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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:

  1. ONE of the following:
    1. The patient has a diagnosis of nasal polyps OR
    2. The patient has another FDA approved indication for the requested agent AND
  2. ONE of the following:
    1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
    2. The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication AND
  3. 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 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
  4. The patient does NOT have any FDA labeled contraindications to the requested agent

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:

  1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
  2. The patient has had clinical benefit with the requested agent (e.g., decreased nasal congestion, pain, pressure, rhinorrhea, nasal polyp size; increased sense of smell) AND
  3. The patient does NOT have any FDA labeled contraindications to the requested agent

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:

  1. The requested quantity (dose) does NOT exceed the program quantity limit OR
  2. ALL of the following:
    1. The requested quantity (dose) is greater than the program quantity limit AND
    2. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
    3. 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. ALL of the following:
    1. The requested quantity (dose) is greater than the program quantity limit AND
    2. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND
    3. The prescriber has provided information in support of therapy with a higher dose for the requested indication

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