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ph-1145

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® (fluticasone propionate) Nasal spray	Treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults Treatment of chronic rhinosinusitis without nasal polyps (CRSsNP) 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)

First line therapy for chronic rhinosinusitis is nasal saline irrigation and intranasal corticosteroid sprays.(2-4) The American Academy of Family Physicians notes that no one intranasal corticosteroid is superior to another or that increased dosing provides greater effectiveness. The American Academy of Otolaryngology recommends a short course of oral corticosteroids if no response is seen with intranasal corticosteroids after 3-months of appropriate use.(4) Short courses of oral corticosteroids (up to three weeks) can improve sinonasal symptoms and endoscopic findings. Surgical intervention may be required in patients who fail medical management.(2,3)

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: ONE of the following: The patient has a diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) OR The patient has a diagnosis of chronic rhinosinusitis without nasal polyps (CRSsNP) OR The patient has another FDA labeled indication for the requested agent and route of administration AND If the patient has an FDA labeled indication, then ONE of the following: The patient’s age is within FDA labeling for the requested indication for the requested agent OR There is support for using the requested agent for the patient’s age for the requested indication AND ONE of the following: The patient has tried and had an inadequate response after 90 days of therapy with ONE generic OR OTC intranasal corticosteroid OR The patient has an intolerance or hypersensitivity to therapy with ONE generic or OTC intranasal corticosteroids that is not expected to occur with the requested agent OR The patient has an FDA labeled contraindication to ALL generic AND OTC intranasal corticosteroids that is not expected to occur with the requested agent AND The patient does NOT have any FDA labeled contraindications to the requested agent 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: The patient has been previously approved for the requested agent through the plan’s Prior Authorization process [Note: patients not previously approved for the requested agent will require initial evaluation review] AND The patient has had clinical benefit with the requested agent AND The patient does NOT have any FDA labeled contraindications to the requested agent Length of Approval: 12 months Note: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Module

Clinical Criteria for Approval

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

ONE of the following:
1. The patient has a diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) OR
2. The patient has a diagnosis of chronic rhinosinusitis without nasal polyps (CRSsNP) OR
3. The patient has another FDA labeled indication for the requested agent and route of administration AND
If the patient has an FDA labeled indication, then ONE of the following:
1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
2. There is support for using the requested agent for the patient’s age for the requested indication AND
ONE of the following:
1. The patient has tried and had an inadequate response after 90 days of therapy with ONE generic OR OTC intranasal corticosteroid OR
2. The patient has an intolerance or hypersensitivity to therapy with ONE generic or OTC intranasal corticosteroids that is not expected to occur with the requested agent OR
3. The patient has an FDA labeled contraindication to ALL generic AND OTC intranasal corticosteroids that is not expected to occur with the requested agent AND
The patient does NOT have any FDA labeled contraindications to the requested agent

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:

The patient has been previously approved for the requested agent through the plan’s Prior Authorization process [Note: patients not previously approved for the requested agent will require initial evaluation review] AND
The patient has had clinical benefit with the requested agent AND
The patient does NOT have any FDA labeled contraindications to the requested agent

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: The requested quantity (dose) does NOT exceed the program quantity limit OR The requested quantity (dose) exceeds the program quantity limit AND ONE of the following: BOTH of the following: The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication OR BOTH of the following: The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR BOTH of the following: The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication Length of Approval: up to 12 months

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:

The requested quantity (dose) does NOT exceed the program quantity limit OR
The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
1. BOTH of the following:
  1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
  2. There is support for therapy with a higher dose for the requested indication OR
2. BOTH of the following:
  1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
  2. There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR
3. BOTH of the following:
  1. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
  2. There is support for therapy with a higher dose for the requested indication

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 _