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    Choosing an
    alternative path
    to current nasal polyp
    treatment
    options with SINUVA

    Which of your patients may benefit from SINUVA?10

    Patients ≥ 18 years of age who:

    • Had previous ethmoid sinus surgery

    • Have nasal polyps

    Patients who meet these requirements and desire an alternative to revision sinus surgery to manage their worsening symptoms may find relief with SINUVA

    About Nasal Polyps
    The road to symptom relief
    can be difficult

    Nasal polyps develop by intrinsic mucosal inflammation that persists in the ethmoid sinuses1

    Symptoms include:

    • Decreased or absent sense of smell

    • Runny nose/post-nasal discharge

    • Facial pain/pressure

    • Nasal obstruction/congestion

    Recommended treatment options for patients with nasal polyps include saline nasal rinses, topical intranasal and oral corticosteroids1

    Challenges of current
    recommendations

    Topical intranasal corticosteroids
    • ~60% of active drug in a metered dose of nasal steroid spray is removed by mucociliary clearance within 15 minutes2

    • Only 32.7% of patients use intranasal corticosteroids as directed3

    Saline nasal rinses
    • Compared directly with topical nasal steroids, the benefits of saline irrigation alone are less pronounced1

    Oral corticosteroids
    • Regardless of dosage and length of treatment, oral corticosteroids carry known safety concerns associated with chronic systemic exposure4

    UNDERSTANDING
    the cyclical nature
    of nasal polyps

    Patients who fail to achieve symptom relief with medication management turn to endoscopic sinus surgery (ESS)

    Patients with nasal polyps require revision ESS more frequently than patients who do not have nasal polyps5,6

    >0,000 ESSs

    are performed in the US annually7

    Challenges of sinus surgery

    ESS for polyp removal is associated with higher blood loss than nonpolyp sinus surgery, with blood loss impairing visualization resulting in a riskier procedure5

    Surgical landmarks are often absent or distorted in revision ESS, making surgery more challenging and increasing risk for patients5

    Despite the use of steroids and endoscopic sinus surgery, recurrence of nasal polyps is common due to the inflammatory nature of the disease, resulting in the need for repeat surgery in patients over time5

    Key benefits of SINUVA

    • SINUVA is a novel implant with a 2-in-1 mechanism that offers patients with nasal polyps symptom relief via:

    • Targeted delivery of 1350 µg of mometasone furoate to the ethmoid nasal polyps10

    • Self-expanding, bioabsorbable design that softens over time10

    • Continuous delivery of mometasone furoate over the course of 90 days10

    • Localized drug delivery minimizes reliance on patient compliance

    • Administered in a non-surgical, in-office procedure with local anesthesia10

    Design of SINUVA10

    Width when crimped: 7.5 mm

    Nominal length
    of 20 mm

    SINUVA (7.5 mm)

    Dress Shirt Button (7 mm)

    Why mometasone furoate compared to alternative corticosteroid options?

    Mometasone furoate offers high potency and low systemic bioavailability11

    lipophilicity

    (absorption into tissue)

    glucocorticoid potency

    (remains in the tissue)

    systemic bioavailability

    (nominal systemic absorption)

    How does SINUVA work?10

    SINUVA is implanted in your sinus cavity amongst the nasal polyps to provide local delivery of a drug called mometasone furoate (a type of steroid). The implant has been shown to be effective in reducing symptoms nasal obstruction/congestion and nasal polyps.

    SINUVA creates
    a path to improvement

    by demonstrating positive
    efficacy data

    *Patients in the SINUVA group also received once daily mometasone furoate nasal spray daily.

