Learn more
about SINUVA!

No, thanks!

Thanks for signing up!

Intersect is now part of Medtronic
I AM A HEALTH CARE PROFESSIONAL
I AM NOT A HEALTH CARE PROFESSIONAL

The information on this site is intended for health care professionals in the United States, its territories, and Puerto Rico, and is not intended for the general public.

Please rotate your device

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 CRS with 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

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

*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

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 (%)
Asthma 12 (4.7) 6 (4.1)
Headache 9 (3.5) 5 (3.4)
Epistaxis 6 (2.4) 2 (1.4)
Presyncope 6 (2.4) 3 (2.1)
Bronchitis 5 (2.0) 2 (1.4)
Otitis media 5 (2.0) 2 (1.4)
Nasopharyngitis 3 (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:

Patient Information Patient Brochure

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

Effective April 1, 2021

The Centers for Medicare and Medicaid Services (CMS) has made the following changes to the HCPCS code set:

New J-Code for SINUVA

(Mometasone furoate sinus implate, 1350 mcg):

J7402

"Mometasone furoate sinus implant, (sinuva), 10mcg"
ICD-10 CODE DESCRIPTOR
J33.0 Polyp of nasal cavity
J33.1 Polypoid sinus degeneration
J33.8 Other polyp of sinus
J33.9 Nasal polyp, unspecified
NDC NUMBER DESCRIPTOR
10599000301 SINUVA (mometasone furoate) sinus implant
HCPCS CODE DESCRIPTOR
J7402 Mometasone Furoate sinus implant, 10 micrograms

Billing units for J7402 is 1 unit for every 10mcg = 135 units for unilateral placement of SINUVA or 270 units for bilateral placement of SINUVA.

When billing, 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 rs.entusreimbursement@medtronic.com.

Resources

Patient Resources

Patient Information Patient Brochure

Connect Support Program

Connect Program Overview Connect Patient Enrollment Form

Coding and Billing

Office Reimbursement Guide

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.

Intersect ENT and SINUVA are registered trademarks of Intersect ENT, Inc. in the United States and other countries.

©2024 Intersect ENT, Inc. All rights reserved.

MPM-11511 Rev. 10.0 03/23

INDICATION

SINUVA Sinus Implant is a corticosteroid-eluting implant indicated for the treatment of chronic rhinosinusitis with nasal polyps in adult patients ≥ 18 years of age who have had ethmoid sinus surgery.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Patients with known hypersensitivity to mometasone furoate and any of the ingredients of the SINUVA Sinus Implant.

WARNINGS AND PRECAUTIONS

Local Nasal Adverse Reactions: 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.

Glaucoma and Cataracts: Nasal steroids may result in development of glaucoma and/or cataracts. Glaucoma, cataracts, and clinically significant elevation of intraocular pressure were not observed in patients from the treatment group of one randomized controlled clinical study (N = 53) who underwent bilateral placement of SINUVA Sinus Implants. Close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

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

Immunosuppression and Risk of Infections: Persons who are using drugs that suppress the immune system, such as corticosteroids, including SINUVA Sinus Implant are more susceptible to infections than healthy individuals. The safety and effectiveness of SINUVA Sinus Implant have not been established in pediatric patients less than 18 years of age and SINUVA is not indicated for use in this population. 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.

ADVERSE REACTIONS

The most common adverse reactions observed (> 1% of subjects) in clinical studies were asthma, headache, epistaxis, presyncope, bronchitis, otitis media, and nasopharyngitis.

POSTMARKETING EXPERIENCE

The following adverse reactions have been identified during post-approval use of the SINUVA sinus implant. These events include implant migration, lack of efficacy, nasal pain, headache, epistaxis.

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

Learn more
about SINUVA!

Click here to subscribe:

STAY INFORMED
SINUVA