT |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
PA |
Initial Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 12 months Note: If Quantity Limit applies, please refer to Quantity Limit Criteria. *Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required. Renewal Evaluation Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 12 months Note: If Quantity Limit applies, please refer to Quantity Limit Criteria. |
QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
QL with PA |
Quantity Limit for the Target Agent(s) will be approved when ONE of the following is met:
Length of Approval: up to 12 months |
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
ALBP _ Commercial _ CSReg _ Xhance__PAQL _ProgSum_ 10-01-2024 _
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