    Co-primary endpoints: Change from baseline to Day 90 in bilateral polyp grade, as determined by an independent panel on a scale of 0 (no visible nasal polyps) to 4 (nasal polyps completely obstructing nasal cavity). Change from baseline to Day 30 in nasal obstruction/congestion score, as determined by patients on a scale of 0 (no symptoms) to 3 (severe symptoms).10

    Co-primary efficacy outcomes10,12,13*†

    In RESOLVE II (n=300), SINUVA patients experienced statistically significant reductions in bilateral polyp grade and nasal obstruction/congestion score

    0

    relative improvement in bilateral polyp grade from baseline to Day 90 compared to once daily mometasone furoate nasal spray alone

    • Mean change (SD) for SINUVA –0.56 (1.06) vs –0.15 (0.91) with control; P=0.0073

    0

    relative improvement in nasal obstruction/congestion score from baseline to Day 30 compared to once daily mometasone furoate nasal spray alone

    • Mean change (SD) for SINUVA –0.80 (0.73) vs –0.56 (0.62) with control; P=0.0074

    Secondary efficacy endpoints (baseline to Day 90)12,13‡

    • Reduced eligibility for repeat surgery

    • SINUVA placement resulted in a 61% reduction in the proportion of patients still indicated for repeat ESS vs 37% in the mometasone furoate nasal spray only arm at Day 90 (P=0.0004)

    • Delivered up to 90 days of sustained symptom relief

    • Patients treated with SINUVA experienced sustained symptomatic improvements in nasal obstruction/congestion at Day 90

    • Mean change (SD) for SINUVA –0.93 (0.80) vs –0.69 (0.79) with control (P=0.0248)

    • Significantly reduced sinus obstruction

    • Patients treated with SINUVA had a significantly greater decrease in percent ethmoid sinus obstruction at Day 90

    • Mean change (SD) for SINUVA –11.3 (18.1) vs –1.9 (14.4) with control (P=0.0007)

    • Improved patients' sense of smell

    • Patients treated with SINUVA experienced a significant improvement in their self-reported sense of smell score on a six-point Likert scale at Day 90

    • Mean change (SD) for SINUVA –1.20 (1.66) vs –0.76 (1.60) with control (P=0.0470)

    Patients treated with SINUVA did not experience a significant improvement in their self-reported facial pain and pressure score. The mean change (SD) for SINUVA was –0.77 (1.21) vs –0.90 (1.27) with control (P=0.9130)

    SD, standard deviation.

    Secondary endpoints: Proportion of patients still indicated for repeat ESS at Day 90 despite ongoing intranasal steroid use based on clinical investigator assessment using study-specific criteria. Change from baseline to Day 90 in nasal obstruction/congestion score, as determined by patients on a scale of 0 (no symptoms) to 3 (severe symptoms). Change in percent ethmoid sinus obstruction at Day 90, as determined by the independent, blinded panel on a 100-mm visual analogue scale (VAS). Decreased sense of smell and facial pain/pressure score change from baseline to Day 90, as determined by patients on a six point Likert scale of 0 (absent) to 5 (very severe). P-values for secondary endpoints were prespecified and adjusted for multiplicity.12

    RESOLVE II: Study design10,12

    Randomized, controlled, double-blind, multicenter study with 300 patients

    Study population:

    • ≥ 18 years of age
    • Diagnosed with chronic sinusitis
    • Had undergone prior bilateral total ethmoidectomy
    • Indicated for revision endoscopic sinus surgery
    • Presented with moderate to severe nasal obstruction/congestion symptoms and recurrent bilateral sinus obstruction due to sinonasal polyposis despite the use of intranasal corticosteroid sprays and recent high-dose steroids

    201 patients were randomized to the SINUVA treatment arm where they underwent bilateral placement of SINUVA in the ethmoid sinuses

    99 patients were randomized to the control arm where they received a sham procedure

    Patients in both study arms received once daily mometasone furoate nasal spray (200 µg) through day 90

    SINUVA
    safety data

    Adverse reactions with > 1% incidence rate and more common in treatment than the control group in combined data from Study 1 and Study 2

