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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 |
4/1/2023 |
7/1/2021 |
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Xhance® (fluticasone 93 mcg/actuation) Nasal spray |
Treatment of nasal polyps in patients 18 years of age or older |
|
1 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Chronic Rhinosinusitis with Nasal Polyposis |
Chronic rhinosinusitis with nasal polyposis (CRSwNP) 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 CRSwNP consists of nasal saline irrigation in combination with intranasal corticosteroids.(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) |
Efficacy |
The efficacy of Xhance was evaluated in two randomized, double-blind, parallel group, multicenter, placebo-controlled, dose-ranging trials in adults 18 years and older with nasal polyps and associated moderate to severe nasal congestion (NCT 01622569, NCT 01624662). The two trials included a total of 646 subjects. Subjects were randomized 1:1:1:1 to receive 93 mcg, 186 mcg, or 372 mcg twice daily or placebo for a period of 16 weeks. At baseline 90.6% of patients reported previous use of a topical steroid nasal spray for the treatment of nasal polyps. The co-primary efficacy endpoints were 1) change from baseline to Week 4 in nasal congestion/obstruction averaged over the preceding 7 days of treatment and 2) change from baseline to Week 16 in bilateral polyp grade. Nasal congestion was rated by the patient on a 0 to 3 categorical severity scale at the time immediately prior to the next dose (instantaneous). Polyp grade was determined by the clinician using nasal endoscopy. Polyps on each side of the nose were graded on a categorical scale. Efficacy was demonstrated for both Xhance 186-mcg twice daily and Xhance 372-mcg twice daily. Onset of action, evaluated by determining the starting period that the treatment effect of Xhance on daily instantaneous AM congestion score started to achieve statistical significance in comparison to placebo and roughly maintained thereafter, was generally observed within 2 weeks for both Xhance doses.(1) |
Safety |
Xhance is contraindicated in patients with a hypersensitivity to any ingredient.(1) |
REFERENCES
Number |
Reference |
1 |
Xhance prescribing information. OptiNose US, Inc. April 2021. |
2 |
Stevens, W. W., Schleimer, R. P., & Kern, R. C. (2016). Chronic Rhinosinusitis with Nasal Polyps. The journal of allergy and clinical immunology. In practice, 4(4), 565–572. doi:10.1016/j.jaip.2016.04.012. |
3 |
Sedaghat, A. R. (2017). Chronic Rhinosinusitis. American Family Physicians, 96(8), 500-506. |
4 |
Rosenfeld, R.M., Piccirillo, J.F., Chandrasekhar, S.S., Itzhak, B., Kumar, K. A., Kramper, M., Orlandi, R. R., Palmer, J. N., Patel, Z. M., Peters, A., Walsh, S. A., Corrigan, M. D. (2015). Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015; 152(2 suppl): S1-S39. |
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Preferred Status |
Effective Date |
|
||||||
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 |
Days Supply |
Duration |
Addtl QL Info |
Allowed Exceptions |
Targeted NDCs When Exclusions Exist |
Effective Date |
|
||||||||||
Xhance |
Fluticasone Propionate Nasal Exhaler Susp 93 MCG/ACT |
93 MCG/ACT |
2.0 |
BOTTS |
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 |
|
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, see Quantity Limit criteria.
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, see 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: 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.
Commercial _ PS _ Xhance Prior Authorization with Quantity Limit _ProgSum_ 4/1/2023