ph-1145
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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.

Xhance Prior Authorization with Quantity Limit

TARGET AGENT(S)

Xhance® (fluticasone 93 mcg/actuation)

Brand (generic)

GPI

Multisource Code

Quantity Limit (per day or as listed)

Xhance (fluticasone 93 mcg/actuation)

93 mcg/actuation (16 mLs, 120 sprays)

4220003230G720

M, N, O, or Y

32 mL (2 bottles)/30 days

PRIOR AUTHORIZATION 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’s age is within FDA labeling for the requested indication for the requested agent

OR

    1. The prescriber has provided information in support of using the requested agent for the patient’s age

AND

  1. ONE of the following:
    1. The patient has a diagnosis of nasal polyps

OR

    1. The patient has another FDA approved indication for the requested agent and route of administration

AND

  1. 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

    1. 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

    1. The patient has an FDA labeled contraindication to ALL generic OR OTC intranasal corticosteroids that is not expected to occur with the requested agent

AND

  1. The patient does NOT have any FDA labeled contraindications to the requested agent

AND

  1. ONE of the following:
    1. The requested quantity (dose) does NOT exceed the program quantity limit

OR

    1. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication

AND

      1. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

OR

    1. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

      1. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication

AND

      1. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months

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

  1. The patient has had clinical benefit with the requested agent (e.g., decrease in nasal congestion, decrease in pain, decrease in pressure, decrease in rhinorrhea, increased sense of smell, decrease in nasal polyps)

AND

  1. The patient does NOT have any FDA labeled contraindications to the requested agent

AND

  1. ONE of the following:
    1. The requested quantity (dose) does NOT exceed the program quantity limit

OR

    1. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication

AND

      1. The requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit

OR

    1. ALL of the following:
      1. The requested quantity (dose) is greater than the program quantity limit

AND

      1. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication

AND

      1. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval: 12 months

FDA APPROVED INDICATIONS AND DOSAGE1

Agent(s)

Indication(s)

Dosage

Xhance®

(fluticasone 93 mcg/actuation)

Treatment of nasal polyps in patients 18 years of age or older

One or two sprays in each nostril twice daily.

CLINICAL RATIONALE

Chronic Rhinosinusitis with Nasal Polyposis

Chronic rhinosinusitis with nasal polyposis (CRSwNP) is an inflammatory condition affecting the paranasal sinuses. 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 in addition to nasal polyps and sinonasal inflammation.2-4 Sinus computed tomography (CT) and/or nasal endoscopy are needed to determine the presence of sinonasal inflammation and nasal polyps.  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 in which medical therapy is ineffective.2,3  

Efficacy1

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.

Xhance 186 mg bid

Xhance 372 mg bid

Placebo

Diff (95% CI) Xhance 186 mg bid vs Placebo

Diff (95% CI) Xhance 372 mg bid vs Placebo

Trial 1

Baseline nasal congestion

2.24

2.29

2.31

-0.30 (-0.48, -0.11)

-0.38 (-0.57, -0.19)

LS mean change from baseline at week 4

-0.54

-0.62

-0.24

Baseline total bilateral polyp grade

3.9

3.7

3.8

-0.59 (-0.93, -0.24)

-0.62 (-0.96, -0.27)

LS mean change from baseline at week 16

-1.03

-1.06

-0.45

Trial 2

Baseline nasal congestion

2.20

2.25

2.29

-0.45 (-0.64, -0.25)

-0.38 (-0.58, -0.18)

LS mean change from baseline at week 4

-0.68

-0.62

-0.24

Baseline total bilateral polyp grade

3.9

3.9

3.8

-0.60 (-0.89, -0.31)

-0.80 (-1.08, -0.51)

LS mean change from baseline at week 16

-1.22

-1.41

-0.61

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.

Safety1

Xhance is contraindicated in patients with a hypersensitivity to any ingredient.

REFERENCES

  1. Xhance prescribing information. OptiNose US, Inc. September 2017.
  2. Stevens, W. W., Schleimer, R. P., & Kern, R. C. (2016). Chronic Rhinosinusitis with Nasal Polyps. The journal of allergy and clinical immunology. In practice4(4), 565–572. doi:10.1016/j.jaip.2016.04.012.
  3. Sedaghat, A. R., MD., PhD. (2017). Chronic Rhinosinusitis. American Family Physicians, 96(8), 500-506. Retrieved July 1, 2019, from https://www.aafp.org/afp/2017/1015/p500.html.
  4. Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, et al. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015; 152(2 suppl): S1-S39.

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 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.

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