    ADVERSE REACTIONSSINUVA (n=254) n (%)CONTROL (Mometasone furoate nasal spray) (n=146) n (%)
    Asthma12 (4.7)6 (4.1)
    Headache9 (3.5)5 (3.4)
    Epistaxis6 (2.4)2 (1.4)
    Presyncope6 (2.4)3 (2.1)
    Bronchitis5 (2.0)2 (1.4)
    Otitis media5 (2.0)2 (1.4)
    Nasopharyngitis3 (1.2)1 (0.7)
    • In clinical trials, SINUVA demonstrated similar local effects and hypersensitivity reactions compared to once daily mometasone furoate nasal spray alone, with a low incidence of serious adverse events10,12

    • Patients on SINUVA did not experience any significant increase in intraocular pressure, glaucoma, or any form of cataract10

    Placement of the SINUVA Sinus Implant10

    Placement of the SINUVA Sinus Implant10

    The SINUVA Sinus Implant is loaded into a Delivery System and placed in the ethmoid sinus under endoscopic visualization. For the complete instructions on how to place SINUVA, see the Full Prescribing Information.

    The SINUVA Sinus Implant is made from bioabsorbable polymers designed to gradually soften over time. The implant was designed to gradually release the corticosteroid directly to the nasal polyps over a period of 90 days. Remove the SINUVA Sinus Implant at day 90 or earlier at the physician’s discretion using standard endoscopic instruments.10

    Preparing your patient
    for implantation
    of SINUVA10,12

    The patient should be prepared following routine protocols for in-office sinonasal endoscopic procedures.

    In the clinical study, topical or local anesthetic—such as sprays, pledgets, and cottonoids—was recommended in accordance with protocols for in-office sinonasal endoscopic procedures.

    In the clinical study, anesthesia injections were used as necessary.

    Note: Patients cannot remove SINUVA themselves. Advise the patient that the implant is bioabsorbable and intended to soften over time. Remove the implant at day 90 or earlier. As the implant softens and polyps decrease, the implant may be expelled out of the nose. If they experience excessive bleeding, pain, or a choking sensation in the throat, they should contact a physician immediately.

    Patient
    Resources

    The following resources can be used to provide your patients with information on SINUVA:

    Ordering
    SINUVA

    SINUVA implants can be obtained through two accessible avenues:

    • Specialty Distributor: providers can purchase SINUVA implants directly from a distributor listed below. If use is for a specific patient, obtaining prior authorization from the payor is recommended prior to ordering.

    • Specialty Pharmacies: SINUVA implants can be filled with a prescription at select specialty pharmacies and delivered directly to the provider.

    The Connect Support Program can assist with the acquisition process by researching and verifying patient insurance benefits for SINUVA.

    To utilize this service, complete the

    Patient Enrollment Form

    and fax it to 1-844-745-2358.

    For questions,

    call Connect directly at 1-833-4-SINUVA (1-833-474-6882)

    Connect Program Overview

    Coding
    SINUVA

    ICD-10 CODEDESCRIPTOR
    J33.0Polyp of nasal cavity
    J33.1Polypoid sinus degeneration
    J33.8Other polyp of sinus
    J33.9Nasal polyp, unspecified
    NDC NUMBERDESCRIPTOR
    10599000301SINUVA (mometasone furoate) sinus implant
    HCPCS CODEDESCRIPTOR
    J7401Mometasone Furoate sinus implant, 10 micrograms

    Download the Office Reimbursement Guide

    Download the Guide
    Ambulatory Surgery Center/Hospital Outpatient Surgery CodeDESCRIPTOR
    C9122Mometasone Furoate sinus implant, 10mcg
    Pass through status code for use with Fee For Service Medicare patients only

    Download the Pass Through Reimbursement Guide

    Download the Guide

    Billing units for J7401 or C9122 is 1 unit for every 10mcg = 135 units for unilateral placement of SINUVA or 270 units for bilateral placement of SINUVA.

    When billing Medicare with C9122, include the NDC number (10599-0003-01) on the claim form along with the CPT code to describe the services provided.

