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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
REACTIONS
SINUVA
(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. The SINUVA Sinus Implant should be removed 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. The implant may be removed 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 ASCENT Reimbursement 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 ASCENT directly at 1-833-4-SINUVA
(1-833-474-6882)

Ascent Program Overview

To obtain SINUVA for patients using a Specialty Pharmacy or Specialty Distributor, complete the required Enrollment Form and submit directly to the Specialty Pharmacy or Specialty Distributor of choice.

Disclaimer: Intersect ENT does not recommend the use of any particular specialty distributor or specialty pharmacy. This information is provided for reference purposes only and all decisions are at the discretion of the physician and their practice.

Note: Evaluation units (samples) of SINUVA are not available.

Coding
SINUVA

ICD-10 CODEDESCRIPTOR
J33.0Polyp of nasal cavity
J33.1Polypoid sinus degeneration
J33.8Other polyp of sinus
J33.9Nasal polyp, unspecified
HCPCS CODEDESCRIPTOR
J3490Unclassified drugs
NDC NUMBERDESCRIPTOR
10599-0003-01SINUVA (mometasone furoate) sinus implant

SINUVA cannot be billed as a product if distributed via a specialty pharmacy or with a specific procedure code. Providers should bill for the procedure being performed at the time of the placement of SINUVA.

Multiple SINUVA implants should be reported as units. Multiple procedure modifiers do not apply to HCPCS Codes.

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

Download the reimbursement guide

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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