    SINUVA should not be billed directly by a provider if it is distributed via specialty pharmacy. Providers should always bill the most applicable CPT code for the procedure performed at the time of placement of SINUVA.

    Codes listed above are recommendations and do not guarantee payment or reimbursement.

    For additional SINUVA reimbursement support, please contact reimbursement@intersectent.com.

    For further information on the price of SINUVA, please contact Intersect ENT at 1-866-531-6004.


    Resources

    References:

    1. Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, et al. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015;152(2 Suppl):S1-S39.
    2. Shah SA, Berger RL, McDermott J, et al. Regional deposition of mometasone furoate nasal spray suspension in humans. Allergy Asthma Proc. 2015;36(1):48-57.
    3. Bender BG. Motivating patient adherence to allergic rhinitis treatments. Curr Allergy Asthma Rep. 2015;15(3):10.
    4. Campbell RG. Risks and management of long-term corticosteroid use in chronic rhinosinusitis. Curr Opin Otolaryngol Head Neck Surg. 2018;26(1):1-7.
    5. Hull BP, Chandra RK. Refractory Chronic Rhinosinusitis with Nasal Polyposis. Otolaryngol Clin North Am. 2017;50(1):61-81.
    6. Stein NR, Jafari A, DeConde AS. Revision rates and time to revision following endoscopic sinus surgery: A large database analysis. Laryngoscope. 2018;128(1):31-36.
    7. Data on File. MRG 2012 US Markets for ENT and Bronchoscopy.
    8. Wynn R, Har-El G. Recurrence rates after endoscopic sinus surgery for massive sinus polyposis. Laryngoscope. 2004;114(5):811-813.
    9. DeConde AS, Mace JC, Levy JM, et al. Prevalence of polyp recurrence after endoscopic sinus surgery for chronic rhinosinusitis with nasal polyposis. Laryngoscope. 2017;127(3):550-555.
    10. SINUVA [Prescribing Information]. Menlo Park, CA: Intersect ENT; 2017.
    11. Sastre J, Mosges R. Local and systemic safety of intranasal corticosteroids. J Investig Allergol. 2012;22(1):1-12.
    12. Kern RC, Stolovitzky JP, Silvers SL, et al. A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps. Int Forum Allergy Rhinol. 2018;8(4):471-481.
    13. Data on file, Intersect ENT, Inc. CR-00014; Supplemental Statistical Analyses Rev 1.0 January 17, 2018.

    INDICATION

    SINUVA Sinus Implant is a corticosteroid-eluting (mometasone furoate) implant indicated for the treatment of nasal polyps, in patients ≥ 18 years of age who have had ethmoid sinus surgery.

    IMPORTANT SAFETY INFORMATION

    CONTRAINDICATIONS

    Patients with a known hypersensitivity to mometasone furoate or any of the ingredients in SINUVA should not use SINUVA.

    WARNINGS AND PRECAUTIONS

    Local Effects: Monitor nasal mucosa adjacent to the SINUVA Sinus Implant for any signs of bleeding (epistaxis), irritation, infection, or perforation. Avoid use in patients with nasal ulcers or trauma.

    Ocular Effects: Monitor patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts closely.

    Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, and angioedema have been reported with the use of corticosteroids.

    Immunosuppression: Patients taking corticosteroids are more susceptible to a more serious or even fatal course of chickenpox or measles than healthy individuals. Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

    Hypercorticism and Adrenal Suppression: If corticosteroid effects such as hypercorticism and adrenal suppression appear in patients, consider sinus implant removal.

    There are no studies evaluating repeat implantation of the SINUVA Sinus Implant.

    ADVERSE REACTIONS

    The most common adverse reactions observed (> 1% of subjects and that occurred more frequently in the treatment group compared to control) in clinical studies were asthma, headache, epistaxis, presyncope, bronchitis, otitis media, and nasopharyngitis.

    Rx only. Please see Full Prescribing Information. for SINUVA.

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